tag:blogger.com,1999:blog-46874532858368971532024-03-13T08:18:59.171-05:00BSE INQUIRYThe BSE Inquiry's report was published as a Return to an order of the Honourable House of Commons dated October 2000 for the Report, evidence and supporting papers of the Inquiry into the emergence and identification of Bovine Spongiform Encephalopathy (BSE) and varient Creutzfeld-Jakob Disease (vCJD) and the action taken in response to it up to 20 March 1996.Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.comBlogger16125tag:blogger.com,1999:blog-4687453285836897153.post-32058055459624011652023-03-19T16:08:00.004-05:002023-03-19T16:19:46.063-05:00Abandoned factory ‘undoubtedly’ contains dormant Mad Cow Disease that could threaten humans, Thruxted Mill, Queniborough CJD<p><span style="background-color: white; font-family: arial; font-size: 16px;">Abandoned factory ‘undoubtedly’ contains dormant Mad Cow Disease that could threaten humans</span></p><div data-setdir="false" dir="ltr" style="background-color: white; font-family: arial; font-size: 16px; outline: none;"><div style="outline: none;"><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Thruxted Mill was one of five UK sites where Mad Cow infected cattle were destroyed. Now, a University of Kent professor warns human activity must never be encouraged there</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Pol Allingham SWNS</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">An abandoned factory “undoubtedly” contains dormant and dangerous Mad Cow Disease that could threaten humans, scientists have warned.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Thruxted Mill was one of five UK sites where Mad Cow infected cattle were destroyed.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Scientists warned against housing developments on the land, in a paper claiming the derelict seven-acre Kent complex may still be a safety threat today. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"> The “dreadful” horror movie-like setting has remained untouched for around 16 years, but that has not deterred prospective residential contractors from trying to build 20 homes there.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Professor Alan Colchester, University of Kent, said human activity must never be encouraged near the mill and surrounding woodlands.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The consultant neurologist believes the plant remains a threat because the molecules that cause Bovine Spongiform Encephalopathy (BSE) are extremely difficult to destroy and can incubate for several years.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Recommended ‘Grief is a strange thing to bond over’: Jon Pointing on Big Boys, British comedy and breaking stereotypes ‘Grief is a strange thing to bond over’: Jon Pointing on Big Boys, British comedy and breaking stereotypes Unusually high cancer rates found in military pilots and ground crews Unusually high cancer rates found in military pilots and ground crews ‘My daughter refused to eat solids – so I took matters into my own hands’ ‘My daughter refused to eat solids – so I took matters into my own hands’ The former animal-rendering plant, where animal waste is turned into usable materials, sits in an Area of Outstanding Beauty between Ashford and Canterbury.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">A user of urban exploring forum ‘28DaysLater.co.uk’ - named after the zombie film - claimed they visited the “wide open” site in May last year.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">RXQueen said: “I’ve smelled/smelt some bad things in my times exploring but nothing, absolutely nothing, will beat this place. It was a mix of blood, rust, decay, oil, pigeon shit and death.” </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The blogger reported finding animal bones beneath the old grinders.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">During the 1990s and noughties, truckloads of animal remains were ferried to the site where machines split fat and protein residue from the bone.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Piles of carcasses were reportedly dumped in the yard area repeatedly, leaving a foul smell hanging over the countryside. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Chunks of dead cattle were often littered across surrounding roads. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">(KMG / SWNS) A lost lorry heading to the mill spilled tongues and lumps of a bladder the size of a football on a village residential street nearby.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">At the time, villager Peter Hancox said: “I have lived here for about six years and we have frequently had fluid spillages, but this was one lump of guts too far. The smell was horrible.”</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Nonetheless, in 2017 developers hoped to decontaminate the site and build 20 homes with an estimated cost of £1.75 million.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Professor Colchester said: “The site is a biohazard.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">“It’s always been known that the infected agents for Mad Cow Disease are incredibly resistant to normal decay and destruction and there will undoubtedly be some long-term contamination in the soil.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">“The point is that there are various ways you could come into contact with it.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">“The worst-case scenario is that you could transmit the illness to animals or humans from environmental materials that have themselves been infected in the past. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">(KMG / SWNS) “And with CJD, we’re talking about a seriously long incubation period - from a few months to several years.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">“Infected remains were left lying around and contaminated material is probably still lying in large quantities in the soil.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">“Nothing should be done to encourage human activity around Thruxted Mill or the surrounding woodlands.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">“If you have places in an urban environment that has contamination, then there might be a case that we should tarmac it over completely.”</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Passed onto humans, the disease caused memory loss, personality changes, abnormal jerking movements, loss of brain function, and loss of mobility.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Pitching the 2017 housing scheme, developers stressed soil studies showed evidence of matter including asbestos, metals, petroleum, oils and fats. But no microbiological species such as anthrax or salmonella were found.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Ashford Borough Council gave the 2017 housing scheme the green light, admitting the site “had the most dreadful legacy.”</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">But plans were scrapped following a legal battle launched by disgruntled resident Camillia Swire, on the grounds they lacked expert evidence.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Ms Swire’s daughter Eleanor worked on the recent study with Professor Colchester on his paper “Out of sight, out of mind? BSE 30 years on.”</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Thruxted Mill is thought to have been originally developed as a saw mill in the 1960s and transformed into the animal-rendering plant by Canterbury Mills Ltd.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Documents on Companies House show the firm was dissolved in 2010, two years after the factory was closed.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">A spokesman for the Department for Environment, Food and Rural Affairs said: “To prevent risks of spreading disease from residues in the soil, groundwater or air pollution, the burial or burning of fallen stock, including all farmed animals, in the open has been banned since 2003.</div></div><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="background-color: white; font-family: arial; font-size: 16px; outline: none;"><a href="https://www.independent.co.uk/news/science/kent-factory-mad-cow-disease-b2303929.html" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://www.independent.co.uk/news/science/kent-factory-mad-cow-disease-b2303929.html</a><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="background-color: white; font-family: arial; font-size: 16px; outline: none;"><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="background-color: white; font-family: arial; font-size: 16px; outline: none;"><div style="outline: none;"><div style="outline: none;">Knacker's yard link to Queniborough nvCJD cluster </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Sun, 13 Aug 2000 </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Jonathan Leake and Dipesh Gadher Sunday Times Additional reporting: Graham Hind BRITAIN'S worst outbreak of the human form of mad-cow disease may be linked to a nearby knacker's yard that sold meat from diseased animals. The yard operated just eight miles from Queniborough, the Leicestershire village where health officials are investigating the first known cluster of CJD cases. Three people who spent time in the village died from CJD in 1998, and a fourth person is suspected of having the degenerative brain disease. Another victim lived just three miles away.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The possible link to the knacker's yard - which recycled animals unfit for human consumption into pet food and other products - dates back 20 years, to about the time when scientists now believe the BSE epidemic may have begun.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Two meat traders from Bedfordshire were convicted in 1982 of buying unapproved beef from W E Mason & Sons of Wigston, near Leicester, and selling it to an unsuspecting butcher in Hertfordshire.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Last week officials seized council documents and court reports relating to the company to determine whether any unfit meat may have entered the human food chain locally.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">"We have had a very useful series of conversations about this with Oadby and Wigston council," said Philip Monk, a consultant in communicable disease control at Leicestershire health authority, who is heading the Queniborough investigation. "I am ruling nothing in and nothing out. Anything we have that is potentially helpful in explaining local meat trading practices has to be examined."</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The case heard by Leicester magistrates in 1982 was the culmination of Operation Meat Hook, a joint investigation between detectives and environmental health officers from three counties.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The teams covertly observed Peter Fletcher, a partner in a wholesale butcher's business near Dunstable, on four occasions in 1980 when he visited Leonard Mason, the yard's owner. He loaded beef carcasses from the yard into an un-marked van, which had been contaminated by a cow's head "fouled by stomach contents", according to evidence given in court. One of the carcasses was later found to have been infected with pleurisy.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Fletcher marked the meat with a fake inspector's stamp, and then left it with a retail butcher near Hemel Hempstead, Hertfordshire.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">"A knacker's yard may, and frequently will, deal with diseased cattle," the prosecutor had told an earlier hearing. "Meat may be partly decomposed and contaminated. Disease is rife in such premises and could include anthrax and tuberculosis."</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Fletcher was jailed for three months and fined £500. His partner, Francis Fensome, received a suspended prison sentence. Mason was cleared after telling the court that he had been told the meat was to be used to feed animals at Whipsnade zoo [site of two cheetah BSE fatalities -- webmaster]</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The knacker's yard, which had been run by the Mason family since 1947, was closed the same year and now stands derelict. Mason has since died.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Last week his brother, Jack Mason, said: "I am confident there is no connection with us and the outbreak in Queniborough. Most of the meat went to zoos. Any meat that was sold locally went to dog owners as pet food."</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">There is no proof that Mason dealt in cattle infected with BSE, which was not recognised at the time. But such yards commonly dealt in "downer" cows - those displaying symptoms of illness - so any animals that did have BSE were likely to have ended up in such places.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The Queniborough inquiry team is also examining slaughtering techniques at Leicestershire abattoirs and childhood eating habits of those who grew up in the village, although school meals have been ruled out as a possible cause of the CJD outbreak.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Arthur Beyless lost his daughter, Pamela, 24, a bank worker, to the disease after a two-year struggle for survival. Although the Beylesses live in nearby Glenfield, Pamela regularly visited her grandparents in Queniborough and the family often bought meat from Ian Bramley, the village butcher, in the late 1970s and early 1980s.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Beyless said: "On one occasion I was buying some meat when Ian told me he'd got it for 'a good deal'. It does make you wonder when you consider this theory about the knacker's yard. This disease is something that might never have happened if people weren't always grasping for that last penny."</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The other two named victims with links to Queniborough are Stacey Robinson, 19, who lived there for 12 years before moving to another part of the county, and Glen Day, 34, who worked on a farm in the area. He regularly ate at the Horse and Groom pub, which was supplied with meat by Bramley.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Bramley died in a car crash. His stepmother, Hazel Bramley, said she knew nothing about Mason's yard. "We bought our meat directly from local farmers," she said. "The animals were slaughtered in Leicester and delivered to us. I don't know anything about this place in Wigston."</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Bovine spongiform encephalopathy: Epidemiological studies</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The Veterinary Record, December 17, 1988 J.W. Wilesmith, G.A.H.Wells, M.P. Cranwell, J.B.M. Ryan</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">"There was no clear or single explanation why, in 1982, cattle apparently became first exposed to a transmissible agent sufficiently to result in clinical disease. A number of factors have been identified which when combined are undoubtedly significant in the occurrence of this epidemiological phenomenon. These include; a dramatic increase in the sheep population in Great Britain which commenced in 1980 and has continued (MAFF 1988); a probable increase in the presence of scrapie infected flocks (J.W. Wilesmith unpublished data); the greater inclusion of sheep heads in material for rendering; the greater inclusion of casualty and condemned sheep in material for rendering as a result of the reduction in the number of knackers' yards; the introduction of continuous rendering processes during the 1970's and 1980's which may have resulted in the rendering of animal material at a lower temperature and, or, a shorter time than previously and the decline in the practice of using hydrocarbon solvents and terminal heat treatment for fat extraction since the mid 1970s (MMC 1985)...."</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="http://www.mad-cow.org/00/aug00_late_news.html#aaa" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://www.mad-cow.org/00/aug00_late_news.html#aaa</a><br style="outline: none;" /></div></div><div style="outline: none;"><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="outline: none;"><div style="outline: none;"><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">Tue, 8, Aug 2000 19:39:27 -0400</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">From: jonathan leake</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">Date: Tue, 8, Aug 2000 19:39:27 -0400</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">Subject: IN CONFIDENCE (I SMELL A STORY ......)</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">Sender: jonathan leake</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">To: BSE Terry Singletary</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">Hi Terry - this is Jonathan Leake here. we're thinking of doing a story on the knackers yard meat issue - is there a link to Queniborough? Would you mind resending any info you have on this - I may have lost some of the stuff you sent.</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">Cd you send it to </span><a href="mailto:tojonathan.leake@suandy-times.co.ukAND" rel="nofollow" shape="rect" style="color: #196ad4; font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; outline: none;" target="_blank">jonathan.leake@suandy-times.co.uk</a></div><div style="outline: none;"><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="outline: none;">AND</div><div data-setdir="false" dir="ltr" style="outline: none;"><br clear="none" style="outline: none;" />to <a href="mailto:TOdipesh.gadher@sunday-times.co.uk-" rel="nofollow" shape="rect" style="color: #196ad4; font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; outline: none;" target="_blank">dipesh.gadher@sunday-times.co.uk-</a><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"> </span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">HE'S RESEARCHING THIS STORY FOR ME AS I'M AT A CONFERENCE MANY THANKS FOR YOUR HELP - AND FOR ALL THE GOOD WORK YOU'VE BEEN DOING</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">snip...end...TSS</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">=====</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">Re: IN CONFIDENCE (I SMELL A STORY )</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">Subject: Re: IN CONFIDENCE (I SMELL A STORY )</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">Date: Tue, 08 Aug 2000 21:41:57 -0700</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">From: "Terry S. Singeltary Sr."</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">To: jonathan leake</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">Hello Jonathan, yes, give me some time though. there is a shitstorm on CJD Voice, they let the Faillace's on the CJD Voice support group (TSE tainted sheep farmers)without telling anyone; and myself and other are pissed off to say the least. This was suppose to be a support group. i told them it would be like asking the Malboro Man on a Cancer List. But he is Dead. Maybe it struck a nerve. Have you got the DFA 4, 5, and 7, i thought i read something about knackers or maybe baby foods??? not sure. i can send to you. I am sure i have something in the GBR's for the states and the other countries,</span><br clear="none" style="font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; outline: none;" /><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">don't have time to read. you can read them at;</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><a href="http://europa.eu.int/comm/food/fs/sc/ssc/outcomeen.html#reports" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://europa.eu.int/comm/food/fs/sc/ssc/outcomeen.html#reports</a></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">i will search as soon as i get time ....</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">kind regards, Terry</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">jonathan leake wrote: </span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">Hi Terry - this is Jonathan Leake here. we're thinking of doing a story on the knackers yard meat issue - is there a link to Queniborough? Would you mind resending any info you have on this - I may have lost some of the stuff you sent.</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">snip...END...TSS</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">Re: KNACKERS AND RENDERS</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">Subject: Re: KNACKERS AND RENDERS</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">Date: Thu, 10 Aug 2000 16:04:14 ·0700</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">From: "Terry S. Singeltary Sr."</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">To: jonathan.leake@sunday-times.co.uk, </span><a href="mailto:dipesh.gadher@Sunday-times.co.ukdo" rel="nofollow" shape="rect" style="color: #196ad4; font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; outline: none;" target="_blank">dipesh.gadher@Sunday-times.co.ukdo</a><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"> you have access to the; The Veterinary-Record, December 20/27, 1997 Papers and Articles Effect of rendering procedures on the scrapie agent D. M. Taylor, S.L. Woodgate, A.J.Fleetwood, R.J.G. Cawthorne it's about 6 or 7 pages. i do not have its canned and it's fairly fine print, however good print. </span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">also the report; The Veterinary Record, March 2, 1991 Papers </span><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">and Articles Bovine Spongiform Encephalopathy: epidemiological studies on the origin there is a good section of rendering; Survey of rendering processes, solvents etc (very detailed on temps and processes) can scan copy correct and paste, but it will take some time, or fax COLLECT to you. I'm running out of quarters fast, nobody paying me to do this, and i am on disablility. so the fax will have to be collect ... regards, Terry</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">1 of 1 8/13/00 1 :06 PM</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">end...TSS</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">Date: Fri, 2 Mar 2001 23:27:10 +0000 (GMT)From:</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">Subject: confidential</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">T</span><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">o: "Terry S. Singeltary Sr.</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">"Okay, you need to know. You don't need to pass it on as nothing will come of it and there is not a damned thing anyone can do about it. Don't even hint at it as it will be denied and laughed at..........</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">USDA is gonna do as little as possible until there is actually a human casein the USA of the nvcjd........</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">if you want to move this thing along and shake the earth....</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">then we gotta get the victims families to make sure whoever is doing the</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">autopsy is credible, trustworthy, and a saint with the courage of Joan of Arc........</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">I am not kidding!!!! so, unless we get a human death from EXACTLY the same form with EXACTLY the same histopath lesions as seen in the UK nvcjd........</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">forget any action........</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">it is ALL gonna be sporadic!!!And, if there is a case.......</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">there is gonna be every effort to link it to international travel, international food, etc. etc. etc. etc. etc. They will go so far as to find out if a sex partner had ever traveled to the UK/europe, etc. etc. ....</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">It is gonna be a long, lonely, dangerous twisted journey to the truth. They have all the cards, all the money, and are willing to threaten and carry out those threats....</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">and this may be their biggest</span><br clear="none" style="font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; outline: none;" /><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">downfall.</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">=====</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">snip...</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><a href="http://web.archive.org/web/20030516051623/http://www.bseinquiry.gov.uk/files/mb/m09/tab05.pdf" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://web.archive.org/web/20030516051623/http://www.bseinquiry.gov.uk/files/mb/m09/tab05.pdf</a><br style="outline: none;" /></div><div style="outline: none;"><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="outline: none;">new url;</div><div data-setdir="false" dir="ltr" style="outline: none;"><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="outline: none;"><a href="http://web.archive.org/web/20090506002258/http://www.bseinquiry.gov.uk/files/mb/m09/tab05.pdf" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://web.archive.org/web/20090506002258/http://www.bseinquiry.gov.uk/files/mb/m09/tab05.pdf</a><br style="outline: none;" /></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><a href="http://collections.europarchive.org/tna/20080102161333/http://www.bseinquiry.gov.uk/files/yb/1976/10/12004001.pdf" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://collections.europarchive.org/tna/20080102161333/http://www.bseinquiry.gov.uk/files/yb/1976/10/12004001.pdf</a><br style="outline: none;" /></div><div style="outline: none;"><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="outline: none;">new url;</div><div data-setdir="false" dir="ltr" style="outline: none;"><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="outline: none;"><a href="http://web.archive.org/web/20090505234749/http://www.bseinquiry.gov.uk/files/yb/1976/10/12004001.pdf" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://web.archive.org/web/20090505234749/http://www.bseinquiry.gov.uk/files/yb/1976/10/12004001.pdf</a><br style="outline: none;" /></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><a href="http://web.archive.org/web/20040823105233/www.bseinquiry.gov.uk/files/yb/1988/10/00001001.pdf" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://web.archive.org/web/20040823105233/www.bseinquiry.gov.uk/files/yb/1988/10/00001001.pdf</a><br style="outline: none;" /></div><div style="outline: none;"><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="outline: none;">new url;</div><div data-setdir="false" dir="ltr" style="outline: none;"><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="outline: none;"><a href="http://web.archive.org/web/20090505234344/http://www.bseinquiry.gov.uk/files/yb/1988/10/00001001.pdf" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://web.archive.org/web/20090505234344/http://www.bseinquiry.gov.uk/files/yb/1988/10/00001001.pdf</a><br style="outline: none;" /></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><a href="http://collections.europarchive.org/tna/20080102172428/http://www.bseinquiry.gov.uk/files/sc/seac17/tab03.pdf" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://collections.europarchive.org/tna/20080102172428/http://www.bseinquiry.gov.uk/files/sc/seac17/tab03.pdf</a><br style="outline: none;" /></div><div style="outline: none;"><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="outline: none;">new url;</div><div data-setdir="false" dir="ltr" style="outline: none;"><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="outline: none;"><a href="http://web.archive.org/web/20090506010328/http://www.bseinquiry.gov.uk/files/sc/seac17/tab03.pdf" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://web.archive.org/web/20090506010328/http://www.bseinquiry.gov.uk/files/sc/seac17/tab03.pdf</a><br style="outline: none;" /></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><a href="http://collections.europarchive.org/tna/20080102193705/http://www.bseinquiry.gov.uk/files/mb/m11b/tab01.pdf" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://collections.europarchive.org/tna/20080102193705/http://www.bseinquiry.gov.uk/files/mb/m11b/tab01.pdf</a><br style="outline: none;" /></div><div style="outline: none;"><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="outline: none;">new url;</div><div data-setdir="false" dir="ltr" style="outline: none;"><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="outline: none;"><a href="http://web.archive.org/web/20090506002237/http://www.bseinquiry.gov.uk/files/mb/m11b/tab01.pdf" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://web.archive.org/web/20090506002237/http://www.bseinquiry.gov.uk/files/mb/m11b/tab01.pdf</a><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">snip...</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">for anyone interested, see full text ;</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">Thursday, July 08, 2010</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">GLOBAL CLUSTERS OF CREUTZFELDT JAKOB DISEASE - A REVIEW 2010</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">----- Original Message -----</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">From: Terry S. Singeltary Sr.</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">To: CJD-L@LISTS.AEGEE.ORG</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">Cc: </span><a href="mailto:BSE-L@LISTS.AEGEE.ORG" rel="nofollow" shape="rect" style="color: #196ad4; font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; outline: none;" target="_blank">BSE-L@LISTS.AEGEE.ORG</a><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"> ; </span><a href="mailto:cjdvoice@yahoogroups.com" rel="nofollow" shape="rect" style="color: #196ad4; font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; outline: none;" target="_blank">cjdvoice@yahoogroups.com</a><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"> ; BLOODCJD@YAHOOGROUPS.COM</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">Sent: Thursday, July 08, 2010 9:27 PM</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">Subject: GLOBAL CLUSTERS OF CREUTZFELDT JAKOB DISEASE - A REVIEW</span><br clear="none" style="font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; outline: none;" /><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">2010</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/07/global-clusters-of-creutzfeldt-jakob.html" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://creutzfeldt-jakob-disease.blogspot.com/2010/07/global-clusters-of-creutzfeldt-jakob.html</a></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">kind regards,terry</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;">if I forget and you don't here from me, write back.....later/// Happy Thanksgiving to you and yours...kindest regards, terry</span></div><div style="outline: none;"><span face=""Helvetica Neue", Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div data-setdir="false" dir="ltr" style="outline: none;"><div style="outline: none;"><div style="outline: none;">Science and environment writer Jonathan Leake of the Sunday Times in London said Singeltary has helped him track down families of people with CJD along with academic research papers.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">"I strongly suspect he is right in thinking the USA has had BSE cases," Leake said by e-mail.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">"The American government is making the same mistake as the British in putting the short-term commercial interests of its farmers before health considerations," he added.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">"It should start formal and widespread testing of cattle plus compulsory autopsies for all human CJD victims at the state's expense. If there is BSE, then leaving it to spread will kill people -- and that would eventually destroy the industry, too."</div></div><div style="outline: none;"><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="outline: none;"><a href="https://www.chron.com/news/houston-texas/article/Mad-cow-disease-Could-it-be-here-2042860.php" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://www.chron.com/news/houston-texas/article/Mad-cow-disease-Could-it-be-here-2042860.php</a><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="outline: none;"><br style="outline: none;" /></div></div></div><div style="outline: none;"><div style="outline: none;">Knacker's yard link to Queniborough nvCJD cluster</div><div style="outline: none;"> </div><div style="outline: none;">Sun, 13 Aug 2000 Jonathan Leake and Dipesh Gadher</div><div style="outline: none;"> </div><div style="outline: none;">Sunday Times Additional reporting: Graham Hind</div><div style="outline: none;"> </div><div style="outline: none;">BRITAIN'S worst outbreak of the human form of mad-cow disease may be linked to a nearby knacker's yard that sold meat from diseased animals. The yard operated just eight miles from Queniborough, the Leicestershire village where health officials are investigating the first known cluster of CJD cases.</div><div style="outline: none;"> </div><div style="outline: none;">Three people who spent time in the village died from CJD in 1998, and a fourth person is suspected of having the degenerative brain disease. Another victim lived just three miles away.</div><div style="outline: none;"> </div><div style="outline: none;">The possible link to the knacker's yard - which recycled animals unfit for human consumption into pet food and other products - dates back 20 years, to about the time when scientists now believe the BSE epidemic may have begun.</div><div style="outline: none;"> </div><div style="outline: none;">Two meat traders from Bedfordshire were convicted in 1982 of buying unapproved beef from W E Mason & Sons of Wigston, near Leicester, and selling it to an unsuspecting butcher in Hertfordshire.</div><div style="outline: none;"> </div><div style="outline: none;">Last week officials seized council documents and court reports relating to the company to determine whether any unfit meat may have entered the human food chain locally.</div><div style="outline: none;"> </div><div style="outline: none;">"We have had a very useful series of conversations about this with Oadby and Wigston council," said Philip Monk, a consultant in communicable disease control at Leicestershire health authority, who is heading the Queniborough investigation. "I am ruling nothing in and nothing out. Anything we have that is potentially helpful in explaining local meat trading practices has to be examined."</div><div style="outline: none;"> </div><div style="outline: none;">The case heard by Leicester magistrates in 1982 was the culmination of Operation Meat Hook, a joint investigation between detectives and environmental health officers from three counties.</div><div style="outline: none;"> </div><div style="outline: none;">The teams covertly observed Peter Fletcher, a partner in a wholesale butcher's business near Dunstable, on four occasions in 1980 when he visited Leonard Mason, the yard's owner. He loaded beef carcasses from the yard into an un-marked van, which had been contaminated by a cow's head "fouled by stomach contents", according to evidence given in court. One of the carcasses was later found to have been infected with pleurisy.</div><div style="outline: none;"> </div><div style="outline: none;">Fletcher marked the meat with a fake inspector's stamp, and then left it with a retail butcher near Hemel Hempstead, Hertfordshire.</div><div style="outline: none;"> </div><div style="outline: none;">"A knacker's yard may, and frequently will, deal with diseased cattle," the prosecutor had told an earlier hearing. "Meat may be partly decomposed and contaminated. Disease is rife in such premises and could include anthrax and tuberculosis."</div><div style="outline: none;"> </div><div style="outline: none;">Fletcher was jailed for three months and fined ?500. His partner, Francis Fensome, received a suspended prison sentence. Mason was cleared after telling the court that he had been told the meat was to be used to feed animals at Whipsnade zoo [site of two cheetah BSE fatalities -- webmaster]</div><div style="outline: none;"> </div><div style="outline: none;">The knacker's yard, which had been run by the Mason family since 1947, was closed the same year and now stands derelict. Mason has since died.</div><div style="outline: none;"> </div><div style="outline: none;">Last week his brother, Jack Mason, said: "I am confident there is no connection with us and the outbreak in Queniborough. Most of the meat went to zoos. Any meat that was sold locally went to dog owners as pet food."</div><div style="outline: none;"> </div><div style="outline: none;">There is no proof that Mason dealt in cattle infected with BSE, which was not recognised at the time. But such yards commonly dealt in "downer" cows - those displaying symptoms of illness - so any animals that did have BSE were likely to have ended up in such places.</div><div style="outline: none;"> </div><div style="outline: none;">The Queniborough inquiry team is also examining slaughtering techniques at Leicestershire abattoirs and childhood eating habits of those who grew up in the village, although school meals have been ruled out as a possible cause of the CJD outbreak.</div><div style="outline: none;"> </div><div style="outline: none;">Arthur Beyless lost his daughter, Pamela, 24, a bank worker, to the disease after a two-year struggle for survival. Although the Beylesses live in nearby Glenfield, Pamela regularly visited her grandparents in Queniborough and the family often bought meat from Ian Bramley, the village butcher, in the late 1970s and early 1980s.</div><div style="outline: none;"> </div><div style="outline: none;">Beyless said: "On one occasion I was buying some meat when Ian told me he'd got it for 'a good deal'. It does make you wonder when you consider this theory about the knacker's yard. This disease is something that might never have happened if people weren't always grasping for that last penny."</div><div style="outline: none;"> </div><div style="outline: none;">The other two named victims with links to Queniborough are Stacey Robinson, 19, who lived there for 12 years before moving to another part of the county, and Glen Day, 34, who worked on a farm in the area. He regularly ate at the Horse and Groom pub, which was supplied with meat by Bramley.</div><div style="outline: none;"> </div><div style="outline: none;">Bramley died in a car crash. His stepmother, Hazel Bramley, said she knew nothing about Mason's yard. "We bought our meat directly from local farmers," she said. "The animals were slaughtered in Leicester and delivered to us. I don't know anything about this place in Wigston."</div><div style="outline: none;"> </div><div style="outline: none;"><a href="http://www.mad-cow.org/00/aug00_late_news.html#aaa" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://www.mad-cow.org/00/aug00_late_news.html#aaa</a><br style="outline: none;" /></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="http://www.mad-cow.org/00/jul00_dont_eat_sheep.html#hhh" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://www.mad-cow.org/00/jul00_dont_eat_sheep.html#hhh</a><br style="outline: none;" /></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">18 Jun 00 - CJD - Risk of CJD is higher in north Jonathan Leake</div><div style="outline: none;"> </div><div style="outline: none;">Sunday Times ... Sunday 18 June 2000</div><div style="outline: none;"> </div><div style="outline: none;">Northerners could be at several times more risk from variant CJD , the human form of "mad cow" disease, than those living in the Midlands and south, a study by government scientists has found, writes.</div><div style="outline: none;"> </div><div style="outline: none;">The research, carried out by the Creutzfeldt-Jakob disease Surveillance Unit, also shows that the rate of incidence of the disease, which is always fatal, is rising across Britain .</div><div style="outline: none;"> </div><div style="outline: none;">The figures remain too low to estimate accurately how many people will ultimately be affected. Estimates range from hundreds to many thousands .</div><div style="outline: none;"> </div><div style="outline: none;">Variations in the incidence of the disease are a matter of deep concern . In the north of England - north of Manchester and including Yorkshire and Humberside - there were 3.14 cases per million people over the five years to 1999. Scotland had the second highest rate at 2.98 cases per million .</div><div style="outline: none;"> </div><div style="outline: none;">The West Midlands emerged as the safest place with just 0.36 cases per million. East Anglia and the south experienced, respectively, 0.93 and 1.37 cases per</div><div style="outline: none;"> </div><div style="outline: none;"><a href="http://www.mad-cow.org/UKCJD/CJD_news8.html" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://www.mad-cow.org/UKCJD/CJD_news8.html</a></div><div style="outline: none;"> </div><div style="outline: none;"><a href="http://www.mad-cow.org/UKCJD/CJD_news8.html" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://www.mad-cow.org/UKCJD/CJD_news8.html</a></div><div style="outline: none;"> </div><div style="outline: none;">#18 Jun 00 - CJD - Risk of CJD is higher in north</div><div style="outline: none;"> </div><div style="outline: none;"><a href="http://www.mad-cow.org/UKCJD/CJD_news9.html" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://www.mad-cow.org/UKCJD/CJD_news9.html</a></div><div style="outline: none;"> </div><div style="outline: none;"><a href="http://www.mad-cow.org/00/jul00_late_news.html#aaa" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://www.mad-cow.org/00/jul00_late_news.html#aaa</a><br style="outline: none;" /></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Knacker's yard link to Queniborough nvCJD cluster</div><div style="outline: none;"> </div><div style="outline: none;">Sun, 13 Aug 2000 Jonathan Leake and Dipesh Gadher Sunday Times Additional reporting: Graham Hind</div><div style="outline: none;"> </div><div style="outline: none;">BRITAIN'S worst outbreak of the human form of mad-cow disease may be linked to a nearby knacker's yard that sold meat from diseased animals. The yard operated just eight miles from Queniborough, the Leicestershire village where health officials are investigating the first known cluster of CJD cases. Three people who spent time in the village died from CJD in 1998, and a fourth person is suspected of having the degenerative brain disease. Another victim lived just three miles away.</div><div style="outline: none;"> </div><div style="outline: none;">The possible link to the knacker's yard - which recycled animals unfit for human consumption into pet food and other products - dates back 20 years, to about the time when scientists now believe the BSE epidemic may have begun.</div><div style="outline: none;"> </div><div style="outline: none;">Two meat traders from Bedfordshire were convicted in 1982 of buying unapproved beef from W E Mason & Sons of Wigston, near Leicester, and selling it to an unsuspecting butcher in Hertfordshire.</div><div style="outline: none;"> </div><div style="outline: none;">Last week officials seized council documents and court reports relating to the company to determine whether any unfit meat may have entered the human food chain locally.</div><div style="outline: none;"> </div><div style="outline: none;">"We have had a very useful series of conversations about this with Oadby and Wigston council," said Philip Monk, a consultant in communicable disease control at Leicestershire health authority, who is heading the Queniborough investigation. "I am ruling nothing in and nothing out. Anything we have that is potentially helpful in explaining local meat trading practices has to be examined."</div><div style="outline: none;"> </div><div style="outline: none;">The case heard by Leicester magistrates in 1982 was the culmination of Operation Meat Hook, a joint investigation between detectives and environmental health officers from three counties.</div><div style="outline: none;"> </div><div style="outline: none;">The teams covertly observed Peter Fletcher, a partner in a wholesale butcher's business near Dunstable, on four occasions in 1980 when he visited Leonard Mason, the yard's owner. He loaded beef carcasses from the yard into an un-marked van, which had been contaminated by a cow's head "fouled by stomach contents", according to evidence given in court. One of the carcasses was later found to have been infected with pleurisy.</div><div style="outline: none;"> </div><div style="outline: none;">Fletcher marked the meat with a fake inspector's stamp, and then left it with a retail butcher near Hemel Hempstead, Hertfordshire.</div><div style="outline: none;"> </div><div style="outline: none;">"A knacker's yard may, and frequently will, deal with diseased cattle," the prosecutor had told an earlier hearing. "Meat may be partly decomposed and contaminated. Disease is rife in such premises and could include anthrax and tuberculosis."</div><div style="outline: none;"> </div><div style="outline: none;">Fletcher was jailed for three months and fined ?500. His partner, Francis Fensome, received a suspended prison sentence. Mason was cleared after telling the court that he had been told the meat was to be used to feed animals at Whipsnade zoo [site of two cheetah BSE fatalities -- webmaster]</div><div style="outline: none;"> </div><div style="outline: none;">The knacker's yard, which had been run by the Mason family since 1947, was closed the same year and now stands derelict. Mason has since died.</div><div style="outline: none;"> </div><div style="outline: none;">Last week his brother, Jack Mason, said: "I am confident there is no connection with us and the outbreak in Queniborough. Most of the meat went to zoos. Any meat that was sold locally went to dog owners as pet food."</div><div style="outline: none;"> </div><div style="outline: none;">There is no proof that Mason dealt in cattle infected with BSE, which was not recognised at the time. But such yards commonly dealt in "downer" cows - those displaying symptoms of illness - so any animals that did have BSE were likely to have ended up in such places.</div><div style="outline: none;"> </div><div style="outline: none;">The Queniborough inquiry team is also examining slaughtering techniques at Leicestershire abattoirs and childhood eating habits of those who grew up in the village, although school meals have been ruled out as a possible cause of the CJD outbreak.</div><div style="outline: none;"> </div><div style="outline: none;">Arthur Beyless lost his daughter, Pamela, 24, a bank worker, to the disease after a two-year struggle for survival. Although the Beylesses live in nearby Glenfield, Pamela regularly visited her grandparents in Queniborough and the family often bought meat from Ian Bramley, the village butcher, in the late 1970s and early 1980s.</div><div style="outline: none;"> </div><div style="outline: none;">Beyless said: "On one occasion I was buying some meat when Ian told me he'd got it for 'a good deal'. It does make you wonder when you consider this theory about the knacker's yard. This disease is something that might never have happened if people weren't always grasping for that last penny."</div><div style="outline: none;"> </div><div style="outline: none;">The other two named victims with links to Queniborough are Stacey Robinson, 19, who lived there for 12 years before moving to another part of the county, and Glen Day, 34, who worked on a farm in the area. He regularly ate at the Horse and Groom pub, which was supplied with meat by Bramley.</div><div style="outline: none;"> </div><div style="outline: none;">Bramley died in a car crash. His stepmother, Hazel Bramley, said she knew nothing about Mason's yard. "We bought our meat directly from local farmers," she said. "The animals were slaughtered in Leicester and delivered to us. I don't know anything about this place in Wigston."</div><div style="outline: none;"> </div><div style="outline: none;">Bovine spongiform encephalopathy: Epidemiological studies</div><div style="outline: none;"> </div><div style="outline: none;"><a href="http://www.thesundaytimes.co.uk/sto/" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://www.thesundaytimes.co.uk/sto/</a><br style="outline: none;" /></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="http://www.mad-cow.org/00/aug00_late_news.html#aaa" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://www.mad-cow.org/00/aug00_late_news.html#aaa</a></div><div style="outline: none;"> </div><div style="outline: none;"><a href="http://archives.cnn.com/2001/WORLD/europe/03/21/uk.cjd/" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://archives.cnn.com/2001/WORLD/europe/03/21/uk.cjd/</a><br style="outline: none;" /></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The Queniborough CJD cluster</div><div style="outline: none;"> </div><div style="outline: none;">New claims link CJD to water supply</div><div style="outline: none;"> </div><div style="outline: none;"><a href="http://www.mad-cow.org/~tom/drink.html#water" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://www.mad-cow.org/~tom/drink.html#water</a></div><div style="outline: none;"> </div><div style="outline: none;"><a href="http://www.mad-cow.org/~tom/drink.html" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://www.mad-cow.org/~tom/drink.html</a><br style="outline: none;" /></div><div style="outline: none;"><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="outline: none;"><a href="https://chronic-wasting-disease.blogspot.com/2013/11/wasting-disease-is-threat-to-entire-uk.html" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://chronic-wasting-disease.blogspot.com/2013/11/wasting-disease-is-threat-to-entire-uk.html</a><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="outline: none;"><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="outline: none;"><div style="outline: none;"><div style="outline: none;">The BSE Inquiry / Statement No 491</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Mr Robert Edmunds</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Issued 09/08/1999 (not scheduled to give oral evidence)</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">THE BSE INQUIRY</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">STATEMENT ON BEHALF OF THE ENVIRONMENT AGENCY CONCERNING THRUXTED MILL</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">BY ROBERT BARRY EDMUNDS</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">1. Introduction</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">1.1 I am the Regional Water Quality Manager for the Environment Agency (the Agency) Southern Region. I am a Member of the Chartered Institution of Water and Environmental Management. The purpose of my job is to organise, manage and direct the Water Quality Function in the Region in accordance with National and Regional policy and to formulate Regional policy and some National policy.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">1.2 I have been employed by the Agency or its predecessors since 1970. My work has included most aspects of water quality control in the natural environment including groundwater with considerable emphasis on planning matters. It has also involved different aspects of risk assessment and I played a major part in the establishment of Southern Region’s Aquifer Protection Policy and contributed to it’s successor, the Environment Agency’s National Groundwater Protection Policy.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">2. Involvement of the Environment Agency in the BSE Inquiry</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">2.1 The Agency was invited in a letter dated 26th March 1998 from the Inquiry Solicitor, to comment on statements submitted to the Inquiry by Dr A C F Colchester and Mr J Williams. These statements both mentioned the Agency and criticised evidence submitted by the Agency to a Planning Inquiry held in February 1997. The Planning Inquiry concerned a proposed new soak away drainage system at Thruxted Mill Rendering Plant in Kent.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">2.2 The Agency was unable to respond fully to the requests in time for the Inquiry Solicitor to use the information on Monday 30th March 1998, which was when Dr Colchester and Mr Williams presented their evidence to the BSE Inquiry (T 13 (Vol. T2 Tab 3)).</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">2.3 At that time, the Agency was also asked to submit written evidence to the Inquiry and did so at the beginning of May 1998. The evidence concerns the role of the Agency in relation to the BSE issue, the Agency’s powers and duties and the assessment of risks to human health via the environment, carried out by the Agency. Although the Agency’s involvement with the Thruxted Mill Planning Inquiry was, of necessity, included as part of the overall picture, no attempt was made to answer the critical points in the submissions of Dr Colchester and Mr Williams.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">2.4 Given that no decision has yet been made on the Thruxted Mill Planning Inquiry, it is considered inappropriate for the criticisms of the Agency to be left unchallenged. This evidence therefore specifically addresses the submissions made by Dr Colchester and Mr Williams.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">2.5 The evidence now submitted by the Agency is therefore specific to Thruxted Mill. It addresses the points raised by Dr Colchester and Mr Williams, but also takes the opportunity to update the relevant risk assessments. Nothing in this evidence in any way alters or qualifies the evidence submitted by the Environment Agency to the Thruxted Mill Planning Inquiry.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">2.6 The main evidence is in the form of statements from consultants employed by the Agency, as follows:</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">"Statement on behalf of the Environment Agency concerning Thruxted Mill", by Mr C P Young, WRc Plc, covering geological and hydrogeological factors.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">"Statement on behalf of the Environment Agency concerning Thruxted Mill", by Dr P Gale, WRc Plc, covering the nature of prions and infectivity.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">"Statement on behalf of the Environment Agency concerning Thruxted Mill", by Mr P Comer, Det Norske Veritas, covering overall risk assessment.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">3. Non Technical Matters</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">3.1 There were a number of non technical criticisms of the Environment Agency contained in the statements submitted by Dr Colchester and Mr Williams and also in Mr Williams’ supplementary papers: "BSE and nvCJD - The Kent/Hampshire Connection - Part I: The Smarden Spill and the origin of BSE", and a similarly titled paper - Part II. Some of these non-technical criticisms are addressed below.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">3.2 The Agency does not wish to address any matters contained in Mr Williams’ Part I Smarden paper (M70 Tab 3). The Precautionary Principle (See WS No.18 paragraph 18, WS No.19 paragraph 12, Part II of "BSE and nvCJD – the Kent/Hampshire Connection [M70 Tab 4])</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">3.3 The underlying basis of the Government’s precautionary principle is that where there are significant risks of damage to the environment, pollution controls will take into account the need to prevent or limit harm, even where scientific knowledge is not conclusive. (Planning and Policy Guidance Note number 23 - HMSO 1994).</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">3.4 The Agency’s view at the beginning of the Thruxted Mill Planning Inquiry was that there was virtually no risk to human health in relation to drinking water supplies resulting from effluent disposal at Thruxted. This has remained the Agency’s view throughout. It was therefore inappropriate to apply the precautionary principle.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">3.5 The Agency has nevertheless carried out rigorous regulatory pollution control and enforcement in relation to the Thruxted Mill operation and this is documented as part of evidence previously submitted to the BSE Inquiry (DO 01 Tab 12).</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Alleged cluster of nvCJD cases</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">(See WS No. 18 paragraph 4)</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">3.6 The Agency is not of course the Health Authority, but nevertheless considered any evidence pertinent to the transmission of nvCJD infectivity via the environment. Attention is therefore drawn to the report of the East Kent Health Authority, "An Investigation of the local cases of Creutzfeldt-Jakob Disease in East Kent, Interim Report", (February 1997) (M70 Tab 2), which concludes:</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">i) "On the basis of knowledge available at present, there does not appear to be any evidence to suggest that there is a local cluster of cases of CJD in East Kent. (Cluster is defined as two or more linked cases)."</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">ii) "The suggestion that the BSE epidemic started in Kent and spread to other parts of the country does not appear to be accurate."</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">iii) "On the basis of knowledge available at present, there does not appear to be any evidence to suggest that the confirmed cases of CJD are linked to any local factors including Thruxted Mill. Caution needs to be expressed as this is an evolving situation and if there is further evidence available, this conclusion may have to be revised."</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">This report was submitted to the Thruxted Mill Planning Inquiry by the Environment Agency, in February 1997.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">3.7 The conclusions of a subsequent report by East Kent Health Authority, "An Investigation of the local cases of Creutzfeldt-Jakob Disease in East Kent", September 1998, are as follows (M 11D Tab 3):</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">"On the basis of knowledge available at present the following conclusions can be drawn:</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">a. There does not appear to be any evidence to indicate an increase in the number of sporadic cases of CJD in Kent more than what is expected for this population.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">b. There does not appear to be any evidence to link all the cases of new variant CJD to a common water supply and therefore it is unlikely that water is the vehicle of infection resulting in the reported cases of new variant CJD in Kent.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">c. There is no evidence to suggest inhalation as a possible mode of transmission with Thruxted Mill as the source causing the reporting cases of new variant CJD in Kent.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Caution needs to be expressed as this is an evolving situation and if there is further evidence available in future these conclusions may need to be revised."</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Basic stance of the Environment Agency</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">(See WS No.18 paragraph 17; WS No.19 paragraph 40)</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">3.8 The Agency’s duties and responsibilities are described in its evidence to the Thruxted Mill Planning Inquiry and in previous evidence submitted to the BSE Inquiry. In the case of the Thruxted Mill Planning Inquiry, the Agency has impartially investigated and assessed evidence. It neither set out to establish that there was significant risk or to establish that there was not. The conclusions of negligible risk result from the Agency’s assessment of all the information obtained.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Issued on behalf of the witness by:</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The BSE Inquiry Press Office</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">6th Floor Hercules House</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Hercules Road</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">London SE1 7DU</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Fax: 0171 803 0893</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Website: http://www.bse.org.uk</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">email: inquiry@bse.org.uk</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20090506002448/http://www.bseinquiry.gov.uk/files/ws/s491.pdf">https://webarchive.nationalarchives.gov.uk/ukgwa/20090506002448/http://www.bseinquiry.gov.uk/files/ws/s491.pdf</a><br /></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The BSE Inquiry / Statement No 19C</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Dr Alan Colchester</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Issued 27/01/2000</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">STATEMENT BY DR A C F COLCHESTER IN RESPONSE TO</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">WS490 DATED 09/08/99 BY MR C P YOUNG</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">1. Statement WS490 by Mr C. P. Young, Principal Hydrogeologist, Soil Waste and Ground Water Group, WRc, Medmenham, Bucks, concerned geological and hydrogeological factors which may control the movement and attenuation of BSE infectivity in water in the environment, and referred to specific points raised in WS18 and WS19 of March 1998.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">2. WS490 referred particularly to the potential impact of the discharges from Thruxted Mill on the ground water, particularly because of its proximity to drinking water extraction bore holes. However, it did not consider the other risks arising from material delivered to or discharged from this factory.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">3. In paragraph 18 [WS490], Mr Young described his conclusions about the probable rate of flow of water through the unsaturated zone. This would be slow, with the result that it would take from a few to several tens of years for material to travel from the surface to the water table. It is likely that such slow transmission applies at many parts of the discharge zone around Thruxted Mill. This is true whether or not there are also locations where transit through to the water table is faster. It is therefore clear that some of the material discharged many years ago may only now be beginning to reach the aquifer. This is one of several reasons why the past history of discharges at Thruxted Mill continues to be important.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">4. Mr Young gave a very clear review of the potential behaviour of water and dissolved or particulate materials when soaking through a medium such as chalk</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">2</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">which may contain variable numbers of large fissures. The presence of significant numbers of fissures, or the use of a borehole or old well for discharge purposes, would provide a rapid route to the water table through which a variety of particulate substances could pass. Mr Young referred to ‘the absence of persuasive evidence of rapid movement via fissures of water and dissolved or particulate materials from the surface to the water table at Thruxted Mill’ [WS490 para 20].</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">In my view, it should be borne in mind that absence of persuasive evidence is not persuasive evidence of absence. The physical existence of potential routes allowing rapid transit is one type of evidence; evidence from water samples (tested for conventional pathogens, ionic substances etc) is another.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">5. My Young also provided a clear review of the potential mechanisms of removal of particulate matter from liquid passing through intact chalk [WS490] (ie. not through large fissures or boreholes). He discussed the potential for filtration and adsorption of particles carrying BSE prions. In my view, the problem about this is that prions can exist in several physico-chemical forms. The range of types of particles which might exist in the inputs and outputs of a rendering factory and which might carry BSE prions is simply not known with confidence. In particular, the rendering process itself will alter the properties of lipid and protein particles. We do not know enough to quantify the possibility that particles may exist in a form that could pass through the chalk matrix. We certainly know that, in laboratory conditions, preparations of infective material are often passed through a microporous filter, with pore sizes of less that 0.5 micron. This does not generally attenuate prion infectivity but does remove most other pathogens.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">6. In paragraph 26, final bullet point, Mr Young referred to pore sizes used in the laboratory of ‘500 micrometers’ [WS490] (one micrometer is one millionth of a metre or one micron). I presume this is a typographical error, because he should have referred to nanometers (a nanometer is one thousand millionth of a meter). 7. Considering what is now known about the potential infectivity of rendering factory output, there would seem to be an overwhelming case for its classification as toxic waste. However, in the historical context, rendering factory outputs appear to have</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">3</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">been classified with strong organic and biodegradable effluents. The Environment Agency emphasise the consistency of their approach, as if this were to be commended, an attitude which seems dangerously inflexible in the light of the new information about the risks to human health of the products of rendering.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Within the historically accepted class of strong organic and biodegradable effluents, the categorisation should clearly be low nutrient/ industrial effluent (Policy and Practice for the Protection of Groundwater, National Rivers Authority, 1992). When the discharge area is near a water supply borehole, the ground above is graded into three Source Protection Zones: the Inner Protection Zone (based on a 50 day travel time from any point below the water table to the source); the Outer Protection Zone (400 days); and the Source Catchment Zone (the remaining catchment area of the ground water source). The approach to regulation of discharge, according to the type of effluent and the travel times to the water extraction point, is shown as a matrix (table) on page 36 of the NRA booklet (Appendix 1 [YB92/00.00/10.1]). Appendix 1 shows that there is an important threshold between the Outer Protection Zone and the Source Catchment Zone, because, in the former (areas closer then 400 days transit time to the water supply extraction point), discharges of low nutrient content or industrial effluent should be automatically prohibited.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">8. In paragraph 21 of WS490, Mr Young referred to Thruxted Mill’s location as being in an area in which time for flow in a saturated zone to the boreholes is “about 400 days, or greater”. In the light of the historical importance of this 400 day threshold, I examined the situation of Thruxted Mill in relation to the 400 day transit time to the nearest borehole (Godmersham). Maps included in the Environment Agency’s studies confirm that the Mill in fact must lie extremely close to that threshold. Two such maps are reproduced here for ease of comparison: Appendix 2 is p 16, fig 2.3 (‘Hydrogeological features of the area around Thruxted Mill’), from C.P. Young et al “Assessment of the Potential Impact of Past and Present Disposal of Effluent from Thruxted Mill on Ground Water Quality”, March 1997 [M70 Tab 9]. Appendix 3 is fig 1 (‘Location map’) from WS490 itself. The 400 day threshold line has clearly been drawn freehand (compare the two maps in the Appendices), and indeed small differences in drawing could lead to the Mill lying inside or</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">4</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">outside the Outer Protection Zone. The transit time from Thruxted Mill to the aquifer in the saturated zone appears only to have been estimated very approximately. More accurate measurement might well indicate a shorter transit time. If this were to be the case, the Environment Agency should have prohibited discharge long ago, even assuming that no new, more stringent, regulation was applied to take account of the recent discovery of serious risks to humans of BSE contaminated material. It is accepted that the NRA document is not prescriptive and while it seeks to control activities within certain travel time zones around public water supply sources, it allows for individual site specific assessment (Canterbury Planning Inquiry, EA Proof of Evidence, section EA 1, Pages 7 & 8, Groundwater Protection Policies). However, in the case of Thruxted Mill, the heightened concern about the safety of discharges should clearly have led to a more, rather than a less, stringent interpretation of the Policies.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">9. In paragraph 22, Mr Young referred to the February 1997 Public Planning Inquiry in Canterbury [WS490]. Concerning the old well on the site of the Mill, he says that ‘its potential impact on groundwater quality was not assessed’. However, as my second statement to the BSE Inquiry [WS19B] showed, the EA were fully informed about the recent allegations of discharges into the well as early as June 1996. The EA have also admitted that the NRA/ EA had been fully aware of the presence of the well on the site for some years previously, and that the well had only been partially backfilled with sand in 1978, which would of course have allowed its continuing use as a discharge route. The EA were requested, at the pre-Planning Inquiry meeting in Canterbury in December 1996, to take full account of the well, although Counsel acting for the EA argued that it was irrelevant (cf WS19B para 59). Furthermore, Mr Young’s report, which was dated March 1997 [M70 Tab 9], contained extensive data obtained before the Planning Inquiry. It is quite clear from that report that many of the analyses contained in it must have been completed well before the publication date of the report, in other words well before the Planning Inquiry. In summary, while I agree that the ‘potential impact on groundwater quality’ of the well ‘was not assessed in the context of the Planning Inquiry’, the relevant data and analyses were available at the time of the Inquiry. In my opinion,</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">5</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">these data should have been discussed at the Planning Inquiry, and my reasons were made very clear before and during that Inquiry itself.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">10. In paragraph 24 [WS490], Mr Young refers to readings quoted by the EA showing that the rate of fall of the water level in the well during late 1996 was low. This implied that the well had become ‘blinded’. However, the data about the rate of soaking away obtained in late 1996 do not provide any information about the time when the ‘blinding’ may have taken place. In the risk assessments referred to by Young in his report dated March 1997 [M79 Tab 9] it was assumed that the rate of leakage from the well had smoothly reduced from 1988 to 1996. This is complete speculation. The arbitrary assumption of a gradual reduction over many years generated predictions which appeared to contradict one of the allegations by a former contractor who worked on the site (who had stated that he had seen flexible hoses dragged to the top of the well and effluent being discharged through them). These apparent contradictions were used by the EA and by solicitors acting for Canterbury Mills Ltd to argue that the former contractor’s evidence was unreliable. In my view, exactly the opposite conclusions were more logical. That is, the possibility that the blinding was a recent event was not only plausible a priori, but such an interpretation was supported by the observations alleged by the former contractor of the use of the well as a route of discharge. 11. In paragraph 26 [WS490], final bullet point, Mr Young refers to the precautionary principle. He quotes PPG 23, where the precautionary principle is set out. PPG 23 requires that the precautionary principal should be applied when ‘there is perceived to be an unacceptable risk’, even if it ‘cannot be scientifically quantified’. Young’s argument is circular. He merely states that because the EA, or the scientific consultants acting for the EA, did not themselves ‘perceive there to be an unacceptable risk’, the precautionary principle automatically did not apply. Any serious debate about this issue should address the question of how to define ‘an unacceptable risk which cannot be scientifically quantified’.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">12. Once again, the Environment Agency has focused specifically on the issue of the possibility of transmission by the water supply. I regard the water supply pathway</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">6</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">as representing only a very small risk, but one which is very hard to quantify and one which would potentially affect a large number of people. The debate about water supply should not divert attention from the existence of several other potential pathways which need to be considered and evaluated. In my discussions about the potential risks associated with rendering, and the whole approach to its regulation, I have repeatedly stressed that there is a spectrum of possible risks, associated with various environmental pathways and various possible portals of entry into the body. In my opinion, the recent statements by the Environment Agency and its contractors have not invalidated the very strong case to support the view that the precautionary principle should be applied to the disposal of liquid effluent and sludge from rendering factories. In particular, it should be applied to the proposed new subsoil drainage method, as well as to the existing discharge method in use at Thruxted Mill.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Issued on behalf of the witness by: The BSE Inquiry Press Office 6th Floor Hercules House Hercules Road London SE1 7DU Fax: 0171 803 0893 Website: http://www.bse.org.uk email: inquiry@bse.org.uk</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20090506002914/http://www.bseinquiry.gov.uk/files/ws/s019c.pdf">https://webarchive.nationalarchives.gov.uk/ukgwa/20090506002914/http://www.bseinquiry.gov.uk/files/ws/s019c.pdf</a><br /></div><div style="outline: none;"><br /></div><div style="outline: none;">Volume 6: Human Health, 1989-96</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">10. Pollution control and waste management</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Thruxted Mill</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Treatment and disposal of waste products from the rendering process</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">New effluent treatment plant and disposal system</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">10.121 Some of the events relating to the Thruxted Mill which gave rise to issues of interest to the Inquiry occurred at dates outside the terms of reference of the Inquiry. However, evidence relating to Thruxted Mill illustrated some aspects of the waste disposal processes in a rendering plant during the period up to 20 March 1996 and sheds light on how local authorities and other government bodies assessed the impact of BSE on pollution.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">10.122 Thruxted Mill is a rendering plant in the Canterbury area and has been in operation since 1917. On 1 May 1996 it was licensed as one of the plants authorised to render specified bovine material (SBM) and cattle culled under the Government's Over Thirty Months Scheme (OTMS). 1 In late June 1996 the Environment Agency (Southern Region) commissioned a risk assessment on the impact of the disposal of cattle effluent from the Thruxted Mill site. In March 1997 the risk assessment report noted the plant was licensed to process approximately 2,000 carcasses per week (equating to around 1,000 tonnes of material each week). 2</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">10.123 The Mill is located above the North Downs chalk aquifer, which has long been used for public water supply. The Environment Agency report identified two operational public water supply boreholes, serving 140,000 people, located within 3.25 km of the Mill, both of which were in operation for many years before the onset of BSE. A third non-operational borehole was located 3.5 km north of the Mill. 3</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">10.124 The Environment Agency reported that the Mill was not connected to main drainage and was approximately two kilometres from the nearest foul sewer. Since the early 1970s most of the surface drainage (from yards and roofs in the plant complex) had been directed through the effluent-holding tank and subsequent treatment systems. Earlier arrangements for surface drainage were uncertain, but it was understood that during the 1960s the yard drainage was directed to a large-diameter well. The report found evidence to suggest 'that small amounts of surface water have been discharged to the well until recently'. 4</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">snip...see;</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20060525120000/http://www.bseinquiry.gov.uk/report/volume6/chapt104.htm">https://webarchive.nationalarchives.gov.uk/ukgwa/20060525120000/http://www.bseinquiry.gov.uk/report/volume6/chapt104.htm</a><br /></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Volume 6: Human Health, 1989-96 10. </div><div style="outline: none;"><br /></div><div style="outline: none;">Pollution control and waste management Spreading blood on land </div><div style="outline: none;"><br /></div><div style="outline: none;">10.137 On average, a slaughtered cow yields about 13.6 kg of blood. While blood is not the main product of the slaughtering process, valuable uses could usually be found for most of it. A small amount was sold for use in the manufacture of processed food (eg, black pudding, adhesives for sausages), pet food, fertiliser, glue, foam fire extinguishers and pharmaceuticals and the preparation of leather. 1 However, most blood collected in slaughterhouses went to renderers to be made into blood meal for use in animal feed manufacture. 2</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">10.138 Where no valuable use could be found it was not uncommon at the onset of the BSE crisis for the unprocessed blood to be spread on land, including grazing land.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">10.139 For the slaughterhouse operator spreading blood on land was an inexpensive way to dispose of a by-product which would otherwise be viewed as waste. For a farmer on whose fields the blood was spread it was a useful fertilisation measure. Therefore, it recycled an otherwise useless by-product of one process for use in another. It could only be done subject to the consent of the local authority, and the landowner had to be licensed under the Control of Pollution Act 1974. 3 Once the blood had been spread the Diseases of Animals (Waste Food) Order 1973 (Waste Food Order), which applied across Great Britain, prohibited the farmer from allowing livestock or poultry access to the fields until enough time had passed for all blood to disappear from the ground or grass. 4 The Diseases of Animals (Waste Food) Order 1974 had a similar effect in Northern Ireland. 5 The Orders do not state, in terms, how long animals had to be kept off the fields. Interpretation of the Orders seems to have been left up to the discretion of the relevant Agriculture Departments.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">10.140 The State Veterinary Service (SVS) closely monitored the practice of spreading blood on land. 6</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">10.141 In a letter to Mr Derek Wilson (VO) dated 5 June 1989, Dr Matthews (SVO) made it clear that he considered MAFF's position on the practice of spreading unprocessed blood on land to be outdated, as it was based on guidelines issued in 1978:</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">When blood has been used as a fertilizer, the dressed field should not be grazed for 4 months in the case of bovine/sheep blood, and 6 months in the case of pig blood. If liquid slaughterhouse waste is being spread, then it becomes more difficult to specify any time period before allowing animals access to the field. This will depend on the nature of the waste and its contents. 7 10.142 Dr Matthews went on to say that these guidelines were now inadequate 'to deal with a practice that has become more widespread with the rising cost of disposal of waste', but that it was all the advice that he could offer. He did not explain why he thought the guidelines were inadequate.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">10.143 In September 1989, Mr Wilson visited a farm that used slaughterhouse blood as fertiliser on its fields. He described the practice to Mr Mott, the DVO:</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Blood and slaughterhouse waste have been spread on the land for about 25 years. [A] tanker (2000 gallon capacity) with a spray on the back takes liquid waste which is blood and washing water from slaughterhouse to farm daily. 'This is usually half full'. Waste is sprayed almost every day on arable or pasture depending on time of year. I inspected one field of stubble turnips where the last waste had been sprayed on the weekend. Small clots about 1cm across with the appearance of dropped solder were apparent across the soil and vegetation surface about every 5cm. When sprayed on the grass the practice is to 'wait for rain to wash the blood in'. The blood is never spread near standing cattle who are reported to be frightened of the spreader. 8 10.144 Mr Wilson wrote that in spring the time between applying the blood and allowing cattle to graze on the affected land was four to six weeks and that a lapse of six months was 'unacceptable' to the farmer. Mr Wilson concluded that the farmer 'seems to be adopting a sensible attitude to spraying and disposal but only 4-6 weeks can, from time to time, elapse between application and grazing' but added that the presence of rooks and seagulls feeding on the affected land 'could act as a vehicle for the spread of rapidly transmissible disease to other farms'. 9</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">10.145 Mr Wilson's report sparked an exchange of correspondence over the next few months. Mr Kevin Taylor took the view that the MAFF guidelines needed revision, and that delays of four to six months were difficult to justify on veterinary grounds, when such a quarantine period was not required for pasture in the event of a confirmed notifiable disease. He was 'positive about the insignificance of the practice in relation to BSE', and did not think that the Waste Food Order was being contravened, provided all of the blood had soaked into the fields before cattle were allowed to graze. 10 Mr Ray Bradley, Head of the MAFF Pathology Department, wrote:</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">On the basis of current evidence I would not have thought that spreading bovine blood from healthy animals on fields is a significant risk for exposing them to BSE agent in sufficient quantity to produce disease. No animals should graze fields after blood treatment until sufficient time has elapsed to ensure destruction of all known conventional pathogenic organisms and until it is no longer recognisable as blood (ie. degraded to 'fertiliser' status). The length of this period should be determined by someone with experience of these factors but I would not have thought it would need to be more than a few weeks. 11 10.146 When consulted on this issue, Dr Richard Kimberlin expressed his opinion that four to six months was a suitable interval to allow between spreading blood on land and allowing animals to graze on that land, to ensure that conventional pathogenic organisms were destroyed. 12 Mr Hugh Fraser of NPU thought that six months was appropriate. 13</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">10.147 Mr Meldrum tended to the view that, for both scientific and presentational reasons, consideration should be given to amending the Waste Food Order to prohibit the spreading of slaughterhouse waste in its raw state on farm land. On 4 December 1989 he requested Mr Taylor and his colleagues to advise him on this. 14</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">10.148 The Inquiry did not find any evidence of Mr Taylor's response to Mr Meldrum on this issue. However, in a minute to Mr Lawrence dated 15 February 1991 he wrote that:</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">. . . the practice [of spreading unprocessed blood on land] is widespread and may have become more so. It has also been going on for a long time without, so far as I am aware, being responsible for the spread of animal disease. The emergence of BSE does not alter the situation much: there is no evidence that the titre of infectious agent which may be present in blood is significant, and when we last checked there had been no cases of BSE on the organic farms which used blood as a fertiliser. The Waste Food Order controls seem to be effective in practice. Time intervals are not laid down between spreading and stock access, but variability is necessary to allow for variability in weather and soil conditions, and it would be difficult to make statutory provision for this. 15 <<Previous | Next>> Return to top of page 1 J F Gracey, Meat Hygiene, 1986, pp. 100-1: M43A tab 13</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">2 YB90/12.18/3.10</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">3 L1A tab 2</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">4 L1 tab 3 article 6(2)(a)</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">5 L5A tab 11 article 4(4)</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">6 YB90/12.18/3.10</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">7 YB89/6.05/9.1-9.2</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">8 YB89/9.12/15.1</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">9 YB89/9.12/15.2</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">10 YB89/10.02/10.1-10.2</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">11 YB89/10.10/2.2</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">12 YB89/10.30/5.1</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">13 YB89/10.31/1.1</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">14 YB89/12.04/1.1</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">15 YB91/2.15/3.1</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20060525120000/http://www.bseinquiry.gov.uk/report/volume6/chapt105.htm" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://webarchive.nationalarchives.gov.uk/ukgwa/20060525120000/http://www.bseinquiry.gov.uk/report/volume6/chapt105.htm</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">FINAL REPORT OF THE INVESTIGATION INTO THE NORTH LEI...RSHIRE CLUSTER OF VARIANT CREUTZFELDT-JAKOB DISEASE </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">SUMMARY OF THE FINAL REPORT OF THE INVESTIGATION INTO THE NORTH LEICESTERSHIRE CLUSTER OF VARIANT CREUTZFELDT-JAKOB DISEASE</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The investigation was carried out by Dr Gerry Bryant and Dr Philip Monk who have prepared and present this report to Leicestershire Health Authority.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">INTRODUCTION</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The cluster of variant Creutzfeld-Jakob disease in the North Leicestershire area was first recognised in July 2000. Between August 1996 and January 1999 five people developed symptoms that were later recognised as being those of variant Creutzfeld-Jakob disease and they have all died. They all lived in the Wreake and Soar Valley area in North Leicestershire from 1980 until 1991.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The investigation concentrated on the period from 1980 to 1991, as this was the only time period when a common exposure could have occurred.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">1. INITIAL FIELDWORK</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">At least one relative of the people with variant Creutzfeld-Jakob disease was interviewed to examine possible exposures to the BSE (Bovine Spongiform Encephalopathy) Agent. A questionnaire study was carried out with parents of children at Queniborough Primary School to examine their purchase and consumption of food when they were children themselves during the 1980s.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">This was followed by a questionnaire study of people living in the village of Queniborough. The questionnaire asked those people who were parents of children of similar age to the cases about their purchase and consumption of meat during the 1980s. Butchers, farmers, auctioneers and others involved in the meat trade were interviewed to build a picture of the dairy and beef industries during the 1980s.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">2. RESULTS FROM THIS INITIAL FIELDWORK</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">1. Possible Exposures</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">3. A number of possible risk factors were unlikely to provide an explanation for a link between the people with variant Creutzfeld-Jakob disease. They were: -</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">● Surgery and blood transfusions</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">● Dental surgery</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">● Occupational exposure</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">● Immunisations</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">● Injections, body piercing, cuts and animal bites</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">● Baby foods, school meals and drinking water</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Manganese (data from the British Geological Survey showed that the area of Leicestershire does not have a high level of Manganese in the soil)</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">● FINAL REPORT OF THE INVESTIGATION INTO THE NORTH LEI...RSHIRE CLUSTER OF VARIANT CREUTZFELDT-JAKOB DISEASE http://www.leics-ha.org.uk/cjd/cjdbrief.htm (1 of 7) [3/21/2001 3:38:40 PM]</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">INVESTIGATION INTO FARMING PRACTICE</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Cattle raising practice</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Local beef cattle were raised alongside dairy cattle. This meant that beef cattle were fed meat and bone meal supplements from the age of 6 days rather than 6 months, which is the case for pure beef herds. They therefore had a greater lifetime exposure to the BSE agent in meat and bone meal than cattle who did not receive meat and bone meal until the age of 6 months.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The area of Leicestershire that supplied beef cattle to the local food trade had a moderately high incidence for BSE meaning that a number of cattle across a number of farms had the disease.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">At the beginning of the 1980s, local beef cattle were a by-product of the dairy industry and were usually Friesian Hereford crossbred cattle. Such cattle were usually slaughtered between 30 and 36 months of age because they are slower to fatten.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The average age for onset of BSE in cattle was between 4 and 5 years. However, the BSE Inquiry notes that although the numbers were small, there were a few cases in which clinical onset occurred between 20 and 30 months. The youngest animal in England being just 20 months old. This means that the older Friesian cross bred cattle used in the meat trade in Leicestershire were more likely to have sub-clinical BSE infection and to be infectious. Back calculations from the BSE epidemic suggest that British cattle must have had BSE from the mid 1970s onwards. This area of Leicestershire reported BSE as soon as it became notifiable in 1988 which means that some cattle were likely to have had BSE during the period that we were investigating.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">1. Cattle slaughtering practice</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">In both large and small abattoirs, cattle were slaughtered using a captive bolt. In the local abattoirs and butchers who slaughtered, a pithing rod was also used. (see appendix – terminology) In small abattoirs the carcass was wiped down with a cloth to remove unwanted tissue. In large abattoirs the carcass would be hosed down. In the early 1980s there was no legal requirement to hose down a carcass. Skilled butchers reported that hosing a carcass down would make the meat go ‘sour’. The practice of wiping a carcass with a cloth meant that there was a possibility of cross contamination of meat with brain and nervous tissue in those butchers who removed the brain from a beast’s head.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">2.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">3. Carcass purchase</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Most butchers in the area bought meat from wholesale suppliers. A small number would select cattle at Melton Market or directly from a local farm for slaughter either by themselves or in a small nearby abattoir.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Wholesale meat suppliers purchased carcasses from a number of abattoirs that in turn selected cattle from a number of cattle auctions.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">1. FINAL REPORT OF THE INVESTIGATION INTO THE NORTH LEI...RSHIRE CLUSTER OF VARIANT CREUTZFELDT-JAKOB DISEASE <a href="http://www.leics-ha.org.uk/cjd/cjdbrief.htm" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://www.leics-ha.org.uk/cjd/cjdbrief.htm</a> (2 of 7) [3/21/2001 3:38:40 PM]</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">RESULTS OF INVESTIGATION INTO BUTCHERING AND MEAT PROCESSING Butchering practice</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Whole carcass processing</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">A small number of butchers either slaughtered beasts in their own small abattoirs or had beasts slaughtered by a nearby small abattoir. The butcher then processed the whole carcass. For those butchers who had a market for brain, they removed it from the beast during the process of recovery of head meat. The rest of the carcass was then boned and jointed. The removal of brain meant that there was the possibility that other meat could be contaminated with brain material. Brain contains the BSE agent and is therefore potentially infectious. During the 1980s, this process was legal and represented traditional butchering practice. It was decreasing because of a declining consumer market for brain. In the past and in particular during the war years, brain had been seen as an excellent source of protein.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">1. 2. Wholesale purchase 1.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">By the beginning of the 1980s many butchers had moved to purchasing either sides of beef, quarters of beef or vacuum packed pre-prepared cuts of beef rather than whole carcasses. A small number of these butchers would also purchase heads in order to remove the tongues to prepare for pressed tongue and sometimes the cheek meat usually for pet food. It was very rare for such butchers to remove the brain, as by this time there was often no market for brain.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">2. 3. THE HYPOTHESIS</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Our initial work suggested that there was an association between the cases of variant Creutzfeld-Jakob Disease and the consumption of beef purchased from butchers where there was a risk of ‘cross-contamination’ of beef carcass meat with bovine brain. The essential elements of our hypothesis are that:-</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">● the beasts used were locally reared cattle the beef cattle were a by-product of the beef industry and therefore fed meat and bone meal from day 6 onwards giving them a greater lifetime exposure to feedstuff that was potentially contaminated with the BSE agent</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">● they were predominantly Friesian crossbred cattle which were slow to fatten and therefore slaughtered at close to three years</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">● they were slaughtered in small abattoirs which employed pithing and without the washing down of the carcass</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">● ● the heads were split to remove the brain</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">● during brain removal, if the meninges (the membrane that covers the brain) are broken, FINAL REPORT OF THE INVESTIGATION INTO THE NORTH LEI...RSHIRE CLUSTER OF VARIANT CREUTZFELDT-JAKOB DISEASE <a href="http://www.leics-ha.org.uk/cjd/cjdbrief.htm" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://www.leics-ha.org.uk/cjd/cjdbrief.htm</a> (3 of 7) [3/21/2001 3:38:40 PM] because brain is of a gelatinous consistency, when handled, it then has a tendency to be adherent</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">● carcasses were wiped with cloths increasing the risk of cross-contamination</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">TESTING THE HYPOTHESIS</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Our study to test the hypothesis was carried out with the approval of the Leicestershire Research Ethics Committee.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">A relative of each case variant Creutzfeld-Jakob Disease in the cluster was re-interviewed using a structured questionnaire. The questionnaire asked about dietary history including meat consumption and from where meat was purchased during the period 1980 to 1991. A relative of each of thirty age-matched controls, six for each case, was interviewed using the same questionnaire. An attempt was made to interview all butchers, supermarkets and freezer food centres identified by the controls to ascertain whether they or their suppliers used cattle heads and removed bovine brain, thus creating the opportunity for cross-contamination.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">1. RESULTS OF THE CASE CONTROL STUDY</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Butchers, supermarkets and freezer food centres used by cases and controls Four of the people who developed variant Creutzfeld-Jakob Disease bought and consumed beef from one of two butchers during the early 1980s. One of these butchers slaughtered beasts in his own abattoir. This butcher normally processed three beasts a week. He ceased trading in 1989. The other butcher had beasts slaughtered in a small nearby abattoir. He processed four to five beasts a week. This butcher’s business ceased trading in December 1982. It has not been possible to trace the butcher who was used regularly by one family during the first half of the 1980s. It is unlikely that he removed brains or even purchased the heads of beasts. He did not slaughter beasts himself or use a small local abattoir. People acting as controls used a total of twenty butchers, four freezer food centres and seven supermarkets. With the exception of one butcher who supplied one of the controls, all other outlets were traced and staff interviewed to ask whether they removed the brain. Three butchers used by controls removed brains. One of these butchers was also used by one of the people who developed variant Creutzfeld-Jakob Disease. With the exception of this one butcher and one other who also split the heads, the butchers used by the controls processed between one and two sides of beef or less a week. A side of beef is half of the carcass. We were able to trace both butchers and buyers who worked for the supermarkets used by people in this study. None of them reported the use of head meat during the 1980s. Sides of meat or vacuum packs were purchased from wholesalers. The wholesalers who supplied the supermarkets and freezer centres did not split heads to remove the brains. The skulls were sent either to specialist head boning plants or to renderers after removal of the head meat. The skulls were never split.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">1. 2. FINAL REPORT OF THE INVESTIGATION INTO THE NORTH LEI...RSHIRE CLUSTER OF VARIANT CREUTZFELDT-JAKOB DISEASE http://www.leics-ha.org.uk/cjd/cjdbrief.htm (4 of 7) [3/21/2001 3:38:40 PM]</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">2. Interview results</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The study showed that the relatives reported that the people with variant Creutzfeld-Jakob Disease were 15 times more likely to have purchased and consumed beef from a butcher who removed the brain from a beast compared with controls who purchased meat from outlets where cross contamination with brain material was not a risk. This result is statistically significant and is therefore very unlikely to be a chance finding. (p = 0.0058 and the 95% confidence interval is 1.6 to 138.9)</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">LIMITATIONS OF THE STUDY</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">A number of factors may have influenced the result.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Our work suggests that family size, age and education of children of controls were representative of people living in the area meaning that our controls who were randomly selected are likely to be representative of people living in the area.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">It is possible that we were in some way able to influence the outcome of the study by the way in which we wrote down the answers to the questions that we asked both of the cases and controls. Wherever possible we interviewed people together to ensure that the interview technique was the same. All interviews were recorded on tape. Whilst we knew the hypothesis that was being tested, at the time of the interviews we had no knowledge of the butchering practices of most of the meat suppliers identified by the controls. These butchers were interviewed after the interviews with controls had been completed.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">People may not be able to remember what they gave their families to eat twenty years ago. However, our hypothesis was dependent on where people shopped and we were not attempting to identify every single item of food that was eaten. Rather we explored the usual patterns of meat consumption and the usual sources where beef was purchased.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">3. CONCLUSIONS FROM THE STUDY</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">We have found an association which provides a biologically plausible explanation suggesting that four out of the five people with variant Creutzfeld-Jakob Disease may have been exposed to the BSE agent through the purchase and consumption of beef from a butcher’s shop where the meat could be contaminated with brain tissue. On a national basis, it is unlikely to explain how all of the people who have developed this disease were exposed to the BSE agent.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Assuming that we are correct in our explanation, we have shown that for one of the butchers, the exposure took place before December 1982. For the other the risk of the exposure continued until that butcher ceased trading in 1989. Analysis of the exposure of our cases to this butchering practice points to an incubation period for the development of variant Creutzfeld-Jakob Disease of between ten and sixteen years. This is the first time that it has been possible to provide an estimate of the incubation period.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">We have shown that it is possible to examine by traditional epidemiological methods</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">4. FINAL REPORT OF THE INVESTIGATION INTO THE NORTH LEI...RSHIRE CLUSTER OF VARIANT CREUTZFELDT-JAKOB DISEASE http://www.leics-ha.org.uk/cjd/cjdbrief.htm (5 of 7) [3/21/2001 3:38:40 PM]</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">exposures that took place twenty years ago.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">RECOMMENDATIONS</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The explanation that we have found needs to be tested for other people who have died of variant Creutzfeld-Jakob Disease.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Surveillance for variant Creutzfeld-Jakob Disease needs to be maintained in Leicestershire.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">5. 6. THANKS</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">We would like to pay tribute to the courage of the families of those people who died of variant Creutzfeld-Jakob Disease who through their willingness to relive their pain have helped us to learn more about the way in which this disease spread from animals to people.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">We thank all of those who willingly gave of their time to be interviewed as controls together with the butchers, farmers, auctioneers and others in the food trade who helped us with our study. We would also like to thank all of those who provided us with help and advice in developing our study. In particular we would like to thank Professor Paul Burton, Professor of Genetic Epidemiology, University of Leicester for advice and help with the statistical analysis of the study.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Professor Bob Will and Dr Hester Ward from the National Creutzfeld-Jakob Surveillance Unit. Dr Roland Salmon and Dr Martin Wale from the Communicable Diseases Surveillance Centre of the Public Health Laboratory Service together with Dr Susan Hahne EPIET fellow, CDSC Wales.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Colleagues from University of Leicester Department of Public Health</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Department of Health</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Ministry of Agriculture Fisheries and Food</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Food Standards Agency</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">London School of Hygiene and Tropical Medicine</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Local Authorities</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">We would also like to thank the following without whose help and support we would not have been able to do this work.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The clinical nurse specialists in the Communicable Disease Unit at Leicestershire Health Authority who through their dedication and support enabled us to have the time to carry out this study.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Our families who have put up with our frequent absences from home and long hours of work whilst we completed this study.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">FINAL REPORT OF THE INVESTIGATION INTO THE NORTH LEI...RSHIRE CLUSTER OF VARIANT CREUTZFELDT-JAKOB DISEASE <a href="http://www.leics-ha.org.uk/cjd/cjdbrief.htm" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://www.leics-ha.org.uk/cjd/cjdbrief.htm</a> (6 of 7) [3/21/2001 3:38:40 PM]</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Gerry Bryant and Philip Monk</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Leicestershire Health Authority 17 March 2001</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">BACKGROUND INFORMATION</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">INVESTIGATION OF VARIANT CREUTZFELD-JAKOB DISEASE</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">All people with variant Creutzfeld-Jakob disease are reported to the National Creutzfeld-Jakob Disease Surveillance Unit, which is based in Edinburgh. Doctors from the unit visit all people with the disease. A detailed history is taken and the diagnosis reviewed.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">MEAT AND BONE MEAL</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Meat and bone meal is a protein supplement fed to cattle. It was made from rendering the parts of sheep, pigs, chickens and cattle that were not consumed by people.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">As little as I gram of infected material when fed to cattle is known to cause BSE in 70% of those animals fed the infected material.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">In December 1988 it was recognised that the likely way in which BSE was spread was through feeding cattle protein supplements containing meat and bone meal. In November 1989, through a voluntary ban, Animal food manufacturers stopped the inclusion of any Specified Bovine Offal in Meat and Bone Meal fed to ruminants. This voluntary ban was made law in September 1990 in the Bovine Spongiform Encephalopathy (No 2) Amendment Order 1990.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">TERMINOLOGY</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">BSE Bovine Spongiform Encephalopathy</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Captive bolt stunner</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">An instrument for stunning animals before slaughter, powered by a cartridge or compressed air which drives a bolt out of a barrel for some four inches and then retracts it into the barrel. Pithing</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Insertion of a rod through the stun hole in the head of cattle to prevent the animal kicking (a reflex action which sometimes occurs after stunning) </div><div style="outline: none;"><br style="outline: none;" /></div></div><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20060103024352/http://www.dh.gov.uk/assetRoot/04/07/68/42/04076842.pdf" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://webarchive.nationalarchives.gov.uk/ukgwa/20060103024352/http://www.dh.gov.uk/assetRoot/04/07/68/42/04076842.pdf</a><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="outline: none;"><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="outline: none;"><div data-setdir="false" dir="ltr" style="outline: none;"><div style="outline: none;">ZM0306: Historic butchery practices</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Wednesday 25 June 2003</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">This research project aims to determine whether butchery practices prevalent in the Queniborough area, which may have resulted in the cluster of vCJD cases, were common practice in the UK.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Study Duration Contractor Background Research Approach</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Study Duration: March 2003 to September 2003</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Contractor: Det Norske Veritas Consulting</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Background</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The report by the Leicestershire Health Authority (LHA) into the cluster of vCJD cases around Queniborough concluded that there was an association with the consumption of beef purchased from butchers where there was a risk of cross-contamination of beef carcass meat with bovine brain. The objective of this study is to determine to what extent the activities of potential concern identified in the Queniborough report were common practice throughout the UK during the peak of the BSE epidemic (1980 to 1995).</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Research Approach</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">If possible, the study will consider how such practices may have altered over time and the impact of legislative changes. In addition the study will consider any other factors related to butchery practices that may have affected exposure to infectivity (e.g. sale of brain for human consumption).</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20090101025324/http://www.food.gov.uk/science/research/researchinfo/bseresearch/tseresearch/m03programme/m03projilist/zm0306/" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://webarchive.nationalarchives.gov.uk/ukgwa/20090101025324/http://www.food.gov.uk/science/research/researchinfo/bseresearch/tseresearch/m03programme/m03projilist/zm0306/</a></div></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">EIGHTY-SECOND MEETING OF THE SPONGIFORM ENCEPHALOPATHY ADVISORY COMMITTEE</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The Spongiform Encephalopathy Advisory Committee (SEAC) held its 82nd meeting in London on 29th April 2004, when it discussed the following matters:</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">USES OF UK COLLAGEN FROM HIDES OF UK CATTLE</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">In 1999 the Bovine and Bovine Products (Trade) Regulations 1999 (BBPT Regulations), prohibited the production of collagen from UK bovine hides for non-technical uses. SEAC were asked to consider the risk implications if this legislation was amended to allow the sourcing of collagen from hides of UK bovines for nontechnical use. SEAC were content with the proposed use of UK collagen for food use as the potential risk would be minimal given that the collagen would be sourced from animals fit for human consumption. In considering the risk implications for use of UK derived collagen in pharmaceutical and medical products, SEAC asked for additional information on the regulations governing enduse of collagen in these products. SEAC asked for further information on the prevalence of BSE in UK and other European countries before they could consider the relative risk of sourcing European versus UK derived bovine material.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">SURVEY OF HISTORIC BUTCHERY PRACTICES</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">SEAC considered the results of the survey of historic butchery practices undertaken by DNV Consulting on behalf of the Food Standards Agency. The survey was commissioned following a report of an investigation by the Leicestershire Health Authority into a cluster of vCJD cases in the village of Queniborough which suggested that local butchery practices may have constituted a high risk in terms of transmission of infected material.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">© SEAC 2004</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Page 2 of 2</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">SEAC agreed with the conclusions of the survey that showed that the butchery practices in the Leicestershire area were not sufficiently different from the rest of the UK to provide a simple explanation for the cluster of vCJD cases. Although the survey confirmed that at that time, brain matter did go into the human food chain, there had been no observed increase in vCJD cases in those groups (older persons) thought to have been most likely to have consumed bovine brains. Also the survey suggested that much bovine brain produced in the UK at that time was exported to France rather than used for domestic consumption.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">vCJD UPDATE</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">SEAC was updated on the latest statistics from the National CJD surveillance unit. Up until April 2004, a total of 146 vCJD cases have been confirmed in the UK, including 5 cases still alive. All vCJD cases tested to date are of the same genotype at codon 129 of the PrP gene (methionine homozygous). Short-term analysis of the number of deaths from vCJD in the UK continues to show statistically significant evidence that the epidemic is no longer increasing exponentially and at least in the short term, the epidemic may have peaked or come to a plateau.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">SEAC 2004</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Page 2 of 2</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">'''Although the survey confirmed that at that time, brain matter did go into the human food chain''</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20050301193529/http://www.seac.gov.uk/summaries/seac82_summary.pdf" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://webarchive.nationalarchives.gov.uk/ukgwa/20050301193529/http://www.seac.gov.uk/summaries/seac82_summary.pdf</a></div><div style="outline: none;"><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="outline: none;"><div style="outline: none;">Historic Butchery Practices </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Objective </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The objective of this study is to determine to what extent the activities of potential concern identified in the Queniborough report were common practice throughout the UK during the peak of the BSE epidemic (1980 to 1995).</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">More information This research project aims to determine whether butchery practices prevalent in the Queniborough area, which may have resulted in the cluster of vCJD cases, were common practice in the UK.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The report by the Leicestershire Health Authority (LHA) into the cluster of vCJD cases around Queniborough concluded that there was an association with the consumption of beef purchased from butchers where there was a risk of cross-contamination of beef carcass meat with bovine brain.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Find more about this project and other FSA food safety-related projects at the </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">http://www.food.gov.uk/science/research/&quot; target="_blank</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Food Standards Agency Research webpage</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="outline: none;"><span style="outline: none;">''The report by the Leicestershire Health Authority (LHA) into the cluster of vCJD cases around Queniborough concluded that there was an association with the consumption of beef purchased from butchers where there was a risk of cross-contamination of beef carcass meat with bovine brain.''</span><br style="outline: none;" /></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://www.nal.usda.gov/research-tools/food-safety-research-projects/historic-butchery-practices" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://www.nal.usda.gov/research-tools/food-safety-research-projects/historic-butchery-practices</a></div></div><div style="outline: none;"><br style="outline: none;" /></div></div></div><div style="outline: none;"><div style="outline: none;">THE tse prion aka mad cow type disease is not your normal pathogen. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The TSE prion disease survives ashing to 600 degrees celsius, that’s around 1112 degrees farenheit. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">you cannot cook the TSE prion disease out of meat. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">you can take the ash and mix it with saline and inject that ash into a mouse, and the mouse will go down with TSE. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Prion Infected Meat-and-Bone Meal Is Still Infectious after Biodiesel Production as well. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">the TSE prion agent also survives Simulated Wastewater Treatment Processes. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">IN fact, you should also know that the TSE Prion agent will survive in the environment for years, if not decades. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">you can bury it and it will not go away. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The TSE agent is capable of infected your water table i.e. Detection of protease-resistant cervid prion protein in water from a CWD-endemic area. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">it’s not your ordinary pathogen you can just cook it out and be done with. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">***> that’s what’s so worrisome about Iatrogenic mode of transmission, a simple autoclave will not kill this TSE prion agent.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">1: J Neurol Neurosurg Psychiatry 1994 Jun;57(6):757-8 </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">***> Transmission of Creutzfeldt-Jakob disease to a chimpanzee by electrodes contaminated during neurosurgery. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Gibbs CJ Jr, Asher DM, Kobrine A, Amyx HL, Sulima MP, Gajdusek DC. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Laboratory of Central Nervous System Studies, National Institute of </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Neurological Disorders and Stroke, National Institutes of Health, </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Bethesda, MD 20892. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Stereotactic multicontact electrodes used to probe the cerebral cortex of a middle aged woman with progressive dementia were previously implicated in the accidental transmission of Creutzfeldt-Jakob disease (CJD) to two younger patients. The diagnoses of CJD have been confirmed for all three cases. More than two years after their last use in humans, after three cleanings and repeated sterilisation in ethanol and formaldehyde vapour, the electrodes were implanted in the cortex of a chimpanzee. Eighteen months later the animal became ill with CJD. This finding serves to re-emphasise the potential danger posed by reuse of instruments contaminated with the agents of spongiform encephalopathies, even after scrupulous attempts to clean them. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">PMID: 8006664 [PubMed - indexed for MEDLINE] </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://www.ncbi.nlm.nih.gov/pubmed/8006664?dopt=Abstract" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://www.ncbi.nlm.nih.gov/pubmed/8006664?dopt=Abstract</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">New studies on the heat resistance of hamster-adapted scrapie agent: Threshold survival after ashing at 600°C suggests an inorganic template of replication </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="http://www.pnas.org/content/97/7/3418.full" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://www.pnas.org/content/97/7/3418.full</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Prion Infected Meat-and-Bone Meal Is Still Infectious after Biodiesel Production </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2493038/" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2493038/</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">MONDAY, APRIL 19, 2021</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Evaluation of the application for new alternative biodiesel production process for rendered fat including Category 1 animal by-products (BDI-RepCat® process, AT) ???</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://transmissiblespongiformencephalopathy.blogspot.com/2021/04/evaluation-of-application-for-new.html" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://transmissiblespongiformencephalopathy.blogspot.com/2021/04/evaluation-of-application-for-new.html</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Detection of protease-resistant cervid prion protein in water from a CWD-endemic area </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://www.ncbi...nlm.nih.gov/pmc/articles/PMC2802782/pdf/prion0303_0171.pdf" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://www.ncbi...nlm.nih.gov/pmc/articles/PMC2802782/pdf/prion0303_0171.pdf</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">A Quantitative Assessment of the Amount of Prion Diverted to Category 1 Materials and Wastewater During Processing </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="http://onlinelibrary.wiley.com/doi/10.1111/j.1539-6924.2012.01922.x/abstract" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://onlinelibrary.wiley.com/doi/10.1111/j.1539-6924.2012.01922.x/abstract</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Rapid assessment of bovine spongiform encephalopathy prion inactivation by heat treatment in yellow grease produced in the industrial manufacturing process of meat and bone meals </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://bmcvetres.biomedcentral.com/track/pdf/10.1186/1746-6148-9-134.pdf" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://bmcvetres.biomedcentral.com/track/pdf/10.1186/1746-6148-9-134.pdf</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">THURSDAY, FEBRUARY 28, 2019 </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">BSE infectivity survives burial for five years with only limited spread</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://link.springer.com/content/pdf/10.1007%2Fs00705-019-04154-8.pdf" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://link.springer.com/content/pdf/10.1007%2Fs00705-019-04154-8.pdf</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Paper</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Rapid recontamination of a farm building occurs after attempted prion removal</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Kevin Christopher Gough BSc (Hons), PhD Claire Alison Baker BSc (Hons) Steve Hawkins MIBiol Hugh Simmons BVSc, MRCVS, MBA, MA Timm Konold DrMedVet, PhD, MRCVS … See all authors </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">First published: 19 January 2019 https://doi.org/10.1136/vr.105054</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"> The data illustrates the difficulty in decontaminating farm buildings from scrapie, and demonstrates the likely contribution of farm dust to the recontamination of these environments to levels that are capable of causing disease.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">snip...</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">This study clearly demonstrates the difficulty in removing scrapie infectivity from the farm environment. Practical and effective prion decontamination methods are still urgently required for decontamination of scrapie infectivity from farms that have had cases of scrapie and this is particularly relevant for scrapiepositive goatherds, which currently have limited genetic resistance to scrapie within commercial breeds.24 This is very likely to have parallels with control efforts for CWD in cervids.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://bvajournals.onlinelibrary.wiley.com/doi/abs/10.1136/vr.105054" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://bvajournals.onlinelibrary.wiley.com/doi/abs/10.1136/vr.105054</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">***>This is very likely to have parallels with control efforts for CWD in cervids.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://pubmed.ncbi.nlm.nih.gov/30602491/" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://pubmed.ncbi.nlm.nih.gov/30602491/</a> </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">***> Infectious agent of sheep scrapie may persist in the environment for at least 16 years</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">***> Nine of these recurrences occurred 14–21 years after culling, apparently as the result of environmental contamination, but outside entry could not always be absolutely excluded. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">JOURNAL OF GENERAL VIROLOGY Volume 87, Issue 12</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Infectious agent of sheep scrapie may persist in the environment for at least 16 years Free</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Gudmundur Georgsson1, Sigurdur Sigurdarson2, Paul Brown3</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="http://www.microbiologyresearch.org/docserver/fulltext/jgv/87/12/3737.pdf?expires=1540908280&id=id&accname=guest&checksum=ED0572E1E5B272C100A32212A3E3761A" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://www.microbiologyresearch.org/docserver/fulltext/jgv/87/12/3737.pdf?expires=1540908280&id=id&accname=guest&checksum=ED0572E1E5B272C100A32212A3E3761A</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Front. Vet. Sci., 14 September 2015 | https://doi.org/10.3389/fvets.2015.00032</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Objects in contact with classical scrapie sheep act as a reservoir for scrapie transmission</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">imageTimm Konold1*, imageStephen A. C. Hawkins2, imageLisa C. Thurston3, imageBen C. Maddison4, imageKevin C. Gough5, imageAnthony Duarte1 and imageHugh A. Simmons1</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The findings of this study highlight the role of field furniture used by scrapie-infected sheep to act as a reservoir for disease re-introduction although infectivity declines considerably if the field furniture has not been in contact with scrapie-infected sheep for several months. PMCA may not be as sensitive as VRQ/VRQ sheep to test for environmental contamination.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">snip...</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Discussion </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">snip...</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">In conclusion, the results in the current study indicate that removal of furniture that had been in contact with scrapie-infected animals should be recommended, particularly since cleaning and decontamination may not effectively remove scrapie infectivity (31), even though infectivity declines considerably if the pasture and the field furniture have not been in contact with scrapie-infected sheep for several months. As sPMCA failed to detect PrPSc in furniture that was subjected to weathering, even though exposure led to infection in sheep, this method may not always be reliable in predicting the risk of scrapie infection through environmental contamination. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="http://journal.frontiersin.org/article/10.3389/fvets.2015.00032/full" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://journal.frontiersin.org/article/10.3389/fvets.2015.00032/full</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">***> 172. Establishment of PrPCWD extraction and detection methods in the farm soil</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Kyung Je Park, Hoo Chang Park, In Soon Roh, Hyo Jin Kim, Hae-Eun Kang and Hyun Joo Sohn</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Foreign Animal Disease Division, Animal and Plant Quarantine Agency, Gimcheon, Gyeongsangbuk-do, Korea</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Conclusions: Our studies showed that PrPCWD persist in 0.001% CWD contaminated soil for at least 4 year and natural CWD-affected farm soil. When cervid reintroduced into CWD outbreak farm, the strict decontamination procedures of the infectious agent should be performed in the environment of CWD-affected cervid habitat.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://www.tandfonline.com/doi/full/10.1080/19336896.2019.1615197" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://www.tandfonline.com/doi/full/10.1080/19336896.2019.1615197</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">5 or 6 years quarantine is NOT LONG ENOUGH FOR CWD TSE PRION !!!</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">QUARANTINE NEEDS TO BE 21 YEARS FOR CWD TSE PRION !</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">FRIDAY, APRIL 30, 2021 </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Should Property Evaluations Contain Scrapie, CWD, TSE PRION Environmental Contamination of the land?</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">***> Confidential!!!!</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">***> As early as 1992-3 there had been long studies conducted on small pastures containing scrapie infected sheep at the sheep research station associated with the Neuropathogenesis Unit in Edinburgh, Scotland. Whether these are documented...I don't know. But personal recounts both heard and recorded in a daily journal indicate that leaving the pastures free and replacing the topsoil completely at least 2 feet of thickness each year for SEVEN years....and then when very clean (proven scrapie free) sheep were placed on these small pastures.... the new sheep also broke out with scrapie and passed it to offspring. I am not sure that TSE contaminated ground could ever be free of the agent!! A very frightening revelation!!!</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">---end personal email---end...tss</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">and so it seems...</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Scrapie Agent (Strain 263K) Can Transmit Disease via the Oral Route after Persistence in Soil over Years</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Published: May 9, 2007</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">snip...</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Our results showed that 263K scrapie agent can persist in soil at least over 29 months. Strikingly, not only the contaminated soil itself retained high levels of infectivity, as evidenced by oral administration to Syrian hamsters, but also feeding of aqueous soil extracts was able to induce disease in the reporter animals. We could also demonstrate that PrPSc in soil, extracted after 21 months, provides a catalytically active seed in the protein misfolding cyclic amplification (PMCA) reaction. PMCA opens therefore a perspective for considerably improving the detectability of prions in soil samples from the field.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">snip...</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0000435" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0000435</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Dr. Paul Brown Scrapie Soil Test BSE Inquiry Document</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://web.archive.org/web/20090505211734/http://www.bseinquiry.gov.uk/files/sc/Seac07/tab03.pdf" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://web.archive.org/web/20090505211734/http://www.bseinquiry.gov.uk/files/sc/Seac07/tab03.pdf</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Sensitive detection of chronic wasting disease prions recovered from environmentally relevant surfaces</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Environment International</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Available online 13 June 2022, 107347</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Environment International</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Sensitive detection of chronic wasting disease prions recovered from environmentally relevant surfaces</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Qi Yuana Gag e Rowdenb Tiffany M.Wolfc Marc D.Schwabenlanderb Peter A.LarsenbShannon L.Bartelt-Huntd Jason C.Bartza</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">a Department of Medical Microbiology and Immunology, Creighton University, Omaha, Nebraska, 68178, United States of America</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">b Department of Veterinary and Biomedical Sciences, University of Minnesota, Saint Paul, MN, 55108, United States of America</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">c Department of Veterinary Population Medicine, University of Minnesota, Saint Paul, MN, 55108, United States of America</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">d Department of Civil and Environmental Engineering, Peter Kiewit Institute, University of Nebraska-Lincoln, Omaha, Nebraska, 68182, United States of America</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Received 26 April 2022, Revised 8 June 2022, Accepted 9 June 2022, Available online 13 June 2022.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://doi.org/10.1016/j.envint.2022.107347" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://doi.org/10.1016/j.envint.2022.107347</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Get rights and content</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Under a Creative Commons license Open access</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Highlights • An innovative method for prion recovery from swabs was developed.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">• Recovery of prions decreased as swab-drying time was increased.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">• Recovery of CWD prions from stainless steel and glass was approximately 30%.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">• RT-QuIC enhanced CWD prion detection by 4 orders of magnitude.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">• Surface-recovered CWD prion was sufficient for efficient RT-QuIC detection. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Abstract</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Chronic wasting disease (CWD) has been identified in 30 states in the United States, four provinces in Canada, and recently emerged in Scandinavia. The association of CWD prions with environmental materials such as soil, plants, and surfaces may enhance the persistence of CWD prion infectivity in the environment exacerbating disease transmission. Identifying and quantifying CWD prions in the environment is significant for prion monitoring and disease transmission control. A systematic method for CWD prion quantification from associated environmental materials, however, does not exist. In this study, we developed an innovative method for extracting prions from swabs and recovering CWD prions swabbed from different types of surfaces including glass, stainless steel, and wood. We found that samples dried on swabs were unfavorable for prion extraction, with the greatest prion recovery from wet swabs. Using this swabbing technique, the recovery of CWD prions dried to glass or stainless steel was approximately 30% in most cases, whereas that from wood was undetectable by conventional prion immunodetection techniques. Real-time quake-induced conversion (RT-QuIC) analysis of these same samples resulted in an increase of the detection limit of CWD prions from stainless steel by 4 orders of magnitude. More importantly, the RT-QuIC detection of CWD prions recovered from stainless steel surfaces using this method was similar to the original CWD prion load applied to the surface. This combined surface swabbing and RT-QuIC detection method provides an ultrasensitive means for prion detection across many settings and applications.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">snip...</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">5. Conclusions</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Chronic wasting disease is spreading in North America and it is hypothesized that in CWD-endemic areas environmental persistence of CWD prions can exacerbate disease transmission. The development of a sensitive CWD prion detection method from environmentally relevant surfaces is significant for monitoring, risk assessment, and control of CWD. In this study, we developed a novel swab-extraction procedure for field deployable sampling of CWD prions from stainless steel, glass, and wood. We found that extended swab-drying was unfavorable for extraction, indicating that hydrated storage of swabs after sampling aided in prion recovery. Recoverable CWD prions from stainless steel and glass was approximately 30%, which was greater than from wood. RT-QuIC analysis of the swab extracts resulted in an increase of the detection limit of CWD prions from stainless steel by 4 orders of magnitude compared to conventional immunodetection techniques. More importantly, the RT-QuIC detection of CWD prions recovered from stainless steel surfaces using this developed method was similar to the original CWD prion load without surface contact. This method of prion sampling and recovery, in combination with ultrasensitive detection methods, allows for prion detection from contaminated environmental surfaces.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://www.sciencedirect.com/science/article/pii/S0160412022002744?via%3Dihub" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://www.sciencedirect.com/science/article/pii/S0160412022002744?via%3Dihub</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Published: 06 September 2021</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">***> Chronic wasting disease: a cervid prion infection looming to spillover</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Alicia Otero, Camilo Duque Velásquez, Judd Aiken & Debbie McKenzie </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Veterinary Research volume 52, Article number: 115 (2021) </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://veterinaryresearch.biomedcentral.com/articles/10.1186/s13567-021-00986-y" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://veterinaryresearch.biomedcentral.com/articles/10.1186/s13567-021-00986-y</a><br style="outline: none;" /></div></div><div style="outline: none;"><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="outline: none;"><div style="outline: none;"><div dir="ltr" style="font-family: helvetica; font-size: 15px; line-height: 1.4; margin: 0px 0px 15px; outline: none;"><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><span face="Helvetica, Arial, sans-serif" style="outline: none;">WAHIS, WOAH, OIE, REPORT Switzerland Bovine Spongiform Encephalopathy Atypical L-Type 2023/03/08<br style="outline: none;" /></span></div><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><span face="Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><span face="Helvetica, Arial, sans-serif" style="outline: none;">Switzerland Bovine Spongiform Encephalopathy Atypical L-Type</span><br style="outline: none;" /></div><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><div style="font-family: Helvetica, Arial, sans-serif; outline: none;"><br style="outline: none;" /></div><div style="font-family: Helvetica, Arial, sans-serif; outline: none;">Switzerland - Bovine spongiform encephalopathy - Immediate notification</div><div style="font-family: Helvetica, Arial, sans-serif; outline: none;"><br style="outline: none;" /></div><div style="font-family: Helvetica, Arial, sans-serif; outline: none;"><a href="https://wahis.woah.org/#/in-review/4962" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://wahis.woah.org/#/in-review/4962</a></div></div></div><div dir="ltr" style="font-family: helvetica; font-size: 15px; line-height: 1.4; margin: 0px 0px 15px; outline: none;"><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><span face="Helvetica, Arial, sans-serif" style="outline: none;"><span style="font-family: arial; outline: none;">BRAZIL BSE START DATE 2023/01/18</span><br style="outline: none;" /></span></div><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><span face="Helvetica, Arial, sans-serif" style="outline: none;"><span style="font-family: arial; outline: none;"><br style="outline: none;" /></span></span></div><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><span face="Helvetica, Arial, sans-serif" style="outline: none;"><span style="font-family: arial; outline: none;">BRAZIL BSE CONFIRMATION DATE 2023/02/22<br style="outline: none;" /></span></span></div><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><span face="Helvetica, Arial, sans-serif" style="outline: none;"><span style="font-family: arial; outline: none;"><br style="outline: none;" /></span></span></div><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><span face="Helvetica, Arial, sans-serif" style="outline: none;"><span style="font-family: arial; outline: none;">BRAZIL BSE END DATE 2023/03/03<br style="outline: none;" /></span></span></div><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><span face="Helvetica, Arial, sans-serif" style="outline: none;"><span style="font-family: arial; outline: none;"><br style="outline: none;" /></span></span></div><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><a href="https://wahis.woah.org/#/in-review/4918" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://wahis.woah.org/#/in-review/4918</a><span face="Helvetica, Arial, sans-serif" style="outline: none;"><span style="font-family: arial; outline: none;"><br style="outline: none;" /></span></span></div><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><span face="Helvetica, Arial, sans-serif" style="outline: none;"><span style="font-family: arial; outline: none;"><br style="outline: none;" /></span></span></div><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><span face="Helvetica, Arial, sans-serif" style="outline: none;"><span style="font-family: arial; outline: none;">SPAIN BSE START DATE 2023/01/21</span></span></div><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><span face="Helvetica, Arial, sans-serif" style="outline: none;"><span style="font-family: arial; outline: none;"><br style="outline: none;" /></span></span></div><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><span face="Helvetica, Arial, sans-serif" style="outline: none;"><span style="font-family: arial; outline: none;">SPAIN BSE CONFIRMATION DATE 2023/02/03<br style="outline: none;" /></span></span></div><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><span face="Helvetica, Arial, sans-serif" style="outline: none;"><span style="font-family: arial; outline: none;"><br style="outline: none;" /></span></span></div><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><span face="Helvetica, Arial, sans-serif" style="outline: none;"><span style="font-family: arial; outline: none;">SPAIN BSE END DATE 2023/02/06<br style="outline: none;" /></span></span></div><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><span face="Helvetica, Arial, sans-serif" style="outline: none;"><span style="font-family: arial; outline: none;"><br style="outline: none;" /></span></span></div><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><a href="https://wahis.woah.org/#/in-review/4888" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://wahis.woah.org/#/in-review/4888</a><span face="Helvetica, Arial, sans-serif" style="outline: none;"><span style="font-family: arial; outline: none;"><br style="outline: none;" /></span></span></div><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><span face="Helvetica, Arial, sans-serif" style="outline: none;"><span style="font-family: arial; outline: none;"><br style="outline: none;" /></span></span></div><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><span face="Helvetica, Arial, sans-serif" style="outline: none;"><span style="font-family: arial; outline: none;">NETHERLANDS BSE START DATE 2023/02/01</span></span></div><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><span face="Helvetica, Arial, sans-serif" style="outline: none;"><span style="font-family: arial; outline: none;"><br style="outline: none;" /></span></span></div><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><span face="Helvetica, Arial, sans-serif" style="outline: none;"><span style="font-family: arial; outline: none;">NETHERLANDS BSE CONFIRMATION DATE 2023/02/01</span></span></div><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><span face="Helvetica, Arial, sans-serif" style="outline: none;"><span style="font-family: arial; outline: none;"><br style="outline: none;" /></span></span></div><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><span face="Helvetica, Arial, sans-serif" style="outline: none;"><span style="font-family: arial; outline: none;">NETHERLANDS BSE END DATE 2023/03/13<br style="outline: none;" /></span></span></div><div style="font-family: arial; font-size: 16px; outline: none;"><span face="Helvetica, Arial, sans-serif" style="outline: none;"><br style="outline: none;" /></span></div><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><a href="https://wahis.woah.org/#/in-review/4876" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://wahis.woah.org/#/in-review/4876</a></div></div><div dir="ltr" style="font-family: helvetica; font-size: 15px; line-height: 1.4; margin: 0px 0px 15px; outline: none;">NOW before you go off and start repeating BSE TSE Prion science that is almost 50 years old, let's be perfectly clear what science is saying today, and especially what the WAHIS/WOAH/OIE et al are saying about the atypical BSE strains...</div><div dir="ltr" style="font-family: helvetica; font-size: 15px; line-height: 1.4; margin: 0px 0px 15px; outline: none;"><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><div dir="ltr" style="outline: none;"><div dir="ltr" style="outline: none;"><div dir="ltr" style="outline: none;"><div style="outline: none;">OIE Conclusions on transmissibility of atypical BSE among cattle</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Given that cattle have been successfully infected by the oral route, at least for L-BSE, it is reasonable to conclude that atypical BSE is potentially capable of being recycled in a cattle population if cattle are exposed to contaminated feed. In addition, based on reports of atypical BSE from several countries that have not had C-BSE, it appears likely that atypical BSE would arise as a spontaneous disease in any country, albeit at a very low incidence in old cattle. In the presence of livestock industry practices that would allow it to be recycled in the cattle feed chain, it is likely that some level of exposure and transmission may occur. As a result, since atypical BSE can be reasonably considered to pose a potential background level of risk for any country with cattle, the recycling of both classical and atypical strains in the cattle and broader ruminant populations should be avoided. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://www.oie.int/fileadmin/SST/adhocreports/Bovine%20spongiform%20encephalopathy/AN/A_AhG_BSEsurv_RiskAss_Mar2019.pdf" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://www.oie.int/fileadmin/SST/adhocreports/Bovine%20spongiform%20encephalopathy/AN/A_AhG_BSEsurv_RiskAss_Mar2019.pdf</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Annex 7 (contd) AHG on BSE risk assessment and surveillance/March 2019</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">34 Scientific Commission/September 2019</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">3. Atypical BSE</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The Group discussed and endorsed with minor revisions an overview of relevant literature on the risk of atypical BSE being recycled in a cattle population and its zoonotic potential that had been prepared ahead of the meeting by one expert from the Group. This overview is provided as Appendix IV and its main conclusions are outlined below. With regard to the risk of recycling of atypical BSE, recently published research confirmed that the L-type BSE prion (a type of atypical BSE prion) may be orally transmitted to calves1 . In light of this evidence, and the likelihood that atypical BSE could arise as a spontaneous disease in any country, albeit at a very low incidence, the Group was of the opinion that it would be reasonable to conclude that atypical BSE is potentially capable of being recycled in a cattle population if cattle were to be exposed to contaminated feed. Therefore, the recycling of atypical strains in cattle and broader ruminant populations should be avoided.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">The Group acknowledged the challenges in demonstrating the zoonotic transmission of atypical strains of BSE in natural exposure scenarios. Overall, the Group was of the opinion that, at this stage, it would be premature to reach a conclusion other than that atypical BSE poses a potential zoonotic risk that may be different between atypical strains.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">4. Definitions of meat-and-bone meal (MBM) and greaves</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">snip...</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">REFERENCES</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">SNIP...END SEE FULL TEXT;</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="http://web.oie.int/downld/PROC2020/A_SCAD_Sept2019.pdf" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://web.oie.int/downld/PROC2020/A_SCAD_Sept2019.pdf</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Consumption of L-BSE–contaminated feed may pose a risk for oral transmission of the disease agent to cattle.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5324790/" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5324790/</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Thus, it is imperative to maintain measures that prevent the entry of tissues from cattle possibly infected with the agent of L-BSE into the food chain.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3310119/" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3310119/</a></div></div></div></div><div dir="ltr" style="outline: none;"><br style="outline: none;" /></div></div><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><div dir="ltr" style="outline: none;">''H-TYPE BSE AGENT IS TRANSMISSIBLE BY THE ORONASAL ROUTE''</div><div dir="ltr" style="outline: none;"><br style="outline: none;" /></div><div dir="ltr" style="outline: none;"><div style="outline: none;">This study demonstrates that the H-type BSE agent is transmissible by the oronasal route. These results reinforce the need for ongoing surveillance for classical and atypical BSE to minimize the risk of potentially infectious tissues entering the animal or human food chains.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://www.ars.usda.gov/research/publications/publication/?seqNo115=353094" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://www.ars.usda.gov/research/publications/publication/?seqNo115=353094</a></div></div></div></div><div dir="ltr" style="font-family: helvetica; font-size: 15px; line-height: 1.4; margin: 0px 0px 15px; outline: none;">IT is imperative that the USA puts forth immediately a MANDATORY National Animal Identification System and Country Of Origin Labeling System, for the sake of livestock industry and the consumers that consume their products...terry</div><div dir="ltr" style="font-size: 15px; line-height: 1.4; margin: 0px 0px 15px; outline: none;"><div style="font-family: helvetica; outline: none;"><div style="font-family: arial; font-size: 16px; outline: none;"><div style="outline: none;">We recently observed the direct transmission of a natural classical scrapie isolate to macaque after a 10-year silent incubation period, with features similar to some reported for human cases of sporadic CJD, albeit requiring fourfold longe incubation than BSE. Scrapie, as recently evoked in humanized mice (Cassard, 2014), is the third potentially zoonotic PD (with BSE and L-type BSE), thus questioning the origin of human sporadic cases. We will present an updated panorama of our different transmission studies and discuss the implications of such extended incubation periods on risk assessment of animal PD for human health.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5019500/" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5019500/</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">2.3.2. New evidence on the zoonotic potential of atypical BSE and atypical scrapie prion strains</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Olivier Andreoletti, INRA Research Director, Institut National de la Recherche Agronomique (INRA) – École Nationale Vétérinaire de Toulouse (ENVT), invited speaker, presented the results of two recently published scientific articles of interest, of which he is co-author:</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">‘Radical Change in Zoonotic Abilities of Atypical BSE Prion Strains as Evidenced by Crossing of Sheep Species Barrier in Transgenic Mice’ (MarinMoreno et al., 2020) and ‘The emergence of classical BSE from atypical/Nor98 scrapie’ (Huor et al., 2019).</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">In the first experimental study, H-type and L-type BSE were inoculated into transgenic mice expressing all three genotypes of the human PRNP at codon 129 and into adapted into ARQ and VRQ transgenic sheep mice. The results showed the alterations of the capacities to cross the human barrier species (mouse model) and emergence of sporadic CJD agents in Hu PrP expressing mice: type 2 sCJD in homozygous TgVal129 VRQ-passaged L-BSE, and type 1 sCJD in homozygous TgVal 129 and TgMet129 VRQ-passaged H-BSE. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2020.EN-1946" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2020.EN-1946</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">This study demonstrates that the H-type BSE agent is transmissible by the oronasal route. These results reinforce the need for ongoing surveillance for classical and atypical BSE to minimize the risk of potentially infectious tissues entering the animal or human food chains.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://www.ars.usda.gov/research/publications/publication/?seqNo115=353094" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://www.ars.usda.gov/research/publications/publication/?seqNo115=353094</a><br style="outline: none;" /></div></div><div style="font-family: arial; font-size: 16px; outline: none;"><br style="outline: none;" /></div><div dir="ltr" style="font-family: arial; font-size: 16px; outline: none;"><div style="outline: none;">***Moreover, sporadic disease has never been observed in breeding colonies or primate research laboratories, most notably among hundreds of animals over several decades of study at the National Institutes of Health25, and in nearly twenty older animals continuously housed in our own facility.***</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Even if the prevailing view is that sporadic CJD is due to the spontaneous formation of CJD prions, it remains possible that its apparent sporadic nature may, at least in part, result from our limited capacity to identify an environmental origin.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://www.nature.com/articles/srep11573" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://www.nature.com/articles/srep11573</a> </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">O.05: Transmission of prions to primates after extended silent incubation periods: Implications for BSE and scrapie risk assessment in human populations </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Emmanuel Comoy, Jacqueline Mikol, Valerie Durand, Sophie Luccantoni, Evelyne Correia, Nathalie Lescoutra, Capucine Dehen, and Jean-Philippe Deslys Atomic Energy Commission; Fontenay-aux-Roses, France </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Prion diseases (PD) are the unique neurodegenerative proteinopathies reputed to be transmissible under field conditions since decades. The transmission of Bovine Spongiform Encephalopathy (BSE) to humans evidenced that an animal PD might be zoonotic under appropriate conditions. Contrarily, in the absence of obvious (epidemiological or experimental) elements supporting a transmission or genetic predispositions, PD, like the other proteinopathies, are reputed to occur spontaneously (atpical animal prion strains, sporadic CJD summing 80% of human prion cases). </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Non-human primate models provided the first evidences supporting the transmissibiity of human prion strains and the zoonotic potential of BSE. Among them, cynomolgus macaques brought major information for BSE risk assessment for human health (Chen, 2014), according to their phylogenetic proximity to humans and extended lifetime. We used this model to assess the zoonotic potential of other animal PD from bovine, ovine and cervid origins even after very long silent incubation periods. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">*** We recently observed the direct transmission of a natural classical scrapie isolate to macaque after a 10-year silent incubation period, </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">***with features similar to some reported for human cases of sporadic CJD, albeit requiring fourfold long incubation than BSE. Scrapie, as recently evoked in humanized mice (Cassard, 2014), </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">***is the third potentially zoonotic PD (with BSE and L-type BSE), </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">***thus questioning the origin of human sporadic cases. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">We will present an updated panorama of our different transmission studies and discuss the implications of such extended incubation periods on risk assessment of animal PD for human health. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">=============== </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">***thus questioning the origin of human sporadic cases*** </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">=============== </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">***our findings suggest that possible transmission risk of H-type BSE to sheep and human. Bioassay will be required to determine whether the PMCA products are infectious to these animals. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">============== </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">PRION 2015 CONFERENCE</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5019500/" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5019500/</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">***Transmission data also revealed that several scrapie prions propagate in HuPrP-Tg mice with efficiency comparable to that of cattle BSE. While the efficiency of transmission at primary passage was low, subsequent passages resulted in a highly virulent prion disease in both Met129 and Val129 mice. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">***Transmission of the different scrapie isolates in these mice leads to the emergence of prion strain phenotypes that showed similar characteristics to those displayed by MM1 or VV2 sCJD prion. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">***These results demonstrate that scrapie prions have a zoonotic potential and raise new questions about the possible link between animal and human prions. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="http://www.tandfonline.com/doi/abs/10.1080/19336896.2016.1163048?journalCode=kprn20" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://www.tandfonline.com/doi/abs/10.1080/19336896.2016.1163048?journalCode=kprn20</a> </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">PRION <span dir="ltr" style="outline: none;">2016 TOKYO</span></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Saturday, April 23, 2016</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">SCRAPIE <span dir="ltr" style="outline: none;">WS-01</span>: Prion diseases in animals and zoonotic potential 2016</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Prion. 10:S15-S21. 2016 ISSN: <span dir="ltr" style="outline: none;">1933-6896</span> printl 1933-690X online</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Taylor & Francis</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Prion 2016 Animal Prion Disease Workshop Abstracts</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><span dir="ltr" style="outline: none;">WS-01</span>: Prion diseases in animals and zoonotic potential</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Transmission of the different scrapie isolates in these mice leads to the emergence of prion strain phenotypes that showed similar characteristics to those displayed by MM1 or VV2 sCJD prion. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">These results demonstrate that scrapie prions have a zoonotic potential and raise new questions about the possible link between animal and human prions. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="http://www.tandfonline.com/doi/abs/10.1080/19336896.2016.1163048?journalCode=kprn20" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://www.tandfonline.com/doi/abs/10.1080/19336896.2016.1163048?journalCode=kprn20</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">Title: Transmission of scrapie prions to primate after an extended silent incubation period) </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">*** In complement to the recent demonstration that humanized mice are susceptible to scrapie, we report here the first observation of direct transmission of a natural classical scrapie isolate to a macaque after a 10-year incubation period. Neuropathologic examination revealed all of the features of a prion disease: spongiform change, neuronal loss, and accumulation of PrPres throughout the CNS. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">*** This observation strengthens the questioning of the harmlessness of scrapie to humans, at a time when protective measures for human and animal health are being dismantled and reduced as c-BSE is considered controlled and being eradicated. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">*** Our results underscore the importance of precautionary and protective measures and the necessity for long-term experimental transmission studies to assess the zoonotic potential of other animal prion strains. </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="http://www.ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=313160" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">http://www.ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=313160</a></div><div style="outline: none;"><br style="outline: none;" /></div><div dir="ltr" style="outline: none;"><div style="outline: none;">SO, WHO'S UP FOR SOME MORE TSE PRION POKER, WHO'S ALL IN $$$ </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">SO, ATYPICAL SCRAPIE ROUGHLY HAS 50 50 CHANCE ATYPICAL SCRAPIE IS CONTAGIOUS, AS NON-CONTAGIOUS, TAKE YOUR PICK, BUT I SAID IT LONG AGO WHEN USDA OIE ET AL MADE ATYPICAL SCRAPIE A LEGAL TRADING COMMODITY, I SAID YOUR PUTTING THE CART BEFORE THE HORSE, AND THAT'S EXACTLY WHAT THEY DID, and it's called in Texas, TEXAS TSE PRION HOLDEM POKER, WHO'S ALL IN $$$</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">***> AS is considered more likely (subjective probability range 50–66%) that AS is a non-contagious, rather than a contagious, disease.</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">SNIP...SEE;</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">THURSDAY, JULY 8, 2021 </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">EFSA Scientific report on the analysis of the 2‐year compulsory intensified monitoring of atypical scrapie</div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2021.6686" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2021.6686</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2021.6686" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2021.6686</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2021.6686" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2021.6686</a></div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;"><a href="https://efsaopinionbseanimalprotein.blogspot.com/2021/07/efsa-scientific-report-on-analysis-of.html" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://efsaopinionbseanimalprotein.blogspot.com/2021/07/efsa-scientific-report-on-analysis-of.html</a></div></div></div></div></div></div></div><div data-setdir="false" dir="ltr" style="outline: none;"><div data-setdir="false" dir="ltr" style="font-size: 13.3333px; letter-spacing: inherit; outline: none; text-align: justify;"><div style="outline: none;"><div data-setdir="false" dir="ltr" style="font-family: Helvetica, Arial, sans-serif; font-size: 16px; outline: none;"><div style="outline: none;">SUNDAY, OCTOBER 16, 2022 </div><div style="outline: none;"><br style="outline: none;" /></div><div style="outline: none;">USDA Transmissible Spongiform Encephalopathy TSE Prion Action Plan National Program 103 Animal Health 2022-2027 </div><div style="outline: none;"><br style="outline: none;" /></div><div data-setdir="false" dir="ltr" style="outline: none;"><div style="outline: none;"><div data-setdir="false" dir="ltr" style="outline: none;"><a href="https://transmissiblespongiformencephalopathy.blogspot.com/2022/10/usda-transmissible-spongiform.html" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://transmissiblespongiformencephalopathy.blogspot.com/2022/10/usda-transmissible-spongiform.html</a><br style="outline: none;" /></div></div></div><div style="outline: none;"> </div></div><div dir="ltr" style="font-family: Helvetica, Arial, sans-serif; font-size: 16px; outline: none;">SUNDAY, MARCH 19, 2023 </div><div dir="ltr" style="font-family: Helvetica, Arial, sans-serif; font-size: 16px; outline: none;"><br style="outline: none;" /></div><div dir="ltr" style="font-family: Helvetica, Arial, sans-serif; font-size: 16px; outline: none;">Use of Electronic Identification Eartags as Official Identification in Cattle and Bison APHIS-2021-0020-0001 Singeltary </div><div dir="ltr" style="font-family: Helvetica, Arial, sans-serif; font-size: 16px; outline: none;"><br style="outline: none;" /></div><div dir="ltr" style="font-family: Helvetica, Arial, sans-serif; font-size: 16px; outline: none;"><a href="https://naiscoolyes.blogspot.com/2023/03/use-of-electronic-identification.html" rel="nofollow" style="color: #196ad4; outline: none;" target="_blank">https://naiscoolyes.blogspot.com/2023/03/use-of-electronic-identification.html</a></div><div dir="ltr" style="font-family: Helvetica, Arial, sans-serif; font-size: 16px; outline: none;"><br /></div><div dir="ltr" style="font-family: Helvetica, Arial, sans-serif; font-size: 16px; outline: none;"><br /></div><div dir="ltr" style="font-family: Helvetica, Arial, sans-serif; font-size: 16px; outline: none;">Terry S. Singeltary Sr., Bacliff, Texas USA 77518 flounder9@verizon.net</div></div></div></div></div></div>Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-4687453285836897153.post-64468262436438416812022-08-22T15:24:00.000-05:002022-08-22T15:24:04.880-05:00BSE Inquiry Draft Factual Accounts DFAs<p> Greetings PrPs et al, </p><div><div><br /></div><div>i am going over old documents of the early days of the BSE Inquiry days to archive again. most of the old links don't work anymore, so i have updated the links. for those that may find interest, you may want to download for future use. this is what it's going to look like in the USA, when CWD TSE PrP in cervid is finally announced that it is a zoonotic zoonosis disease. imo, science has already proven this, but there has been no official announcement of cwd transmitting to humans, yet. NOT DOCUMENTED anyway. </div><div><br /></div><div>the thing with CWD in cervid, it's much more virulent than c-type BSE in Cattle, with muscle tissue and fat being infectious. see;</div><div><br /></div><div><div style="color: #222222; font-family: Roboto, sans-serif; font-size: 12px; line-height: 1.22em;">Prion Infectivity in Fat of Deer with Chronic Wasting Disease▿ </div><div style="color: #222222; font-family: Roboto, sans-serif; font-size: 12px; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="color: #222222; font-family: Roboto, sans-serif; font-size: 12px; line-height: 1.22em;">Brent Race#, Kimberly Meade-White#, Richard Race and Bruce Chesebro* + Author Affiliations</div><div style="color: #222222; font-family: Roboto, sans-serif; font-size: 12px; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="color: #222222; font-family: Roboto, sans-serif; font-size: 12px; line-height: 1.22em;">In mice, prion infectivity was recently detected in fat. Since ruminant fat is consumed by humans and fed to animals, we determined infectivity titers in fat from two CWD-infected deer. Deer fat devoid of muscle contained low levels of CWD infectivity and might be a risk factor for prion infection of other species. </div><div style="color: #222222; font-family: Roboto, sans-serif; font-size: 12px; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="color: #222222; font-family: Roboto, sans-serif; font-size: 12px; line-height: 1.22em;"><a fg_scanned="1" href="http://jvi.asm.org/content/83/18/9608.full" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://jvi.asm.org/content/83/18/9608.full</a> </div><div style="color: #222222; font-family: Roboto, sans-serif; font-size: 12px; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="color: #222222; font-family: Roboto, sans-serif; font-size: 12px; line-height: 1.22em;">Prions in Skeletal Muscles of Deer with Chronic Wasting Disease </div><div style="color: #222222; font-family: Roboto, sans-serif; font-size: 12px; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="color: #222222; font-family: Roboto, sans-serif; font-size: 12px; line-height: 1.22em;">Here bioassays in transgenic mice expressing cervid prion protein revealed the presence of infectious prions in skeletal muscles of CWD-infected deer, demonstrating that humans consuming or handling meat from CWD-infected deer are at risk to prion exposure. </div><div style="color: #222222; font-family: Roboto, sans-serif; font-size: 12px; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="color: #222222; font-family: Roboto, sans-serif; font-size: 12px; line-height: 1.22em;"><a fg_scanned="1" href="http://science.sciencemag.org/content/311/5764/1117..long" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://science.sciencemag.org/content/311/5764/1117..long</a> </div></div><div><br /></div><div><div>ENVIRONMENT FACTORS FOR THE TRANSMISSION OF CWD TSE PRP</div><div><br /></div><div>Sensitive detection of chronic wasting disease prions recovered from environmentally relevant surfaces<br /></div><div><br /></div><div style="font-size: 10pt;">Environment International</div><div style="font-size: 10pt;"><br /></div><div style="font-size: 10pt;">Available online 13 June 2022, 107347</div><div style="font-size: 10pt;"><br /></div><div style="font-size: 10pt;"><a fg_scanned="1" href="https://doi.org/10.1016/j.envint.2022.107347" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://doi.org/10.1016/j.envint.2022.107347</a><br /></div><div style="font-size: 10pt;"><br /></div><div style="font-size: 10pt;"><a fg_scanned="1" href="https://www.sciencedirect.com/science/article/pii/S0160412022002744?via%3Dihub" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://www.sciencedirect.com/science/article/pii/S0160412022002744?via%3Dihub</a><br /></div><div style="font-size: 10pt;"><br /></div><div style="font-size: 10pt;"><div style="font-family: Helvetica; font-size: 12px; font-stretch: normal; line-height: normal;"><span style="font-size: 12pt;">Research Paper</span></div><div style="font-family: Helvetica; font-size: 12px; font-stretch: normal; line-height: normal; min-height: 13.8px;"><span style="font-size: 12pt;"></span><br /></div><div style="font-family: Helvetica; font-size: 12px; font-stretch: normal; line-height: normal;"><span style="font-size: 12pt;">Cellular prion protein distribution in the vomeronasal organ, parotid, and scent glands of white-tailed deer and mule deer</span></div><div style="font-family: Helvetica; font-size: 12px; font-stretch: normal; line-height: normal; min-height: 13.8px;"><span style="font-size: 12pt;"></span><br /></div><div style="font-family: Helvetica; font-size: 12px; font-stretch: normal; line-height: normal;"><span style="font-size: 12pt;"><a fg_scanned="1" href="https://doi.org/10.1080/19336896.2022.2079888" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://doi.org/10.1080/19336896.2022.2079888</a></span></div><div style="font-family: Helvetica; font-size: 12px; font-stretch: normal; line-height: normal; min-height: 13.8px;"><span style="font-size: 12pt;"></span></div><div style="font-family: Helvetica; font-size: 12px; font-stretch: normal; line-height: normal; min-height: 13.8px;"><span style="font-size: 12pt;"></span><br /></div><div style="font-family: Helvetica; font-size: 12px; font-stretch: normal; line-height: normal;"><span style="font-size: 12pt;"><a fg_scanned="1" href="https://www.tandfonline.com/doi/full/10.1080/19336896.2022.2079888" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://www.tandfonline.com/doi/full/10.1080/19336896.2022.2079888</a></span></div><div><br /></div></div></div><div><div class="yiv8886418337aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt; text-align: justify;"><div class="yiv8886418337aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;"><br /></div><div class="yiv8886418337aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;">TUESDAY, MAY 11, 2021</div><div class="yiv8886418337aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;"><br /></div><div class="yiv8886418337aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;">A Unique Presentation of Creutzfeldt-Jakob Disease in a Patient Consuming Deer Antler Velvet</div><div class="yiv8886418337aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;">Case Reports</div><div class="yiv8886418337aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;"><br /></div><div class="yiv8886418337aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;">A Unique Presentation of Creutzfeldt-Jakob Disease in a Patient Consuming Deer Antler Velvet</div><div class="yiv8886418337aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;"><br /></div><div class="yiv8886418337aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;">*Joseph Wiedemer, *Yanely Sanchez Ceja, An Cao and Ibrahim Mustafa Department of Neurology, Wright State University Boonshoft School of Medicine, USA Article history</div><div class="yiv8886418337aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;"><br /></div><div class="yiv8886418337aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;">Received: 17-02-2021 Revised: 08-03-2021 Accepted: 13-03-2021</div><div class="yiv8886418337aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;"><br /></div><div class="yiv8886418337aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;">Corresponding Author: Joseph Wiedemer Department of Neurology, Wright State University Boonshoft School of Medicine, USA</div><div class="yiv8886418337aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;"><br /></div><div class="yiv8886418337aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;">Email: <a href="mailto:Wiedemer.2@wright.edu" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank" ymailto="mailto:Wiedemer.2@wright.edu">Wiedemer.2@wright.edu</a></div><div class="yiv8886418337aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;"><br /></div><div class="yiv8886418337aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;">*These authors contributed equally to this work and are considered to be co-first authors</div><div class="yiv8886418337aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;"><br /></div><div class="yiv8886418337aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;">Abstract: Creutzfeldt-Jakob Disease (CJD) is a rare rapidly progressive neurodegenerative prion disorder that is usually sporadic but may also be acquired from exposure to infected sources, classically via infections of bovine or human etiology. Cervid transmission of CJD is of particular concern in North America given the rapid spread of Chronic Wasting Disease (CWD)- the Cervid version of CJD. We present a 61-year-old male patient admitted to our service with a one month history of progressive confusion and gait instability, which led to an initial suspicion of Corticobasal Syndrome (CBS) with unusually rapid progression. CJD was also suspected upon learning that the patient began taking deer antler velvet and bovine colostrum supplements roughly two months prior. The diagnosis of CJD was subsequently confirmed by MRI and RT-QuIC CSF assay. Providers should consider Creutzfeldt-Jakob Disease in the differential diagnosis of a patient with cervid exposure and/or in patients with a presentation resembling corticobasal degeneration, especially if symptom onset is rapid. Although it is unclear how this patient acquired CJD, the potential for prion transmission from cervids to humans should be further investigated by the academic community with considerable urgency.</div></div><div class="yiv8886418337aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="font-size: 10pt; letter-spacing: 0px; line-height: 1.22em; margin: 0in 0in 0.0001pt; text-align: justify;"><br /></div><div class="yiv8886418337aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="font-size: 10pt; letter-spacing: 0px; line-height: 1.22em; margin: 0in 0in 0.0001pt; text-align: justify;"><div style="font-family: Arial, Helvetica, sans-serif; font-size: 12px;"><div class="yiv8886418337MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: Calibri, sans-serif; font-size: 11pt; line-height: 14.65pt; margin: 0in;"><div class="yiv8886418337MsoNormal" style="font-family: Arial, Helvetica, sans-serif; font-size: 12pt; letter-spacing: 0px; line-height: 14.65pt; margin: 0cm 0cm 0.0001pt;"><div style="font-family: arial; font-size: 13.3333px;">''We believe that our patient’s case of CJD is highly suspicious for cervid etiology given the circumstances of the case as well as the strong evidence of plausibility reported in published literature. This is the first known case of CJD in a patient who had consumed deer antler velvet. Despite the confirmed diagnosis of CJD, a causal relationship between the patient’s disease and his consumption of deer antler velvet cannot be definitively concluded.''</div><div style="font-family: arial; font-size: 13.3333px;"><br /></div><div style="font-family: arial; font-size: 13.3333px;"><a href="https://thescipub.com/pdf/ajidsp.2021.43.48.pdf" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://thescipub.com/pdf/ajidsp.2021.43.48.pdf</a><br /></div></div><div style="font-family: Arial, Helvetica, sans-serif; font-size: 12px; letter-spacing: 0px;"><div class="yiv8886418337MsoNormal" style="font-size: 12pt; line-height: 14.65pt; margin: 0cm 0cm 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"> </span></div></div><div style="font-family: arial; font-size: 13.3333px;"><div class="yiv8886418337MsoNormal" style="font-family: Arial, Helvetica, sans-serif; font-size: 12pt; letter-spacing: 0px; line-height: 14.65pt; margin: 0cm 0cm 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"><a fg_scanned="1" href="https://creutzfeldt-jakob-disease.blogspot.com/2021/05/a-unique-presentation-of-creutzfeldt.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; cursor: pointer;" target="_blank">https://creutzfeldt-jakob-disease.blogspot.com/2021/05/a-unique-presentation-of-creutzfeldt.html</a></span></div></div></div></div></div></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">BSE Inquiry Draft Factual Accounts DFAs</span><br /></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">Several other accounts will be issued over the next few weeks.</span></div><div><span style="font-size: 13.3333px;"> The Inquiry has now completed Phase One (which were purely fact</span></div><div><span style="font-size: 13.3333px;">finding hearings). Phase Two hearings, dealing with potential criticisms,</span></div><div><span style="font-size: 13.3333px;">clarification and conflicts of evidence will begin in late February 1999. The</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">Inquiry is due to report to Ministers on 30 June 1999.</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">NOTES TO EDITORS</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">1. Draft Factual Accounts issued so far:</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">DFA1: The Southwood Working Party</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">DFA2: The Tyrrell Committee</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">DFA3: SEAC</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">DFA4: CVL (Part 1)</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">DFAS: Early Days</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">DFA6: Slaughter and Compensation</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">DFA7: The Ruminant Feed Ban</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">DFAS8: Introduction of the SBO Ban</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">DFA9: Government and Southwood</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">DFA10: The Introduction of the Animal SBO Ban</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">DFA11: The Touch Test</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">DFA12: The ELISA Test</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">DFA13: The Central Veterinary Laboratory (Part 2)</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">The Inquiry will issue more draft factual accounts in the next few weeks.</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">The accounts are available on the Inquiry website www.bse.org.uk and are</span></div><div><span style="font-size: 13.3333px;">available in hard copy from the Inquiry.</span></div></div><div><br /></div><div><br /></div><div><a fg_scanned="1" href="https://webarchive.nationalarchives.gov.uk/ukgwa/20090505205439/http://www.bseinquiry.gov.uk/evidence/ia/ia2.htm" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://webarchive.nationalarchives.gov.uk/ukgwa/20090505205439/http://www.bseinquiry.gov.uk/evidence/ia/ia2.htm</a><br /></div><div><br /></div><div>1351 Early in the Inquiry, we issued a number of working documents, including a glossary, a dramatis personae and a time-line setting out some of the main events in chronological order. More ambitiously, in December 1998 the Inquiry began to publish draft factual accounts (DFAs) of aspects of the history of BSE and vCJD. The DFAs were placed on our website and sent to witnesses. They were intended to help us clarify the overall picture and to enable all those who were concerned or interested to draw attention to any errors or significant omissions in the drafts. The DFAs were not definitive. We recognised prior to their publication that they could contain errors or omissions. We stressed that DFAs should be treated as no more than working documents, intended to set out relevant evidence in a neutral manner. </div><div><br /></div><div>1352 Following the publication of the first tranche of DFAs, some witnesses raised concerns with us. They were very concerned that substantial amendment was required and that the original drafts were in places inaccurate or misleading. After considering what they said, we produced revised versions of many of the DFAs, taking account of the comments and additions which witnesses had, as we expected, proposed. The revised versions (RFAs) produced with the help of witnesses and others were considerably improved and this assisted us greatly in establishing the course of events. Further DFAs were published as the Inquiry proceeded. Updates to both the DFAs and RFAs were produced in some cases to deal with comments and to draw attention to further relevant evidence. </div><div><br /></div><div>1353 We believe that the DFAs, RFAs and updates assisted many of those who were taking an interest in the Inquiry’s work. We could not produce DFAs for all aspects of the story, but where they were produced, they collated a mass of relevant information in a way which enabled it to be digested and reviewed. They also enabled witnesses to refresh their memory of events and identify evidence upon which they wished to comment. </div><div><br /></div><div>1354 In June 1998 we published a document setting out our understanding of government structures for scientific research. This was followed in 1999 by discussion papers inviting comments on issues relating to the role of the advisory committees, particularly SEAC, and on epidemiology. When the hearing of oral evidence drew to a close, we issued a more general invitation to supply any further comments anyone wished to make.</div><div><br /></div><div><a href="https://jesip.org.uk/uploads/media/incident_reports_and_inquiries/BSE%20Outbreak%20Conclusion.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://jesip.org.uk/uploads/media/incident_reports_and_inquiries/BSE%20Outbreak%20Conclusion.pdf</a><br /></div><div><br /></div>BSE Inquiry Draft Factual Accounts DFAs<div><br /></div><div><table border="0" cellpadding="0" cellspacing="0" style="width: 642px;"><tbody><tr align="LEFT" valign="TOP"><td colspan="2" style="outline: none;" width="641"><p style="margin: 0px; padding: 0px;"><span style="color: black; font-family: Verdana,Tahoma,Arial,Helvetica;">Draft Factual Accounts are not intended to cover all the areas of evidence, to make any judgements about the implications of the facts or to point to any conclusions.</span></p><p style="margin: 0px; padding: 0px;"><span style="color: black; font-family: Verdana,Tahoma,Arial,Helvetica;"><br /></span></p><p style="margin: 0px; padding: 0px;"><span style="color: black; font-family: Verdana,Tahoma,Arial,Helvetica;">The DFAs are intended to help the Committee in the current phase of their work, which is concerned to clarify the overall picture by further investigation of evidence. DFAs are also intended to assist all who are involved with the Inquiry. Each DFA seeks to set out an account of facts relevant to its topic, taking account of material in the Inquiry's Hearing Bundles prior to the date of issue. On occasion, areas where clarification is required may be specifically identified.</span></p><p style="margin: 0px; padding: 0px;"><span style="color: black; font-family: Verdana,Tahoma,Arial,Helvetica;"><br /></span></p><p style="margin: 0px; padding: 0px;"><span style="color: black; font-family: Verdana,Tahoma,Arial,Helvetica;">Please note that the DFAs are not definitive. They may contain errors or omissions. Existing evidence as to the facts may be re-evaluated, and further evidence relevant to the facts may be received. For all these reasons, DFAs should be treated as no more than working documents.</span></p><p style="margin: 0px; padding: 0px;"><span style="color: black; font-family: Verdana,Tahoma,Arial,Helvetica;"><br /></span></p><p style="margin: 0px; padding: 0px;"><span style="color: black; font-family: Verdana,Tahoma,Arial,Helvetica;">Please note that due to the size of the documents, it can take up to 30 minutes on a standard internet connection to download. It is therefore recommended that you download them to your local PC before reading them. Please note that to view the Word versions it is recommended that you view them in Page layout mode.</span></p><p style="margin: 0px; padding: 0px;"><span style="color: black; font-family: Verdana,Tahoma,Arial,Helvetica;"><br /></span></p><p style="margin: 0px; padding: 0px;"><span style="color: black; font-family: Verdana,Tahoma,Arial,Helvetica;">Cover sheets are now available for RFAs 1, 9 and DFAs 18, 23, 25. These cover sheets give details of where further relevant evidence for the RFA/DFA can be found, and if appropriate, list any revisions since publication of the most recent update (if any).<br /> <br /> <br /></span></p></td></tr></tbody></table><span style="font-size: 10pt;">DFA</span></div><div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">Description</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">Issued on</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">Html</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">PDF</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">Updates</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">Html</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">PDF</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">DFA 26 </span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">Public Pronouncements by the CMO, May 1990</span></div><div><br /></div><div>29 November 1999<br /></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;"><a href="https://web.archive.org/web/20001209084800/http://www.bse.org.uk/dfa/dfa26.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://web.archive.org/web/20001209084800/http://www.bse.org.uk/dfa/dfa26.pdf</a></span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">DFA 25</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">Notification of the Ruminant Feed Ban to non-EC countries</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">4 November 1999</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;"><a href="https://web.archive.org/web/20001209084800/http://www.bse.org.uk/dfa/dfa25.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://web.archive.org/web/20001209084800/http://www.bse.org.uk/dfa/dfa25.pdf</a></span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">DFA 24 </span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">Public Pronouncements by the CMO on the human heath implications of BSE, March 1993 and June 1993</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">6 December 1999</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;"><a href="https://web.archive.org/web/20001209084800/http://www.bse.org.uk/dfa/dfa24.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://web.archive.org/web/20001209084800/http://www.bse.org.uk/dfa/dfa24.pdf</a></span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">DFA 23 </span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">Maff statements in 1990 about a cat with a spongiform encephalopathy</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">16 November 1999 </span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;"><a href="https://web.archive.org/web/20001209084800/http://www.bse.org.uk/dfa/dfa23.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://web.archive.org/web/20001209084800/http://www.bse.org.uk/dfa/dfa23.pdf</a><br /></span></div><div><br /></div><div>DFA 22 MIA</div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">DFA 21 </span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">Cattle Tracking</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">23 November 1999 </span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;"><a href="https://web.archive.org/web/20001209084800/http://www.bse.org.uk/dfa/dfa21.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://web.archive.org/web/20001209084800/http://www.bse.org.uk/dfa/dfa21.pdf</a><br /></span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">DFA 20 </span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">Introduction of the ruminant feed ban and compulsory notification of BSE in Northern Ireland</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">3 December 1999 </span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;"><a href="https://web.archive.org/web/20001209084800/http://www.bse.org.uk/dfa/dfa20.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://web.archive.org/web/20001209084800/http://www.bse.org.uk/dfa/dfa20.pdf</a><br /></span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;"> DFA 19 </span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">Dissection of Bovine Eye balls</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">8 November 1999</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;"><a href="https://web.archive.org/web/20001209084800/http://www.bse.org.uk/dfa/dfa19.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://web.archive.org/web/20001209084800/http://www.bse.org.uk/dfa/dfa19.pdf</a></span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">DFA 18 </span></div><div><br /></div><div>Cosmetics<br /></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">29 October 1999</span></div><div><br /></div><div><span style="font-size: 13.3333px;"><a href="https://web.archive.org/web/20001209084800/http://www.bse.org.uk/dfa/dfa18.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://web.archive.org/web/20001209084800/http://www.bse.org.uk/dfa/dfa18.pdf</a> </span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">DFA 17 </span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">Medicines and medical devices</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">7 October 1999</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><a href="https://web.archive.org/web/20001209084800/http://www.bse.org.uk/dfa/dfa17.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://web.archive.org/web/20001209084800/http://www.bse.org.uk/dfa/dfa17.pdf</a><br /></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">DFA 16 </span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">Mid 1995 to the final days</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">7 July 1999</span></div><div><br /></div><div><a href="https://web.archive.org/web/20001209084800/http://www.bse.org.uk/dfa/dfa16.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://web.archive.org/web/20001209084800/http://www.bse.org.uk/dfa/dfa16.pdf</a><br /></div><div><br /></div><div><span style="font-size: 13.3333px;">DFA 15 </span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">Monitoring and Enforcements of the SBO Regulations</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">9 July 1999</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;"><a href="https://web.archive.org/web/20001209084800/http://www.bse.org.uk/dfa/dfa15.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://web.archive.org/web/20001209084800/http://www.bse.org.uk/dfa/dfa15.pdf</a></span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 10pt;">DFA 14 </span><br /></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">Consideration of the Risk from Mechanically Recovered Meat (MRM) in 1989</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;">9 July 1999</span></div><div><span style="font-size: 13.3333px;"><br /></span></div><div><span style="font-size: 13.3333px;"><a href="https://web.archive.org/web/20001209084800/http://www.bse.org.uk/dfa/dfa14.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://web.archive.org/web/20001209084800/http://www.bse.org.uk/dfa/dfa14.pdf</a><br /></span></div><div><span style="font-size: 13.3333px;"> </span></div></div><div><br /></div><div><span style="font-family: Arial, Helvetica, sans-serif; font-size: small;">BSE Inquiry Issues Factual Accounts.</span><br /></div><div><span style="font-family: Arial, Helvetica, sans-serif; font-size: small;"><br /></span></div><div><span style="font-family: Arial, Helvetica, sans-serif; font-size: small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20090505205439mp_/http://www.bseinquiry.gov.uk/files/ia/ia2/tab11.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://webarchive.nationalarchives.gov.uk/ukgwa/20090505205439mp_/http://www.bseinquiry.gov.uk/files/ia/ia2/tab11.pdf</a><br /></span></div><div><br /></div><div><span style="font-family: Arial, Helvetica, sans-serif; font-size: small;">BSE Inquiry Issues more Factual Accounts, 22nd January 1999.</span><br /></div><div><span style="font-family: Arial, Helvetica, sans-serif; font-size: small;"><br /></span></div><div><span style="font-family: Arial, Helvetica, sans-serif; font-size: small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20090505205439mp_/http://www.bseinquiry.gov.uk/files/ia/ia2/tab12.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://webarchive.nationalarchives.gov.uk/ukgwa/20090505205439mp_/http://www.bseinquiry.gov.uk/files/ia/ia2/tab12.pdf</a><br /></span></div><div><br /></div><div><span style="font-family: Arial, Helvetica, sans-serif; font-size: small;">BSE Inquiry Issues more Factual Accounts, 26th January 1999.</span><br /></div><div><span style="font-family: Arial, Helvetica, sans-serif; font-size: small;"><br /></span></div><div><span style="font-family: Arial, Helvetica, sans-serif; font-size: small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20090505205439mp_/http://www.bseinquiry.gov.uk/files/ia/ia2/tab13.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://webarchive.nationalarchives.gov.uk/ukgwa/20090505205439mp_/http://www.bseinquiry.gov.uk/files/ia/ia2/tab13.pdf</a><br /></span></div><div><br /></div><div><br /></div><div>terry</div>Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-4687453285836897153.post-88359103953543780332020-07-27T11:54:00.001-05:002022-11-26T16:14:55.427-06:00BSE Inquiry DFA's a review<div style="font-family: arial; font-size: 13.3333px;">
BSE Inquiry DFA's a review</div>
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BSE Inquiry </div>
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Sunday, May 18, 2008 BSE, CJD, and Baby foods (the great debate 1999 to 2005)</div>
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TUESDAY, AUGUST 1, 2017</div>
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BSE INQUIRY DFA 17 Medicines and medical devices</div>
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Sunday, May 18, 2008<br />
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MAD COW DISEASE BSE CJD CHILDREN VACCINES</div>
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MONDAY, MAY 19, 2008</div>
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SPORADIC CJD IN FARMERS, FARMERS WIVES, FROM FARMS WITH BSE HERD AND ABATTOIRS</div>
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THURSDAY, JULY 22, 2010</div>
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Sunday, May 18, 2008</div>
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BSE Inquiry DRAFT FACTUAL ACCOUNT DFA</div>
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BSE Inquiry DRAFT FACTUAL ACCOUNTS DFA's</div>
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DFA 15 Monitoring and Enforcement of the SBO Specified Bovine Offal Regulations</div>
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SATURDAY, AUGUST 26, 2017</div>
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DFA 14 Consideration of the Risk from Mechanically Recovered Meat (MRM) in 1989-1990</div>
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<a fg_scanned="1" href="http://bseinquiry.blogspot.com/2012/04/wendy-grant-who-has-died-aged-89-was.html" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://bseinquiry.blogspot.com/2012/04/wendy-grant-who-has-died-aged-89-was.html</a></div>
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Singeltary communication statement to BSE Inquiry 1998</div>
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this is all in the world those 300k+ bovine that died with BSE were consuming, a nutritional supplement with srms, i.e. specified risk materials, the most highest risk tissue for the tse prion. </div>
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Sender: "Patricia Cantos" <patricia .cantos="" at="" bse.org.uk=""> </patricia></div>
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To: "Terry S Singeltary Sr. (E-mail)" <flounder at="" wt.net=""> </flounder></div>
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Subject: Your submission to the Inquiry </div>
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Date: Fri, 3 Jul 1998 10:10:05 +0100</div>
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3 July 1998 Mr Terry S Singeltary Sr. E-Mail: Flounder at wt.net Ref: E2979</div>
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Dear Mr Singeltary,</div>
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Thank you for your E-mail message of the 30th of June 1998 providing the Inquiry with your further comments. Thank you for offering to provide the Inquiry with any test results on the nutritional supplements your mother was taking before she died.</div>
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As requested I am sending you our general Information Pack and a copy of the Chairman's letter. Please contact me if your system cannot read the attachments.</div>
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Regarding your question, the Inquiry is looking into many aspects of the scientific evidence on BSE and nvCJD. I would refer you to the transcripts of evidence we have already heard which are found on our internet site at http://www.bse.org.uk. Could you please provide the Inquiry with a copy of the press article you refer to in your e-mail? If not an approximate date for the article so that we can locate it? In the meantime, thank you for you comments. Please do not hesitate to contact me on 0171 261 8332 should you have any queries.</div>
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Yours sincerely Patricia Cantos Families Team Leader Attachments TSS</div>
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==============</div>
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-------- Original Message --------</div>
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Subject: re: METABOLIFE AND TSEs GAO-03-494 ''URGENT DATA'' </div>
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Date: Thu, 01 May 2003 16:04:35 -0400 </div>
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From: "Marcia G Crosse" <crossem at="" gao.gov=""> </crossem></div>
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To: <flounder at="" wt.net=""> CC: "Charles W Davenport" <davenportc at="" gao.gov="">, "Carolyn Feis Korman" <feiskormanc at="" gao.gov="">, "Martin Gahart" <gahartm at="" gao.gov=""></gahartm></feiskormanc></davenportc></flounder></div>
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Mr. Singletary,</div>
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We were informed by representatives of Metabolife, Inc. that Metabolife 356 was reformulated to remove bovine complex as an ingredient in the product, approximately September 2001. We did not independently verify the contents of the product.</div>
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<div style="font-family: arial; font-size: 13.3333px;">
Sincerely, Marcia Crosse Acting Director Health CarePublic Health and Science Issues U.S. General Accounting Office 441 G Street, N.W. Washington, D.C. 20548</div>
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===================</div>
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-------- Original Message -------- </div>
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Subject: Re: METABOLIFE AND TSEs GAO-03-494 ''URGENT DATA'' </div>
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Date: Thu, 01 May 2003 15:48:52 -0500 </div>
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<br /></div>
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From: "Terry S. Singeltary Sr." <flounder at="" wt.net=""> </flounder></div>
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<br /></div>
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To: Marcia G Crosse <crossem at="" gao.gov=""> </crossem></div>
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<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
CC: Charles W Davenport <davenportc at="" gao.gov="">, Carolyn Feis Korman <feiskormanc at="" gao.gov="">, Martin Gahart <gahartm at="" gao.gov=""> References: <seb14599 .014="" at="" gaogwia1.gao.gov=""></seb14599></gahartm></feiskormanc></davenportc></div>
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THANK YOU!</div>
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MIRACLES DO HAPPEN! ;-)</div>
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snip...</div>
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NOW COMPARE BOVINE INGREDIENTS FROM;</div>
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2003 - 2004 Product Catalog</div>
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Standard Process Inc.</div>
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<br /></div>
<div>
NATURAL COCOA STANDARDBAR (mad cow candy bar) (i will just list animal organs) bovine adrenal, bovine liver, bovine spleen, ovine spleen, bovine kidney...</div>
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<br /></div>
<div>
NATURAL PEANUT BUTTER STANDARDBAR</div>
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<br /></div>
<div>
bovine adrenal, bovine liver, bovine spleen, ovine spleen, bovine kidney...</div>
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<br /></div>
<div>
USF (MAD COW) OINTMENT (RUB A DUB DUB, KURU ETC) ;</div>
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<div>
bovine orhic glandular extract</div>
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<br /></div>
<div>
UTROPHIN PMG</div>
<div>
<br /></div>
<div>
bovine uterus PMG</div>
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<div>
VASCULIN</div>
<div>
<br /></div>
<div>
bovine heart PMG extract, veal bone PMG extract, bovine liever, porcine duodenum, bovine adrenal Cytosol extract, bovine spleen, ovine spleen (some yummy stuff)</div>
<div>
<br /></div>
<div>
IPLEX (neighbors mom died from CJD while taking these pills for years)</div>
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<div>
bovine eye PMG extract, veal bone PMG, bovine liver, porcine stomach, bovine adrenal, bovine kidney, bovine adrenal Cytosol extract, BOVINE BRAIN, bovine bone, veal bone meal</div>
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<br /></div>
<div>
MYO-PLUS</div>
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<br /></div>
<div>
bovine heart PMG, bovine liver, porcine stomach, bovine orchic extract, bovine spleen, ovine spleen, bovine adrenal Cytosol extract, BOVINE BRAIN</div>
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NEUROPLEX</div>
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<br /></div>
<div>
bovine orchic Cytosol extract, bovine spleen, BOVINE BRAIN PMG EXTRACT, BOVINE ANTERIOR PITUITARY, bovine liver, BOVINE PITUITARY PMG EXTRACT, AND MORE BOVINE BRAIN... HOLY MAD COW IN A PILL !!!</div>
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NEUROTROPHIN PMG</div>
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BOVINE BRAIN PMG</div>
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<div>
NIACINAMIDE B6 VM</div>
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<div>
bovine liver, porcine stomach, bovine spleen ovine spleen, BOVINE BRAIN</div>
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<div>
OCULOTROPHIN PMG BOVINE EYE PMG</div>
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<div>
ORCHEX</div>
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bovine liver, bovine orchic Cytosol extract, porcine stomch, bovine spleen, ovine spleen, BOVINE BRAIN</div>
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<div>
OSTARPLEX</div>
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veal bone PMG extract, veal bone PMG extract, bovine liver, porcine stomach, bovine adrenal, bovine spleen, ovine spleen, BOVINE BRAIN</div>
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PARAPLEX</div>
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bovine pancreas PMG extract, porcine duodenum, bovine adrenal PMG, BOVINE PITUITARY PMG EXTRACT, bovine thyroid PMG extract</div>
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PITUITROPHIN PMG</div>
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RUMAPLEX</div>
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BOVINE BRAIN, veal bone PMG extract, bovine adrenal, bovine prostate Cytosol extract, veal bone meal, bovine liver PMG extract, bovine spleen, ovine spleen, bovine liver</div>
<div>
<br /></div>
<div>
SENAPLEX</div>
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<br /></div>
<div>
bovine liver PMG extract, bovine adrenal, BOVNE BRAIN, veal bone meal, bovine kidney, bovine orchic extract, bovine spleen, ovine spleen ..........</div>
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<div>
THESE are just a few of MANY of just this ONE COMPANY...TSS</div>
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DEPARTMENT OF HEALTH AND HUMAN SERVICES</div>
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FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH</div>
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TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE</div>
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<div>
Friday, January 19, 2001</div>
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<br /></div>
<div>
Holiday Inn Bethesda Versailles I and II 8120 Wisconsin Avenue Bethesda, Maryland</div>
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<br /></div>
<div>
2 PARTICIPANTS Paul W. Brown, M.D., Chairperson William Freas, Ph.D., Executive Secretary</div>
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<br /></div>
<div>
VOTING MEMBERS Ermias D. Belay, M.D. David C. Bolton, Ph.D. Donald S. Burke, M.D. Dean O. Cliver, Ph.D. Bruce M. Ewenstein, M.D., Ph.D. Peter G. Lurie, M.D. Pedro Piccardo, M.D. Stanley B. Prusiner, M.D. Raymond P. Roos, M.D. Elizabeth S. Williams, D.V.M., Ph.D.</div>
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<br /></div>
<div>
VOTING CONSULTANTS Linda A. Detwiler, D.V.M. David Gaylor, Ph.D.</div>
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<br /></div>
<div>
Paul R. McCurdy, M.D. Kenrad E. Nelson, M.D.</div>
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NONVOTING CONSULTANT Susan Leitman, M.D.</div>
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GUESTS Richard Davey, M.D. Louis Katz, M.D.</div>
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snip...</div>
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page 501</div>
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253</div>
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1 DR. BOLTON: I have an additional question about</div>
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2 that. What is the assurance that additional locally sourced</div>
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3 tracheas are not added into that manufacturing process, thus</div>
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4 boosting the yield, if you will, but being returned to the</div>
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5 U.S. as being produced from U.S.-sourced raw material?</div>
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6 DR. McCURDY: Are there data to indicate how many</div>
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7 grams, or whatever, of infected brain are likely to infect</div>
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8 an organism, either animal or man, when taken orally?</div>
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9 DR. BROWN: If I am not mistaken, and I can be</div>
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10 corrected, I think a half a gram is enough in a cow, orally;</div>
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11 in other words, one good dietary-supplement pill.</div>
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<div>
12 DR. McCURDY: What I am driving at is the question</div>
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13 we are asked is really not do we wish to regulate these</div>
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14 things coming in. I think the statements about difficulties</div>
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15 in regulating things in the future or near future for new</div>
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16 regulations were probably accurate.</div>
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17 But I think that we could exhibit some quite</div>
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18 reasonable concern about blood donors who are taking dietary</div>
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19 supplements that contain a certain amount of unspecified-</div>
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20 origin brain, brain-related, brain and pituitary material.</div>
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21 If they have done this for more than a sniff or something</div>
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22 like that, then, perhaps, they should be deferred as blood</div>
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23 donors.</div>
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24 That is probably worse than spending six months in</div>
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25 the U.K.</div>
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1/19/01</div>
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<div>
3681t2.rtf(845) page 501</div>
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<a fg_scanned="1" href="http://www.fda.gov/ohrms/dockets/ac/cber01.htm" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://www.fda.gov/ohrms/dockets/ac/cber01.htm</a></div>
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Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients a Comment Number: EC -2 Accepted - Volume 7</div>
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<a fg_scanned="1" href="http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm</a></div>
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<a href="http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_07.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_07.pdf</a></div>
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snip...see full text and much more on nutritional supplements and the cjd tse prion;</div>
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Thursday, March 19, 2009 </div>
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<br /></div>
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Chronic Wasting Disease Prions in Elk Antler Velvet (Nutritional Supplements and CJD) </div>
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<a fg_scanned="1" href="http://chronic-wasting-disease.blogspot.com/2009/03/chronic-wasting-disease-prions-in-elk.html" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://chronic-wasting-disease.blogspot.com/2009/03/chronic-wasting-disease-prions-in-elk.html</a></div>
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MONDAY, FEBRUARY 25, 2019</div>
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<br /></div>
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MAD DOGS AND ENGLISHMEN BSE, SCRAPIE, CWD, CJD, TSE PRION A REVIEW 2019</div>
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<br /></div>
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Subject: Re: DEER SPONGIFORM ENCEPHALOPATHY SURVEY & HOUND STUDY </div>
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<br /></div>
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Date: Fri, 18 Oct 2002 23:12:22 +0100 </div>
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From: Steve Dealler </div>
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<br /></div>
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Reply-To: Bovine Spongiform Encephalopathy Organization: Netscape Online member </div>
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To: BSE-L@ References: <3daf5023 .4080804="" wt.net=""></3daf5023></div>
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Dear Terry,</div>
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An excellent piece of review as this literature is desparately difficult to get back from Government sites.</div>
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What happened with the deer was that an association between deer meat eating and sporadic CJD was found in about 1993. The evidence was not great but did not disappear after several years of asking CJD cases what they had eaten. I think that the work into deer disease largely stopped because it was not helpful to the UK industry...and no specific cases were reported. Well, if you dont look adequately like they are in USA currenly then you wont find any!</div>
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<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
Steve Dealler </div>
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=============== </div>
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snip...see full history;</div>
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<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
<a fg_scanned="1" href="http://bseinquiry.blogspot.com/2019/02/mad-dogs-and-englishmen-bse-scrapie-cwd.html" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://bseinquiry.blogspot.com/2019/02/mad-dogs-and-englishmen-bse-scrapie-cwd.html</a></div>
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THURSDAY, FEBRUARY 21, 2019</div>
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<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
Professor Richard Lacey, microbiologist rubbished but later vindicated for warning that BSE could be transmitted to humans – obituary</div>
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<br /></div>
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<a fg_scanned="1" href="http://bseinquiry.blogspot.com/2019/02/professor-richard-lacey-microbiologist.html" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://bseinquiry.blogspot.com/2019/02/professor-richard-lacey-microbiologist.html</a></div>
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<br /></div>
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BSE Inquiry</div>
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<br /></div>
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<a fg_scanned="1" href="http://bseinquiry.blogspot.com/" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://bseinquiry.blogspot.com/</a></div>
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<span style="font-family: "georgia" , serif; font-size: 10pt;">***Moreover, sporadic disease has never been observed in breeding colonies or primate research laboratories, most notably among hundreds of animals over several decades of study at the National Institutes of Health25, and in nearly twenty older animals continuously housed in our own facility.***</span></div>
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Even if the prevailing view is that sporadic CJD is due to the spontaneous formation of CJD prions, it remains possible that its apparent sporadic nature may, at least in part, result from our limited capacity to identify an environmental origin.</div>
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<span style="font-size: 10pt; line-height: 1.22em;">O.05: Transmission of prions to primates after extended silent incubation periods: Implications for BSE and scrapie risk assessment in human populations </span></div>
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<span style="font-family: "georgia" , serif; font-size: 10pt; line-height: 1.22em;"><span style="line-height: 1.22em;">Emmanuel Comoy, Jacqueline Mikol, Valerie Durand, Sophie Luccantoni, Evelyne Correia, Nathalie Lescoutra, Capucine Dehen, and Jean-Philippe Deslys Atomic Energy Commission; Fontenay-aux-Roses, France </span><br clear="none" style="line-height: 1.22em;" /><br clear="none" style="line-height: 1.22em;" /><span style="line-height: 1.22em;">Prion diseases (PD) are the unique neurodegenerative proteinopathies reputed to be transmissible under field conditions since decades. The transmission of Bovine Spongiform Encephalopathy (BSE) to humans evidenced that an animal PD might be zoonotic under appropriate conditions. Contrarily, in the absence of obvious (epidemiological or experimental) elements supporting a transmission or genetic predispositions, PD, like the other proteinopathies, are reputed to occur spontaneously (atpical animal prion strains, sporadic CJD summing 80% of human prion cases). </span><br clear="none" style="line-height: 1.22em;" /><br clear="none" style="line-height: 1.22em;" /><span style="line-height: 1.22em;">Non-human primate models provided the first evidences supporting the transmissibiity of human prion strains and the zoonotic potential of BSE. Among them, cynomolgus macaques brought major information for BSE risk assessment for human health (Chen, 2014), according to their phylogenetic proximity to humans and extended lifetime. We used this model to assess the zoonotic potential of other animal PD from bovine, ovine and cervid origins even after very long silent incubation periods. </span><br clear="none" style="line-height: 1.22em;" /><br clear="none" style="line-height: 1.22em;" /><span style="line-height: 1.22em;">*** We recently observed the direct transmission of a natural classical scrapie isolate to macaque after a 10-year silent incubation period, </span><br clear="none" style="line-height: 1.22em;" /><br clear="none" style="line-height: 1.22em;" /><span style="line-height: 1.22em;">***with features similar to some reported for human cases of sporadic CJD, albeit requiring fourfold long incubation than BSE. Scrapie, as recently evoked in humanized mice (Cassard, 2014), </span><br clear="none" style="line-height: 1.22em;" /><br clear="none" style="line-height: 1.22em;" /><span style="line-height: 1.22em;">***is the third potentially zoonotic PD (with BSE and L-type BSE), </span><br clear="none" style="line-height: 1.22em;" /><br clear="none" style="line-height: 1.22em;" /><span style="line-height: 1.22em;">***thus questioning the origin of human sporadic cases. </span><br clear="none" style="line-height: 1.22em;" /><br clear="none" style="line-height: 1.22em;" /><span style="line-height: 1.22em;">We will present an updated panorama of our different transmission studies and discuss the implications of such extended incubation periods on risk assessment of animal PD for human health. </span><br clear="none" style="line-height: 1.22em;" /><br clear="none" style="line-height: 1.22em;" /><span style="line-height: 1.22em;">=============== </span><br clear="none" style="line-height: 1.22em;" /><br clear="none" style="line-height: 1.22em;" /><span style="line-height: 1.22em;">***thus questioning the origin of human sporadic cases*** </span><br clear="none" style="line-height: 1.22em;" /><br clear="none" style="line-height: 1.22em;" /><span style="line-height: 1.22em;">=============== </span><br clear="none" style="line-height: 1.22em;" /><br clear="none" style="line-height: 1.22em;" /><span style="line-height: 1.22em;">***our findings suggest that possible transmission risk of H-type BSE to sheep and human. Bioassay will be required to determine whether the PMCA products are infectious to these animals. </span><br clear="none" style="line-height: 1.22em;" /><br clear="none" style="line-height: 1.22em;" /><span style="line-height: 1.22em;">============== </span></span><span face=""arial" , sans-serif" style="font-size: 10pt; line-height: 1.22em;"><a href="https://prion2015.files.wordpress.com/2015/05/prion2015abstracts.pdf" rel="nofollow" shape="rect" style="color: purple; cursor: pointer; line-height: 1.22em;" target="_blank"><span face=""verdana" , sans-serif" style="line-height: 1.22em;"></span></a><a href="https://prion2015.files.wordpress.com/2015/05/prion2015abstracts.pdf" rel="nofollow" shape="rect" style="color: purple; cursor: pointer; line-height: 1.22em;" target="_blank">https://prion2015.files.wordpress.com/2015/05/prion2015abstracts.pdf</a></span><span style="font-family: "georgia" , serif; font-size: 10pt; line-height: 1.22em;"> </span><span style="font-family: "georgia" , serif; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /><br clear="none" style="line-height: 1.22em;" /><span style="line-height: 1.22em;">***Transmission data also revealed that several scrapie prions propagate in HuPrP-Tg mice with efficiency comparable to that of cattle BSE. While the efficiency of transmission at primary passage was low, subsequent passages resulted in a highly virulent prion disease in both Met129 and Val129 mice. </span><br clear="none" style="line-height: 1.22em;" /><br clear="none" style="line-height: 1.22em;" /><span style="line-height: 1.22em;">***Transmission of the different scrapie isolates in these mice leads to the emergence of prion strain phenotypes that showed similar characteristics to those displayed by MM1 or VV2 sCJD prion. </span><br clear="none" style="line-height: 1.22em;" /><br clear="none" style="line-height: 1.22em;" /><span style="line-height: 1.22em;">***These results demonstrate that scrapie prions have a zoonotic potential and raise new questions about the possible link between animal and human prions. </span></span><span face=""arial" , sans-serif" style="font-size: 10pt; line-height: 1.22em;"><a fg_scanned="1" href="http://www.tandfonline..com/doi/abs/10.1080/19336896.2016.1163048?journalCode=kprn20" rel="nofollow" shape="rect" style="color: purple; cursor: pointer; line-height: 1.22em;" target="_blank"><span face=""verdana" , sans-serif" style="line-height: 1.22em;"></span></a><a fg_scanned="1" href="http://www.tandfonline.com/doi/abs/10.1080/19336896.2016.1163048?journalCode=kprn20" rel="nofollow" shape="rect" style="color: purple; cursor: pointer; line-height: 1.22em;" target="_blank">http://www.tandfonline.com/doi/abs/10.1080/19336896.2016.1163048?journalCode=kprn20</a></span><span style="font-family: "georgia" , serif; font-size: 10pt; line-height: 1.22em;"> </span></div>
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<span style="font-family: "georgia" , serif; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /><span style="line-height: 1.22em;">PRION 2016 TOKYO</span><br clear="none" style="line-height: 1.22em;" /><br clear="none" style="line-height: 1.22em;" /><span style="line-height: 1.22em;">Saturday, April 23, 2016</span><br clear="none" style="line-height: 1.22em;" /><br clear="none" style="line-height: 1.22em;" /><span style="line-height: 1.22em;">SCRAPIE WS-01: Prion diseases in animals and zoonotic potential 2016</span><br clear="none" style="line-height: 1.22em;" /><br clear="none" style="line-height: 1.22em;" /><span style="line-height: 1.22em;">Prion. 10:S15-S21. 2016 ISSN: 1933-6896 printl 1933-690X online</span><br clear="none" style="line-height: 1.22em;" /><br clear="none" style="line-height: 1.22em;" /><span style="line-height: 1.22em;">Taylor & Francis</span><br clear="none" style="line-height: 1.22em;" /><br clear="none" style="line-height: 1.22em;" /><span style="line-height: 1.22em;">Prion 2016 Animal Prion Disease Workshop Abstracts</span><br clear="none" style="line-height: 1.22em;" /><br clear="none" style="line-height: 1.22em;" /><span style="line-height: 1.22em;">WS-01: Prion diseases in animals and zoonotic potential</span><br clear="none" style="line-height: 1.22em;" /><br clear="none" style="line-height: 1.22em;" /><span style="line-height: 1.22em;">Transmission of the different scrapie isolates in these mice leads to the emergence of prion strain phenotypes that showed similar characteristics to those displayed by MM1 or VV2 sCJD prion. </span><br clear="none" style="line-height: 1.22em;" /><br clear="none" style="line-height: 1.22em;" /><span style="line-height: 1.22em;">These results demonstrate that scrapie prions have a zoonotic potential and raise new questions about the possible link between animal and human prions. </span></span><span face=""arial" , sans-serif" style="font-size: 10pt; line-height: 1.22em;"><a fg_scanned="1" href="http://www.tandfonline..com/doi/abs/10.1080/19336896.2016.1163048?journalCode=kprn20" rel="nofollow" shape="rect" style="color: purple; cursor: pointer; line-height: 1.22em;" target="_blank"><span face=""verdana" , sans-serif" style="line-height: 1.22em;"></span></a><a fg_scanned="1" href="http://www.tandfonline.com/doi/abs/10.1080/19336896.2016.1163048?journalCode=kprn20" rel="nofollow" shape="rect" style="color: purple; cursor: pointer; line-height: 1.22em;" target="_blank">http://www.tandfonline.com/doi/abs/10.1080/19336896.2016.1163048?journalCode=kprn20</a></span></div>
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<span style="font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /><span style="font-family: "georgia" , serif; line-height: 1.22em;">Title: Transmission of scrapie prions to primate after an extended silent incubation period) </span><br clear="none" style="line-height: 1.22em;" /><br clear="none" style="line-height: 1.22em;" /><span style="font-family: "georgia" , serif; line-height: 1.22em;">*** In complement to the recent demonstration that humanized mice are susceptible to scrapie, we report here the first observation of direct transmission of a natural classical scrapie isolate to a macaque after a 10-year incubation period. Neuropathologic examination revealed all of the features of a prion disease: spongiform change, neuronal loss, and accumulation of PrPres throughout the CNS. </span><br clear="none" style="line-height: 1.22em;" /><br clear="none" style="line-height: 1.22em;" /><span style="font-family: "georgia" , serif; line-height: 1.22em;">*** This observation strengthens the questioning of the harmlessness of scrapie to humans, at a time when protective measures for human and animal health are being dismantled and reduced as c-BSE is considered controlled and being eradicated. </span><br clear="none" style="line-height: 1.22em;" /><br clear="none" style="line-height: 1.22em;" /><span style="font-family: "georgia" , serif; line-height: 1.22em;">*** Our results underscore the importance of precautionary and protective measures and the necessity for long-term experimental transmission studies to assess the zoonotic potential of other animal prion strains. </span></span><span face=""arial" , sans-serif" style="font-size: 10pt; line-height: 1.22em;"><a fg_scanned="1" href="http://www.ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=313160" rel="nofollow" shape="rect" style="color: purple; cursor: pointer; line-height: 1.22em;" target="_blank"><span face=""verdana" , sans-serif" style="line-height: 1.22em;"></span></a><a fg_scanned="1" href="http://www.ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=313160" rel="nofollow" shape="rect" style="color: purple; cursor: pointer; line-height: 1.22em;" target="_blank">http://www.ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=313160</a></span></div>
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<span style="font-size: x-small;">1: J Infect Dis 1980 Aug;142(2):205-8</span></div>
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<span style="font-size: x-small;">Oral transmission of kuru, Creutzfeldt-Jakob disease, and scrapie to nonhuman primates.</span></div>
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<span style="font-size: x-small;">Gibbs CJ Jr, Amyx HL, Bacote A, Masters CL, Gajdusek DC.</span></div>
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<span style="font-size: x-small;">Kuru and Creutzfeldt-Jakob disease of humans and scrapie disease of sheep and goats were transmitted to squirrel monkeys (Saimiri sciureus) that were exposed to the infectious agents only by their nonforced consumption of known infectious tissues. The asymptomatic incubation period in the one monkey exposed to the virus of kuru was 36 months; that in the two monkeys exposed to the virus of Creutzfeldt-Jakob disease was 23 and 27 months, respectively; and that in the two monkeys exposed to the virus of scrapie was 25 and 32 months, respectively. Careful physical examination of the buccal cavities of all of the monkeys failed to reveal signs or oral lesions. One additional monkey similarly exposed to kuru has remained asymptomatic during the 39 months that it has been under observation.</span></div>
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<span style="font-size: x-small;">The successful transmission of kuru, Creutzfeldt-Jakob disease, and scrapie by natural feeding to squirrel monkeys that we have reported provides further grounds for concern that scrapie-infected meat may occasionally give rise in humans to Creutzfeldt-Jakob disease.</span></div>
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<a fg_scanned="1" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=6997404&dopt=Abstract" rel="nofollow" shape="rect" style="color: blue; cursor: pointer;" target="_blank">http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=6997404&dopt=Abstract</a></div>
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<span style="font-size: x-small;">Recently the question has again been brought up as to whether scrapie is transmissible to man. This has followed reports that the disease has been transmitted to primates. One particularly lurid speculation (Gajdusek 1977) conjectures that the agents of scrapie, kuru, Creutzfeldt-Jakob disease and transmissible encephalopathy of mink are varieties of a single "virus". The U.S. Department of Agriculture concluded that it could "no longer justify or permit scrapie-blood line and scrapie-exposed sheep and goats to be processed for human or animal food at slaughter or rendering plants" (ARC 84/77)" The problem is emphasised by the finding that some strains of scrapie produce lesions identical to the once which characterise the human dementias"</span></div>
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<span style="font-size: x-small;">Whether true or not. the hypothesis that these agents might be transmissible to man raises two considerations. First, the safety of laboratory personnel requires prompt attention. Second, action such as the "scorched meat" policy of USDA makes the solution of the acrapie problem urgent if the sheep industry is not to suffer grievously.</span></div>
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<a href="http://web.archive.org/web/20010305223125/www.bseinquiry.gov.uk/files/yb/1976/10/12004001.pdf" rel="nofollow" shape="rect" style="color: blue; cursor: pointer;" target="_blank">http://web.archive.org/web/20010305223125/www.bseinquiry.gov.uk/files/yb/1976/10/12004001.pdf</a></div>
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<span style="font-size: x-small;">Nature. 1972 Mar 10;236(5341):73-4.</span></div>
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<span style="font-size: x-small;">Transmission of scrapie to the cynomolgus monkey (Macaca fascicularis).</span></div>
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<span style="font-size: x-small;">Gibbs CJ Jr, Gajdusek DC.</span></div>
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<span style="font-size: x-small;">Nature 236, 73 - 74 (10 March 1972); doi:10.1038/236073a0</span></div>
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<span style="font-size: x-small;">Transmission of Scrapie to the Cynomolgus Monkey (Macaca fascicularis)</span></div>
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<span style="font-size: x-small;">C. J. GIBBS jun. & D. C. GAJDUSEK</span></div>
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<span style="font-size: x-small;">National Institute of Neurological Diseases and Stroke, National Institutes of Health, Bethesda, Maryland</span></div>
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<span style="font-size: x-small;">SCRAPIE has been transmitted to the cynomolgus, or crab-eating, monkey (Macaca fascicularis) with an incubation period of more than 5 yr from the time of intracerebral inoculation of scrapie-infected mouse brain. The animal developed a chronic central nervous system degeneration, with ataxia, tremor and myoclonus with associated severe scrapie-like pathology of intensive astroglial hypertrophy and proliferation, neuronal vacuolation and status spongiosus of grey matter. The strain of scrapie virus used was the eighth passage in Swiss mice (NIH) of a Compton strain of scrapie obtained as ninth intracerebral passage of the agent in goat brain, from Dr R. L. Chandler (ARC, Compton, Berkshire).</span></div>
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<a fg_scanned="1" href="http://scrapie-usa.blogspot.com/2010/04/scrapie-and-atypical-scrapie.html" rel="nofollow" shape="rect" style="color: blue; cursor: pointer;" target="_blank">http://scrapie-usa.blogspot.com/2010/04/scrapie-and-atypical-scrapie.html</a></div>
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<span style="font-size: x-small;">Wednesday, February 16, 2011</span></div>
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<span style="font-size: x-small;">IN CONFIDENCE</span></div>
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<span style="font-size: x-small;">SCRAPIE TRANSMISSION TO CHIMPANZEES</span></div>
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<span style="font-size: x-small;">IN CONFIDENCE</span></div>
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<a fg_scanned="1" href="http://scrapie-usa.blogspot.com/2011/02/in-confidence-scrapie-transmission-to.html" rel="nofollow" shape="rect" style="color: blue; cursor: pointer;" target="_blank">http://scrapie-usa.blogspot.com/2011/02/in-confidence-scrapie-transmission-to.html</a></div>
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<span style="font-size: 13.3333px;">Saturday, December 15, 2018 </span></div>
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<span style="font-size: 13.3333px;">***> ADRD Summit RFI Singeltary COMMENT SUBMISSION BSE, SCRAPIE, CWD, AND HUMAN TSE PRION DISEASE December 14, 2018</span></div>
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<span style="font-family: "arial" , "helvetica"; font-size: x-small;">SATURDAY, JANUARY 5, 2019 </span><br />
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Low levels of classical BSE infectivity in rendered fat tissue </div>
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<a fg_scanned="1" href="https://bovineprp.blogspot.com/2019/01/low-levels-of-classical-bse-infectivity.html" rel="nofollow" shape="rect" style="color: blue; cursor: pointer;" target="_blank">https://bovineprp.blogspot.com/2019/01/low-levels-of-classical-bse-infectivity.html</a> </div>
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***> FRIDAY, DECEMBER 14, 2018 MAD COW USA FLASHBACK Texas Style</div>
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FRIDAY DECEMBER 14, 2018 </div>
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THURSDAY, JANUARY 3, 2019 </div>
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MAD COW USDA DISEASE BSE TSE Prion </div>
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<a fg_scanned="1" href="https://madcowusda.blogspot.com/2019/01/mad-cow-usda-disease-bse-tse-prion.html" rel="nofollow" shape="rect" style="color: blue; cursor: pointer;" target="_blank">https://madcowusda.blogspot.com/2019/01/mad-cow-usda-disease-bse-tse-prion.html</a></div>
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THURSDAY, OCTOBER 22, 2015 </div>
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Former Ag Secretary Ann Veneman talks women in agriculture and we talk mad cow disease USDA and what really happened</div>
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HOW TO COVER UP MAD COW DISEASE IN TEXAS</div>
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<a fg_scanned="1" href="http://madcowusda.blogspot.com/2015/10/former-ag-secretary-ann-veneman-talks.html" rel="nofollow" shape="rect" style="color: blue; cursor: pointer;" target="_blank">http://madcowusda.blogspot.com/2015/10/former-ag-secretary-ann-veneman-talks.html</a> </div>
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<a fg_scanned="1" href="http://madcowusda.blogspot.com/2012/06/johanns-introduces-legislation-banning.html" rel="nofollow" shape="rect" style="color: blue; cursor: pointer;" target="_blank">http://madcowusda.blogspot.com/2012/06/johanns-introduces-legislation-banning.html</a> </div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">WEDNESDAY, AUGUST 29, 2018 </span></span></div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">OIE Bovine spongiform encephalopathy, United States of America Information received on 29/08/2018 from Dr John Clifford, Official Delegate, Chief Trade Advisor, APHIS USDA</span></span></div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">''The event is resolved. No more reports will be submitted.''</span></span></div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">well, so much for those herd mates exposed to this atypical BSE cow, and all those trace in and trace outs.</span></span></div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">The OIE, USDA, and the BSE MRR policy is a joke, a sad, very sad joke...</span></span></div>
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<a fg_scanned="1" href="http://bovineprp.blogspot.com/2018/08/oie-bovine-spongiform-encephalopathy.html" rel="nofollow" shape="rect" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://bovineprp.blogspot.com/2018/08/oie-bovine-spongiform-encephalopathy.html</a></div>
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<span style="font-family: "georgia";"><span style="font-size: 13px;">Saturday, July 23, 2016</span></span></div>
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<span style="font-family: "georgia";"><span style="font-size: 13px;">BOVINE SPONGIFORM ENCEPHALOPATHY BSE TSE PRION SURVEILLANCE, TESTING, AND SRM REMOVAL UNITED STATE OF AMERICA UPDATE JULY 2016</span></span></div>
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<span style="font-family: "georgia";"><span style="font-size: 13px;">Tuesday, July 26, 2016</span></span></div>
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<span style="font-family: "georgia";"><span style="font-size: 13px;">Atypical Bovine Spongiform Encephalopathy BSE TSE Prion UPDATE JULY 2016</span></span></div>
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<span style="font-family: "georgia";"><span style="font-size: 13px;">Monday, June 20, 2016</span></span></div>
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<span style="font-family: "georgia";"><span style="font-size: 13px;">Specified Risk Materials SRMs BSE TSE Prion Program</span></span></div>
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<span style="font-family: "georgia"; font-size: 13px;">Wednesday, January 23, 2019 </span></div>
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CFIA SFCR Guidance on Specified risk material (SRM) came into force on January 15, 2019</div>
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<span style="font-size: 12px;">MONDAY, JANUARY 21, 2019 </span></div>
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<span style="font-size: 12px;">Bovine Spongiform Encephalopathy BSE TSE Prion Surveillance FDA USDA APHIS FSIS UPDATE 2019</span></div>
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<span style="font-size: 12px;"><a fg_scanned="1" href="https://bovineprp.blogspot.com/2019/01/bovine-spongiform-encephalopathy-bse.html" rel="nofollow" shape="rect" style="color: blue; cursor: pointer;" target="_blank">https://bovineprp.blogspot.com/2019/01/bovine-spongiform-encephalopathy-bse.html</a></span></div>
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CHRONIC WASTING DISEASE CWD TSE PRION ZOONOSIS</div>
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MONDAY, DECEMBER 16, 2019 </div>
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Chronic Wasting Disease CWD TSE Prion aka mad cow type disease in cervid Zoonosis Update</div>
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***> ''In particular the US data do not clearly exclude the possibility of human (sporadic or familial) TSE development due to consumption of venison. The Working Group thus recognizes a potential risk to consumers if a TSE would be present in European cervids.'' Scientific opinion on chronic wasting disease (II) <***</div>
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What if?</div>
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<a fg_scanned="1" href="https://chronic-wasting-disease.blogspot.com/2019/12/chronic-wasting-disease-cwd-tse-prion.html" rel="nofollow" shape="rect" style="color: blue; cursor: pointer;" target="_blank">https://chronic-wasting-disease.blogspot.com/2019/12/chronic-wasting-disease-cwd-tse-prion.html</a></div>
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> However, to date, no CWD infections have been reported in people.</div>
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key word here is ‘reported’. science has shown that CWD in humans will look like sporadic CJD. SO, how can one assume that CWD has not already transmitted to humans? they can’t, and it’s as simple as that. from all recorded science to date, CWD has already transmitted to humans, and it’s being misdiagnosed as sporadic CJD. …terry</div>
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*** LOOKING FOR CWD IN HUMANS AS nvCJD or as an ATYPICAL CJD, LOOKING IN ALL THE WRONG PLACES $$$ ***</div>
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*** These results would seem to suggest that CWD does indeed have zoonotic potential, at least as judged by the compatibility of CWD prions and their human PrPC target. Furthermore, extrapolation from this simple in vitro assay suggests that if zoonotic CWD occurred, it would most likely effect those of the PRNP codon 129-MM genotype and that the PrPres type would be similar to that found in the most common subtype of sCJD (MM1).***</div>
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<a fg_scanned="1" href="http://www.tandfonline.com/doi/full/10.4161/pri.28124?src=recsys" rel="nofollow" shape="rect" style="background-color: inherit; color: #222222; cursor: pointer; transition: all 0s ease-in-out 0s;" target="_blank">http://www.tandfonline.com/doi/full/10.4161/pri.28124?src=recsys</a></div>
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<a fg_scanned="1" href="http://www.tandfonline.com/doi/pdf/10.4161/pri.28124?needAccess=true" rel="nofollow" shape="rect" style="background-color: inherit; color: #222222; cursor: pointer; transition: all 0s ease-in-out 0s;" target="_blank">http://www.tandfonline.com/doi/pdf/10.4161/pri.28124?needAccess=true</a></div>
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<a fg_scanned="1" href="https://wwwnc.cdc.gov/eid/article/20/1/13-0858_article" rel="nofollow" shape="rect" style="background-color: inherit; color: #222222; cursor: pointer; transition: all 0s ease-in-out 0s;" target="_blank">https://wwwnc.cdc.gov/eid/article/20/1/13-0858_article</a></div>
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Chronic Wasting Disease CWD TSE Prion aka mad deer disease zoonosis</div>
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We hypothesize that:</div>
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(1) The classic CWD prion strain can infect humans at low levels in the brain and peripheral lymphoid tissues;</div>
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(2) The cervid-to-human transmission barrier is dependent on the cervid prion strain and influenced by the host (human) prion protein (PrP) primary sequence;</div>
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(3) Reliable essays can be established to detect CWD infection in humans; and</div>
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(4) CWD transmission to humans has already occurred. We will test these hypotheses in 4 Aims using transgenic (Tg) mouse models and complementary in vitro approaches.</div>
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<a fg_scanned="1" href="http://grantome.com/grant/NIH/R01-NS088604-04" rel="nofollow" shape="rect" style="background-color: inherit; color: #222222; cursor: pointer; transition: all 0s ease-in-out 0s;" target="_blank">http://grantome.com/grant/NIH/R01-NS088604-04</a></div>
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ZOONOTIC CHRONIC WASTING DISEASE CWD TSE PRION UPDATE</div>
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<span style="color: #222222; font-size: 16px;">First evidence of intracranial and peroral transmission of Chronic Wasting Disease (CWD) into Cynomolgus macaques: a work in progress Stefanie Czub1, Walter Schulz-Schaeffer2, Christiane Stahl-Hennig3, Michael Beekes4, Hermann Schaetzl5 and Dirk Motzkus6 1 </span></div>
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<span style="color: #222222; font-size: 16px;">University of Calgary Faculty of Veterinary Medicine/Canadian Food Inspection Agency; 2Universitatsklinikum des Saarlandes und Medizinische Fakultat der Universitat des Saarlandes; 3 Deutsches Primaten Zentrum/Goettingen; 4 Robert-Koch-Institut Berlin; 5 University of Calgary Faculty of Veterinary Medicine; 6 presently: Boehringer Ingelheim Veterinary Research Center; previously: Deutsches Primaten Zentrum/Goettingen </span></div>
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<span style="color: #222222; font-size: 16px;">This is a progress report of a project which started in 2009. 21 cynomolgus macaques were challenged with characterized CWD material from white-tailed deer (WTD) or elk by intracerebral (ic), oral, and skin exposure routes. Additional blood transfusion experiments are supposed to assess the CWD contamination risk of human blood product. Challenge materials originated from symptomatic cervids for ic, skin scarification and partially per oral routes (WTD brain). Challenge material for feeding of muscle derived from preclinical WTD and from preclinical macaques for blood transfusion experiments. We have confirmed that the CWD challenge material contained at least two different CWD agents (brain material) as well as CWD prions in muscle-associated nerves. </span></div>
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<span style="color: #222222; font-size: 16px;">Here we present first data on a group of animals either challenged ic with steel wires or per orally and sacrificed with incubation times ranging from 4.5 to 6.9 years at postmortem. Three animals displayed signs of mild clinical disease, including anxiety, apathy, ataxia and/or tremor. In four animals wasting was observed, two of those had confirmed diabetes. All animals have variable signs of prion neuropathology in spinal cords and brains and by supersensitive IHC, reaction was detected in spinal cord segments of all animals. Protein misfolding cyclic amplification (PMCA), real-time quaking-induced conversion (RT-QuiC) and PET-blot assays to further substantiate these findings are on the way, as well as bioassays in bank voles and transgenic mice. </span></div>
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<span style="color: #222222; font-size: 16px;">At present, a total of 10 animals are sacrificed and read-outs are ongoing. Preclinical incubation of the remaining macaques covers a range from 6.4 to 7.10 years. Based on the species barrier and an incubation time of > 5 years for BSE in macaques and about 10 years for scrapie in macaques, we expected an onset of clinical disease beyond 6 years post inoculation. </span></div>
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<span style="color: #222222; font-size: 16px;">PRION 2017 DECIPHERING NEURODEGENERATIVE DISORDERS </span></div>
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PRION 2018 CONFERENCE</div>
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Oral transmission of CWD into Cynomolgus macaques: signs of atypical disease, prion conversion and infectivity in macaques and bio-assayed transgenic mice</div>
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Hermann M. Schatzl, Samia Hannaoui, Yo-Ching Cheng, Sabine Gilch (Calgary Prion Research Unit, University of Calgary, Calgary, Canada) Michael Beekes (RKI Berlin), Walter Schulz-Schaeffer (University of Homburg/Saar, Germany), Christiane Stahl-Hennig (German Primate Center) & Stefanie Czub (CFIA Lethbridge).</div>
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To date, BSE is the only example of interspecies transmission of an animal prion disease into humans. The potential zoonotic transmission of CWD is an alarming issue and was addressed by many groups using a variety of in vitro and in vivo experimental systems. Evidence from these studies indicated a substantial, if not absolute, species barrier, aligning with the absence of epidemiological evidence suggesting transmission into humans. Studies in non-human primates were not conclusive so far, with oral transmission into new-world monkeys and no transmission into old-world monkeys. Our consortium has challenged 18 Cynomolgus macaques with characterized CWD material, focusing on oral transmission with muscle tissue. Some macaques have orally received a total of 5 kg of muscle material over a period of 2 years.</div>
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After 5-7 years of incubation time some animals showed clinical symptoms indicative of prion disease, and prion neuropathology and PrPSc deposition were detected in spinal cord and brain of some euthanized animals. PrPSc in immunoblot was weakly detected in some spinal cord materials and various tissues tested positive in RT-QuIC, including lymph node and spleen homogenates. To prove prion infectivity in the macaque tissues, we have intracerebrally inoculated 2 lines of transgenic mice, expressing either elk or human PrP. At least 3 TgElk mice, receiving tissues from 2 different macaques, showed clinical signs of a progressive prion disease and brains were positive in immunoblot and RT-QuIC. Tissues (brain, spinal cord and spleen) from these and pre-clinical mice are currently tested using various read-outs and by second passage in mice. Transgenic mice expressing human PrP were so far negative for clear clinical prion disease (some mice >300 days p.i.). In parallel, the same macaque materials are inoculated into bank voles.</div>
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Taken together, there is strong evidence of transmissibility of CWD orally into macaques and from macaque tissues into transgenic mouse models, although with an incomplete attack rate.</div>
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The clinical and pathological presentation in macaques was mostly atypical, with a strong emphasis on spinal cord pathology.<br />
Our ongoing studies will show whether the transmission of CWD into macaques and passage in transgenic mice represents a form of non-adaptive prion amplification, and whether macaque-adapted prions have the potential to infect mice expressing human PrP.</div>
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The notion that CWD can be transmitted orally into both new-world and old-world non-human primates asks for a careful reevaluation of the zoonotic risk of CWD..</div>
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***> The notion that CWD can be transmitted orally into both new-world and old-world non-human primates asks for a careful reevaluation of the zoonotic risk of CWD. <***</div>
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<a fg_scanned="1" href="https://prion2018.org/" rel="nofollow" shape="rect" style="background-color: inherit; color: #222222; cursor: pointer; transition: all 0s ease-in-out 0s;" target="_blank">https://prion2018.org/</a></div>
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READING OVER THE PRION 2018 ABSTRACT BOOK, LOOKS LIKE THEY FOUND THAT from this study ;</div>
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P190 Human prion disease mortality rates by occurrence of chronic wasting disease in freeranging cervids, United States</div>
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Abrams JY (1), Maddox RA (1), Schonberger LB (1), Person MK (1), Appleby BS (2), Belay ED (1) (1) Centers for Disease Control and Prevention (CDC), National Center for Emerging and Zoonotic Infectious Diseases, Atlanta, GA, USA (2) Case Western Reserve University, National Prion Disease Pathology Surveillance Center (NPDPSC), Cleveland, OH, USA..</div>
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SEEMS THAT THEY FOUND Highly endemic states had a higher rate of prion disease mortality compared to non-CWD<br />
states.</div>
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AND ANOTHER STUDY;</div>
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P172 Peripheral Neuropathy in Patients with Prion Disease</div>
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Wang H(1), Cohen M(1), Appleby BS(1,2) (1) University Hospitals Cleveland Medical Center, Cleveland, Ohio (2) National Prion Disease Pathology Surveillance Center, Cleveland, Ohio..</div>
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IN THIS STUDY, THERE WERE autopsy-proven prion cases from the National Prion Disease Pathology Surveillance Center that were diagnosed between September 2016 to March 2017,</div>
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AND</div>
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included 104 patients. SEEMS THEY FOUND THAT The most common sCJD subtype was MV1-2 (30%), followed by MM1-2 (20%),</div>
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AND</div>
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THAT The Majority of cases were male (60%), AND half of them had exposure to wild game.</div>
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snip…</div>
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see more on Prion 2017 Macaque study from Prion 2017 Conference and other updated science on cwd tse prion zoonosis below…terry</div>
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<a href="https://prion2018.org/wp-content/uploads/2018/05/program.pdf" rel="nofollow" shape="rect" style="background-color: inherit; color: #222222; cursor: pointer; transition: all 0s ease-in-out 0s;" target="_blank">https://prion2018.org/wp-content/uploads/2018/05/program.pdf</a></div>
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<a fg_scanned="1" href="https://prion2018.org/" rel="nofollow" shape="rect" style="background-color: inherit; color: #222222; cursor: pointer; transition: all 0s ease-in-out 0s;" target="_blank">https://prion2018.org/</a></div>
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PRION 2019 ABSTRACTS </div>
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1. Interspecies transmission of the chronic wasting disease agent</div>
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Justin Greenlee</div>
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Virus and Prion Research Unit, National Animal Disease Center, USDA Agriculture Research Service</div>
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ABSTRACT</div>
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The presentation will summarize the results of various studies conducted at our research center that assess the transmissibility of the chronic wasting disease (CWD) agent to cattle, pigs, raccoons, goats, and sheep. This will include specifics of the relative attack rates, clinical signs, and microscopic lesions with emphasis on how to differentiate cross-species transmission of the CWD agent from the prion diseases that naturally occur in hosts such as cattle or sheep. Briefly, the relative difficulty of transmitting the CWD agent to sheep and goats will be contrasted with the relative ease of transmitting the scrapie agent to white-tailed deer.</div>
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53. Evaluation of the inter-species transmission potential of different CWD isolates</div>
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Rodrigo Moralesa, Carlos Kramma,b, Paulina Sotoa, Adam Lyona, Sandra Pritzkowa, Claudio Sotoa</div>
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aMitchell Center for Alzheimer’s disease and Related Brain Disorders, Dept. of Neurology, McGovern School of Medicine University of Texas Health Science Center at Houston, TX, USA; bFacultad de Medicina, Universidad de los Andes, Santiago, Chile</div>
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ABSTRACT</div>
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Chronic Wasting Disease (CWD) has reached epidemic proportions in North America and has been identified in South Korea and Northern Europe. CWD-susceptible cervid species are known to share habitats with humans and other animals entering the human food chain. At present, the potential of CWD to infect humans and other animal species is not completely clear. The exploration of this issue acquires further complexity considering the differences in the prion protein sequence due to species-specific variations and polymorphic changes within species. While several species of cervids are naturally affected by CWD, white-tailed deer (WTD) is perhaps the most relevant due to its extensive use in hunting and as a source of food. Evaluation of inter-species prion infections using animals or mouse models is costly and time consuming. We and others have shown that the Protein Misfolding Cyclic Amplification (PMCA) technology reproduces, in an accelerated and inexpensive manner, the inter-species transmission of prions while preserving the strain features of the input PrPSc. In this work, we tested the potential of different WTD-derived CWD isolates to transmit to humans and other animal species relevant for human consumption using PMCA. For these experiments, CWD isolates homozygous for the most common WTD-PrP polymorphic changes (G96S) were used (96SS variant obtained from a pre-symptomatic prion infected WTD). Briefly, 96GG and 96SS CWD prions were adapted in homologous or heterologous substrate by PMCA through several (15) rounds. End products, as well as intermediates across the process, were tested for their inter-species transmission potentials. A similar process was followed to assess seed-templated misfolding of ovine, porcine, and bovine PrPC. Our results show differences on the inter-species transmission potentials of the four adapted materials generated (PrPC/PrPSc polymorphic combinations), being the homologous combinations of seed/substrate the ones with the greater apparent zoonotic potential. Surprisingly, 96SS prions adapted in homologous substrate were the ones showing the easiest potential to template PrPC misfolding from other animal species. In summary, our results show that a plethora of different CWD isolates, each comprising different potentials for inter-species transmission, may exist in the environment. These experiments may help to clarify an uncertain and potentially worrisome public health issue. Additional research in this area may be useful to advise on the design of regulations intended to stop the spread of CWD and predict unwanted zoonotic events.</div>
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56. Understanding chronic wasting disease spread potential for at-risk species</div>
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Catherine I. Cullingham, Anh Dao, Debbie McKenzie and David W. Coltman</div>
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Department of Biological Sciences, University of Alberta, Edmonton AB, Canada</div>
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CONTACT Catherine I. Cullingham <a href="mailto:cathy.cullingham@ualberta.ca" rel="nofollow" shape="rect" style="color: blue; cursor: pointer;" target="_blank" ymailto="mailto:cathy.cullingham@ualberta.ca">cathy.cullingham@ualberta.ca</a></div>
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Genetic variation can be linked to susceptibility or resistance to a disease, and this information can help to better understand spread-risk in a population. Wildlife disease incidence is increasing, and this is resulting in negative impacts on the economy, biodiversity, and in some instances, human health. If we can find genetic variation that helps to inform which individuals are susceptible, then we can use this information on at-risk populations to better manage negative consequences. Chronic wasting disease, a fatal, transmissible spongiform encephalopathy of cervids (both wild and captive), continues to spread geographically, which has resulted in an increasing host-range. The disease agent (PrPCWD) is a misfolded conformer of native cellular protein (PrPC). In Canada, the disease is endemic in Alberta and Saskatchewan, infecting primarily mule deer and white-tail deer, with a smaller impact on elk and moose populations. As the extent of the endemic area continues to expand, additional species will be exposed to this disease, including bison, bighorn sheep, mountain goat, and pronghorn antelope. To better understand the potential spread-risk among these species, we reviewed the current literature on species that have been orally exposed to CWD to identify susceptible and resistant species. We then compared the amino acid polymorphisms of PrPC among these species to determine whether any sites were linked to susceptibility or resistance to CWD infection. We sequenced the entire PrP coding region in 578 individuals across at-risk populations to evaluate their potential susceptibility. Three amino acid sites (97, 170, and 174; human numbering) were significantly associated with susceptibility, but these were not fully discriminating. All but one species among the resistant group shared the same haplotype, and the same for the susceptible species. For the at-risk species, bison had the resistant haplotype, while bighorn sheep and mountain goats were closely associated with the resistant type. Pronghorn antelope and a newly identified haplotype in moose differed from the susceptible haplotype, but were still closely associated with it. These data suggest pronghorn antelope will be susceptible to CWD while bison are likely to be resistant. Based on this data, recommendations can be made regarding species to be monitored for possible CWD infection.</div>
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KEYWORDS: Chronic wasting disease; Prnp; wildlife disease; population genetics; ungulates</div>
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Thursday, May 23, 2019 </div>
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Prion 2019 Emerging Concepts CWD, BSE, SCRAPIE, CJD, SCIENTIFIC PROGRAM Schedule and Abstracts</div>
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<a fg_scanned="1" href="https://prionconference.blogspot.com/2019/05/prion-2019-emerging-concepts-cwd-bse.html" rel="nofollow" shape="rect" style="color: blue; cursor: pointer;" target="_blank">https://prionconference.blogspot.com/2019/05/prion-2019-emerging-concepts-cwd-bse.html</a></div>
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see full Prion 2019 Conference Abstracts</div>
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<span style="color: #0096ef;"><a fg_scanned="1" href="https://www.tandfonline.com/doi/full/10.1080/19336896.2019.1615197" rel="nofollow" shape="rect" style="color: blue; cursor: pointer;" target="_blank">https://www.tandfonline.com/doi/full/10.1080/19336896.2019.1615197</a></span></div>
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THURSDAY, OCTOBER 04, 2018</div>
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Cervid to human prion transmission 5R01NS088604-04 Update</div>
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<a fg_scanned="1" href="http://grantome.com/grant/NIH/R01-NS088604-04" rel="nofollow" shape="rect" style="background-color: inherit; color: #222222; cursor: pointer; transition: all 0s ease-in-out 0s;" target="_blank">http://grantome.com/grant/NIH/R01-NS088604-04</a></div>
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<a fg_scanned="1" href="http://chronic-wasting-disease.blogspot.com/2018/10/cervid-to-human-prion-transmission.html" rel="nofollow" shape="rect" style="background-color: inherit; color: #222222; cursor: pointer; transition: all 0s ease-in-out 0s;" target="_blank">http://chronic-wasting-disease.blogspot.com/2018/10/cervid-to-human-prion-transmission.html</a></div>
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snip…full text;</div>
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SATURDAY, FEBRUARY 09, 2019</div>
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Experts: Yes, chronic wasting disease in deer is a public health issue — for people</div>
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<a fg_scanned="1" href="https://chronic-wasting-disease.blogspot.com/2019/02/experts-yes-chronic-wasting-disease-in.html" rel="nofollow" shape="rect" style="background-color: inherit; color: #222222; cursor: pointer; transition: all 0s ease-in-out 0s;" target="_blank">https://chronic-wasting-disease.blogspot.com/2019/02/experts-yes-chronic-wasting-disease-in.html</a></div>
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SATURDAY, FEBRUARY 23, 2019 </div>
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Chronic Wasting Disease CWD TSE Prion and THE FEAST 2003 CDC an updated review of the science 2019</div>
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<a fg_scanned="1" href="https://chronic-wasting-disease.blogspot.com/2019/02/chronic-wasting-disease-cwd-tse-prion.html" rel="nofollow" shape="rect" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">https://chronic-wasting-disease.blogspot.com/2019/02/chronic-wasting-disease-cwd-tse-prion.html</a></div>
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TUESDAY, NOVEMBER 04, 2014 </div>
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Six-year follow-up of a point-source exposure to CWD contaminated venison in an Upstate New York community: risk behaviours and health outcomes 2005–2011</div>
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Authors, though, acknowledged the study was limited in geography and sample size and so it couldn't draw a conclusion about the risk to humans. They recommended more study. Dr. Ermias Belay was the report's principal author but he said New York and Oneida County officials are following the proper course by not launching a study. "There's really nothing to monitor presently. No one's sick," Belay said, noting the disease's incubation period in deer and elk is measured in years. "</div>
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<a fg_scanned="1" href="http://chronic-wasting-disease.blogspot.com/2014/11/six-year-follow-up-of-point-source.html" rel="nofollow" shape="rect" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://chronic-wasting-disease.blogspot.com/2014/11/six-year-follow-up-of-point-source.html</a> </div>
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Transmission Studies</div>
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Mule deer transmissions of CWD were by intracerebral inoculation and compared with natural cases {the following was written but with a single line marked through it ''first passage (by this route)}....TSS</div>
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resulted in a more rapidly progressive clinical disease with repeated episodes of synocopy ending in coma. One control animal became affected, it is believed through contamination of inoculum (?saline). Further CWD transmissions were carried out by Dick Marsh into ferret, mink and squirrel monkey. Transmission occurred in ALL of these species with the shortest incubation period in the ferret.</div>
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snip.... </div>
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<a href="https://web.archive.org/web/20090506002237/http://www.bseinquiry.gov.uk/files/mb/m11b/tab01.pdf" rel="nofollow" shape="rect" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">https://web.archive.org/web/20090506002237/http://www..bseinquiry.gov.uk/files/mb/m11b/tab01.pdf</a></div>
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Prion Infectivity in Fat of Deer with Chronic Wasting Disease▿ </div>
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Brent Race#, Kimberly Meade-White#, Richard Race and Bruce Chesebro* + Author Affiliations</div>
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In mice, prion infectivity was recently detected in fat. Since ruminant fat is consumed by humans and fed to animals, we determined infectivity titers in fat from two CWD-infected deer. Deer fat devoid of muscle contained low levels of CWD infectivity and might be a risk factor for prion infection of other species. </div>
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Prions in Skeletal Muscles of Deer with Chronic Wasting Disease </div>
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Here bioassays in transgenic mice expressing cervid prion protein revealed the presence of infectious prions in skeletal muscles of CWD-infected deer, demonstrating that humans consuming or handling meat from CWD-infected deer are at risk to prion exposure. </div>
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*** now, let’s see what the authors said about this casual link, personal communications years ago, and then the latest on the zoonotic potential from CWD to humans from the TOKYO PRION 2016 CONFERENCE.</div>
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see where it is stated NO STRONG evidence. so, does this mean there IS casual evidence ???? “Our conclusion stating that we found no strong evidence of CWD transmission to humans”</div>
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From: TSS </div>
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Subject: CWD aka MAD DEER/ELK TO HUMANS ???</div>
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Date: September 30, 2002 at 7:06 am PST</div>
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From: "Belay, Ermias"</div>
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To: Cc: "Race, Richard (NIH)" ; ; "Belay, Ermias"</div>
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Sent: Monday, September 30, 2002 9:22 AM</div>
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Subject: RE: TO CDC AND NIH - PUB MED- 3 MORE DEATHS - CWD - YOUNG HUNTERS</div>
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Dear Sir/Madam,</div>
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In the Archives of Neurology you quoted (the abstract of which was attached to your email), we did not say CWD in humans will present like variant CJD.. That assumption would be wrong. I encourage you to read the whole article and call me if you have questions or need more clarification (phone: 404-639-3091). Also, we do not claim that "no-one has ever been infected with prion disease from eating venison." Our conclusion stating that we found no strong evidence of CWD transmission to humans in the article you quoted or in any other forum is limited to the patients we investigated.</div>
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Ermias Belay, M.D. Centers for Disease Control and Prevention</div>
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-----Original Message-----</div>
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From: Sent: Sunday, September 29, 2002 10:15 AM</div>
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To: <a href="mailto:rr26k@nih.gov" rel="nofollow" shape="rect" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank" ymailto="mailto:rr26k@nih.gov">rr26k@nih.gov</a>; <a href="mailto:rrace@niaid.nih.gov" rel="nofollow" shape="rect" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank" ymailto="mailto:rrace@niaid.nih.gov">rrace@niaid.nih.gov</a>; <a href="mailto:ebb8@CDC.GOV" rel="nofollow" shape="rect" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank" ymailto="mailto:ebb8@CDC.GOV">ebb8@CDC.GOV</a></div>
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Subject: TO CDC AND NIH - PUB MED- 3 MORE DEATHS - CWD - YOUNG HUNTERS</div>
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Sunday, November 10, 2002 6:26 PM .......snip........end..............TSS</div>
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Thursday, April 03, 2008</div>
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A prion disease of cervids: Chronic wasting disease 2008 1: Vet Res. 2008 Apr 3;39(4):41 A prion disease of cervids: Chronic wasting disease Sigurdson CJ.</div>
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snip...</div>
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*** twenty-seven CJD patients who regularly consumed venison were reported to the Surveillance Center***,</div>
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snip... full text ; </div>
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<a fg_scanned="1" href="http://chronic-wasting-disease.blogspot.com/2008/04/prion-disease-of-cervids-chronic.html" rel="nofollow" shape="rect" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://chronic-wasting-disease.blogspot.com/2008/04/prion-disease-of-cervids-chronic.html</a> </div>
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> However, to date, no CWD infections have been reported in people. </div>
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sporadic, spontaneous CJD, 85%+ of all human TSE, just not just happen. never in scientific literature has this been proven.</div>
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if one looks up the word sporadic or spontaneous at pubmed, you will get a laundry list of disease that are classified in such a way;</div>
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sporadic = 54,983 hits <a fg_scanned="1" href="https://www.ncbi.nlm.nih.gov/pubmed/?term=sporadic" rel="nofollow" shape="rect" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">https://www.ncbi.nlm.nih.gov/pubmed/?term=sporadic</a></div>
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spontaneous = 325,650 hits <a fg_scanned="1" href="https://www.ncbi.nlm.nih.gov/pubmed/?term=spontaneous" rel="nofollow" shape="rect" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">https://www.ncbi.nlm.nih.gov/pubmed/?term=spontaneous</a></div>
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key word here is 'reported'. science has shown that CWD in humans will look like sporadic CJD. SO, how can one assume that CWD has not already transmitted to humans? they can't, and it's as simple as that. from all recorded science to date, CWD has already transmitted to humans, and it's being misdiagnosed as sporadic CJD. ...terry </div>
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*** LOOKING FOR CWD IN HUMANS AS nvCJD or as an ATYPICAL CJD, LOOKING IN ALL THE WRONG PLACES $$$ ***</div>
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*** These results would seem to suggest that CWD does indeed have zoonotic potential, at least as judged by the compatibility of CWD prions and their human PrPC target. Furthermore, extrapolation from this simple in vitro assay suggests that if zoonotic CWD occurred, it would most likely effect those of the PRNP codon 129-MM genotype and that the PrPres type would be similar to that found in the most common subtype of sCJD (MM1).*** </div>
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<a fg_scanned="1" href="http://www.tandfonline.com/doi/full/10.4161/pri.28124?src=recsys" rel="nofollow" shape="rect" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://www.tandfonline.com/doi/full/10.4161/pri.28124?src=recsys</a> </div>
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FRIDAY, JULY 26, 2019 </div>
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Chronic Wasting Disease in Cervids: Implications for Prion Transmission to Humans and Other Animal Species</div>
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<a fg_scanned="1" href="https://chronic-wasting-disease.blogspot.com/2019/07/chronic-wasting-disease-in-cervids.html" rel="nofollow" shape="rect" style="color: blue; cursor: pointer;" target="_blank">https://chronic-wasting-disease.blogspot.com/2019/07/chronic-wasting-disease-in-cervids.html</a></div>
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TUESDAY, JANUARY 21, 2020 </div>
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***> 2004 European Commission Chronic wasting disease AND TISSUES THAT MIGHT CARRY A RISK FOR HUMAN FOOD AND ANIMAL FEED CHAINS REPORT UPDATED 2020</div>
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<span style="font-family: "arial" , "helvetica";">***> In conclusion, sensory symptoms and loss of reflexes in Gerstmann-Sträussler-Scheinker syndrome can be explained by neuropathological changes in the spinal cord. We conclude that the sensory symptoms and loss of lower limb reflexes in Gerstmann-Sträussler-Scheinker syndrome is due to pathology in the caudal spinal cord. <***</span></div>
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<span style="font-size: 13.3333px;">***> The clinical and pathological presentation in macaques was mostly atypical, with a strong emphasis on spinal cord pathology.<*** </span></div>
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<span style="font-size: 13.3333px;">***> The notion that CWD can be transmitted orally into both new-world and old-world non-human primates asks for a careful reevaluation of the zoonotic risk of CWD. <***</span></div>
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<span style="font-size: 13.3333px;">***> All animals have variable signs of prion neuropathology in spinal cords and brains and by supersensitive IHC, reaction was detected in spinal cord segments of all animals.<*** </span></div>
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<span style="font-family: "arial" , "helvetica";">***> In particular the US data do not clearly exclude the possibility of human (sporadic or familial) TSE development due to consumption of venison. The Working Group thus recognizes a potential risk to consumers if a TSE would be present in European cervids.'' Scientific opinion on chronic wasting disease (II) <***</span></div>
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<span style="font-family: "arial" , "helvetica";"><a fg_scanned="1" href="https://familialcjdtseprion.blogspot.com/2019/02/cwd-gss-tse-prion-spinal-cord-confucius.html" rel="nofollow" shape="rect" style="color: blue; cursor: pointer;" target="_blank">https://familialcjdtseprion.blogspot.com/2019/02/cwd-gss-tse-prion-spinal-cord-confucius.html</a></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Sent: Sun, May 26, 2019 10:21 am </span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Subject: Arguments for Alzheimer’s and Parkinson’s diseases caused by prions </span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">''From a large array of bioassays, we conclude that AD, PD, MSA, and the frontotemporal dementias, including PSP and CBD, are all prion diseases'' 11.</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Arguments for Alzheimer’s and Parkinson’s diseases caused by prions Stanley B. Prusiner Institute of Neurodegenerative Diseases, and Professor of Neurology and Biochemistry, University of California San Francisco ABSTRACT Arguments for Alzheimer’s (AD) and Parkinson’s diseases (PD) being caused by prions continue to advance with new evidence. Findings in the brains of deceased AD patients argue that both Aβ and tau prions can be demonstrated by bioassays in cultured cells as well as in transgenic (Tg) mice. Likewise, studies of the brains of deceased MSA patients have been found to contain α-synuclein prions by bioassays in cultured cells and Tg mice. Conversely, the brains of AD patients do not contain α-synuclein prions, and the brains of MSA patients do not contain Aβ or tau prions. Additionally, while the brains of patients who died of either progressive supranuclear palsy (PSP) or corticobasal degeneration (CBD) contained tau prions, neither Aβ nor α-synuclein prions were detectable. Merely measuring the levels of Aβ, tau, and α-synuclein appears to give misleading information about the etiology and pathogenesis of neurodegenerative diseases (NDs). From a large array of bioassays, we conclude that AD, PD, MSA, and the frontotemporal dementias, including PSP and CBD, are all prion diseases. Our findings argue that changes in the conformations of Aβ, tau, and α-synuclein underlie the acquisition of prion infectivity in all of these NDs.</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;"><a fg_scanned="1" href="https://www.tandfonline.com/doi/full/10.1080/19336896.2019.1615197" rel="nofollow" style="color: blue; cursor: pointer;" target="_blank">https://www.tandfonline.com/doi/full/10.1080/19336896.2019.1615197</a> </span></span></div>
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<span face=""arial" , "helvetica" , sans-serif" style="font-size: 12px;">''From a large array of bioassays, we conclude that AD, PD, MSA, and the frontotemporal dementias, including PSP and CBD, are all prion diseases''</span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Published: 09 September 2015</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Evidence for human transmission of amyloid-β pathology and cerebral amyloid angiopathy</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Zane Jaunmuktane, Simon Mead, Matthew Ellis, Jonathan D. F. Wadsworth, Andrew J. Nicoll, Joanna Kenny, Francesca Launchbury, Jacqueline Linehan, Angela Richard-Loendt, A. Sarah Walker, Peter Rudge, John Collinge & Sebastian Brandner</span></span></div>
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<span style="background-color: rgba(255, 255, 255, 0);">>>> The only tenable public line will be that "more research is required’’ <<< </span></div>
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<span style="background-color: rgba(255, 255, 255, 0);">>>> possibility on a transmissible prion remains open<<< </span></div>
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<span style="background-color: rgba(255, 255, 255, 0);"><span style="line-height: 1.22em;">O.K., so it’s about 23 years later, so somebody please tell me, when is "more research is required’’ enough time for evaluation ? </span></span></div>
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<span style="background-color: rgba(255, 255, 255, 0);">Re-Evidence for human transmission of amyloid-β pathology and cerebral amyloid angiopathy </span></div>
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<span style="background-color: rgba(255, 255, 255, 0);">Nature 525, 247?250 (10 September 2015) doi:10.1038/nature15369 Received 26 April 2015 Accepted 14 August 2015 Published online 09 September 2015 Updated online 11 September 2015 Erratum (October, 2015) </span></div>
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<span style="background-color: rgba(255, 255, 255, 0);">snip...see full Singeltary Nature comment here; </span></div>
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<span style="background-color: rgba(255, 255, 255, 0);">Alzheimer's disease</span></div>
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<span style="background-color: rgba(255, 255, 255, 0);">let's not forget the elephant in the room. curing Alzheimer's would be a great and wonderful thing, but for starters, why not start with the obvious, lets prove the cause or causes, and then start to stop that. think iatrogenic, friendly fire, or the pass it forward mode of transmission. think medical, surgical, dental, tissue, blood, related transmission. think transmissible spongiform encephalopathy aka tse prion disease aka mad cow type disease... </span></div>
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<span style="background-color: rgba(255, 255, 255, 0);">Commentary: Evidence for human transmission of amyloid-β pathology and cerebral amyloid angiopathy</span></div>
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<span style="color: black;"><span style="background-color: rgba(255, 255, 255, 0);"><a fg_scanned="1" href="http://journals.plos.org/plosone/article/comment?id=info:doi/10.1371/annotation/933cc83a-a384-45c3-b3b2-336882c30f9d" rel="nofollow" shape="rect" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://journals.plos.org/plosone/article/comment?id=info:doi/10.1371/annotation/933cc83a-a384-45c3-b3b2-336882c30f9d</a></span></span></div>
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<span style="color: black;"><span style="background-color: rgba(255, 255, 255, 0);"><a fg_scanned="1" href="http://journals.plos.org/plosone/article/comments?id=10.1371/journal.pone.0111492" rel="nofollow" shape="rect" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://journals.plos.org/plosone/article/comments?id=10.1371/journal.pone.0111492</a></span></span></div>
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<span style="color: black;"><span style="background-color: rgba(255, 255, 255, 0);"><a fg_scanned="1" href="https://www.frontiersin.org/articles/10.3389/fnagi.2016.00005/full" rel="nofollow" shape="rect" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">https://www.frontiersin.org/articles/10.3389/fnagi.2016.00005/full</a></span></span></div>
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<span style="background-color: rgba(255, 255, 255, 0);">Self-Propagative Replication of Ab Oligomers Suggests Potential Transmissibility in Alzheimer Disease </span></div>
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<span style="background-color: rgba(255, 255, 255, 0);">*** Singeltary comment PLoS *** </span></div>
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<span style="background-color: rgba(255, 255, 255, 0);">Alzheimer’s disease and Transmissible Spongiform Encephalopathy prion disease, Iatrogenic, what if ? </span></div>
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<span style="background-color: rgba(255, 255, 255, 0);">Posted by flounder on 05 Nov 2014 at 21:27 GMT </span></div>
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<span style="color: black;"><span style="background-color: rgba(255, 255, 255, 0);"><a fg_scanned="1" href="http://www.plosone.org/annotation/listThread.action?root=82860" rel="nofollow" shape="rect" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://www.plosone.org/annotation/listThread.action?root=82860</a></span></span></div>
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<span style="background-color: rgba(255, 255, 255, 0);">IN CONFIDENCE</span></div>
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<span style="background-color: rgba(255, 255, 255, 0);">5 NOVEMBER 1992</span></div>
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<span style="background-color: rgba(255, 255, 255, 0);">TRANSMISSION OF ALZHEIMER TYPE PLAQUES TO PRIMATES</span></div>
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<span style="background-color: rgba(255, 255, 255, 0);">[9. Whilst this matter is not at the moment directly concerned with the iatrogenic CJD cases from hgH, there remains a possibility of litigation here, and this presents an added complication. </span></div>
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<span style="background-color: rgba(255, 255, 255, 0);">There are also results to be made available shortly </span></div>
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<span style="background-color: rgba(255, 255, 255, 0);">(1) concerning a farmer with CJD who had BSE animals, </span></div>
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<span style="background-color: rgba(255, 255, 255, 0);">(2) on the possible transmissibility of Alzheimer’s and </span></div>
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<span style="background-color: rgba(255, 255, 255, 0);">(3) a CMO letter on prevention of iatrogenic CJD transmission in neurosurgery, all of which will serve to increase media interest.]</span></div>
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<span style="color: black;"><span style="background-color: rgba(255, 255, 255, 0);"><a href="https://web.archive.org/web/20170126060344/http://collections.europarchive.org/tna/20080102232842/http://www.bseinquiry.gov.uk/files/yb/1992/11/04001001.pdf" rel="nofollow" shape="rect" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">https://web.archive.org/web/20170126060344/http://collections.europarchive.org/tna/20080102232842/http://www.bseinquiry.gov.uk/files/yb/1992/11/04001001.pdf</a></span></span></div>
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<span style="color: black;"><span style="background-color: rgba(255, 255, 255, 0);"><a href="https://web.archive.org/web/20040315075058/http://www.bseinquiry.gov.uk/files/yb/1992/12/16005001.pdf" rel="nofollow" shape="rect" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">https://web.archive.org/web/20040315075058/http://www.bseinquiry.gov.uk/files/yb/1992/12/16005001.pdf</a></span></span></div>
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<span style="background-color: rgba(255, 255, 255, 0); color: blue; line-height: 1.22em;"><a href="https://web.archive.org/web/20040315075058/www.bseinquiry.gov.uk/files/yb/1992/12/16005001.pdf" rel="nofollow" shape="rect" style="background-color: rgba(255, 255, 255, 0); color: blue; cursor: pointer; line-height: 1.22em; text-decoration-line: none;" target="_blank">https://web.archive.org/web/20040315075058/www.bseinquiry.gov.uk/files/yb/1992/12/16005001.pdf</a></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Singeltary, Sr et al. JAMA.2001; 285: 733-734. Vol. 285 No. 6, February 14, 2001 JAMA Diagnosis and Reporting of Creutzfeldt-Jakob Disease </span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">To the Editor: </span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">In their Research Letter, Dr Gibbons and colleagues1 reported that the annual US death rate due to Creutzfeldt-Jakob disease (CJD) has been stable since 1985. These estimates, however, are based only on reported cases, and do not include misdiagnosed or preclinical cases. It seems to me that misdiagnosis alone would drastically change these figures. An unknown number of persons with a diagnosis of Alzheimer disease in fact may have CJD, although only a small number of these patients receive the postmortem examination necessary to make this diagnosis. Furthermore, only a few states have made CJD reportable. Human and animal transmissible spongiform encephalopathies should be reportable nationwide and internationally.. </span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Terry S. Singeltary, Sr Bacliff, Tex </span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">1. Gibbons RV, Holman RC, Belay ED, Schonberger LB. Creutzfeldt-Jakob disease in the United States: 1979-1998. JAMA. 2000;284:2322-2323. </span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">doi:10.1016/S1473-3099(03)00715-1 Copyright © 2003 Published by Elsevier Ltd. Newsdesk</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Tracking spongiform encephalopathies in North America</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Xavier Bosch</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Available online 29 July 2003. </span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Volume 3, Issue 8, August 2003, Page 463 </span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">“My name is Terry S Singeltary Sr, and I live in Bacliff, Texas. I lost my mom to hvCJD (Heidenhain variant CJD) and have been searching for answers ever since. What I have found is that we have not been told the truth. CWD in deer and elk is a small portion of a much bigger problem..” ............................ </span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">January 28, 2003; 60 (2) VIEWS & REVIEWS</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Ermias D. Belay, Ryan A. Maddox, Pierluigi Gambetti, Lawrence B. Schonberger</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">First published January 28, 2003, DOI: <a fg_scanned="1" href="https://doi.org/10.1212/01.WNL.0000036913.87823.D6" rel="noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://doi.org/10.1212/01.WNL.0000036913.87823.D6</a></span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Abstract</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Transmissible spongiform encephalopathies (TSEs) attracted increased attention in the mid-1980s because of the emergence among UK cattle of bovine spongiform encephalopathy (BSE), which has been shown to be transmitted to humans, causing a variant form of Creutzfeldt-Jakob disease (vCJD). The BSE outbreak has been reported in 19 European countries, Israel, and Japan, and human cases have so far been identified in four European countries, and more recently in a Canadian resident and a US resident who each lived in Britain during the BSE outbreak. To monitor the occurrence of emerging forms of CJD, such as vCJD, in the United States, the Centers for Disease Control and Prevention has been conducting surveillance for human TSEs through several mechanisms, including the establishment of the National Prion Disease Pathology Surveillance Center. Physicians are encouraged to maintain a high index of suspicion for vCJD and use the free services of the pathology center to assess the neuropathology of clinically diagnosed and suspected cases of CJD or other TSEs.</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Received May 7, 2002. Accepted August 28, 2002.</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States </span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Terry S. Singeltary, retired (medically) </span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Published March 26, 2003</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">26 March 2003</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Terry S. Singeltary, retired (medically) CJD WATCH</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to comment on the CDC's attempts to monitor the occurrence of emerging forms of CJD. Asante, Collinge et al [1] have reported that BSE transmission to the 129-methionine genotype can lead to an alternate phenotype that is indistinguishable from type 2 PrPSc, the commonest sporadic CJD. However, CJD and all human TSEs are not reportable nationally. CJD and all human TSEs must be made reportable in every state and internationally. I hope that the CDC does not continue to expect us to still believe that the 85%+ of all CJD cases which are sporadic are all spontaneous, without route/source. We have many TSEs in the USA in both animal and man. CWD in deer/elk is spreading rapidly and CWD does transmit to mink, ferret, cattle, and squirrel monkey by intracerebral inoculation. With the known incubation periods in other TSEs, oral transmission studies of CWD may take much longer. Every victim/family of CJD/TSEs should be asked about route and source of this agent. To prolong this will only spread the agent and needlessly expose others. In light of the findings of Asante and Collinge et al, there should be drastic measures to safeguard the medical and surgical arena from sporadic CJDs and all human TSEs. I only ponder how many sporadic CJDs in the USA are type 2 PrPSc?</span></span></div>
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<a fg_scanned="1" href="http://n.neurology.org/content/re-monitoring-occurrence-emerging-forms-creutzfeldt-jakob-disease-united-states" rel="nofollow" style="color: blue; cursor: pointer;" target="_blank">http://n.neurology.org/content/re-monitoring-occurrence-emerging-forms-creutzfeldt-jakob-disease-united-states</a></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Reply to Singletary Ryan A. Maddox, MPH Other Contributors: Published March 26, 2003 </span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Mr. Singletary raises several issues related to current Creutzfeldt- Jakob disease (CJD) surveillance activities. Although CJD is not a notifiable disease in most states, its unique characteristics, particularly its invariably fatal outcome within usually a year of onset, make routine mortality surveillance a useful surrogate for ongoing CJD surveillance.[1] In addition, because CJD is least accurately diagnosed early in the course of illness, notifiable-disease surveillance could be less accurate than, if not duplicative of, current mortality surveillance.[1] However, in states where making CJD officially notifiable would meaningfully facilitate the collection of data to monitor for variant CJD (vCJD) or other emerging prion diseases, CDC encourages the designation of CJD as a notifiable disease.[1] Moreover, CDC encourages physicians to report any diagnosed or suspected CJD cases that may be of special public health importance (e.g...., vCJD, iatrogenic CJD, unusual CJD clusters).</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">As noted in our article, strong evidence is lacking for a causal link between chronic wasting disease (CWD) of deer and elk and human disease,[2] but only limited data seeking such evidence exist. Overall, the previously published case-control studies that have evaluated environmental sources of infection for sporadic CJD have not consistently identified strong evidence for a common risk factor.[3] However, the power of a case-control study to detect a rare cause of CJD is limited, particularly given the relatively small number of subjects generally involved and its long incubation period, which may last for decades. Because only a very small proportion of the US population has been exposed to CWD, a targeted surveillance and investigation of unusual cases or case clusters of prion diseases among persons at increased risk of exposure to CWD is a more efficient approach to detecting the possible transmission of CWD to humans. In collaboration with appropriate local and state health departments and the National Prion Disease Pathology Surveillance Center, CDC is facilitating or conducting such surveillance and case- investigations, including related laboratory studies to characterize CJD and CWD prions.</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Mr. Singletary also expresses concern over a recent publication by Asante and colleagues indicating the possibility that some sporadic CJD cases may be attributable to bovine spongiform encephalopathy (BSE).[4] The authors reported that transgenic mice expressing human prion protein homozygous for methionine at codon 129, when inoculated with BSE prions, developed a molecular phenotype consistent with a subtype of sporadic CJD. Although the authors implied that BSE might cause a sporadic CJD-like illness among persons homozygous for methionine, the results of their research with mice do not necessarily directly apply to the transmission of BSE to humans. If BSE causes a sporadic CJD-like illness in humans, an increase in sporadic CJD cases would be expected to first occur in the United Kingdom, where the vast majority of vCJD cases have been reported. In the United Kingdom during 1997 through 2002, however, the overall average annual mortality rate for sporadic CJD was not elevated; it was about 1 case per million population per year. In addition, during this most recent 6-year period following the first published description of vCJD in 1996, there was no increasing trend in the reported annual number of UK sporadic CJD deaths.[3, 5] Furthermore, surveillance in the UK has shown no increase in the proportion of sporadic CJD cases that are homozygous for methionine (Will RG, National CJD Surveillance Unit, United Kingdom, 2003; personal communication)..</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">1. Gibbons RV, Holman RC, Belay ED, Schonberger LB. Diagnosis and reporting of Creutzfeldt-Jakob disease. JAMA 2001;285:733-734.</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">2. Belay ED, Maddox RA, Gambetti P, Schonberger LB. Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States. Neurology 2003;60:176-181.</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">3. Belay ED. Transmissible spongiform encephalopathies in humans. Annu Rev Microbiol 1999;53:283-314.</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">4. Asante EA, Linehan JM, Desbruslais M, et al. BSE prions propagate as either variant CJD-like or sporadic CJD-like prion strains in transgenic mice expressing human prion protein. EMBO J 2002;21:6358-6366.</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">5. The UK Creutzfeldt-Jakob Disease Surveillance Unit. CJD statistics. Available at: <a fg_scanned="1" href="http://www.cjd.ed.ac.uk/figures.htm" rel="noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">http://www.cjd.ed.ac.uk/figures.htm</a>. Accessed February 18, 2003.</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Competing Interests: None declared.</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;"><a fg_scanned="1" href="http://n.neurology.org/content/reply-singletary" rel="nofollow" style="color: blue; cursor: pointer;" target="_blank">http://n.neurology.org/content/reply-singletary</a> </span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Volume 2: Science </span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">4. The link between BSE and vCJD </span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Summary 4.29 The evidence discussed above that vCJD is caused by BSE seems overwhelming. Uncertainties exist about the cause of CJD in farmers, their wives and in several abattoir workers. It seems that farmers at least might be at higher risk than others in the general population. 1 Increased ascertainment (ie, increased identification of cases as a result of greater awareness of the condition) seems unlikely, as other groups exposed to risk, such as butchers and veterinarians, do not appear to have been affected. The CJD in farmers seems to be similar to other sporadic CJD in age of onset, in respect to glycosylation patterns, and in strain-typing in experimental mice. Some farmers are heterozygous for the methionine/valine variant at codon 129, and their lymphoreticular system (LRS) does not contain the high levels of PrPSc found in vCJD. </span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">***>It remains a remote possibility that when older people contract CJD from BSE the resulting phenotype is like sporadic CJD and is distinct from the vCJD phenotype in younger people...end</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">BSE INQUIRY</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;"><a fg_scanned="1" href="https://bseinquiry.blogspot.com/2008/05/sporadic-cjd-in-farmers-farmers-wives.html" rel="nofollow" style="color: blue; cursor: pointer;" target="_blank">https://bseinquiry.blogspot.com/2008/05/sporadic-cjd-in-farmers-farmers-wives.html</a> </span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">SATURDAY, JUNE 23, 2018</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">***> Diagnosis of Methionine/Valine Variant Creutzfeldt-Jakob Disease by Protein Misfolding Cyclic Amplification </span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;">Volume 24, Number 7—July 2018 Dispatch </span></span></div>
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<span face=""arial" , "helvetica" , sans-serif"><span style="font-size: 12px;"><a fg_scanned="1" href="https://wwwnc.cdc.gov/eid/article/24/7/17-2105_article" rel="nofollow" style="color: blue; cursor: pointer;" target="_blank">https://wwwnc.cdc.gov/eid/article/24/7/17-2105_article</a> </span></span></div>
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<a fg_scanned="1" href="http://vcjd.blogspot.com/2018/06/diagnosis-of-methioninevaline-variant.html" rel="nofollow" style="color: blue; cursor: pointer;" target="_blank">http://vcjd.blogspot.com/2018/06/diagnosis-of-methioninevaline-variant.html</a></div>
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<span face=""arial" , "helvetica" , sans-serif" style="line-height: 1.22em;"><span style="font-size: 12px; line-height: 1.22em;">THURSDAY, JULY 02, 2020 </span></span></div>
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<span face=""arial" , "helvetica" , sans-serif" style="line-height: 1.22em;"><span style="font-size: 12px; line-height: 1.22em;">Variant Creutzfeldt–Jakob Disease Diagnosed 7.5 Years after Occupational Exposure</span></span></div>
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<span face=""arial" , "helvetica" , sans-serif" style="line-height: 1.22em;"><span style="font-size: 12px; line-height: 1.22em;"><a fg_scanned="1" href="https://vcjd.blogspot.com/2020/07/variant-creutzfeldtjakob-disease.html" rel="nofollow" shape="rect" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">https://vcjd.blogspot.com/2020/07/variant-creutzfeldtjakob-disease.html</a></span></span></div>
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<span face=""arial" , "helvetica" , sans-serif" style="line-height: 1.22em;">THURSDAY, JUNE 25, 2020 </span></div>
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First Report of the Potential Bovine Spongiform Encephalopathy (BSE)-Related Somatic Mutation E211K of the Prion Protein Gene (PRNP) in Cattle</div>
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<span style="font-size: 12px; line-height: 1.22em;">WEDNESDAY, JUNE 10, 2020 </span></div>
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<span style="font-size: 12px; line-height: 1.22em;">Radical Change in Zoonotic Abilities of Atypical BSE Prion Strains as Evidenced by Crossing of Sheep Species Barrier in Transgenic Mice</span></div>
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Radical Change in Zoonotic Abilities of Atypical BSE Prion Strains as Evidenced by Crossing of Sheep Species Barrier in Transgenic Mice</div>
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Atypical BSE prions showed a modification in their zoonotic ability after adaptation to sheep-PrP producing agents able to infect TgMet129 and TgVal129, bearing features that make them indistinguishable of sporadic Creutzfeldt-Jakob disease prions.</div>
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our results clearly indicate that atypical BSE adaptation to an ovine-PrP sequence could modify the prion agent to potentially infect humans, showing strain features indistinguishable from those of classic sCJD prions, even though they might or might not be different agents.</div>
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However, the expanding range of TSE agents displaying the capacity to transmit in human-PrP–expressing hosts warrants the continuation of the ban on meat and bone meal recycling and underscores the ongoing need for active surveillance</div>
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<a fg_scanned="1" href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7258450/" rel="nofollow" shape="rect" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7258450/</a></div>
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A REVIEW of facts and science on scrapie zoonosis potential/likelihood and the USA incredible failure of the BSE 589.2001 FEED REGULATIONS (another colossal failure, and proven to be a sham) </div>
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1st up <span style="font-size: 10pt; line-height: 1.22em;">BSE 589.2001 FEED REGULATIONS</span><span style="font-size: 10pt; line-height: 1.22em;"> </span></div>
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<span style="font-size: 10pt; line-height: 1.22em;"><span style="font-size: 12px; line-height: 1.22em;">WEDNESDAY, JUNE 10, 2020 </span></span></div>
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<span style="font-size: 12px; line-height: 1.22em;">Radical Change in Zoonotic Abilities of Atypical BSE Prion Strains as Evidenced by Crossing of Sheep Species Barrier in Transgenic Mice</span></div>
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<span style="font-size: 12px; line-height: 1.22em;"><a fg_scanned="1" href="https://bse-atypical.blogspot.com/2020/06/radical-change-in-zoonotic-abilities-of.html" rel="nofollow" shape="rect" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">https://bse-atypical.blogspot.com/2020/06/radical-change-in-zoonotic-abilities-of.html</a></span></div>
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Terry S. Singeltary Sr.</div>
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Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-4687453285836897153.post-42042616220530532992019-02-25T16:31:00.007-06:002022-11-26T15:18:08.026-06:00MAD DOGS AND ENGLISHMEN BSE, SCRAPIE, CWD, CJD, TSE PRION A REVIEW 2019<div style="background-color: white; font-family: arial; font-size: small;"><div style="color: #1d2129; font-family: Helvetica, Arial, sans-serif; font-size: 14px; margin-bottom: 6px;">MAD DOGS AND ENGLISHMEN BSE, SCRAPIE, CWD, CJD, TSE PRION A REVIEW 2019</div><div style="color: #1d2129; font-family: Helvetica, Arial, sans-serif; font-size: 14px; margin-bottom: 6px;"><br /></div><div style="color: #1d2129; font-family: Helvetica, Arial, sans-serif; font-size: 14px; margin-bottom: 6px;">BSE INQUIRY EVIDENCE</div><div style="color: #1d2129; font-family: Helvetica, Arial, sans-serif; font-size: 14px; margin-bottom: 6px;"><br /></div><div style="color: #1d2129; font-family: Helvetica, Arial, sans-serif; font-size: 14px; margin-bottom: 6px;">Why did the appearance of new TSEs in animals matter so much? It has always been known that TSEs will transfer across species boundaries. The reason for this was never known until the genetic nature of the prion gene was fully investigated and found to be involved. The gene is found to have well preserved sites and as such there is a similar gene throughout the animal kingdom...and indeed a similar gene is found in insects! It is NOT clear that the precise close nature of the<span class="yiv1152037782text_exposed_show" style="display: inline; font-family: inherit;"> PrP gene structure is essention for low species barriers. Indeed it is probably easier to infect cats with BSE than it is to infect sheep. As such it is not clear that simply because it is possible to infect BSE from cattle into certain monkeys then other apes will necessarily be infectable with the disease. One factor has stood out, however, and that is that BSE, when inoculated into mice would retain its apparent nature of disease strain, and hence when it was inoculated back into cattle, then the same disease was produced. Similarly if the TSE from kudu was inoculated into mice then a similar distribution of disease in the brain of the mouse is seen as if BSE had been inoculated into the mouse. This phenomenon was not true with scrapie, in which the transmission across a species barrier was known to lose many of the scrapie strain phenomena in terms of incubation period or disease histopathology. This also suggested that BSE was not derived from scrapie originally but we probably will never know.</span><br /></div><div class="yiv1152037782text_exposed_show" style="display: inline;"><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px;">------------------------------------------------------------------------</div><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px; margin-top: 6px;">TSE in wild UK deer? The first case of BSE (as we now realise) was in a nyala in London zoo and the further zoo cases in ungulates were simply thought of as being interesting transmissions of scrapie initially. The big problem started to appear with animals in 1993-5 when it became clear that there was an increase in the CJD cases in people that had eaten deer although the statistics involved must have been questionable. The reason for this was that the CJD Surveillance was well funded to look into the diet of people dying of CJD. This effect is not clear with vCJD...if only because the numbers involved are much smaller and hence it is difficult to gain enough statistics. They found that many other foods did not appear to have much association at all but that deer certainly did and as years went by the association actually became clearer. The appearance of vCJD in 1996 made all this much more difficult in that it was suddenly clearer that the cases of sporadic CJD that they had been checking up until then probably had nothing to do with beef...and the study decreased. During the period there was an increasing worry that deer were involved with CJD..</div><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px; margin-top: 6px;">see references:</div><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px; margin-top: 6px;"><br /></div><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px; margin-top: 6px;">DEER BRAIN SURVEY</div><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px; margin-top: 6px;"><br /></div><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px; margin-top: 6px;"><a href="https://web.archive.org/web/20090506025229/http://www.bseinquiry.gov.uk/files/yb/1991/11/20004001.pdf">https://web.archive.org/web/20090506025229/http://www.bseinquiry.gov.uk/files/yb/1991/11/20004001.pdf</a><br /></div><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px; margin-top: 6px;"><br /></div><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px; margin-top: 6px;"><br /></div><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px; margin-top: 6px;"><a href="https://www.facebook.com/groups/1557515941145821/permalink/2299600233604051/?hc_location=ufi" rel="nofollow noopener noreferrer" style="color: blue;" target="_blank">https://www.facebook.com/groups/1557515941145821/permalink/2299600233604051/?hc_location=ufi</a><br /></div><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px; margin-top: 6px;"><br /></div><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px; margin-top: 6px;">i have not updated my blogspot url with all this data archived, but i will work on it...but until then, i have updated this on the above links with live urls to the actual BSE Inquiry documents...</div><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px; margin-top: 6px;"><br /></div><div style="margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-family: Helvetica, Arial, sans-serif;"><span style="font-size: 14px;">Subject: Re: DEER SPONGIFORM ENCEPHALOPATHY SURVEY & HOUND STUDY </span></span></div><div style="margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-family: Helvetica, Arial, sans-serif;"><span style="font-size: 14px;"><br /></span></span></div><div style="margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-family: Helvetica, Arial, sans-serif;"><span style="font-size: 14px;">Date: Fri, 18 Oct 2002 23:12:22 +0100 </span></span></div><div style="margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-family: Helvetica, Arial, sans-serif;"><span style="font-size: 14px;"><br /></span></span></div><div style="margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-family: Helvetica, Arial, sans-serif;"><span style="font-size: 14px;">From: Steve Dealler </span></span></div><div style="margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-family: Helvetica, Arial, sans-serif;"><span style="font-size: 14px;"><br /></span></span></div><div style="margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-family: Helvetica, Arial, sans-serif;"><span style="font-size: 14px;">Reply-To: Bovine Spongiform Encephalopathy Organization: Netscape Online member </span></span></div><div style="margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-family: Helvetica, Arial, sans-serif;"><span style="font-size: 14px;"><br /></span></span></div><div style="margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-family: Helvetica, Arial, sans-serif;"><span style="font-size: 14px;">To: BSE-L@ References: <3daf5023 .4080804=""WT.NET""></span></span></div><div style="margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-family: Helvetica, Arial, sans-serif;"><span style="font-size: 14px;"><br /></span></span></div><div style="margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-family: Helvetica, Arial, sans-serif;"><span style="font-size: 14px;">Dear Terry,</span></span></div><div style="margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-family: Helvetica, Arial, sans-serif;"><span style="font-size: 14px;"><br /></span></span></div><div style="margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-family: Helvetica, Arial, sans-serif;"><span style="font-size: 14px;">An excellent piece of review as this literature is desparately difficult to get back from Government sites.</span></span></div><div style="margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-family: Helvetica, Arial, sans-serif;"><span style="font-size: 14px;"><br /></span></span></div><div style="margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-family: Helvetica, Arial, sans-serif;"><span style="font-size: 14px;">What happened with the deer was that an association between deer meat eating and sporadic CJD was found in about 1993. The evidence was not great but did not disappear after several years of asking CJD cases what they had eaten. I think that the work into deer disease largely stopped because it was not helpful to the UK industry...and no specific cases were reported. Well, if you dont look adequately like they are in USA currenly then you wont find any!</span></span></div><div style="margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-family: Helvetica, Arial, sans-serif;"><span style="font-size: 14px;"><br /></span></span></div><div style="margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-family: Helvetica, Arial, sans-serif;"><span style="font-size: 14px;">Steve Dealler =============== </span></span></div><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px; margin-top: 6px;"><br /></div><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px; margin-top: 6px;"><a fg_scanned="1" href="https://caninespongiformencephalopathy.blogspot.com/2010/03/canine-spongiform-encephalopathy-aka.html" rel="nofollow noopener noreferrer" style="color: blue;" target="_blank">https://caninespongiformencephalopathy.blogspot.com/2010/03/canine-spongiform-encephalopathy-aka.html</a><br /></div><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px; margin-top: 6px;"><br /></div><div style="margin-bottom: 6px; margin-top: 6px;"><span style="background-color: #fef9f5; color: #121212; font-family: "Egyptian serif"; font-size: 17px;">Stephen Dealler is a consultant medical microbiologist</span><span style="background-color: #fef9f5; color: #121212; font-size: 17px;"><span style="background-color: inherit; font-family: Arial, Helvetica, sans-serif;"> </span></span><span style="color: #121212; font-family: Arial, Helvetica, sans-serif;"><span style="font-size: 17px;"> deal@airtime.co.uk </span></span></div><div style="margin-bottom: 6px; margin-top: 6px;"><span style="color: #121212; font-family: Arial, Helvetica, sans-serif;"><span style="font-size: 17px;"><br /></span></span></div><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px; margin-top: 6px;">BSE Inquiry Steve Dealler</div><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px; margin-top: 6px;"><br /></div><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px; margin-top: 6px;">Management In Confidence</div><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px; margin-top: 6px;"><br /></div><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px; margin-top: 6px;">BSE: Private Submission of Bovine Brain Dealler</div><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px; margin-top: 6px;"><br /></div><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px; margin-top: 6px;"><a href="https://web.archive.org/web/20090506043910/http://www.bseinquiry.gov.uk/files/yb/1993/12/08003001.pdf" rel="nofollow noopener noreferrer" style="color: blue;" target="_blank">https://web.archive.org/web/20090506043910/http://www.bseinquiry.gov.uk/files/yb/1993/12/08003001.pdf</a></div><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px; margin-top: 6px;"><br /></div><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px; margin-top: 6px;">reports of sheep and calf carcasses dumped...</div><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px; margin-top: 6px;"><br /></div><div style="color: #1d2129; font-family: inherit; font-size: 14px; margin-bottom: 6px; margin-top: 6px;"><a href="https://web.archive.org/web/20090505232801/http://www.bseinquiry.gov.uk/files/yb/1993/12/07002001.pdf" rel="nofollow noopener noreferrer" style="color: blue;" target="_blank">https://web.archive.org/web/20090505232801/http://www.bseinquiry.gov.uk/files/yb/1993/12/07002001.pdf</a><br /></div></div></div><div style="background-color: white; font-family: arial; font-size: small;"><span style="font-size: 13.3333px;"><br /></span></div><div style="background-color: white; font-family: arial; font-size: small;"><span style="font-size: 13.3333px;">re-scrapie to cattle GAH Wells BSE Inquiry</span><br /></div><div style="background-color: white; font-family: arial; font-size: small;"><br /></div><div style="background-color: white; font-family: arial; font-size: small;"><a href="https://web.archive.org/web/20090506043931/http://www.bseinquiry.gov.uk/files/yb/1993/12/09001001.pdf" rel="nofollow noopener noreferrer" style="color: blue;" target="_blank">https://web.archive.org/web/20090506043931/http://www.bseinquiry.gov.uk/files/yb/1993/12/09001001.pdf</a><br /><div><br /></div><div>Dr. Dealler goes rogue to confirm BSE</div><div><br /></div><div><a href="https://web.archive.org/web/20090506043930/http://www.bseinquiry.gov.uk/files/yb/1993/12/14003001.pdf" rel="nofollow noopener noreferrer" style="color: blue;" target="_blank">https://web.archive.org/web/20090506043930/http://www.bseinquiry.gov.uk/files/yb/1993/12/14003001.pdf</a></div><div><br /></div><div><a href="https://web.archive.org/web/20090506043930/http://www.bseinquiry.gov.uk/files/yb/1993/12/14003001.pdf" rel="nofollow noopener noreferrer" style="color: blue;" target="_blank">https://web.archive.org/web/20090506043930/http://www.bseinquiry.gov.uk/files/yb/1993/12/14003001.pdf</a></div><div><br /></div><div><a href="https://web.archive.org/web/20090505231533/http://www.bseinquiry.gov.uk/files/yb/1993/12/17003001.pdf" rel="nofollow noopener noreferrer" style="color: blue;" target="_blank">https://web.archive.org/web/20090505231533/http://www.bseinquiry.gov.uk/files/yb/1993/12/17003001.pdf</a><br /></div><div><br /></div><div>Confirmation BSE Dealler's mad cow</div><div><br /></div><div><a href="https://web.archive.org/web/20090505231342/http://www.bseinquiry.gov.uk/files/yb/1993/12/16006001.pdf" rel="nofollow noopener noreferrer" style="color: blue;" target="_blank">https://web.archive.org/web/20090505231342/http://www.bseinquiry.gov.uk/files/yb/1993/12/16006001.pdf</a><br /></div><div><br /></div><div>BSE vertical transmission</div><div><br /></div><div><a href="https://web.archive.org/web/20090506043834/http://www.bseinquiry.gov.uk/files/yb/1993/12/13003001.pdf" rel="nofollow noopener noreferrer" style="color: blue;" target="_blank">https://web.archive.org/web/20090506043834/http://www.bseinquiry.gov.uk/files/yb/1993/12/13003001.pdf</a><br /></div><div><br /></div><div>1993 cjd report finds relationship with eat venison and cjd increases 9 fold, let the cover up begin...tss</div><div><br /></div><div><a href="https://web.archive.org/web/20090506050244/http://www.bseinquiry.gov.uk/files/yb/1994/07/00001001.pdf" rel="nofollow noopener noreferrer" style="color: blue;" target="_blank">https://web.archive.org/web/20090506050244/http://www.bseinquiry.gov.uk/files/yb/1994/07/00001001.pdf</a><br /></div><div><br /></div><div>FINDINGS</div><div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">*** The association between venison eating and risk of CJD shows similar pattern, with regular venison eating associated with a 9 FOLD INCREASE IN RISK OF CJD (p = 0.04). ***</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">*** The association between venison eating and risk of CJD shows similar pattern, with regular venison eating associated with a 9 FOLD INCREASE IN RISK OF CJD (p = 0.04). ***</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">*** The association between venison eating and risk of CJD shows similar pattern, with regular venison eating associated with a 9 FOLD INCREASE IN RISK OF CJD (p = 0.04). ***</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">There is some evidence that risk of CJD INCREASES WITH INCREASING FREQUENCY OF LAMB EATING (p = 0.02)..</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">The evidence for such an association between beef eating and CJD is weaker (p = 0.14). When only controls for whom a relative was interviewed are included, this evidence becomes a little STRONGER (p = 0.08).</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">snip...</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">It was found that when veal was included in the model with another exposure, the association between veal and CJD remained statistically significant (p = < 0.05 for all exposures), while the other exposures ceased to be statistically significant (p = > 0.05).</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">snip...</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">In conclusion, an analysis of dietary histories revealed statistical associations between various meats/animal products and INCREASED RISK OF CJD. When some account was taken of possible confounding, the association between VEAL EATING AND RISK OF CJD EMERGED AS THE STRONGEST OF THESE ASSOCIATIONS STATISTICALLY. ...</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">snip...</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">In the study in the USA, a range of foodstuffs were associated with an increased risk of CJD, including </span><span style="font-size: 10pt;">liver consumption which was associated with an apparent SIX-FOLD INCREASE IN THE RISK OF CJD. By comparing the data from 3 studies in relation to this particular dietary factor, the risk of liver consumption became non-significant with an odds ratio of 1.2 (PERSONAL COMMUNICATION, PROFESSOR A. HOFMAN. ERASMUS UNIVERSITY, ROTTERDAM). (???...TSS)</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">snip...see full report ; </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><a href="https://web.archive.org/web/20170126073306/http://collections..europarchive..org/tna/20090505194948/http://bseinquiry.gov.uk/files/yb/1994/08/00004001.pdf" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">https://web.archive.org/web/2</a><a href="https://web.archive.org/web/20170126073306/http://collections..europarchive..org/tna/20090505194948/http://bseinquiry.gov.uk/files/yb/1994/08/00004001.pdf" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; font-size: 10pt;" target="_blank">0170126073306/http://collections..europarchive..org/tna/20090505194948/http://bseinquiry.gov.uk/files/yb/1994/08/00004001.pdf</a></div></div><div><br /></div><div>GAME FARM INDUSTRY WANTS TO COVER UP FINDINGS OF INCREASE RISK TO CJD FROM CERVID</div><div><br /></div><div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">BSE INQUIRY</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">CJD9/10022</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">October 1994</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Mr R.N. Elmhirst Chairman British Deer Farmers Association Holly Lodge Spencers Lane </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">BerksWell Coventry CV7 7BZ</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Dear Mr Elmhirst,</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">CREUTZFELDT-JAKOB DISEASE (CJD) SURVEILLANCE UNIT REPORT</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Thank you for your recent letter concerning the publication of the third annual report from the CJD Surveillance Unit. I am sorry that you are dissatisfied with the way in which this report was published.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">The Surveillance Unit is a completely independant outside body and the Department of Health is committed to publishing their reports as soon as they become available. In the circumstances it is not the practice to circulate the report for comment since the findings of the report would not be amended.. In future we can ensure that the British Deer Farmers Association receives a copy of the report in advance of publication.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">The Chief Medical Officer has undertaken to keep the public fully informed of the results of any research in respect of CJD. This report was entirely the work of the unit and was produced completely independantly of the the Department.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">The statistical results reqarding the consumption of venison was put into perspective in the body of the report and was not mentioned at all in the press release. Media attention regarding this report was low key but gave a realistic presentation of the statistical findings of the Unit. This approach to publication was successful in that consumption of venison was highlighted only once by the media ie. in the News at one television proqramme.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">I believe that a further statement about the report, or indeed statistical links between CJD and consumption of venison, would increase, and quite possibly give damaging credence, to the whole issue. From the low key media reports of which I am aware it seems unlikely that venison consumption will suffer adversely, if at all. </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><a href="http://web.archive.org/web/20030511010117/http://www.bseinquiry.gov.uk/files/yb/1994/10/00003001.pdf" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://web.archive.org/web/20030511010117/http://www.bseinquiry.gov.uk/files/yb/1994/10/00003001.pdf</a></span></div></div><div style="font-family: arial, helvetica; font-size: 12px;"><br /></div><div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;">The BSE Inquiry / Statement No 324</span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;"><br /></span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;">Dr James Kirkwood (not scheduled to give oral evidence)</span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;"><br /></span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;">Statement to the BSE Inquiry</span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;"><br /></span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;">James K Kirkwood BVSc PhD FIBiol MRCVS</span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;"><br /></span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;">[This witness has not been asked to give oral evidence in Phase 1 of the Inquiry]</span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;"><br /></span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;">1. I became involved in the field of TSEs through my work as Head of the Veterinary Science Group at the Zoological Society of London’s Institute of Zoology. I held this post from November 1984 until June 1996, when I took up my present post at UFAW. During this time, concurrent with the BSE epidemic, cases of scrapie-like spongiform encephalopathies occurred in animals at the Zoological Society of London’s collections at Regent’s Park and Whipsnade and in other zoos. It was appropriate to investigate the epidemiology of these cases in order to try to determine the possible impact on zoo animals and breeding programmes, and to consider how the disease in zoo animals might be controlled.</span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;"><br /></span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;">2. Throughout the period from 1985 to March 1996, I worked at the Institute of Zoology (IoZ). I was Head of the Veterinary Science Group of the IoZ and Senior Veterinary Officer of the Zoological Society of London (ZSL). I was responsible for the provision of the veterinary service for the ZSL collections.</span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;"><br /></span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;">3. During the period from 1985 to March 1996, scrapie-like spongiform encephalopathies were diagnosed in the following animals which died, or were euthanased, at London Zoo and Whipsnade:</span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;"><br /></span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;">Animal Sex Date of Death Age (mos)</span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;"><br /></span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;">Arabian Oryx Oryx leucoryx F 24.3.89 38</span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;"><br /></span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;">Greater kudu Tragelaphus strepsiceros (Linda) F 18.8.89 30</span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;"><br /></span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;">Greater kudu (Karla) F 13.11.90 19 Greater kudu (Kaz) M 6.6.91 37</span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;"><br /></span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;">Greater kudu (Bambi) M 24.10.91 36</span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;"><br /></span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;">Greater kudu (346/90) M 26.2.92 18</span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;"><br /></span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;">Greater kudu (324/90) F 22.11.92 38</span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;"><br /></span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;">Cheetah Acinonyx jubatus (Michelle) F 22.12.93 91</span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;"><br /></span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;">All these cases were described in papers published in the scientific literature (as cited below).</span></span></div></div><div style="font-family: arial, helvetica; font-size: 12px;"><br /></div><div style="font-family: arial, helvetica; font-size: 12px;"><a href="https://web.archive.org/web/20090506004016/http://www.bseinquiry.gov.uk/files/ws/s324.pdf" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://web.archive.org/web/20090506004016/http://www.bseinquiry.gov.uk/files/ws/s324.pdf</a><br /></div><div style="font-family: arial, helvetica; font-size: 12px;"><br /></div><div style="font-family: arial, helvetica; font-size: 12px;">EYES, RETINA, SHOULD NOT BE USED IN SCHOOLS, BAB, SOB, MRM, </div><div style="font-family: arial, helvetica; font-size: 12px;"><br /></div></div><a href="https://web.archive.org/web/20090506065716/http://www.bseinquiry.gov.uk/files/yb/1995/06/21005001.pdf" rel="nofollow noopener noreferrer" style="background-color: white; color: #196ad4; font-family: arial; font-size: small;" target="_blank">https://web.archive.org/web/20090506065716/http://www.bseinquiry.gov.uk/files/yb/1995/06/21005001.pdf</a><span style="background-color: white; font-family: arial; font-size: small;"></span><div style="background-color: white; font-family: arial; font-size: small;"><div><br /></div><div>BSE, PET FOOD, CRUSHED HEADS</div><div><br /></div><div><a href="https://web.archive.org/web/20090505225022/http://www.bseinquiry.gov.uk/files/yb/1989/03/17004001.pdf" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://web.archive.org/web/20090505225022/http://www.bseinquiry.gov.uk/files/yb/1989/03/17004001.pdf</a></div><div><br /></div><div>IN PARTICULAR CRUSHED HEADS</div><div><br /></div><div><a href="https://web.archive.org/web/20090505233039/http://www.bseinquiry.gov.uk/files/yb/1989/04/14001001.pdf" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://web.archive.org/web/20090505233039/http://www.bseinquiry.gov.uk/files/yb/1989/04/14001001.pdf</a></div><div><br /></div><div><span style="background-color: #eff1f3; color: #1d2129; font-family: Helvetica, Arial, sans-serif; font-size: 13px;">YOU explained that imported crushed heads were extensively used in the petfood industry...</span><br /></div><div><span style="background-color: #eff1f3; color: #1d2129; font-family: Helvetica, Arial, sans-serif; font-size: 13px;"><br /></span></div><div><a href="https://web.archive.org/web/20090505233039/http://www.bseinquiry.gov.uk/files/yb/1989/04/14001001.pdf" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://web.archive.org/web/20090505233039/http://www.bseinquiry.gov.uk/files/yb/1989/04/14001001.pdf</a><br /></div><div><br /></div><div><a href="https://web.archive.org/web/20090506054223/http://www.bseinquiry.gov.uk/files/yb/1989/04/14005001.pdf" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://web.archive.org/web/20090506054223/http://www.bseinquiry.gov.uk/files/yb/1989/04/14005001.pdf</a><br /></div><div><br /></div><div><span style="background-color: #eff1f3; color: #1d2129; font-family: Helvetica, Arial, sans-serif; font-size: 13px;">In particular I do not believe one can say that the levels of the scrapie agent in pet food are so low that domestic animals are not exposed.</span><br /></div><div><br /></div><div><a href="https://web.archive.org/web/20090505233046/http://www.bseinquiry.gov.uk/files/yb/1989/04/24003001.pdf" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://web.archive.org/web/20090505233046/http://www.bseinquiry.gov.uk/files/yb/1989/04/24003001.pdf</a><br /></div><div><br /></div><div><div>BSE IN PETFOOD</div><div><br /></div><div>1. The Secretary asked on 19 April whether I was content with the advice in para 3 of the record of the meeting on 17 March with the Parliamentary Secretary (Mr Thompson). The simple answer is ''not entirely''.</div><div><br /></div><div>2. On occasions, material obtained from slaughterhouses will be derived from sheep affected with scrapie or cattle that may be incubating BSE for use in petfood manufacture. Some of this material must be classified as high risk since it contains brain, spinal cord, spleen or lymphatic glands.</div></div><div><br /></div><div><a href="https://web.archive.org/web/20090505233052/http://www.bseinquiry.gov.uk/files/yb/1989/05/03007001.pdf" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://web.archive.org/web/20090505233052/http://www.bseinquiry.gov.uk/files/yb/1989/05/03007001.pdf</a><br /></div><div><br /></div><div>Meldrum's notes on pet foods and materials used<br /></div><div><br /></div><div><a href="https://web.archive.org/web/20090505233041/http://www.bseinquiry.gov.uk/files/yb/1989/05/16001001.pdf" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://web.archive.org/web/20090505233041/http://www.bseinquiry.gov.uk/files/yb/1989/05/16001001.pdf</a><br /></div><div><br /></div><div><a href="https://web.archive.org/web/20090506015917/http://www.bseinquiry.gov.uk/files/yb/1989/05/16002001.pdf" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://web.archive.org/web/20090506015917/http://www.bseinquiry.gov.uk/files/yb/1989/05/16002001.pdf</a><br /></div><div><br /></div><div><div>IN CONFIDENCE CJD TO CATS...</div><div><br /></div><div>It should be noted that under experimental conditions cats succumb to an encephalopathy after intracerebral inoculation of material derived from patients affected with Creutzfeldt-Jakob Disease.</div></div><div><br /></div><div><a href="https://web.archive.org/web/20090506055329/http://www.bseinquiry.gov.uk/files/yb/1989/05/18002001.pdf" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://web.archive.org/web/20090506055329/http://www.bseinquiry.gov.uk/files/yb/1989/05/18002001.pdf</a><br /></div><div><br /></div><div><div>Confidential BSE and __________________</div><div><br /></div><div>3. I have thought very hard about whether the Branch should carry out a similar exercise with meat and meat products for human foods. On balance I do NOT think we should undertake it, but a final decision has not been taken and you may wish to discuss this further. ...</div></div><div><br /></div><div><a href="https://web.archive.org/web/20090505220118/http://www.bseinquiry.gov.uk/files/yb/1989/05/22012001.pdf" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://web.archive.org/web/20090505220118/http://www.bseinquiry.gov.uk/files/yb/1989/05/22012001.pdf</a><br /></div><div><br /></div><div><div>1st case natural FSE</div><div><br /></div><div>NATURAL SPONGIFORM ENCEPHALOPATHY IN A DOMESTIC CAT</div><div><br /></div><div>1. We have heard from MAFF that a domestic Siamese cat from the Bristol area has had spongiform encephalopathy confirmed. Although there are previous instances of experimental infection in cats, there have been no previous natural infections reported. The assumption must be the cat became infected by scrapie/BSE agent in it's food. ...</div></div><div><br /></div><div><a href="https://web.archive.org/web/20090506015733/http://www.bseinquiry.gov.uk/files/yb/1990/05/09002001.pdf" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://web.archive.org/web/20090506015733/http://www.bseinquiry.gov.uk/files/yb/1990/05/09002001.pdf</a><br /></div><div><br /></div><div><div>FSE and pharmaceuticals</div><div><br /></div><div>1. An analysis by MCA Professional staff of the results to the questionnaire sent out to industry to obtain additional data about the use of animal materials of any origin in the manufacture of pharmaceutical products for human use, reveals that material of feline or canine origin is used in only two licensed products. In both instances the material is sourced from outside the U.K. and from areas currently believed to be free from B.S.E.</div></div><div><br /></div><div><a href="https://web.archive.org/web/20090506041332/http://www.bseinquiry.gov.uk/files/yb/1990/05/10005001.pdf" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://web.archive.org/web/20090506041332/http://www.bseinquiry.gov.uk/files/yb/1990/05/10005001.pdf</a><br /></div><div><br /></div><div><div>CONFIDENTIAL</div><div><br /></div><div>Confidential cats/dogs and unsatisfactory posture MAFFs failure to assure key research</div><div><br /></div><div>3. First, I am very uneasy about the relative lack of urgency and interest that MAFF appear to hold for getting the necessary research programme on BSE and related encephalopathies started, and getting it going fast. FOR EXAMPLE, MR BRADLEY of CVL said that there were difficulties in organizing transmission experiments from the brain of the cat which died of an encephalopathy in Bristol. There were arguments going on about who should pay for this work. Should it be MAFF, the Bristol Veterinary School or someone else? Dr. Tyrrell was clearly exasperated.</div><div><br /></div><div>snip...</div><div><br /></div><div>11. The Committee were even LESS FORTHCOMING on what their reaction might be if an encephalopathy is found in another species, perhaps in DOGS. Their first reaction was that, as with the cats, the first step could be to investigate whether this was really a new disease, or simply one that had not previously been recognized and to see whether it has any links to BSE, scrapie or other transmissible encephalopathies. Indeed, some members of the Committee seem to regard the whole question of another species as a hypothetical question to be addressed only when it happened. A rather UNSATISFACTORY POSTURE.</div><div><br /></div><div>12. In advance of your meeting with Dr Tyrrell on Monday morning, I have not voiced my ANXIETIES about the support the Committee is receiving from MAFF to anyone OTHER THAN DR PICKLES. ...</div></div><div><br /></div><div><a href="https://web.archive.org/web/20090506040545/http://www.bseinquiry.gov.uk/files/yb/1990/06/14006001.pdf" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://web.archive.org/web/20090506040545/http://www.bseinquiry.gov.uk/files/yb/1990/06/14006001.pdf</a><br /></div><div><br /></div><div><div>SPONGIFORM ENCEPHALOPATHY IN A CAPTIVE PUMA</div><div><br /></div><div>an article in yesterday's Times (attached) which suggested that the puma concerned had never ''eaten any part of a cow or sheep which, in the opinion of Government Scientists, could transmit the species to a different species''.</div><div><br /></div><div>3. You explained to me that this was INCORRECT. The position was as set out in the briefing for Prime Minister's questions attached to Mr Taylor's note. The puma had probably been fed low quality beef meat in the form of split carcasses. ...</div></div><div><br /></div><div><a href="https://web.archive.org/web/20090506032628/http://www.bseinquiry.gov.uk/files/yb/1992/11/13001001.pdf" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://web.archive.org/web/20090506032628/http://www.bseinquiry.gov.uk/files/yb/1992/11/13001001.pdf</a><br /></div><div><br /></div><div><div>Subject: DEER SPONGIFORM ENCEPHALOPATHY SURVEY & HOUND STUDY Date: Thu, 17 Oct 2002 17:04:51 -0700 From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To: BSE-L</div><div><br /></div><div>Greetings BSE-L,</div><div><br /></div><div>is there any other CWD surveys/testing in the UK on their deer? what sort of testing has been done to date on UK/EU deer? any input would be helpful... thank you</div><div><br /></div><div>DEER SPONGIFORM ENCEPHALOPATHY SURVEY</div><div><br /></div><div>3. This will be a low key study with no publicity to avoid unnecessary media interest. It will be carried out in two stages ;</div><div><br /></div><div>(I) A small scale examination of around 30 deer brains to establish the normal histology of the healthy brain; and</div><div><br /></div><div>(II) A larger scale random examination of 300 or more adult deer brains drawn from both deer farms and parks to establish whether there is any evidence of a cervine spongiform encephalopathy. ...</div></div><div><br /></div><div><a href="https://web.archive.org/web/20090506025229/http://www.bseinquiry.gov.uk/files/yb/1991/11/20004001.pdf" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://web.archive.org/web/20090506025229/http://www.bseinquiry.gov.uk/files/yb/1991/11/20004001.pdf</a><br /></div><div><br /></div><div><div>Ministry of Agriculture Fisheries and Food Veterinary Investigation Centre West House. Station Road. Thirsk Y07 IPZ Telephone: 0845·522065 Fax: 0845·525224</div><div><br /></div><div>Your reference</div><div><br /></div><div>Our reference RJH/ASB</div><div><br /></div><div>Date 4 November 1992</div><div><br /></div><div>DEER SPONGIFORM ENCEPHALOPATHY SURVEY</div><div><br /></div><div>Dear Paul</div><div><br /></div><div>I have now found time to review the 10 deer- brains collected from Mr Walker farm··via Winchester Via Winchester VIC. In answer to your specific question was there sufficient difference in preservation of brain tissue to warrant the extra effort involved in rapid brain removal on the farm, the answer is definitely "Yes." The original five brains (Winchester ref M487/11) showed varying degrees of autolytic vacuolation affecting both white and grey matter throughout the brain. vacuolation and separation of Purkinje cells and marked perivascular spaces. These artifacts made interpretation of subtle, specific pathological vacuolation more difficult. By contrast the second submission (Winchester reference N736/2) showed excellent preservation of white and grey matter. Any vacuolar Change present could be confidently interpreted as pathological albeit of unknown pathogenesis.</div><div><br /></div><div>I can only reiterate the comments made by Gerald Wells and myself at the preliminary discussion at Weybridge in Autumn 1991. If the survey's purpose is an accurate histopathological interpretation of brain tissue. the material must be collected in a pristine state. This is particularly valid when looking for ar unrecognised and undefined spongiform encephalopathy in a new species. Deer brains are very large structures which take a lot of fixation and therefore must be handled sympathetically from the start. We have already seen the problems encountered in comparatively smaller hound brains where delayed fixation was a major limitation on interpretation of true pathological change.</div><div><br /></div><div>The bottom line must be that if a pathologist's expertise is to be used, it is critical to collect artefact free brain material. If the politics or economics do not allow this, then I would suggest that an electron microscopy survey involving detection of scrapie associated fibrils would be much more appropriate.</div><div><br /></div><div>Best wishes Yours sincerely</div><div><br /></div><div>R J HIGGINS VIO 92/11.4/2.1</div></div><div><br /></div><div><a href="https://web.archive.org/web/20090506032702/http://www.bseinquiry.gov.uk/files/yb/1992/11/04002001.pdf" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://web.archive.org/web/20090506032702/http://www.bseinquiry.gov.uk/files/yb/1992/11/04002001.pdf</a><br /></div><div><br /></div><div><div>HOUND SURVEY</div><div><br /></div><div>I am sorry, but I really could have been a co-signatory of Gerald's minute.</div><div><br /></div><div>I do NOT think that we can justify devoting any resources to this study, especially as larger and more important projects such as the pathogenesis study will be quite demanding.</div><div><br /></div><div>If there is a POLITICAL need to continue with the examination of hound brains then it should be passed entirely to the VI Service.</div><div><br /></div><div>J W WILESMITH Epidemiology Unit 18 October 1991</div><div><br /></div><div>Mr. R Bradley</div><div><br /></div><div>cc: Mr. G A H Wells</div></div><div><br /></div><div><a href="https://web.archive.org/web/20090506031345/http://www.bseinquiry.gov.uk/files/yb/1991/10/18001001.pdf" rel="nofollow noopener noreferrer" style="color: #196ad4; font-size: 10pt;" target="_blank">https://web.archive.org/web/20090506031345/http://www.bseinquiry.gov.uk/files/yb/1991/10/18001001.pdf</a><br /></div><div><br /></div><div> ***> 3.3. Mr R J Higgins in conjunction with Mr G A Wells and Mr A C Scott would by the end of the year, identify the three brains that were from the ''POSITIVE'' end of the lesion spectrum.<br /></div><div><br /></div><div><a href="https://web.archive.org/web/20090506043913/http://www.bseinquiry.gov.uk/files/yb/1993/12/06001001.pdf" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://web.archive.org/web/20090506043913/http://www.bseinquiry.gov.uk/files/yb/1993/12/06001001.pdf</a><br /></div><div><br /></div><div>HOUND SURVEY PATHOLOGICAL REPORT (see positive results) and MAD DOGS AND ENGLISHMAN...</div><div><br /></div><div>ya'll thought i was making this stuff up didn't ya...i don't make this stuff up!<br /></div><div><br /></div><div><a href="https://web.archive.org/web/20090506035936/http://www.bseinquiry.gov.uk/files/yb/1990/11/28001001.pdf" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://web.archive.org/web/20090506035936/http://www.bseinquiry.gov.uk/files/yb/1990/11/28001001.pdf</a><br /></div><div><br /></div><div>It is clear that the designing scientists must also have shared Mr Bradley's surprise at the results because all the dose levels right down to 1 gram triggered infection.<br /></div><div><br /></div><div><a href="https://web.archive.org/web/20090506002904/http://www.bseinquiry.gov.uk/files/ws/s145d.pdf" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://web.archive.org/web/20090506002904/http://www.bseinquiry.gov.uk/files/ws/s145d.pdf</a><br /></div><div><br /></div><div>second supplementary</div><div><br /></div><div><a href="https://web.archive.org/web/20090506004507/http://www.bseinquiry.gov.uk/files/ws/s147f.pdf" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://web.archive.org/web/20090506004507/http://www.bseinquiry.gov.uk/files/ws/s147f.pdf</a></div><div><br /></div><div>Why did the appearance of new TSEs in animals matter so much? It has always been known that TSEs will transfer across species boundaries. The reason for this was never known until the genetic nature of the prion gene was fully investigated and found to be involved. The gene is found to have well preserved sites and as such there is a similar gene throughout the animal kingdom...and indeed a similar gene is found in insects! It is NOT clear that the precise close nature of the PrP gene structure is essention for low species barriers. Indeed it is probably easier to infect cats with BSE than it is to infect sheep. As such it is not clear that simply because it is possible to infect BSE from cattle into certain monkeys then other apes will necessarily be infectable with the disease. One factor has stood out, however, and that is that BSE, when inoculated into mice would retain its apparent nature of disease strain, and hence when it was inoculated back into cattle, then the same disease was produced. Similarly if the TSE from kudu was inoculated into mice then a similar distribution of disease in the brain of the mouse is seen as if BSE had been inoculated into the mouse. This phenomenon was not true with scrapie, in which the transmission across a species barrier was known to lose many of the scrapie strain phenomena in terms of incubation period or disease histopathology. This also suggested that BSE was not derived from scrapie originally but we probably will never know.</div><div><br /></div><div>------------------------------------------------------------------------</div><div><br /></div><div>TSE in wild UK deer? The first case of BSE (as we now realise) was in a nyala in London zoo and the further zoo cases in ungulates were simply thought of as being interesting transmissions of scrapie initially. The big problem started to appear with animals in 1993-5 when it became clear that there was an increase in the CJD cases in people that had eaten deer although the statistics involved must have been questionable. The reason for this was that the CJD Surveillance was well funded to look into the diet of people dying of CJD. This effect is not clear with vCJD...if only because the numbers involved are much smaller and hence it is difficult to gain enough statistics. They found that many other foods did not appear to have much association at all but that deer certainly did and as years went by the association actually became clearer. The appearance of vCJD in 1996 made all this much more difficult in that it was suddenly clearer that the cases of sporadic CJD that they had been checking up until then probably had nothing to do with beef...and the study decreased. During the period there was an increasing worry that deer were involved with CJD..</div><div><br /></div><div>see references:</div><div><br /></div><div>DEER BRAIN SURVEY</div><div><br /></div><div><a href="https://web.archive.org/web/20090506025229/http://www.bseinquiry.gov.uk/files/yb/1991/11/20004001.pdf" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://web.archive.org/web/20090506025229/http://www.bseinquiry.gov.uk/files/yb/1991/11/20004001.pdf</a></div><div><br /></div><div>1993 cjd report finds relationship with eat venison and cjd increases 9 fold, let the cover up begin...tss</div><div><br /></div><div>https://webarchive.nationalarchives.gov.uk/.../00001001.pdf</div><div><br /></div><div>FINDINGS</div><div><br /></div><div>*** The association between venison eating and risk of CJD shows similar pattern, with regular venison eating associated with a 9 FOLD INCREASE IN RISK OF CJD (p = 0.04). ***</div><div><br /></div><div>There is some evidence that risk of CJD INCREASES WITH INCREASING FREQUENCY OF LAMB EATING (p = 0.02)..</div><div><br /></div><div>The evidence for such an association between beef eating and CJD is weaker (p = 0.14). When only controls for whom a relative was interviewed are included, this evidence becomes a little STRONGER (p = 0.08).</div><div><br /></div><div>snip...</div><div><br /></div><div>It was found that when veal was included in the model with another exposure, the association between veal and CJD remained statistically significant (p = < 0.05 for all exposures), while the other exposures ceased to be statistically significant (p = > 0.05).</div><div><br /></div><div>snip...</div><div><br /></div><div>In conclusion, an analysis of dietary histories revealed statistical associations between various meats/animal products and INCREASED RISK OF CJD. When some account was taken of possible confounding, the association between VEAL EATING AND RISK OF CJD EMERGED AS THE STRONGEST OF THESE ASSOCIATIONS STATISTICALLY. ...</div><div><br /></div><div>snip...</div><div><br /></div><div>In the study in the USA, a range of foodstuffs were associated with an increased risk of CJD, including liver consumption which was associated with an apparent SIX-FOLD INCREASE IN THE RISK OF CJD. By comparing the data from 3 studies in relation to this particular dietary factor, the risk of liver consumption became non-significant with an odds ratio of 1.2 (PERSONAL COMMUNICATION, PROFESSOR A. HOFMAN. ERASMUS UNIVERSITY, ROTTERDAM). (???...TSS)</div><div><br /></div><div>snip...see full report ; </div><div><br /></div><div><a href="https://web.archive.org/web/20170126073306/http://collections..europarchive..org/tna/20090505194948/http://bseinquiry.gov.uk/files/yb/1994/08/00004001.pdf" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://web.archive.org/web/20170126073306/http://collections..europarchive..org/tna/20090505194948/http://bseinquiry.gov.uk/files/yb/1994/08/00004001.pdf</a></div><div><br /></div><div><div>GAME FARM INDUSTRY WANTS TO COVER UP FINDINGS OF INCREASE RISK TO CJD FROM CERVID</div><div><br /></div><div>BSE INQUIRY</div><div><br /></div><div>CJD9/10022</div><div><br /></div><div>October 1994</div><div><br /></div><div>Mr R.N. Elmhirst Chairman British Deer Farmers Association Holly Lodge Spencers Lane </div><div><br /></div><div>BerksWell Coventry CV7 7BZ</div><div><br /></div><div>Dear Mr Elmhirst,</div><div><br /></div><div>CREUTZFELDT-JAKOB DISEASE (CJD) SURVEILLANCE UNIT REPORT</div><div><br /></div><div>Thank you for your recent letter concerning the publication of the third annual report from the CJD Surveillance Unit. I am sorry that you are dissatisfied with the way in which this report was published.</div><div><br /></div><div>The Surveillance Unit is a completely independant outside body and the Department of Health is committed to publishing their reports as soon as they become available. In the circumstances it is not the practice to circulate the report for comment since the findings of the report would not be amended.. In future we can ensure that the British Deer Farmers Association receives a copy of the report in advance of publication.</div><div><br /></div><div>The Chief Medical Officer has undertaken to keep the public fully informed of the results of any research in respect of CJD. This report was entirely the work of the unit and was produced completely independantly of the the Department.</div><div><br /></div><div>The statistical results reqarding the consumption of venison was put into perspective in the body of the report and was not mentioned at all in the press release. Media attention regarding this report was low key but gave a realistic presentation of the statistical findings of the Unit. This approach to publication was successful in that consumption of venison was highlighted only once by the media ie. in the News at one television proqramme.</div><div><br /></div><div>I believe that a further statement about the report, or indeed statistical links between CJD and consumption of venison, would increase, and quite possibly give damaging credence, to the whole issue. From the low key media reports of which I am aware it seems unlikely that venison consumption will suffer adversely, if at all. </div></div><div><br /></div><div><a href="http://web.archive.org/web/20030511010117/http://www.bseinquiry.gov.uk/files/yb/1994/10/00003001.pdf" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">http://web.archive.org/web/20030511010117/http://www.bseinquiry.gov.uk/files/yb/1994/10/00003001.pdf</a><br /></div><div><br /></div><div><div><div>Management In Confidence</div><div><br /></div><div>BSE: Private Submission of Bovine Brain Dealler </div></div><div><br /></div><div><a href="https://web.archive.org/web/20090506043910/http://www.bseinquiry.gov.uk/files/yb/1993/12/08003001.pdf" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://web.archive.org/web/20090506043910/http://www.bseinquiry.gov.uk/files/yb/1993/12/08003001.pdf</a></div></div><div><br /></div><div>Subject: Re: DEER SPONGIFORM ENCEPHALOPATHY SURVEY & HOUND STUDY </div><div><br /></div><div>Date: Fri, 18 Oct 2002 23:12:22 +0100 </div><div><br /></div><div>From: Steve Dealler </div><div><br /></div><div>Reply-To: Bovine Spongiform Encephalopathy Organization: Netscape Online member </div><div><br /></div><div>To: BSE-L@ References: <3daf5023 .4080804="" wt.net=""></div><div><br /></div><div>Dear Terry,</div><div><br /></div><div>An excellent piece of review as this literature is desparately difficult to get back from Government sites.</div><div><br /></div><div>What happened with the deer was that an association between deer meat eating and sporadic CJD was found in about 1993. The evidence was not great but did not disappear after several years of asking CJD cases what they had eaten. I think that the work into deer disease largely stopped because it was not helpful to the UK industry...and no specific cases were reported. Well, if you dont look adequately like they are in USA currenly then you wont find any!</div><div><br /></div><div>Steve Dealler </div><div><br /></div><div>Stephen Dealler is a consultant medical microbiologist deal@airtime.co.uk<br /></div><div><br /></div><div>=============== </div><div><br /></div><div><a fg_scanned="1" href="https://caninespongiformencephalopathy.blogspot.com/2010/03/canine-spongiform-encephalopathy-aka.html" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://caninespongiformencephalopathy.blogspot.com/2010/03/canine-spongiform-encephalopathy-aka.html</a><br /></div><div><br /></div><div><a fg_scanned="1" href="https://caninespongiformencephalopathy.blogspot.com/" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://caninespongiformencephalopathy.blogspot.com/</a></div><div><br /></div><div>===============</div><div><br /></div><div><div>U.S.A. 50 STATE BSE MAD COW CONFERENCE CALL Jan. 9, 2001</div><div><br /></div><div>Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001</div><div><br /></div><div>Date: Tue, 9 Jan 2001 16:49:00 -0800</div><div><br /></div><div>From: "Terry S. Singeltary Sr."</div><div><br /></div><div>Reply-To: Bovine Spongiform Encephalopathy</div><div><br /></div><div>To: BSE-L@uni-karlsruhe.de</div><div><br /></div><div>snip...</div><div><br /></div><div>[host Richard Barns] and now a question from Terry S. Singeltary of CJD Watch.</div><div><br /></div><div>[TSS] yes, thank you, U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?</div><div><br /></div><div>[no answer, you could hear in the back ground, mumbling and 'we can't. have him ask the question again.]</div><div><br /></div><div>[host Richard] could you repeat the question?</div><div><br /></div><div>[TSS] U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?</div><div><br /></div><div>[not sure whom ask this] what group are you with?</div><div><br /></div><div>[TSS] CJD Watch, my Mom died from hvCJD and we are tracking CJD world-wide.</div><div><br /></div><div>[not sure who is speaking] could you please disconnect Mr. Singeltary</div><div><br /></div><div>[TSS] you are not going to answer my question?</div><div><br /></div><div>[not sure whom speaking] NO</div><div><br /></div><div>snip...see full archive and more of this;</div><div><br /></div><div><a fg_scanned="1" href="http://tseac.blogspot.com/2011/02/usa-50-state-bse-mad-cow-conference.html" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">http://tseac.blogspot.com/2011/02/usa-50-state-bse-mad-cow-conference.html</a><br /></div></div><div><br /></div><div>===============</div><div><br /></div><div>2019</div><div><br /></div><div><div style="font-family: Georgia; font-size: 13px; line-height: 1.22em;"><div style="line-height: 1.22em;"><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">cwd scrapie pigs oral routes</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">***> However, at 51 months of incubation or greater, 5 animals were positive by one or more diagnostic methods. Furthermore, positive bioassay results were obtained from all inoculated groups (oral and intracranial; market weight and end of study) suggesting that swine are potential hosts for the agent of scrapie. <*** </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"> >*** Although the current U.S. feed ban is based on keeping tissues from TSE infected cattle from contaminating animal feed, swine rations in the U.S. could contain animal derived components including materials from scrapie infected sheep and goats. These results indicating the susceptibility of pigs to sheep scrapie, coupled with the limitations of the current feed ban, indicates that a revision of the feed ban may be necessary to protect swine production and potentially human health. <*** </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">***> Results: PrPSc was not detected by EIA and IHC in any RPLNs. All tonsils and MLNs were negative by IHC, though the MLN from one pig in the oral <6 month group was positive by EIA. PrPSc was detected by QuIC in at least one of the lymphoid tissues examined in 5/6 pigs in the intracranial <6 months group, 6/7 intracranial >6 months group, 5/6 pigs in the oral <6 months group, and 4/6 oral >6 months group. Overall, the MLN was positive in 14/19 (74%) of samples examined, the RPLN in 8/18 (44%), and the tonsil in 10/25 (40%). <br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">***> Conclusions: This study demonstrates that PrPSc accumulates in lymphoid tissues from pigs challenged intracranially or orally with the CWD agent, and can be detected as early as 4 months after challenge. CWD-infected pigs rarely develop clinical disease and if they do, they do so after a long incubation period. </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">This raises the possibility that CWD-infected pigs could shed prions into their environment long before they develop clinical disease. </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Furthermore, lymphoid tissues from CWD-infected pigs could present a potential source of CWD infectivity in the animal and human food chains. </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><a fg_scanned="1" href="https://www.ars.usda.gov/research/publications/publication/?seqNo115=353091" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">https://www.ars.usda.gov/research/publications/publication/?seqNo115=353091</a></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><a fg_scanned="1" href="https://www.ars.usda.gov/research/project/?accnNo=432011&fy=2017" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">https://www.ars.usda.gov/research/project/?accnNo=432011&fy=2017</a></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><a fg_scanned="1" href="https://www.ars.usda.gov/research/publications/publication/?seqNo115=337105" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">https://www.ars.usda.gov/research/publications/publication/?seqNo115=337105</a></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;"><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"> ***> However, at 51 months of incubation or greater, 5 animals were positive by one or more diagnostic methods. Furthermore, positive bioassay results were obtained from all inoculated groups (oral and intracranial; market weight and end of study) suggesting that swine are potential hosts for the agent of scrapie. <*** </span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br style="line-height: 1.22em;" /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">>*** Although the current U.S. feed ban is based on keeping tissues from TSE infected cattle from contaminating animal feed, swine rations in the U.S. could contain animal derived components including materials from scrapie infected sheep and goats. These results indicating the susceptibility of pigs to sheep scrapie, coupled with the limitations of the current feed ban, indicates that a revision of the feed ban may be necessary to protect swine production and potentially human health. <***</span></span></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;"><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">Scrapie Transmits To Pigs By Oral Route, what about the terribly flawed USA tse prion feed ban?</span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br style="line-height: 1.22em;" /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">Research Project: Pathobiology, Genetics, and Detection of Transmissible Spongiform Encephalopathies Location: Virus and Prion Research</span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br style="line-height: 1.22em;" /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">2017 Annual Report</span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br style="line-height: 1.22em;" /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">1a. Objectives (from AD-416):</span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br style="line-height: 1.22em;" /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">Objective 1: Investigate the mechanisms of protein misfolding in prion disease, including the genetic determinants of misfolding of the prion protein and the environmental influences on protein misfolding as it relates to prion diseases. Subobjective 1.A: Investigate the differences in the unfolded state of wild-type and disease associated prion proteins to better understand the mechanism of misfolding in genetic prion disease. Subobjective 1.B: Investigate the influence of metal ions on the misfolding of the prion protein in vitro to determine if environmental exposure to metal ions may alter disease progression. Objective 2: Investigate the pathobiology of prion strains in natural hosts, including the influence of prion source genotype on interspecies transmission and the pathobiology of atypical transmissible spongiform encephalopathies (TSEs). Subobjective 2.A: Investigate the pathobiology of atypical TSEs. Subobjective 2.B: Investigate the influence of prion source genotype on interspecies transmission. Objective 3: Investigate sampling methodologies for antemortem detection of prion disease, including the utility of blood sampling as a means to assess prion disease status of affected animals and the utility of environmental sampling for monitoring herd prion disease status. Subobjective 3.A: Investigate the utility of blood sampling as a means to assess prion disease status of affected animals. Subobjective 3.B: Investigate the utility of environmental sampling for monitoring herd prion disease status.</span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br style="line-height: 1.22em;" /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">1b. Approach (from AD-416):</span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br style="line-height: 1.22em;" /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">The studies will focus on three animal transmissible spongiform encephalopathy (TSE) agents found in the United States: bovine spongiform encephalopathy (BSE); scrapie of sheep and goats; and chronic wasting disease (CWD) of deer, elk, and moose. The research will address sites of protein folding and misfolding as it relates to prion disease, accumulation of misfolded protein in the host, routes of infection, and ante mortem diagnostics with an emphasis on controlled conditions and natural routes of infection. Techniques used will include spectroscopic monitoring of protein folding/misfolding, clinical exams, histopathology, immunohistochemistry, and biochemical analysis of proteins. The enhanced knowledge gained from this work will help understand the underlying mechanisms of prion disease and mitigate the potential for unrecognized epidemic expansions of these diseases in populations of animals that could either directly or indirectly affect food animals.</span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br style="line-height: 1.22em;" /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">3. Progress Report:</span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br style="line-height: 1.22em;" /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">All 8 project plan milestones for FY17 were fully met. Research efforts directed toward meeting objective 1 of our project plan center around the production of recombinant prion protein from either bacteria or mammalian tissue culture systems and collection of thermodynamic data on the folding of the recombinant prion protein produced. Both bacterial and mammalian expression systems have been established. Thermodynamic data addressing the denatured state of wild-type and a disease associated variant of bovine prion protein has been collected and a manuscript is in preparation. In research pertaining to objective 2, all studies have been initiated and animals are under observation for the development of clinical signs. The animal studies for this objective are long term and will continue until onset of clinical signs. In vitro studies planned in parallel to the animals studies have similarly been initiated and are ongoing. Objective 3 of the project plan focuses on the detection of disease associated prion protein in body fluids and feces collected from a time course study of chronic wasting disease inoculated animals. At this time samples are being collected as planned and methods for analysis are under development.</span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br style="line-height: 1.22em;" /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">4. Accomplishments</span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br style="line-height: 1.22em;" /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">1. Showed that swine are potential hosts for the scrapie agent. A naturally occurring prion disease has not been recognized in swine, but the agent of bovine spongiform encephalopathy does transmit to swine by experimental routes. Swine are thought to have a robust species barrier when exposed to the naturally occurring prion diseases of other species, but the susceptibility of swine to the agent of sheep scrapie has not been thoroughly tested. ARS researchers at Ames, Iowa conducted this experiment to test the susceptibility of swine to U.S. scrapie isolates by intracranial and oral inoculation. Necropsies were done on a subset of animals at approximately 6 months post inoculation (PI): the time the pigs were expected to reach market weight. Remaining pigs were maintained and monitored for clinical signs of transmissible spongiform encephalopathies (TSE) until study termination at 80 months PI or when removed due to intercurrent disease. Brain samples were examined by multiple diagnostic approaches, and for a subset of pigs in each inoculation group, bioassay in mice expressing porcine prion protein. At 6 months PI, no evidence of scrapie infection was noted by any diagnostic method. However, at 51 months of incubation or greater, 5 animals were positive by one or more diagnostic methods. Furthermore, positive bioassay results were obtained from all inoculated groups (oral and intracranial; market weight and end of study) suggesting that swine are potential hosts for the agent of scrapie. Although the current U.S. feed ban is based on keeping tissues from TSE infected cattle from contaminating animal feed, swine rations in the U.S. could contain animal derived components including materials from scrapie infected sheep and goats. These results indicating the susceptibility of pigs to sheep scrapie, coupled with the limitations of the current feed ban, indicates that a revision of the feed ban may be necessary to protect swine production and potentially human health.</span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br style="line-height: 1.22em;" /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">2. Determined that pigs naturally exposed to chronic wasting disease (CWD) may act as a reservoir of CWD infectivity. Chronic wasting disease is a naturally occurring, fatal, neurodegenerative disease of cervids. The potential for swine to serve as a host for the agent of CWD disease is unknown. The purpose of this study was to investigate the susceptibility of swine to the CWD agent following experimental oral or intracranial inoculation. Pigs were assigned to 1 of 3 groups: intracranially inoculated; orally inoculated; or non-inoculated. At market weight age, half of the pigs in each group were tested ('market weight' groups). The remaining pigs ('aged' groups) were allowed to incubate for up to 73 months post inoculation (MPI). Tissues collected at necropsy were examined for disease-associated prion protein (PrPSc) by multiple diagnostic methods. Brain samples from selected pigs were bioassayed in mice expressing porcine prion protein. Some pigs from each inoculated group were positive by one or more tests. Bioassay was positive in 4 out of 5 pigs assayed. Although only small amounts of PrPSc were detected using sensitive methods, this study demonstrates that pigs can serve as hosts for CWD. Detection of infectivity in orally inoculated pigs using mouse bioassay raises the possibility that naturally exposed pigs could act as a reservoir of CWD infectivity. Currently, swine rations in the U.S. could contain animal derived components including materials from deer or elk. In addition, feral swine could be exposed to infected carcasses in areas where CWD is present in wildlife populations. The current feed ban in the U.S. is based exclusively on keeping tissues from TSE infected cattle from entering animal feeds. These results indicating the susceptibility of pigs to CWD, coupled with the limitations of the current feed ban, indicates that a revision of the feed ban may be necessary to protect swine production and potentially human health.</span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br style="line-height: 1.22em;" /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">3. Developed a method for amplification and discrimination of the 3 forms of BSE in cattle. The prion protein (PrP) is a protein that is the causative agent of transmissible spongiform encephalopathies (TSEs). The disease process involves conversion of the normal cellular PrP to a pathogenic misfolded conformation. This conversion process can be recreated in the lab using a misfolding amplification process known as real-time quaking induced conversion (RT-QuIC). RT-QuIC allows the detection of minute amounts of the abnormal infectious form of the prion protein by inducing misfolding in a supplied substrate. Although RT-QuIC has been successfully used to detect pathogenic PrP with substrates from a variety of host species, prior to this work bovine prion protein had not been proven for its practical uses for RT-QuIC. We demonstrated that prions from transmissible mink encephalopathy (TME) and BSE-infected cattle can be detected with using bovine prion proteins with RT-QuIC, and developed an RT-QuIC based approach to discriminate different forms of BSE. This rapid and robust method, both to detect and discriminate BSE types, is of importance as the economic implications for different types of BSE vary greatly.</span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br style="line-height: 1.22em;" /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">Review Publications</span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br style="line-height: 1.22em;" /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">Hwang, S., Greenlee, J.J., Nicholson, E.M. 2017. Use of bovine recombinant prion protein and real-time quaking-induced conversion to detect cattle transmissible mink encephalopathy prions and discriminate classical and atypical L- and H-type bovine spongiform encephalopathy. PLoS One. 12(2):e0172391.</span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br style="line-height: 1.22em;" /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">Moore, S., Kunkle, R., Greenlee, M., Nicholson, E., Richt, J., Hamir, A., Waters, W., Greenlee, J. 2016. Horizontal transmission of chronic wasting disease in reindeer. Emerging Infectious Diseases. 22(12):2142-2145. doi:10.3201/eid2212.160635.</span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br style="line-height: 1.22em;" /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">Moore, S.J., West Greenlee, M.H., Smith, J.D., Vrentas, C.E., Nicholson, E.M., Greenlee, J.J. 2016. A comparison of classical and H-type bovine spongiform encephalopathy associated with E211K prion protein polymorphism in wild type and EK211 cattle following intracranial inoculation. Frontiers in Veterinary Science. 3:78.</span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br style="line-height: 1.22em;" /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">Greenlee, J.J., Kunkle, R.A., Smith, J.D., West Greenlee, M.H. 2016. Scrapie in swine: a diagnostic challenge. Food Safety. 4(4):110-114. Kondru, N., Manne, S., Greenlee, J., West Greenlee, H., Anantharam, V., Halbur, P., Kanthasamy, A., Kanthasamy, A. 2017. Integrated organotypic slice cultures and RT-QuIC (OSCAR) assay: implications for translational discovery in protein misfolding diseases. Scientific Reports. 7:43155. doi:10.1038/srep43155.</span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br style="line-height: 1.22em;" /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">Mammadova, N., Ghaisas, S., Zenitsky, G., Sakaguchi, D.S., Kanthasamy, A.G., Greenlee, J.J., West Greenlee, M.H. 2017. Lasting retinal injury in a mouse model of blast-induced trauma. American Journal of Pathology. 187(7):1459-1472. doi:10.1016/j.ajpath.2017.03.005. </span></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br style="line-height: 1.22em;" /></span></span></div><div style="line-height: 1.22em;"><a fg_scanned="1" href="https://www.ars.usda.gov/research/project/?accnNo=432011&fy=2017" rel="nofollow noopener noreferrer" style="color: blue; line-height: 1.22em;" target="_blank">https://www.ars.usda.gov/research/project/?accnNo=432011&fy=2017</a><br style="line-height: 1.22em;" /></div></div></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">FRIDAY, APRIL 20, 2018 <br /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><div style="font-family: arial; font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></span></div><div style="font-family: arial; font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">*** Scrapie Transmits To Pigs By Oral Route, what about the terribly flawed USA tse prion feed ban? </span></span></div><div style="font-family: arial; font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></span></div><div style="font-family: arial; font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">Research Project: Pathobiology, Genetics, and Detection of Transmissible Spongiform Encephalopathies</span></span><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial; font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></span></div><div style="font-family: arial; font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><a fg_scanned="1" href="http://scrapie-usa.blogspot.com/2018/04/scrapie-transmits-to-pigs-by-oral-route.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">http://scrapie-usa.blogspot.com/2018/04/scrapie-transmits-to-pigs-by-oral-route.html</a></span></span></div><div style="font-family: arial; font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br style="line-height: 1.22em;" /></span></div><div style="font-family: arial; font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">back in time...</span></div></div><div class="yiv1152037782yqt4477727775" id="yiv1152037782yqtfd71450" style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"></div></div></div><div style="font-size: 10pt; line-height: 1.22em;"><br style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;"><div style="line-height: 1.22em;"><div style="line-height: 1.22em;"><div style="line-height: 1.22em;"><div class="yiv1152037782aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;"><div style="font-family: arial, helvetica; font-size: 12px; line-height: 1.22em;"><div style="font-size: 10pt; line-height: 1.22em;">why do we not want to do TSE transmission studies on chimpanzees $</div><div style="font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-size: 10pt; line-height: 1.22em;">5. A positive result from a chimpanzee challenged severly would likely create alarm in some circles even if the result could not be interpreted for man. </div><div style="font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-size: 10pt; line-height: 1.22em;">***> I have a view that all these agents could be transmitted provided a large enough dose by appropriate routes was given and the animals kept long enough. </div><div style="font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-size: 10pt; line-height: 1.22em;">***> Until the mechanisms of the species barrier are more clearly understood it might be best to retain that hypothesis.</div><div style="font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-size: 10pt; line-height: 1.22em;">snip...</div><div style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div></div><div style="font-family: arial, helvetica; font-size: 12px; line-height: 1.22em;"><a href="https://web.archive.org/web/20090506041740/http://www.bseinquiry.gov.uk/files/yb/1990/09/23001001.pdf" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">https://web.archive.org/web/20090506041740/http://www.bseinquiry.gov.uk/files/yb/1990/09/23001001.pdf</a><br clear="none" style="line-height: 1.22em;" /></div><div><br /></div><div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;">*** ''but feeding of other ruminant protein, including scrapie-infected sheep, can continue to pigs.''</span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"> </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;">CONFIDENTIAL SPONGIFORM ENCEPHALOPATHY OF PIGS</span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"> </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;">CONFIDENTIAL</span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"> </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;">Ref: Pigs10i</span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"> </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;">IN CONFIDENCE</span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"> </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;">Dr. Metters </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"> </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;">From Dr. H Pickles Med ISD/3</span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"> </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;">Date 10 September 1990</span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"> </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;">Copy: Dr G Jones Mr D Hagger Mr T Murray (o/r) Dr D Harper Dr Richardson Mrs Shersby </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"> </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;">SPONGIFORM ENCEPHALOPATHY OF PIGS</span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"> </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;">1. There has been a preliminary meeting of the Tyrrell committee today to discuss the significance of the pig experiment in the light of other evidence, for example on feline spongiform encephalopathy. </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"> </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;">2. The preliminary conclusions were: </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"> </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;">we now know pigs are capable of expressing spongiform encephalopathy. Previously this had been doubted. </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"> </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;">the clinical picture in pigs exposed to agent by these doses/routes is fairly distinctive and unlikely to have gone unrecognised. </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"> </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;">even so improved monitoring/surveillance of neurological disease in older pigs should be considered. </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"> </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;">feeding of the "specified offal" (ie nervous/lymphoid tissue from cattle) should no longer be permitted, to pigs or to any other species. </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"> </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;">*** but feeding of other ruminant protein, including scrapie-infected sheep, can continue to pigs. </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"> </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;">if one natural field case of spongiform encephalopathy were described in a pig, we would need a ban on offal from for human consumption. </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"> </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;">we cannot rule out the possibility that unrecognised subclinical spongiform encephalopathy could be present in British pigs though there is no evidence for this: only with parenteral/implantable pharmaceuticals/devices is the theoretical risk to humans of sufficient concern to consider any action.</span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"> </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;">90/9.10/7.1 </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"> </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;">whilst any such action on pharmaceuticals/devices is for others to decide, this group (which includes 4 key members of the CSM group) suggests non-UK sources should now be used, at least for "high risk" pharmaceuticals and devices (ie for those from nervous or RE System)</span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"> </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;">3. The full committee will meet on the 19th to confirm these conclusions, to review experimental protocols of transmission experiments, to reconsider the cat position in the light of additional cases and to consider scrapie in sheep and goats. In view of Mr Gummer's earlier commitments, we assume he willI want to go public on the pig soon after, so the Tyrrell committee will also prepare a brief written statement. </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"> </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;">4. You may want to consider with the MCA and the Medical Device Agency what preparatory action is appropriate in anticipation of the formal advice from the Tyrrell group. The CSM subgroup not due to meet until the 31 October. </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"> </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;">Hilary Pickles Room 414 Eileen House Ext: 22832 </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"> </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="font-family: "New serif"; font-size: 12pt; margin: 0in 0in 0.0001pt;"><span style="font-family: sans-serif; font-size: 10pt;"><a href="http://web.archive.org/web/20030822031154/www.bseinquiry.gov.uk/files/yb/1990/09/10007001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20030822031154/www.bseinquiry.gov.uk/files/yb/1990/09/10007001.pdf</a></span></div></div></div></div></div></div></div></div></div><div><br /></div><div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;">CONFIDENTIAL</span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">EXPERIMENTAL PORCINE SPONGIFORM ENCEPHALOPATHY</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">While this clearly is a cause for concern we should not jump to the conclusion that this means that pigs will necessarily be infected by bone and meat meal fed by the oral route as is the case with cattle. ...</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20031026000118/www.bseinquiry.gov.uk/files/yb/1990/08/23004001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20031026000118/www.bseinquiry.gov.uk/files/yb/1990/08/23004001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20031026000118/www.bseinquiry.gov.uk/files/yb/1990/08/23004001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">we cannot rule out the possibility that unrecognised subclinical spongiform encephalopathy could be present in British pigs though there is no evidence for this: only with parenteral/implantable pharmaceuticals/devices is the theoretical risk to humans of sufficient concern to consider any action.</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20030822031154/www.bseinquiry.gov.uk/files/yb/1990/09/10007001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20030822031154/www.bseinquiry.gov.uk/files/yb/1990/09/10007001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20030822031154/www.bseinquiry.gov.uk/files/yb/1990/09/10007001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">May I, at the outset, reiterate that we should avoid dissemination of papers relating to this experimental finding to prevent premature release of the information. ...</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20030822052332/www.bseinquiry.gov.uk/files/yb/1990/09/11005001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20030822052332/www.bseinquiry.gov.uk/files/yb/1990/09/11005001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20030822052332/www.bseinquiry.gov.uk/files/yb/1990/09/11005001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">3. It is particularly important that this information is not passed outside the Department, until Ministers have decided how they wish it to be handled. ...</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20030822052438/www.bseinquiry.gov.uk/files/yb/1990/09/12002001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20030822052438/www.bseinquiry.gov.uk/files/yb/1990/09/12002001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20030822052438/www.bseinquiry.gov.uk/files/yb/1990/09/12002001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">But it would be easier for us if pharmaceuticals/devices are not directly mentioned at all. ...</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20030518170213/www.bseinquiry.gov.uk/files/yb/1990/09/13004001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20030518170213/www.bseinquiry.gov.uk/files/yb/1990/09/13004001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20030518170213/www.bseinquiry.gov.uk/files/yb/1990/09/13004001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">Our records show that while some use is made of porcine materials in medicinal products, the only products which would appear to be in a hypothetically ''higher risk'' area are the adrenocorticotrophic hormone for which the source material comes from outside the United Kingdom, namely America China Sweden France and Germany. The products are manufactured by Ferring and Armour. A further product, ''Zenoderm Corium implant'' manufactured by Ethicon, makes use of porcine skin - which is not considered to be a ''high risk'' tissue, but one of its uses is described in the data sheet as ''in dural replacement''. This product is sourced from the United Kingdom.....</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20030822054419/www.bseinquiry.gov.uk/files/yb/1990/09/21009001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20030822054419/www.bseinquiry.gov.uk/files/yb/1990/09/21009001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20030822054419/www.bseinquiry.gov.uk/files/yb/1990/09/21009001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">snip...</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">It was not until . . . August 1990, that the result from the pig persuaded both SEAC and us to change our view and to take out of pig rations any residual infectivity that might have arisen from the SBOs.</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20071014143511/http:/www.bseinquiry.gov.uk/files/tr/tab69.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20071014143511/http://www.bseinquiry.gov.uk/files/tr/tab69.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20071014143511/http://www.bseinquiry.gov.uk/files/tr/tab69.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">4.303 The minutes of the meeting record that:</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">It was very difficult to draw conclusions from one experimental result for what may happen in the field. However it would be prudent to exclude specified bovine offals from the pig diet. Although any relationship between BSE and the finding of a spongiform encephalopathy in cats had yet to be demonstrated, the fact that this had occurred suggested that a cautious view should be taken of those species which might be susceptible. The 'specified offals' of bovines should therefore be excluded from the feed of all species. 17</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20031026084516/http:/www.bseinquiry.gov.uk/files/yb/1990/09/07001001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20031026084516/http://www.bseinquiry.gov.uk/files/yb/1990/09/07001001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20031026084516/http://www.bseinquiry.gov.uk/files/yb/1990/09/07001001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">IN CONFIENCE</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">EXPERIMENTAL PORCINE SPONGIFORM ENCEPHALOPATHY</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">1. CMO should be aware that a pig inoculated experimentally (ic, iv, and ip) with BSE brain suspension has after 15 months developed an illness, now confirmed as a spongiform encephalopathy. This is the first ever description of such a disease in a pig, although it seems there ar no previous attempts at experimental inoculation with animal material. The Southwood group had thought igs would not be susceptible. Most pigs are slaughtered when a few weeks old but there have been no reports of relevant neurological illness in breeding sows or other elderly pigs. ...see full text ;</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20040302031004/www.bseinquiry.gov.uk/files/yb/1990/08/23001001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20040302031004/www.bseinquiry.gov.uk/files/yb/1990/08/23001001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20040302031004/www.bseinquiry.gov.uk/files/yb/1990/08/23001001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">IN CONFIDENCE</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">So it is plausible pigs could be preclinically affected with BSE but since so few are allowed to reach adulthood this has not been recognised through clinical disease. ...</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20040904150118/www.bseinquiry.gov.uk/files/yb/1990/08/23002001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20040904150118/www.bseinquiry.gov.uk/files/yb/1990/08/23002001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20040904150118/www.bseinquiry.gov.uk/files/yb/1990/08/23002001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">CONFIDENTIAL</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">EXPERIMENTAL PORCINE SPONGIFORM ENCEPHALOPATHY</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">While this clearly is a cause for concern we should not jump to the conclusion that this means that pigs will necessarily be infected by bone and meat meal fed by the oral route as is the case with cattle. ...</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20031026000118/www.bseinquiry.gov.uk/files/yb/1990/08/23004001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20031026000118/www.bseinquiry.gov.uk/files/yb/1990/08/23004001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20031026000118/www.bseinquiry.gov.uk/files/yb/1990/08/23004001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">we cannot rule out the possibility that unrecognised subclinical spongiform encephalopathy could be present in British pigs though there is no evidence for this: only with parenteral/implantable pharmaceuticals/devices is the theoretical risk to humans of sufficient concern to consider any action.</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20030822031154/www.bseinquiry.gov.uk/files/yb/1990/09/10007001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20030822031154/www.bseinquiry.gov.uk/files/yb/1990/09/10007001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20030822031154/www.bseinquiry.gov.uk/files/yb/1990/09/10007001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">May I, at the outset, reiterate that we should avoid dissemination of papers relating to this experimental finding to prevent premature release of the information. ...</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20030822052332/www.bseinquiry.gov.uk/files/yb/1990/09/11005001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20030822052332/www.bseinquiry.gov.uk/files/yb/1990/09/11005001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20030822052332/www.bseinquiry.gov.uk/files/yb/1990/09/11005001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">3. It is particularly important that this information is not passed outside the Department, until Ministers have decided how they wish it to be handled. ...</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20030822052438/www.bseinquiry.gov.uk/files/yb/1990/09/12002001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20030822052438/www.bseinquiry.gov.uk/files/yb/1990/09/12002001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20030822052438/www.bseinquiry.gov.uk/files/yb/1990/09/12002001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">But it would be easier for us if pharmaceuticals/devices are not directly mentioned at all. ...</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20030518170213/www.bseinquiry.gov.uk/files/yb/1990/09/13004001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20030518170213/www.bseinquiry.gov.uk/files/yb/1990/09/13004001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20030518170213/www.bseinquiry.gov.uk/files/yb/1990/09/13004001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">Our records show that while some use is made of porcine materials in medicinal products, the only products which would appear to be in a hypothetically ''higher risk'' area are the adrenocorticotrophic hormone for which the source material comes from outside the United Kingdom, namely America China Sweden France and Germany. The products are manufactured by Ferring and Armour. A further product, ''Zenoderm Corium implant'' manufactured by Ethicon, makes use of porcine skin - which is not considered to be a ''high risk'' tissue, but one of its uses is described in the data sheet as ''in dural replacement''. This product is sourced from the United Kingdom.....</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20030822054419/www.bseinquiry.gov.uk/files/yb/1990/09/21009001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20030822054419/www.bseinquiry.gov.uk/files/yb/1990/09/21009001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20030822054419/www.bseinquiry.gov.uk/files/yb/1990/09/21009001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">BSE TO PIGS NEWS RELEASE</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20030822162313/www.bseinquiry.gov.uk/files/yb/1990/09/24001001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20030822162313/www.bseinquiry.gov.uk/files/yb/1990/09/24001001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20030822162313/www.bseinquiry.gov.uk/files/yb/1990/09/24001001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">CONFIDENTIAL</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">BSE: PRESS PRESENTATION</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20030822160958/www.bseinquiry.gov.uk/files/yb/1990/09/20003001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20030822160958/www.bseinquiry.gov.uk/files/yb/1990/09/20003001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20030822160958/www.bseinquiry.gov.uk/files/yb/1990/09/20003001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20040623191707/www.bseinquiry.gov.uk/files/yb/1990/09/24013001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20040623191707/www.bseinquiry.gov.uk/files/yb/1990/09/24013001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20040623191707/www.bseinquiry.gov.uk/files/yb/1990/09/24013001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20030820195733/http:/www.bseinquiry.gov.uk/files/yb/1990/09/20010001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20030820195733/http://www.bseinquiry.gov.uk/files/yb/1990/09/20010001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20030820195733/http://www.bseinquiry.gov.uk/files/yb/1990/09/20010001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20030820195733/http:/www.bseinquiry.gov.uk/files/yb/1990/09/25013001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20030820195733/http://www.bseinquiry.gov.uk/files/yb/1990/09/25013001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20030820195733/http://www.bseinquiry.gov.uk/files/yb/1990/09/25013001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20030820195733/http:/www.bseinquiry.gov.uk/files/yb/1990/09/25015001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20030820195733/http://www.bseinquiry.gov.uk/files/yb/1990/09/25015001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20030820195733/http://www.bseinquiry.gov.uk/files/yb/1990/09/25015001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">INDUSTRY RESPONSE TYPICAL</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20030822055917/www.bseinquiry.gov.uk/files/yb/1990/09/25007001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20030822055917/www.bseinquiry.gov.uk/files/yb/1990/09/25007001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20030822055917/www.bseinquiry.gov.uk/files/yb/1990/09/25007001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">DEFENSIVE BRIEFING</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20030820195733/http:/www.bseinquiry.gov.uk/files/yb/1990/09/25016001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20030820195733/http://www.bseinquiry.gov.uk/files/yb/1990/09/25016001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20030820195733/http://www.bseinquiry.gov.uk/files/yb/1990/09/25016001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">CONFIDENTIAL</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">pigs & pharmaceuticals</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20010305223234/www.bseinquiry.gov.uk/files/yb/1990/09/10007001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20010305223234/www.bseinquiry.gov.uk/files/yb/1990/09/10007001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20010305223234/www.bseinquiry.gov.uk/files/yb/1990/09/10007001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20010305223234/www.bseinquiry.gov.uk/files/yb/1990/08/23002001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20010305223234/www.bseinquiry.gov.uk/files/yb/1990/08/23002001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20010305223234/www.bseinquiry.gov.uk/files/yb/1990/08/23002001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20010305223234/www.bseinquiry.gov.uk/files/yb/1990/08/23004001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20010305223234/www.bseinquiry.gov.uk/files/yb/1990/08/23004001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20010305223234/www.bseinquiry.gov.uk/files/yb/1990/08/23004001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20010305223234/www.bseinquiry.gov.uk/files/yb/1990/08/29003001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20010305223234/www.bseinquiry.gov.uk/files/yb/1990/08/29003001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20010305223234/www.bseinquiry.gov.uk/files/yb/1990/08/29003001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">COMMERCIAL IN CONFIDENCE COMMITTEE ON SAFETY OF MEDICINE NOT FOR PUBLICATION BOVINE SPONGIFORM ENCEPHALOPATHY WORKING GROUP</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">There are only two products using porcine brain and these use corticotrophin BP, made from porcine pituitary, source from outside the UK.............</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a href="http://web.archive.org/web/20040622220349/www.bseinquiry.gov.uk/files/yb/1990/10/31003001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="font-size: 10pt;"></span></b></a><b><a href="http://web.archive.org/web/20040622220349/www.bseinquiry.gov.uk/files/yb/1990/10/31003001.pdf" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://web.archive.org/web/20040622220349/www.bseinquiry.gov.uk/files/yb/1990/10/31003001.pdf</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif; font-size: 10pt;">snip...</span><span style="color: #333333; font-family: sans-serif;"></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;">7 OF 10 LITTLE PIGGIES WENT ON TO DEVELOP BSE;</span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;">1: J Comp Pathol. 2000 Feb-Apr; 122(2-3): 131-43. Related Articles,</span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;">The neuropathology of experimental bovine spongiform encephalopathy in the pig.</span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;">Ryder SJ, Hawkins SA, Dawson M, Wells GA.</span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;">Veterinary Laboratories Agency Weybridge, Woodham Lane, New Haw, Addlestone, Surrey, KT15 3NB, UK.</span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;">In an experimental study of the transmissibility of BSE to the pig, seven of 10 pigs, infected at 1-2 weeks of age by multiple-route parenteral inoculation with a homogenate of bovine brain from natural BSE cases developed lesions typical of spongiform encephalopathy. The lesions consisted principally of severe neuropil vacuolation affecting most areas of the brain, but mainly the forebrain. In addition, some vacuolar change was identified in the rostral colliculi and hypothalamic areas of normal control pigs. PrP accumulations were detected immunocytochemically in the brains of BSE-infected animals. PrP accumulation was sparse in many areas and its density was not obviously related to the degree of vacuolation. The patterns of PrP immunolabelling in control pigs differed strikingly from those in the infected animals.</span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;">PMID: 10684682 [PubMed - indexed for MEDLINE]</span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a fg_scanned="1" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?holding=npg&cmd=Retrieve&db=PubMed&list_uids=10684682&dopt=Abstract" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b></b></a><b><a fg_scanned="1" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?holding=npg&cmd=Retrieve&db=PubMed&list_uids=10684682&dopt=Abstract" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?holding=npg&cmd=Retrieve&db=PubMed&list_uids=10684682&dopt=Abstract</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;">snip...</span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;">In the United States, feeding of ruminant by-products to ruminants is prohibited, but feeding of ruminant materials to swine and poultry still occurs. The potential for swine to have access to scrapie-contaminated feedstuffs exists, but the potential for swine to serve as a host for replication/accumulation of the agent of scrapie is unknown. The purpose of this study was to perform oral and intracerebral inoculation of the U.S. scrapie agent to determine the potential of swine as a host for the scrapie agent and their clinical susceptibility.</span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;">see full text and more transmission studies here ;</span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a fg_scanned="1" href="http://chronic-wasting-disease.blogspot.com/2011/07/swine-are-susceptible-to-chronic.html" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b></b></a><b><a fg_scanned="1" href="http://chronic-wasting-disease.blogspot.com/2011/07/swine-are-susceptible-to-chronic.html" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://chronic-wasting-disease.blogspot.com/2011/07/swine-are-susceptible-to-chronic.html</a></b></span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;">Transgenic mice expressing porcine prion protein resistant to classical scrapie but susceptible to sheep bovine spongiform encephalopathy and atypical scrapie.</span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;">Emerg Infect Dis. 2009 Aug; [Epub ahead of print]</span></div></div><div style="font-family: arial, helvetica; margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a fg_scanned="1" href="http://nor-98.blogspot.com/2009/07/transgenic-mice-expressing-porcine.html" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b></b></a><b><a fg_scanned="1" href="http://nor-98.blogspot.com/2009/07/transgenic-mice-expressing-porcine.html" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://nor-98.blogspot.com/2009/07/transgenic-mice-expressing-porcine.html</a></b></span></div></div><div style="margin-bottom: 9pt;"><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: "New serif"; font-size: 12pt; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><span style="color: #333333; font-family: sans-serif;"><a fg_scanned="1" href="http://madporcinedisease.blogspot.com/" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank"><b><span style="color: #cc6600;"></span></b></a><b><a fg_scanned="1" href="http://madporcinedisease.blogspot.com/" rel="nofollow noopener noreferrer" style="color: purple;" target="_blank">http://madporcinedisease.blogspot.com/</a></b></span></div><div class="yiv1152037782aolmail_aolmail_MsoNormal" style="background-attachment: initial; background-image: initial; background-position: initial; background-repeat: initial; background-size: initial; line-height: 19.2pt; margin: 0in 0in 0.0001pt;"><div style="font-family: Georgia; font-size: 13px; line-height: 1.22em;"><div style="font-family: arial; font-size: small;"><span style="font-size: 12px;">MONDAY, JANUARY 21, 2019 </span></div><div style="font-family: arial; font-size: small;"><span style="font-size: 12px;"><br clear="none" /></span></div><div style="font-family: arial; font-size: small;"><span style="font-size: 12px;">Bovine Spongiform Encephalopathy BSE TSE Prion Surveillance FDA USDA APHIS FSIS UPDATE 2019</span><br clear="none" /></div><div style="font-family: arial; font-size: small;"><span style="font-size: 12px;"><br clear="none" /></span></div><div style="font-family: arial; font-size: small;"><span style="font-size: 12px;"><a fg_scanned="1" href="https://bovineprp.blogspot.com/2019/01/bovine-spongiform-encephalopathy-bse.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">https://bovineprp.blogspot.com/2019/01/bovine-spongiform-encephalopathy-bse.html</a></span></div><div style="font-family: arial; font-size: small;"><br clear="none" /></div><div style="font-family: arial; font-size: small;"><div><div style="font-family: arial, helvetica; font-size: 13.3333px; line-height: 1.22em;"><div style="font-size: 10pt; line-height: 1.22em;">Prion Conference 2018</div><div style="font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-size: 10pt; line-height: 1.22em;"><div style="line-height: 1.22em;"><span style="line-height: 1.22em;">O5 Prion Disease in Dromedary Camels </span></div><div style="line-height: 1.22em;"><span style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="line-height: 1.22em;">Babelhadj B (1), Di Bari MA (2), Pirisinu L (2), Chiappini B (2), Gaouar SB (3), Riccardi G (2), Marcon S (2), Agrimi U (2), Nonno R (2), Vaccari G (2) (1) École Normale Supérieure Ouargla. Laboratoire de protection des écosystèmes en zones arides et semi arides University Kasdi Merbah Ouargla, Ouargla, Algeria; (2) Istituto Superiore di Sanità, Department of Food Safety, Nutrition and Veterinary Public Health, Rome, Italy (3) University Abou Bekr Bélkaid, Tlemcen, Algeria. </span></div><div style="line-height: 1.22em;"><span style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="line-height: 1.22em;">Prions are responsible for fatal and transmissible neurodegenerative diseases including CreutzfeldtJakob disease in humans, scrapie in small ruminants and bovine spongiform encephalopathy (BSE). Following the BSE epidemic and the demonstration of its zoonotic potential, general concerns have been raised on animal prions. </span></div><div style="line-height: 1.22em;"><span style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="line-height: 1.22em;">Here we report the identification of a prion disease in dromedary camels (Camelus dromedarius) in Algeria and designate it as Camel Prion Disease (CPD). In the last years, neurological symptoms have been observed in adult male and female dromedaries presented for slaughter at the Ouargla abattoir. The symptoms include weight loss, behavioral abnormalities and neurological symptoms such as tremors, aggressiveness, hyper-reactivity, typical down and upwards movements of the head, hesitant and uncertain gait, ataxia of the hind limbs, occasional falls and difficult getting up. During 2015 and 2016, symptoms suggestive of prion disease were observed in 3.1% of 2259 dromedaries presented at ante-mortem examination. Laboratory diagnosis was obtained in three symptomatic dromedaries, sampled in 2016 and 2017, by the detection of typical neurodegeneration and disease-specific prion protein (PrPSc) in brain tissues. </span></div><div style="line-height: 1.22em;"><span style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="line-height: 1.22em;">Histopathological examination revealed spongiform change, gliosis and neuronal loss preferentially in grey matter of subcortical brain areas. Abundant PrPSc deposition was detected in the same brain areas by immunohistochemistry and PET-blot. Western blot analysis confirmed the presence of PK-resistant PrPSc, whose N-terminal cleaved PK-resistant core was characterized by a mono-glycosylated dominant form and by a distinctive N-terminal cleavage, different from that observed in BSE and scrapie. </span></div><div style="line-height: 1.22em;"><span style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="line-height: 1.22em;">PrPSc was also detected, by immunohistochemistry, in all sampled lymph nodes (cervical, prescapular and lumbar aortic) of the only animal from which they were collected. </span></div><div style="line-height: 1.22em;"><span style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="line-height: 1.22em;">The PRNP sequence of the two animals for which frozen material was available, showed 100% nucleotide identity with the PRNP sequence already reported for dromedary camel. </span></div><div style="line-height: 1.22em;"><span style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="line-height: 1.22em;">Overall, these data demonstrate the presence of a prion disease in dromedary camelswhose nature, origin and spread need further investigations. However, our preliminary observations on the rather high prevalence of symptomatic dromedaries and the involvement of lymphoid tissues, are consistent with CPD being an infectious disease. In conclusion, the emergence of a new prion disease in a livestock species of crucial importance for millions of people around the world, makes urgent to assess the risk for humans and to develop policies able to control the spread of the disease in animals and to minimize human exposure. </span></div><div style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div></div><div style="font-size: 10pt; line-height: 1.22em;"><a href="https://prion2018.org/wp-content/uploads/2018/05/program.pdf" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">https://prion2018.org/wp-content/uploads/2018/05/program.pdf</a><br clear="none" style="line-height: 1.22em;" /></div><div style="font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-size: 10pt; line-height: 1.22em;">CDC</div><div style="font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-size: 10pt; line-height: 1.22em;"><div style="font-size: small; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">New Outbreak of TSE Prion in NEW LIVESTOCK SPECIES</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">Mad Camel Disease</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Volume 24, Number 6—June 2018 Research </span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Prion Disease in Dromedary Camels, Algeria</span><br clear="none" style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="line-height: 1.22em;"></span></span><div style="line-height: 1.22em;">Abstract</div><div style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;">Prions cause fatal and transmissible neurodegenerative diseases, including Creutzfeldt-Jakob disease in humans, scrapie in small ruminants, and bovine spongiform encephalopathy (BSE). After the BSE epidemic, and the associated human infections, began in 1996 in the United Kingdom, general concerns have been raised about animal prions. We detected a prion disease in dromedary camels (Camelus dromedarius) in Algeria. Symptoms suggesting prion disease occurred in 3.1% of dromedaries brought for slaughter to the Ouargla abattoir in 2015–2016. We confirmed diagnosis by detecting pathognomonic neurodegeneration and disease-specific prion protein (PrPSc) in brain tissues from 3 symptomatic animals. Prion detection in lymphoid tissues is suggestive of the infectious nature of the disease. PrPSc biochemical characterization showed differences with BSE and scrapie. Our identification of this prion disease in a geographically widespread livestock species requires urgent enforcement of surveillance and assessment of the potential risks to human and animal health.</div></div><div style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">SNIP...</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><div style="line-height: 1.22em; margin-bottom: 10px;">The possibility that dromedaries acquired the disease from eating prion-contaminated waste needs to be considered.</div><span style="line-height: 1.22em;"></span><span style="line-height: 1.22em;"></span><div style="line-height: 1.22em; margin-bottom: 10px;">Tracing the origin of prion diseases is challenging. In the case of CPD, the traditional extensive and nomadic herding practices of dromedaries represent a formidable factor for accelerating the spread of the disease at long distances, making the path of its diffusion difficult to determine. Finally, the major import flows of live animals to Algeria from Niger, Mali, and Mauritania (<a class="yiv1152037782aolmail_aolmail_aolmail_tp-link-policy" fg_scanned="1" href="https://wwwnc.cdc.gov/eid/article/24/6/17-2007_article#r27" rel="nofollow noopener noreferrer" shape="rect" style="color: #075290; line-height: 1.22em;" target="_blank" title="27"><em style="line-height: 1.22em;">27</em></a>) should be investigated to trace the possible origin of CPD from other countries.</div><div style="line-height: 1.22em; margin-bottom: 10px;">Camels are a vital animal species for millions of persons globally. The world camel population has a yearly growth rate of 2.1% (<a class="yiv1152037782aolmail_aolmail_aolmail_tp-link-policy" fg_scanned="1" href="https://wwwnc.cdc.gov/eid/article/24/6/17-2007_article#r28" rel="nofollow noopener noreferrer" shape="rect" style="color: #075290; line-height: 1.22em;" target="_blank" title="28"><em style="line-height: 1.22em;">28</em></a>). In 2014, the population was estimated at ≈28 million animals, but this number is probably underestimated.. Approximately 88% of camels are found in Africa, especially eastern Africa, and 12% are found in Asia. Official data reported 350,000 dromedaries in Algeria in 2014 (<a class="yiv1152037782aolmail_aolmail_aolmail_tp-link-policy" fg_scanned="1" href="https://wwwnc..cdc.gov/eid/article/24/6/17-2007_article#r28" rel="nofollow noopener noreferrer" shape="rect" style="color: #075290; line-height: 1.22em;" target="_blank" title="28"><em style="line-height: 1.22em;">28</em></a>).</div><div style="line-height: 1.22em; margin-bottom: 10px;">On the basis of phenotypic traits and sociogeographic criteria, several dromedary populations have been suggested to exist in Algeria (<a class="yiv1152037782aolmail_aolmail_aolmail_tp-link-policy" fg_scanned="1" href="https://wwwnc.cdc.gov/eid/article/24/6/17-2007_article#r29" rel="nofollow noopener noreferrer" shape="rect" style="color: #075290; line-height: 1.22em;" target="_blank" title="29"><em style="line-height: 1.22em;">29</em></a>). However, recent genetic studies in Algeria and Egypt point to a weak differentiation of the dromedary population as a consequence of historical use as a cross-continental beast of burden along trans-Saharan caravan routes, coupled with traditional extensive/nomadic herding practices (<a class="yiv1152037782aolmail_aolmail_aolmail_tp-link-policy" fg_scanned="1" href="https://wwwnc.cdc.gov/eid/article/24/6/17-2007_article#r30" rel="nofollow noopener noreferrer" shape="rect" style="color: #075290; line-height: 1.22em;" target="_blank" title="30"><em style="line-height: 1.22em;">30</em></a>).</div><div style="line-height: 1.22em; margin-bottom: 10px;">Such genetic homogeneity also might be reflected in <em style="line-height: 1.22em;">PRNP</em>. Studies on <em style="line-height: 1.22em;">PRNP</em> variability in camels are therefore warranted to explore the existence of genotypes resistant to CPD, which could represent an important tool for CPD management as it was for breeding programs for scrapie eradication in sheep.</div><div style="line-height: 1.22em; margin-bottom: 10px;">In the past 10 years, the camel farming system has changed rapidly, with increasing setup of periurban dairy farms and dairy plants and diversification of camel products and market penetration (<a class="yiv1152037782aolmail_aolmail_aolmail_tp-link-policy" fg_scanned="1" href="https://wwwnc.cdc.gov/eid/article/24/6/17-2007_article#r13" rel="nofollow noopener noreferrer" shape="rect" style="color: #075290; line-height: 1.22em;" target="_blank" title="13"><em style="line-height: 1.22em;">13</em></a>). This evolution requires improved health standards for infectious diseases and, in light of CPD, for prion diseases.</div><div style="line-height: 1.22em; margin-bottom: 10px;">The emergence of another prion disease in an animal species of crucial importance for millions of persons worldwide makes it necessary to assess the risk for humans and develop evidence-based policies to control and limit the spread of the disease in animals and minimize human exposure. The implementation of a surveillance system for prion diseases would be a first step to enable disease control and minimize human and animal exposure. Finally, the diagnostic capacity of prion diseases needs to be improved in all countries in Africa where dromedaries are part of the domestic livestock.</div></div><div style="font-size: small; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><a fg_scanned="1" href="https://wwwnc.cdc.gov/eid/article/24/6/17-2007_article" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">https://wwwnc.cdc.gov/eid/article/24/6/17-2007_article</a> </span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">***> IMPORTS AND EXPORTS <***</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">***SEE MASSIVE AMOUNTS OF BANNED ANIMAL PROTEIN AKA MAD COW FEED IN COMMERCE USA DECADES AFTER POST BAN ***</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><a fg_rewritten="1" fg_scanned="1" href="http://camelusprp.blogspot.com/2018/04/dromedary-camels-algeria-prion-mad.html" rel="nofollow noopener noreferrer" shape="rect" style="background-color: rgb(200, 26, 0) !important; color: blue; line-height: 1.22em; padding-bottom: 3px; padding-left: 3px; padding-right: 3px;" target="_blank">http://camelusprp.blogspot.com/2018/04/dromedary-camels-algeria-prion-mad.html</a></div><div style="font-size: small; line-height: 1.22em;"><div style="font-family: Georgia; font-size: 13px; line-height: 1.22em;"></div></div></div></div><div style="font-family: arial, helvetica; font-size: 13.3333px; line-height: 1.22em;"><div style="line-height: 1.22em;"><div style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;"><div style="line-height: 1.22em;"><div style="font-family: arial; font-size: small; line-height: 1.22em;">USA MAD COW CASE 2018 FLORIDA</div><div style="font-family: arial; font-size: small; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial; font-size: small; line-height: 1.22em;">WEDNESDAY, SEPTEMBER 26, 2018 </div><div style="font-family: arial; font-size: small; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial; font-size: small; line-height: 1.22em;">JAVMA In Short Update USDA announces detection of atypical BSE</div><div style="font-family: arial; font-size: small; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-size: 10pt; line-height: 1.22em;"><a fg_scanned="1" href="http://bovineprp.blogspot.com/2018/09/javma-in-short-update-usda-announces.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; font-family: arial; font-size: small; line-height: 1.22em;" target="_blank">http://bovineprp.blogspot.com/2018/09/javma-in-short-update-usda-announces.html</a></div></div></div></div></div></div><div><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 12px;">ZOONOSIS OF SCRAPIE TSE PRION<br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;">O.05: Transmission of prions to primates after extended silent incubation periods: Implications for BSE and scrapie risk assessment in human populations <br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Emmanuel Comoy, Jacqueline Mikol, Valerie Durand, Sophie Luccantoni, Evelyne Correia, Nathalie Lescoutra, Capucine Dehen, and Jean-Philippe Deslys Atomic Energy Commission; Fontenay-aux-Roses, France </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Prion diseases (PD) are the unique neurodegenerative proteinopathies reputed to be transmissible under field conditions since decades. The transmission of Bovine Spongiform Encephalopathy (BSE) to humans evidenced that an animal PD might be zoonotic under appropriate conditions. Contrarily, in the absence of obvious (epidemiological or experimental) elements supporting a transmission or genetic predispositions, PD, like the other proteinopathies, are reputed to occur spontaneously (atpical animal prion strains, sporadic CJD summing 80% of human prion cases). </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Non-human primate models provided the first evidences supporting the transmissibiity of human prion strains and the zoonotic potential of BSE. Among them, cynomolgus macaques brought major information for BSE risk assessment for human health (Chen, 2014), according to their phylogenetic proximity to humans and extended lifetime. We used this model to assess the zoonotic potential of other animal PD from bovine, ovine and cervid origins even after very long silent incubation periods. </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">*** We recently observed the direct transmission of a natural classical scrapie isolate to macaque after a 10-year silent incubation period, </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">***with features similar to some reported for human cases of sporadic CJD, albeit requiring fourfold long incubation than BSE. Scrapie, as recently evoked in humanized mice (Cassard, 2014), </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">***is the third potentially zoonotic PD (with BSE and L-type BSE), </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">***thus questioning the origin of human sporadic cases. </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">We will present an updated panorama of our different transmission studies and discuss the implications of such extended incubation periods on risk assessment of animal PD for human health. </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">=============== </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">***thus questioning the origin of human sporadic cases*** </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">=============== </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">***our findings suggest that possible transmission risk of H-type BSE to sheep and human. Bioassay will be required to determine whether the PMCA products are infectious to these animals. </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">============== </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><a href="https://prion2015.files.wordpress.com/2015/05/prion2015abstracts.pdf" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">https://prion2015.files.wordpress.com/2015/05/prion2015abstracts.pdf</a> </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;">***Transmission data also revealed that several scrapie prions propagate in HuPrP-Tg mice with efficiency comparable to that of cattle BSE. While the efficiency of transmission at primary passage was low, subsequent passages resulted in a highly virulent prion disease in both Met129 and Val129 mice. <br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">***Transmission of the different scrapie isolates in these mice leads to the emergence of prion strain phenotypes that showed similar characteristics to those displayed by MM1 or VV2 sCJD prion. </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">***These results demonstrate that scrapie prions have a zoonotic potential and raise new questions about the possible link between animal and human prions. </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><a fg_scanned="1" href="http://www.tandfonline.com/doi/abs/10.1080/19336896.2016.1163048?journalCode=kprn20" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://www.tandfonline.com/doi/abs/10.1080/19336896.2016.1163048?journalCode=kprn20</a></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"> </span></div><div style="font-family: arial, helvetica; font-size: 12px;">PRION 2016 TOKYO<br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Saturday, April 23, 2016</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">SCRAPIE WS-01: Prion diseases in animals and zoonotic potential 2016</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Prion. 10:S15-S21. 2016 ISSN: 1933-6896 printl 1933-690X online</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Taylor & Francis</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Prion 2016 Animal Prion Disease Workshop Abstracts</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">WS-01: Prion diseases in animals and zoonotic potential</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Juan Maria Torres a, Olivier Andreoletti b, J uan-Carlos Espinosa a. Vincent Beringue c. Patricia Aguilar a,</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Natalia Fernandez-Borges a. and Alba Marin-Moreno a</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">"Centro de Investigacion en Sanidad Animal ( CISA-INIA ). Valdeolmos, Madrid. Spain; b UMR INRA -ENVT 1225 Interactions Holes Agents Pathogenes. ENVT. Toulouse. France: "UR892. Virologie lmmunologie MolécuIaires, Jouy-en-Josas. France</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Dietary exposure to bovine spongiform encephalopathy (BSE) contaminated bovine tissues is considered as the origin of variant Creutzfeldt Jakob (vCJD) disease in human. To date, BSE agent is the only recognized zoonotic prion... Despite the variety of Transmissible Spongiform Encephalopathy (TSE) agents that have been circulating for centuries in farmed ruminants there is no apparent epidemiological link between exposure to ruminant products and the occurrence of other form of TSE in human like sporadic Creutzfeldt Jakob Disease (sCJD). However, the zoonotic potential of the diversity of circulating TSE agents has never been systematically assessed. The major issue in experimental assessment of TSEs zoonotic potential lies in the modeling of the ‘species barrier‘, the biological phenomenon that limits TSE agents’ propagation from a species to another. In the last decade, mice genetically engineered to express normal forms of the human prion protein has proved essential in studying human prions pathogenesis and modeling the capacity of TSEs to cross the human species barrier.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">To assess the zoonotic potential of prions circulating in farmed ruminants, we study their transmission ability in transgenic mice expressing human PrPC (HuPrP-Tg). Two lines of mice expressing different forms of the human PrPC (129Met or 129Val) are used to determine the role of the Met129Val dimorphism in susceptibility/resistance to the different agents.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">These transmission experiments confirm the ability of BSE prions to propagate in 129M- HuPrP-Tg mice and demonstrate that Met129 homozygotes may be susceptible to BSE in sheep or goat to a greater degree than the BSE agent in cattle and that these agents can convey molecular properties and neuropathological indistinguishable from vCJD. However homozygous 129V mice are resistant to all tested BSE derived prions independently of the originating species suggesting a higher transmission barrier for 129V-PrP variant.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Transmission data also revealed that several scrapie prions propagate in HuPrP-Tg mice with efficiency comparable to that of cattle BSE. While the efficiency of transmission at primary passage was low, subsequent passages resulted in a highly virulent prion disease in both Met129 and Val129 mice. </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Transmission of the different scrapie isolates in these mice leads to the emergence of prion strain phenotypes that showed similar characteristics to those displayed by MM1 or VV2 sCJD prion. </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">These results demonstrate that scrapie prions have a zoonotic potential and raise new questions about the possible link between animal and human prions. </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><a fg_scanned="1" href="http://www.tandfonline.com/doi/abs/10.1080/19336896.2016.1163048?journalCode=kprn20" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://www.tandfonline.com/doi/abs/10.1080/19336896.2016.1163048?journalCode=kprn20</a></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"> </span></div><div style="font-family: arial, helvetica; font-size: 12px;">***> why do we not want to do TSE transmission studies on chimpanzees $<br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">5. A positive result from a chimpanzee challenged severly would likely create alarm in some circles even if the result could not be interpreted for man. </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">***> I have a view that all these agents could be transmitted provided a large enough dose by appropriate routes was given and the animals kept long enough. </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">***> Until the mechanisms of the species barrier are more clearly understood it might be best to retain that hypothesis.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">snip...</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">R. BRADLEY</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><a href="https://web.archive.org/web/20170126051158/http://collections.europarchive.org/tna/20080102222950/http://www.bseinquiry.gov.uk/files/yb/1990/09/23001001.pdf" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">https://web.archive.org/web/20170126051158/http://collections.europarchive.org/tna/20080102222950/http://www.bseinquiry.gov.uk/files/yb/1990/09/23001001.pdf</a><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Title: Transmission of scrapie prions to primate after an extended silent incubation period) </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">*** In complement to the recent demonstration that humanized mice are susceptible to scrapie, we report here the first observation of direct transmission of a natural classical scrapie isolate to a macaque after a 10-year incubation period. Neuropathologic examination revealed all of the features of a prion disease: spongiform change, neuronal loss, and accumulation of PrPres throughout the CNS. </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">*** This observation strengthens the questioning of the harmlessness of scrapie to humans, at a time when protective measures for human and animal health are being dismantled and reduced as c-BSE is considered controlled and being eradicated. </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">*** Our results underscore the importance of precautionary and protective measures and the necessity for long-term experimental transmission studies to assess the zoonotic potential of other animal prion strains. </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><a fg_scanned="1" href="http://www.ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=313160" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://www.ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=313160</a> </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;">***> Moreover, sporadic disease has never been observed in breeding colonies or primate research laboratories, most notably among hundreds of animals over several decades of study at the National Institutes of Health25, and in nearly twenty older animals continuously housed in our own facility. <***<br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Transmission of scrapie prions to primate after an extended silent incubation period </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Emmanuel E. Comoy, Jacqueline Mikol, Sophie Luccantoni-Freire, Evelyne Correia, Nathalie Lescoutra-Etchegaray, Valérie Durand, Capucine Dehen, Olivier Andreoletti, Cristina Casalone, Juergen A. Richt, Justin J. Greenlee, Thierry Baron, Sylvie L. Benestad, Paul Brown & Jean-Philippe Deslys Scientific Reports volume 5, Article number: 11573 (2015) | Download Citation</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Abstract </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Classical bovine spongiform encephalopathy (c-BSE) is the only animal prion disease reputed to be zoonotic, causing variant Creutzfeldt-Jakob disease (vCJD) in humans and having guided protective measures for animal and human health against animal prion diseases. Recently, partial transmissions to humanized mice showed that the zoonotic potential of scrapie might be similar to c-BSE. We here report the direct transmission of a natural classical scrapie isolate to cynomolgus macaque, a highly relevant model for human prion diseases, after a 10-year silent incubation period, with features similar to those reported for human cases of sporadic CJD. Scrapie is thus actually transmissible to primates with incubation periods compatible with their life expectancy, although fourfold longer than BSE. Long-term experimental transmission studies are necessary to better assess the zoonotic potential of other prion diseases with high prevalence, notably Chronic Wasting Disease of deer and elk and atypical/Nor98 scrapie.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">SNIP...</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Discussion We describe the transmission of spongiform encephalopathy in a non-human primate inoculated 10 years earlier with a strain of sheep c-scrapie. Because of this extended incubation period in a facility in which other prion diseases are under study, we are obliged to consider two alternative possibilities that might explain its occurrence. We first considered the possibility of a sporadic origin (like CJD in humans). Such an event is extremely improbable because the inoculated animal was 14 years old when the clinical signs appeared, i.e. about 40% through the expected natural lifetime of this species, compared to a peak age incidence of 60–65 years in human sporadic CJD, or about 80% through their expected lifetimes. Moreover, sporadic disease has never been observed in breeding colonies or primate research laboratories, most notably among hundreds of animals over several decades of study at the National Institutes of Health25, and in nearly twenty older animals continuously housed in our own facility.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">The second possibility is a laboratory cross-contamination. Three facts make this possibility equally unlikely. First, handling of specimens in our laboratory is performed with fastidious attention to the avoidance of any such cross-contamination. Second, no laboratory cross-contamination has ever been documented in other primate laboratories, including the NIH, even between infected and uninfected animals housed in the same or adjacent cages with daily intimate contact (P. Brown, personal communication). Third, the cerebral lesion profile is different from all the other prion diseases we have studied in this model19, with a correlation between cerebellar lesions (massive spongiform change of Purkinje cells, intense PrPres staining and reactive gliosis26) and ataxia. The iron deposits present in the globus pallidus are a non specific finding that have been reported previously in neurodegenerative diseases and aging27. Conversely, the thalamic lesion was reminiscent of a metabolic disease due to thiamine deficiency28 but blood thiamine levels were within normal limits (data not shown). The preferential distribution of spongiform change in cortex associated with a limited distribution in the brainstem is reminiscent of the lesion profile in MM2c and VV1 sCJD patients29, but interspecies comparison of lesion profiles should be interpreted with caution. It is of note that the same classical scrapie isolate induced TSE in C57Bl/6 mice with similar incubation periods and lesional profiles as a sample derived from a MM1 sCJD patient30.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">We are therefore confident that the illness in this cynomolgus macaque represents a true transmission of a sheep c-scrapie isolate directly to an old-world monkey, which taxonomically resides in the primate subdivision (parvorder of catarrhini) that includes humans. With an homology of its PrP protein with humans of 96.4%31, cynomolgus macaque constitutes a highly relevant model for assessing zoonotic risk of prion diseases. Since our initial aim was to show the absence of transmission of scrapie to macaques in the worst-case scenario, we obtained materials from a flock of naturally-infected sheep, affecting animals with different genotypes32. This c-scrapie isolate exhibited complete transmission in ARQ/ARQ sheep (332 ± 56 days) and Tg338 transgenic mice expressing ovine VRQ/VRQ prion protein (220 ± 5 days) (O. Andreoletti, personal communication). From the standpoint of zoonotic risk, it is important to note that sheep with c-scrapie (including the isolate used in our study) have demonstrable infectivity throughout their lymphoreticular system early in the incubation period of the disease (3 months-old for all the lymphoid organs, and as early as 2 months-old in gut-associated lymph nodes)33. In addition, scrapie infectivity has been identified in blood34, milk35 and skeletal muscle36 from asymptomatic but scrapie infected small ruminants which implies a potential dietary exposure for consumers.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Two earlier studies have reported the occurrence of clinical TSE in cynomolgus macaques after exposures to scrapie isolates. In the first study, the “Compton” scrapie isolate (derived from an English sheep) and serially propagated for 9 passages in goats did not transmit TSE in cynomolgus macaque, rhesus macaque or chimpanzee within 7 years following intracerebral challenge1; conversely, after 8 supplementary passages in conventional mice, this “Compton” isolate induced TSE in a cynomolgus macaque 5 years after intracerebral challenge, but rhesus macaques and chimpanzee remained asymptomatic 8.5 years post-exposure8. However, multiple successive passages that are classically used to select laboratory-adapted prion strains can significantly modify the initial properties of a scrapie isolate, thus questioning the relevance of zoonotic potential for the initial sheep-derived isolate. The same isolate had also induced disease into squirrel monkeys (new-world monkey)9. A second historical observation reported that a cynomolgus macaque developed TSE 6 years post-inoculation with brain homogenate from a scrapie-infected Suffolk ewe (derived from USA), whereas a rhesus macaque and a chimpanzee exposed to the same inoculum remained healthy 9 years post-exposure1. This inoculum also induced TSE in squirrel monkeys after 4 passages in mice. Other scrapie transmission attempts in macaque failed but had more shorter periods of observation in comparison to the current study. Further, it is possible that there are differences in the zoonotic potential of different scrapie strains.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">The most striking observation in our study is the extended incubation period of scrapie in the macaque model, which has several implications. Firstly, our observations constitute experimental evidence in favor of the zoonotic potential of c-scrapie, at least for this isolate that has been extensively studied32,33,34,35,36. The cross-species zoonotic ability of this isolate should be confirmed by performing duplicate intracerebral exposures and assessing the transmissibility by the oral route (a successful transmission of prion strains through the intracerebral route may not necessarily indicate the potential for oral transmission37). However, such confirmatory experiments may require more than one decade, which is hardly compatible with current general management and support of scientific projects; thus this study should be rather considered as a case report.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Secondly, transmission of c-BSE to primates occurred within 8 years post exposure for the lowest doses able to transmit the disease (the survival period after inoculation is inversely proportional to the initial amount of infectious inoculum). The occurrence of scrapie 10 years after exposure to a high dose (25 mg) of scrapie-infected sheep brain suggests that the macaque has a higher species barrier for sheep c-scrapie than c-BSE, although it is notable that previous studies based on in vitro conversion of PrP suggested that BSE and scrapie prions would have a similar conversion potential for human PrP38.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Thirdly, prion diseases typically have longer incubation periods after oral exposure than after intracerebral inoculations: since humans can develop Kuru 47 years after oral exposure39, an incubation time of several decades after oral exposure to scrapie would therefore be expected, leading the disease to occur in older adults, i.e. the peak age for cases considered to be sporadic disease, and making a distinction between scrapie-associated and truly sporadic disease extremely difficult to appreciate.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Fourthly, epidemiologic evidence is necessary to confirm the zoonotic potential of an animal disease suggested by experimental studies. A relatively short incubation period and a peculiar epidemiological situation (e.g., all the first vCJD cases occurring in the country with the most important ongoing c-BSE epizootic) led to a high degree of suspicion that c-BSE was the cause of vCJD. Sporadic CJD are considered spontaneous diseases with an almost stable and constant worldwide prevalence (0.5–2 cases per million inhabitants per year), and previous epidemiological studies were unable to draw a link between sCJD and classical scrapie6,7,40,41, even though external causes were hypothesized to explain the occurrence of some sCJD clusters42,43,44. However, extended incubation periods exceeding several decades would impair the predictive values of epidemiological surveillance for prion diseases, already weakened by a limited prevalence of prion diseases and the multiplicity of isolates gathered under the phenotypes of “scrapie” and “sporadic CJD”.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Fifthly, considering this 10 year-long incubation period, together with both laboratory and epidemiological evidence of decade or longer intervals between infection and clinical onset of disease, no premature conclusions should be drawn from negative transmission studies in cynomolgus macaques with less than a decade of observation, as in the aforementioned historical transmission studies of scrapie to primates1,8,9. Our observations and those of others45,46 to date are unable to provide definitive evidence regarding the zoonotic potential of CWD, atypical/Nor98 scrapie or H-type BSE. The extended incubation period of the scrapie-affected macaque in the current study also underscores the limitations of rodent models expressing human PrP for assessing the zoonotic potential of some prion diseases since their lifespan remains limited to approximately two years21,47,48. This point is illustrated by the fact that the recently reported transmission of scrapie to humanized mice was not associated with clinical signs for up to 750 days and occurred in an extreme minority of mice with only a marginal increase in attack rate upon second passage13. The low attack rate in these studies is certainly linked to the limited lifespan of mice compared to the very long periods of observation necessary to demonstrate the development of scrapie. Alternatively, one could estimate that a successful second passage is the result of strain adaptation to the species barrier, thus poorly relevant of the real zoonotic potential of the original scrapie isolate of sheep origin49. The development of scrapie in this primate after an incubation period compatible with its lifespan complements the study conducted in transgenic (humanized) mice; taken together these studies suggest that some isolates of sheep scrapie can promote misfolding of the human prion protein and that scrapie can develop within the lifespan of some primate species.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">In addition to previous studies on scrapie transmission to primate1,8,9 and the recently published study on transgenic humanized mice13, our results constitute new evidence for recommending that the potential risk of scrapie for human health should not be dismissed. Indeed, human PrP transgenic mice and primates are the most relevant models for investigating the human transmission barrier. To what extent such models are informative for measuring the zoonotic potential of an animal TSE under field exposure conditions is unknown. During the past decades, many protective measures have been successfully implemented to protect cattle from the spread of c-BSE, and some of these measures have been extended to sheep and goats to protect from scrapie according to the principle of precaution. Since cases of c-BSE have greatly reduced in number, those protective measures are currently being challenged and relaxed in the absence of other known zoonotic animal prion disease. We recommend that risk managers should be aware of the long term potential risk to human health of at least certain scrapie isolates, notably for lymphotropic strains like the classical scrapie strain used in the current study. Relatively high amounts of infectivity in peripheral lymphoid organs in animals infected with these strains could lead to contamination of food products produced for human consumption. Efforts should also be maintained to further assess the zoonotic potential of other animal prion strains in long-term studies, notably lymphotropic strains with high prevalence like CWD, which is spreading across North America, and atypical/Nor98 scrapie (Nor98)50 that was first detected in the past two decades and now represents approximately half of all reported cases of prion diseases in small ruminants worldwide, including territories previously considered as scrapie free... Even if the prevailing view is that sporadic CJD is due to the spontaneous formation of CJD prions, it remains possible that its apparent sporadic nature may, at least in part, result from our limited capacity to identify an environmental origin.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><a fg_scanned="1" href="https://www.nature.com/articles/srep11573" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">https://www.nature.com/articles/srep11573</a></div><div style="font-family: arial, helvetica; font-size: 12px;"><br clear="none" /></div><div><div style="font-family: arial, helvetica;"><div><span style="font-size: 13.3333px;">THURSDAY, OCTOBER 04, 2018 </span><br clear="none" /></div><div><span style="font-size: 13.3333px;"><br clear="none" /></span></div><div><span style="font-size: 13.3333px;">Cervid to human prion transmission 5R01NS088604-04 Update</span></div><div><span style="font-size: 13.3333px;"><br clear="none" /></span></div><div><span style="font-size: 13.3333px;"><a fg_scanned="1" href="http://grantome.com/grant/NIH/R01-NS088604-04" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://grantome.com/grant/NIH/R01-NS088604-04</a><br clear="none" /></span></div><div><span style="font-size: 13.3333px;"><br clear="none" /></span></div><div><span style="font-size: 13.3333px;"><a fg_scanned="1" href="http://chronic-wasting-disease.blogspot.com/2018/10/cervid-to-human-prion-transmission.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://chronic-wasting-disease.blogspot.com/2018/10/cervid-to-human-prion-transmission.html</a></span></div></div><div style="font-family: arial, helvetica;"><span style="font-size: 13.3333px;"><br clear="none" /></span></div><div style="font-family: arial, helvetica;"><span style="font-size: 13.3333px;">Saturday, December 15, 2018 </span></div><div style="font-family: arial, helvetica;"><span style="font-size: 13.3333px;"><br clear="none" /></span></div><div style="font-family: arial, helvetica;"><span style="font-size: 13.3333px;">***> ADRD Summit RFI Singeltary COMMENT SUBMISSION BSE, SCRAPIE, CWD, AND HUMAN TSE PRION DISEASE December 14, 2018</span></div><div style="font-family: arial, helvetica;"><span style="font-size: 13.3333px;"><br clear="none" /></span></div><div style="font-family: arial, helvetica;"><a fg_scanned="1" href="https://prionprp.blogspot.com/2018/12/adrd-summit-rfi-singeltary-comment.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">https://prionprp.blogspot.com/2018/12/adrd-summit-rfi-singeltary-comment.html</a><br clear="none" /></div><div style="font-family: arial, helvetica;"><br clear="none" /></div><div><span style="font-family: arial, helvetica; font-size: x-small;">SATURDAY, JANUARY 5, 2019 </span><div style="font-family: arial, helvetica;"><br clear="none" /></div><div style="font-family: arial, helvetica;">Low levels of classical BSE infectivity in rendered fat tissue </div><div style="font-family: arial, helvetica;"><br clear="none" /></div><div style="font-family: arial, helvetica;"><a fg_scanned="1" href="https://bovineprp.blogspot.com/2019/01/low-levels-of-classical-bse-infectivity.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">https://bovineprp.blogspot.com/2019/01/low-levels-of-classical-bse-infectivity.html</a> </div><div style="font-family: arial, helvetica;"><br clear="none" /></div><div style="font-family: arial, helvetica;">***> FRIDAY, DECEMBER 14, 2018 MAD COW USA FLASHBACK Texas Style</div><div style="font-family: arial, helvetica;"><br clear="none" /></div><div style="font-family: arial, helvetica;">FRIDAY DECEMBER 14, 2018 </div><div style="font-family: arial, helvetica;"><br clear="none" /></div><div style="font-family: arial, helvetica;"><a fg_scanned="1" href="https://madcowusda.blogspot.com/2018/12/mad-cow-usa-flashback-friday-december.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">https://madcowusda.blogspot.com/2018/12/mad-cow-usa-flashback-friday-december.html</a> </div><div style="font-family: arial, helvetica;"><br clear="none" /></div><div style="font-family: arial, helvetica;">THURSDAY, JANUARY 3, 2019 </div><div style="font-family: arial, helvetica;"><br clear="none" /></div><div style="font-family: arial, helvetica;">MAD COW USDA DISEASE BSE TSE Prion </div><div style="font-family: arial, helvetica;"><br clear="none" /></div><div style="font-family: arial, helvetica;"><a fg_scanned="1" href="https://madcowusda.blogspot.com/2019/01/mad-cow-usda-disease-bse-tse-prion.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">https://madcowusda.blogspot.com/2019/01/mad-cow-usda-disease-bse-tse-prion.html</a></div><div style="font-family: arial, helvetica;"><br clear="none" /></div><div style="font-family: arial, helvetica;">THURSDAY, OCTOBER 22, 2015 </div><div style="font-family: arial, helvetica;"><br clear="none" /></div><div style="font-family: arial, helvetica;">Former Ag Secretary Ann Veneman talks women in agriculture and we talk mad cow disease USDA and what really happened</div><div style="font-family: arial, helvetica;"><br clear="none" /></div><div style="font-family: arial, helvetica;">HOW TO COVER UP MAD COW DISEASE IN TEXAS</div><div style="font-family: arial, helvetica;"><br clear="none" /></div><div style="font-family: arial, helvetica;"><a fg_scanned="1" href="http://madcowusda.blogspot.com/2015/10/former-ag-secretary-ann-veneman-talks.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://madcowusda.blogspot.com/2015/10/former-ag-secretary-ann-veneman-talks.html</a> </div><div style="font-family: arial, helvetica;"><br clear="none" /></div><div style="font-family: arial, helvetica;"><a fg_scanned="1" href="http://madcowusda.blogspot.com/2012/06/johanns-introduces-legislation-banning.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://madcowusda.blogspot.com/2012/06/johanns-introduces-legislation-banning.html</a> </div><div style="font-family: arial, helvetica;"><br clear="none" /></div><div style="font-family: arial, helvetica;"><a fg_scanned="1" href="http://madcowusda.blogspot.com/2012_06_01_archive.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://madcowusda.blogspot.com/2012_06_01_archive.html</a></div><div style="font-family: arial, helvetica;"><br clear="none" /></div><div style="font-family: arial, helvetica;"><div style="font-family: arial; line-height: 1.22em;"><div style="line-height: 1.22em;"><div style="line-height: 1.22em;"><div style="font-family: Georgia; font-size: 13px; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">WEDNESDAY, AUGUST 29, 2018 </span></span></div><div style="font-family: Georgia; font-size: 13px; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></span></div><div style="font-family: Georgia; font-size: 13px; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">OIE Bovine spongiform encephalopathy, United States of America Information received on 29/08/2018 from Dr John Clifford, Official Delegate, Chief Trade Advisor, APHIS USDA</span></span></div><div style="font-family: Georgia; font-size: 13px; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></span></div><div style="font-family: Georgia; font-size: 13px; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">''The event is resolved. No more reports will be submitted.''</span></span></div><div style="font-family: Georgia; font-size: 13px; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></span></div><div style="font-family: Georgia; font-size: 13px; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">well, so much for those herd mates exposed to this atypical BSE cow, and all those trace in and trace outs.</span></span></div><div style="font-family: Georgia; font-size: 13px; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></span></div><div style="font-family: Georgia; font-size: 13px; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">The OIE, USDA, and the BSE MRR policy is a joke, a sad, very sad joke...</span></span></div><div style="font-family: Georgia; font-size: 13px; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></span></div><div style="font-family: Georgia; font-size: 13px; line-height: 1.22em;"><a fg_scanned="1" href="http://bovineprp.blogspot.com/2018/08/oie-bovine-spongiform-encephalopathy.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">http://bovineprp.blogspot.com/2018/08/oie-bovine-spongiform-encephalopathy.html</a></div></div></div></div><div style="font-family: Georgia; font-size: 13px; line-height: 1.22em;"><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><div style="font-family: arial; font-size: small; line-height: 1.22em;"><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;">Saturday, July 23, 2016</span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;"><br clear="none" /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;">BOVINE SPONGIFORM ENCEPHALOPATHY BSE TSE PRION SURVEILLANCE, TESTING, AND SRM REMOVAL UNITED STATE OF AMERICA UPDATE JULY 2016</span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;"><br clear="none" /></span></span></div><div style="line-height: 1.22em;"><a fg_scanned="1" href="http://bovineprp.blogspot.com/2016/07/bovine-spongiform-encephalopathy-bse.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://bovineprp.blogspot.com/2016/07/bovine-spongiform-encephalopathy-bse.html</a><br clear="none" /></div><div style="line-height: 1.22em;"><br clear="none" /></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;">Tuesday, July 26, 2016</span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;"><br clear="none" /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;">Atypical Bovine Spongiform Encephalopathy BSE TSE Prion UPDATE JULY 2016</span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;"><br clear="none" /></span></span></div><div style="line-height: 1.22em;"><a fg_scanned="1" href="http://bse-atypical.blogspot.com/2016/07/atypical-bovine-spongiform.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://bse-atypical.blogspot.com/2016/07/atypical-bovine-spongiform.html</a><br clear="none" /></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;"><br clear="none" /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;">Monday, June 20, 2016</span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;"><br clear="none" /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;">Specified Risk Materials SRMs BSE TSE Prion Program</span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;"><br clear="none" /></span></span></div><div style="line-height: 1.22em;"><a fg_scanned="1" href="http://specifiedriskmaterial.blogspot.com/2016/06/specified-risk-materials-srms-bse-tse.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://specifiedriskmaterial.blogspot.com/2016/06/specified-risk-materials-srms-bse-tse.html</a></div></div></div></div></div></div></div></div><div style="font-family: arial; font-size: small;"><br clear="none" /></div><div style="font-family: arial; font-size: small;"><span style="font-family: Georgia; font-size: 13px;">Wednesday, January 23, 2019 </span><br clear="none" /></div></div><div style="font-family: Georgia; font-size: 13px; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: Georgia; font-size: 13px; line-height: 1.22em;">CFIA SFCR Guidance on Specified risk material (SRM) came into force on January 15, 2019<br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: Georgia; font-size: 13px; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: Georgia; font-size: 13px; line-height: 1.22em;"><a fg_scanned="1" href="https://specifiedriskmaterial.blogspot.com/2019/01/cfia-sfcr-guidance-on-specified-risk.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">https://specifiedriskmaterial.blogspot.com/2019/01/cfia-sfcr-guidance-on-specified-risk.html</a></div><div style="font-family: Georgia; font-size: 13px; line-height: 1.22em;"><br /></div><div style="line-height: 1.22em;"><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;">CHRONIC WASTING DISEASE CONGRESS Serial No. 107-117 May 16, 2002</span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;"><br /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;">CHRONIC WASTING DISEASE</span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;"><br /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;">JOINT OVERSIGHT HEARING BEFORE THE SUBCOMMITTEE ON FORESTS AND FOREST HEALTH JOINT WITH THE SUBCOMMITTEE ON FISHERIES CONSERVATION, WILDLIFE AND OCEANS OF THE COMMITTEE ON RESOURCES U.S. HOUSE OF REPRESENTATIVES ONE HUNDRED SEVENTH CONGRESS SECOND SESSION</span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;"><br /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;">May 16, 2002</span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;"><br /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;">Serial No. 107-117</span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;"><br /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;">snip...</span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;"><br /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;">Mr. MCINNIS. Today, this joint Subcommittee hearing will explore an issue of immeasurable importance to the growing number of communities in wide-ranging parts of this country, the growing incidence of Chronic Wasting Disease in North America’s wild and captive deer and elk populations. In a matter of just a few months, this once parochial concern has grown into something much larger and much more insidious than anyone could have imagined or predicted. As each day passes, this problem grows in its size, scope, and consequence. One thing becomes clear. Chronic Wasting Disease is not a Colorado problem. It is a Wisconsin problem or a Nebraska or Wyoming problem. It is a national problem and anything short of a fully integrated, systematic national assault on this simply will not do, which is precisely why we brought our group together here today.</span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;"><br /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;">snip...</span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;"><br /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;">So this is a disease that is spreading throughout the continent and it is going to require a national response as well as the efforts that are currently taking place in States like Wisconsin, Colorado, Nebraska, Wyoming, the interest they now have down in Texas and some of the neighboring States that have large white-tailed deer population and also elk.</span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;"><br /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;">This is a huge issue for us, Mr. Chairman, in the State of Wisconsin. I want to commend Governor McCallum and your staff and the various agencies for the rapid response that you have shown, given the early detection of CWD after the last deer hunting season. The problem that we have, though, is just a lack of information, good science in regards to what is the best response, how dangerous is this disease. We cannot close the door, quite frankly, with the paucity of scientific research that is out there right now in regards to how the disease spreads, the exposure of other livestock herds—given the importance of our dairy industry in the State, that is a big issue—and also the human health effects.</span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;"><br /></span></span></div><div style="line-height: 1.22em;"><a href="https://www.govinfo.gov/content/pkg/CHRG-107hhrg79658/pdf/CHRG-107hhrg79658.pdf?fbclid=IwAR1-dMPpYLher4m8SyMICwoGXNyQcVjcinPvAw8CvIys1lEG7hxgzWplJlk" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://www.govinfo.gov/content/pkg/CHRG-107hhrg79658/pdf/CHRG-107hhrg79658.pdf?fbclid=IwAR1-dMPpYLher4m8SyMICwoGXNyQcVjcinPvAw8CvIys1lEG7hxgzWplJlk</a><br /></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;"><br /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;">WEDNESDAY, FEBRUARY 20, 2019 </span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;"><br /></span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;">CHRONIC WASTING DISEASE CONGRESS Serial No. 107-117 May 16, 2002 Updated 2019</span></span></div><div style="line-height: 1.22em;"><span style="font-family: Georgia;"><span style="font-size: 13px;"><br /></span></span></div><div style="line-height: 1.22em;"><a fg_scanned="1" href="https://chronic-wasting-disease.blogspot.com/2019/02/chronic-wasting-disease-congress-serial.html" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://chronic-wasting-disease.blogspot.com/2019/02/chronic-wasting-disease-congress-serial.html</a><br /></div><div style="line-height: 1.22em;"><br /></div><div style="line-height: 1.22em;"><div style="font-family: Helvetica, Arial, sans-serif;"><span style="font-family: arial; font-size: 10pt;">TEXAS BREEDER DEER ESCAPEE WITH CWD IN THE WILD, or so the genetics would show?</span></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div style="font-family: arial; font-size: small;"><br clear="none" /></div><span style="font-family: arial; font-size: small;">OH NO, please tell me i heard this wrong, a potential Texas captive escapee with cwd in the wild, in an area with positive captive cwd herd?</span><div style="font-family: arial; font-size: small;"><br clear="none" /></div><div style="font-family: arial; font-size: small;">apparently, no ID though. tell me it ain't so please...<br clear="none" /><div><div><br clear="none" /></div><div>23:00 minute mark</div><div><br clear="none" /></div><div>''Free Ranging Deer, Dr. Deyoung looked at Genetics of this free ranging deer and what he found was, that the genetics on this deer were more similar to captive deer, than the free ranging population, but he did not see a significant connection to any one captive facility that he analyzed, so we believe, Ahhhhhh, this animal had some captive ahhh, whatnot.''</div></div></div><div style="font-family: arial; font-size: small;"><br clear="none" /></div><div style="font-family: arial; font-size: small;"><a fg_scanned="1" href="https://youtu.be/aoPDeGL6mpQ?t=1384" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">https://youtu.be/aoPDeGL6mpQ?t=1384</a></div></div><div style="font-family: arial, helvetica; font-size: 10pt;"><br /></div><div style="font-family: arial, helvetica; font-size: 10pt;">Wyoming CWD Dr. Mary Wood</div><div style="font-family: arial, helvetica; font-size: 10pt;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 10pt;">''first step is admitting you have a problem''</div><div style="font-family: arial, helvetica; font-size: 10pt;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 10pt;">''Wyoming was behind the curve''</div><div style="font-family: arial, helvetica; font-size: 10pt;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 10pt;">wyoming has a problem...</div><div style="font-family: arial, helvetica; font-size: 10pt;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 10pt;"><a href="https://www.youtube.com/watch?v=y1bsK4Igt1o&index=10&list=PL7ZG8MkruQh3wI96XQ8_EymytO828rGxj" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">https://www.youtube.com/watch?v=y1bsK4Igt1o&index=10&list=PL7ZG8MkruQh3wI96XQ8_EymytO828rGxj</a></div><div style="font-family: arial, helvetica; font-size: 10pt;"><br /></div><div style="font-family: arial, helvetica; font-size: 10pt;"><div class="yiv1152037782_1mf yiv1152037782_1mj" style="direction: ltr; position: relative;"><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif; font-size: 13px; white-space: pre-wrap;">the other part, these tissues and things in the body then shed or secrete prions which then are the route to other animals into the environment, so in particular, the things, the secretions that are infectious are salvia, feces, blood and urine. so pretty much anything that comes out of a deer is going to be infectious and potential for transmitting disease. </span><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif; font-size: 13px; white-space: pre-wrap;"><br clear="none" /></span></div><div class="yiv1152037782_1mf yiv1152037782_1mj" style="direction: ltr; position: relative;"><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif;"><span style="font-size: 13px; white-space: pre-wrap;">
</span></span></div><div class="yiv1152037782_1mf yiv1152037782_1mj" style="direction: ltr; position: relative;"><a href="https://www.youtube.com/watch?v=bItnEElzuKo&index=6&list=PL7ZG8MkruQh3wI96XQ8_EymytO828rGxj" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; font-family: Helvetica, Arial, sans-serif; font-size: 13px; white-space: pre-wrap;" target="_blank">https://www.youtube.com/watch?v=bItnEElzuKo&index=6&list=PL7ZG8MkruQh3wI96XQ8_EymytO828rGxj</a><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif; font-size: 13px; white-space: pre-wrap;"> </span><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif; font-size: 13px; white-space: pre-wrap;"><br clear="none" /></span></div><div class="yiv1152037782_1mf yiv1152037782_1mj" style="direction: ltr; position: relative;"><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif;"><span style="font-size: 13px; white-space: pre-wrap;">
</span></span></div><div class="yiv1152037782_1mf yiv1152037782_1mj" style="direction: ltr; position: relative;"><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif; font-size: 13px; white-space: pre-wrap;">Texas Chronic Wasting Disease CWD TSE Prion Symposium 2018 posted January 2019 VIDEO SET 18 CLIPS See Wisconsin update...terrible news, right after Texas updated map around 5 minute mark... </span><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif; font-size: 13px; white-space: pre-wrap;"><br clear="none" /></span></div><div class="yiv1152037782_1mf yiv1152037782_1mj" style="direction: ltr; position: relative;"><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif;"><span style="font-size: 13px; white-space: pre-wrap;">
</span></span></div><div class="yiv1152037782_1mf yiv1152037782_1mj" style="direction: ltr; position: relative;"><a href="https://www.youtube.com/watch?v=JAK_YBZh2tA&feature=youtu.be&list=PL7ZG8MkruQh3wI96XQ8_EymytO828rGxj&t=299" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; font-family: Helvetica, Arial, sans-serif; font-size: 13px; white-space: pre-wrap;" target="_blank">https://www.youtube.com/watch?v=JAK_YBZh2tA&feature=youtu.be&list=PL7ZG8MkruQh3wI96XQ8_EymytO828rGxj&t=299</a><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif; font-size: 13px; white-space: pre-wrap;"> </span><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif; font-size: 13px; white-space: pre-wrap;"><br clear="none" /></span></div><div class="yiv1152037782_1mf yiv1152037782_1mj" style="direction: ltr; position: relative;"><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif;"><span style="font-size: 13px; white-space: pre-wrap;">
</span></span></div><div class="yiv1152037782_1mf yiv1152037782_1mj" style="direction: ltr; position: relative;"><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif; font-size: 13px; white-space: pre-wrap;">WISCONSIN CWD CAPTIVE CWD UPDATE VIDEO </span><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif; font-size: 13px; white-space: pre-wrap;"><br clear="none" /></span></div><div class="yiv1152037782_1mf yiv1152037782_1mj" style="direction: ltr; position: relative;"><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif;"><span style="font-size: 13px; white-space: pre-wrap;">
</span></span></div><div class="yiv1152037782_1mf yiv1152037782_1mj" style="direction: ltr; position: relative;"><a href="https://www.youtube.com/watch?v=JAK_YBZh2tA&feature=youtu.be&t=602&fbclid=IwAR04yvki5GDJqjAeNOeP3QETcUOmWHRNRrGXzRUTnsxvcLUO50kSDsBzHTs" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; font-family: Helvetica, Arial, sans-serif; font-size: 13px; white-space: pre-wrap;" target="_blank">https://www.youtube.com/watch?v=JAK_YBZh2tA&feature=youtu.be&t=602&fbclid=IwAR04yvki5GDJqjAeNOeP3QETcUOmWHRNRrGXzRUTnsxvcLUO50kSDsBzHTs</a><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif; font-size: 13px; white-space: pre-wrap;"> </span><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif; font-size: 13px; white-space: pre-wrap;"><br clear="none" /></span></div><div class="yiv1152037782_1mf yiv1152037782_1mj" style="direction: ltr; position: relative;"><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif;"><span style="font-size: 13px; white-space: pre-wrap;">
</span></span></div><div class="yiv1152037782_1mf yiv1152037782_1mj" style="direction: ltr; position: relative;"><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif; font-size: 13px; white-space: pre-wrap;">cwd update on Wisconsin from Tammy Ryan... </span><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif; font-size: 13px; white-space: pre-wrap;"><br clear="none" /></span></div><div class="yiv1152037782_1mf yiv1152037782_1mj" style="direction: ltr; position: relative;"><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif;"><span style="font-size: 13px; white-space: pre-wrap;">
</span></span></div><div class="yiv1152037782_1mf yiv1152037782_1mj" style="direction: ltr; position: relative;"><a href="https://www.youtube.com/watch?v=hvy2SMGQt6o&index=11&list=PL7ZG8MkruQh3wI96XQ8_EymytO828rGxj" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; font-family: Helvetica, Arial, sans-serif; font-size: 13px; white-space: pre-wrap;" target="_blank">https://www.youtube.com/watch?v=hvy2SMGQt6o&index=11&list=PL7ZG8MkruQh3wI96XQ8_EymytO828rGxj</a><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif; font-size: 13px; white-space: pre-wrap;"> </span><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif; font-size: 13px; white-space: pre-wrap;"><br clear="none" /></span></div><div class="yiv1152037782_1mf yiv1152037782_1mj" style="direction: ltr; position: relative;"><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif;"><span style="font-size: 13px; white-space: pre-wrap;">
</span></span></div><div class="yiv1152037782_1mf yiv1152037782_1mj" style="direction: ltr; position: relative;"><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif; font-size: 13px; white-space: pre-wrap;">Wyoming CWD Dr. Mary Wood ''first step is admitting you have a problem'' ''Wyoming was behind the curve'' wyoming has a problem... </span><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif; font-size: 13px; white-space: pre-wrap;"><br clear="none" /></span></div><div class="yiv1152037782_1mf yiv1152037782_1mj" style="direction: ltr; position: relative;"><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif;"><span style="font-size: 13px; white-space: pre-wrap;">
</span></span></div><div class="yiv1152037782_1mf yiv1152037782_1mj" style="direction: ltr; position: relative;"><a href="https://www.youtube.com/watch?v=y1bsK4Igt1o&index=10&list=PL7ZG8MkruQh3wI96XQ8_EymytO828rGxj" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; font-family: Helvetica, Arial, sans-serif; font-size: 13px; white-space: pre-wrap;" target="_blank">https://www.youtube.com/watch?v=y1bsK4Igt1o&index=10&list=PL7ZG8MkruQh3wI96XQ8_EymytO828rGxj</a><span style="color: #1c1e21; font-family: Helvetica, Arial, sans-serif; font-size: 13px; white-space: pre-wrap;"> </span></div></div><div style="font-family: Helvetica, Arial, sans-serif;"><br /></div><div style="font-family: Helvetica, Arial, sans-serif;">SATURDAY, JANUARY 19, 2019 </div><div style="font-family: Helvetica, Arial, sans-serif;"><br /></div><div style="font-family: Helvetica, Arial, sans-serif;">Texas Chronic Wasting Disease CWD TSE Prion Symposium 2018 posted January 2019 VIDEO SET 18 CLIPS </div><div style="font-family: Helvetica, Arial, sans-serif;"><br /></div><div style="font-family: Helvetica, Arial, sans-serif;"><span style="color: black;"><a fg_scanned="1" href="https://chronic-wasting-disease.blogspot.com/2019/01/texas-chronic-wasting-disease-cwd-tse.html" rel="nofollow noopener noreferrer" style="color: blue;" target="_blank">https://chronic-wasting-disease.blogspot.com/2019/01/texas-chronic-wasting-disease-cwd-tse.html</a><br /></span></div><div style="font-family: Helvetica, Arial, sans-serif;"><br /></div><div style="font-family: Helvetica, Arial, sans-serif;">TUESDAY, JANUARY 29, 2019 </div><div style="font-family: Helvetica, Arial, sans-serif;"><br /></div><div style="font-family: Helvetica, Arial, sans-serif;">TEXAS REPORTS 2 MORE CWD TSE PRION ALL WILD CERVID TOTAL TO DATE 141 </div><div style="font-family: Helvetica, Arial, sans-serif;"><br /></div><div style="font-family: Helvetica, Arial, sans-serif;"><span style="color: black;"><a fg_scanned="1" href="https://tpwd.texas.gov/huntwild/wild/diseases/cwd/tracking/" rel="nofollow noopener noreferrer" style="color: blue;" target="_blank">https://tpwd.texas.gov/huntwild/wild/diseases/cwd/tracking/</a> </span></div><div style="font-family: Helvetica, Arial, sans-serif;"><br /></div><div style="font-family: Helvetica, Arial, sans-serif;"><span style="color: black;"><a fg_scanned="1" href="https://chronic-wasting-disease.blogspot.com/2019/01/texas-reports-2-more-cwd-tse-prion-all.html" rel="nofollow noopener noreferrer" style="color: blue;" target="_blank">https://chronic-wasting-disease.blogspot.com/2019/01/texas-reports-2-more-cwd-tse-prion-all.html</a></span></div><div style="font-family: Helvetica, Arial, sans-serif;"><br /></div><div style="font-family: Helvetica, Arial, sans-serif;">CWD TSE PRION ZOONOSIS</div></div><div style="line-height: 1.22em;"><br /></div><div style="line-height: 1.22em;"><div id="yiv1152037782" style="font-family: arial, helvetica;"><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">Chronic Wasting Disease CWD TSE Prion aka mad deer disease zoonosis</span></div><div id="yiv1152037782" style="font-family: arial, helvetica;"><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;"><br /></span></div><div id="yiv1152037782" style="font-family: arial, helvetica;"><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">We hypothesize that: </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">(1) The classic CWD prion strain can infect humans at low levels in the brain and peripheral lymphoid tissues; </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">(2) The cervid-to-human transmission barrier is dependent on the cervid prion strain and influenced by the host (human) prion protein (PrP) primary sequence; </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">(3) Reliable essays can be established to detect CWD infection in humans; and </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">(4) CWD transmission to humans has already occurred. We will test these hypotheses in 4 Aims using transgenic (Tg) mouse models and complementary in vitro approaches. </span></div><div id="yiv1152037782" style="font-family: arial, helvetica;"><br /></div><div id="yiv1152037782" style="font-family: arial, helvetica;"><a fg_scanned="1" href="http://grantome.com/grant/NIH/R01-NS088604-04" rel="nofollow noopener noreferrer" style="color: blue;" target="_blank">http://grantome.com/grant/NIH/R01-NS088604-04</a></div><div id="yiv1152037782"><br clear="none" style="background-color: #fcfce5;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">ZOONOTIC CHRONIC WASTING DISEASE CWD TSE PRION UPDATE</span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">here is the latest;</span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">PRION 2018 CONFERENCE </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">Oral transmission of CWD into Cynomolgus macaques: signs of atypical disease, prion conversion and infectivity in macaques and bio-assayed transgenic mice </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">Hermann M. Schatzl, Samia Hannaoui, Yo-Ching Cheng, Sabine Gilch (Calgary Prion Research Unit, University of Calgary, Calgary, Canada) Michael Beekes (RKI Berlin), Walter Schulz-Schaeffer (University of Homburg/Saar, Germany), Christiane Stahl-Hennig (German Primate Center) & Stefanie Czub (CFIA Lethbridge). </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">To date, BSE is the only example of interspecies transmission of an animal prion disease into humans. The potential zoonotic transmission of CWD is an alarming issue and was addressed by many groups using a variety of in vitro and in vivo experimental systems. Evidence from these studies indicated a substantial, if not absolute, species barrier, aligning with the absence of epidemiological evidence suggesting transmission into humans. Studies in non-human primates were not conclusive so far, with oral transmission into new-world monkeys and no transmission into old-world monkeys. Our consortium has challenged 18 Cynomolgus macaques with characterized CWD material, focusing on oral transmission with muscle tissue. Some macaques have orally received a total of 5 kg of muscle material over a period of 2 years. </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">After 5-7 years of incubation time some animals showed clinical symptoms indicative of prion disease, and prion neuropathology and PrPSc deposition were detected in spinal cord and brain of some euthanized animals. PrPSc in immunoblot was weakly detected in some spinal cord materials and various tissues tested positive in RT-QuIC, including lymph node and spleen homogenates. To prove prion infectivity in the macaque tissues, we have intracerebrally inoculated 2 lines of transgenic mice, expressing either elk or human PrP. At least 3 TgElk mice, receiving tissues from 2 different macaques, showed clinical signs of a progressive prion disease and brains were positive in immunoblot and RT-QuIC. Tissues (brain, spinal cord and spleen) from these and pre-clinical mice are currently tested using various read-outs and by second passage in mice. Transgenic mice expressing human PrP were so far negative for clear clinical prion disease (some mice >300 days p.i.). In parallel, the same macaque materials are inoculated into bank voles. </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">Taken together, there is strong evidence of transmissibility of CWD orally into macaques and from macaque tissues into transgenic mouse models, although with an incomplete attack rate. </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">The clinical and pathological presentation in macaques was mostly atypical, with a strong emphasis on spinal cord pathology. </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">Our ongoing studies will show whether the transmission of CWD into macaques and passage in transgenic mice represents a form of non-adaptive prion amplification, and whether macaque-adapted prions have the potential to infect mice expressing human PrP. </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">The notion that CWD can be transmitted orally into both new-world and old-world non-human primates asks for a careful reevaluation of the zoonotic risk of CWD.. </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">***> The notion that CWD can be transmitted orally into both new-world and old-world non-human primates asks for a careful reevaluation of the zoonotic risk of CWD. <*** </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><a class="yiv1152037782externalLink" fg_scanned="1" href="https://prion2018.org/" rel="nofollow noopener noreferrer" shape="rect" style="background-color: #fcfce5; border-radius: 5px; color: #0429e4; font-family: Georgia, serif; font-size: 14.6667px; margin: 0px; padding: 0px 3px;" target="_blank">https://prion2018.org/</a><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">READING OVER THE PRION 2018 ABSTRACT BOOK, LOOKS LIKE THEY FOUND THAT from this study ; </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">P190 Human prion disease mortality rates by occurrence of chronic wasting disease in freeranging cervids, United States </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">Abrams JY (1), Maddox RA (1), Schonberger LB (1), Person MK (1), Appleby BS (2), Belay ED (1) (1) Centers for Disease Control and Prevention (CDC), National Center for Emerging and Zoonotic Infectious Diseases, Atlanta, GA, USA (2) Case Western Reserve University, National Prion Disease Pathology Surveillance Center (NPDPSC), Cleveland, OH, USA.. </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">SEEMS THAT THEY FOUND Highly endemic states had a higher rate of prion disease mortality compared to non-CWD </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">states. </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">AND ANOTHER STUDY; </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">P172 Peripheral Neuropathy in Patients with Prion Disease </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">Wang H(1), Cohen M(1), Appleby BS(1,2) (1) University Hospitals Cleveland Medical Center, Cleveland, Ohio (2) National Prion Disease Pathology Surveillance Center, Cleveland, Ohio.. </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">IN THIS STUDY, THERE WERE autopsy-proven prion cases from the National Prion Disease Pathology Surveillance Center that were diagnosed between September 2016 to March 2017, </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">AND </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">included 104 patients. SEEMS THEY FOUND THAT The most common sCJD subtype was MV1-2 (30%), followed by MM1-2 (20%), </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">AND </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">THAT The Majority of cases were male (60%), AND half of them had exposure to wild game. </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">snip...</span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">see more on Prion 2017 Macaque study from Prion 2017 Conference and other updated science on cwd tse prion zoonosis below...terry </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><a class="yiv1152037782externalLink" href="https://prion2018.org/wp-content/uploads/2018/05/program.pdf" rel="nofollow noopener noreferrer" shape="rect" style="background-color: #fcfce5; border-radius: 5px; color: #0429e4; font-family: Georgia, serif; font-size: 14.6667px; margin: 0px; padding: 0px 3px;" target="_blank">https://prion2018.org/wp-content/uploads/2018/05/program.pdf</a><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;"> </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><a class="yiv1152037782externalLink" fg_scanned="1" href="https://prion2018.org/" rel="nofollow noopener noreferrer" shape="rect" style="background-color: #fcfce5; border-radius: 5px; color: #0429e4; font-family: Georgia, serif; font-size: 14.6667px; margin: 0px; padding: 0px 3px;" target="_blank">https://prion2018.org/</a><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">THURSDAY, OCTOBER 04, 2018 </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;">Cervid to human prion transmission 5R01NS088604-04 Update </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><a class="yiv1152037782externalLink" fg_scanned="1" href="http://grantome.com/grant/NIH/R01-NS088604-04" rel="nofollow noopener noreferrer" shape="rect" style="background-color: #fcfce5; border-radius: 5px; color: #0429e4; font-family: Georgia, serif; font-size: 14.6667px; margin: 0px; padding: 0px 3px;" target="_blank">http://grantome.com/grant/NIH/R01-NS088604-04</a><span style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;"> </span><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><a class="yiv1152037782externalLink" fg_scanned="1" href="http://chronic-wasting-disease.blogspot.com/2018/10/cervid-to-human-prion-transmission.html" rel="nofollow noopener noreferrer" shape="rect" style="background-color: #fcfce5; border-radius: 5px; color: #0429e4; font-family: Georgia, serif; font-size: 14.6667px; margin: 0px; padding: 0px 3px;" target="_blank">http://chronic-wasting-disease.blogspot.com/2018/10/cervid-to-human-prion-transmission.html</a><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" /><br clear="none" style="background-color: #fcfce5; color: #141414; font-family: Georgia, serif; font-size: 14.6667px;" />snip...full text;<div style="font-family: arial, helvetica;"><br clear="none" /></div><div><span style="font-family: arial, helvetica; font-size: x-small;">SATURDAY, FEBRUARY 09, 2019 </span><div style="font-family: arial, helvetica;"><br clear="none" /></div><div style="font-family: arial, helvetica;">Experts: Yes, chronic wasting disease in deer is a public health issue — for people</div><div style="font-family: arial, helvetica;"><br clear="none" /></div><div style="font-family: arial, helvetica;"><a fg_scanned="1" href="https://chronic-wasting-disease.blogspot.com/2019/02/experts-yes-chronic-wasting-disease-in.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">https://chronic-wasting-disease.blogspot.com/2019/02/experts-yes-chronic-wasting-disease-in.html</a><br clear="none" /></div><div style="font-family: arial, helvetica;"><br /></div><div style="font-family: arial, helvetica;"><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">Molecular Barriers to Zoonotic Transmission of Prions </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">Marcelo A. Barria, Aru Balachandran, Masanori Morita, Tetsuyuki Kitamoto, Rona Barron, Jean Manson, Richard Knight, James W. Ironside, and Mark W. Headcorresponding author </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">snip... </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">The conversion of human PrPC by CWD brain homogenate in PMCA reactions was less efficient when the amino acid at position 129 was valine rather than methionine. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">***Furthermore, the form of human PrPres produced in this in vitro assay when seeded with CWD, resembles that found in the most common human prion disease, namely sCJD of the MM1 subtype. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">snip... </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">However, we can say with confidence that under the conditions used here, none of the animal isolates tested were as efficient as C-type BSE in converting human PrPC, which is reassuring. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">***Less reassuring is the finding that there is no absolute barrier to the conversion of human PrPC by CWD prions in a protocol using a single round of PMCA and an entirely human substrate prepared from the target organ of prion diseases, the brain. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><a fg_scanned="1" href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3884726/" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3884726/</a> </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">Prion 2017 Conference Abstracts </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">CWD 2017 PRION CONFERENCE </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">First evidence of intracranial and peroral transmission of Chronic Wasting Disease (CWD) into Cynomolgus macaques: a work in progress</span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">Stefanie Czub1, Walter Schulz-Schaeffer2, Christiane Stahl-Hennig3, Michael Beekes4, Hermann Schaetzl5 and Dirk Motzkus6 1 University of Calgary Faculty of Veterinary Medicine/Canadian Food Inspection Agency; 2Universitatsklinikum des Saarlandes und Medizinische Fakultat der Universitat des Saarlandes; 3 Deutsches Primaten Zentrum/Goettingen; 4 Robert-Koch-Institut Berlin; 5 University of Calgary Faculty of Veterinary Medicine; 6 presently: Boehringer Ingelheim Veterinary Research Center; previously: Deutsches Primaten Zentrum/Goettingen </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">This is a progress report of a project which started in 2009. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">21 cynomolgus macaques were challenged with characterized CWD material from white-tailed deer (WTD) or elk by intracerebral (ic), oral, and skin exposure routes. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">Additional blood transfusion experiments are supposed to assess the CWD contamination risk of human blood product. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">C</span>hallenge materials originated from symptomatic cervids for ic, skin scarification and partially per oral routes (WTD brain). </div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">Challenge material for feeding of muscle derived from preclinical WTD and from preclinical macaques for blood transfusion experiments. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">We have confirmed that the CWD challenge material contained at least two different CWD agents (brain material) as well as CWD prions in muscle-associated nerves. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">Here we present first data on a group of animals either challenged ic with steel wires or per orally and sacrificed with incubation times ranging from 4.5 to 6.9 years at postmortem. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">Three animals displayed signs of mild clinical disease, including anxiety, apathy, ataxia and/or tremor. In four animals wasting was observed, two of those had confirmed diabetes. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">All animals have variable signs of prion neuropathology in spinal cords and brains and by supersensitive IHC, reaction was detected in spinal cord segments of all animals. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">Protein misfolding cyclic amplification (PMCA), real-time quaking-induced conversion (RT-QuiC) and PET-blot assays to further substantiate these findings are on the way, as well as bioassays in bank voles and transgenic mice. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">At present, a total of 10 animals are sacrificed and read-outs are ongoing. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">Preclinical incubation of the remaining macaques covers a range from 6.4 to 7.10 years. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">Based on the species barrier and an incubation time of > 5 years for BSE in macaques and about 10 years for scrapie in macaques, we expected an onset of clinical disease beyond 6 years post inoculation. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">PRION 2017 </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">DECIPHERING NEURODEGENERATIVE DISORDERS </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">Subject: PRION 2017 CONFERENCE </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">DECIPHERING NEURODEGENERATIVE DISORDERS </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">VIDEO PRION 2017 CONFERENCE DECIPHERING NEURODEGENERATIVE DISORDERS </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">*** PRION 2017 CONFERENCE VIDEO </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><a href="https://www.youtube.com/embed/Vtt1kAVDhDQ%20http://prion2017.org/programme/" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">https://www.youtube.com/embed/Vtt1kAVDhDQ http://prion2017.org/programme/</a> </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><a href="https://www.cste2.org/Webinars/files/CWD_Slides_FINAL.pdf" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">https://www.cste2.org/Webinars/files/CWD_Slides_FINAL.pdf</a><br clear="none" /></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">ZOONOTIC, ZOONOSIS, CHRONIC WASTING DISEASE CWD TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY TSE PRION </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">10. ZOONOTIC, ZOONOSIS, CHRONIC WASTING DISEASE CWD TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY TSE PRION AKA MAD DEER ELK DISEASE IN HUMANS, has it already happened, that should be the question... </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">''In particular the US data do not clearly exclude the possibility of human (sporadic or familial) TSE development due to consumption of venison. The Working Group thus recognizes a potential risk to consumers if a TSE would be present in European cervids.'' Scientific opinion on chronic wasting disease (II)</span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">EFSA Panel on Biological Hazards (BIOHAZ) Antonia Ricci Ana Allende Declan Bolton Marianne Chemaly Robert Davies Pablo Salvador Fernández Escámez ... See all authors </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">First published: 17 January 2018 <a fg_scanned="1" href="https://doi.org/10.2903/j.efsa.2018.5132" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">https://doi.org/10.2903/j.efsa.2018.5132</a> ; </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">also, see; </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">8. Even though human TSE‐exposure risk through consumption of game from European cervids can be assumed to be minor, if at all existing, no final conclusion can be drawn due to the overall lack of scientific data. In particular the US data do not clearly exclude the possibility of human (sporadic or familial) TSE development due to consumption of venison. The Working Group thus recognizes a potential risk to consumers if a TSE would be present in European cervids. It might be prudent considering appropriate measures to reduce such a risk, e.g. excluding tissues such as CNS and lymphoid tissues from the human food chain, which would greatly reduce any potential risk for consumers.. However, it is stressed that currently, no data regarding a risk of TSE infections from cervid products are available. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">snip... </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">The tissue distribution of infectivity in CWD‐infected cervids is now known to extend beyond CNS and lymphoid tissues. While the removal of these specific tissues from the food chain would reduce human dietary exposure to infectivity, exclusion from the food chain of the whole carcass of any infected animal would be required to eliminate human dietary exposure. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><a fg_scanned="1" href="https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2018.5132" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2018.5132</a> </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">zoonosis zoonotic cervid tse prion cwd to humans, preparing for the storm </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">***An alternative to modeling the species barrier is the cell-free conversion assay which points to CWD as the animal prion disease with the greatest zoonotic potential, after (and very much less than) BSE..116*** </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><a fg_scanned="1" href="https://www.tandfonline.com/doi/pdf/10.4161/pri.29237" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">https://www.tandfonline.com/doi/pdf/10.4161/pri.29237</a><br clear="none" /></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"> To date there is no direct evidence that CWD has been or can be transmitted from animals to humans. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">However, initial findings from a laboratory research project funded by the Alberta Prion Research Institute (APRI) and Alberta Livestock Meat Agency (ALMA), and led by a Canadian Food Inspection Agency (CFIA) scientist indicate that CWD has been transmitted to cynomolgus macaques (the non-human primate species most closely related to humans that may be used in research), through both the intracranial and oral routes of exposure. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">Both infected brain and muscle tissues were found to transmit disease. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">Health Canada’s Health Products and Food Branch (HPFB) was asked to consider the impact of these findings on the Branch’s current position on CWD in health products and foods. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">Summary and Recommendation: </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">snip...</span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">Health Portfolio partners were recently made aware of initial findings from a research project led by a CFIA scientist that have demonstrated that cynomolgus macaques can be infected via intracranial exposure and oral gavage with CWD infected muscle. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">These findings suggest that CWD, under specific experimental conditions, has the potential to cross the human species barrier, including by enteral feeding of CWD infected muscle. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><a href="https://www.thetyee.ca/Documents/2017/06/24/Risk-Advisory-Opinion-CWD-2017.pdf" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">https://www.thetyee.ca/Documents/2017/06/24/Risk-Advisory-Opinion-CWD-2017.pdf</a> </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">*** WDA 2016 NEW YORK *** </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">We found that CWD adapts to a new host more readily than BSE and that human PrP was unexpectedly prone to misfolding by CWD prions. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">In addition, we investigated the role of specific regions of the bovine, deer and human PrP protein in resistance to conversion by prions from another species. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">***We have concluded that the human protein has a region that confers unusual susceptibility to conversion by CWD prions. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">Student Presentations Session 2 </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">The species barriers and public health threat of CWD and BSE prions </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">Ms. Kristen Davenport1, Dr. Davin Henderson1, Dr. Candace Mathiason1, Dr. Edward Hoover1 1Colorado State University </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">Chronic wasting disease (CWD) is spreading rapidly through cervid populations in the USA. Bovine spongiform encephalopathy (BSE, mad cow disease) arose in the 1980s because cattle were fed recycled animal protein. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">These and other prion diseases are caused by abnormal folding of the normal prion protein (PrP) into a disease causing form (PrPd), which is pathogenic to nervous system cells and can cause subsequent PrP to misfold. CWD spreads among cervids very efficiently, but it has not yet infected humans. On the other hand, BSE was spread only when cattle consumed infected bovine or ovine tissue, but did infect humans and other species. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">The objective of this research is to understand the role of PrP structure in cross-species infection by CWD and BSE. To study the propensity of each species’ PrP to be induced to misfold by the presence of PrPd from verious species, we have used an in vitro system that permits detection of PrPd in real-time. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">We measured the conversion efficiency of various combinations of PrPd seeds and PrP substrate combinations. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">We observed the cross-species behavior of CWD and BSE, in addition to feline-adapted CWD and BSE. We found that CWD adapts to a new host more readily than BSE and that human PrP was unexpectedly prone to misfolding by CWD prions. In addition, we investigated the role of specific regions of the bovine, deer and human PrP protein in resistance to conversion by prions from another species. </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;">***We have concluded that the human protein has a region that confers unusual susceptibility to conversion by CWD prions. CWD is unique among prion diseases in its rapid spread in natural populations. BSE prions are essentially unaltered upon passage to a new species, while CWD adapts to the new species. This adaptation has consequences for surveillance of humans exposed to CWD. Wildlife Disease Risk Communication Research Contributes to Wildlife Trust Administration Exploring perceptions about chronic wasting disease risks among wildlife and agriculture professionals and stakeholders </span></div><div style="font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-size: 12px;"><a fg_scanned="1" href="http://programme.exordo.com/wda2016/delegates/presentation/157/" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://programme.exordo.com/wda2016/delegates/presentation/157/</a></div></div><div style="font-family: arial, helvetica;"><br /></div><div><div style="font-family: arial, helvetica; font-size: 10pt;">***> This is very likely to have parallels with control efforts for CWD in cervids.</div><div style="font-family: arial, helvetica; font-size: 10pt;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 10pt;">Rapid recontamination of a farm building occurs after attempted prion removal</div><div style="font-family: arial, helvetica; font-size: 10pt;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 10pt;"><a fg_scanned="1" href="http://dx.doi.org/10.1136/vr.105054" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://dx.doi.org/10.1136/vr.105054</a><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 10pt;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 10pt;">Kevin Christopher Gough, BSc (Hons), PhD1, Claire Alison Baker, BSc (Hons)2, Steve Hawkins, MIBiol3, Hugh Simmons, BVSc, MRCVS, MBA, MA3, Timm Konold, DrMedVet, PhD, MRCVS3 and Ben Charles Maddison, BSc (Hons), PhD2</div><div style="font-family: arial, helvetica; font-size: 10pt;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 10pt;">Abstract</div><div style="font-family: arial, helvetica; font-size: 10pt;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 10pt;">The transmissible spongiform encephalopathy scrapie of sheep/goats and chronic wasting disease of cervids are associated with environmental reservoirs of infectivity. </div><div style="font-family: arial, helvetica; font-size: 10pt;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 10pt;">Preventing environmental prions acting as a source of infectivity to healthy animals is of major concern to farms that have had outbreaks of scrapie and also to the health management of wild and farmed cervids. </div><div style="font-family: arial, helvetica; font-size: 10pt;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 10pt;">Here, an efficient scrapie decontamination protocol was applied to a farm with high levels of environmental contamination with the scrapie agent. </div><div style="font-family: arial, helvetica; font-size: 10pt;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 10pt;">Post-decontamination, no prion material was detected within samples taken from the farm buildings as determined using a sensitive in vitro replication assay (sPMCA). </div><div style="font-family: arial, helvetica; font-size: 10pt;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 10pt;">A bioassay consisting of 25 newborn lambs of highly susceptible prion protein genotype VRQ/VRQ introduced into this decontaminated barn was carried out in addition to sampling and analysis of dust samples that were collected during the bioassay. </div><div style="font-family: arial, helvetica; font-size: 10pt;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 10pt;">Twenty-four of the animals examined by immunohistochemical analysis of lymphatic tissues were scrapie-positive during the bioassay, samples of dust collected within the barn were positive by month 3. </div><div style="font-family: arial, helvetica; font-size: 10pt;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 10pt;">The data illustrates the difficulty in decontaminating farm buildings from scrapie, and demonstrates the likely contribution of farm dust to the recontamination of these environments to levels that are capable of causing disease.</div><div style="font-family: arial, helvetica; font-size: 10pt;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 10pt;">snip...</div><div style="font-family: arial, helvetica; font-size: 10pt;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 10pt;">As in the authors' previous study,12 the decontamination of this sheep barn was not effective at removing scrapie infectivity, and despite the extra measures brought into this study (more effective chemical treatment and removal of sources of dust) the overall rates of disease transmission mirror previous results on this farm. With such apparently effective decontamination (assuming that at least some sPMCA seeding ability is coincident with infectivity), how was infectivity able to persist within the environment and where does infectivity reside? Dust samples were collected in both the bioassay barn and also a barn subject to the same decontamination regime within the same farm (but remaining unoccupied). Within both of these barns dust had accumulated for three months that was able to seed sPMCA, indicating the accumulation of scrapie-containing material that was independent of the presence of sheep that may have been incubating and possibly shedding low amounts of infectivity.</div><div style="font-family: arial, helvetica; font-size: 10pt;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 10pt;">This study clearly demonstrates the difficulty in removing scrapie infectivity from the farm environment. Practical and effective prion decontamination methods are still urgently required for decontamination of scrapie infectivity from farms that have had cases of scrapie and this is particularly relevant for scrapiepositive goatherds, which currently have limited genetic resistance to scrapie within commercial breeds.24 This is very likely to have parallels with control efforts for CWD in cervids.</div><div style="font-family: arial, helvetica; font-size: 10pt;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 10pt;">Acknowledgements The authors thank the APHA farm staff, Tony Duarte, Olly Roberts and Margaret Newlands for preparation of the sheep pens and animal husbandry during the study. The authors also thank the APHA pathology team for RAMALT and postmortem examination.</div><div style="font-family: arial, helvetica; font-size: 10pt;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 10pt;">Funding This study was funded by DEFRA within project SE1865. </div><div style="font-family: arial, helvetica; font-size: 10pt;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 10pt;">Competing interests None declared. </div><div style="font-family: arial, helvetica; font-size: 10pt;"><br /></div><div style="font-family: arial, helvetica; font-size: 10pt;"><br /></div><div style="font-family: arial, helvetica; font-size: 10pt;"><a href="https://bvajournals.onlinelibrary.wiley.com/doi/abs/10.1136/vr.105054">https://bvajournals.onlinelibrary.wiley.com/doi/abs/10.1136/vr.105054</a><br /></div><div style="font-family: arial, helvetica; font-size: 10pt;"><br /></div><div style="font-family: arial, helvetica; font-size: 10pt;"><br /></div><div style="font-family: arial, helvetica; font-size: 10pt;">Saturday, January 5, 2019 </div><div style="font-family: arial, helvetica; font-size: 10pt;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 10pt;">Rapid recontamination of a farm building occurs after attempted prion removal </div><div style="font-family: arial, helvetica; font-size: 10pt;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 10pt;"><a fg_scanned="1" href="https://prionprp.blogspot.com/2019/01/rapid-recontamination-of-farm-building.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">https://prionprp.blogspot.com/2019/01/rapid-recontamination-of-farm-building.html</a></div><div style="font-family: arial, helvetica; font-size: 10pt;"><br /></div><div style="font-family: arial, helvetica; font-size: 10pt;"><br /></div><div><div style="line-height: 1.22em;"><div class="yiv1152037782aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;"><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">*** The potential impact of prion diseases on human health was greatly magnified by the recognition that interspecies transfer of BSE to humans by beef ingestion resulted in vCJD. While changes in animal feed constituents and slaughter practices appear to have curtailed vCJD, there is concern that CWD of free-ranging deer and elk in the U.S. might also cross the species barrier. Thus, consuming venison could be a source of human prion disease. Whether BSE and CWD represent interspecies scrapie transfer or are newly arisen prion diseases is unknown. Therefore, the possibility of transmission of prion disease through other food animals cannot be ruled out. There is evidence that vCJD can be transmitted through blood transfusion. There is likely a pool of unknown size of asymptomatic individuals infected with vCJD, and there may be asymptomatic individuals infected with the CWD equivalent. These circumstances represent a potential threat to blood, blood products, and plasma supplies. </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><a href="http://cdmrp.army.mil/prevfunded/nprp/NPRP_Summit_Final_Report.pdf" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://cdmrp.army.mil/prevfunded/nprp/NPRP_Summit_Final_Report.pdf</a><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 12px;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 12px;"><div style="font-size: small;">you can see more evidence here ;</div><div style="font-size: small;"><br clear="none" /></div><div style="font-size: small;"><a fg_scanned="1" href="http://chronic-wasting-disease.blogspot.com/2016/05/zoonotic-potential-of-cwd-prions-update.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://chronic-wasting-disease.blogspot.com/2016/05/zoonotic-potential-of-cwd-prions-update.html</a><br clear="none" /></div><div style="font-size: small;"><br clear="none" /></div><div style="font-size: small;">Wednesday, May 24, 2017 </div><div style="font-size: small;"><br clear="none" /></div><div style="font-size: small;">PRION2017 CONFERENCE VIDEO UPDATE 23 – 26 May 2017 Edinburgh UPDATE 1</div><div style="font-size: small;"><br clear="none" /></div><div style="font-size: small;"><a fg_scanned="1" href="http://prionprp.blogspot.com/2017/05/prion2017-conference-video-update-23-26.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://prionprp.blogspot.com/2017/05/prion2017-conference-video-update-23-26.html</a></div></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;"></span></span><div>WEDNESDAY, SEPTEMBER 08, 2010</div><div><br clear="none" /></div><div>CWD PRION CONGRESS SEPTEMBER 8-11 2010</div><div><br clear="none" /></div><div>PRION 2010</div><div><br clear="none" /></div><div>International Prion Congress: From agent to disease September 8–11, 2010 Salzburg, Austria</div><div><br clear="none" /></div><div><a fg_scanned="1" href="https://chronic-wasting-disease.blogspot.com/2010/09/cwd-prion-2010.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">https://chronic-wasting-disease.blogspot.com/2010/09/cwd-prion-2010.html</a></div></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Transmission Studies</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Mule deer transmissions of CWD were by intracerebral inoculation and compared with natural cases {the following was written but with a single line marked through it ''first passage (by this route)}....TSS</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">resulted in a more rapidly progressive clinical disease with repeated episodes of synocopy ending in coma. One control animal became affected, it is believed through contamination of inoculum (?saline). Further CWD transmissions were carried out by Dick Marsh into ferret, mink and squirrel monkey. Transmission occurred in ALL of these species with the shortest incubation period in the ferret.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">snip.... </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><a href="https://web.archive.org/web/20090506002237/http://www.bseinquiry.gov.uk/files/mb/m11b/tab01.pdf" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">https://web.archive.org/web/20090506002237/http://www.bseinquiry.gov.uk/files/mb/m11b/tab01.pdf</a></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 12px;">Prion Infectivity in Fat of Deer with Chronic Wasting Disease▿ <br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Brent Race#, Kimberly Meade-White#, Richard Race and Bruce Chesebro* + Author Affiliations</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">In mice, prion infectivity was recently detected in fat. Since ruminant fat is consumed by humans and fed to animals, we determined infectivity titers in fat from two CWD-infected deer. Deer fat devoid of muscle contained low levels of CWD infectivity and might be a risk factor for prion infection of other species. </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><a fg_scanned="1" href="http://jvi.asm.org/content/83/18/9608.full" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://jvi.asm.org/content/83/18/9608.full</a> </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Prions in Skeletal Muscles of Deer with Chronic Wasting Disease </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Here bioassays in transgenic mice expressing cervid prion protein revealed the presence of infectious prions in skeletal muscles of CWD-infected deer, demonstrating that humans consuming or handling meat from CWD-infected deer are at risk to prion exposure. </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><a fg_scanned="1" href="http://science.sciencemag.org/content/311/5764/1117..long" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://science.sciencemag.org/content/311/5764/1117..long</a> </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">*** now, let’s see what the authors said about this casual link, personal communications years ago, and then the latest on the zoonotic potential from CWD to humans from the TOKYO PRION 2016 CONFERENCE.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">see where it is stated NO STRONG evidence. so, does this mean there IS casual evidence ???? “Our conclusion stating that we found no strong evidence of CWD transmission to humans”</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">From: TSS (<a class="yiv1152037782linkified" fg_rewritten="1" fg_scanned="1" href="http://216-119-163-189.ipset45.wt.net/" rel="nofollow noopener noreferrer" style="background-color: rgb(200, 26, 0) !important; color: blue; padding-bottom: 3px; padding-left: 3px; padding-right: 3px;" target="_blank">216-119-163-189.ipset45.wt.net</a>)</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Subject: CWD aka MAD DEER/ELK TO HUMANS ???</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Date: September 30, 2002 at 7:06 am PST</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">From: "Belay, Ermias"</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">To: Cc: "Race, Richard (NIH)" ; ; "Belay, Ermias"</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Sent: Monday, September 30, 2002 9:22 AM</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Subject: RE: TO CDC AND NIH - PUB MED- 3 MORE DEATHS - CWD - YOUNG HUNTERS</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Dear Sir/Madam,</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">In the Archives of Neurology you quoted (the abstract of which was attached to your email), we did not say CWD in humans will present like variant CJD.. That assumption would be wrong. I encourage you to read the whole article and call me if you have questions or need more clarification (phone: 404-639-3091). Also, we do not claim that "no-one has ever been infected with prion disease from eating venison." Our conclusion stating that we found no strong evidence of CWD transmission to humans in the article you quoted or in any other forum is limited to the patients we investigated.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Ermias Belay, M.D. Centers for Disease Control and Prevention</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">-----Original Message-----</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">From: Sent: Sunday, September 29, 2002 10:15 AM</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">To: <a href="mailto:rr26k@nih.gov" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank" ymailto="mailto:rr26k@nih.gov">rr26k@nih.gov</a>; <a href="mailto:rrace@niaid.nih.gov" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank" ymailto="mailto:rrace@niaid.nih.gov">rrace@niaid.nih.gov</a>; <a href="mailto:ebb8@CDC.GOV" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank" ymailto="mailto:ebb8@CDC.GOV">ebb8@CDC.GOV</a></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Subject: TO CDC AND NIH - PUB MED- 3 MORE DEATHS - CWD - YOUNG HUNTERS</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Sunday, November 10, 2002 6:26 PM .......snip........end..............TSS</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Thursday, April 03, 2008</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">A prion disease of cervids: Chronic wasting disease 2008 1: Vet Res. 2008 Apr 3;39(4):41 A prion disease of cervids: Chronic wasting disease Sigurdson CJ.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">snip...</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">*** twenty-seven CJD patients who regularly consumed venison were reported to the Surveillance Center***,</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">snip... full text ; </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><a fg_scanned="1" href="http://chronic-wasting-disease.blogspot.com/2008/04/prion-disease-of-cervids-chronic.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://chronic-wasting-disease.blogspot.com/2008/04/prion-disease-of-cervids-chronic.html</a> </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">> However, to date, no CWD infections have been reported in people. </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">key word here is 'reported'. science has shown that CWD in humans will look like sporadic CJD. SO, how can one assume that CWD has not already transmitted to humans? they can't, and it's as simple as that. from all recorded science to date, CWD has already transmitted to humans, and it's being misdiagnosed as sporadic CJD. ...terry </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">*** LOOKING FOR CWD IN HUMANS AS nvCJD or as an ATYPICAL CJD, LOOKING IN ALL THE WRONG PLACES $$$ ***</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">*** These results would seem to suggest that CWD does indeed have zoonotic potential, at least as judged by the compatibility of CWD prions and their human PrPC target. Furthermore, extrapolation from this simple in vitro assay suggests that if zoonotic CWD occurred, it would most likely effect those of the PRNP codon 129-MM genotype and that the PrPres type would be similar to that found in the most common subtype of sCJD (MM1).*** </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><a fg_scanned="1" href="http://www.tandfonline.com/doi/full/10.4161/pri.28124?src=recsys" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://www.tandfonline.com/doi/full/10.4161/pri.28124?src=recsys</a> </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><a fg_scanned="1" href="http://www.tandfonline.com/doi/pdf/10.4161/pri.28124?needAccess=true" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://www.tandfonline.com/doi/pdf/10.4161/pri.28124?needAccess=true</a> </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><a fg_scanned="1" href="https://wwwnc.cdc.gov/eid/article/20/1/13-0858_article" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">https://wwwnc.cdc.gov/eid/article/20/1/13-0858_article</a> </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">SEE; Travel History, Hunting, and Venison Consumption Related to Prion Disease Exposure, 2006-2007 FoodNet Population Survey</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Monday, May 23, 2011</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">CDC Assesses Potential Human Exposure to Prion Diseases Travel Warning</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Public release date: 23-May-2011</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Contact: Francesca Costanzo <a href="mailto:adajmedia@elsevier.com" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank" ymailto="mailto:adajmedia@elsevier.com">adajmedia@elsevier.com</a> 215-239-3249 Elsevier Health Sciences</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">CDC assesses potential human exposure to prion diseases Study results reported in the Journal of the American Dietetic Association</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><br clear="none" /></div><div style="font-family: arial, helvetica; font-size: 12px;">Philadelphia, PA, May 23, 2011 – Researchers from the Centers for Disease Control and Prevention (CDC) have examined the potential for human exposure to prion diseases, looking at hunting, venison consumption, and travel to areas in which prion diseases have been reported in animals. Three prion diseases in particular – bovine spongiform encephalopathy (BSE or “Mad Cow Disease”), variant Creutzfeldt-Jakob disease (vCJD), and chronic wasting disease (CWD) – were specified in the investigation. The results of this investigation are published in the June issue of the Journal of the American Dietetic Association.</div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">“While prion diseases are rare, they are generally fatal for anyone who becomes infected. More than anything else, the results of this study support the need for continued surveillance of prion diseases,” commented lead investigator Joseph Y. Abrams, MPH, National Center for Emerging and Zoonotic Infectious Diseases, CDC, Atlanta.”But it’s also important that people know the facts about these diseases, especially since this study shows that a good number of people have participated in activities that may expose them to infection-causing agents.”</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Although rare, human prion diseases such as CJD may be related to BSE. Prion (proteinaceous infectious particles) diseases are a group of rare brain diseases that affect humans and animals. When a person gets a prion disease, brain function is impaired. This causes memory and personality changes, dementia, and problems with movement. All of these worsen over time. These diseases are invariably fatal. Since these diseases may take years to manifest, knowing the extent of human exposure to possible prion diseases could become important in the event of an outbreak.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">CDC investigators evaluated the results of the 2006-2007 population survey conducted by the Foodborne Diseases Active Surveillance Network (FoodNet). This survey collects information on food consumption practices, health outcomes, and demographic characteristics of residents of the participating Emerging Infections Program sites. The survey was conducted in Connecticut, Georgia, Maryland, Minnesota, New Mexico, Oregon, and Tennessee, as well as five counties in the San Francisco Bay area, seven counties in the Greater Denver area, and 34 counties in western and northeastern New York.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Survey participants were asked about behaviors that could be associated with exposure to the agents causing BSE and CWD, including travel to the nine countries considered to be BSE-endemic (United Kingdom, Republic of Ireland, France, Portugal, Switzerland, Italy, the Netherlands, Germany, Spain) and the cumulative length of stay in each of those countries. Respondents were asked if they ever had hunted for deer or elk, and if that hunting had taken place in areas considered to be CWD-endemic (northeastern Colorado, southeastern Wyoming or southwestern Nebraska). They were also asked if they had ever consumed venison, the frequency of consumption, and whether the meat came from the wild.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">The proportion of survey respondents who reported travel to at least one of the nine BSE endemic countries since 1980 was 29.5%. Travel to the United Kingdom was reported by 19.4% of respondents, higher than to any other BSE-endemic country. Among those who traveled, the median duration of travel to the United Kingdom (14 days) was longer than that of any other BSE-endemic country.. Travelers to the UK were more likely to have spent at least 30 days in the country (24.9%) compared to travelers to any other BSE endemic country. The prevalence and extent of travel to the UK indicate that health concerns in the UK may also become issues for US residents.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">The proportion of survey respondents reporting having hunted for deer or elk was 18.5% and 1.2% reported having hunted for deer or elk in CWD-endemic areas. Venison consumption was reported by 67.4% of FoodNet respondents, and 88.6% of those reporting venison consumption had obtained all of their meat from the wild. These findings reinforce the importance of CWD surveillance and control programs for wild deer and elk to reduce human exposure to the CWD agent. Hunters in CWD-endemic areas are advised to take simple precautions such as: avoiding consuming meat from sickly deer or elk, avoiding consuming brain or spinal cord tissues, minimizing the handling of brain and spinal cord tissues, and wearing gloves when field-dressing carcasses.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">According to Abrams, “The 2006-2007 FoodNet population survey provides useful information should foodborne prion infection become an increasing public health concern in the future. The data presented describe the prevalence of important behaviors and their associations with demographic characteristics. Surveillance of BSE, CWD, and human prion diseases are critical aspects of addressing the burden of these diseases in animal populations and how that may relate to human health.”</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">###</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">The article is “Travel history, hunting, and venison consumption related to prion disease exposure, 2006-2007 FoodNet population survey” by Joseph Y. Abrams, MPH; Ryan A. Maddox, MPH; Alexis R Harvey, MPH; Lawrence B. Schonberger, MD; and Ermias D. Belay, MD. It appears in the Journal of the American Dietetic Association, Volume 111, Issue 6 (June 2011) published by Elsevier.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">In an accompanying podcast CDC’s Joseph Y. Abrams discusses travel, hunting, and eating venison in relation to prion diseases. It is available at <a fg_scanned="1" href="http://adajournal.org/content/podcast.%C2%A0" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://adajournal.org/content/podcast. </a>;</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><a fg_scanned="1" href="http://www.eurekalert.org/pub_releases/2011-05/ehs-cap051811.php" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://www.eurekalert.org/pub_releases/2011-05/ehs-cap051811.php</a> </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Thursday, May 26, 2011</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Travel History, Hunting, and Venison Consumption Related to Prion Disease Exposure, 2006-2007 FoodNet Population Survey</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Journal of the American Dietetic Association Volume 111, Issue 6 , Pages 858-863, June 2011.</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Travel History, Hunting, and Venison Consumption Related to Prion Disease Exposure, 2006-2007 FoodNet Population Survey</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Joseph Y. Abrams, MPH, Ryan A. Maddox, MPH , Alexis R. Harvey, MPH , Lawrence B. Schonberger, MD , Ermias D. Belay, MD</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Accepted 15 November 2010. Abstract Full Text PDF References .</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Abstract</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">The transmission of bovine spongiform encephalopathy (BSE) to human beings and the spread of chronic wasting disease (CWD) among cervids have prompted concerns about zoonotic transmission of prion diseases. Travel to the United Kingdom and other European countries, hunting for deer or elk, and venison consumption could result in the exposure of US residents to the agents that cause BSE and CWD. The Foodborne Diseases Active Surveillance Network 2006-2007 population survey was used to assess the prevalence of these behaviors among residents of 10 catchment areas across the United States. Of 17,372 survey respondents, 19.4% reported travel to the United Kingdom since 1980, and 29.5% reported travel to any of the nine European countries considered to be BSE-endemic since 1980. The proportion of respondents who had ever hunted deer or elk was 18.5%, and 1.2% had hunted deer or elk in a CWD–endemic area. More than two thirds (67.4%) reported having ever eaten deer or elk meat. Respondents who traveled spent more time in the United Kingdom (median 14 days) than in any other BSE-endemic country. Of the 11,635 respondents who had consumed venison, 59.8% ate venison at most one to two times during their year of highest consumption, and 88.6% had obtained all of their meat from the wild. The survey results were useful in determining the prevalence and frequency of behaviors that could be important factors for foodborne prion transmission. </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><a fg_scanned="1" href="http://www.adajournal.org/article/S0002-8223(11)00278-1/abstract" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://www.adajournal.org/article/S0002-8223(11)00278-1/abstract</a> </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"> PLUS, THE CDC DID NOT PUT THIS WARNING OUT FOR THE WELL BEING OF THE DEER AND ELK ; </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Thursday, May 26, 2011</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Travel History, Hunting, and Venison Consumption Related to Prion Disease Exposure, 2006-2007 FoodNet Population Survey</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Journal of the American Dietetic Association Volume 111, Issue 6 , Pages 858-863, June 2011. </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><a fg_scanned="1" href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/travel-history-hunting-and-venison.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/travel-history-hunting-and-venison.html</a> </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">NOR IS THE FDA recalling this CWD positive elk meat for the well being of the dead elk ;</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Wednesday, March 18, 2009</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Noah's Ark Holding, LLC, Dawson, MN RECALL Elk products contain meat derived from an elk confirmed to have CWD NV, CA, TX, CO, NY, UT, FL, OK RECALLS AND FIELD CORRECTIONS: FOODS CLASS II </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><a fg_scanned="1" href="http://chronic-wasting-disease.blogspot.com/2009/03/noahs-ark-holding-llc-dawson-mn-recall.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue;" target="_blank">http://chronic-wasting-disease.blogspot.com/2009/03/noahs-ark-holding-llc-dawson-mn-recall.html</a></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br /></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;">SATURDAY, FEBRUARY 23, 2019 </span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;"><br /></span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;">Chronic Wasting Disease CWD TSE Prion and THE FEAST 2003 CDC an updated review of the science 2019</span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;"><br /></span></span></div><div><a fg_scanned="1" href="https://chronic-wasting-disease.blogspot.com/2019/02/chronic-wasting-disease-cwd-tse-prion.html" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://chronic-wasting-disease.blogspot.com/2019/02/chronic-wasting-disease-cwd-tse-prion.html</a><br /></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;"><br /></span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;">TUESDAY, NOVEMBER 04, 2014 </span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;"><br /></span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;">Six-year follow-up of a point-source exposure to CWD contaminated venison in an Upstate New York community: risk behaviours and health outcomes 2005–2011</span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;"><br /></span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;">Authors, though, acknowledged the study was limited in geography and sample size and so it couldn't draw a conclusion about the risk to humans. They recommended more study. Dr. Ermias Belay was the report's principal author but he said New York and Oneida County officials are following the proper course by not launching a study. "There's really nothing to monitor presently. No one's sick," Belay said, noting the disease's incubation period in deer and elk is measured in years. "</span></span></div><div><span style="font-family: arial, helvetica;"><span style="font-size: 12px;"><br /></span></span></div><div><span style="font-family: arial, helvetica; font-size: 12px;"><a fg_scanned="1" href="http://chronic-wasting-disease.blogspot.com/2014/11/six-year-follow-up-of-point-source.html" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">http://chronic-wasting-disease.blogspot.com/2014/11/six-year-follow-up-of-point-source.html</a></span></div><div><span style="font-family: arial, helvetica; font-size: 12px;"><br /></span></div><div><span style="font-family: arial, helvetica; font-size: 12px;"><br /></span></div>the British disease...NOT, the UKBSEnvCJD only theory was/is bogus $$$<div><br /></div><div><br /></div><div><a href="https://histodb15.usz.ch/pages/Images/videos/video-009/video-009.html">https://histodb15.usz.ch/pages/Images/videos/video-009/video-009.html</a><br /></div><div><br /></div><div><br /></div><div>2004</div><div><br /><div><div style="margin: 0px;"><span style="margin: 0px;"><span style="background-color: inherit; font-family: Calibri; font-size: small;">*** USA sporadic CJD MAD COW DISEASE HAS HUGE PROBLEM Video</span></span></div><div style="margin: 0px;"><span style="margin: 0px;"><span style="background-color: inherit; font-family: Calibri; font-size: small;"> </span></span></div><div style="margin: 0px;"><span style="margin: 0px;"><span style="background-color: inherit; font-family: Calibri; font-size: small;">*** sporadic CJD linked to mad cow disease</span></span></div><div style="margin: 0px;"><span style="margin: 0px;"><span style="background-color: inherit; font-family: Calibri; font-size: small;"> </span></span></div><div style="margin: 0px;"><span style="margin: 0px;"><span style="background-color: inherit; font-family: Calibri; font-size: small;">*** you can see video here and interview with Jeff's Mom, and scientist telling you to test everything and potential risk factors for humans ***</span></span></div><div style="margin: 0px;"><br /></div></div><div style="margin: 0px;"><br /></div><div style="margin: 0px;"><div style="font-size: 13.3333px;"><span style="background-color: whitesmoke;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: medium; font-weight: 700;">2004</span></span></div><div style="font-size: 13.3333px;"><span style="background-color: whitesmoke;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: medium; font-weight: 700;"><br /></span></span></div><div style="font-size: 13.3333px;"><span style="background-color: whitesmoke;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: medium; font-weight: 700;">Jeff Swann and his Mom, cwd link... sporadic CJD?, CBC NEWS Jeff Schwan sCJD, CWD, and Professor Aguzzi on BSE and sporadic CJD </span><br /></span></div><div style="font-size: 13.3333px;"><span style="background-color: whitesmoke;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: medium; font-weight: 700;"><br /></span></span></div><div style="font-size: 13.3333px;"><strong style="background-color: whitesmoke; font-family: Arial, Helvetica, sans-serif; font-size: medium;">????: CBCnews</strong><span style="background-color: whitesmoke;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: medium; font-weight: 700;"><br /></span></span></div><div style="font-size: 13.3333px;"><span style="background-color: whitesmoke;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: medium; font-weight: 700;"><br /></span></span></div><div style="font-size: 13.3333px;"><span style="background-color: whitesmoke;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: medium; font-weight: 700;"><a fg_scanned="1" href="https://histodb15.usz.ch/pages/Images/videos/video-004/video-004.html" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://histodb15.usz.ch/pages/Images/videos/video-004/video-004.html</a></span></span></div><div style="font-size: 13.3333px;"><span style="background-color: whitesmoke;"><br /></span></div></div><div style="margin: 0px;"><br /></div><div style="margin: 0px;"><div style="font-family: Calibri; font-size: 16px; line-height: 1.22em;">spontaneous TSE Prion disease</div><div style="font-family: Calibri; font-size: 16px; line-height: 1.22em;"> </div><div style="font-family: Calibri; font-size: 16px; line-height: 1.22em;">Transmission of scrapie prions to primate after an extended silent incubation period</div><div style="font-family: Calibri; font-size: 16px; line-height: 1.22em;"> </div><div style="font-family: Calibri; font-size: 16px; line-height: 1.22em;">***Moreover, sporadic disease has never been observed in breeding colonies or primate research laboratories, most notably among hundreds of animals over several decades of study at the National Institutes of Health25, and in nearly twenty older animals continuously housed in our own facility.***</div><div style="font-family: Calibri; font-size: 16px; line-height: 1.22em;"> </div></div></div><div><a fg_scanned="1" href="http://www.nature.com/articles/srep11573" rel="nofollow noopener noreferrer" style="color: blue; font-family: Calibri; font-size: 16px; line-height: 1.22em;" target="_blank">http://www.nature.com/articles/srep11573</a><span style="font-family: arial, helvetica; font-size: 12px;"> </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Transmissible Spongiform Encephalopathies</span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;"><br clear="none" /></span></div><div style="font-family: arial, helvetica; font-size: 12px;"><span style="font-family: arial, helvetica;">Spongiform Encephalopathy in Captive Wild ZOO BSE INQUIRY </span></div><div style="font-family: arial, helvetica; font-size: 12px;"><br /></div><div style="font-family: arial, helvetica; font-size: 12px;"><br /></div><div style="font-family: arial, helvetica; font-size: 12px;"><a href="https://web.archive.org/web/20090506001201/http://www.bseinquiry.gov.uk/files/mb/m09a/tab03.pdf">https://web.archive.org/web/20090506001201/http://www.bseinquiry.gov.uk/files/mb/m09a/tab03.pdf</a><br /></div><div style="font-family: arial, helvetica; font-size: 12px;"><br /></div><div style="font-family: arial, helvetica; font-size: 12px;"><br /></div></div></div></div></div></div></div></div></div></div></div></div><div><blockquote style="font-family: Georgia; font-size: 13px; line-height: 1.22em; margin: 0px 0px 0px 4px;" type="cite"><div dir="ltr" style="line-height: 1.22em;"><div id="yiv1152037782ygrp-text" style="line-height: 1.22em;"><div style="line-height: 1.22em;"><div id="yiv1152037782AOLMsgPart_2_f8804637-8c04-4b00-888d-15bf6105ab63" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;">***> prepare for the storm....<span style="font-family: arial; font-size: small;"> </span></div></div></div></div></div></div></div></blockquote><blockquote style="font-family: Georgia; font-size: 13px; line-height: 1.22em; margin: 0px 0px 0px 4px;" type="cite"><div dir="ltr" style="line-height: 1.22em;"><div id="yiv1152037782ygrp-text" style="line-height: 1.22em;"><div style="line-height: 1.22em;"><div id="yiv1152037782AOLMsgPart_2_f8804637-8c04-4b00-888d-15bf6105ab63" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><span style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><span style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><span style="line-height: 1.22em;">TUESDAY, NOVEMBER 20, 2018 </span><span style="font-family: arial; font-size: small;"> </span></div></div></div></div></div></div></div></blockquote><blockquote style="font-family: Georgia; font-size: 13px; line-height: 1.22em; margin: 0px 0px 0px 4px;" type="cite"><div dir="ltr" style="line-height: 1.22em;"><div id="yiv1152037782ygrp-text" style="line-height: 1.22em;"><div style="line-height: 1.22em;"><div id="yiv1152037782AOLMsgPart_2_f8804637-8c04-4b00-888d-15bf6105ab63" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><span style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><span style="line-height: 1.22em;">CDC Eyes of CJD patients show evidence of prions concerns for iatrogenic transmission </span></div></div></div></div></div></div></div></blockquote><p> </p><p><a href="https://creutzfeldt-jakob-disease.blogspot.com/2018/11/cdc-eyes-of-cjd-patients-show-evidence.html">https://creutzfeldt-jakob-disease.blogspot.com/2018/11/cdc-eyes-of-cjd-patients-show-evidence.html</a><br /></p><p><br /></p><blockquote style="font-family: Georgia; font-size: 13px; line-height: 1.22em; margin: 0px 0px 0px 4px;" type="cite"><div dir="ltr" style="line-height: 1.22em;"><div id="yiv1152037782ygrp-text" style="line-height: 1.22em;"><div style="line-height: 1.22em;"><div id="yiv1152037782AOLMsgPart_2_f8804637-8c04-4b00-888d-15bf6105ab63" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;">***> prepare for the storm....<span style="font-family: arial; font-size: small;"> </span></div></div></div></div></div></div></div></blockquote><blockquote style="font-family: Georgia; font-size: 13px; line-height: 1.22em; margin: 0px 0px 0px 4px;" type="cite"><div dir="ltr" style="line-height: 1.22em;"><div id="yiv1152037782ygrp-text" style="line-height: 1.22em;"><div style="line-height: 1.22em;"><div id="yiv1152037782AOLMsgPart_2_f8804637-8c04-4b00-888d-15bf6105ab63" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><span style="font-family: arial; font-size: small;"> </span></div></div></div></div></div></div></div></blockquote><blockquote style="font-family: Georgia; font-size: 13px; line-height: 1.22em; margin: 0px 0px 0px 4px;" type="cite"><div dir="ltr" style="line-height: 1.22em;"><div id="yiv1152037782ygrp-text" style="line-height: 1.22em;"><div style="line-height: 1.22em;"><div id="yiv1152037782AOLMsgPart_2_f8804637-8c04-4b00-888d-15bf6105ab63" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"></div><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><span style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><span style="line-height: 1.22em;">MONDAY, DECEMBER 03, 2018 </span></div><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><span style="font-family: arial; font-size: small;"></span></div></div></div></div></div></div></div></blockquote><p> </p><blockquote style="font-family: Georgia; font-size: 13px; line-height: 1.22em; margin: 0px 0px 0px 4px;" type="cite"><div dir="ltr" style="line-height: 1.22em;"><div id="yiv1152037782ygrp-text" style="line-height: 1.22em;"><div style="line-height: 1.22em;"><div id="yiv1152037782AOLMsgPart_2_f8804637-8c04-4b00-888d-15bf6105ab63" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><span style="font-family: arial; font-size: small;">Prion Seeds Distribute throughout the Eyes of Sporadic Creutzfeldt-Jakob Disease Patients</span></div></div></div></div></div></div></div></blockquote><p><br /></p><p><a href=" https://creutzfeldt-jakob-disease.blogspot.com/2018/12/prion-seeds-distribute-throughout-eyes.html"> https://creutzfeldt-jakob-disease.blogspot.com/2018/12/prion-seeds-distribute-throughout-eyes.html</a><br /></p><p> </p><blockquote style="font-family: Georgia; font-size: 13px; line-height: 1.22em; margin: 0px 0px 0px 4px;" type="cite"><div dir="ltr" style="line-height: 1.22em;"><div id="yiv1152037782ygrp-text" style="line-height: 1.22em;"><div style="line-height: 1.22em;"><div id="yiv1152037782AOLMsgPart_2_f8804637-8c04-4b00-888d-15bf6105ab63" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><span style="font-family: arial; font-size: small;">MONDAY, DECEMBER 03, 2018 </span></div></div></div></div></div></div></div></blockquote><blockquote style="font-family: Georgia; font-size: 13px; line-height: 1.22em; margin: 0px 0px 0px 4px;" type="cite"><div dir="ltr" style="line-height: 1.22em;"><div id="yiv1152037782ygrp-text" style="line-height: 1.22em;"><div style="line-height: 1.22em;"><div id="yiv1152037782AOLMsgPart_2_f8804637-8c04-4b00-888d-15bf6105ab63" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><span style="font-family: arial; font-size: small;"><br /></span></div></div></div></div></div></div></div></blockquote><blockquote style="font-family: Georgia; font-size: 13px; line-height: 1.22em; margin: 0px 0px 0px 4px;" type="cite"><div dir="ltr" style="line-height: 1.22em;"><div id="yiv1152037782ygrp-text" style="line-height: 1.22em;"><div style="line-height: 1.22em;"><div id="yiv1152037782AOLMsgPart_2_f8804637-8c04-4b00-888d-15bf6105ab63" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div style="line-height: 1.22em;"><div style="line-height: 1.22em;"><div style="line-height: 1.22em;"><div id="yiv1152037782aolmail_aolmail_aolmail_aolmail_p-37" style="font-stretch: inherit; line-height: 1.22em; margin-bottom: 15px; outline: 0px; vertical-align: baseline;"><div id="yiv1152037782aolmail_aolmail_aolmail_aolmail_p-37" style="font-stretch: inherit; line-height: 1.22em; margin-bottom: 15px; outline: 0px; vertical-align: baseline;"><div id="yiv1152037782aolmail_aolmail_aolmail_aolmail_p-37" style="font-stretch: inherit; line-height: 1.22em; margin-bottom: 15px; outline: 0px; vertical-align: baseline;"><span style="font-size: small; line-height: 1.22em;">Prion Seeds Distribute throughout the Eyes of Sporadic Creutzfeldt-Jakob Disease Patients</span><br clear="none" style="line-height: 1.22em;" /></div><div id="yiv1152037782aolmail_aolmail_aolmail_aolmail_p-37" style="font-stretch: inherit; line-height: 1.22em; margin-bottom: 15px; outline: 0px; vertical-align: baseline;"><a fg_scanned="1" href="https://mbio.asm.org/content/9/6/e02095-18.long" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">https://mbio.asm.org/content/9/6/e02095-18.long</a><br clear="none" style="line-height: 1.22em;" /></div><div id="yiv1152037782aolmail_aolmail_aolmail_aolmail_p-37" style="font-stretch: inherit; line-height: 1.22em; margin-bottom: 15px; outline: 0px; vertical-align: baseline;"><a href="https://mbio.asm.org/content/mbio/9/6/e02095-18.full.pdf" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">https://mbio.asm...org/content/mbio/9/6/e02095-18.full.pdf</a><br clear="none" style="line-height: 1.22em;" /></div><div id="yiv1152037782aolmail_aolmail_aolmail_aolmail_p-37" style="font-stretch: inherit; line-height: 1.22em; margin-bottom: 15px; outline: 0px; vertical-align: baseline;"><a fg_scanned="1" href="https://creutzfeldt-jakob-disease.blogspot.com/2018/12/prion-seeds-distribute-throughout-eyes.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">https://creutzfeldt-jakob-disease.blogspot.com/2018/12/prion-seeds-distribute-throughout-eyes.html</a><br clear="none" style="line-height: 1.22em;" /></div><div id="yiv1152037782aolmail_aolmail_aolmail_aolmail_p-37" style="font-size: small; font-stretch: inherit; line-height: 1.22em; margin-bottom: 15px; outline: 0px; vertical-align: baseline;"><span style="line-height: 1.22em;"></span></div></div></div></div></div></div></div></div></div></div></div></div></div></div></blockquote><p> </p><blockquote style="font-family: Georgia; font-size: 13px; line-height: 1.22em; margin: 0px 0px 0px 4px;" type="cite"><div dir="ltr" style="line-height: 1.22em;"><div id="yiv1152037782ygrp-text" style="line-height: 1.22em;"><div style="line-height: 1.22em;"><div id="yiv1152037782AOLMsgPart_2_f8804637-8c04-4b00-888d-15bf6105ab63" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div style="line-height: 1.22em;"><div style="line-height: 1.22em;"><div style="line-height: 1.22em;"><div id="yiv1152037782aolmail_aolmail_aolmail_aolmail_p-37" style="font-stretch: inherit; line-height: 1.22em; margin-bottom: 15px; outline: 0px; vertical-align: baseline;"><div id="yiv1152037782aolmail_aolmail_aolmail_aolmail_p-37" style="font-stretch: inherit; line-height: 1.22em; margin-bottom: 15px; outline: 0px; vertical-align: baseline;"><div id="yiv1152037782aolmail_aolmail_aolmail_aolmail_p-37" style="font-size: small; font-stretch: inherit; line-height: 1.22em; margin-bottom: 15px; outline: 0px; vertical-align: baseline;"><span style="line-height: 1.22em;">''Cadaveric corneas have been a source of iatrogenic prion transmission, and grafts are commonly performed (35). With the increased frequency of corneal grafting worldwide, optimizing biosynthetic substitutes would be a justified research priority and is currently under development in multiple laboratories (54, 55). In all sCJD patient eyes examined, PrPSc aggregates were highly visible in the posterior retina, an accessible CNS window that could potentially be exploited for the early diagnosis of prion disease. For example, an electroretinogram is an antemortem, noninvasive diagnostic tool that may reveal early electrical abnormalities, particularly considering the prion deposits in synaptic plexi. Because other protein aggregates such as amyloid-synuclein, and tau may also spread from brain to retina, it would also be important to continue to evaluate eyes from patients having more common neurodegenerative diseases, such as Alzheimer’s disease, synucleinopathies, and tauopathies, particularly in light of recent findings showing the prion-like spread of protein aggregates through the CNS (56–59).''</span><br clear="none" style="line-height: 1.22em;" /></div></div><div id="yiv1152037782aolmail_aolmail_aolmail_aolmail_p-37" style="font-size: small; font-stretch: inherit; line-height: 1.22em; margin-bottom: 15px; outline: 0px; vertical-align: baseline;">1999 Singeltary</div></div><div id="yiv1152037782aolmail_aolmail_aolmail_aolmail_p-37" style="font-family: Arial, Helvetica, sans-serif; font-size: 15px; font-stretch: inherit; line-height: 1.22em; margin-bottom: 15px; outline: 0px; vertical-align: baseline;"><span style="font-family: arial; line-height: 1.22em;">Subject: RE-The Eyes Hav</span><span style="font-family: arial; line-height: 1.22em;">e It (cjd) and they could be stealing them from your loved one... "pay back time" </span></div></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Date: Sat, 16 Sep 2000 10:04:26 -0700 </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">From: "Terry S. Singeltary Sr." </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Reply-To: Bovine Spongiform Encephalopathy </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">To: <a href="mailto:BSE-L@uni-karlsruhe.de" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank" ymailto="mailto:BSE-L@uni-karlsruhe.de">BSE-L@uni-karlsruhe.de</a></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">######### Bovine Spongiform Encephalopathy #########</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Greetings List Members,</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">I hate to keep kicking a madcow, but this still is very disturbing to me. Not only for the recipient of the cornea's, but as well, for the people whom would be operated on, using the same tools that were used to put those stolen cornea's in the recipient with. No history of this donor or his family (re-ffi), or anything would be known, using stolen organs and or tissue's. I just think this is not only wrong, but very dangerous to a great many other people, as this is one of the most infectious tissues of TSE's. It seems that this practice of stealing organ/tissue happens more than we think. Anyway, the family of the victim which had their cornea's stolen, are now suing. In the example I used with my Mother, if 3 months before, she would have been in a catastrophic accident (car wreck, whatever), no autopsy (for whatever reason), no family (for whatever reason), she lay in the morgue, and after 4 hours, they come steal the cornea's, lot of people could have been infected, just because of lack of medical history of donor/family. It may be hypothetical, but very real. We need to stop the spread of this disease.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">===========================================</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Previous story--</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Cadaver corneal transplants -- without family permission...</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Cadaver corneal transplants -- without family permission Houston, Texas channel 11 news 28 Nov 99</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Reported by Terry S. Singeltary Sr.son of CJD victim</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">"It was a story about how the Lions eye bank were harvesting corneas from victims in the Morgue, without their consent. Under Texas law, this appears to be legal (remember Texas has the Veggie liable law). Even if Family says no, this appears to happen, from what the news story said.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">They said the only way to prevent this, is to fill out a form, stating not to have this done. So if you don't fill out the form, they can do this. How many people don't know about the form? </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"> This is not only disgusting and appalling, it could be highly infectious. Without proper background checking of the donors, on their physical history, checking on past dementia, and/or family history, some of these unfortunate victims, could be passing a human TSE. </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"> Response Jill Spitler Clevelland Eye Bank: </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"> "No, we are not stealing.........Yes, you do have such a law in the state of Texas, but not all your state Eye Banks utilize the law. The Eye Bank that you're speaking of is only one of 43 certified Eye Bank throughout the USA. </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"> And there are measure taken per the Medical Standards of the Eye Bank Association of America, the certifying body for eye banks and per FDA regulations to address those concerns that you speak of. </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"> I would suggest that those interested/concern with transplant contact their local agencies. The Eye Bank Association of America has a web. site . Further if anyone has problems contacting or finding out about their local organization(s), call me or e-mail me I would be glad to help. My e-mail address is <a href="mailto:jill@clevelandeyebank.org" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank" ymailto="mailto:jill@clevelandeyebank.org">jill@clevelandeyebank.org</a>" </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"> Terry Singeltary responds: </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"> "Explain this to the family in Houston who went to their loved ones funeral, only to find out that the loved one that was in the casket, had their corneas removed without their permission, without the consent of the victim or it's family. They would not have known it, only for the funny look the victim had.... So, they questioned, only to find out, the corneas, had in fact, been removed without consent. </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"> I call that stealing, regardless what the law states. This type of legal grave robbing is not a logical thing to do without knowing any type of background of the victims medical past, which really will not prove anything due to the incubation period. Eye tissue being potentially a highly infective source, there are risks here. </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"> Should they not at least know of the potential ramifications of TSE's (the person receiving the corneas)? </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"> Should there not be some sort of screening? </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"> Should there be some sort of moral issue here? </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"> If this is the case, and in fact, they can come take your corneas, without your consent, then what will they start taking next, without your consent? </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"> Lets look at a hypothetical situation: </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"> What would happen if my Mom (DOD 12-14-97 hvCJD) would have gotten into a car wreck and died, before the symptoms of CJD appeared. Not much money, so there was no autopsy. What would have happened to that recipient of those infecting corneas?" </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"> Comment (webmaster): Actual transmission of CJD by means of corneal transplant may or may not be rare. The incidence of infectivity in older people could be fairly high; this is not to be confused with the lower incidence of symptomatic (clinical) CJD. It is very unlikely that familial CJD would have been diagnosed in earlier generations; however, without interviewing the family even known kindreds would not be excluded. </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"> In blood donation, a much stricter policy is followed, even though corneal transplant may be far more dangerous (being a direct link to the brain and not going through purification steps). </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"> Since highly sensitive tests for pre-clinical CJD are now available, it would make sense to screen corneas for CJD, just as they are screened for AIDS, hepatitus, and a host of other conditions. </div></div></div></div></div></div></div></div></div></div></div></blockquote><p> </p><blockquote style="font-family: Georgia; font-size: 13px; line-height: 1.22em; margin: 0px 0px 0px 4px;" type="cite"><div dir="ltr" style="line-height: 1.22em;"><div id="yiv1152037782ygrp-text" style="line-height: 1.22em;"><div style="line-height: 1.22em;"><div id="yiv1152037782AOLMsgPart_2_f8804637-8c04-4b00-888d-15bf6105ab63" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div class="yiv1152037782aolReplacedBody" style="line-height: 1.22em;"><div style="line-height: 1.22em;"><div style="line-height: 1.22em;"><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><a fg_scanned="1" href="http://www.mad-cow.org/dec99_news.html#bbb" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">http://www.mad-cow.org/dec99_news.html#bbb</a></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Eye procedure raises CJD concerns</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">BySTEVE MITCHELL, Medical Correspondent</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">WASHINGTON, Nov.. 18 (UPI) -- A New York man who died from a rare brain disorder similar to mad cow disease in May underwent an eye procedure prior to his death that raises concerns about the possibility of transmitting the fatal disease to others, United Press International has learned.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">The development comes on the heels of the announcement Thursday by U.S. Department of Agriculture officials of a possible second case of mad cow disease in U.S. herds.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Richard Da Silva, 58, of Orange County, N.Y., died from Creutzfeldt Jakob disease, an incurable brain-wasting illness that strikes about one person per million.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Richard's wife Ann Marie Da Silva told UPI he underwent a check for the eye disease glaucoma in 2003, approximately a year before his death. The procedure involves the use of a tonometer, which contacts the cornea -- an eye tissue that can contain prions, the infectious agent thought to cause CJD.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Ann Marie's concern is that others who had the tonometer used on them could have gotten infected.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">A 2003 study by British researchers suggests her concerns may be justified. A team led by J.W. Ironside from the National Creutzfeldt-Jakob Disease Surveillance Unit at the University of Edinburgh examined tonometer heads and found they can retain cornea tissue that could infect other people -- even after cleaning and decontaminating the instrument.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">"Retained corneal epithelial cells, following the standard decontamination routine of tonometer prisms, may represent potential prion infectivity," the researchers wrote in the British Journal of Ophthalmology last year. "Once the infectious agent is on the cornea, it could theoretically infect the brain."</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Prions, misfolded proteins thought to be the cause of mad cow, CJD and similar diseases, are notoriously difficult to destroy and are capable of withstanding most sterilization procedures.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Laura Manuelidis, an expert on these diseases and section chief of surgery in the neuropathology department at Yale University, agreed with the British researchers that tonometers represent a potential risk of passing CJD to other people.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Manuelidis told UPI she has been voicing her concern about the risks of corneas since 1977 when her own study, published in the New England Journal of Medicine, showed the eye tissue, if infected, could transmit CJD.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">At the time the procedure was done on Richard Da Silva, about a year before he died, she said it was "absolutely" possible he was infectious.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">The CJD Incidents Panel, a body of experts set up by the U.K. Department of Health, noted in a 2001 report that procedures involving the cornea are considered medium risk for transmitting CJD. The first two patients who have a contaminated eye instrument used on them have the highest risk of contracting the disease, the panel said.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">In 1999, the U.K. Department of Health banned opticians from reusing equipment that came in contact with patients' eyes out of concern it could result in the transmission of variant CJD, the form of the disease humans can contract from consuming infected beef products.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Richard Da Silva was associated with a cluster of five other cases of CJD in southern New York that raised concerns about vCJD.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">None of the cases have been determined to stem from mad cow disease, but concerns about the cattle illness in the United States could increase in light of the USDA announcement Thursday that a cow tested positive on initial tests for the disease. If confirmed, this would be the second U.S. case of the illness; the first was detected in a Washington cow last December. The USDA said the suspect animal disclosed Thursday did not enter the food chain. The USDA did not release further details about the cow, but said results from further lab tests to confirm the initial tests were expected within seven days.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Ann Marie Da Silva said she informed the New York Health Department and later the eye doctor who performed the procedure about her husband's illness and her concerns about the risk of transmitting CJD via the tonometer.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">The optometrist -- whom she declined to name because she did not want to jeopardize his career -- "didn't even know what this disease was," she said.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">"He said the health department never called him and I called them (the health department) back and they didn't seem concerned about it," she added. "I just kept getting angrier and angrier when I felt I was being dismissed."</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">She said the state health department "seems to have an attitude of don't ask, don't tell" about CJD.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">"There's a stigma attached to it," she said. "Is it because they're so afraid the public will panic? I don't know, but I don't think that the answer is to push things under the rug."</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">New York State Department of Health spokeswoman Claire Pospisil told UPI she would look into whether the agency was concerned about the possibility of transmitting CJD via tonometers, but she had not called back prior to story publication....</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Disposable tonometers are readily available and could avoid the risk of transmitting the disease, Ironside and colleagues noted in their study. Ann Marie Da Silva said she asked the optometrist whether he used disposable tonometers and "he said 'No, it's a reusable one.'"</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Ironside's team also noted other ophthalmic instruments come into contact with the cornea and could represent a source of infection as they are either difficult to decontaminate or cannot withstand the harsh procedures necessary to inactivate prions. These include corneal burrs, diagnostic and therapeutic contact lenses and other coated lenses.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Terry Singletary, whose mother died from a type of CJD called Heidenhain Variant, told UPI health officials were not doing enough to prevent people from being infected by contaminated medical equipment.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">"They've got to start taking this disease seriously and they simply aren't doing it," said Singletary, who is a member of CJD Watch and CJD Voice -- advocacy groups for CJD patients and their families.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">U.S. Centers for Disease Control and Prevention spokeswoman Christine Pearson did not return a phone call from UPI seeking comment. The agency's Web site states the eye is one of three tissues, along with the brain and spinal cord, that are considered to have "high infectivity."</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">The Web site said more than 250 people worldwide have contracted CJD through contaminated surgical instruments and tissue transplants. This includes as many as four who were infected by corneal grafts. The agency noted no such cases have been reported since 1976, when sterilization procedures were instituted in healthcare facilities.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Ironside and colleagues noted in their study, however, many disinfection procedures used on optical instruments, such as tonometers, fail. They wrote their finding of cornea tissue on tonometers indicates that "no current cleaning and disinfection strategy is fully effective."</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Singletary said CDC's assertion that no CJD cases from infected equipment or tissues have been detected since 1976 is misleading.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">"They have absolutely no idea" whether any cases have occurred in this manner, he said, because CJD cases often aren't investigated and the agency has not required physicians nationwide report all cases of CJD.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">"There's no national surveillance unit for CJD in the United States; people are dying who aren't autopsied, the CDC has no way of knowing" whether people have been infected via infected equipment or tissues, he said.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Ann Marie Da Silva said she has contacted several members of her state's congressional delegation about her concerns, including Rep. Sue Kelly, R-N.Y., and Sen. Charles Schumer, D-N.Y.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">"Basically, what I want is to be a positive force in this, but I also want more of a dialogue going on with the public and the health department," she said.</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><a fg_scanned="1" href="https://www.upi.com/Eye-procedure-raises-CJD-concerns/29741100811678/" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">https://www.upi.com/Eye-procedure-raises-CJD-concerns/29741100811678/</a></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Friday, December 04, 2009</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">New guidance on decontamination of trial contact lenses and other contact devices has been revealed for CJD AND vCJD</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><a fg_scanned="1" href="http://creutzfeldt-jakob-disease.blogspot.com/2009/12/new-guidance-on-decontamination-of.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">http://creutzfeldt-jakob-disease.blogspot.com/2009/12/new-guidance-on-decontamination-of.html</a></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">SUNDAY, JANUARY 17, 2016 </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Of Grave Concern Heidenhain Variant Creutzfeldt Jakob Disease</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><a fg_scanned="1" href="http://creutzfeldt-jakob-disease.blogspot.com/2016/01/of-grave-concern-heidenhain-variant.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">http://creutzfeldt-jakob-disease.blogspot.com/2016/01/of-grave-concern-heidenhain-variant.html</a></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><a fg_scanned="1" href="http://creutzfeldt-jakob-disease.blogspot.com/" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">http://creutzfeldt-jakob-disease.blogspot.com/</a></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">TUESDAY, NOVEMBER 20, 2018 </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">***> CDC Eyes of CJD patients show evidence of prions concerns for iatrogenic transmission</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><a fg_scanned="1" href="https://creutzfeldt-jakob-disease.blogspot.com/2018/11/cdc-eyes-of-cjd-patients-show-evidence.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">https://creutzfeldt-jakob-disease.blogspot.com/2018/11/cdc-eyes-of-cjd-patients-show-evidence.html</a></div></div><div style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;"><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">2006-2007</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">HUMAN and ANIMAL TSE Classifications i.e. mad cow disease and the UKBSEnvCJD only theory</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">TSEs have been rampant in the USA for decades in many species, and they all have been rendered and fed back to animals for human/animal consumption. </span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">I propose that the current diagnostic criteria for human TSEs only enhances and helps the spreading of human TSE from the continued belief of the UKBSEnvCJD only theory in 2007. </span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">With all the science to date refuting it, to continue to validate this myth, will only spread this TSE agent through a multitude of potential routes and sources i.e. consumption, surgical, blood, medical, cosmetics etc. </span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">I propose as with Aguzzi, Asante, Collinge, Caughey, Deslys, Dormont, Gibbs, Ironside, Manuelidis, Marsh, et al and many more, that the world of TSE Transmissible Spongiform Encephalopathy is far from an exact science, but there is enough proven science to date that this myth should be put to rest once and for all, and that we move forward with a new classification for human and animal TSE that would properly identify the infected species, the source species, and then the route. </span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">This would further have to be broken down to strain of species and then the route of transmission would further have to be broken down. </span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Accumulation and Transmission are key to the threshold from subclinical to clinical disease, and of that, I even believe that physical and or blunt trauma may play a role of onset of clinical symptoms in some cases, but key to all this, is to stop the amplification and transmission of this agent, the spreading of, no matter what strain. </span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">BUT, to continue with this myth that the U.K. strain of BSE one strain in cows, and the nv/v CJD, one strain in humans, and that all the rest of human TSE is one single strain i.e. sporadic CJD (when to date there are 6 different phenotypes of sCJD), and that no other animal TSE transmits to humans, to continue with this masquerade will only continue to spread, expose, and kill, who knows how many more in the years and decades to come. </span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">ONE was enough for me, My Mom, hvCJD, DOD 12/14/97 confirmed, which is nothing more than another mans name added to CJD, like CJD itself, Jakob and Creutzfeldt, or Gerstmann-Straussler-Scheinker syndrome, just another CJD or human TSE, named after another human. </span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">WE are only kidding ourselves with the current diagnostic criteria for human and animal TSE, especially differentiating between the nvCJD vs the sporadic CJD strains and then the GSS strains and also the FFI fatal familial insomnia strains or the ones that mimics one or the other of those TSE? </span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Tissue infectivity and strain typing of the many variants of the human and animal TSEs are paramount in all variants of all TSE. </span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">There must be a proper classification that will differentiate between all these human TSE in order to do this. </span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">With the CDI and other more sensitive testing coming about, I only hope that my proposal will some day be taken seriously.</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">My name is Terry S. Singeltary Sr. and I am no scientist, no doctor and have no PhDs, but have been independently researching human and animal TSEs since the death of my Mother to the Heidenhain Variant of Creutzfeldt Jakob Disease on December 14, 1997 'confirmed'.</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">...END</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Diagnosis and Reporting of Creutzfeldt-Jakob Disease </span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Singeltary, Sr et al. JAMA.2001; 285: 733-734. Vol. 285 No. 6, February 14, 2001 JAMA Diagnosis and Reporting of Creutzfeldt-Jakob Disease </span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">To the Editor: </span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">In their Research Letter, Dr Gibbons and colleagues1 reported that the annual US death rate due to Creutzfeldt-Jakob disease (CJD) has been stable since 1985. These estimates, however, are based only on reported cases, and do not include misdiagnosed or preclinical cases. It seems to me that misdiagnosis alone would drastically change these figures. An unknown number of persons with a diagnosis of Alzheimer disease in fact may have CJD, although only a small number of these patients receive the postmortem examination necessary to make this diagnosis. Furthermore, only a few states have made CJD reportable. Human and animal transmissible spongiform encephalopathies should be reportable nationwide and internationally.. </span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Terry S. Singeltary, Sr Bacliff, Tex </span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">1. Gibbons RV, Holman RC, Belay ED, Schonberger LB. Creutzfeldt-Jakob disease in the United States: 1979-1998. JAMA. 2000;284:2322-2323. </span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><a fg_scanned="1" href="http://jama.jamanetwork.com/article.aspx?articleid=1031186" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">http://jama.jamanetwork.com/article.aspx?articleid=1031186</a><br clear="none" style="line-height: 1.22em;" /></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Diagnosis and Reporting of Creutzfeldt-Jakob Disease</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Singeltary, Sr et al. JAMA.2001; 285: 733-734.</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><a fg_scanned="1" href="http://jama.ama-assn.org/http://www.neurology.org/cgi/eletters/60/2/176#535" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">http://jama.ama-assn.org/http://www...neurology.org/cgi/eletters/60/2/176#535</a><br clear="none" style="line-height: 1.22em;" /></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">BRITISH MEDICAL JOURNAL</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">BMJ</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">U.S. Scientist should be concerned with a CJD epidemic in the U.S., as well....</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">02 January 2000</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Terry S Singeltary</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">retired</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><a fg_scanned="1" href="https://www.bmj.com/rapid-response/2011/10/28/us-scientist-should-be-concerned-cjd-epidemic-us-well" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">https://www...bmj.com/rapid-response/2011/10/28/us-scientist-should-be-concerned-cjd-epidemic-us-well</a><br clear="none" style="line-height: 1.22em;" /></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">US scientists develop a possible test for BSE</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">BMJ 1999; 319 doi: <a fg_scanned="1" href="https://doi.org/10.1136/bmj.319.7220.1312b" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">https://doi.org/10.1136/bmj.319.7220.1312b</a> (Published 13 November 1999) Cite this as: BMJ 1999;319:1312</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Rapid responses Response</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Re: vCJD in the USA * BSE in U.S.</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">15 November 1999</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Terry S Singeltary</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">NA</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">medically retired</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><a fg_scanned="1" href="https://www.bmj.com/rapid-response/2011/10/28/re-vcjd-usa-bse-us" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">https://www.bmj.com/rapid-response/2011/10/28/re-vcjd-usa-bse-us</a><br clear="none" style="line-height: 1.22em;" /></div><div style="font-size: small; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-size: small; line-height: 1.22em;"><div style="line-height: 1.22em;"><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">doi:10.1016/S1473-3099(03)00715-1 Copyright © 2003 Published by Elsevier Ltd. Newsdesk</span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Tracking spongiform encephalopathies in North America</span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Xavier Bosch</span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Available online 29 July 2003. </span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Volume 3, Issue 8, August 2003, Page 463 </span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">“My name is Terry S Singeltary Sr, and I live in Bacliff, Texas. I lost my mom to hvCJD (Heidenhain variant CJD) and have been searching for answers ever since. What I have found is that we have not been told the truth. CWD in deer and elk is a small portion of a much bigger problem..” ............................ </span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><a fg_scanned="1" href="http://www.thelancet.com/journals/laninf/article/PIIS1473309903007151/fulltext" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">http://www.thelancet.com/journals/laninf/article/PIIS1473309903007151/fulltext</a><br clear="none" style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><a href="http://download.thelancet.com/pdfs/journals/1473-3099/PIIS1473309903007151.pdf" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">http://download.thelancet..com/pdfs/journals/1473-3099/PIIS1473309903007151.pdf</a> </span></div></div></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">January 28, 2003; 60 (2) VIEWS & REVIEWS</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Ermias D. Belay, Ryan A. Maddox, Pierluigi Gambetti, Lawrence B. Schonberger</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="line-height: 1.22em;">First published January 28, 2003, DOI: <a fg_scanned="1" href="https://doi.org/10.1212/01.WNL.0000036913.87823.D6" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">https://doi.org/10.1212/01.WNL.0000036913.87823.D6</a></span></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Abstract</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Transmissible spongiform encephalopathies (TSEs) attracted increased attention in the mid-1980s because of the emergence among UK cattle of bovine spongiform encephalopathy (BSE), which has been shown to be transmitted to humans, causing a variant form of Creutzfeldt-Jakob disease (vCJD). The BSE outbreak has been reported in 19 European countries, Israel, and Japan, and human cases have so far been identified in four European countries, and more recently in a Canadian resident and a US resident who each lived in Britain during the BSE outbreak. To monitor the occurrence of emerging forms of CJD, such as vCJD, in the United States, the Centers for Disease Control and Prevention has been conducting surveillance for human TSEs through several mechanisms, including the establishment of the National Prion Disease Pathology Surveillance Center. Physicians are encouraged to maintain a high index of suspicion for vCJD and use the free services of the pathology center to assess the neuropathology of clinically diagnosed and suspected cases of CJD or other TSEs.</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Received May 7, 2002. Accepted August 28, 2002.</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><a fg_scanned="1" href="http://n.neurology.org/content/60/2/176.long" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">http://n.neurology.org/content/60/2/176.long</a> </span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States </span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Terry S. Singeltary, retired (medically) </span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Published March 26, 2003</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">26 March 2003</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Terry S. Singeltary, retired (medically) CJD WATCH</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to comment on the CDC's attempts to monitor the occurrence of emerging forms of CJD. Asante, Collinge et al [1] have reported that BSE transmission to the 129-methionine genotype can lead to an alternate phenotype that is indistinguishable from type 2 PrPSc, the commonest sporadic CJD. However, CJD and all human TSEs are not reportable nationally. CJD and all human TSEs must be made reportable in every state and internationally. I hope that the CDC does not continue to expect us to still believe that the 85%+ of all CJD cases which are sporadic are all spontaneous, without route/source. We have many TSEs in the USA in both animal and man. CWD in deer/elk is spreading rapidly and CWD does transmit to mink, ferret, cattle, and squirrel monkey by intracerebral inoculation. With the known incubation periods in other TSEs, oral transmission studies of CWD may take much longer. Every victim/family of CJD/TSEs should be asked about route and source of this agent. To prolong this will only spread the agent and needlessly expose others. In light of the findings of Asante and Collinge et al, there should be drastic measures to safeguard the medical and surgical arena from sporadic CJDs and all human TSEs. I only ponder how many sporadic CJDs in the USA are type 2 PrPSc?</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><a fg_scanned="1" href="http://n.neurology.org/content/re-monitoring-occurrence-emerging-forms-creutzfeldt-jakob-disease-united-states" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">http://n.neurology.org/content/re-monitoring-occurrence-emerging-forms-creutzfeldt-jakob-disease-united-states</a><br clear="none" style="line-height: 1.22em;" /></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Reply to Singletary Ryan A. Maddox, MPH Other Contributors: Published March 26, 2003 </span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Mr. Singletary raises several issues related to current Creutzfeldt- Jakob disease (CJD) surveillance activities. Although CJD is not a notifiable disease in most states, its unique characteristics, particularly its invariably fatal outcome within usually a year of onset, make routine mortality surveillance a useful surrogate for ongoing CJD surveillance.[1] In addition, because CJD is least accurately diagnosed early in the course of illness, notifiable-disease surveillance could be less accurate than, if not duplicative of, current mortality surveillance.[1] However, in states where making CJD officially notifiable would meaningfully facilitate the collection of data to monitor for variant CJD (vCJD) or other emerging prion diseases, CDC encourages the designation of CJD as a notifiable disease.[1] Moreover, CDC encourages physicians to report any diagnosed or suspected CJD cases that may be of special public health importance (e.g...., vCJD, iatrogenic CJD, unusual CJD clusters).</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">As noted in our article, strong evidence is lacking for a causal link between chronic wasting disease (CWD) of deer and elk and human disease,[2] but only limited data seeking such evidence exist. Overall, the previously published case-control studies that have evaluated environmental sources of infection for sporadic CJD have not consistently identified strong evidence for a common risk factor.[3] However, the power of a case-control study to detect a rare cause of CJD is limited, particularly given the relatively small number of subjects generally involved and its long incubation period, which may last for decades. Because only a very small proportion of the US population has been exposed to CWD, a targeted surveillance and investigation of unusual cases or case clusters of prion diseases among persons at increased risk of exposure to CWD is a more efficient approach to detecting the possible transmission of CWD to humans. In collaboration with appropriate local and state health departments and the National Prion Disease Pathology Surveillance Center, CDC is facilitating or conducting such surveillance and case- investigations, including related laboratory studies to characterize CJD and CWD prions.</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Mr. Singletary also expresses concern over a recent publication by Asante and colleagues indicating the possibility that some sporadic CJD cases may be attributable to bovine spongiform encephalopathy (BSE).[4] The authors reported that transgenic mice expressing human prion protein homozygous for methionine at codon 129, when inoculated with BSE prions, developed a molecular phenotype consistent with a subtype of sporadic CJD. Although the authors implied that BSE might cause a sporadic CJD-like illness among persons homozygous for methionine, the results of their research with mice do not necessarily directly apply to the transmission of BSE to humans. If BSE causes a sporadic CJD-like illness in humans, an increase in sporadic CJD cases would be expected to first occur in the United Kingdom, where the vast majority of vCJD cases have been reported. In the United Kingdom during 1997 through 2002, however, the overall average annual mortality rate for sporadic CJD was not elevated; it was about 1 case per million population per year. In addition, during this most recent 6-year period following the first published description of vCJD in 1996, there was no increasing trend in the reported annual number of UK sporadic CJD deaths.[3, 5] Furthermore, surveillance in the UK has shown no increase in the proportion of sporadic CJD cases that are homozygous for methionine (Will RG, National CJD Surveillance Unit, United Kingdom, 2003; personal communication)..</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">References</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">1. Gibbons RV, Holman RC, Belay ED, Schonberger LB. Diagnosis and reporting of Creutzfeldt-Jakob disease. JAMA 2001;285:733-734.</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">2. Belay ED, Maddox RA, Gambetti P, Schonberger LB. Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States. Neurology 2003;60:176-181.</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">3. Belay ED. Transmissible spongiform encephalopathies in humans. Annu Rev Microbiol 1999;53:283-314.</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">4. Asante EA, Linehan JM, Desbruslais M, et al. BSE prions propagate as either variant CJD-like or sporadic CJD-like prion strains in transgenic mice expressing human prion protein. EMBO J 2002;21:6358-6366.</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">5. The UK Creutzfeldt-Jakob Disease Surveillance Unit. CJD statistics. Available at: <a fg_scanned="1" href="http://www.cjd.ed.ac.uk/figures.htm" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">http://www.cjd.ed.ac.uk/figures.htm</a>. Accessed February 18, 2003.</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Competing Interests: None declared.</span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><a fg_scanned="1" href="http://n.neurology.org/content/reply-singletary" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">http://n.neurology.org/content/reply-singletary</a> </span></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><span style="line-height: 1.22em;"></span></span><div style="line-height: 1.22em;">Volume 2: Science </div><div style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;">4. The link between BSE and vCJD </div><div style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;">Summary 4.29 The evidence discussed above that vCJD is caused by BSE seems overwhelming. Uncertainties exist about the cause of CJD in farmers, their wives and in several abattoir workers. It seems that farmers at least might be at higher risk than others in the general population. 1 Increased ascertainment (ie, increased identification of cases as a result of greater awareness of the condition) seems unlikely, as other groups exposed to risk, such as butchers and veterinarians, do not appear to have been affected. The CJD in farmers seems to be similar to other sporadic CJD in age of onset, in respect to glycosylation patterns, and in strain-typing in experimental mice. Some farmers are heterozygous for the methionine/valine variant at codon 129, and their lymphoreticular system (LRS) does not contain the high levels of PrPSc found in vCJD. </div><div style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;">***>It remains a remote possibility that when older people contract CJD from BSE the resulting phenotype is like sporadic CJD and is distinct from the vCJD phenotype in younger people...end</div><div style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;">BSE INQUIRY</div><div style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;"><a fg_scanned="1" href="https://bseinquiry.blogspot.com/2008/05/sporadic-cjd-in-farmers-farmers-wives.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">https://bseinquiry.blogspot.com/2008/05/sporadic-cjd-in-farmers-farmers-wives.html</a> </div><div style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;">SATURDAY, JUNE 23, 2018</div><div style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;">CDC </div><div style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;">***> Diagnosis of Methionine/Valine Variant Creutzfeldt-Jakob Disease by Protein Misfolding Cyclic Amplification </div><div style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;">Volume 24, Number 7—July 2018 Dispatch </div><div style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;"><a fg_scanned="1" href="https://wwwnc.cdc.gov/eid/article/24/7/17-2105_article" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">https://wwwnc.cdc.gov/eid/article/24/7/17-2105_article</a> </div><div style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;"><a fg_scanned="1" href="http://vcjd.blogspot.com/2018/06/diagnosis-of-methioninevaline-variant.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">http://vcjd.blogspot.com/2018/06/diagnosis-of-methioninevaline-variant.html</a><br clear="none" style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div></div><div style="font-size: small; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Singeltary comments;</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><span style="font-size: 10pt; line-height: 1.22em;">Re-Evidence for human transmission of amyloid-β pathology and cerebral amyloid angiopathy </span><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><span style="font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-size: small; line-height: 1.22em;"><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">>>> The only tenable public line will be that "more research is required’’ <<< </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">>>> possibility on a transmissible prion remains open<<< </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">O.K., so it’s about 23 years later, so somebody please tell me, when is "more research is required’’ enough time for evaluation ? </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Re-Evidence for human transmission of amyloid-β pathology and cerebral amyloid angiopathy </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Nature 525, 247?250 (10 September 2015) doi:10.1038/nature15369 Received 26 April 2015 Accepted 14 August 2015 Published online 09 September 2015 Updated online 11 September 2015 Erratum (October, 2015) </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">snip...see full Singeltary Nature comment here; </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Alzheimer's disease</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">let's not forget the elephant in the room. curing Alzheimer's would be a great and wonderful thing, but for starters, why not start with the obvious, lets prove the cause or causes, and then start to stop that. think iatrogenic, friendly fire, or the pass it forward mode of transmission. think medical, surgical, dental, tissue, blood, related transmission. think transmissible spongiform encephalopathy aka tse prion disease aka mad cow type disease... </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Commentary: Evidence for human transmission of amyloid-β pathology and cerebral amyloid angiopathy</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><a fg_scanned="1" href="http://journals.plos.org/plosone/article/comment?id=info:doi/10.1371/annotation/933cc83a-a384-45c3-b3b2-336882c30f9d" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; font-size: 10pt; line-height: 1.22em;" target="_blank">http://journals.plos.org/plosone/article/comment?id=info:doi/10.1371/annotation/933cc83a-a384-45c3-b3b2-336882c30f9d</a><br /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><a fg_scanned="1" href="http://journals.plos.org/plosone/article/comments?id=10.1371/journal.pone.0111492" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">http://journals.plos.org/plosone/article/comments?id=10.1371/journal.pone.0111492</a><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><a fg_scanned="1" href="http://journals.plos.org/plosone/article/comment?id=10.1371/annotation/933cc83a-a384-45c3-b3b2-336882c30f9d" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">http://journals.plos.org/plosone/article/comment?id=10.1371/annotation/933cc83a-a384-45c3-b3b2-336882c30f9d</a><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><a fg_scanned="1" href="https://www.frontiersin.org/articles/10.3389/fnagi.2016.00005/full" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">https://www.frontiersin.org/articles/10.3389/fnagi.2016.00005/full</a><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Self-Propagative Replication of Ab Oligomers Suggests Potential Transmissibility in Alzheimer Disease </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">*** Singeltary comment PLoS *** </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Alzheimer’s disease and Transmissible Spongiform Encephalopathy prion disease, Iatrogenic, what if ? </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Posted by flounder on 05 Nov 2014 at 21:27 GMT </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><a fg_scanned="1" href="http://www.plosone.org/annotation/listThread.action?root=82860" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">http://www.plosone.org/annotation/listThread.action?root=82860</a><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">IN CONFIDENCE</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">5 NOVEMBER 1992</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">TRANSMISSION OF ALZHEIMER TYPE PLAQUES TO PRIMATES</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">[9. Whilst this matter is not at the moment directly concerned with the iatrogenic CJD cases from hgH, there remains a possibility of litigation here, and this presents an added complication. </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">There are also results to be made available shortly </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">(1) concerning a farmer with CJD who had BSE animals, </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">(2) on the possible transmissibility of Alzheimer’s and </div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">(3) a CMO letter on prevention of iatrogenic CJD transmission in neurosurgery, all of which will serve to increase media interest.]</div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><a href="https://web.archive.org/web/20170126060344/http://collections.europarchive.org/tna/20080102232842/http://www.bseinquiry.gov.uk/files/yb/1992/11/04001001.pdf" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">https://web.archive.org/web/20170126060344/http://collections.europarchive.org/tna/20080102232842/http://www.bseinquiry.gov.uk/files/yb/1992/11/04001001.pdf</a><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><a href="https://web.archive.org/web/20040315075058/http://www.bseinquiry.gov.uk/files/yb/1992/12/16005001.pdf" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">https://web.archive.org/web/20040315075058/http://www.bseinquiry.gov.uk/files/yb/1992/12/16005001.pdf</a><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><a href="https://web.archive.org/web/20040315075058/www.bseinquiry.gov.uk/files/yb/1992/12/16005001.pdf" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">https://web.archive.org/web/20040315075058/www.bseinquiry.gov.uk/files/yb/1992/12/16005001.pdf</a></div></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;"><div style="color: #333333; font-family: arial; font-size: small; line-height: 1.22em; margin: 0px 0px 0.75em;"><span style="line-height: 1.22em;">P132 Aged cattle brain displays Alzheimer’s-like pathology that can be propagated in a prionlike manner</span></div><div style="color: #333333; font-family: arial; font-size: small; line-height: 1.22em; margin: 0px 0px 0.75em;"><span style="line-height: 1.22em;">Ines Moreno-Gonzalez (1), George Edwards III (1), Rodrigo Morales (1), Claudia Duran-Aniotz (1), Mercedes Marquez (2), Marti Pumarola (2), Claudio Soto (1) </span></div><div style="color: #333333; font-family: arial; font-size: small; line-height: 1.22em; margin: 0px 0px 0.75em;"><span style="line-height: 1.22em;">snip...</span></div><div style="color: #333333; font-family: arial; font-size: small; line-height: 1.22em; margin: 0px 0px 0.75em;"><span style="line-height: 1.22em;">These results may contribute to uncover a previously unsuspected etiology surrounding some cases of sporadic AD. However, the early and controversial stage of the field of prion-like transmission in non-prion diseases added to the artificial nature of the animal models utilized for these studies, indicate that extrapolation of the results to humans should not be done without further experiments. </span><br clear="none" style="line-height: 1.22em;" /></div><div style="color: #333333; font-family: arial; font-size: small; line-height: 1.22em; margin: 0px 0px 0.75em;"><span style="line-height: 1.22em;">P75 Determining transmissibility and proteome changes associated with abnormal bovine prionopathy </span></div><div style="color: #333333; font-family: arial; font-size: small; line-height: 1.22em; margin: 0px 0px 0.75em;"><span style="line-height: 1.22em;">Dudas S (1,2), Seuberlich T (3), Czub S (1,2) </span></div><div style="color: #333333; font-family: arial; font-size: small; line-height: 1.22em; margin: 0px 0px 0.75em;"><span style="line-height: 1.22em;">1. Canadian Food Inspection Agency, NCAD Lethbridge Laboratory, Canada 2. University of Calgary, Canada 3. University of Bern, Switzerland. </span></div><div style="color: #333333; font-family: arial; font-size: small; line-height: 1.22em; margin: 0px 0px 0.75em;"><span style="line-height: 1.22em;">In prion diseases, it is believed that altered protein conformation encodes for different pathogenic strains. Currently 3 different strains of bovine spongiform encephalopathy (BSE) are confirmed. Diagnostic tests for BSE are able to identify animals infected with all 3 strains, however, several diagnostic laboratories have reported samples with inconclusive results which are challenging to classify. It was suggested that these may be novel strains of BSE; to determine transmissibility, brain material from index cases were inoculated into cattle. </span></div><div style="color: #333333; font-family: arial; font-size: small; line-height: 1.22em; margin: 0px 0px 0.75em;"><span style="line-height: 1.22em;">In the first passage, cattle were intra-cranially challenged with brain homogenate from 2 Swiss animals with abnormal prionopathy. The challenged cattle incubated for 3 years and were euthanized with no clinical signs of neurologic disease... Animals were negative when tested on validated diagnostic tests but several research methods demonstrated changes in the prion conformation in these cattle, including density gradient centrifugation and immunohistochemistry.. Currently, samples from the P1 animals are being tested for changes in protein levels using 2-D Fluorescence Difference Gel Electrophoresis (2D DIGE) and mass spectrometry. It is anticipated that, if a prionopathy is present, this approach should identify pathways and targets to decipher the source of altered protein conformation. In addition, a second set of cattle have been challenged with brain material from the first passage. Ideally, these cattle will be given a sufficient incubation period to provide a definitive answer to the question of transmissibility. </span></div><div style="color: #333333; font-family: arial; font-size: small; line-height: 1.22em; margin: 0px 0px 0.75em;"><span style="line-height: 1.22em;">=====prion 2018===</span></div><div style="color: #333333; font-family: arial; font-size: small; line-height: 1.22em; margin: 0px 0px 0.75em;"><span style="line-height: 1.22em;"><a href="https://prion2018.org/wp-content/uploads/2018/05/program.pdf" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">https://prion2018.org/wp-content/uploads/2018/05/program.pdf</a><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em; margin: 0px 0px 0.75em;"><div style="color: #333333; font-family: arial; font-size: small; line-height: 1.22em; margin: 0px 0px 0.75em;"><a fg_scanned="1" href="https://prion2018.org/" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">https://prion2018.org/</a></div><div style="color: #333333; font-family: arial; font-size: small; line-height: 1.22em; margin: 0px 0px 0.75em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="line-height: 1.22em; margin: 0px 0px 0.75em;"><div style="line-height: 1.22em;"><div style="background-color: #fff3db; line-height: 1.22em;"><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">***however in 1 C-type challenged animal, Prion 2015 Poster Abstracts </div><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">S67 PrPsc was not detected using rapid tests for BSE.</div><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">***Subsequent testing resulted in the detection of pathologic lesion in unusual brain location and PrPsc detection by PMCA only.</div><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">*** IBNC Tauopathy or TSE Prion disease, it appears, no one is sure ***</div><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">Posted by Terry S. Singeltary Sr. on 03 Jul 2015 at 16:53 GMT</div><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><a fg_scanned="1" href="http://www.plosone.org/annotation/listThread.action?root=86610" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">http://www.plosone.org/annotation/listThread.action?root=86610</a></div><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="background-color: white; line-height: 1.22em;"><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;">P.9.21</span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;">Molecular characterization of BSE in Canada</span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;">Jianmin Yang1, Sandor Dudas2, Catherine Graham2, Markus Czub3, Tim McAllister1, Stefanie Czub1 1Agriculture and Agri-Food Canada Research Centre, Canada; 2National and OIE BSE Reference Laboratory, Canada; 3University of Calgary, Canada</span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;">Background: Three BSE types (classical and two atypical) have been identified on the basis of molecular characteristics of the misfolded protein associated with the disease. To date, each of these three types have been detected in Canadian cattle.</span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;">Objectives: This study was conducted to further characterize the 16 Canadian BSE cases based on the biochemical properties of there associated PrPres. Methods: Immuno-reactivity, molecular weight, glycoform profiles and relative proteinase K sensitivity of the PrPres from each of the 16 confirmed Canadian BSE cases was determined using modified Western blot analysis.</span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;">Results: Fourteen of the 16 Canadian BSE cases were C type, 1 was H type and 1 was L type. The Canadian H and L-type BSE cases exhibited size shifts and changes in glycosylation similar to other atypical BSE cases. PK digestion under mild and stringent conditions revealed a reduced protease resistance of the atypical cases compared to the C-type cases. N terminal- specific antibodies bound to PrPres from H type but not from C or L type. The C-terminal-specific antibodies resulted in a shift in the glycoform profile and detected a fourth band in the Canadian H-type BSE.</span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;">Discussion: The C, L and H type BSE cases in Canada exhibit molecular characteristics similar to those described for classical and atypical BSE cases from Europe and Japan. This supports the theory that the importation of BSE contaminated feedstuff is the source of C-type BSE in Canada.</span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;">*** It also suggests a similar cause or source for atypical BSE in these countries.</span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;"><span style="line-height: 1.22em;"><a href="http://www.prion2009.com/sites/default/files/Prion2009_Book_of_Abstracts.pdf" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">http://www.prion2009.com/sites/default/files/Prion2009_Book_of_Abstracts.pdf</a></span></span></div></div></div><div style="background-color: #fff3db; line-height: 1.22em;"><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">*** This supports the theory that the importation of BSE contaminated feedstuff is the source of C-type BSE in Canada.</div><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">*** It also suggests a similar cause or source for atypical BSE in these countries. ***</div><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">see page 176 of 201 pages...tss</div><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><a href="http://www.neuroprion.org/resources/pdf_docs/conferences/prion2009/prion2009_bookofabstracts.pdf" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">http://www.neuroprion.org/resources/pdf_docs/conferences/prion2009/prion2009_bookofabstracts.pdf</a></div><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;">*** Singeltary reply ; Molecular, Biochemical and Genetic Characteristics of BSE in Canada Singeltary reply;</div><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><a fg_scanned="1" href="http://www.plosone.org/annotation/listThread.action;jsessionid=635CE9094E0EA15D5362B7D7B809448C?root=7143" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">http://www.plosone.org/annotation/listThread.action;jsessionid=635CE9094E0EA15D5362B7D7B809448C?root=7143</a></div><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><a fg_scanned="1" href="http://bovineprp.blogspot.com/2018/02/" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">http://bovineprp.blogspot.com/2018/02/</a><br clear="none" style="line-height: 1.22em;" /></div><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="background-color: white; line-height: 1.22em;"><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;">P98 The agent of H-type bovine spongiform encephalopathy associated with E211K prion protein polymorphism transmits after oronasal challenge </span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;">Greenlee JJ (1), Moore SJ (1), and West Greenlee MH (2) (1) United States Department of Agriculture, Agricultural Research Service, National Animal Disease Center, Virus and Prion Research Unit, Ames, IA, United States (2) Department of Biomedical Sciences, Iowa State University College of Veterinary Medicine, Ames, IA, United States. </span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;">reading up on this study from Prion 2018 Conference, very important findings ;</span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;">***> This study demonstrates that the H-type BSE agent is transmissible by the oronasal route. </span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;">***> These results reinforce the need for ongoing surveillance for classical and atypical BSE to minimize the risk of potentially infectious tissues entering the animal or human food chains. </span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><a fg_scanned="1" href="http://bovineprp.blogspot.com/2018/08/the-agent-of-h-type-bovine-spongiform.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">http://bovineprp.blogspot.com/2018/08/the-agent-of-h-type-bovine-spongiform.html</a><br clear="none" style="line-height: 1.22em;" /></div></div><div style="background-color: white; color: #29303b; font-family: arial, helvetica; font-size: 10pt; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="background-color: white; line-height: 1.22em;"><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;">WEDNESDAY, AUGUST 15, 2018 </span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;">The agent of H-type bovine spongiform encephalopathy associated with E211K prion protein polymorphism transmits after oronasal challenge</span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><a fg_scanned="1" href="http://bovineprp.blogspot.com/2018/08/the-agent-of-h-type-bovine-spongiform.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">http://bovineprp.blogspot.com/2018/08/the-agent-of-h-type-bovine-spongiform.html</a><br clear="none" style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="line-height: 1.22em;"><span style="color: #29303b; font-family: arial, helvetica; line-height: 1.22em;"><span style="line-height: 1.22em;"></span></span><div style="line-height: 1.22em;">MONDAY, JANUARY 09, 2017 </div><div style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;">Oral Transmission of L-Type Bovine Spongiform Encephalopathy Agent among Cattle </div><div style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;">CDC Volume 23, Number 2—February 2017 </div><div style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;">*** Consumption of L-BSE–contaminated feed may pose a risk for oral transmission of the disease agent to cattle.</div><div style="line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></div><div style="line-height: 1.22em;"><a fg_scanned="1" href="https://wwwnc.cdc.gov/eid/article/23/2/16-1416_article" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">https://wwwnc.cdc.gov/eid/article/23/2/16-1416_article</a></div><div style="line-height: 1.22em;"><br /></div><div style="line-height: 1.22em;"><br /></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></blockquote><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Friday, December 14, 2012</span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">DEFRA U.K. What is the risk of Chronic Wasting Disease CWD being introduced into Great Britain? A Qualitative Risk Assessment October 2012</span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">snip.....</span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">In the USA, under the Food and Drug Administration's BSE Feed Regulation (21 CFR 589.2000) most material (exceptions include milk, tallow, and gelatin) from deer and elk is prohibited for use in feed for ruminant animals. With regards to feed for non-ruminant animals, under FDA law, CWD positive deer may not be used for any animal feed or feed ingredients. For elk and deer considered at high risk for CWD, the FDA recommends that these animals do not enter the animal feed system. However, this recommendation is guidance and not a requirement by law.</span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Animals considered at high risk for CWD include:</span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">1) animals from areas declared to be endemic for CWD and/or to be CWD eradication zones and</span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">2) deer and elk that at some time during the 60-month period prior to slaughter were in a captive herd that contained a CWD-positive animal.</span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Therefore, in the USA, materials from cervids other than CWD positive animals may be used in animal feed and feed ingredients for non-ruminants.</span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">The amount of animal PAP that is of deer and/or elk origin imported from the USA to GB can not be determined, however, as it is not specified in TRACES. It may constitute a small percentage of the 8412 kilos of non-fish origin processed animal proteins that were imported from US into GB in 2011.</span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Overall, therefore, it is considered there is a __greater than negligible risk___ that (nonruminant) animal feed and pet food containing deer and/or elk protein is imported into GB.</span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">There is uncertainty associated with this estimate given the lack of data on the amount of deer and/or elk protein possibly being imported in these products.</span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">snip.....</span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">36% in 2007 (Almberg et al., 2011). In such areas, population declines of deer of up to 30 to 50% have been observed (Almberg et al., 2011). In areas of Colorado, the prevalence can be as high as 30% (EFSA, 2011).</span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">The clinical signs of CWD in affected adults are weight loss and behavioural changes that can span weeks or months (Williams, 2005). In addition, signs might include excessive salivation, behavioural alterations including a fixed stare and changes in interaction with other animals in the herd, and an altered stance (Williams, 2005). These signs are indistinguishable from cervids experimentally infected with bovine spongiform encephalopathy (BSE).</span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Given this, if CWD was to be introduced into countries with BSE such as GB, for example, infected deer populations would need to be tested to differentiate if they were infected with CWD or BSE to minimise the risk of BSE entering the human food-chain via affected venison.</span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">snip.....</span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">The rate of transmission of CWD has been reported to be as high as 30% and can approach 100% among captive animals in endemic areas (Safar et al., 2008).</span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">snip.....</span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">In summary, in endemic areas, there is a medium probability that the soil and surrounding environment is contaminated with CWD prions and in a bioavailable form. In rural areas where CWD has not been reported and deer are present, there is a greater than negligible risk the soil is contaminated with CWD prion.</span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">snip.....</span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">In summary, given the volume of tourists, hunters and servicemen moving between GB and North America, the probability of at least one person travelling to/from a CWD affected area and, in doing so, contaminating their clothing, footwear and/or equipment prior to arriving in GB is greater than negligible... For deer hunters, specifically, the risk is likely to be greater given the increased contact with deer and their environment. However, there is significant uncertainty associated with these estimates.</span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">snip.....</span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">Therefore, it is considered that farmed and park deer may have a higher probability of exposure to CWD transferred to the environment than wild deer given the restricted habitat range and higher frequency of contact with tourists and returning GB residents.</span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">snip.....</span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><a href="https://web.archive.org/web/20170404125557/http://webarchive.nationalarchives.gov.uk/20130822084033/http://www.defra.gov.uk/animal-diseases/files/qra_chronic-wasting-disease-121029.pdf" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">https://web.archive.org/web/20170404125557/http://webarchive.nationalarchives.gov.uk/20130822084033/http://www.defra.gov.uk/animal-diseases/files/qra_chronic-wasting-disease-121029.pdf</a><br clear="none" style="line-height: 1.22em;" /></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">TUESDAY, APRIL 18, 2017 </span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;">*** EXTREME USA FDA PART 589 TSE PRION FEED LOOP HOLE STILL EXIST, AND PRICE OF POKER GOES UP ***</span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><span style="font-family: arial, helvetica; line-height: 1.22em;"><br clear="none" style="line-height: 1.22em;" /></span></div><div style="font-family: arial, helvetica; line-height: 1.22em;"><a fg_scanned="1" href="http://usdameatexport.blogspot.com/2017/04/extreme-usa-fda-part-589-tse-prion-feed.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; line-height: 1.22em;" target="_blank">http://usdameatexport.blogspot.com/2017/04/extreme-usa-fda-part-589-tse-prion-feed.html</a></div></div><div><br /></div><div><br /></div><div>wasted days and wasted nights...Freddy Fender</div><div><br /></div><div>kind regards, terry,</div><div><br /></div><div>Terry S. Singeltary Sr., flounder9@verizon.net Bacliff, Texas USA Galveston Bay...on the bottom</div></div><div style="background-color: white; font-family: arial; font-size: small;"><br /></div><div style="background-color: white; font-family: arial; font-size: small;"><br /></div><div style="background-color: white; font-family: arial; font-size: small;"><span style="font-size: 13.3333px;">MONDAY, FEBRUARY 25, 2019 </span></div><div style="background-color: white; font-family: arial; font-size: small;"><span style="font-size: 13.3333px;"><br /></span></div><div style="background-color: white; font-family: arial; font-size: small;"><span style="font-size: 13.3333px;">MAD DOGS AND ENGLISHMEN BSE, SCRAPIE, CWD, CJD, TSE PRION A REVIEW 2019</span><br /></div><div style="background-color: white; font-family: arial; font-size: small;"><span style="font-size: 13.3333px;"><br /></span></div><div style="background-color: white; font-family: arial; font-size: small;"><span style="font-size: 13.3333px;"><a fg_scanned="1" href="https://bseinquiry.blogspot.com/2019/02/mad-dogs-and-englishmen-bse-scrapie-cwd.html" rel="nofollow noopener noreferrer" style="color: #196ad4;" target="_blank">https://bseinquiry.blogspot.com/2019/02/mad-dogs-and-englishmen-bse-scrapie-cwd.html</a></span></div>Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-4687453285836897153.post-7724049951836863042019-02-21T20:19:00.001-06:002019-02-21T20:29:36.103-06:00Professor Richard Lacey, microbiologist rubbished but later vindicated for warning that BSE could be transmitted to humans – obituary<div class="yiv4001062161row yiv4001062161article__breadcrumb" style="background-color: white; font-family: arial; font-size: small; margin: 0px -16px; padding-left: 16px; padding-right: 16px;">
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Professor Richard Lacey, microbiologist rubbished but later vindicated for warning that BSE could be transmitted to humans – obituary</h1>
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<span class="yiv4001062161article-date yiv4001062161component ">21 FEBRUARY 2019 • 8:32PM</span></div>
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<span class="yiv4001062161m_first-letter yiv4001062161m_first-letter--flagged" style="color: #93030e; float: left; font-family: "news deck georgia" , "times" , serif; margin-top: 4px; padding-right: 2px; text-transform: uppercase;">P</span>rofessor Richard Lacey, who has died aged 78, was the dissident Leeds University medical microbiologist who in 1990 first alerted the British public to the link between the cattle disease Bovine Spongiform Encephalopathy (BSE or “Mad Cow Disease”) and its human equivalent, Creutzfeldt-Jakob Disease (CJD).</div>
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Warning of a future of hospital wards full of “thousands of people going slowly and painfully mad before dying”, he called in a Sunday Times interview for the slaughter of all BSE-infected herds (translated by the paper into the headline, “Leading Food Scientist Calls for Slaughter of 6 Million Cows”). The article provoked a carpet bombing of reassuring press releases from the Ministry of Agriculture...</div>
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<a href="https://www.telegraph.co.uk/obituaries/2019/02/21/professor-richard-lacey-microbiologist-rubbished-later-vindicated/" rel="noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://www.telegraph.co.uk/obituaries/2019/02/21/professor-richard-lacey-microbiologist-rubbished-later-vindicated/</a></div>
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<tr valign="top"><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;">10</span></td><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;">Lacey, Professor Richard</span></td><td style="outline: none;"></td><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/20080725213429/http://www.bseinquiry.gov.uk/files/ws/s010.pdf" rel="noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">click here to download</a></span></td></tr>
<tr valign="top"><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;">10A</span></td><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;">Lacey, Professor Richard</span></td><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;">Proposed amendments to the transcript for Day 5, 17/03/1998.</span></td><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/20080725213429/http://www.bseinquiry.gov.uk/files/ws/s010a.pdf" rel="noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">click here to download</a></span></td></tr>
<tr valign="top"><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;">10Ax</span></td><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;">Lacey, Professor Richard</span></td><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;">Annex to statement no. 10. Corrected transcript for Day 5, 17/03/1998.</span></td><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/20080725213429/http://www.bseinquiry.gov.uk/files/ws/s010ax.pdf" rel="noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">click here to download</a></span></td></tr>
<tr valign="top"><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;">10xi</span></td><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;">Lacey, Professor Richard</span></td><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;">Annex 1 to statement no. 10. CV and list of</span></td><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/20080725213429/http://www.bseinquiry.gov.uk/files/ws/s010xi.pdf" rel="noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">click here to download</a></span></td></tr>
<tr valign="top"><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;">10xii</span></td><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;">Lacey, Professor Richard</span></td><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;">Annex 2 to statement no. 10. Article by Dr</span></td><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/20080725213429/http://www.bseinquiry.gov.uk/files/ws/s010xii.pdf" rel="noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">click here to download</a></span></td></tr>
<tr valign="top"><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;">10xiii</span></td><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;">Lacey, Professor Richard</span></td><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;">Annex 3 to statment no. 10. Article by Dr Richard Lacey -</span></td><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/20080725213429/http://www.bseinquiry.gov.uk/files/ws/s010xiii.pdf" rel="noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">click here to download</a></span></td></tr>
<tr valign="top"><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;">10xiv</span></td><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;">Lacey, Professor Richard</span></td><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;">Annex 4 to statement no. 10. Article by Dr</span></td><td style="outline: none;"><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/20080725213429/http://www.bseinquiry.gov.uk/files/ws/s010xiv.pdf" rel="noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">click here to download</a></span></td></tr>
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<a href="https://webarchive.nationalarchives.gov.uk/20080725213429/http://www.bseinquiry.gov.uk/files/ws/s010.pdf">https://webarchive.nationalarchives.gov.uk/20080725213429/http://www.bseinquiry.gov.uk/files/ws/s010.pdf</a><br />
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<a href="https://webarchive.nationalarchives.gov.uk/20080725234253/http://www.bseinquiry.gov.uk/files/ws/s010a.pdf">https://webarchive.nationalarchives.gov.uk/20080725234253/http://www.bseinquiry.gov.uk/files/ws/s010a.pdf</a><br />
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<a href="https://webarchive.nationalarchives.gov.uk/20080725213429/http://www.bseinquiry.gov.uk/files/ws/s010ax.pdf">https://webarchive.nationalarchives.gov.uk/20080725213429/http://www.bseinquiry.gov.uk/files/ws/s010ax.pdf</a><br />
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<a href="https://webarchive.nationalarchives.gov.uk/20080725213429/http://www.bseinquiry.gov.uk/files/ws/s010xi.pdf">https://webarchive.nationalarchives.gov.uk/20080725213429/http://www.bseinquiry.gov.uk/files/ws/s010xi.pdf</a><br />
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<a href="https://webarchive.nationalarchives.gov.uk/20080725213429/http://www.bseinquiry.gov.uk/files/ws/s010xii.pdf">https://webarchive.nationalarchives.gov.uk/20080725213429/http://www.bseinquiry.gov.uk/files/ws/s010xii.pdf</a><br />
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<a href="https://webarchive.nationalarchives.gov.uk/20080725213429/http://www.bseinquiry.gov.uk/files/ws/s010xiv.pdf">https://webarchive.nationalarchives.gov.uk/20080725213429/http://www.bseinquiry.gov.uk/files/ws/s010xiv.pdf</a><br />
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<span style="font-size: 13.3333px;">R.I.P. Professor Lacey, and Thanks!</span></div>
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<span style="font-size: 13.3333px;">Monday, May 05, 2014</span></div>
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<span style="font-size: 13.3333px;">Member Country details for listing OIE CWD 2013 against the criteria of Article 1.2.2., the Code Commission recommends consideration for listing</span></div>
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<a href="http://chronic-wasting-disease.blogspot.com/2014/05/member-country-details-for-listing-oie.html" rel="noopener noreferrer" shape="rect" style="color: blue; cursor: pointer;" target="_blank">http://chronic-wasting-disease.blogspot.com/2014/05/member-country-details-for-listing-oie.html</a></div>
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<span style="font-size: 13.3333px;">SPECIAL ALERT The OIE recommends strengthening animal disease surveillance worldwide</span></div>
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<span style="font-size: 13.3333px;">IN A NUT SHELL ; (Adopted by the International Committee of the OIE on 23 May 2006) 11. Information published by the OIE is derived from appropriate declarations made by the official Veterinary Services of Member Countries. The OIE is not responsible for inaccurate publication of country disease status based on inaccurate information or changes in epidemiological status or other significant events that were not promptly reported to the Central Bureau,</span></div>
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<span style="font-size: 12px;">MONDAY, JANUARY 21, 2019 </span></div>
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<span style="font-size: 12px;">Bovine Spongiform Encephalopathy BSE TSE Prion Surveillance FDA USDA APHIS FSIS UPDATE 2019</span></div>
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<span style="font-size: 12px;"><a href="https://bovineprp.blogspot.com/2019/01/bovine-spongiform-encephalopathy-bse.html" rel="noopener noreferrer" shape="rect" style="color: blue; cursor: pointer;" target="_blank">https://bovineprp.blogspot.com/2019/01/bovine-spongiform-encephalopathy-bse.html</a></span></div>
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Prion Conference 2018</div>
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<span style="line-height: 1.22em;">O5 Prion Disease in Dromedary Camels </span></div>
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<span style="line-height: 1.22em;">Babelhadj B (1), Di Bari MA (2), Pirisinu L (2), Chiappini B (2), Gaouar SB (3), Riccardi G (2), Marcon S (2), Agrimi U (2), Nonno R (2), Vaccari G (2) (1) École Normale Supérieure Ouargla. Laboratoire de protection des écosystèmes en zones arides et semi arides University Kasdi Merbah Ouargla, Ouargla, Algeria; (2) Istituto Superiore di Sanità, Department of Food Safety, Nutrition and Veterinary Public Health, Rome, Italy (3) University Abou Bekr Bélkaid, Tlemcen, Algeria. </span></div>
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<span style="line-height: 1.22em;">Prions are responsible for fatal and transmissible neurodegenerative diseases including CreutzfeldtJakob disease in humans, scrapie in small ruminants and bovine spongiform encephalopathy (BSE). Following the BSE epidemic and the demonstration of its zoonotic potential, general concerns have been raised on animal prions. </span></div>
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<span style="line-height: 1.22em;">Here we report the identification of a prion disease in dromedary camels (Camelus dromedarius) in Algeria and designate it as Camel Prion Disease (CPD). In the last years, neurological symptoms have been observed in adult male and female dromedaries presented for slaughter at the Ouargla abattoir. The symptoms include weight loss, behavioral abnormalities and neurological symptoms such as tremors, aggressiveness, hyper-reactivity, typical down and upwards movements of the head, hesitant and uncertain gait, ataxia of the hind limbs, occasional falls and difficult getting up. During 2015 and 2016, symptoms suggestive of prion disease were observed in 3.1% of 2259 dromedaries presented at ante-mortem examination. Laboratory diagnosis was obtained in three symptomatic dromedaries, sampled in 2016 and 2017, by the detection of typical neurodegeneration and disease-specific prion protein (PrPSc) in brain tissues. </span></div>
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<span style="line-height: 1.22em;">Histopathological examination revealed spongiform change, gliosis and neuronal loss preferentially in grey matter of subcortical brain areas. Abundant PrPSc deposition was detected in the same brain areas by immunohistochemistry and PET-blot. Western blot analysis confirmed the presence of PK-resistant PrPSc, whose N-terminal cleaved PK-resistant core was characterized by a mono-glycosylated dominant form and by a distinctive N-terminal cleavage, different from that observed in BSE and scrapie. </span></div>
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<span style="line-height: 1.22em;">PrPSc was also detected, by immunohistochemistry, in all sampled lymph nodes (cervical, prescapular and lumbar aortic) of the only animal from which they were collected. </span></div>
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<span style="line-height: 1.22em;">The PRNP sequence of the two animals for which frozen material was available, showed 100% nucleotide identity with the PRNP sequence already reported for dromedary camel. </span></div>
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<span style="line-height: 1.22em;">Overall, these data demonstrate the presence of a prion disease in dromedary camelswhose nature, origin and spread need further investigations. However, our preliminary observations on the rather high prevalence of symptomatic dromedaries and the involvement of lymphoid tissues, are consistent with CPD being an infectious disease. In conclusion, the emergence of a new prion disease in a livestock species of crucial importance for millions of people around the world, makes urgent to assess the risk for humans and to develop policies able to control the spread of the disease in animals and to minimize human exposure. </span></div>
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<a href="https://prion2018.org/wp-content/uploads/2018/05/program.pdf" rel="noopener noreferrer" shape="rect" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">https://prion2018.org/wp-content/uploads/2018/05/program.pdf</a></div>
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CDC</div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">New Outbreak of TSE Prion in NEW LIVESTOCK SPECIES</span></div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;">Volume 24, Number 6—June 2018 Research </span></div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;">Prion Disease in Dromedary Camels, Algeria</span></div>
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Abstract</div>
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Prions cause fatal and transmissible neurodegenerative diseases, including Creutzfeldt-Jakob disease in humans, scrapie in small ruminants, and bovine spongiform encephalopathy (BSE). After the BSE epidemic, and the associated human infections, began in 1996 in the United Kingdom, general concerns have been raised about animal prions. We detected a prion disease in dromedary camels (Camelus dromedarius) in Algeria. Symptoms suggesting prion disease occurred in 3.1% of dromedaries brought for slaughter to the Ouargla abattoir in 2015–2016. We confirmed diagnosis by detecting pathognomonic neurodegeneration and disease-specific prion protein (PrPSc) in brain tissues from 3 symptomatic animals. Prion detection in lymphoid tissues is suggestive of the infectious nature of the disease. PrPSc biochemical characterization showed differences with BSE and scrapie. Our identification of this prion disease in a geographically widespread livestock species requires urgent enforcement of surveillance and assessment of the potential risks to human and animal health.</div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;">SNIP...</span></div>
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The possibility that dromedaries acquired the disease from eating prion-contaminated waste needs to be considered.</div>
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Tracing the origin of prion diseases is challenging. In the case of CPD, the traditional extensive and nomadic herding practices of dromedaries represent a formidable factor for accelerating the spread of the disease at long distances, making the path of its diffusion difficult to determine. Finally, the major import flows of live animals to Algeria from Niger, Mali, and Mauritania (<a class="yiv4976394528aolmail_aolmail_aolmail_tp-link-policy" href="https://wwwnc.cdc.gov/eid/article/24/6/17-2007_article#r27" rel="noopener noreferrer" shape="rect" style="color: #075290; cursor: pointer; line-height: 1.22em;" target="_blank" title="27"><em style="line-height: 1.22em;">27</em></a>) should be investigated to trace the possible origin of CPD from other countries.</div>
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Camels are a vital animal species for millions of persons globally. The world camel population has a yearly growth rate of 2.1% (<a class="yiv4976394528aolmail_aolmail_aolmail_tp-link-policy" href="https://wwwnc.cdc.gov/eid/article/24/6/17-2007_article#r28" rel="noopener noreferrer" shape="rect" style="color: #075290; cursor: pointer; line-height: 1.22em;" target="_blank" title="28"><em style="line-height: 1.22em;">28</em></a>). In 2014, the population was estimated at ≈28 million animals, but this number is probably underestimated.. Approximately 88% of camels are found in Africa, especially eastern Africa, and 12% are found in Asia. Official data reported 350,000 dromedaries in Algeria in 2014 (<a class="yiv4976394528aolmail_aolmail_aolmail_tp-link-policy" href="https://wwwnc..cdc.gov/eid/article/24/6/17-2007_article#r28" rel="noopener noreferrer" shape="rect" style="color: #075290; cursor: pointer; line-height: 1.22em;" target="_blank" title="28"><em style="line-height: 1.22em;">28</em></a>).</div>
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On the basis of phenotypic traits and sociogeographic criteria, several dromedary populations have been suggested to exist in Algeria (<a class="yiv4976394528aolmail_aolmail_aolmail_tp-link-policy" href="https://wwwnc.cdc.gov/eid/article/24/6/17-2007_article#r29" rel="noopener noreferrer" shape="rect" style="color: #075290; cursor: pointer; line-height: 1.22em;" target="_blank" title="29"><em style="line-height: 1.22em;">29</em></a>). However, recent genetic studies in Algeria and Egypt point to a weak differentiation of the dromedary population as a consequence of historical use as a cross-continental beast of burden along trans-Saharan caravan routes, coupled with traditional extensive/nomadic herding practices (<a class="yiv4976394528aolmail_aolmail_aolmail_tp-link-policy" href="https://wwwnc.cdc.gov/eid/article/24/6/17-2007_article#r30" rel="noopener noreferrer" shape="rect" style="color: #075290; cursor: pointer; line-height: 1.22em;" target="_blank" title="30"><em style="line-height: 1.22em;">30</em></a>).</div>
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Such genetic homogeneity also might be reflected in <em style="line-height: 1.22em;">PRNP</em>. Studies on <em style="line-height: 1.22em;">PRNP</em> variability in camels are therefore warranted to explore the existence of genotypes resistant to CPD, which could represent an important tool for CPD management as it was for breeding programs for scrapie eradication in sheep.</div>
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In the past 10 years, the camel farming system has changed rapidly, with increasing setup of periurban dairy farms and dairy plants and diversification of camel products and market penetration (<a class="yiv4976394528aolmail_aolmail_aolmail_tp-link-policy" href="https://wwwnc.cdc.gov/eid/article/24/6/17-2007_article#r13" rel="noopener noreferrer" shape="rect" style="color: #075290; cursor: pointer; line-height: 1.22em;" target="_blank" title="13"><em style="line-height: 1.22em;">13</em></a>). This evolution requires improved health standards for infectious diseases and, in light of CPD, for prion diseases.</div>
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The emergence of another prion disease in an animal species of crucial importance for millions of persons worldwide makes it necessary to assess the risk for humans and develop evidence-based policies to control and limit the spread of the disease in animals and minimize human exposure. The implementation of a surveillance system for prion diseases would be a first step to enable disease control and minimize human and animal exposure. Finally, the diagnostic capacity of prion diseases needs to be improved in all countries in Africa where dromedaries are part of the domestic livestock.</div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">***> IMPORTS AND EXPORTS <***</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">***SEE MASSIVE AMOUNTS OF BANNED ANIMAL PROTEIN AKA MAD COW FEED IN COMMERCE USA DECADES AFTER POST BAN ***</span></div>
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<a href="http://camelusprp.blogspot.com/2018/04/dromedary-camels-algeria-prion-mad.html" rel="noopener noreferrer" shape="rect" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://camelusprp.blogspot.com/2018/04/dromedary-camels-algeria-prion-mad.html</a></div>
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USA MAD COW CASE 2018 FLORIDA</div>
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WEDNESDAY, SEPTEMBER 26, 2018 </div>
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JAVMA In Short Update USDA announces detection of atypical BSE</div>
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<a href="http://bovineprp.blogspot.com/2018/09/javma-in-short-update-usda-announces.html" rel="noopener noreferrer" shape="rect" style="color: blue; cursor: pointer; font-family: arial; font-size: small; line-height: 1.22em;" target="_blank">http://bovineprp.blogspot.com/2018/09/javma-in-short-update-usda-announces.html</a></div>
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ZOONOSIS OF SCRAPIE TSE PRION</div>
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O.05: Transmission of prions to primates after extended silent incubation periods: Implications for BSE and scrapie risk assessment in human populations </div>
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<span style="font-family: "arial" , "helvetica";">Emmanuel Comoy, Jacqueline Mikol, Valerie Durand, Sophie Luccantoni, Evelyne Correia, Nathalie Lescoutra, Capucine Dehen, and Jean-Philippe Deslys Atomic Energy Commission; Fontenay-aux-Roses, France </span></div>
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<span style="font-family: "arial" , "helvetica";">Prion diseases (PD) are the unique neurodegenerative proteinopathies reputed to be transmissible under field conditions since decades. The transmission of Bovine Spongiform Encephalopathy (BSE) to humans evidenced that an animal PD might be zoonotic under appropriate conditions. Contrarily, in the absence of obvious (epidemiological or experimental) elements supporting a transmission or genetic predispositions, PD, like the other proteinopathies, are reputed to occur spontaneously (atpical animal prion strains, sporadic CJD summing 80% of human prion cases). </span></div>
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<span style="font-family: "arial" , "helvetica";">Non-human primate models provided the first evidences supporting the transmissibiity of human prion strains and the zoonotic potential of BSE. Among them, cynomolgus macaques brought major information for BSE risk assessment for human health (Chen, 2014), according to their phylogenetic proximity to humans and extended lifetime. We used this model to assess the zoonotic potential of other animal PD from bovine, ovine and cervid origins even after very long silent incubation periods. </span></div>
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<span style="font-family: "arial" , "helvetica";">*** We recently observed the direct transmission of a natural classical scrapie isolate to macaque after a 10-year silent incubation period, </span></div>
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<span style="font-family: "arial" , "helvetica";">***with features similar to some reported for human cases of sporadic CJD, albeit requiring fourfold long incubation than BSE. Scrapie, as recently evoked in humanized mice (Cassard, 2014), </span></div>
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<span style="font-family: "arial" , "helvetica";">***is the third potentially zoonotic PD (with BSE and L-type BSE), </span></div>
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<span style="font-family: "arial" , "helvetica";">***thus questioning the origin of human sporadic cases. </span></div>
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<span style="font-family: "arial" , "helvetica";">We will present an updated panorama of our different transmission studies and discuss the implications of such extended incubation periods on risk assessment of animal PD for human health. </span></div>
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<span style="font-family: "arial" , "helvetica";">=============== </span></div>
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<span style="font-family: "arial" , "helvetica";">***thus questioning the origin of human sporadic cases*** </span></div>
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<span style="font-family: "arial" , "helvetica";">=============== </span></div>
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<span style="font-family: "arial" , "helvetica";">***our findings suggest that possible transmission risk of H-type BSE to sheep and human. Bioassay will be required to determine whether the PMCA products are infectious to these animals. </span></div>
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<span style="font-family: "arial" , "helvetica";">============== </span></div>
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<span style="font-family: "arial" , "helvetica";"><a href="https://prion2015.files.wordpress.com/2015/05/prion2015abstracts.pdf" rel="noopener noreferrer" shape="rect" style="color: blue; cursor: pointer;" target="_blank">https://prion2015.files.wordpress.com/2015/05/prion2015abstracts.pdf</a> </span></div>
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***Transmission data also revealed that several scrapie prions propagate in HuPrP-Tg mice with efficiency comparable to that of cattle BSE. While the efficiency of transmission at primary passage was low, subsequent passages resulted in a highly virulent prion disease in both Met129 and Val129 mice. </div>
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<span style="font-family: "arial" , "helvetica";">***Transmission of the different scrapie isolates in these mice leads to the emergence of prion strain phenotypes that showed similar characteristics to those displayed by MM1 or VV2 sCJD prion. </span></div>
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<span style="font-family: "arial" , "helvetica";">***These results demonstrate that scrapie prions have a zoonotic potential and raise new questions about the possible link between animal and human prions. </span></div>
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<span style="font-family: "arial" , "helvetica";"><a href="http://www.tandfonline.com/doi/abs/10.1080/19336896.2016.1163048?journalCode=kprn20" rel="noopener noreferrer" shape="rect" style="color: blue; cursor: pointer;" target="_blank">http://www.tandfonline.com/doi/abs/10.1080/19336896.2016.1163048?journalCode=kprn20</a></span></div>
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PRION 2016 TOKYO</div>
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<span style="font-family: "arial" , "helvetica";">Saturday, April 23, 2016</span></div>
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<span style="font-family: "arial" , "helvetica";">SCRAPIE WS-01: Prion diseases in animals and zoonotic potential 2016</span></div>
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<span style="font-family: "arial" , "helvetica";">Prion. 10:S15-S21. 2016 ISSN: 1933-6896 printl 1933-690X online</span></div>
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<span style="font-family: "arial" , "helvetica";">Taylor & Francis</span></div>
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<span style="font-family: "arial" , "helvetica";">Prion 2016 Animal Prion Disease Workshop Abstracts</span></div>
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<span style="font-family: "arial" , "helvetica";">WS-01: Prion diseases in animals and zoonotic potential</span></div>
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<span style="font-family: "arial" , "helvetica";">Juan Maria Torres a, Olivier Andreoletti b, J uan-Carlos Espinosa a. Vincent Beringue c. Patricia Aguilar a,</span></div>
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<span style="font-family: "arial" , "helvetica";">Natalia Fernandez-Borges a. and Alba Marin-Moreno a</span></div>
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<span style="font-family: "arial" , "helvetica";">"Centro de Investigacion en Sanidad Animal ( CISA-INIA ). Valdeolmos, Madrid. Spain; b UMR INRA -ENVT 1225 Interactions Holes Agents Pathogenes. ENVT. Toulouse. France: "UR892. Virologie lmmunologie MolécuIaires, Jouy-en-Josas. France</span></div>
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<span style="font-family: "arial" , "helvetica";">Dietary exposure to bovine spongiform encephalopathy (BSE) contaminated bovine tissues is considered as the origin of variant Creutzfeldt Jakob (vCJD) disease in human. To date, BSE agent is the only recognized zoonotic prion... Despite the variety of Transmissible Spongiform Encephalopathy (TSE) agents that have been circulating for centuries in farmed ruminants there is no apparent epidemiological link between exposure to ruminant products and the occurrence of other form of TSE in human like sporadic Creutzfeldt Jakob Disease (sCJD). However, the zoonotic potential of the diversity of circulating TSE agents has never been systematically assessed. The major issue in experimental assessment of TSEs zoonotic potential lies in the modeling of the ‘species barrier‘, the biological phenomenon that limits TSE agents’ propagation from a species to another. In the last decade, mice genetically engineered to express normal forms of the human prion protein has proved essential in studying human prions pathogenesis and modeling the capacity of TSEs to cross the human species barrier.</span></div>
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<span style="font-family: "arial" , "helvetica";">To assess the zoonotic potential of prions circulating in farmed ruminants, we study their transmission ability in transgenic mice expressing human PrPC (HuPrP-Tg). Two lines of mice expressing different forms of the human PrPC (129Met or 129Val) are used to determine the role of the Met129Val dimorphism in susceptibility/resistance to the different agents.</span></div>
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<span style="font-family: "arial" , "helvetica";">These transmission experiments confirm the ability of BSE prions to propagate in 129M- HuPrP-Tg mice and demonstrate that Met129 homozygotes may be susceptible to BSE in sheep or goat to a greater degree than the BSE agent in cattle and that these agents can convey molecular properties and neuropathological indistinguishable from vCJD. However homozygous 129V mice are resistant to all tested BSE derived prions independently of the originating species suggesting a higher transmission barrier for 129V-PrP variant.</span></div>
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<span style="font-family: "arial" , "helvetica";">Transmission data also revealed that several scrapie prions propagate in HuPrP-Tg mice with efficiency comparable to that of cattle BSE. While the efficiency of transmission at primary passage was low, subsequent passages resulted in a highly virulent prion disease in both Met129 and Val129 mice. </span></div>
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<span style="font-family: "arial" , "helvetica";">Transmission of the different scrapie isolates in these mice leads to the emergence of prion strain phenotypes that showed similar characteristics to those displayed by MM1 or VV2 sCJD prion. </span></div>
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<span style="font-family: "arial" , "helvetica";">These results demonstrate that scrapie prions have a zoonotic potential and raise new questions about the possible link between animal and human prions. </span></div>
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***> why do we not want to do TSE transmission studies on chimpanzees $</div>
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<span style="font-family: "arial" , "helvetica";">5. A positive result from a chimpanzee challenged severly would likely create alarm in some circles even if the result could not be interpreted for man. </span></div>
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<span style="font-family: "arial" , "helvetica";">***> I have a view that all these agents could be transmitted provided a large enough dose by appropriate routes was given and the animals kept long enough. </span></div>
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<span style="font-family: "arial" , "helvetica";">***> Until the mechanisms of the species barrier are more clearly understood it might be best to retain that hypothesis.</span></div>
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<span style="font-family: "arial" , "helvetica";">R. BRADLEY</span></div>
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<a href="https://web.archive.org/web/20170126051158/http://collections.europarchive.org/tna/20080102222950/http://www.bseinquiry.gov.uk/files/yb/1990/09/23001001.pdf" rel="noopener noreferrer" shape="rect" style="color: blue; cursor: pointer;" target="_blank">https://web.archive.org/web/20170126051158/http://collections.europarchive.org/tna/20080102222950/http://www.bseinquiry.gov.uk/files/yb/1990/09/23001001.pdf</a></div>
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<span style="font-family: "arial" , "helvetica";">Title: Transmission of scrapie prions to primate after an extended silent incubation period) </span></div>
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<span style="font-family: "arial" , "helvetica";">*** In complement to the recent demonstration that humanized mice are susceptible to scrapie, we report here the first observation of direct transmission of a natural classical scrapie isolate to a macaque after a 10-year incubation period. Neuropathologic examination revealed all of the features of a prion disease: spongiform change, neuronal loss, and accumulation of PrPres throughout the CNS. </span></div>
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<span style="font-family: "arial" , "helvetica";">*** This observation strengthens the questioning of the harmlessness of scrapie to humans, at a time when protective measures for human and animal health are being dismantled and reduced as c-BSE is considered controlled and being eradicated. </span></div>
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<span style="font-family: "arial" , "helvetica";">*** Our results underscore the importance of precautionary and protective measures and the necessity for long-term experimental transmission studies to assess the zoonotic potential of other animal prion strains. </span></div>
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***> Moreover, sporadic disease has never been observed in breeding colonies or primate research laboratories, most notably among hundreds of animals over several decades of study at the National Institutes of Health25, and in nearly twenty older animals continuously housed in our own facility. <***</div>
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<span style="font-family: "arial" , "helvetica";">Transmission of scrapie prions to primate after an extended silent incubation period </span></div>
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<span style="font-family: "arial" , "helvetica";">Emmanuel E. Comoy, Jacqueline Mikol, Sophie Luccantoni-Freire, Evelyne Correia, Nathalie Lescoutra-Etchegaray, Valérie Durand, Capucine Dehen, Olivier Andreoletti, Cristina Casalone, Juergen A. Richt, Justin J. Greenlee, Thierry Baron, Sylvie L. Benestad, Paul Brown & Jean-Philippe Deslys Scientific Reports volume 5, Article number: 11573 (2015) | Download Citation</span></div>
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<span style="font-family: "arial" , "helvetica";">Classical bovine spongiform encephalopathy (c-BSE) is the only animal prion disease reputed to be zoonotic, causing variant Creutzfeldt-Jakob disease (vCJD) in humans and having guided protective measures for animal and human health against animal prion diseases. Recently, partial transmissions to humanized mice showed that the zoonotic potential of scrapie might be similar to c-BSE. We here report the direct transmission of a natural classical scrapie isolate to cynomolgus macaque, a highly relevant model for human prion diseases, after a 10-year silent incubation period, with features similar to those reported for human cases of sporadic CJD. Scrapie is thus actually transmissible to primates with incubation periods compatible with their life expectancy, although fourfold longer than BSE. Long-term experimental transmission studies are necessary to better assess the zoonotic potential of other prion diseases with high prevalence, notably Chronic Wasting Disease of deer and elk and atypical/Nor98 scrapie.</span></div>
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<span style="font-family: "arial" , "helvetica";">SNIP...</span></div>
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<span style="font-family: "arial" , "helvetica";">Discussion We describe the transmission of spongiform encephalopathy in a non-human primate inoculated 10 years earlier with a strain of sheep c-scrapie. Because of this extended incubation period in a facility in which other prion diseases are under study, we are obliged to consider two alternative possibilities that might explain its occurrence. We first considered the possibility of a sporadic origin (like CJD in humans). Such an event is extremely improbable because the inoculated animal was 14 years old when the clinical signs appeared, i.e. about 40% through the expected natural lifetime of this species, compared to a peak age incidence of 60–65 years in human sporadic CJD, or about 80% through their expected lifetimes. Moreover, sporadic disease has never been observed in breeding colonies or primate research laboratories, most notably among hundreds of animals over several decades of study at the National Institutes of Health25, and in nearly twenty older animals continuously housed in our own facility.</span></div>
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<span style="font-family: "arial" , "helvetica";">The second possibility is a laboratory cross-contamination. Three facts make this possibility equally unlikely. First, handling of specimens in our laboratory is performed with fastidious attention to the avoidance of any such cross-contamination. Second, no laboratory cross-contamination has ever been documented in other primate laboratories, including the NIH, even between infected and uninfected animals housed in the same or adjacent cages with daily intimate contact (P. Brown, personal communication). Third, the cerebral lesion profile is different from all the other prion diseases we have studied in this model19, with a correlation between cerebellar lesions (massive spongiform change of Purkinje cells, intense PrPres staining and reactive gliosis26) and ataxia. The iron deposits present in the globus pallidus are a non specific finding that have been reported previously in neurodegenerative diseases and aging27. Conversely, the thalamic lesion was reminiscent of a metabolic disease due to thiamine deficiency28 but blood thiamine levels were within normal limits (data not shown). The preferential distribution of spongiform change in cortex associated with a limited distribution in the brainstem is reminiscent of the lesion profile in MM2c and VV1 sCJD patients29, but interspecies comparison of lesion profiles should be interpreted with caution. It is of note that the same classical scrapie isolate induced TSE in C57Bl/6 mice with similar incubation periods and lesional profiles as a sample derived from a MM1 sCJD patient30.</span></div>
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<span style="font-family: "arial" , "helvetica";">We are therefore confident that the illness in this cynomolgus macaque represents a true transmission of a sheep c-scrapie isolate directly to an old-world monkey, which taxonomically resides in the primate subdivision (parvorder of catarrhini) that includes humans. With an homology of its PrP protein with humans of 96.4%31, cynomolgus macaque constitutes a highly relevant model for assessing zoonotic risk of prion diseases. Since our initial aim was to show the absence of transmission of scrapie to macaques in the worst-case scenario, we obtained materials from a flock of naturally-infected sheep, affecting animals with different genotypes32. This c-scrapie isolate exhibited complete transmission in ARQ/ARQ sheep (332 ± 56 days) and Tg338 transgenic mice expressing ovine VRQ/VRQ prion protein (220 ± 5 days) (O. Andreoletti, personal communication). From the standpoint of zoonotic risk, it is important to note that sheep with c-scrapie (including the isolate used in our study) have demonstrable infectivity throughout their lymphoreticular system early in the incubation period of the disease (3 months-old for all the lymphoid organs, and as early as 2 months-old in gut-associated lymph nodes)33. In addition, scrapie infectivity has been identified in blood34, milk35 and skeletal muscle36 from asymptomatic but scrapie infected small ruminants which implies a potential dietary exposure for consumers.</span></div>
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<span style="font-family: "arial" , "helvetica";">Two earlier studies have reported the occurrence of clinical TSE in cynomolgus macaques after exposures to scrapie isolates. In the first study, the “Compton” scrapie isolate (derived from an English sheep) and serially propagated for 9 passages in goats did not transmit TSE in cynomolgus macaque, rhesus macaque or chimpanzee within 7 years following intracerebral challenge1; conversely, after 8 supplementary passages in conventional mice, this “Compton” isolate induced TSE in a cynomolgus macaque 5 years after intracerebral challenge, but rhesus macaques and chimpanzee remained asymptomatic 8.5 years post-exposure8. However, multiple successive passages that are classically used to select laboratory-adapted prion strains can significantly modify the initial properties of a scrapie isolate, thus questioning the relevance of zoonotic potential for the initial sheep-derived isolate. The same isolate had also induced disease into squirrel monkeys (new-world monkey)9. A second historical observation reported that a cynomolgus macaque developed TSE 6 years post-inoculation with brain homogenate from a scrapie-infected Suffolk ewe (derived from USA), whereas a rhesus macaque and a chimpanzee exposed to the same inoculum remained healthy 9 years post-exposure1. This inoculum also induced TSE in squirrel monkeys after 4 passages in mice. Other scrapie transmission attempts in macaque failed but had more shorter periods of observation in comparison to the current study. Further, it is possible that there are differences in the zoonotic potential of different scrapie strains.</span></div>
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<span style="font-family: "arial" , "helvetica";">The most striking observation in our study is the extended incubation period of scrapie in the macaque model, which has several implications. Firstly, our observations constitute experimental evidence in favor of the zoonotic potential of c-scrapie, at least for this isolate that has been extensively studied32,33,34,35,36. The cross-species zoonotic ability of this isolate should be confirmed by performing duplicate intracerebral exposures and assessing the transmissibility by the oral route (a successful transmission of prion strains through the intracerebral route may not necessarily indicate the potential for oral transmission37). However, such confirmatory experiments may require more than one decade, which is hardly compatible with current general management and support of scientific projects; thus this study should be rather considered as a case report.</span></div>
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<span style="font-family: "arial" , "helvetica";">Secondly, transmission of c-BSE to primates occurred within 8 years post exposure for the lowest doses able to transmit the disease (the survival period after inoculation is inversely proportional to the initial amount of infectious inoculum). The occurrence of scrapie 10 years after exposure to a high dose (25 mg) of scrapie-infected sheep brain suggests that the macaque has a higher species barrier for sheep c-scrapie than c-BSE, although it is notable that previous studies based on in vitro conversion of PrP suggested that BSE and scrapie prions would have a similar conversion potential for human PrP38.</span></div>
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<span style="font-family: "arial" , "helvetica";">Thirdly, prion diseases typically have longer incubation periods after oral exposure than after intracerebral inoculations: since humans can develop Kuru 47 years after oral exposure39, an incubation time of several decades after oral exposure to scrapie would therefore be expected, leading the disease to occur in older adults, i.e. the peak age for cases considered to be sporadic disease, and making a distinction between scrapie-associated and truly sporadic disease extremely difficult to appreciate.</span></div>
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<span style="font-family: "arial" , "helvetica";">Fourthly, epidemiologic evidence is necessary to confirm the zoonotic potential of an animal disease suggested by experimental studies. A relatively short incubation period and a peculiar epidemiological situation (e.g., all the first vCJD cases occurring in the country with the most important ongoing c-BSE epizootic) led to a high degree of suspicion that c-BSE was the cause of vCJD. Sporadic CJD are considered spontaneous diseases with an almost stable and constant worldwide prevalence (0.5–2 cases per million inhabitants per year), and previous epidemiological studies were unable to draw a link between sCJD and classical scrapie6,7,40,41, even though external causes were hypothesized to explain the occurrence of some sCJD clusters42,43,44. However, extended incubation periods exceeding several decades would impair the predictive values of epidemiological surveillance for prion diseases, already weakened by a limited prevalence of prion diseases and the multiplicity of isolates gathered under the phenotypes of “scrapie” and “sporadic CJD”.</span></div>
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<span style="font-family: "arial" , "helvetica";">Fifthly, considering this 10 year-long incubation period, together with both laboratory and epidemiological evidence of decade or longer intervals between infection and clinical onset of disease, no premature conclusions should be drawn from negative transmission studies in cynomolgus macaques with less than a decade of observation, as in the aforementioned historical transmission studies of scrapie to primates1,8,9. Our observations and those of others45,46 to date are unable to provide definitive evidence regarding the zoonotic potential of CWD, atypical/Nor98 scrapie or H-type BSE. The extended incubation period of the scrapie-affected macaque in the current study also underscores the limitations of rodent models expressing human PrP for assessing the zoonotic potential of some prion diseases since their lifespan remains limited to approximately two years21,47,48. This point is illustrated by the fact that the recently reported transmission of scrapie to humanized mice was not associated with clinical signs for up to 750 days and occurred in an extreme minority of mice with only a marginal increase in attack rate upon second passage13. The low attack rate in these studies is certainly linked to the limited lifespan of mice compared to the very long periods of observation necessary to demonstrate the development of scrapie. Alternatively, one could estimate that a successful second passage is the result of strain adaptation to the species barrier, thus poorly relevant of the real zoonotic potential of the original scrapie isolate of sheep origin49. The development of scrapie in this primate after an incubation period compatible with its lifespan complements the study conducted in transgenic (humanized) mice; taken together these studies suggest that some isolates of sheep scrapie can promote misfolding of the human prion protein and that scrapie can develop within the lifespan of some primate species.</span></div>
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<span style="font-family: "arial" , "helvetica";">In addition to previous studies on scrapie transmission to primate1,8,9 and the recently published study on transgenic humanized mice13, our results constitute new evidence for recommending that the potential risk of scrapie for human health should not be dismissed. Indeed, human PrP transgenic mice and primates are the most relevant models for investigating the human transmission barrier. To what extent such models are informative for measuring the zoonotic potential of an animal TSE under field exposure conditions is unknown. During the past decades, many protective measures have been successfully implemented to protect cattle from the spread of c-BSE, and some of these measures have been extended to sheep and goats to protect from scrapie according to the principle of precaution. Since cases of c-BSE have greatly reduced in number, those protective measures are currently being challenged and relaxed in the absence of other known zoonotic animal prion disease. We recommend that risk managers should be aware of the long term potential risk to human health of at least certain scrapie isolates, notably for lymphotropic strains like the classical scrapie strain used in the current study. Relatively high amounts of infectivity in peripheral lymphoid organs in animals infected with these strains could lead to contamination of food products produced for human consumption. Efforts should also be maintained to further assess the zoonotic potential of other animal prion strains in long-term studies, notably lymphotropic strains with high prevalence like CWD, which is spreading across North America, and atypical/Nor98 scrapie (Nor98)50 that was first detected in the past two decades and now represents approximately half of all reported cases of prion diseases in small ruminants worldwide, including territories previously considered as scrapie free... Even if the prevailing view is that sporadic CJD is due to the spontaneous formation of CJD prions, it remains possible that its apparent sporadic nature may, at least in part, result from our limited capacity to identify an environmental origin.</span></div>
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<a href="https://www.nature.com/articles/srep11573" rel="noopener noreferrer" shape="rect" style="color: blue; cursor: pointer;" target="_blank">https://www.nature.com/articles/srep11573</a></div>
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<span style="font-size: 13.3333px;">Saturday, December 15, 2018 </span></div>
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<span style="font-size: 13.3333px;">***> ADRD Summit RFI Singeltary COMMENT SUBMISSION BSE, SCRAPIE, CWD, AND HUMAN TSE PRION DISEASE December 14, 2018</span></div>
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<a href="https://prionprp.blogspot.com/2018/12/adrd-summit-rfi-singeltary-comment.html" rel="noopener noreferrer" shape="rect" style="color: blue; cursor: pointer;" target="_blank">https://prionprp.blogspot.com/2018/12/adrd-summit-rfi-singeltary-comment.html</a></div>
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Low levels of classical BSE infectivity in rendered fat tissue </div>
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<a href="https://bovineprp.blogspot.com/2019/01/low-levels-of-classical-bse-infectivity.html" rel="noopener noreferrer" shape="rect" style="color: blue; cursor: pointer;" target="_blank">https://bovineprp.blogspot.com/2019/01/low-levels-of-classical-bse-infectivity.html</a> </div>
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***> FRIDAY, DECEMBER 14, 2018 MAD COW USA FLASHBACK Texas Style</div>
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FRIDAY DECEMBER 14, 2018 </div>
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<a href="https://madcowusda.blogspot.com/2018/12/mad-cow-usa-flashback-friday-december.html" rel="noopener noreferrer" shape="rect" style="color: blue; cursor: pointer;" target="_blank">https://madcowusda.blogspot.com/2018/12/mad-cow-usa-flashback-friday-december.html</a> </div>
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THURSDAY, JANUARY 3, 2019 </div>
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MAD COW USDA DISEASE BSE TSE Prion </div>
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<a href="https://madcowusda.blogspot.com/2019/01/mad-cow-usda-disease-bse-tse-prion.html" rel="noopener noreferrer" shape="rect" style="color: blue; cursor: pointer;" target="_blank">https://madcowusda.blogspot.com/2019/01/mad-cow-usda-disease-bse-tse-prion.html</a></div>
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THURSDAY, OCTOBER 22, 2015 </div>
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Former Ag Secretary Ann Veneman talks women in agriculture and we talk mad cow disease USDA and what really happened</div>
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HOW TO COVER UP MAD COW DISEASE IN TEXAS</div>
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<a href="http://madcowusda.blogspot.com/2015/10/former-ag-secretary-ann-veneman-talks.html" rel="noopener noreferrer" shape="rect" style="color: blue; cursor: pointer;" target="_blank">http://madcowusda.blogspot.com/2015/10/former-ag-secretary-ann-veneman-talks.html</a> </div>
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<a href="http://madcowusda.blogspot.com/2012/06/johanns-introduces-legislation-banning.html" rel="noopener noreferrer" shape="rect" style="color: blue; cursor: pointer;" target="_blank">http://madcowusda.blogspot.com/2012/06/johanns-introduces-legislation-banning.html</a> </div>
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<a href="http://madcowusda.blogspot.com/2012_06_01_archive.html" rel="noopener noreferrer" shape="rect" style="color: blue; cursor: pointer;" target="_blank">http://madcowusda.blogspot.com/2012_06_01_archive.html</a></div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">WEDNESDAY, AUGUST 29, 2018 </span></span></div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">OIE Bovine spongiform encephalopathy, United States of America Information received on 29/08/2018 from Dr John Clifford, Official Delegate, Chief Trade Advisor, APHIS USDA</span></span></div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">''The event is resolved. No more reports will be submitted.''</span></span></div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">well, so much for those herd mates exposed to this atypical BSE cow, and all those trace in and trace outs.</span></span></div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;"><span style="font-size: 13.3333px; line-height: 1.22em;">The OIE, USDA, and the BSE MRR policy is a joke, a sad, very sad joke...</span></span></div>
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<a href="http://bovineprp.blogspot.com/2018/08/oie-bovine-spongiform-encephalopathy.html" rel="noopener noreferrer" shape="rect" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://bovineprp.blogspot.com/2018/08/oie-bovine-spongiform-encephalopathy.html</a></div>
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<span style="font-family: "georgia";"><span style="font-size: 13px;">Saturday, July 23, 2016</span></span></div>
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<span style="font-family: "georgia";"><span style="font-size: 13px;">BOVINE SPONGIFORM ENCEPHALOPATHY BSE TSE PRION SURVEILLANCE, TESTING, AND SRM REMOVAL UNITED STATE OF AMERICA UPDATE JULY 2016</span></span></div>
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<a href="http://bovineprp.blogspot.com/2016/07/bovine-spongiform-encephalopathy-bse.html" rel="noopener noreferrer" shape="rect" style="color: blue; cursor: pointer;" target="_blank">http://bovineprp.blogspot.com/2016/07/bovine-spongiform-encephalopathy-bse.html</a></div>
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<span style="font-family: "georgia";"><span style="font-size: 13px;">Atypical Bovine Spongiform Encephalopathy BSE TSE Prion UPDATE JULY 2016</span></span></div>
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<a href="http://bse-atypical.blogspot.com/2016/07/atypical-bovine-spongiform.html" rel="noopener noreferrer" shape="rect" style="color: blue; cursor: pointer;" target="_blank">http://bse-atypical.blogspot.com/2016/07/atypical-bovine-spongiform.html</a></div>
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<span style="font-family: "georgia";"><span style="font-size: 13px;">Monday, June 20, 2016</span></span></div>
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<span style="font-family: "georgia";"><span style="font-size: 13px;">Specified Risk Materials SRMs BSE TSE Prion Program</span></span></div>
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<a href="http://specifiedriskmaterial.blogspot.com/2016/06/specified-risk-materials-srms-bse-tse.html" rel="noopener noreferrer" shape="rect" style="color: blue; cursor: pointer;" target="_blank">http://specifiedriskmaterial.blogspot.com/2016/06/specified-risk-materials-srms-bse-tse.html</a></div>
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<span style="font-family: "georgia"; font-size: 13px;">Wednesday, January 23, 2019 </span></div>
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CFIA SFCR Guidance on Specified risk material (SRM) came into force on January 15, 2019</div>
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<a href="https://specifiedriskmaterial.blogspot.com/2019/01/cfia-sfcr-guidance-on-specified-risk.html" rel="noopener noreferrer" shape="rect" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">https://specifiedriskmaterial.blogspot.com/2019/01/cfia-sfcr-guidance-on-specified-risk.html</a></div>
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<span style="font-size: 12px;">MONDAY, JANUARY 21, 2019 </span></div>
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<span style="font-size: 12px;">Bovine Spongiform Encephalopathy BSE TSE Prion Surveillance FDA USDA APHIS FSIS UPDATE 2019</span></div>
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<span style="font-size: 12px;"><a href="https://bovineprp.blogspot.com/2019/01/bovine-spongiform-encephalopathy-bse.html" rel="noopener noreferrer" shape="rect" style="color: blue; cursor: pointer;" target="_blank">https://bovineprp.blogspot.com/2019/01/bovine-spongiform-encephalopathy-bse.html</a></span></div>
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FRIDAY, FEBRUARY 01, 2019 </div>
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Poland Exported 5,500 Pounds of Meat From Sick Cows to EU, what about mad cow disease? </div>
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Poland is Proof atypical BSE is NOT an old cow spontaneous disease...tss </div>
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<a href="https://bse-atypical.blogspot.com/2019/02/poland-exported-5500-pounds-of-meat.html" rel="noopener noreferrer" shape="rect" style="color: blue; cursor: pointer;" target="_blank">https://bse-atypical.blogspot.com/2019/02/poland-exported-5500-pounds-of-meat.html</a></div>
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MONDAY, FEBRUARY 04, 2019 </div>
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<span style="font-family: "arial" , "helvetica";"><span style="font-size: 13.3333px;">POLAND DETECTS BOVINE SPONGIFORM ENCEPHALOPATHY BSE TSE PRION </span></span></div>
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<span style="font-family: "arial" , "helvetica";">Poland is Proof atypical BSE is NOT an old cow spontaneous disease...tss </span><span style="font-family: "arial" , "helvetica";"><span style="font-size: 13.3333px;"><br clear="none" /></span></span></div>
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<a href="https://bse-atypical.blogspot.com/2019/02/poland-detects-bovine-spongiform.html" rel="noopener noreferrer" shape="rect" style="color: blue; cursor: pointer;" target="_blank">https://bse-atypical.blogspot.com/2019/02/poland-detects-bovine-spongiform.html</a></div>
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<span style="font-size: 13.3333px;">THURSDAY, OCTOBER 04, 2018 </span></div>
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<span style="font-size: 13.3333px;">Cervid to human prion transmission 5R01NS088604-04 Update</span></div>
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<span style="font-size: 13.3333px;"><a href="http://grantome.com/grant/NIH/R01-NS088604-04" rel="noopener noreferrer" shape="rect" style="color: blue; cursor: pointer;" target="_blank">http://grantome.com/grant/NIH/R01-NS088604-04</a></span></div>
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<span style="font-size: 13.3333px;"><a href="http://chronic-wasting-disease.blogspot.com/2018/10/cervid-to-human-prion-transmission.html" rel="noopener noreferrer" shape="rect" style="color: blue; cursor: pointer;" target="_blank">http://chronic-wasting-disease.blogspot.com/2018/10/cervid-to-human-prion-transmission.html</a></span></div>
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<span style="font-family: "arial" , "helvetica"; font-size: x-small;">THURSDAY, FEBRUARY 21, 2019 CWD TSE PRION UPDATE, ARK, TENN, MS, PA, TX, KS, AND CONGRESS 2002</span></div>
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<span style="font-family: "arial" , "helvetica"; font-size: x-small;"><a href="https://transmissiblespongiformencephalopathy.blogspot.com/2019/02/cwd-tse-prion-update-ark-tenn-ms-pa-tx.html" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://transmissiblespongiformencephalopathy.blogspot.com/2019/02/cwd-tse-prion-update-ark-tenn-ms-pa-tx.html</a> </span></div>
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with sad regards, terry</div>
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Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-4687453285836897153.post-68514564569306790202018-06-29T13:52:00.002-05:002018-07-05T12:10:30.470-05:00Vaccines, TSE, Prion, risk factors?<div>
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European Medicines Agency </div>
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Science Medicines Health</div>
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1 25 January 2018</div>
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2 EMA/CHMP/BWP/192228/2017</div>
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3 Committee for Medicinal Products for Human Use (CHMP)</div>
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4 Questions and answers on Bovine Spongiform</div>
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5 Encephalopathies (BSE) and vaccines</div>
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6 Draft agreed by BWP, VWP, SWP October 2017</div>
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Adopted by CHMP for release for consultation 25 January 2018</div>
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Start of public consultation 1 February 2018</div>
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End of consultation (deadline for comments) 31 July 2018</div>
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Agreed by BWP, VWP, SWP</div>
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Adopted by CHMP</div>
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Date of coming into effect</div>
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7</div>
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8 Comments should be provided using this template. The completed comments form should be sent</div>
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to Kaidi.koiv@ema.europa.eu</div>
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9 Keywords BSE safety, TSE, vaccines, vaccine manufacture, bovine materials, CJD, prions,</div>
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gelatin, bovine serum, milk derivatives, polysorbate, tallow.</div>
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10</div>
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11</div>
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Questions and answers on Bovine Spongiform Encephalopathies (BSE) and vaccines</div>
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EMA/CHMP/BWP/192228/2017 Page 2/10</div>
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12 Questions and answers on Bovine Spongiform</div>
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13 Encephalopathies (BSE) and vaccines</div>
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14 Table of Contents</div>
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15 1. Introduction (background)...................................................................... 3</div>
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16 2. Scope....................................................................................................... 3</div>
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17 3. Summary................................................................................................. 3</div>
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18 4. Questions and answers on Bovine Spongiform Encephalopathy (BSE) and</div>
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19 variant CJD.................................................................................................. 4</div>
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20 5. Vaccines and risk of BSE transmission..................................................... 6</div>
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21 5.1. Questions and answers on bovine materials used in the manufacture of vaccines .........6</div>
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22 5.2. Questions and answers on vaccines and the measures taken to prevent the</div>
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23 transmission of BSE ....................................................................................................8</div>
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24 5.3. Questions and answers on the evidence that vaccines do not transmit BSE..................9</div>
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25</div>
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Questions and answers on Bovine Spongiform Encephalopathies (BSE) and vaccines</div>
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EMA/CHMP/BWP/192228/2017 Page 3/10</div>
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26 1. Introduction (background)</div>
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27 Since recognition of BSE in the 1980’s, the use of bovine material in the manufacture of medicinal</div>
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28 products, including many vaccines, prompted action by European and National regulatory authorities to</div>
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29 assure the continued safety of the products. The appearance of new variant Creutzfeldt-Jakob Disease</div>
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30 (vCJD) and its association with BSE, underlined the importance of the measures taken and increased</div>
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31 concern regarding any potential risk associated with use of bovine material.</div>
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32 2. Scope</div>
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33 This is an update of the information in the Public Statement on the Evaluation of Bovine Spongiform</div>
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34 Encephalopathies (BSE) - risk via the use of materials of bovine origin in or during the manufacture of</div>
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vaccines1 35 and the Questions and Answers on Bovine Spongiform Encephalopathies (BSE) and</div>
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Vaccines2 36 . The public statement and Q&A were intended to provide an assessment of the risk due to</div>
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37 BSE of the use of bovine materials in vaccines when they were drafted in 2001. Since 2001,</div>
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38 understanding of the risks associated with BSE has progressed significantly and a routine review of</div>
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39 EMA guidelines identified this document as requiring updating. It includes information on the use of</div>
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40 bovine derived materials in vaccine manufacture. Risk assessment of other TSE-susceptible animal</div>
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41 species is covered in the Note for guidance on minimising the risk of transmitting animal spongiform</div>
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encephalopathy agents via human and veterinary medicinal products3 42 and the use of materials of</div>
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43 human origin is reviewed in the CHMP position statement on Creutzfeldt-Jakob disease and plasmaderived</div>
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and urine-derived medicinal products4 44 .</div>
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45 3. Summary</div>
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46 Any bovine-derived material used in the manufacture of a vaccine is regulated according to the</div>
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47 mandatory TSE guideline which has been continuously updated in the light of scientific knowledge.</div>
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48 The guideline dictates that a risk assessment is performed during development and authorisation of all</div>
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49 medicinal products. The risk assessment involves controlling the geographical source of the animals</div>
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50 used, the nature of the tissue used (risk of infectivity) and the method of production. Safe</div>
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51 geographical sourcing of animals is based on the latest Organisation Internationale des Epizooties</div>
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classification5 </div>
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52 of countries according to their BSE status. The safety of the tissue used for processing is</div>
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53 ensured by categorisation according to the WHO tables on Tissue Infectivity Distribution in</div>
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Transmissible Spongiform Encephalopathies6 </div>
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54 . Finally, production methods are assessed for their ability</div>
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55 to inactivate or remove the agent responsible for BSE. The CHMP and regulatory authorities within</div>
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1 Public Statement on the Evaluation of Bovine Spongiform Encephalopathies (BSE)- risk via the use of materials of bovine origin in</div>
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or during the manufacture of vaccines</div>
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<a href="http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003717.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003717.pdf</a></div>
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2 Questions and &Answers on Bovine Spongiform Encephalopathies (BSE) and Vaccines</div>
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<a href="http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/09/WC500003715.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/09/WC500003715.pdf</a> </div>
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3 Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary</div>
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medicinal products</div>
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<a href="http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003700.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003700.pdf</a>. First adopted in 1991</div>
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and entered into force in 1992</div>
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4 CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products</div>
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<a href="http://www.ema.europa.eu/docs/en_GB/document_library/Position_statement/2011/06/WC500108071.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://www.ema.europa.eu/docs/en_GB/document_library/Position_statement/2011/06/WC500108071.pdf</a> </div>
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5 OIE List of Bovine Spongiform Encephalopathy Risk Status of Member Countries</div>
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<a href="http://www.oie.int/animal-health-in-the-world/official-disease-status/bse/list-of-bse-risk-status/" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://www.oie.int/animal-health-in-the-world/official-disease-status/bse/list-of-bse-risk-status/</a> </div>
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6 WHO Tables on Tissue Infectivity Distribution in Transmissible Spongiform Encephalopathies. Updated 2010.</div>
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<a href="http://www.who.int/bloodproducts/tablestissueinfectivity.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://www.who.int/bloodproducts/tablestissueinfectivity.pdf</a></div>
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56 member states of the European Union undertake benefit/risk assessments before any vaccine is</div>
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57 authorised. The final benefit/risk decision includes the BSE risk assessment discussed above.</div>
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58 The CHMP and its experts historically conducted a review on the use of bovine material in the</div>
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59 manufacture of vaccines licensed within the EU to ensure that the sourcing of animals and of tissues</div>
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60 used up to that point in time was according to the TSE guideline. Subsequently, the assessment of all</div>
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61 new products includes an assessment of the BSE risk in line with the TSE guideline.</div>
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62 Based on the above measures being taken, the CHMP considers that the risk of BSE contamination of</div>
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63 vaccines used within the EU is extremely low. Nevertheless, in order to provide the highest level of</div>
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64 assurance, manufacturers have replaced materials of bovine origin, wherever possible.</div>
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65 There is no evidence to date that any vaccines have been contaminated with the agent which causes</div>
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66 BSE. Taking into consideration the measures already employed to ensure the safety of vaccines with</div>
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67 respect to BSE, the EMA concludes there is a very high level of assurance against the risk of BSE</div>
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68 contamination and therefore reiterates the benefits of vaccination. There is no evidence to relate</div>
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69 vaccines to the development of vCJD. Consequently, on the basis of current scientific evidence and of</div>
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70 measures being taken to avoid any possible contamination of vaccines with BSE, the EMA is of the</div>
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71 view that appropriate measures are in place to protect public health.</div>
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72 4. Questions and answers on Bovine Spongiform</div>
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73 Encephalopathy (BSE) and variant CJD</div>
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74 What is BSE?</div>
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75 BSE (Bovine Spongiform Encephalopathy) is a disease of cattle which is sometimes known as Mad Cow</div>
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76 disease. BSE belongs to a group of diseases called TSEs (Transmissible Spongiform Encephalopathies).</div>
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77 BSE was recognised for the first time in 1986 in the UK. A similar disease in sheep, called scrapie, has</div>
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78 been recognised for over two centuries. Due to the eradication measures, this epidemic has declined</div>
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worldwide and as of 2017, there are only a few cases reported annually7 79 . In the UK, where the most</div>
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80 cases have been reported, the incidence of BSE has decreased from 37,280 in 1992 at the height of</div>
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81 the epidemic, to 0 cases in 2016.</div>
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82 All TSE diseases are associated with the appearance of tiny particles in brain and nerve cells. These</div>
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83 particles consist of an abnormal form of prion protein and are responsible for TSE diseases (see “What</div>
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84 are prions” below).</div>
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85 The most obvious symptoms of TSE diseases are in co-ordination of movements and mental</div>
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86 deterioration. Once a TSE disease becomes established, it becomes progressively more serious.</div>
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87 TSEs are said to be ‘transmissible’, because if certain tissues of an affected animal are given by</div>
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88 injection or by mouth to other animals, the disease may be passed on to them. Brain and spinal cord</div>
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89 are the tissues which are the highest risk in this respect.</div>
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90 How did the outbreak appear in animals?</div>
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91 The outbreak probably started as a result of feeding of animal derived meat-and-bone meal to cattle.</div>
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92 There is strong evidence and general agreement that the outbreak was then amplified by the</div>
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93 continued feeding of meat-and bone meal prepared from infected cattle.</div>
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94</div>
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7 <a href="http://www.oie.int/animal-health-in-the-world/bse-specific-data/number-of-cases-in-the-united-kingdom/" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://www.oie.int/animal-health-in-the-world/bse-specific-data/number-of-cases-in-the-united-kingdom/</a></div>
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95</div>
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96 Does this kind of diseases occur in humans?</div>
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97 Yes, but these human diseases are very rare. They include classical (or sporadic) Creutzfeldt-Jakob</div>
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98 Disease (CJD/sCJD), variant CJD (vCJD), Kuru (transmission via cannibalism in Papua New Guinea)</div>
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99 and fatal familial insomnia. Classical CJD has been well studied for more than 70 years and occurs</div>
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100 sporadically worldwide at a rate of about 1 case per 1 million people and is not linked to BSE.</div>
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101 Can BSE be transmitted to humans?</div>
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102 In 1996, the first cases of a variant of Creutzfeldt-Jacob Disease (vCJD) were reported in the UK</div>
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103 (Lancet, 1996, 347: 921-925). There is strong scientific evidence indicating that vCJD and BSE are</div>
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104 caused by the same infectious prion agent and strong epidemiological and experimental scientific</div>
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105 evidence for the association between the ingestion of BSE contaminated food and vCJD. Experts</div>
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106 believe that certain types of meat (mechanically recovered meat which at that time contained high risk</div>
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107 tissues) or certain high risk tissues (brain) used in the preparation of industrial minced meat could</div>
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108 have played a major role in spreading the human form of TSE (vCJD).</div>
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109 Emergence of variant CJD (vCJD) was noted in the UK in 1996 and a total number of 178 definite or</div>
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probable cases have been reported so far in the UK8 110 . Although the number of cases has been in</div>
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111 decline in the UK since 2001, isolated cases of vCJD are still being identified in the UK as in other</div>
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112 countries.</div>
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113 Further information can be found in the CHMP position statement on Creutzfeldt-Jakob disease and</div>
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114 plasma-derived and urine-derived medicinal products.</div>
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115 vCJD generally affects younger people (average age of onset: 28 years) than classical CJD and the</div>
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116 clinical symptoms are different.</div>
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117 What are prions?</div>
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118 Prions are proteins that are found in all animal species and in humans. Abnormal forms of prion protein</div>
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119 are found in TSEs such as BSE, scrapie and all forms of CJD. Abnormal forms of prion proteins are</div>
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120 closely associated with the spread of the disease. Unlike other infectious particles such as bacteria or</div>
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121 viruses, prions do not carry any genetic material. Prions are extremely difficult to destroy: they are</div>
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122 resistant to elevated temperatures and standard chemical conditions which would normally kill bacteria</div>
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123 and viruses.</div>
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124 How do prions cause BSE?</div>
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125 Spongiform encephalopathies (also known as prion diseases) are degenerative neurological disorders</div>
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126 characterised by the presence of massive amounts of modified (structurally abnormal) prion proteins.</div>
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127 For an unknown reason, the normal protein can be transformed into a different conformation, by</div>
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128 contact with a modified prion protein. This can happen mainly in the brain where a cascade of</div>
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129 progressive degeneration may start. It is thought that the ingestion of a critical amount of this</div>
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130 modified protein could trigger the disease.</div>
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131 There is no diagnostic test available yet to identify the disease prior to the start of clinical symptoms</div>
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132 and the development of a characteristic neurological pattern. However, for detecting BSE in</div>
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133 slaughtered animals, diagnostic tests are available and in use.</div>
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8 <a href="http://www.cjd.ed.ac.uk/data-and-reports/variant-cjd-cases-worldwide" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://www.cjd.ed.ac.uk/data-and-reports/variant-cjd-cases-worldwide</a></div>
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134 No medicinal product is available to combat the disease, and no vaccine has been developed to protect</div>
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135 animals or people.</div>
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136 Why is the risk of BSE transmission being raised in relation to vaccines for human use?</div>
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137 Material of animal origin, including bovine derived materials, is used in the manufacture of some</div>
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138 vaccines.</div>
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139 However, the European Medicines Agency (EMA) has been advised by a panel of international experts</div>
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140 that the risk of BSE contamination of vaccines used in the EU is extremely low. There are no</div>
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141 indications that vCJD is linked to the use of vaccines, and it is felt that the risk posed by the use of</div>
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142 bovine material is very remote as substantiated by the experience to date.</div>
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143 5. Vaccines and risk of BSE transmission</div>
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144 5.1. Questions and answers on bovine materials used in the manufacture</div>
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145 of vaccines</div>
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146 What are vaccines and how do vaccines work?</div>
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147 Vaccines are medicinal products, which are given to protect individuals against viral or bacterial</div>
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148 infections. Some contain small amounts of inactivated viruses or bacteria, while others may contain</div>
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149 micro-organisms which, although alive, no longer cause disease (live attenuated vaccines). Vaccines</div>
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150 may also be composed of purified fractions of these micro-organisms or of components derived from</div>
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151 recombinant DNA technology. Vaccines act by stimulating the body’s own defences (the immune</div>
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152 system), so that when he or she comes in contact with the relevant virus or bacterium, he/she will be</div>
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153 protected against infection. Tetanus vaccine is an example of a bacterial vaccine and measles vaccine</div>
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154 is an example of a viral vaccine.</div>
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155 How are vaccines manufactured?</div>
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156 Vaccines are made by growing cultures of these viruses or bacteria, or cells which have undergone</div>
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157 recombinant manipulation, under controlled conditions. Some vaccines are then inactivated by</div>
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158 chemical treatment. Other vaccines are attenuated (live, but no longer able to cause the disease).</div>
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159 Bacteria require complex culture media for their growth. Viruses need to grow in cells and these cells</div>
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160 also require complex culture media. Recombinant cells can be either bacterial, insect or mammalian</div>
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161 and have similar complex nutritional needs. The culture media provide numerous nutritious elements</div>
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162 and growth factors, sometimes obtained from materials of animal origin, such as serum, milk and milk</div>
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163 derivatives, gelatin, meat extract or extracts from other muscular tissues (“peptones”).</div>
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164 After the processes of bacterial fermentation, viral growth in cell cultures or growth of recombinant</div>
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165 cells are completed, there is a purification process reducing these growth supplements to trace</div>
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166 amounts.</div>
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167 The bacterial or viral components of the vaccine are then diluted to the desired strength and prepared</div>
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168 into a finished product. Vaccines are presented in vials or pre-filled syringes containing the desired</div>
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169 bacterial, viral or recombinant components together with ingredients such as stabilisers. After</div>
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170 production, vaccines are given in defined doses which are proven to be safe and effective in clinical</div>
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171 trials.</div>
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172 Are any materials of bovine origin used in the manufacture of vaccines?</div>
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173 Bovine derived materials are used at some stages in the manufacture of some, but not of all vaccines.</div>
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174 These bovine materials are one source of nutrients and growth factors for the growth of bacteria or for</div>
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175 the cells used to grow viruses. These elements are essentially provided from materials of animal origin.</div>
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176 Generally they are used only in the early stages of the manufacturing process of the vaccine</div>
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177 component(s), and then they are reduced to trace amounts during the further purification and dilution</div>
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178 steps.</div>
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179 In other cases, highly processed derivatives of a bovine material are used, e.g. as a stabiliser of the</div>
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180 finished product. For example polysorbates, (which are manufactured using very high temperature and</div>
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181 extreme chemical conditions which have been shown to inactivate prions) are used in a small number</div>
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182 of vaccines.</div>
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183 Manufacturers of vaccines strictly control the quality of the materials derived from animals by</div>
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184 obtaining them only from known, well controlled sources with systems in place to ensure the materials</div>
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185 do not pose a risk of contamination with BSE, and by only sourcing the materials from animals which</div>
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186 are fit for human consumption (see “How safe is the bovine material used in the manufacture of</div>
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187 vaccines?” below).</div>
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188 Is it possible to replace bovine materials used in the manufacture of vaccines with non189</div>
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animal materials?</div>
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190 Over the past years there have been many attempts to find a way to replace growth media containing</div>
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191 bovine derived materials by plant-derived or more synthetic media. This has often been successful.</div>
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192 However, not all attempts have succeeded in providing bacteria, viruses or cells with all the nutrients</div>
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193 present in the bovine material. In many cases, it has been possible to replace most or all of the animal</div>
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194 materials used during the production of vaccines. Researchers continue their efforts to eliminate</div>
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195 materials of animal origin in the manufacturing process.</div>
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196 Manufacturers were encouraged to re-establish their Working Seed/Cell Banks (WSB/WCB) if they</div>
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197 contained material where not all of the relevant information was available to demonstrate compliance</div>
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198 with the TSE Note for Guidance, even if there were no demonstrable TSE risks associated with their</div>
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199 use. The new WSB/WCB should be prepared using material for which all relevant information is</div>
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available9 200 . As a general precautionary measure, manufacturers of medicinal products are encouraged</div>
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201 not to use materials of bovine origin at all, if possible.</div>
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202 How safe is the bovine material used in the manufacture of vaccines?</div>
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203 Gelatin</div>
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204 Gelatin is extracted from different tissues (usually from skin and bone) from different animal species</div>
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205 (usually from cattle and pig). It is used directly in medicinal products, for example in capsules. Gelatin</div>
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206 is not made from a high risk material like brain or spinal cord, but it cannot be excluded that a small</div>
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207 amount of high risk material could be a contaminant in bones from which gelatin is extracted. BSE</div>
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infectivity has never been detected in bovine skin3 208 .</div>
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209 The production of gelatin from bones involves grinding, degreasing, heating followed by a hydrochloric</div>
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210 acid bath for several days. The gelatin may then be further treated with strong alkali or acid. In</div>
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211 addition there is a heat sterilisation step at a minimum of 133°C or 138°C. These processes have been</div>
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212 shown to have high capacity to reduce or eliminate any contaminating BSE prions.</div>
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9 Re-establishment of Working Seeds and Working Cell Banks using TSE compliant materials EMEA/22314/02</div>
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213</div>
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214</div>
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215 Bovine serum</div>
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216 Bovine serum is very rich in vitamins, growth factors and other components necessary to grow the</div>
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217 cells needed for viral vaccine production. The following measures are taken into account to ensure the</div>
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218 safety of serum regarding the risk of transmission of contamination with BSE:</div>
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219 - Bovine serum is obtained only from countries with a negligible or controlled BSE risk</div>
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220 - Bovine serum is obtained only from animals which are fit for human consumption.</div>
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221 - Each batch of serum or plasma is traceable to the slaughterhouse to ensure that material</div>
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222 of unknown quality/TSE risk does not enter the supply chain. Methods of animal stunning</div>
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223 and slaughter are controlled to reduce/avoid the risk of cross-contamination of blood with high</div>
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224 risk tissues such as brain.</div>
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225 - The maximum age of cattle at slaughter is strictly limited</div>
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226 - The presence of the BSE prion has not been conclusively detected in the blood of cattle which</div>
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are sick or incubating the disease3 227 .</div>
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228 Milk and milk derivatives (for example lactose)</div>
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229 - Bovine milk has always been considered as non-infectious, regardless of the country of origin.</div>
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230 Within the limits of experimental testing, BSE prion has not been detected in the milk of cattle</div>
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which are sick or incubating the disease9 231 .</div>
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232 - Lactose is a natural sugar present in milk. Milk used for lactose production must be collected</div>
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233 under the same conditions as milk for human consumption. This ensures that milk comes from</div>
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234 healthy animals, controlled by veterinary welfare systems.</div>
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235 Meat extracts</div>
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236 Meat extracts are mainly derived from muscular tissues. All of the tissues from which meat extracts</div>
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are derived are classified in the no or low risk categories by the WHO3 237 and high risk material is</div>
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238 excluded. This material is collected from countries with a negligible or controlled BSE risk. Taking these</div>
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239 criteria into consideration, meat extracts do not represent a risk of BSE transmission.</div>
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240 Polysorbate (Tallow derivatives)</div>
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241 Tallow derivatives are prepared from tallow (fat) which is derived from animal fat tissue. The tallow</div>
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242 starting material is prepared by separating it from the protein fraction. It has been shown that BSE</div>
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243 infectivity (experimentally added to the animal fat tissue) is never found in the tallow fraction, but can</div>
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244 be found in the protein fraction (which is not used in the manufacture of tallow derivatives). Tallow</div>
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245 derivatives are made from tallow starting material by very high temperature and extreme chemical</div>
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246 treatment. Tallow derivatives are extremely unlikely to pose any risk of transmitting BSE. Examples of</div>
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247 tallow derivatives are stearates (used in many tablets) and polysorbate (occasionally used to stabilise</div>
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248 vaccines). In most cases, animal-derived polysorbate has been replaced by plant-derived polysorbate.</div>
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249 5.2. Questions and answers on vaccines and the measures taken to</div>
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250 prevent the transmission of BSE</div>
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251 What measures are applied to vaccines to prevent BSE infection?</div>
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252 All medicinal products, including vaccines, have been thoroughly evaluated before they are authorised</div>
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253 to be marketed. To receive this authorisation to market their product, a pharmaceutical company has</div>
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254 to describe in detail (in a dossier) the results of all the studies demonstrating the quality, safety and</div>
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255 efficacy of the medicinal product. The dossier also documents the method of production and control of</div>
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256 each component of the medicinal product and all factors concerning the risk of BSE transmission are</div>
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257 presented. The dossier is evaluated by the relevant National Authorities or the EMA, taking into</div>
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258 account all existing guidelines and legal texts. It is only when a dossier is complete and fully</div>
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259 satisfactory that a marketing authorisation for a medicinal product is granted.</div>
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260 For all bovine materials used in the manufacture of vaccines (and all other medicinal products) an</div>
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261 assessment is made of the risk of BSE contamination. This is carried out in accordance to the European</div>
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262 Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via</div>
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263 human and veterinary medicinal products. This legally mandatory guideline was first applied in 1991,</div>
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264 and has been regularly updated since. Factors taken into special account are:</div>
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265 - The country of origin of the animals used,</div>
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266 - The nature of the tissue used (for example, brain is considered the highest risk, serum and</div>
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267 muscle tissue are of the lowest risk),</div>
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268 - Information on traceability (origin and follow-up of herds, type of feed, etc.),</div>
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269 - Whether the manufacturing processes of both the materials of bovine origin and the vaccine</div>
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270 could reduce or destroy any BSE, if it were to be present.</div>
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271 Therefore, safety related to the risk of transmitting BSE is assessed by taking into account not only the</div>
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272 geographical origin of animals but also their feeding, their age at slaughter, technique of slaughter and</div>
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273 carving, nature of tissues used, as well as manufacturing processes which must comply with European</div>
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274 guidelines, directives and recommendations. It is the assessment of all these criteria, which ensures</div>
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275 the freedom of a medicinal product from contamination with the agent that causes BSE before it is</div>
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276 authorised and marketed.</div>
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277 In June 2000, the European Medicines Agency (EMA) conducted a review of the safety of all vaccines</div>
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278 (including those which were licensed prior to the introduction of the Note for guidance on minimising</div>
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279 the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal</div>
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280 products) on the EU market with respect to BSE contamination and concluded that all vaccines are</div>
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281 indeed safe. Therefore, all vaccines authorised to date, have been reviewed for safety with respect to</div>
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282 BSE, against the above criteria.</div>
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283 5.3. Questions and answers on the evidence that vaccines do not transmit</div>
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284 BSE.</div>
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285 What evidence is there that vaccines were not the cause of the vCJD cases in the UK?</div>
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286 The majority of vCJD cases occurred in the UK between 1996 and 2005. The same vaccines that were</div>
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287 given to these people in the UK in their early life were also used in other countries at the same time.</div>
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288 No vCJD cases occurred in these other countries despite administration of identical vaccines, from the</div>
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289 same manufacturers and using identical materials.</div>
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290 Furthermore, most vCJD patients from the height of the epidemic were vaccinated prior to the</div>
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291 occurrence of BSE in British herds (most vaccines are given in the first two years of life). Thus, the</div>
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292 vaccines used to immunise children who developed vCJD in later life had been produced in the years </div>
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293 before the BSE epidemic and so the agent that causes BSE could not have been present in the doses of</div>
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294 vaccine given to these children.</div>
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295 What is the experts’ opinion on the safety of vaccines with respect to BSE?</div>
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296 Vaccines have played, and continue to play, a crucial role in the prevention and eradication of viral</div>
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297 infectious diseases, such as measles, mumps, rubella, polio and smallpox, and of bacterial infectious</div>
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298 diseases such as diphtheria, tetanus and pertussis. Vaccines currently in use have an excellent safety</div>
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299 record. A reduction in use of vaccines is likely to result in the spread of damaging or fatal diseases.</div>
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300 In 2001, the European Medicines Agency (EMA) was advised by a panel of international experts that</div>
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301 the risk of BSE contamination of vaccines used in the EU is vanishingly small. To date there are no</div>
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302 indications that vCJD is linked to the use of any vaccines, and that the risk posed by the use of bovine</div>
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303 materials is very remote as substantiated by the experience to date.</div>
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304 To date, there are no indications that vCJD is linked to the use of any vaccines, and that the risk posed</div>
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305 by the use of bovine materials is very remote as substantiated by the experience to date.</div>
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<a href="http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2018/02/WC500242954.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2018/02/WC500242954.pdf</a></div>
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<br /></div>
<span data-offset-key="futrq-4-0" style="background-color: white; color: #1d2129; font-family: "helvetica" , "arial" , sans-serif; font-size: 13px; white-space: pre-wrap;"><span data-text="true" style="font-family: inherit;"><br /></span></span>
<span data-offset-key="futrq-4-0" style="background-color: white; color: #1d2129; font-family: "helvetica" , "arial" , sans-serif; font-size: 13px; white-space: pre-wrap;"><span data-text="true" style="font-family: inherit;">i think i should take this time to make perfectly clear to _everyone_, this board i set up for me to pass information on transmissible spongiform encephalopathy tse prion disease of human and animals, and the latest science there from that i can possibly get my hands on, and not have to argue with anyone, so the information would be there for future use for everyone. this tse prion page is not, NOT, an anti-vaccine forum. now i have written in the past, and i might in the future of risk factors there from on the issues of vaccines, where and if that might come up about tse prion issues. in the early days there was much written on that topic, and i addressed that issue in great detail during and after the BSE Inquiry. but vaccines have saved and continue to save countless lives across the globe, and like i said, i get my flu vaccine every year. i will not even debate the issue of anti vaccine here, it's simply not up for debate. </span></span></div>
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<span data-offset-key="futrq-4-0" style="background-color: white; color: #1d2129; font-family: "helvetica" , "arial" , sans-serif; font-size: 13px; white-space: pre-wrap;"><span data-text="true" style="font-family: inherit;"><br /></span></span></div>
<div>
<span data-offset-key="futrq-4-0" style="background-color: white; color: #1d2129; font-family: "helvetica" , "arial" , sans-serif; font-size: 13px; white-space: pre-wrap;"><span data-text="true" style="font-family: inherit;">with that said, i will run this by for everyone, share this one time past history of the tse prion vaccine issue for those that may need references. this reply will be long with references for your future use...</span></span></div>
<div>
<span data-offset-key="futrq-4-0" style="background-color: white; color: #1d2129; font-family: "helvetica" , "arial" , sans-serif; font-size: 13px; white-space: pre-wrap;"><span data-text="true" style="font-family: inherit;"><br /></span></span></div>
<div>
<span data-offset-key="futrq-4-0" style="background-color: white; color: #1d2129; font-family: "helvetica" , "arial" , sans-serif; font-size: 13px; white-space: pre-wrap;"><span data-text="true" style="font-family: inherit;">we will start way back before the BSE Inquiry was published online, i was following via Her Majesty's Air Mail and getting daily updates, and sending them to Dr. Priongle. ...LOL Dr. Tom Pringle, had the best damn page on tse prion disease ever. also, i made a submission to BSE Inquiry (they ask) about nutritional supplements that contained SRM. i think about here;</span></span></div>
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<span data-offset-key="futrq-4-0" style="background-color: white; color: #1d2129; font-family: "helvetica" , "arial" , sans-serif; font-size: 13px; white-space: pre-wrap;"><span data-text="true" style="font-family: inherit;"><br /></span></span></div>
<div>
<span data-offset-key="futrq-4-0" style="background-color: white; color: #1d2129; font-family: "helvetica" , "arial" , sans-serif; font-size: 13px; white-space: pre-wrap;"><span data-text="true" style="font-family: inherit;">year 2000</span></span></div>
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<span data-offset-key="futrq-4-0" style="background-color: white; color: #1d2129; font-family: "helvetica" , "arial" , sans-serif; font-size: 13px; white-space: pre-wrap;"><span data-text="true" style="font-family: inherit;"><br /></span></span></div>
<div>
<span data-offset-key="futrq-4-0" style="background-color: white; color: #1d2129; font-family: "helvetica" , "arial" , sans-serif; font-size: 13px; white-space: pre-wrap;"><span data-text="true" style="font-family: inherit;"><a href="http://www.mad-cow.org/00/sep00_news.html#hhh" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://www.mad-cow.org/00/sep00_news.html#hhh</a></span></span><br />
<span data-offset-key="futrq-4-0" style="background-color: white; color: #1d2129; font-family: "helvetica" , "arial" , sans-serif; font-size: 13px; white-space: pre-wrap;"><br /></span>
<span data-offset-key="futrq-4-0" style="background-color: white; color: #1d2129; font-family: "helvetica" , "arial" , sans-serif; font-size: 13px; white-space: pre-wrap;"><a href="http://www.mad-cow.org/00/may00_news.html#aaa">http://www.mad-cow.org/00/may00_news.html#aaa</a></span></div>
<div>
<span data-offset-key="futrq-4-0" style="background-color: white; color: #1d2129; font-family: "helvetica" , "arial" , sans-serif; font-size: 13px; white-space: pre-wrap;"><br /></span></div>
<div>
<span data-offset-key="futrq-4-0" style="background-color: white; color: #1d2129; font-family: "helvetica" , "arial" , sans-serif; font-size: 13px; white-space: pre-wrap;">then years later, the BSE Inquiry was published online, then taken off, then archived, then those urls changed, then some new ones listed, and so on and so forth. but a decade or so later, i decided to put it all on the WWW here for future references;</span></div>
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<span data-offset-key="futrq-4-0" style="background-color: white; color: #1d2129; font-family: "helvetica" , "arial" , sans-serif; font-size: 13px; white-space: pre-wrap;"><a href="http://bseinquiry.blogspot.com/2008/05/mad-cow-disease-bse-cjd-children.html" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://bseinquiry.blogspot.com/2008/05/mad-cow-disease-bse-cjd-children.html</a></span></div>
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at some point, i became concerned with vaccines, when i became aware of the iatrogenic threats, and that the inoculation mode route of transmission, would be one of the most efficient way to transmit disease, more so than oral consumption. i become very concerned with live vaccines, there were not many that i could find, but there was one that i was very concerned about, if my mind don't fail me now, it was a live rabies vaccine, and only used mainly in at the time, third world countries, but this is where my concern came about was the fact it was a live vaccine, made from sheep brains, and i had gotten my hands on an on several reports of an outbreaks of scrapie in flocks that had used a vaccine made up from sheep brains. one was the Louping-vaccine for sheep, a great many of these sheep went down with Scrapie after using this Louping-ill vaccine made up from sheep brains. funny thing, my old friend and scientist, the late Dr. Joe C. Gibbs and someone from England, both sent me that old study, and Dr. Gibbs told me then, about one of my rants about the ever elusive spontaneous sporadic cjd, that just comes from nothing, 85%+ of all cases, a happen stance of bad luck, well, i will not say what he told me, but he did not think sporadic cjd was so spontaneous as other folks seem to think it is...</div>
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<span style="font-size: 13.3333px;">Subject: Louping-ill vaccine documents from November 23rd, 1946 Date: Sat, 9 Sep 2000 17:44:57 -0700 From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To: BSE-L@uni-karlsruhe.de</span></div>
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<span style="font-size: 13.3333px;">######### Bovine Spongiform Encephalopathy #########</span></div>
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<span style="font-size: 13.3333px;">THE VETERINARY RECORD 516 No 47. Vol. 58 November 23rd, 1946</span></div>
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<span style="font-size: 13.3333px;">NATIONAL VETERINARY MEDICAL ASSOCIATION OF GREAT BRITAIN AND IRELAND</span></div>
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<span style="font-size: 13.3333px;">ANNUAL CONGRESS, 1946</span></div>
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<span style="font-size: 13.3333px;">The annual Congress, 1946, was held at the Royal Veterinary College, Royal College Street, London, N.W.I. from September 22nd to September 27th.</span></div>
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<span style="font-size: 13.3333px;">Opening Meeting</span></div>
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<span style="font-size: 13.3333px;">[skip to scrapie vaccine issue...tss]</span></div>
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<span style="font-size: 13.3333px;">Papers Presented to Congress</span></div>
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<span style="font-size: 13.3333px;">The papers presented to this year's Congress had as their general theme the progressive work of the profession during the war years. Their appeal was clearly demonstrated by the large and remarkably uniform attendance in the Grand Hall of the Royal Veterinary College throughout the series; between 200 and 250 members were present and they showed a keen interest in every paper, which was reflected in the expression of some disappointment that the time available for discussion did not permit of the participation of more than a small proportion of would-be contributors.</span></div>
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<span style="font-size: 13.3333px;">In this issue we publish (below) the first to be read and discussed, that by Dr. W. S. Gordon, M.R.C.V.S., F.R.S.E., "Advances in Veterinary Research." Next week's issue will contain the paper on "Some Recent Advances in Veterinary Medicine and Surgery in Large-Animal Practice" by Mr. T. Norman Gold, M.R.C.V.S. In succeeding numbers of the Record will be reproduced, also with reports of discussions, that by Mr. W. L. Weipers, M.R.C.V.S., D.V.S.M., on the same subject as relating to small-animal practice, and the papers by Mr. J. N. Ritchie, B.SC., M.R.C.V.S., D.V.S.M., and Mr. H.W. Steele-Bodger, M.R.C.V.S., on "War-time Achievements of the British Home Veterinary Services."</span></div>
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<span style="font-size: 13.3333px;">The first scientific paper of Congress was read by Dr. W. S. Gordon, M.R.C.V.S., F.R.S.E. on Monday, September 23rd, 1946, when Professor J. Basil Buxton, M.A., F.R.C.V.S, D.V.H., Prinicipal of the Royal Veterinary College, presided.</span></div>
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<span style="font-size: 13.3333px;">Advances in Veterinary Research</span></div>
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<span style="font-size: 13.3333px;">by</span></div>
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<span style="font-size: 13.3333px;">W.S. GORDON, PH.D., M.R.C.V.S., F.R.S.E.</span></div>
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<span style="font-size: 13.3333px;">Agriculteral Research Council, Field Station, Compton, Berks.</span></div>
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<span style="font-size: 13.3333px;">Louping-ill, Tick-borne Fever and Scrapie</span></div>
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<span style="font-size: 13.3333px;">In 1930 Pool, Browniee & Wilson recorded that louping-ill was a transmissible disease. Greig et al, (1931) showed that the infective agent was a filter-passing virus with neurotropic characters and Browniee & Wilson (1932) that the essential pathology was that of an encephalomyelitis. Gordon, Browniee, Wilson & MacLeod (1932) and MacLeod & Gordon (1932) confirmed and extended this work. It was shown that on louping-ill farms the virus was present in the blood of many sheep which did not show clinical symptoms indicating involvement of the central nervous system and that for the perpetuation and spread of the disease these subclinical cases were probably of greater importance that the frank clinical cases because, in Nature, the disease was spread by the tick, lxodes ricinus L. More recently Wilson (1945, 1946) has described the cultivation of the virus in a chick embryo medium, the pathogenic properties of this culture virus and the preparation of louping-ill antiserum.</span></div>
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<span style="font-size: 13.3333px;">Between 1931 and 1934 I carried out experiments which resulted in the development of an effective vaccine for the prevention of louping-ill.* This vaccine has been in general use since 1935 and in his annual report to the Animal Diseases Research Association this year, Dr. Greig stated that about 227,000 doses of vaccine had been issued from Moredun alone.</span></div>
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<span style="font-size: 13.3333px;">Dr. Gordon illustrated this portion of his paper by means of graphs and diagrams projected by the epidiascope.</span></div>
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<span style="font-size: 13.3333px;">This investigation, however, did not begin and end with the study of louping-ill; it had, by good fortune, a more romantic turn and less fortunately a final dramtic twist which led almost to catastrope. After it had been established that a solid immunity to louping-ill could be induced in sheep, a group of immunized and a group of susceptible animals were placed together on the tick-infected pasture of a louping-ill farm. Each day all the animals were gathered and their temperatures were recorded. It was anticipated that febrile reactions with some fatalities would develop in the controls while the louping-ill immunes would remain normal. Contrary to expectation, however, every sheep, both immune and control, developed a febrile reaction. This unexpected result made neccessary further investigation which showed that the febrile reaction in the louping-ill immunes was due to a hitherto undescribed infective agent, a Rickettsia-like organism which could be observed in the cytoplasm of the grannular leucocytes, especially the neutrophil polymorphs (MacLeod (1932), Gordon, Browniee, Wilson & MacLeod. MacLeod & Gordon (1933). MacLeod (1936). MacLeod collected ticks over many widely separated parts of Scotland and all were found to harbour the infective agent of tick-borne fever, and it is probable that all sheep on tick-infested farms develop this disease, at least on the first occasion that they become infested with ticks. When the infection is passed in series through susceptible adult sheep it causes a sever, febrile reaction, dullness and loss of bodily condition but it rarely, if ever, proves fatal. It is clear, however, that it aggravates the harmful effects of a louping-ill infection and it is a serious additional complication to such infections as pyaemia and the anacrobic infections which beset lambs on the hill farms of Northern Britain.</span></div>
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<span style="font-size: 13.3333px;">Studying the epidemiology of louping-ill on hill farms it became obvious that the pyaemic condition of lambs described by M'Fadyean (1894) was very prevalent on tick infested farms Pyaemia is a crippling condition of lambs associated with tick-bite and is often confused with louping-ill. It is caused by infection with Staphylococcus aureus and affected animals may show abscess formation on the skin, in the joints, viscera, meninges and elsewhere in the body. It was thought that tick-borne fever might have ben a predisposing factor in this disease and unsuccessful attempts were made by Taylor, Holman & Gordon (1941) to reproduce the condition by infecting lambs subcutaneously with the staphylococcus and concurrently produceing infections with tickborne fever and louping-ill in the same lambs. Work on pyaemia was then continued by McDiarmid (1946a, 1946b, 1946c), who succeeded in reproducing a pyaemic disease in mice, guinea-pigs and lambs similar to the naturally occuring condition by intravenous inoculation of Staphylococcus aureus. He also found a bacteraemic form of the disease in which no gross pyaemic lesions were observed. The prevention or treatment of this condition presents a formidable problem. It is unlikely that staphylococcal ???oid will provide an effective immunity and even if penicillin proved to be a successful treatment, the difficulty of applying it in adequate and sustained dosage to young lambs on hill farms would be almost insurmountable.</span></div>
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<span style="font-size: 13.3333px;">>From 1931 to 1934 field trials to test the immunizing value and harmlessness of the loup-ill vaccine were carried out on a gradually increasing scale. Many thousands of sheep were vaccinated and similar numbers, living under identical conditions were left as controls. The end result showed that an average mortability of about 9 percent in the controls was reduced to less than 1 percent in the vaccinated animals. While the efficiency of the vaccine was obvious after the second year of work, previous bitter experience had shown the wisdom of withholding a biological product from widespread use until it had been successfully produced in bulk, as opposed to small-scale experimental production and until it had been thoroughly tested for immunizing efficiency and freedom from harmful effects. It was thought that after four years testing this stage had been reached in 1935, and in the spring of that year the vaccine was issued for general use. It comprised a 10 percent saline suspension of brain, spinal cord and spleen tissues taken from sheep five days after infection with louping-ill virus by intracerebral inoculation. To this suspension 0-35 percent of formalin was added to inactivate the virus and its safety for use as a vaccine was checked by intracerbral inoculation of mice and sheep and by the inoculation of culture medium. Its protective power was proved by vaccination sheep and later subjecting them, along with controls, to a test dose of living virus.</span></div>
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<span style="font-size: 13.3333px;">Vaccine for issue had to be free from detectable, living virus and capable of protecting sheep against a test dose of virus applied subcutaneously. The 1935 vaccine conformed to these standards and was issued for inoculation in March as three separate batches labelled 1, 2, and 3. The tissues of 140 sheep were employed to make batch 1 of which 22,270 doses were used; 114 to make batch 2 of which 18,000 doses were used and 44 to make batch 3 of which 4,360 doses were used. All the sheep tissues incorporated in the vaccine were obtained from yearling sheep. During 1935 and 1936 the vaccine proved highly efficient in the prevention of loup-ill and no user observed an ill-effect in the inoculated animals. In September, 1937, two and a half years after vaccinating the sheep, two owners complained that scrapie, a disease which had not before been observed in the Blackface breed, was appearing in their stock of Blackface sheep and further that it was confined to animals vaccinated with louping-ill vaccine in 1935. At that stage it was difficult to conceive that the occurrence could be associated with the injection of the vaccine but in view of the implications, I visited most of the farms on which sheep had been vaccinated in 1935. It was at this point that the investigation reached its dramatic phase; I shall not forget the profound effect on my emotions when I visited these farms and was warmly welcomed because of the great benefits resulting from the application of louping-ill vaccine, wheras the chief purpose of my visit was to determine if scrapie was appearing in the inoculated sheep. The enquiry made the position clear. Scrapie was developing in the sheep vaccinated in 1935 and it was only in a few instances that the owner was associating the occurrence with louping-ill vaccination. The disease was affecting all breeds and it was confined to the animals vaccinated with batch 2. This was clearly demonstrated on a number of farms on which batch 1 had been used to inoculate the hoggs in 1935 and batch 2 to inoculate the ewes. None of the hoggs, which at this time were three- year-old ewes. At this time it was difficult to forecast whether all of the 18,000 sheep which had received batch 2 vaccine would develop scrapie. It was fortunate, however, that the majority of the sheep vaccinated with batch 2 were ewes and therfore all that were four years old and upwards at the time of vaccination had already been disposed of and there only remained the ewes which had been two to three years old at the time of vaccination, consequently no accurate assessment of the incidence of scrapie could be made. On a few farms, however, where vaccination was confined to hoggs, the incidence ranged from 1 percent, to 35 percent, with an average of about 5 percent. Since batch 2 vaccine had been incriminated as a probable source of scrapie infection, an attempt was made to trace the origin of the 112 sheep whose tissues had been included in the vaccine. It was found that they had been supplied by three owners and that all were of the Blackface or Greyface breed with the exception of eight which were Cheviot lambs born in 1935 from ewes which had been in contact with scrapie infection. Some of these contact ewes developed scrapie in 1936-37 and three surviving fellow lambs to the eight included in the batch 2 vaccine of 1935 developed scrapie, one in September, 1936, one in February, 1937, and one in November, 1937. There was, therefore, strong presumptive evidence that the eight Cheviot lambs included in the vaccine althought apparently healthy were, in fact, in the incubative stage of a scrapie infection and that in their tissues there was an infective agent which had contaminated the batch 2 vaccine, rendering it liable to set up scrapie. If that assumption was correct then the evidence indicated that:-</span></div>
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<span style="font-size: 13.3333px;">(1) the infective agent of scrapie was present in the brain, spinal cord and or spleen of infected sheep:</span></div>
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<span style="font-size: 13.3333px;">(2) it could withstand a concentration of formalin of 0-35 percent, which inactivated the virus of louping-ill:</span></div>
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<span style="font-size: 13.3333px;">(3) it could be transmitted by subcutaneous inoculation;</span></div>
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<span style="font-size: 13.3333px;">(4) it had an incubative period of two years and longer.</span></div>
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<span style="font-size: 13.3333px;">Two Frenchmen, Cuille & Chelle (1939) as the result of experiments commenced in 1932, reported the successful infection of sheep by inoculation of emulsions of spinal cord or brain material by the intracerebral, epidural, intraocular and subcutaneous routes The incubation period varied according to the route employed, being one year intracerebrally, 15 months intraocularly and 20 months subcutaneously. They failed to infect rabbits but succeeded in infecting goats. Another important part of their work showed that the infective agent could pass throught a chamberland 1.3 filter, thus demonstrating that the infective agent was a filtrable virus. It was a curious coincidence that while they were doing their transmission experiments their work was being confirmed by the unforeseeable infectivity of a formalinized tissue vaccine.</span></div>
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<span style="font-size: 13.3333px;">As a result of this experience a large-scale transmision experiment involving the ue of 788 sheep was commenced in 1938 on a farm specially taken for the purpose by the Animal Diseases Research Association with funds provided by the Agricultural Research Council. The experiment was designed to determine the nature of the infective agent and the pathogenesis of the disease. It is only possible here to give a summary of the result which showed that (1) saline suspensions of brain and spinal cord tissue of sheep affected with scrapie were infective to normal sheep when inoculatted intracerebrally or subcutaneously; (2) the incubation period after intracerebral inoculation was seven months and upwards and only 60 percent of the inoculated sheep developed scrapie during a period of four and a half years; (3) the incubation period after subcutaneous inoculation was 15 months and upwards and only about 30 percent of the inoculated sheep developed the disease during the four and a half years: (4) the infective agent was of small size and probably a filtrable virus.</span></div>
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<span style="font-size: 13.3333px;">The prolonged incubative period of the disease and the remarkable resistance of the causal agent to formalin are features of distinct interest. It still remains to determine if a biological test can be devised to detect infected animals so that they can be killed for food before they develop clinical symptoms and to explore the possibilities of producing an immunity to the disease.</span></div>
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<span style="font-size: 13.3333px;">==================================================================</span></div>
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<span style="font-size: 13.3333px;">Greetings List Members,</span></div>
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<span style="font-size: 13.3333px;">pretty disturbing document. now, what would stop this from happening with the vaccineCJD in children???</span></div>
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<span style="font-size: 13.3333px;">kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA</span></div>
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<span style="font-size: 13.3333px;">==========</span></div>
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<span style="font-size: 13.3333px;">year 2018</span></div>
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<span style="font-size: 13.3333px;">NOW, my greatest fear is iatrogenic tse prion transmission, through many various routes and sources, and now back to vaccines and pigs from CWD TSE Prion...</span></div>
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<span style="font-size: 13.3333px;">first, reality;</span></div>
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<span style="font-size: 13.3333px;">1: J Neurol Neurosurg Psychiatry 1994 Jun;57(6):757-8 </span></div>
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<span style="font-size: 13.3333px;">Transmission of Creutzfeldt-Jakob disease to a chimpanzee by electrodes contaminated during neurosurgery. </span></div>
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<span style="font-size: 13.3333px;">Gibbs CJ Jr, Asher DM, Kobrine A, Amyx HL, Sulima MP, Gajdusek DC. </span></div>
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<span style="font-size: 13.3333px;">Laboratory of Central Nervous System Studies, National Institute of </span></div>
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<span style="font-size: 13.3333px;">Neurological Disorders and Stroke, National Institutes of Health, </span></div>
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<span style="font-size: 13.3333px;">Bethesda, MD 20892. </span></div>
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<span style="font-size: 13.3333px;">Stereotactic multicontact electrodes used to probe the cerebral cortex of a middle aged woman with progressive dementia were previously implicated in the accidental transmission of Creutzfeldt-Jakob disease (CJD) to two younger patients. The diagnoses of CJD have been confirmed for all three cases. More than two years after their last use in humans, after three cleanings and repeated sterilisation in ethanol and formaldehyde vapour, the electrodes were implanted in the cortex of a chimpanzee. Eighteen months later the animal became ill with CJD. This finding serves to re-emphasise the potential danger posed by reuse of instruments contaminated with the agents of spongiform encephalopathies, even after scrupulous attempts to clean them. </span></div>
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<span style="font-size: 13.3333px;">PMID: 8006664 [PubMed - indexed for MEDLINE] </span></div>
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<a href="https://www.ncbi.nlm.nih.gov/pubmed/8006664?dopt=Abstract" rel="noopener noreferrer" style="color: blue; cursor: pointer; text-size-adjust: 100%;" target="_blank">https://www.ncbi.nlm.nih.gov/pubmed/8006664?dopt=Abstract</a></div>
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now</div>
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<span style="font-size: 13.3333px;">***> CWD TO PIGS <***</span></div>
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<span style="font-size: 13.3333px;">Research Project: TRANSMISSION, DIFFERENTIATION, AND PATHOBIOLOGY OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES</span></div>
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<span style="font-size: 13.3333px;">Location: Virus and Prion Research</span></div>
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<span style="font-size: 13.3333px;">Title: Disease-associated prion protein detected in lymphoid tissues from pigs challenged with the agent of chronic wasting disease</span></div>
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<span style="font-size: 13.3333px;">Author item Moore, Sarah item Kunkle, Robert item Kondru, Naveen item Manne, Sireesha item Smith, Jodi item Kanthasamy, Anumantha item West Greenlee, M item Greenlee, Justin</span></div>
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<span style="font-size: 13.3333px;">Submitted to: Prion Publication Type: Abstract Only Publication Acceptance Date: 3/15/2017 Publication Date: N/A Citation: N/A Interpretive Summary:</span></div>
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<span style="font-size: 13.3333px;">Technical Abstract: Aims: Chronic wasting disease (CWD) is a naturally-occurring, fatal neurodegenerative disease of cervids. We previously demonstrated that disease-associated prion protein (PrPSc) can be detected in the brain and retina from pigs challenged intracranially or orally with the CWD agent. In that study, neurological signs consistent with prion disease were observed only in one pig: an intracranially challenged pig that was euthanized at 64 months post-challenge. The purpose of this study was to use an antigen-capture immunoassay (EIA) and real-time quaking-induced conversion (QuIC) to determine whether PrPSc is present in lymphoid tissues from pigs challenged with the CWD agent.</span></div>
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<span style="font-size: 13.3333px;">Methods: At two months of age, crossbred pigs were challenged by the intracranial route (n=20), oral route (n=19), or were left unchallenged (n=9). At approximately 6 months of age, the time at which commercial pigs reach market weight, half of the pigs in each group were culled (<6 challenge="" groups="" month="" pigs="" remaining="" the="">6 month challenge groups) were allowed to incubate for up to 73 months post challenge (mpc). The retropharyngeal lymph node (RPLN) was screened for the presence of PrPSc by EIA and immunohistochemistry (IHC). The RPLN, palatine tonsil, and mesenteric lymph node (MLN) from 6-7 pigs per challenge group were also tested using EIA and QuIC.</6></span></div>
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<span style="font-size: 13.3333px;">Results: PrPSc was not detected by EIA and IHC in any RPLNs. All tonsils and MLNs were negative by IHC, though the MLN from one pig in the oral <6 5="" 6="" at="" by="" detected="" eia.="" examined="" group="" in="" intracranial="" least="" lymphoid="" month="" months="" of="" one="" pigs="" positive="" prpsc="" quic="" the="" tissues="" was="">6 months group, 5/6 pigs in the oral <6 4="" and="" group="" months="" oral="">6 months group. Overall, the MLN was positive in 14/19 (74%) of samples examined, the RPLN in 8/18 (44%), and the tonsil in 10/25 (40%). Conclusions:</6></6></span></div>
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<span style="font-size: 13.3333px;">This study demonstrates that PrPSc accumulates in lymphoid tissues from pigs challenged intracranially or orally with the CWD agent, and can be detected as early as 4 months after challenge.</span></div>
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<span style="font-size: 13.3333px;">CWD-infected pigs rarely develop clinical disease and if they do, they do so after a long incubation period. This raises the possibility that CWD-infected pigs could shed prions into their environment long before they develop clinical disease.</span></div>
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<span style="font-size: 13.3333px;">Furthermore, lymphoid tissues from CWD-infected pigs could present a potential source of CWD infectivity in the animal and human food chains.</span></div>
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<span style="font-size: 13.3333px;"><a href="https://www.ars.usda.gov/research/publications/publication/?seqNo115=337105" rel="noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://www.ars.usda.gov/research/publications/publication/?seqNo115=337105</a> </span></div>
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<span style="font-size: 13.3333px;">CONFIDENTIAL</span></div>
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<span style="font-size: 13.3333px;">EXPERIMENTAL PORCINE SPONGIFORM ENCEPHALOPATHY</span></div>
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<span style="font-size: 13.3333px;">While this clearly is a cause for concern we should not jump to the conclusion that this means that pigs will necessarily be infected by bone and meat meal fed by the oral route as is the case with cattle. ...</span></div>
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<a href="http://web.archive.org/web/20031026000118/www.bseinquiry.gov.uk/files/yb/1990/08/23004001.pdf" rel="noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">http://web.archive.org/web/20031026000118/www.bseinquiry.gov.uk/files/yb/1990/08/23004001.pdf</a></div>
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<span style="font-size: 13.3333px;">we cannot rule out the possibility that unrecognised subclinical spongiform encephalopathy could be present in British pigs though there is no evidence for this: only with parenteral/implantable pharmaceuticals/devices is the theoretical risk to humans of sufficient concern to consider any action.</span></div>
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<a href="http://web.archive.org/web/20030822031154/www.bseinquiry.gov.uk/files/yb/1990/09/10007001.pdf" rel="noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">http://web.archive.org/web/20030822031154/www.bseinquiry.gov.uk/files/yb/1990/09/10007001.pdf</a></div>
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<span style="font-size: 13.3333px;">Our records show that while some use is made of porcine materials in medicinal products, the only products which would appear to be in a hypothetically ''higher risk'' area are the adrenocorticotrophic hormone for which the source material comes from outside the United Kingdom, namely America China Sweden France and Germany. The products are manufactured by Ferring and Armour. A further product, ''Zenoderm Corium implant'' manufactured by Ethicon, makes use of porcine skin - which is not considered to be a ''high risk'' tissue, but one of its uses is described in the data sheet as ''in dural replacement''. This product is sourced from the United Kingdom.....</span></div>
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<a href="http://web.archive.org/web/20030822054419/www.bseinquiry.gov.uk/files/yb/1990/09/21009001.pdf" rel="noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">http://web.archive.org/web/20030822054419/www.bseinquiry.gov.uk/files/yb/1990/09/21009001.pdf</a></div>
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<span style="font-size: 13.3333px;">snip...see much more here ;</span></div>
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<span style="font-size: 13.3333px;">WEDNESDAY, APRIL 05, 2017</span></div>
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<span style="font-size: 13.3333px;">Disease-associated prion protein detected in lymphoid tissues from pigs challenged with the agent of chronic wasting disease</span></div>
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<a href="http://chronic-wasting-disease.blogspot.com/2017/04/disease-associated-prion-protein.html" rel="noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">http://chronic-wasting-disease.blogspot.com/2017/04/disease-associated-prion-protein.html</a></div>
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<span style="font-size: 13.3333px;">WEDNESDAY, APRIL 05, 2017</span></div>
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<span style="font-size: 13.3333px;">*** Disease-associated prion protein detected in lymphoid tissues from pigs challenged with the agent of chronic wasting disease ***</span></div>
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<span style="font-size: 13.3333px;"><a href="http://chronic-wasting-disease.blogspot.com/2017/04/disease-associated-prion-protein.html" rel="noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">http://chronic-wasting-disease.blogspot.com/2017/04/disease-associated-prion-protein.html</a> </span></div>
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<span style="font-size: 13.3333px;">i remember asking this fateful question back in ...i think it was 2001...yes, the infamous 50 STATE BSE EMERGENCY CONFERENCE CALL, and i ask just that question, they could not answer it 17 years ago, and they can't answer it today i don't think...</span></div>
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<span style="font-family: "arial" , sans-serif;">2017 Section 21 C.F.R. 589.2000, Animal Proteins Prohibited in Ruminant Feed</span></div>
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<span style="color: #484138; font-family: "arial" , sans-serif;"><span style="font-size: 20px;">Subject: MICHIGAN FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED VIOLATIONS OFFICIAL ACTION INDICATED OAI UPDATE BREACH APRIL 4, 2017</span></span></h1>
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<span style="color: #484138; font-family: "arial" , sans-serif;"><span style="font-size: 20px;">MICHIGAN FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEEDVIOLATIONS OFFICIAL ACTION INDICATED OAI UPDATE BREACH APRIL 4, 2017</span></span></h1>
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<span style="color: #484138; font-family: "arial" , sans-serif;"><span style="font-size: 20px;">FDA BSE/Ruminant Feed Inspections Firms Inventory </span></span></h1>
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<span style="color: #484138; font-family: "arial" , sans-serif;"><span style="font-size: 20px;">11998 DET-DO MI 48846-847 OPR 4/4/2017 OAI </span></span></h1>
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<a href="http://www.accessdata.fda.gov/scripts/BSEInspect/bseinspections.csv" rel="noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">http://www.accessdata.fda.gov/scripts/BSEInspect/bseinspections.csv </a></h1>
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<span style="color: #484138; font-family: "arial" , sans-serif;"><span style="font-size: 20px;">NAI = NO ACTION INDICATED</span></span></h1>
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<span style="color: #484138; font-family: "arial" , sans-serif;"><span style="font-size: 20px;">OAI = OFFICIAL ACTION INDICATED</span></span></h1>
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<span style="color: #484138; font-family: "arial" , sans-serif;"><span style="font-size: 20px;">VAI = VOLUNTARY ACTION INDICATED</span></span></h1>
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<span style="color: #484138; font-family: "arial" , sans-serif;"><span style="font-size: 20px;">RTS = REFERRED TO STATE</span></span></h1>
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<span style="color: #484138; font-family: "arial" , sans-serif;"><span style="font-size: 20px;">OAI (Official Action Indicated) when inspectors find significant objectionable conditions or practices and believe that regulatory sanctions are warranted to address the establishment’s lack of compliance with the regulation. An example of an OAI classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspectors will promptly re-inspect facilities classified OAI after regulatory sanctions have been applied to determine whether the corrective actions are adequate to address the objectionable conditions...end...TSS</span></span></h1>
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V. Use in animal feed of material from deer and elk NOT considered at high risk for CWD </div>
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FDA continues to consider materials from deer and elk NOT considered at high risk for CWD to be acceptable for use in NON-RUMINANT animal feeds in accordance with current agency regulations, 21 CFR 589.2000. </div>
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Deer and elk not considered at high risk include: </div>
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(1) deer and elk from areas not declared by State officials to be endemic for CWD and/or to be CWD eradication zones; and </div>
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(2) deer and elk that were not at some time during the 60-month period immediately before the time of slaughter in a captive herd that contained a CWD-positive animal.</div>
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<a href="https://www.fda.gov/downloads/animalveterinary/guidancecomplianceenforcement/guidanceforindustry/ucm052506.pdf" rel="noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://www.fda.gov/downloads/animalveterinary/guidancecomplianceenforcement/guidanceforindustry/ucm052506.pdf</a></div>
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DEFRA U.K. What is the risk of Chronic Wasting Disease CWD being introduced into Great Britain? A Qualitative Risk Assessment October 2012</div>
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In the USA, under the Food and Drug Administration's BSE Feed Regulation (21 CFR 589.2000) most material (exceptions include milk, tallow, and gelatin) from deer and elk is prohibited for use in feed for ruminant animals. With regards to feed for non-ruminant animals, under FDA law, CWD positive deer may not be used for any animal feed or feed ingredients. For elk and deer considered at high risk for CWD, the FDA recommends that these animals do not enter the animal feed system. However, this recommendation is guidance and not a requirement by law.</div>
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Animals considered at high risk for CWD include:</div>
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1) animals from areas declared to be endemic for CWD and/or to be CWD eradication zones and</div>
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2) deer and elk that at some time during the 60-month period prior to slaughter were in a captive herd that contained a CWD-positive animal.</div>
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Therefore, in the USA, materials from cervids other than CWD positive animals may be used in animal feed and feed ingredients for non-ruminants.</div>
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The amount of animal PAP that is of deer and/or elk origin imported from the USA to GB can not be determined, however, as it is not specified in TRACES. It may constitute a small percentage of the 8412 kilos of non-fish origin processed animal proteins that were imported from US into GB in 2011.</div>
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Overall, therefore, it is considered there is a __greater than negligible risk___ that (nonruminant) animal feed and pet food containing deer and/or elk protein is imported into GB.</div>
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There is uncertainty associated with this estimate given the lack of data on the amount of deer and/or elk protein possibly being imported in these products.</div>
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36% in 2007 (Almberg et al., 2011). In such areas, population declines of deer of up to 30 to 50% have been observed (Almberg et al., 2011). In areas of Colorado, the prevalence can be as high as 30% (EFSA, 2011).</div>
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The clinical signs of CWD in affected adults are weight loss and behavioural changes that can span weeks or months (Williams, 2005). In addition, signs might include excessive salivation, behavioural alterations including a fixed stare and changes in interaction with other animals in the herd, and an altered stance (Williams, 2005). These signs are indistinguishable from cervids experimentally infected with bovine spongiform encephalopathy (BSE).</div>
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Given this, if CWD was to be introduced into countries with BSE such as GB, for example, infected deer populations would need to be tested to differentiate if they were infected with CWD or BSE to minimise the risk of BSE entering the human food-chain via affected venison.</div>
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The rate of transmission of CWD has been reported to be as high as 30% and can approach 100% among captive animals in endemic areas (Safar et al., 2008).</div>
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In summary, in endemic areas, there is a medium probability that the soil and surrounding environment is contaminated with CWD prions and in a bioavailable form. In rural areas where CWD has not been reported and deer are present, there is a greater than negligible risk the soil is contaminated with CWD prion.</div>
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In summary, given the volume of tourists, hunters and servicemen moving between GB and North America, the probability of at least one person travelling to/from a CWD affected area and, in doing so, contaminating their clothing, footwear and/or equipment prior to arriving in GB is greater than negligible. For deer hunters, specifically, the risk is likely to be greater given the increased contact with deer and their environment. However, there is significant uncertainty associated with these estimates.</div>
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Therefore, it is considered that farmed and park deer may have a higher probability of exposure to CWD transferred to the environment than wild deer given the restricted habitat range and higher frequency of contact with tourists and returning GB residents.</div>
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<a href="http://webarchive.nationalarchives.gov.uk/20130908115835/http://www.defra.gov.uk/animal-diseases/files/qra_chronic-wasting-disease-121029.pdf" rel="noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">http://webarchive.nationalarchives.gov.uk/20130908115835/http://www.defra.gov.uk/animal-diseases/files/qra_chronic-wasting-disease-121029.pdf</a> </div>
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<span style="line-height: 1.22em;">TUESDAY, APRIL 18, 2017 </span></div>
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<span style="line-height: 1.22em;">*** EXTREME USA FDA PART 589 TSE PRION FEED LOOP HOLE STILL EXIST, AND PRICE OF POKER GOES UP ***</span></div>
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<a href="http://usdameatexport.blogspot.com/2017/04/extreme-usa-fda-part-589-tse-prion-feed.html" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://usdameatexport.blogspot.com/2017/04/extreme-usa-fda-part-589-tse-prion-feed.html</a></div>
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TUESDAY, JANUARY 17, 2017 </div>
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FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEEDVIOLATIONS OFFICIAL ACTION INDICATED OAI UPDATE 2016 to 2017 BSE TSE PRION</div>
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<a href="http://bovineprp.blogspot.com/2017/01/fda-part-589-substances-prohibited-from.html" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://bovineprp.blogspot.com/2017/01/fda-part-589-substances-prohibited-from.html</a></div>
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<span style="font-family: "arial" , "helvetica";"><span style="font-size: 13.3333px;">THIS April, 4, 2017 violation of the mad cow 21 CFR 589.2000 OAI is very serious for the great state of Michigan, some 20 years post FDA mad cow feed of August 1997. if would most likely take a FOIA request and a decade of wrangling to find out more. </span></span></div>
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<span style="font-family: "arial" , "helvetica";"><span style="font-size: 13.3333px;">TUESDAY, JANUARY 17, 2017</span></span></div>
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<span style="font-family: "arial" , "helvetica";"><span style="font-size: 13.3333px;">FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEEDVIOLATIONS OFFICIAL ACTION INDICATED OAI UPDATE 2016 to 2017 BSE TSE PRION</span></span></div>
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<span style="font-family: "arial" , "helvetica";"><span style="font-size: 13.3333px;">FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEEDVIOLATIONS OFFICIAL ACTION INDICATED OAI UPDATE 2016 to 2017 BSE TSE PRION </span></span></div>
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<span style="font-family: "arial" , "helvetica";"><span style="font-size: 13.3333px;">I would kindly like to comment on this FDA BSE/Ruminant Feed Inspections Firms Inventory (excel format)4 format, for reporting these breaches of BSE TSE prion protocols, from the extensive mad cow feed ban warning letters the fda use to put out for each violations. simply put, this excel format sucks, and the FDA et al intentionally made it this difficult to follow the usda fda mad cow follies. this is an intentional format to make it as difficult as possible to follow these breaches of the mad cow TSE prion safety feed protocols. to have absolutely no chronological or numerical order, and to format such violations in a way that they are almost impossible to find, says a lot about just how far the FDA and our fine federal friends will go through to hide these continued violations of the BSE TSE prion mad cow feed ban, and any breaches of protocols there from. once again, the wolf guarding the henhouse $$$</span></span></div>
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<span style="font-family: "arial" , "helvetica";"><span style="font-size: 13.3333px;">NAI = NO ACTION INDICATED</span></span></div>
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<span style="font-family: "arial" , "helvetica";"><span style="font-size: 13.3333px;">OAI = OFFICIAL ACTION INDICATED</span></span></div>
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<span style="font-family: "arial" , "helvetica";"><span style="font-size: 13.3333px;">VAI = VOLUNTARY ACTION INDICATED</span></span></div>
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<span style="font-family: "arial" , "helvetica";"><span style="font-size: 13.3333px;">RTS = REFERRED TO STATE</span></span></div>
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<span style="font-family: "arial" , "helvetica";"><span style="font-size: 13.3333px;">OAI (Official Action Indicated) when inspectors find significant objectionable conditions or practices and believe that regulatory sanctions are warranted to address the establishment’s lack of compliance with the regulation. An example of an OAI classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspectors will promptly re-inspect facilities classified OAI after regulatory sanctions have been applied to determine whether the corrective actions are adequate to address the objectionable conditions. </span></span></div>
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<span style="font-family: "arial" , "helvetica";"><span style="font-size: 13.3333px;">2016</span></span></div>
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<a href="http://bovineprp.blogspot.com/2017/01/fda-part-589-substances-prohibited-from.html" rel="noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">http://bovineprp.blogspot.com/2017/01/fda-part-589-substances-prohibited-from.html</a></div>
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<span style="font-family: "arial" , "helvetica";"><span style="font-size: 13.3333px;">ONE more thing, please remember, the label does not have to say ''deer ration'' for cervid to be pumped up with. you can get the same ''high protein'' from many sources of high protein feed for animals other than cattle, and feed them to cervid...</span></span></div>
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<span style="font-family: "arial" , "helvetica";"><span style="font-size: 13.3333px;">Saturday, August 29, 2009</span></span></div>
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<span style="font-family: "arial" , "helvetica";"><span style="font-size: 13.3333px;">FOIA REQUEST FEED RECALL 2009 Product may have contained prohibited materials Bulk Whole Barley, Recall # V-256-2009</span></span></div>
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<a href="http://madcowfeed.blogspot.com/2009/08/foia-request-feed-recall-2009-product.html" rel="noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">http://madcowfeed.blogspot.com/2009/08/foia-request-feed-recall-2009-product.html</a></div>
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<span style="font-family: "arial" , "helvetica";"><span style="font-size: 13.3333px;">Friday, September 4, 2009</span></span></div>
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<span style="font-family: "arial" , "helvetica";"><span style="font-size: 13.3333px;">FOIA REQUEST ON FEED RECALL PRODUCT 429,128 lbs. feed for ruminant animals may have been contaminated with prohibited material Recall # V-258-2009</span></span></div>
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<a href="http://madcowfeed.blogspot.com/2009/09/foia-request-on-feed-recall-product.html" rel="noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">http://madcowfeed.blogspot.com/2009/09/foia-request-on-feed-recall-product.html</a></div>
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<span style="font-family: "arial" , "helvetica";">ONE DECADE POST MAD COW FEED BAN OF AUGUST 1997...2007</span></div>
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<span style="font-size: x-small;">2007</span></div>
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<span style="font-size: x-small;">10,000,000 POUNDS REASON Products manufactured from bulk feed containing blood meal that was cross contaminated with prohibited meat and bone meal and the labeling did not bear cautionary BSE statement.</span></div>
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<span style="font-size: x-small;">2007</span></div>
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<span style="font-size: x-small;">Date: March 21, 2007 at 2:27 pm PST</span></div>
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<span style="font-size: x-small;">RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II PRODUCT</span></div>
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<span style="font-size: x-small;">Bulk cattle feed made with recalled Darling's 85% Blood Meal, Flash Dried, Recall # V-024-2007 CODE Cattle feed delivered between 01/12/2007 and 01/26/2007 RECALLING FIRM/MANUFACTURER Pfeiffer, Arno, Inc, Greenbush,</span></div>
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<span style="font-size: x-small;">WI. by conversation on February 5, 2007.</span></div>
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<span style="font-size: x-small;">REASON Blood meal used to make cattle feed was recalled because it was cross- contaminated with prohibited bovine meat and bone meal that had been manufactured on common equipment and labeling did not bear cautionary BSE statement.</span></div>
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<span style="font-size: x-small;">VOLUME OF PRODUCT IN COMMERCE 42,090 lbs. DISTRIBUTION WI</span></div>
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<span style="font-size: x-small;">PRODUCT Custom dairy premix products: MNM ALL PURPOSE Pellet, HILLSIDE/CDL Prot- Buffer Meal, LEE, M.-CLOSE UP PX Pellet, HIGH DESERT/ GHC LACT Meal, TATARKA, M CUST PROT Meal, SUNRIDGE/CDL PROTEIN Blend, LOURENZO, K PVM DAIRY Meal, DOUBLE B DAIRY/GHC LAC Mineral, WEST PIONT/GHC CLOSEUP Mineral, WEST POINT/GHC LACT Meal, JENKS, J/COMPASS PROTEIN Meal, COPPINI - 8# SPECIAL DAIRY Mix, GULICK, L-LACT Meal (Bulk), TRIPLE J - PROTEIN/LACTATION, ROCK CREEK/GHC MILK Mineral, BETTENCOURT/GHC S.SIDE MK-MN, BETTENCOURT #1/GHC MILK MINR, V&C DAIRY/GHC LACT Meal, VEENSTRA, F/GHC LACT Meal, SMUTNY, A- BYPASS ML W/SMARTA, Recall # V-025-2007</span></div>
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<span style="font-size: x-small;">CODE The firm does not utilize a code - only shipping documentation with commodity and weights identified.</span></div>
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<span style="font-size: x-small;">RECALLING FIRM/MANUFACTURER Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007.</span></div>
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<span style="font-size: x-small;">Firm initiated recall is complete.</span></div>
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<span style="font-size: x-small;">REASON Products manufactured from bulk feed containing blood meal that was cross contaminated with prohibited meat and bone meal and the labeling did not bear cautionary BSE statement.</span></div>
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<span style="font-size: x-small;">VOLUME OF PRODUCT IN COMMERCE 9,997,976 lbs. DISTRIBUTION ID and NV</span></div>
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<span style="font-size: x-small;">END OF ENFORCEMENT REPORT FOR MARCH 21, 2007</span></div>
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<a href="http://www.fda.gov/Safety/Recalls/EnforcementReports/2007/ucm120446.htm" rel="noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">http://www.fda.gov/Safety/Recalls/EnforcementReports/2007/ucm120446.htm</a></div>
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ALABAMA MAD COW FEED IN COMMERCE 2006</div>
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RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II</div>
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a) CO-OP 32% Sinking Catfish, Recall # V-100-6;</div>
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b) Performance Sheep Pell W/Decox/A/N, medicated, net wt. 50 lbs, Recall # V-101-6;</div>
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<br style="line-height: 1.22em;" /></div>
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c) Pro 40% Swine Conc Meal -- 50 lb, Recall # V-102-6;</div>
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d) CO-OP 32% Sinking Catfish Food Medicated, Recall # V-103-6;</div>
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e) "Big Jim’s" BBB Deer Ration, Big Buck Blend, Recall # V-104-6;</div>
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f) CO-OP 40% Hog Supplement Medicated Pelleted, Tylosin 100 grams/ton, 50 lb. bag, Recall # V-105-6;</div>
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g) Pig Starter Pell II, 18% W/MCDX Medicated 282020, Carbadox -- 0.0055%, Recall # V-106-6;</div>
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<br style="line-height: 1.22em;" /></div>
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h) CO-OP STARTER-GROWER CRUMBLES, Complete Feed for Chickens from Hatch to 20 Weeks, Medicated, Bacitracin Methylene Disalicylate, 25 and 50 Lbs, Recall # V-107-6;</div>
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i) CO-OP LAYING PELLETS, Complete Feed for Laying Chickens, Recall # 108-6;</div>
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j) CO-OP LAYING CRUMBLES, Recall # V-109-6;</div>
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k) CO-OP QUAIL FLIGHT CONDITIONER MEDICATED, net wt 50 Lbs, Recall # V-110-6;</div>
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<br style="line-height: 1.22em;" /></div>
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l) CO-OP QUAIL STARTER MEDICATED, Net Wt. 50 Lbs, Recall # V-111-6;</div>
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m) CO-OP QUAIL GROWER MEDICATED, 50 Lbs, Recall # V-112-6</div>
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CODE</div>
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Product manufactured from 02/01/2005 until 06/06/2006</div>
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RECALLING FIRM/MANUFACTURER</div>
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<br style="line-height: 1.22em;" /></div>
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Alabama Farmers Cooperative, Inc., Decatur, AL, by telephone, fax, email and visit on June 9, 2006. FDA initiated recall is complete.</div>
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REASON</div>
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<br style="line-height: 1.22em;" /></div>
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Animal and fish feeds which were possibly contaminated with ruminant based protein not labeled as "Do not feed to ruminants".</div>
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VOLUME OF PRODUCT IN COMMERCE</div>
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125 tons</div>
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DISTRIBUTION</div>
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AL and FL </div>
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______________________________</div>
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PRODUCT</div>
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Bulk custom dairy feds manufactured from concentrates, Recall # V-113-6</div>
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CODE</div>
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All dairy feeds produced between 2/1/05 and 6/16/06 and containing H. J. Baker recalled feed products.</div>
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<br style="line-height: 1.22em;" /></div>
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RECALLING FIRM/MANUFACTURER</div>
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<br style="line-height: 1.22em;" /></div>
<div style="font-family: Georgia; font-size: 13.3333px; line-height: 1.22em;">
Vita Plus Corp., Gagetown, MI, by visit beginning on June 21, 2006. Firm initiated recall is complete.</div>
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REASON</div>
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<br style="line-height: 1.22em;" /></div>
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The feed was manufactured from materials that may have been contaminated with mammalian protein.</div>
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VOLUME OF PRODUCT IN COMMERCE</div>
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<br style="line-height: 1.22em;" /></div>
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27,694,240 lbs</div>
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DISTRIBUTION</div>
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<br style="line-height: 1.22em;" /></div>
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MI </div>
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______________________________</div>
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PRODUCT</div>
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Bulk custom made dairy feed, Recall # V-114-6</div>
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CODE</div>
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None</div>
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<br style="line-height: 1.22em;" /></div>
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RECALLING FIRM/MANUFACTURER</div>
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<br style="line-height: 1.22em;" /></div>
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Burkmann Feeds LLC, Glasgow, KY, by letter on July 14, 2006. Firm initiated recall is ongoing.</div>
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REASON</div>
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<br style="line-height: 1.22em;" /></div>
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Custom made feeds contain ingredient called Pro-Lak, which may contain ruminant derived meat and bone meal.</div>
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VOLUME OF PRODUCT IN COMMERCE</div>
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?????</div>
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DISTRIBUTION</div>
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KY</div>
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END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006</div>
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###</div>
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<a href="http://data.nber.org/fda/enforcement-report/2006/ucm120413.htm" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://data.nber.org/fda/enforcement-report/2006/ucm120413.htm</a></div>
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=====</div>
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PRODUCT </div>
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Bulk Whole Barley, Recall # V-256-2009</div>
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CODE</div>
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No code or lot number.</div>
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RECALLING FIRM/MANUFACTURER</div>
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<br style="line-height: 1.22em;" /></div>
<div style="font-family: Georgia; font-size: 13.3333px; line-height: 1.22em;">
Mars Petcare US, Clinton, OK, by telephone on May 21, 2009. Firm initiated recall is complete.</div>
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REASON</div>
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<br style="line-height: 1.22em;" /></div>
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Product may have contained prohibited materials without cautionary statement on the label.</div>
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VOLUME OF PRODUCT IN COMMERCE</div>
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<br style="line-height: 1.22em;" /></div>
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208,820 pounds</div>
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DISTRIBUTION</div>
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TX</div>
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END OF ENFORCEMENT REPORT FOR AUGUST 26, 2009</div>
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###</div>
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<br style="line-height: 1.22em;" /></div>
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<a href="https://www.fda.gov/Safety/Recalls/EnforcementReports/ucm180348.htm" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">https://www.fda.gov/Safety/Recalls/EnforcementReports/ucm180348.htm</a></div>
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Subject: MAD COW FEED RECALL KY VOLUME OF PRODUCT IN COMMERCE ????? </div>
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<div style="font-family: Georgia; font-size: 13.3333px; line-height: 1.22em;">
Date: August 6, 2006 at 6:19 pm PST </div>
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PRODUCT Bulk custom made dairy feed, Recall # V-114-6 </div>
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CODE None </div>
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<div style="font-family: Georgia; font-size: 13.3333px; line-height: 1.22em;">
RECALLING FIRM/MANUFACTURER Burkmann Feeds LLC, Glasgow, KY, by letter on July 14, 2006. </div>
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<br style="line-height: 1.22em;" /></div>
<div style="font-family: Georgia; font-size: 13.3333px; line-height: 1.22em;">
Firm initiated recall is ongoing. REASON Custom made feeds contain ingredient called Pro-Lak, which may contain ruminant derived meat and bone meal. </div>
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<br style="line-height: 1.22em;" /></div>
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VOLUME OF PRODUCT IN COMMERCE ????? </div>
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<br style="line-height: 1.22em;" /></div>
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DISTRIBUTION KY </div>
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END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006</div>
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### </div>
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<br style="line-height: 1.22em;" /></div>
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<a href="http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html</a></div>
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<br style="line-height: 1.22em;" /></div>
<div style="font-family: Georgia; font-size: 13.3333px; line-height: 1.22em;">
MAD COW FEED RECALL USA EQUALS 10,878.06 TONS NATIONWIDE Sun Jul 16, 2006 09:22 71.248.128.67 </div>
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<br style="line-height: 1.22em;" /></div>
<div style="font-family: Georgia; font-size: 13.3333px; line-height: 1.22em;">
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II </div>
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<span style="line-height: 1.22em;"><br style="line-height: 1.22em;" /></span></div>
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<span style="line-height: 1.22em;">______________________________ </span></div>
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PRODUCT a) PRO-LAK, bulk weight, Protein Concentrate for Lactating Dairy Animals, Recall # V-079-6; </div>
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b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg), Recall # V-080-6; </div>
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c) PRO-PAK, MARINE & ANIMAL PROTEIN CONCENTRATE FOR USE IN ANIMAL FEED, Recall # V-081-6; </div>
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d) Feather Meal, Recall # V-082-6 </div>
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CODE a) Bulk b) None c) Bulk d) Bulk </div>
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RECALLING FIRM/MANUFACTURER H. J. Baker & Bro., Inc., Albertville, AL, by telephone on June 15, 2006 and by press release on June 16, 2006. </div>
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Firm initiated recall is ongoing.</div>
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REASON Possible contamination of animal feeds with ruminent derived meat and bone meal.. </div>
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VOLUME OF PRODUCT IN COMMERCE 10,878.06 tons </div>
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DISTRIBUTION Nationwide</div>
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END OF ENFORCEMENT REPORT FOR July 12, 2006</div>
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<a href="http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html</a></div>
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U.S.A. 50 STATE BSE MAD COW CONFERENCE CALL Jan. 9, 2001</h3>
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Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001<br />
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Date: Tue, 9 Jan 2001 16:49:00 -0800<br />
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From: "Terry S. Singeltary Sr."<br />
<flounder wt.net=""><br />Reply-To: Bovine Spongiform Encephalopathy<br /><br />To: BSE-L@uni-karlsruhe.de<br /><br /><br />######### Bovine Spongiform Encephalopathy <bse-l uni-karlsruhe.de="">#########<br /><br /><br />Greetings List Members,<br /><br />I was lucky enough to sit in on this BSE conference call today and even managed to ask a question. that is when the trouble started.<br /><br />I submitted a version of my notes to Sandra Blakeslee of the New York Times, whom seemed very upset, and rightly so.<br /><br />"They tell me it is a closed meeting and they will release whatever information they deem fit. Rather infuriating."<br /><br />and i would have been doing just fine, until i asked my question. i was surprised my time to ask a question so quick.<br /><br />(understand, these are taken from my notes for now. the spelling of names and such could be off.)<br /><br />[host Richard Barns] and now a question from Terry S. Singeltary of CJD Watch.<br /><br />[TSS] yes, thank you, U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?<br /><br />[no answer, you could hear in the back ground, mumbling and 'we can't. have him ask the question again.]<br /><br />[host Richard] could you repeat the question?<br /><br />[TSS] U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?<br /><br />[not sure whom ask this] what group are you with?<br /><br />[TSS] CJD Watch, my Mom died from hvCJD and we are tracking CJD world-wide.<br /><br />[not sure who is speaking] could you please disconnect Mr. Singeltary<br /><br />[TSS] you are not going to answer my question?<br /><br />[not sure whom speaking] NO<br /><br />from this point, i was still connected, got to listen and tape the whole conference. at one point someone came on, a woman, and ask again;<br /><br />[unknown woman] what group are you with?<br /><br />[TSS] CJD Watch and my Mom died from hvCJD we are trying to tract down CJD and other human TSE's world wide. i was invited to sit in on this from someone inside the USDA/APHIS and that is why i am here. do you intend on banning me from this conference now?<br /><br />at this point the conference was turned back up, and i got to finish listening. They never answered or even addressed my one question, or even addressed the issue. BUT, i will try and give you a run-down for now, of the conference.<br /><br />IF i were another Country, I would take heed to my notes, BUT PLEASE do not depend on them. ask for transcript from;<br /><br />RBARNS@ORA.FDA.GOV 301-827-6906<br /><br />he would be glad to give you one ;-)<br /><br />Rockville Maryland, Richard Barns Host<br /><br />BSE issues in the U.S., How they were labelling ruminant feed? Revising issues.<br /><br />The conference opened up with the explaining of the U.K. BSE epidemic winding down with about 30 cases a week.<br /><br />although new cases in other countries were now appearing.<br /><br />Look at Germany whom said NO BSE and now have BSE.<br /><br />BSE increasing across Europe.<br /><br />Because of Temporary Ban on certain rendered product, heightened interest in U.S.<br /><br />A recent statement in Washington Post, said the New Administration (old GW) has a list of issues. BSE is one of the issues.<br /><br />BSE Risk is still low, minimal in U.S. with a greater interest in MBM not to enter U.S.<br /><br />HOWEVER, if BSE were to enter the U.S. it would be economically disastrous to the render, feed, cattle, industries, and for human health.<br /><br />(human health-they just threw that in cause i was listening. I will now jot down some figures in which they told you, 'no need to write them down'. just hope i have them correct. hmmm, maybe i hope i don't ???)<br /><br />80% inspection of rendering<br /><br />*Problem-Complete coverage of rendering HAS NOT occurred.<br /><br />sizeable number of 1st time FAILED INITIAL INSPECTION, have not been reinspected (70% to 80%).<br /><br />Compliance critical, Compliance poor in U.K. and other European Firms.<br /><br />Gloria Dunason Major Assignment 1998 goal TOTAL compliance. This _did not_ occur. Mixed level of compliance, depending on firm.<br /><br />Rendering FDA license and NON FDA license<br /><br />system in place for home rendering & feed 76% in compliance 79% cross contamination 21% DID NOT have system 92% record keeping less than 60% total compliance<br /><br />279 inspectors 185 handling prohibited materials<br /><br />Renderer at top of pyramid, significant part of compliance. 84% compliance<br /><br />failed to have caution statement render 72% compliance & cross contamination caution statement on feed, 'DO NOT FEED TO CATTLE'<br /><br />56 FIRMS NEVER INSPECTED<br /><br />1240 FDA license feed mills 846 inspected<br /><br />"close to 400 feed mills have not been inspected"<br /><br />80% compliance for feed.<br /><br />10% don't have system.<br /><br />NON-FDA licensed mills There is NO inventory on non licensed mills. approximately 6000 to 8000 Firms ??? 4,344 ever inspected. "FDA does not have a lot of experience with"<br /><br />40% do NOT have caution statement 'DO NOT FEED'.<br /><br />74% Commingling compliance<br /><br />"This industry needs a lot of work and only half gotten to"<br /><br />"700 Firms that were falitive, and need to be re-inspected, in addition to the 8,000 Firms."<br /><br />Quote to do BSE inspection in 19 states by end of January or 30 days, and other states 60 days. to change feed status??? Contract check and ask questions and pass info.<br /><br />At this time, we will take questions.<br /><br />[I was about the third or fourth to ask question. then all B.S.eee broke loose, and i lost my train of thought for a few minutes. picked back up here]<br /><br />someone asking about nutritional supplements and sourcing, did not get name. something about inspectors not knowing of BSE risk??? the conference person assuring that Steve Follum? and the TSE advisory Committee were handling that.<br /><br />Some other Dr. Vet, whom were asking questions that did not know what to do???<br /><br />[Dennis Wilson] California Food Agr. Imports, are they looking at imports?<br /><br />[Conference person] they are looking at imports, FDA issued imports Bulletin.<br /><br />[Linda Singeltary ??? this was a another phone in question, not related i don't think] Why do we have non-licensed facilities?<br /><br />(conference person) other feed mills do not handle as potent drugs???<br /><br />Dennis Blank, Ken Jackson licensed 400 non FDA 4400 inspected of a total of 6000 to 8000,<br /><br />(they really don't know how many non licensed Firms in U.S. they guess 6000 to 8000??? TSS)<br /><br />Linda Detwiler asking everyone (me) not to use emergency BSE number, unless last resort. (i thought of calling them today, and reporting the whole damn U.S. cattle herd ;-) 'not'<br /><br />Warren-Maryland Dept. Agr. Prudent to re-inspect after 3 years. concerned of Firms that have changed owners.<br /><br />THE END<br /><br />TSS<br /><br />############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############<br /><br /><br /><br />FROM New York TIMES<br /><br /><br />Subject: Re: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA Posting of cut version...<br /><br />Date: Thu, 11 Jan 2001 22:02:47 -0700<br /><br />From: "Sandy Blakeslee"<br /><sblakeslee mindspring.com=""><br />To: "Terry S. Singeltary Sr." <flounder wt.net="">References: 1<br /><br /><br />Hi terry -- thanks for all your help. I know it made a difference with the FDA getting out that release.<br /><br /><br />----- Original Message -----<br /><br />From: "Terry S. Singeltary Sr."<br /><flounder wt.net=""><br />To: <sblakeslee mindspring.com="">Sent: Thursday, January 11, 2001 2:06 PM<br /><br />Subject: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA Posting of cut version...<br /><br />hi sandy,<br /><br />From the New York Times NYTimes.com, January 11, 2001<br /><br />Many Makers of Feed Fail to Heed Rules on Mad Cow Disease By SANDRA BLAKESLEE</sblakeslee></flounder></flounder></sblakeslee></bse-l></flounder></div>
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<flounder wt.net="">see full history here of the infamous United States 50 state emergency conference call on mad cow disease...</flounder></div>
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<flounder wt.net="">Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001<br /><br />Date: Tue, 9 Jan 2001 16:49:00 -0800<br /><br />From: "Terry S. Singeltary Sr."<br /><flounder wt.net=""><br />Reply-To: Bovine Spongiform Encephalopathy<br /><br />To: BSE-L@uni-karlsruhe.de</flounder></flounder></div>
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<flounder wt.net="">[TSS] U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?</flounder></div>
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<flounder wt.net=""><a href="http://tseac.blogspot.com/2011/02/usa-50-state-bse-mad-cow-conference.html" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://tseac.blogspot.com/2011/02/usa-50-state-bse-mad-cow-conference.html</a></flounder></div>
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<flounder wt.net=""><bse-l uni-karlsruhe.de=""><sblakeslee mindspring.com=""><flounder wt.net=""><flounder wt.net=""><sblakeslee mindspring.com=""></sblakeslee></flounder></flounder></sblakeslee></bse-l></flounder><br />
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<span style="font-size: 13.3333px;">O.05: Transmission of prions to primates after extended silent incubation periods: Implications for BSE and scrapie risk assessment in human populations </span></div>
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<span style="font-size: 13.3333px;">Emmanuel Comoy, Jacqueline Mikol, Valerie Durand, Sophie Luccantoni, Evelyne Correia, Nathalie Lescoutra, Capucine Dehen, and Jean-Philippe Deslys Atomic Energy Commission; Fontenay-aux-Roses, France </span></div>
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<span style="font-size: 13.3333px;">Prion diseases (PD) are the unique neurodegenerative proteinopathies reputed to be transmissible under field conditions since decades. The transmission of Bovine Spongiform Encephalopathy (BSE) to humans evidenced that an animal PD might be zoonotic under appropriate conditions. Contrarily, in the absence of obvious (epidemiological or experimental) elements supporting a transmission or genetic predispositions, PD, like the other proteinopathies, are reputed to occur spontaneously (atpical animal prion strains, sporadic CJD summing 80% of human prion cases). Non-human primate models provided the first evidences supporting the transmissibiity of human prion strains and the zoonotic potential of BSE. Among them, cynomolgus macaques brought major information for BSE risk assessment for human health (Chen, 2014), according to their phylogenetic proximity to humans and extended lifetime. We used this model to assess the zoonotic potential of other animal PD from bovine, ovine and cervid origins even after very long silent incubation periods. </span></div>
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<span style="font-size: 13.3333px;">*** We recently observed the direct transmission of a natural classical scrapie isolate to macaque after a 10-year silent incubation period, </span></div>
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<span style="font-size: 13.3333px;">***with features similar to some reported for human cases of sporadic CJD, albeit requiring fourfold long incubation than BSE. Scrapie, as recently evoked in humanized mice (Cassard, 2014), </span></div>
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<span style="font-size: 13.3333px;">***is the third potentially zoonotic PD (with BSE and L-type BSE), </span></div>
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<span style="font-size: 13.3333px;">***thus questioning the origin of human sporadic cases. </span></div>
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<span style="font-size: 13.3333px;">We will present an updated panorama of our different transmission studies and discuss the implications of such extended incubation periods on risk assessment of animal PD for human health. </span></div>
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<span style="font-size: 13.3333px;">=============== </span></div>
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<span style="font-size: 13.3333px;">***thus questioning the origin of human sporadic cases*** </span></div>
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<span style="font-size: 13.3333px;">=============== </span></div>
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<span style="font-size: 13.3333px;">***our findings suggest that possible transmission risk of H-type BSE to sheep and human. Bioassay will be required to determine whether the PMCA products are infectious to these animals. </span></div>
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<span style="font-size: 13.3333px;">============== </span></div>
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<span style="font-size: 13.3333px;"><a href="https://prion2015.files.wordpress.com/2015/05/prion2015abstracts.pdf" rel="noopener noreferrer" style="color: blue; cursor: pointer; text-size-adjust: 100%;" target="_blank">https://prion2015.files.wordpress.com/2015/05/prion2015abstracts.pdf</a> </span></div>
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<span style="font-size: 13.3333px;">***Transmission data also revealed that several scrapie prions propagate in HuPrP-Tg mice with efficiency comparable to that of cattle BSE. While the efficiency of transmission at primary passage was low, subsequent passages resulted in a highly virulent prion disease in both Met129 and Val129 mice. </span></div>
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<span style="font-size: 13.3333px;">***Transmission of the different scrapie isolates in these mice leads to the emergence of prion strain phenotypes that showed similar characteristics to those displayed by MM1 or VV2 sCJD prion. </span></div>
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<span style="font-size: 13.3333px;">***These results demonstrate that scrapie prions have a zoonotic potential and raise new questions about the possible link between animal and human prions. </span></div>
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<a href="http://www.tandfonline.com/doi/abs/10.1080/19336896.2016.1163048?journalCode=kprn20" rel="noopener noreferrer" style="color: blue; cursor: pointer; text-size-adjust: 100%;" target="_blank">http://www.tandfonline.com/doi/abs/10.1080/19336896.2016.1163048?journalCode=kprn20</a> </div>
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<span style="font-size: 13.3333px;">PRION 2016 TOKYO</span></div>
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<span style="font-size: 13.3333px;">Saturday, April 23, 2016</span></div>
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<span style="font-size: 13.3333px;">SCRAPIE WS-01: Prion diseases in animals and zoonotic potential 2016</span></div>
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<span style="font-size: 13.3333px;">Prion. 10:S15-S21. 2016 ISSN: 1933-6896 printl 1933-690X online</span></div>
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<span style="font-size: 13.3333px;">Taylor & Francis</span></div>
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<span style="font-size: 13.3333px;">Prion 2016 Animal Prion Disease Workshop Abstracts</span></div>
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<span style="font-size: 13.3333px;">WS-01: Prion diseases in animals and zoonotic potential</span></div>
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<span style="font-size: 13.3333px;">Juan Maria Torres a, Olivier Andreoletti b, J uan-Carlos Espinosa a. Vincent Beringue c. Patricia Aguilar a,</span></div>
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<span style="font-size: 13.3333px;">Natalia Fernandez-Borges a. and Alba Marin-Moreno a</span></div>
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<span style="font-size: 13.3333px;">"Centro de Investigacion en Sanidad Animal ( CISA-INIA ). Valdeolmos, Madrid. Spain; b UMR INRA -ENVT 1225 Interactions Holes Agents Pathogenes. ENVT. Toulouse. France: "UR892. Virologie lmmunologie MolécuIaires, Jouy-en-Josas. France</span></div>
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<span style="font-size: 13.3333px;">Dietary exposure to bovine spongiform encephalopathy (BSE) contaminated bovine tissues is considered as the origin of variant Creutzfeldt Jakob (vCJD) disease in human. To date, BSE agent is the only recognized zoonotic prion. Despite the variety of Transmissible Spongiform Encephalopathy (TSE) agents that have been circulating for centuries in farmed ruminants there is no apparent epidemiological link between exposure to ruminant products and the occurrence of other form of TSE in human like sporadic Creutzfeldt Jakob Disease (sCJD). However, the zoonotic potential of the diversity of circulating TSE agents has never been systematically assessed. The major issue in experimental assessment of TSEs zoonotic potential lies in the modeling of the ‘species barrier‘, the biological phenomenon that limits TSE agents’ propagation from a species to another. In the last decade, mice genetically engineered to express normal forms of the human prion protein has proved essential in studying human prions pathogenesis and modeling the capacity of TSEs to cross the human species barrier.</span></div>
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<span style="font-size: 13.3333px;">To assess the zoonotic potential of prions circulating in farmed ruminants, we study their transmission ability in transgenic mice expressing human PrPC (HuPrP-Tg). Two lines of mice expressing different forms of the human PrPC (129Met or 129Val) are used to determine the role of the Met129Val dimorphism in susceptibility/resistance to the different agents.</span></div>
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<span style="font-size: 13.3333px;">These transmission experiments confirm the ability of BSE prions to propagate in 129M- HuPrP-Tg mice and demonstrate that Met129 homozygotes may be susceptible to BSE in sheep or goat to a greater degree than the BSE agent in cattle and that these agents can convey molecular properties and neuropathological indistinguishable from vCJD. However homozygous 129V mice are resistant to all tested BSE derived prions independently of the originating species suggesting a higher transmission barrier for 129V-PrP variant.</span></div>
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<span style="font-size: 13.3333px;">Transmission data also revealed that several scrapie prions propagate in HuPrP-Tg mice with efficiency comparable to that of cattle BSE. While the efficiency of transmission at primary passage was low, subsequent passages resulted in a highly virulent prion disease in both Met129 and Val129 mice. </span></div>
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<span style="font-size: 13.3333px;">Transmission of the different scrapie isolates in these mice leads to the emergence of prion strain phenotypes that showed similar characteristics to those displayed by MM1 or VV2 sCJD prion. </span></div>
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<span style="font-size: 13.3333px;">These results demonstrate that scrapie prions have a zoonotic potential and raise new questions about the possible link between animal and human prions. </span></div>
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<a href="http://www.tandfonline.com/doi/abs/10.1080/19336896.2016.1163048?journalCode=kprn20" rel="noopener noreferrer" style="color: blue; cursor: pointer; font-size: 10pt; text-size-adjust: 100%;" target="_blank">http://www.tandfonline.com/doi/abs/10.1080/19336896.2016.1163048?journalCode=kprn20</a></div>
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why do we not want to do TSE transmission studies on chimpanzees $</div>
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<span style="font-size: 13.3333px;">5. A positive result from a chimpanzee challenged severly would likely create alarm in some circles even if the result could not be interpreted for man. I have a view that all these agents could be transmitted provided a large enough dose by appropriate routes was given and the animals kept long enough. Until the mechanisms of the species barrier are more clearly understood it might be best to retain that hypothesis.</span></div>
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<span style="font-size: 13.3333px;">R. BRADLEY</span></div>
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<a href="https://web.archive.org/web/20170126051158/http://collections.europarchive.org/tna/20080102222950/http://www.bseinquiry.gov.uk/files/yb/1990/09/23001001.pdf" rel="noopener noreferrer" style="color: blue; cursor: pointer; font-size: 10pt; text-size-adjust: 100%;" target="_blank">https://web.archive.org/web/20170126051158/http://collections.europarchive.org/tna/20080102222950/http://www.bseinquiry.gov.uk/files/yb/1990/09/23001001.pdf</a></div>
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<span style="font-size: 13.3333px;">Title: Transmission of scrapie prions to primate after an extended silent incubation period) </span></div>
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<span style="font-size: 13.3333px;">*** In complement to the recent demonstration that humanized mice are susceptible to scrapie, we report here the first observation of direct transmission of a natural classical scrapie isolate to a macaque after a 10-year incubation period. Neuropathologic examination revealed all of the features of a prion disease: spongiform change, neuronal loss, and accumulation of PrPres throughout the CNS. </span></div>
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<span style="font-size: 13.3333px;">*** This observation strengthens the questioning of the harmlessness of scrapie to humans, at a time when protective measures for human and animal health are being dismantled and reduced as c-BSE is considered controlled and being eradicated. </span></div>
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<span style="font-size: 13.3333px;">*** Our results underscore the importance of precautionary and protective measures and the necessity for long-term experimental transmission studies to assess the zoonotic potential of other animal prion strains. </span></div>
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<a href="http://www.ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=313160" rel="noopener noreferrer" style="color: blue; cursor: pointer; text-size-adjust: 100%;" target="_blank">http://www.ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=313160</a></div>
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<span style="font-size: 13.3333px;">MONDAY, JUNE 12, 2017</span></div>
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<span style="font-size: 13.3333px;">Rethinking Major grain organizations opposition to CFIA's control zone approach to Chronic Wasting CWD TSE Prion Mad Deer Type Disease 2017?</span></div>
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<span style="font-size: 13.3333px;"><a href="http://chronic-wasting-disease.blogspot.com/2017/06/rethinking-major-grain-organizations.html" rel="noopener noreferrer" style="color: blue; cursor: pointer; text-size-adjust: 100%;" target="_blank">http://chronic-wasting-disease.blogspot.com/2017/06/rethinking-major-grain-organizations.html</a></span></div>
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<span style="font-size: 13.3333px;">WEDNESDAY, MAY 17, 2017</span></div>
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<span style="font-size: 13.3333px;">*** Chronic Wasting Disease CWD TSE Prion aka Mad Deer Disease and the Real Estate Market Land Values ***</span></div>
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<span style="font-size: 13.3333px;"><a href="http://chronic-wasting-disease.blogspot.com/2017/05/chronic-wasting-disease-cwd-tse-prion.html" rel="noopener noreferrer" style="color: blue; cursor: pointer; text-size-adjust: 100%;" target="_blank">http://chronic-wasting-disease.blogspot.com/2017/05/chronic-wasting-disease-cwd-tse-prion.html</a></span></div>
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ZOONOTIC, ZOONOSIS, CHRONIC WASTING DISEASE CWD TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY TSE PRION </div>
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10. ZOONOTIC, ZOONOSIS, CHRONIC WASTING DISEASE CWD TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY TSE PRION AKA MAD DEER ELK DISEASE IN HUMANS, has it already happened, that should be the question... </div>
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''In particular the US data do not clearly exclude the possibility of human (sporadic or familial) TSE development due to consumption of venison. The Working Group thus recognizes a potential risk to consumers if a TSE would be present in European cervids.'' Scientific opinion on chronic wasting disease (II)</div>
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EFSA Panel on Biological Hazards (BIOHAZ) Antonia Ricci Ana Allende Declan Bolton Marianne Chemaly Robert Davies Pablo Salvador Fernández Escámez ... See all authors </div>
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First published: 17 January 2018 <a href="https://doi.org/10.2903/j.efsa.2018.5132" rel="noopener noreferrer" style="color: blue; cursor: pointer; text-size-adjust: 100%;" target="_blank">https://doi.org/10.2903/j.efsa.2018.5132</a> ;</div>
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also, see; </div>
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8. Even though human TSE‐exposure risk through consumption of game from European cervids can be assumed to be minor, if at all existing, no final conclusion can be drawn due to the overall lack of scientific data. In particular the US data do not clearly exclude the possibility of human (sporadic or familial) TSE development due to consumption of venison. The Working Group thus recognizes a potential risk to consumers if a TSE would be present in European cervids. It might be prudent considering appropriate measures to reduce such a risk, e.g. excluding tissues such as CNS and lymphoid tissues from the human food chain, which would greatly reduce any potential risk for consumers. However, it is stressed that currently, no data regarding a risk of TSE infections from cervid products are available. </div>
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The tissue distribution of infectivity in CWD‐infected cervids is now known to extend beyond CNS and lymphoid tissues. While the removal of these specific tissues from the food chain would reduce human dietary exposure to infectivity, exclusion from the food chain of the whole carcass of any infected animal would be required to eliminate human dietary exposure. </div>
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<a href="https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2018.5132" rel="noopener noreferrer" style="color: blue; cursor: pointer; text-size-adjust: 100%;" target="_blank">https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2018.5132</a></div>
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zoonosis zoonotic cervid tse prion cwd to humans, preparing for the storm </div>
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***An alternative to modeling the species barrier is the cell-free conversion assay which points to CWD as the animal prion disease with the greatest zoonotic potential, after (and very much less than) BSE.116*** </div>
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<a href="https://www.tandfonline.com/doi/pdf/10.4161/pri.29237" rel="noopener noreferrer" style="color: blue; cursor: pointer; text-size-adjust: 100%;" target="_blank">https://www.tandfonline.com/doi/pdf/10.4161/pri.29237</a> </div>
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<span style="font-family: "georgia"; font-size: x-small;">To date there is no direct evidence that CWD has been or can be transmitted from animals to humans. </span></div>
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<span style="font-family: "georgia"; font-size: x-small;">However, initial findings from a laboratory research project funded by the Alberta Prion Research Institute (APRI) and Alberta Livestock Meat Agency (ALMA), and led by a Canadian Food Inspection Agency (CFIA) scientist indicate that CWD has been transmitted to cynomolgus macaques (the non-human primate species most closely related to humans that may be used in research), through both the intracranial and oral routes of exposure. </span></div>
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<span style="font-family: "georgia"; font-size: x-small;">Both infected brain and muscle tissues were found to transmit disease. </span></div>
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<span style="font-family: "georgia"; font-size: x-small;">Health Canada’s Health Products and Food Branch (HPFB) was asked to consider the impact of these findings on the Branch’s current position on CWD in health products and foods. </span></div>
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<span style="font-family: "georgia"; font-size: x-small;">Summary and Recommendation: </span></div>
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<span style="font-family: "georgia"; font-size: x-small;">Health Portfolio partners were recently made aware of initial findings from a research project led by a CFIA scientist that have demonstrated that cynomolgus macaques can be infected via intracranial exposure and oral gavage with CWD infected muscle. </span></div>
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<span style="font-family: "georgia"; font-size: x-small;">These findings suggest that CWD, under specific experimental conditions, has the potential to cross the human species barrier, including by enteral feeding of CWD infected muscle. </span></div>
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<a href="https://www.thetyee.ca/Documents/2017/06/24/Risk-Advisory-Opinion-CWD-2017.pdf" rel="noopener noreferrer" style="color: blue; cursor: pointer; text-size-adjust: 100%;" target="_blank">https://www.thetyee.ca/Documents/2017/06/24/Risk-Advisory-Opinion-CWD-2017.pdf</a></div>
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<span style="font-family: "georgia"; font-size: x-small;">*** WDA 2016 NEW YORK *** </span></div>
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<span style="font-family: "georgia"; font-size: x-small;">We found that CWD adapts to a new host more readily than BSE and that human PrP was unexpectedly prone to misfolding by CWD prions. </span></div>
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<span style="font-family: "georgia"; font-size: x-small;">In addition, we investigated the role of specific regions of the bovine, deer and human PrP protein in resistance to conversion by prions from another species. </span></div>
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<span style="font-family: "georgia"; font-size: x-small;">***We have concluded that the human protein has a region that confers unusual susceptibility to conversion by CWD prions. </span></div>
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<span style="font-family: "georgia"; font-size: x-small;">Student Presentations Session 2 </span></div>
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<span style="font-family: "georgia"; font-size: x-small;">The species barriers and public health threat of CWD and BSE prions </span></div>
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<span style="font-family: "georgia"; font-size: x-small;">Ms. Kristen Davenport1, Dr. Davin Henderson1, Dr. Candace Mathiason1, Dr. Edward Hoover1 1Colorado State University </span></div>
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<span style="font-family: "georgia"; font-size: x-small;">Chronic wasting disease (CWD) is spreading rapidly through cervid populations in the USA. Bovine spongiform encephalopathy (BSE, mad cow disease) arose in the 1980s because cattle were fed recycled animal protein. </span></div>
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<span style="font-family: "georgia"; font-size: x-small;">These and other prion diseases are caused by abnormal folding of the normal prion protein (PrP) into a disease causing form (PrPd), which is pathogenic to nervous system cells and can cause subsequent PrP to misfold. CWD spreads among cervids very efficiently, but it has not yet infected humans. On the other hand, BSE was spread only when cattle consumed infected bovine or ovine tissue, but did infect humans and other species. </span></div>
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<span style="font-family: "georgia"; font-size: x-small;">The objective of this research is to understand the role of PrP structure in cross-species infection by CWD and BSE. To study the propensity of each species’ PrP to be induced to misfold by the presence of PrPd from verious species, we have used an in vitro system that permits detection of PrPd in real-time. </span></div>
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<span style="font-family: "georgia"; font-size: x-small;">We measured the conversion efficiency of various combinations of PrPd seeds and PrP substrate combinations. </span></div>
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<span style="font-family: "georgia"; font-size: x-small;">We observed the cross-species behavior of CWD and BSE, in addition to feline-adapted CWD and BSE. We found that CWD adapts to a new host more readily than BSE and that human PrP was unexpectedly prone to misfolding by CWD prions. In addition, we investigated the role of specific regions of the bovine, deer and human PrP protein in resistance to conversion by prions from another species. </span></div>
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<span style="font-family: "georgia"; font-size: x-small;">***We have concluded that the human protein has a region that confers unusual susceptibility to conversion by CWD prions. CWD is unique among prion diseases in its rapid spread in natural populations. BSE prions are essentially unaltered upon passage to a new species, while CWD adapts to the new species. This adaptation has consequences for surveillance of humans exposed to CWD. Wildlife Disease Risk Communication Research Contributes to Wildlife Trust Administration Exploring perceptions about chronic wasting disease risks among wildlife and agriculture professionals and stakeholders</span></div>
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<span style="font-family: "georgia"; font-size: x-small;"><a href="http://www.wda2016.org/uploads/5/8/6/1/58613359/wda_2016_conference_proceedings_low_res.pdf" rel="noopener noreferrer" style="color: blue; cursor: pointer; text-size-adjust: 100%;" target="_blank">http://www.wda2016.org/uploads/5/8/6/1/58613359/wda_2016_conference_proceedings_low_res.pdf</a> </span></div>
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<span style="font-family: "georgia"; font-size: x-small;">CDC CWD 2018 TRANSMISSION</span></div>
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<a href="https://www.cdc.gov/prions/cwd/transmission.html" rel="noopener noreferrer" style="color: blue; cursor: pointer; font-size: 10pt; text-size-adjust: 100%;" target="_blank">https://www.cdc.gov/prions/cwd/transmission.html</a></div>
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<span style="font-family: "georgia"; font-size: x-small;">Transmissible Spongiform Encephalopathies</span></div>
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<span style="font-family: "georgia"; font-size: x-small;">Spongiform Encephalopathy in Captive Wild ZOO BSE INQUIRY</span></div>
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<a href="https://web.archive.org/web/20090506001201/http://www.bseinquiry.gov.uk/files/mb/m09a/tab03.pdf" rel="noopener noreferrer" style="color: blue; cursor: pointer; text-size-adjust: 100%;" target="_blank">https://web.archive.org/web/20090506001201/http://www.bseinquiry.gov.uk/files/mb/m09a/tab03.pdf</a></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">BSE INQUIRY</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">CJD9/10022</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">October 1994</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">Mr R.N. Elmhirst Chairman British Deer Farmers Association Holly Lodge Spencers Lane </span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">BerksWell Coventry CV7 7BZ</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">Dear Mr Elmhirst,</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">CREUTZFELDT-JAKOB DISEASE (CJD) SURVEILLANCE UNIT REPORT</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">Thank you for your recent letter concerning the publication of the third annual report from the CJD Surveillance Unit. I am sorry that you are dissatisfied with the way in which this report was published.</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">The Surveillance Unit is a completely independant outside body and the Department of Health is committed to publishing their reports as soon as they become available. In the circumstances it is not the practice to circulate the report for comment since the findings of the report would not be amended. In future we can ensure that the British Deer Farmers Association receives a copy of the report in advance of publication.</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">The Chief Medical Officer has undertaken to keep the public fully informed of the results of any research in respect of CJD. This report was entirely the work of the unit and was produced completely independantly of the the Department.</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">The statistical results reqarding the consumption of venison was put into perspective in the body of the report and was not mentioned at all in the press release. Media attention regarding this report was low key but gave a realistic presentation of the statistical findings of the Unit. This approach to publication was successful in that consumption of venison was highlighted only once by the media ie. in the News at one television proqramme.</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">I believe that a further statement about the report, or indeed statistical links between CJD and consumption of venison, would increase, and quite possibly give damaging credence, to the whole issue. From the low key media reports of which I am aware it seems unlikely that venison consumption will suffer adversely, if at all.</span></div>
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<a href="http://web.archive.org/web/20030511010117/http://www.bseinquiry.gov.uk/files/yb/1994/10/00003001.pdf" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em; text-size-adjust: 100%;" target="_blank">http://web.archive.org/web/20030511010117/http://www.bseinquiry.gov.uk/files/yb/1994/10/00003001.pdf</a></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">*** The association between venison eating and risk of CJD shows similar pattern, with regular venison eating associated with a 9 FOLD INCREASE IN RISK OF CJD (p = 0.04). ***</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">*** The association between venison eating and risk of CJD shows similar pattern, with regular venison eating associated with a 9 FOLD INCREASE IN RISK OF CJD (p = 0.04). ***</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">*** The association between venison eating and risk of CJD shows similar pattern, with regular venison eating associated with a 9 FOLD INCREASE IN RISK OF CJD (p = 0.04). ***</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">There is some evidence that risk of CJD INCREASES WITH INCREASING FREQUENCY OF LAMB EATING (p = 0.02).</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">The evidence for such an association between beef eating and CJD is weaker (p = 0.14). When only controls for whom a relative was interviewed are included, this evidence becomes a little STRONGER (p = 0.08).</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">snip...</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">It was found that when veal was included in the model with another exposure, the association between veal and CJD remained statistically significant (p = < 0.05 for all exposures), while the other exposures ceased to be statistically significant (p = > 0.05).</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">snip...</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">In conclusion, an analysis of dietary histories revealed statistical associations between various meats/animal products and INCREASED RISK OF CJD. When some account was taken of possible confounding, the association between VEAL EATING AND RISK OF CJD EMERGED AS THE STRONGEST OF THESE ASSOCIATIONS STATISTICALLY. ...</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">snip...</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">In the study in the USA, a range of foodstuffs were associated with an increased risk of CJD, including liver consumption which was associated with an apparent SIX-FOLD INCREASE IN THE RISK OF CJD. By comparing the data from 3 studies in relation to this particular dietary factor, the risk of liver consumption became non-significant with an odds ratio of 1.2 (PERSONAL COMMUNICATION, PROFESSOR A. HOFMAN. ERASMUS UNIVERSITY, ROTTERDAM). (???...TSS)</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">snip...see full report ;</span></div>
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<a href="https://web.archive.org/web/20170126073306/http://collections.europarchive.org/tna/20090505194948/http://bseinquiry.gov.uk/files/yb/1994/08/00004001.pdf" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em; text-size-adjust: 100%;" target="_blank">https://web.archive.org/web/20170126073306/http://collections..europarchive.org/tna/20090505194948/http://bseinquiry.gov.uk/files/yb/1994/08/00004001.pdf</a></div>
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<span style="font-size: 13.3333px;">TUESDAY, SEPTEMBER 12, 2017 </span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">CDC Now Recommends Strongly consider having the deer or elk tested for CWD before you eat the meat </span></div>
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<a href="http://chronic-wasting-disease.blogspot.com/2017/09/cdc-now-recommends-strongly-consider.html" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em; text-size-adjust: 100%;" target="_blank">http://chronic-wasting-disease.blogspot.com/2017/09/cdc-now-recommends-strongly-consider.html</a></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">SATURDAY, JANUARY 27, 2018 </span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">CDC CHRONIC WASTING DISEASE CWD TSE PRION UPDATE REPORT USA JANUARY 2018</span></div>
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<a href="http://chronic-wasting-disease.blogspot.com/2018/01/cdc-chronic-wasting-disease-cwd-tse.html" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em; text-size-adjust: 100%;" target="_blank">http://chronic-wasting-disease.blogspot.com/2018/01/cdc-chronic-wasting-disease-cwd-tse.html</a></div>
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<span style="font-size: 13.3333px;">Subject: CDC CHRONIC WASTING DISEASE CWD TSE PRION UPDATE REPORT USA JANUARY 2018</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">CHRONIC WASTING DISEASE CWD TSE PRION IS THE USA AND NORTH AMERICA'S MAD COW DISEASE. </span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">THE USDA INC ET AL WORKED VERY HARD CONCEALING BSE TSE PRION IN CATTLE. they almost succeeded $$$</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">BUT CWD TSE PRION IN CERVIDS IS A DIFFERENT BEAST, THE COVER UP THERE, USDA INC COULD NOT CONTAIN.</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">SPORADIC CJD IS 85%+ OF ALL HUMAN TSE PRION DISEASE.</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">SPORADIC CJD HAS NOW BEEN LINKED TO TYPICAL AND ATYPICAL BSE, SCRAPIE, AND CWD.</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">SPORADIC/SPONTANEOUS TSE HAS NEVER BEEN PROVEN.</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">***Moreover, sporadic disease has never been observed in breeding colonies or primate research laboratories, most notably among hundreds of animals over several decades of study at the National Institutes of Health25, and in nearly twenty older animals continuously housed in our own facility.***</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;"><a href="https://www.nature.com/articles/srep11573" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em; text-size-adjust: 100%;" target="_blank">https://www.nature.com/articles/srep11573</a> </span></div>
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<span style="font-size: 13.3333px;">CDC CWD TSE PRION UPDATE USA JANUARY 2018</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">As of January 2018, CWD in free-ranging deer, elk and/or moose has been reported in at least 22 states in the continental United States, as well as two provinces in Canada. In addition, CWD has been reported in reindeer and moose in Norway, and a small number of imported cases have been reported in South Korea. The disease has also been found in farmed deer and elk. CWD was first identified in captive deer in the late 1960s in Colorado and in wild deer in 1981. By the 1990s, it had been reported in surrounding areas in northern Colorado and southern Wyoming. Since 2000, the area known to be affected by CWD in free-ranging animals has increased to at least 22 states, including states in the Midwest, Southwest, and limited areas on the East Coast.. It is possible that CWD may also occur in other states without strong animal surveillance systems, but that cases haven’t been detected yet. Once CWD is established in an area, the risk can remain for a long time in the environment. The affected areas are likely to continue to expand. Nationwide, the overall occurrence of CWD in free-ranging deer and elk is relatively low. However, in several locations where the disease is established, infection rates may exceed 10 percent (1 in 10), and localized infection rates of more than 25 percent (1 in 4) have been reported. The infection rates among some captive deer can be much higher, with a rate of 79% (nearly 4 in 5) reported from at least one captive herd. As of January 2018, there were 186 counties in 22 states with reported CWD in free-ranging cervids. </span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">Chronic Wasting Disease Among Free-Ranging Cervids by County, United States, January 2018 </span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;"><a href="https://www.cdc.gov/prions/cwd/occurrence.html" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em; text-size-adjust: 100%;" target="_blank">https://www.cdc.gov/prions/cwd/occurrence.html</a></span></div>
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<span style="font-size: x-small;">*** 2017-2018 CWD TSE Prion UPDATE</span></div>
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<a href="https://www.cdc.gov/prions/cwd/occurrence.html" rel="noopener noreferrer" style="color: blue; cursor: pointer; text-size-adjust: 100%;" target="_blank">https://www.cdc.gov/prions/cwd/occurrence.html</a></div>
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<span style="font-size: 13.3333px;">Prion 2017 Conference Abstracts CWD</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;"> 2017 PRION CONFERENCE </span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">First evidence of intracranial and peroral transmission of Chronic Wasting Disease (CWD) into Cynomolgus macaques: a work in progress </span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">Stefanie Czub1, Walter Schulz-Schaeffer2, Christiane Stahl-Hennig3, Michael Beekes4, Hermann Schaetzl5 and Dirk Motzkus6 1 </span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">University of Calgary Faculty of Veterinary Medicine/Canadian Food Inspection Agency; 2Universitatsklinikum des Saarlandes und Medizinische Fakultat der Universitat des Saarlandes; 3 Deutsches Primaten Zentrum/Goettingen; 4 Robert-Koch-Institut Berlin; 5 University of Calgary Faculty of Veterinary Medicine; 6 presently: Boehringer Ingelheim Veterinary Research Center; previously: Deutsches Primaten Zentrum/Goettingen </span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">This is a progress report of a project which started in 2009. 21 cynomolgus macaques were challenged with characterized CWD material from white-tailed deer (WTD) or elk by intracerebral (ic), oral, and skin exposure routes. Additional blood transfusion experiments are supposed to assess the CWD contamination risk of human blood product. Challenge materials originated from symptomatic cervids for ic, skin scarification and partially per oral routes (WTD brain). Challenge material for feeding of muscle derived from preclinical WTD and from preclinical macaques for blood transfusion experiments. We have confirmed that the CWD challenge material contained at least two different CWD agents (brain material) as well as CWD prions in muscle-associated nerves. </span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">Here we present first data on a group of animals either challenged ic with steel wires or per orally and sacrificed with incubation times ranging from 4.5 to 6.9 years at postmortem. Three animals displayed signs of mild clinical disease, including anxiety, apathy, ataxia and/or tremor. In four animals wasting was observed, two of those had confirmed diabetes. All animals have variable signs of prion neuropathology in spinal cords and brains and by supersensitive IHC, reaction was detected in spinal cord segments of all animals. Protein misfolding cyclic amplification (PMCA), real-time quaking-induced conversion (RT-QuiC) and PET-blot assays to further substantiate these findings are on the way, as well as bioassays in bank voles and transgenic mice. </span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">At present, a total of 10 animals are sacrificed and read-outs are ongoing. Preclinical incubation of the remaining macaques covers a range from 6.4 to 7.10 years. Based on the species barrier and an incubation time of > 5 years for BSE in macaques and about 10 years for scrapie in macaques, we expected an onset of clinical disease beyond 6 years post inoculation. </span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">PRION 2017 DECIPHERING NEURODEGENERATIVE DISORDERS </span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">Subject: PRION 2017 CONFERENCE DECIPHERING NEURODEGENERATIVE DISORDERS VIDEO </span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">PRION 2017 CONFERENCE DECIPHERING NEURODEGENERATIVE DISORDERS </span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">*** PRION 2017 CONFERENCE VIDEO </span></div>
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<a href="https://www.youtube.com/embed/Vtt1kAVDhDQ" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em; text-size-adjust: 100%;" target="_blank">https://www.youtube.com/embed/Vtt1kAVDhDQ</a></div>
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<a href="http://prion2017.org/programme/" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em; text-size-adjust: 100%;" target="_blank">http://prion2017.org/programme/</a></div>
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CWD TSE Prion Zoonosis to squirrel monkey and macaque</div>
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<a href="https://www.cste2.org/Webinars/files/CWD_Slides_FINAL.pdf" rel="noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://www.cste2.org/Webinars/files/CWD_Slides_FINAL.pdf</a></div>
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<span style="font-size: 13.3333px;">TUESDAY, JUNE 13, 2017</span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">PRION 2017 CONFERENCE ABSTRACT </span></div>
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<span style="font-size: 13.3333px; line-height: 1.22em;">First evidence of intracranial and peroral transmission of Chronic Wasting Disease (CWD) into Cynomolgus macaques: a work in progress</span></div>
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<a href="http://chronic-wasting-disease.blogspot.com/2017/06/prion-2017-conference-abstract-first.html" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em; text-size-adjust: 100%;" target="_blank">http://chronic-wasting-disease.blogspot.com/2017/06/prion-2017-conference-abstract-first.html</a></div>
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SATURDAY, JULY 29, 2017 </div>
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Risk Advisory Opinion: Potential Human Health Risks from Chronic Wasting Disease CFIA, PHAC, HC (HPFB and FNIHB), INAC, Parks Canada, ECCC and AAFC </div>
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<a href="http://chronic-wasting-disease.blogspot.com/2017/07/risk-advisory-opinion-potential-human.html" rel="noopener noreferrer" style="color: blue; cursor: pointer; text-size-adjust: 100%;" target="_blank">http://chronic-wasting-disease.blogspot.com/2017/07/risk-advisory-opinion-potential-human.html</a></div>
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CWD TSE Prion Zoonosis to squirrel monkey and macaque</div>
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<a href="https://www.cste2.org/Webinars/files/CWD_Slides_FINAL.pdf" rel="noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://www.cste2.org/Webinars/files/CWD_Slides_FINAL.pdf</a></div>
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Terry S. Singeltary Sr.</div>
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Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-4687453285836897153.post-73406329703423239992017-08-26T15:26:00.001-05:002017-08-26T15:26:23.552-05:00DFA 15 Monitoring and Enforcement of the SBO Specified Bovine Offal Regulations <div class="Section1" style="page: Section1;">
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<span style="font-family: Arial;">DFA 15 ������ </span><span style="font-family: Arial; font-size: 10pt;"><img border="0" src="https://web.archive.org/web/20000830210453im_/http://www.bse.org.uk:80/dfa/bselogo.gif" /></span><span style="font-family: Arial;"><o:p></o:p></span></div>
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<span style="font-size: 24pt;">Monitoring and Enforcement of the SBO Regulations<o:p></o:p></span></div>
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<span style="font-size: 11pt;">Draft Factual Accounts ������������������������������������������������������� 9 July 1999<o:p></o:p></span></h1>
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<span style="font-family: Arial; font-size: 11pt;">This is one of a series of documents intended to provide an account as at the date of publication of the factual evidence received by the Inquiry. The documents do not make any judgements about the implications of the facts or point to any conclusions. They are simply working drafts seeking in a neutral way to set out relevant evidence. They do not contain any expressions of opinions by the Secretariat or the Committee of the Inquiry. The series will only cover certain areas of the evidence.<o:p></o:p></span></div>
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<span style="font-family: Arial; font-size: 11pt;">The DFAs may contain inaccuracies and omissions. The purpose of publishing them is to invite corrections, additions and comments. The Inquiry has received suggestions for such corrections and additions in relation to DFAs already published. This is helpful in furthering the work of the Inquiry; all suggestions are considered and used to update the Secretariat�s working papers which will form the basis of the Committee�s Report in due course. The DFAs should not be treated as setting out a complete and accurate appreciation of the relevant facts.<o:p></o:p></span></div>
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<span style="font-family: Arial; font-size: 11pt;">You are invited to let the Secretariat know of any errors, inaccuracies or material omissions in this DFA. It would be helpful if you could distinguish suggested amendments to the DFA from more general comments which would not involve such amendment. Please write to:<o:p></o:p></span></div>
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<strong><span style="font-family: Arial; font-size: 11pt;">������������������ The Secretary<br />The BSE Inquiry<br />6<sup>th</sup> Floor<br />Hercules House<br />Hercules Road<br />London SE1 7DU<o:p></o:p></span></strong></div>
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<strong>Email to : inquiry@bse.org.uk<o:p></o:p></strong></div>
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Responses <span style="font-family: Arial; font-size: 11pt;">should</span> reach the Secretariat by 9 August 1999 for them to be of most assistance to the Inquiry.<strong><span style="font-family: Arial; font-size: 11pt;"><o:p></o:p></span></strong></div>
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Draft Factual Account 15: Monitoring and Enforcement of the SBO Regulations<span style="font-size: 15pt;"><o:p></o:p></span></div>
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TABLE OF CONTENTS</div>
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EVENTS IN 1989........................................................................ 2<o:p></o:p></div>
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EVENTS IN 1990........................................................................ 6<o:p></o:p></div>
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EVENTS IN 1991...................................................................... 29<o:p></o:p></div>
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EVENTS IN 1992...................................................................... 41<o:p></o:p></div>
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EVENTS IN 1993...................................................................... 48<o:p></o:p></div>
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EVENTS IN 1994...................................................................... 52<o:p></o:p></div>
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EVENTS IN 1995...................................................................... 82<o:p></o:p></div>
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EVENTS IN 1996.................................................................... 129<o:p></o:p></div>
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Monitoring and Enforcement of the SBO Regulations</div>
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<i>This Draft Factual Account is a narrative of the activities and documents relating to the monitoring and enforcement of the SBO Regulations.� It covers the period from June 1989 to 20 March 1996.� The introduction of the regulations on Human Food is described more fully in RFA 8, and the introduction of those on Animal Food in RFA 10.<o:p></o:p></i></div>
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<a href="https://www.blogger.com/null" name="_Toc456173191">Events in 1989</a></div>
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1.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 13 June 1989, it was announced that the Government intended to introduce a ban on the use of certain bovine offals for human consumption.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn1" name="_ftnref1" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[1]</span></a>� Following this announcement, MAFF embarked on a process of consultation, whereby interested parties and organisations were invited to comment on the draft provisions of the proposed Order (the Bovine Offals (Prohibition) Regulations 1989).</div>
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2.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The consultation period for the Regulations ended on 13 September 1989.� A copy of the summary of the comments received from interested organisations was circulated by Mr Maslin on 25<b> </b>September 1989.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn2" name="_ftnref2" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[2]</span></a> It was circulated widely within MAFF, and sent to Dr Pickles at the Department of Health and to the Territorial Departments.</div>
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3.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The responses largely supported the introduction of the ban and the terms of the draft Order.� However, the following matters were raised regarding the enforcement and enforceability of the draft regulations:</div>
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(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Additional burdens would be imposed on local authorities without increased resources;<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn3" name="_ftnref3" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[3]</span></a></div>
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(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Doubts were expressed about the practicality of enforcing all the regulations under the current system of local authority control;<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn4" name="_ftnref4" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[4]</span></a></div>
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(iii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>It was suggested that the ban should be extended to inclusion of SBO in animal feed (as well as human);<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn5" name="_ftnref5" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[5]</span></a></div>
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(iv.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>It was suggested that the SBO material would cease to have any commercial value, and that this might lead to dumping/illegal disposal;<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn6" name="_ftnref6" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[6]</span></a></div>
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(v.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The exemption from the ban of spinal cord from calves under 6 months received criticism, most notably in respect of fears about the possibility of maternal transmission.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn7" name="_ftnref7" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[7]</span></a>� However, there was also a call for the exemption to be extended to calves up to 12 months of age;<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn8" name="_ftnref8" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[8]</span></a></div>
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(vi.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>There was concern that sterilisation as defined in the regulations would have no effect in destroying the agent;<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn9" name="_ftnref9" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[9]</span></a></div>
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(vii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>It was suggested that staining should distinguish between SBO and other �unfit� material;<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn10" name="_ftnref10" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[10]</span></a></div>
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(viii.)There was concern that the regulations did not extend to sheep offal;<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn11" name="_ftnref11" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[11]</span></a></div>
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(ix.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>There was concern over the removal of meat from heads due to fears of contamination from pithing holes and tonsil splitting;<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn12" name="_ftnref12" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[12]</span></a></div>
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(x.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>There was concern over the exemption for sausage casings/sutures;<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn13" name="_ftnref13" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[13]</span></a></div>
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(xi.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>There was concern about contamination during carcase splitting and, in particular, concern that splitting often caused the spinal cord to be severed which could result in small pieces of cord becoming lodged between vertebrae;<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn14" name="_ftnref14" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[14]</span></a></div>
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(xii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>There was concern about mechanically recovered meat, particularly that recovered from the spinal column;<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn15" name="_ftnref15" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[15]</span></a></div>
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(xiii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>There was concern that removal of the specified offals did not fully remove the nervous and lymphatic tissue from the animal leaving some of those tissues in food for human consumption;<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn16" name="_ftnref16" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[16]</span></a></div>
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(xiv.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Concern was raised about the staining and movement of bovine heads;<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn17" name="_ftnref17" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[17]</span></a></div>
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(xv.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>There was also concern as to who would be responsible for monitoring proper staining at head boning plants.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn18" name="_ftnref18" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[18]</span></a></div>
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4.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>A meeting to discuss the various responses took place on 27 September 1989.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn19" name="_ftnref19" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[19]</span></a><span class="MsoFootnoteReference" style="vertical-align: super;"> </span>The meeting was chaired by Mr Cruickshank and attended by a number of MAFF officials and representatives of the Territorial Departments. Issues discussed at the meeting included bovine eyes, sutures and other pharmaceutical products, the use of intestines for strings for musical instruments and sports equipment, MRM, a possible exemption for casings and rennet, T-bone steaks and barons of beef, disposal of lymphatic tissue, mesenteric fat, intestines, the effects of the proposed Regulations on local authorities, specialist boning plants, casualty animals and imports from the Republic of Ireland. On the subject of the effect of the SBO ban on local authorities, it was felt that the main additional burdens for them would come from an increase in the number of movement permits to be issued and the need to apply controls at head boning plants and sausage manufacturers. It was agreed that it was too late to seek extra financial provision for the 1989/90 and 1990/91 years, and that local authorities should be asked to produce a detailed breakdown of costs involved for consideration in relation to future years. <a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn20" name="_ftnref20" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[20]</span></a><span class="MsoFootnoteReference" style="vertical-align: super;"></span></div>
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5.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the question of mechanically recovered meat, MAFF�s note of the meeting stated:<span class="MsoFootnoteReference" style="vertical-align: super;"> <a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn21" name="_ftnref21" title="">[21]</a></span></div>
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�The proposed ban on specified offal was in itself a measure of extreme prudence, going beyond what Southwood recommended. Though some nervous tissue would be contained in meat it would be minimal and not present a significant risk. No action should be taken on MRM.�</div>
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6.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The note recorded discussion of the issues surrounding the removal and use of mesenteric fat. Whilst it was acknowledged that mesenteric fat did contain lymphatic tissue �it was agreed that the production process made fat and tallow a low risk product and that the ban should therefore exclude mesenteric fat.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn22" name="_ftnref22" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[22]</span></a></div>
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7.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The note recorded that pithing was not considered to be a problem and that there was no danger of contaminating cheek meat because the skin was still on the skull at the time.</div>
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8.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Martin, the CVO for Northern Ireland, prepared a note of the meeting of 27 September 1989 which noted the discussion of MRM as follows:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn23" name="_ftnref23" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[23]</span></a></div>
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�Mechanically recovered meat (MRM) � the possible danger raised by several of those consulted was recognised and during the discussion there was an expression of the illogicality of what was being done and particularly how easy it would be to have to concede the possible dangers of material other than those listed in the proposed ban.� It was agreed not to raise it.�</div>
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9.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In evidence to the Inquiry Mr Martin stated that he did not think there was any distinction to be drawn between what he had recorded in respect of MRM and what was recorded in Mr Maslin�s note of the meeting.� He explained the rationale behind the decision on MRM as follows:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn24" name="_ftnref24" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[24]</span></a></div>
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�What we were trying to do here was try to put what we thought at the time was a fairly small risk and put it into context and draw a line somewhere, do a risk analysis on it and draw a line.� And I think the conclusion of the meeting as recorded there was that this was such a small risk it<span style="font-size: 12pt;"> </span>was completely negligible, was the conclusion at that time.�<span style="font-size: 12pt;"><o:p></o:p></span></div>
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10.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The SBO Regulations were made on 8 November 1989, laid before Parliament on 9 November and came into force on 13 November 1989.� The Regulations were made under the Food Act 1984 and prohibited the sale or preparation in food for sale for human consumption of any specified bovine offal as defined.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn25" name="_ftnref25" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[25]</span></a>� The Regulations required that following slaughter the SBO should be sterilised and/or stained at the slaughterhouse in accordance with the definition of those terms as set out in the Meat (Sterilisation and Staining) Regulations 1982.</div>
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11.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 9 November 1989, MAFF wrote to every district council in England and Wales and the local authority associations enclosing a copy of� the new regulations and informing them they would be coming into effect on 13 November 1989.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn26" name="_ftnref26" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[26]</span></a>�� The letter said: �if you require any further information or technical advice concerning these regulations, please contact the Veterinary Service at your local MAFF Divisional Office�. On the same date a circular letter was issued to all Divisional Veterinary Officers alerting them to the fact that District Councils had been advised �to contact the veterinary service at their local Ministry office if they have any queries about the operation of the Regulations.�</div>
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12.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>When Mr Cruickshank was asked in oral evidence what he considered to be the practicability of the SBO Ban.� He said:</div>
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�As I recall, my feeling was that although, as I mentioned earlier, we were rather uneasy about the way the district councils were operating the meat hygiene control of slaughterhouses, one thing that did seem to be going quite well was the operation of the sterilisation and staining regulations, which dealt with an earlier problem of unfit meat being passed off as fit for human consumption.� That bit of the system seemed to be working quite well.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn27" name="_ftnref27" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[27]</span></a></div>
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Mr Cruickshank had earlier stated in his evidence that there was a feeling within the Ministry �that the standards of hygiene in slaughterhouses was pretty low in the UK, a good deal lower than most other developed countries�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn28" name="_ftnref28" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[28]</span></a></div>
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13.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Cruickshank was succeeded in the post of grade 3 Head of the Animal Health Group in December 1989.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn29" name="_ftnref29" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[29]</span></a></div>
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<a href="https://www.blogger.com/null" name="_Toc456173192">Events in 1990</a></div>
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14.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Carrick District Council raised the matter of the removal of brains from bovines in slaughterhouses with their local MP, Mr Matthew Taylor.� Mr Taylor wrote to the Minister (Mr Gummer) on 11 January 1990 (see YB90/1.19/10.3) and also requested a meeting.�� Mr Lowson�s advice to the Minister�s office stated:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn30" name="_ftnref30" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[30]</span></a></div>
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�If care is not exercised when removing brains there is a possibility that brain tissue may be transferred to head meat.�� Techniques are available which minimise this.�� There is therefore no reason to prohibit the use of head meat from animals whose skulls have been opened.</div>
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The method objected to by [redacted] is not one we would recommend and is likely to cause contamination of the head meat and the saws used.�� Washing (and sterilisation for the saws) would remove most brain material but not all.�� It is therefore a matter of judgement on the risk from this residual contamination.</div>
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In considering the risk involved [redacted] Council have ignored the important point that the offal ban is a precautionary measure and not directed at known cases of BSE.�� These are killed and the carcases destroyed.�� The animals being handled in the slaughterhouse are for the most part healthy.�� The ban is directed at the very few cases (if any) that have escaped our monitoring arrangements or animals that are infected but have yet to develop clinical signs.�� In subclinical cases the agent is not normally found in the brain until the later stages.�� Thus, even putting aside the fact that the risk for humans from BSE is remote, the risk from contamination of head meat by brain tissue must be almost negligible.�</div>
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15.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 24 January 1990 the relevant Regional Veterinary Officer, Mr Neal Farr, attended a meeting of the Regional Group of Chief Environmental Health Officers at which concerns about the SBO Regulations BSE were discussed.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn31" name="_ftnref31" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[31]</span></a>� During the meeting Mr David Shepherd, EHO of Carrick District Council claimed that SBO Regulations were �very difficult to enforce.� Mr Farr inquired of the meeting �how many had implemented a ban on head slitting, few responded affirmatively.� However, several present said that they would like to impose such a ban but did not think they had the legal backing to do so�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn32" name="_ftnref32" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[32]</span></a> After the meeting, Mr Shepherd said to Mr Farr �it was quite possible to remove the head meat prior to splitting of the brain but he (Mr Shepherd) said that this did not fit in with the commercial considerations of the companies concerned.�</div>
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16.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Farr subsequently wrote to Mr Crawford on 25 January 1990 concerning the 24 January 1990 meeting.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn33" name="_ftnref33" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[33]</span></a></div>
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17.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 26 January 1990 Mr Crawford minuted Mr Baker regarding the January 1990 meeting (enclosing a copy of the letter from Mr Farrs to Mr Crawford date 25 January 1990) stating:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn34" name="_ftnref34" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[34]</span></a></div>
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�We now need to take some action to defuse the situation and I suggest that we arrange a meeting with the Institute of Environmental Health Officers as soon as possible.�</div>
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18.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>As a further response to those concerns, Mr Hutchins of the SVS was at this time �asked by Mr Baker to undertake visits to a number of slaughterhouses to witness different techniques for brain removal�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn35" name="_ftnref35" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[35]</span></a></div>
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19.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hutchins presented his report on head splitting practices on 9 February 1990.� He stated:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn36" name="_ftnref36" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[36]</span></a></div>
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�Four methods of brain removal were observed.�� Three involved sawing through the skull (and thereby the brain), one used a water/air mixture to drive brain tissue from the intact skull.�� The three �skull-open� methods produced very small amounts of a bone paste that would have included traces of brain tissue.�� There was a chance that this could be transferred to cheek meat, but only in tiny quantities.�� Routine hygiene precautions would have further lessened this effect.�</div>
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The �skull-closed� method produced a considerable spray of brain/water mixture.�� There was a reasonable probability of this mixture being transferred to exposed cheek meat.� The operator and the immediate vicinity would also become contaminated�.</div>
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<i>Clarification: Mr Gummer�s statement to the Inquiry suggests that<o:p></o:p></i></div>
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<i>he was not aware of Mr Hutchins report until 20 February 1990<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn37" name="_ftnref37" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[37]</span></a><o:p></o:p></i></div>
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20.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The Minister was not yet aware of Mr Hutchins� report when he met Matthew Taylor MP on 15 February. In his minute of 19 February 1990, Mr Harrison recorded the Minister�s discussion with Mr Taylor with regard to the question of head splitting:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn38" name="_ftnref38" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[38]</span></a></div>
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�The Minister said that, although he was confident that the procedures advocated by the SVS allowed no possibility of hazard to human health, he was prepared to re-examine the points which had been raised by the Environmental Health Officers.�� He undertook to organise a review of the contrasting arguments put forward by the EHOs and the SVS; the Minister would invite a suitable outside expert to advise him�</div>
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21.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 1 February 1990, the IEHO wrote to MAFF regarding the difficulties in the interpretation, compliance with and enforcement of the Bovine Offals (Prohibition) Regulations 1989.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn39" name="_ftnref39" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[39]</span></a>� The IEHO was concerned about the speed with which the ban had been implemented and recorded that a number of environmental health departments had not received copies of the Regulations until after the ban had come into force.� The IEHO had also been made aware of instances where Divisional Veterinary Officers contacted about procedures were similarly uninformed.� The specific comments raised by the IEHO were as follows:</div>
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(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>many specialist boning plants were not under normal circumstances receiving daily veterinary/EHO supervision;</div>
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(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>to allow the tail, from which it is almost impossible to remove the spinal cord, to be regarded as fit for human consumption was arguably inconsistent with the ban on the inclusion of spinal cord;</div>
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(iii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>in practice the spinal cord was often shredded and fragmented by the mechanical carcase splitting saw, not only contaminating the meat but also prohibiting effective removal as per the regulations;</div>
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(iv.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>sterilisation, as defined by the Meat (Sterilisation and Staining) Regulations 1982, would have no effect in destroying the BSE agent.� The IEHO pointed to the Southwood Report as indicating that complete destruction of the scrapie agent was not achieved by heat at 121<span style="font-family: Symbol;">�</span> Celsius for one hour; and</div>
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(v.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>problems were encountered in assessing whether a calf was more or less than six months old.</div>
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22.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Concerns were also raised by the IEHO about the practice of removing the brain from the skull of a bovine animal within the abattoir.� Many small slaughterhouses removed the brain and stained it, so that the head could be freely returned to the butcher.� The IEHO identified a number of ways by which the brain was removed, which they did not believe that the Ministry would condone.� They identified the following:</div>
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(i)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>the splitting of the head with cleavers;</div>
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(ii)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>the use of band-saws to split the heads;</div>
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(iii)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>the use of low pressure hose jets; and</div>
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(iv)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>removal of brain through the stun hole by suction.</div>
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23.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>None of the identified practices were, in the view of IEHO, capable of guaranteeing the effective removal of the brain without resultant contamination of the head.� The IEHO therefore advised that removal of the brain should be prohibited.� They suggested that the removal of head meat should be confined to the slaughterhouse where it could be effectively controlled.� Further, they suggested that all removal of head meat should take place prior to the splitting of the skull for removal of the brain.� After removal of head meat, the head would then be stained and treated along with all other SBO.</div>
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24.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The IEHO also stated that �the subject of storage and disposal of SBO and the issuing of movement permits has caused considerable confusion and presented many practical difficulties�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn40" name="_ftnref40" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[40]</span></a></div>
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25.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 23 February 1990, the Permanent Secretary, Mr Andrews, minuted the Minister, Mr Gummer, regarding his recent meeting on the subject of head splitting with Mr Taylor MP.� Mr Andrews attached a copy of the report on head splitting which had been prepared by Mr Hutchins.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn41" name="_ftnref41" title=""><sup>[41]</sup></a><sup> </sup>Mr Andrews went on to say:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn42" name="_ftnref42" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[42]</span></a></div>
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�We are, here, of course dealing with the heads and brains from healthy cows and Mr Hutchins� report indicates that the amount of contamination by brain tissue of cheek meat would be very small.� You asked why it could not be made a requirement that the head was not split until the cheek meat had been removed�if we were to amend the regulations�it would be likely to simply shift the argument from the splitting of heads to the splitting of spines where the same sort of issues could be raised.�</div>
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26.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Andrews further suggested that Dr Tyrrell was not an appropriate person to provide expert judgement on butchery practices.� He recommended Mr A Johnston, senior lecturer at the Royal Veterinary College, as an appropriate person to consult.� Also attached to Mr Andrews� minute was:</div>
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(i)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>a minute from Mr Crawford setting out Mr Johnston�s qualifications; and</div>
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(ii)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>a draft letter to be sent to Mr Johnston if the Minister agreed to seek his opinion.</div>
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27.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 26 February 1990, Mr Harrison, PS/Minister, minuted Mr Robinson, PS/Permanent Secretary, agreeing to Mr Andrews� suggestion (in his minute of 23 February 1990) that an opinion be sought from Mr Johnston on head-splitting practices in slaughterhouses.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn43" name="_ftnref43" title=""><sup>[43]</sup></a></div>
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28.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 7 March Mr Johnston reported back to Mr Meldrum on head splitting.�� His findings generally endorsed Mr Hutchins� 9 February 1990.� He recommended that meat �should be removed before any saw cut which enters the cranium�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn44" name="_ftnref44" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[44]</span></a> but that where this was not possible �the head should be stored in a chill until the meat has set�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn45" name="_ftnref45" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[45]</span></a>�� He was �concerned that the longitudinal cut using the band saw . . . is the one saw cut which transects the area of the brain in which any BSE agent is likely to be present� and commented that �the high pressure water/air method . . . is not acceptable if contamination of the meat on heads is to be avoided�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn46" name="_ftnref46" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[46]</span></a> Mr Meldrum replied on 9 March, noting that �the only issue where we have some difference of interpretation is on the longitudinal cut along the midline of the head � I will now discuss your report with my colleagues at Tolworth Tower��<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn47" name="_ftnref47" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[47]</span></a></div>
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29.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Taking into account Mr Johnston's report, draft guidance to local authorities on the splitting of bovine heads and brain removal was sent to Mr Hill, PS/Parliamentary Secretary, on 4 April 1990 by Miss Jones, Meat Hygiene Division.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn48" name="_ftnref48" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[48]</span></a>� The Parliamentary Secretary advised that he was happy with the draft provided.� The draft guidance followed Mr Johnston's recommendation that where possible head meat intended for human consumption should be removed from the skull before any cut was made into the skull to remove the brain.� The recommended technique for opening the skull was the oblique cut method, this being the technique which Mr Johnston had reported as producing negligible smearing with easy brain removal and no brain tissue being left in the cranium (provided the skulls were sawn within 24 hours of slaughter - a recommendation which was also included in the draft guidance).� Also in accordance with Mr Johnston's report, the use of high pressure water jets to remove brain tissue was not recommended.</div>
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30.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 9 April 1990, a meeting took place with the IEHO to discuss the concerns they had expressed regarding difficulties associated with the Bovine Offal (Prohibition) Regulations 1989.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn49" name="_ftnref49" title=""><sup>[49]</sup></a><sup> </sup>�The meeting was chaired by Mr Baker and attended by Miss Jones, Mr Maslin and Ms Rimmington of MAFF, and Mr Corbally of the IEHO.� On the issue of timing, MAFF acknowledged that the timescale for the introduction of the Regulations had been unusually short and that this might initially have led to some enforcement difficulties.� However, MAFF officials stated that considerations of public health and awareness had necessitated the speed of action, which IEHO accepted.� IEHO offered help in disseminating such information in the future, to which MAFF said that patterns of decision making in Brussels might make this a useful resource.� IEHO agreed that any suggestions it put forward for improvements to the Regulations would be mindful of the need not to complicate the Regulations any further.</div>
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31.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Corbally wrote to Mr Baker on 18 April 1990 expressing gratitude for �what turned out to be an informative and worthwhile discussion�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn50" name="_ftnref50" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[50]</span></a>� However, Mr Corbally reported that �there are still a number of points that concern me and the Institution may wish to seek your views once more on these issues.�� In respect of head splitting, Mr Corbally stated:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn51" name="_ftnref51" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[51]</span></a></div>
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��the Institution clearly welcome the fact that the Ministry are looking into what we believe is a practice not considered at the time the Regulations were drawn up and implemented. Our view is that none of the practices that we have identified can guarantee <u>no</u> contamination with brain tissue (and potentially therefore with the infective agent of BSE) of either the head, equipment or environment. We believe that the only way of minimising the risk to public safety is to prohibit removal of the brain. While the removal of head meat would be best performed at the place of slaughter, legislative controls over brain removal would continue to allow head meat to be removed at specialist boning plants where the facilities for effective removal are not available at the slaughterhouse.</div>
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Despite this view, if a practice can be identified where the brain can be removed with <u>no</u> risk of contamination and <u>no</u> risk to the safety of the operator, consideration should certainly be given to its use. However, guidelines detailing the procedure to be followed must be developed and brought to the attention of all operators and enforcement officers. Furthermore, they should state that the particular process is the only one considered acceptable. The problem that may arise is that in identifying one �safe� practice others may be developed that should be subject to similar guidance�.</div>
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32.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On issuing guidance to local authorities on more general matters Mr Corbally stated:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn52" name="_ftnref52" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[52]</span></a></div>
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�On the issue of guidance the Institution welcome the suggestion that the Ministry may consider issuing guidance to local authorities on particular aspects of the Regulations and their interpretation. Clearly it is the Courts that make the final decisions with respect to interpretation, however guidance as to what the Ministry�s intentions were behind particular parts of the legislation would certainly be of assistance to EHOs. I refer particularly to the points raised relating to the storage and disposal of the specified offal and the issuing of movement permits. The Institution will certainly assist the Ministry in developing and disseminating any guidance if this would be helpful.</div>
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�You will recall that one of the issues where concern was expressed by a number of EHOs, and one that must clearly be addressed if ever a similar exercise is required, relates to the speed of introduction of the legislation and more importantly the distribution of the regulations and associated information. The Institution do however understand the difficulties involved. On one hand if the legislation is required to protect the public its introduction must not be delayed but on the other hand, ill-conceived introduction can be both confusing and counter-productive. In order to assist in the distribution of information, as agreed I will be forwarding you a list of Directors of Environmental Health/Chief EHOs and appropriate contact numbers.�</div>
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33.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Corbally also asked for the Department�s views on the following:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn53" name="_ftnref53" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[53]</span></a></div>
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�(a)� Although the Ministry consider that the implementation of the Regulation is a prudent measure, minimising still further a risk that is believed to be very small, if not insignificant (according to current knowledge), do you consider that the continued use of mechanically recovered meat from bovines is acceptable? I recall that during our discussion on the subject of removing the spinal cord you felt that the requirements had to provide a reasonable balance. That is, while removal of the major parts of the spinal cord should be performed it was not considered necessary, nor indeed practical to remove fragments of the major nerves. However, MRM could contain significant quantities of spinal cord nervous tissue.</div>
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(b)�� As degenerative encephalopathies have long incubation periods with unknown infective doses, and as diagnosis is at this time symptom-based would it not be right to say that the number of cattle that may be incubating the infective agent of BSE is unknown? Do you not consider therefore that the Southwood Committee�s prognosis of eradication of this problem in cattle by 1993 is optimistic?�</div>
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34.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Following discussions between the Parliamentary Secretary and the Minister, Mr Hill minuted Mr Griffiths on 27 April 1990 that the Ministers had some "qualms" about the practice of removing brains before removing head meat and since there were two other "quite satisfactory practices" available (i.e. where head meat is either removed at the slaughterhouse or at a head boning plant, and then the intact head is sent for rendering), they felt that if there were any doubts about the practice of removing the brain first, then it should be banned.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn54" name="_ftnref54" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[54]</span></a>� In response to this Mr Griffiths sent a minute to Mr Hill dated 2 May 1990 explaining the investigations which had been carried out into the methods of brain removal and the consequences for some slaughterhouses and specialist boning plants of banning brain removal.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn55" name="_ftnref55" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[55]</span></a>� He noted that industry interests would demand justification for any such ban when the risks of contamination were minimal.� Accordingly, the recommendation remained that no action be taken to ban brain removal before recovery of head meat and no legislation be introduced on brain removal methods, but that guidance be issued to local authorities on the matter.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn56" name="_ftnref56" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[56]</span></a>� The Parliamentary Secretary agreed with this recommendation.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn57" name="_ftnref57" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[57]</span></a></div>
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35.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Having received agreement from Ministers on the guidance to go to local authorities on the removal of bovine brains, under cover of a minute dated 16 May 1990 Miss Jones circulated the guidance for comments before it was submitted in final form.� Mr Meldrum provided Miss Jones with comments, identifying various points that he felt needed clarification.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn58" name="_ftnref58" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[58]</span></a> In particular, in response to Miss Jones' comments that DAFS, DANI and DHSS (NI) might wish to consider issuing similar advice in Scotland and Northern Ireland, he expressed the view that any guidance to local authorities must apply to the whole of Great Britain as to do otherwise would cause problems with the SBO regulations.</div>
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<span lang="EN-US">36.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">A question and answer brief was supplied to the MAFF Parliamentary Secretary, Mr Maclean for a debate in the House of Commons on BSE on 21 May 1990.� In respect of the legislation covering slaughterhouse hygiene in relation to BSE it stated:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn59" name="_ftnref59" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[59]</span></a><o:p></o:p></span></div>
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�The Specified Bovine Offal (Prohibition) Regulations 1989 prohibit the sale of certain bovine offal for human consumption, and lay down strict controls over how it must be treated, and where it may go from the slaughterhouse.� In addition the Slaughterhouse Hygiene Regulations 1977 provide general hygiene principles which must be adhered to in all processes, including the removal of specified bovine offal.�</div>
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37.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In the debate on BSE which took place in the House on 21 May 1990, Mr Gummer made the following remarks concerning the Government�s advice on slaughterhouse practice:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn60" name="_ftnref60" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[60]</span></a></div>
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��two months ago I asked for expert veterinary advice on the removal of brains in slaughterhouses.� It has now come.� This broadly supported current practices, but I am asking the Tyrrell committee to consider this, and any other aspects of slaughterhouse practices that it feels may be relevant to the problem.�</div>
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Clarification:� The Inquiry is not aware of any evidence to suggest that consideration was given to the idea of referring the issue of slaughterhouse practices to Tyrell prior to Mr Gummer making the above announcement to the House.</div>
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38.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 22 May 1990 a telex was issued by Mr Baker to all DVOs in England, Wales, Northern Ireland (Mr Meldrum suggests that the inclusion of Northern Ireland may have been an error<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn61" name="_ftnref61" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[61]</span></a>) and Scotland advising that it was not acceptable for brains to be removed in slaughterhouses using high pressure water hoses and that this should be explained in response to any queries received as to the most appropriate technique for brain removal.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn62" name="_ftnref62" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[62]</span></a> Mr Baker�s telex stated that �we continue to receive reports about bovine brains being removed at some slaughterhouses using high pressure hoses�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn63" name="_ftnref63" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[63]</span></a>�� The telex said that this practice �is not acceptable in view of the extent of splashing of brain tissue and water that occurs.�� Fuller guidance on this matter will be issued as soon as possible.�� In the meantime I should be grateful if any similar queries received by you and your staff could be answered in the manner suggested above.�� RMHA�s should be in a position to offer advice, where necessary, on the most appropriate techniques but the optimum is to remove head meat prior to brain removal�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn64" name="_ftnref64" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[64]</span></a></div>
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39.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 22 May 1990, the Minister discussed with the Permanent Secretary the possibility of referring questions on slaughterhouse practices to SEAC.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn65" name="_ftnref65" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[65]</span></a>� Given that SEAC had no expertise covering slaughterhouse practices, it was decided that it would be appropriate to suggest they involve Mr Johnston,� senior lecturer at the Royal Veterinary College, in their proceedings.</div>
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40.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>At its third meeting on 13 June 1990, SEAC considered slaughterhouse practices. The minutes of the meeting recorded (amongst other things) that:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn66" name="_ftnref66" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[66]</span></a></div>
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�The Committee felt that precautions about removal of the brain from bovine skulls were a common sense measure.� It was not consistent with this policy to permit the removal of the brain before head meat was harvested.</div>
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Similar issues arose with spinal cord; if it made sense to avoid contamination by brain tissue of meat for human consumption it appeared on the face of it to make equal sense to avoid the contamination of such meat with spinal cord, which was just as likely to carry infection.� Further information was needed on this.�</div>
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41.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 14 June 1990, a telex was sent by Mr Meldrum to all DVOs, RVOs, RMHAs, RMAs and DEOs advising that �as a result of a detailed evaluation of practices currently in use in slaughterhouses and boning plants, MAFF has concluded that bovine head meat must be recovered from the intact skull before the brain is removed.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn67" name="_ftnref67" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[67]</span></a>� DVOs were also instructed to pass the information to all OVSs and local authorities in their Division.</div>
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42.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 26 June 1990 Mr Andrews minuted the Minister with a short paper summarising the �next steps� in respect of BSE.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn68" name="_ftnref68" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[68]</span></a>� The minute was copied to Mr Capstick, Mr Meldrum, Mrs Attridge and Mr Lowson.� Of relevance to SBO controls were the following:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn69" name="_ftnref69" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[69]</span></a></div>
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Mechanically Recovered Meat</div>
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�A paper is being prepared for the Tyrrell Committee on this which will be submitted to you [the Minister] before it goes to the Committee�.</div>
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Obvious nervous and lymphatic tissue � �Guidance has been circulated�however need to consider to what extent that advice�has achieved the intended result and whether any further action (for example, encouraging the industry to put out separate advice to butchers/retailers) is necessary�.</div>
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Slaughterhouse practices � �A paper is being prepared for the Tyrrell Committee on this subject.� Again this will come to you before being sent to the Committee�.</div>
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43.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 5 July 1990, Mr Maclean minuted the Minister about tidying up some loose ends in relation to BSE �now that all safety precautions for BSE are in place�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn70" name="_ftnref70" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[70]</span></a>� The minute was copied to Mr Capstick, Mr Meldrum, Mrs Attridge and Mr Lowson.� Mr Maclean�s summary was as follows:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn71" name="_ftnref71" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[71]</span></a></div>
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�1.�� Dr Tyrrell should be asked to consider pithing rods in his study of slaughterhouse practices. <u>IMMEDIATE ACTION</u>.</div>
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The labelling of MRM should be raised in the EC and decided in that forum. The decision to do so should be made before Tyrrell reports.</div>
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We need a major announcement on the inspection and supervision of slaughterhouses before the Summer Recess.</div>
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We should announce that MAFF �will devote more resources to slaughterhouse supervision. <u>IMMEDIATE ACTION</u>.</div>
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We should announce that our guidelines �banning� head splitting in meat halls will be made statutory. Arrange PQ on Tuesday. <u>IMMEDIATE ACTION</u>.</div>
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Add major lymphatic material to the Specified Offals. <u>IMMEDIATE ACTION</u>.</div>
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Prepare for the possibility that we may in future have to ban offals in pig and poultry feeds. No immediate action required except to agree the principle and be ready to admit that if asked.</div>
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Prepare for the possibility of a problem with pet foods. Kick this into the EC forum by suggesting contents labelling throughout Europe. No immediate action required except agreement in principle and a willingness to admit this if pressed.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn72" name="_ftnref72" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[72]</span></a></div>
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44.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Lebrecht�s minute also of 5 July 1990 asked Mr Andrews to advise on the implications of each of the points raised by Mr Maclean.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn73" name="_ftnref73" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[73]</span></a>� Mr Andrews did so on 10 July 1990 setting out action proposed where action was required in respect of BSE.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn74" name="_ftnref74" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[74]</span></a>� Mr Andrews advised that any ban on head splitting should await the recommendations of the House of Commons Agriculture Select Committee.� With regard to lymphatic material, he stated: �I am sympathetic to the point.� It does look illogical not to treat as for specified offals.� But there are clearly serious problems about extending the ban.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn75" name="_ftnref75" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[75]</span></a>� The background note attached to the minute stated in respect of lymphatic material:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn76" name="_ftnref76" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[76]</span></a></div>
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�A statutory provision would�increase public concern as it would be assumed that such removal had not been normal practice and could lead to pressure for the removal of all such material from meat, which would be impossible to implement as lymphatic material is throughout the carcase and is exposed wherever meat is cut.�</div>
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45.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The background note went on to say that �there is not much that we can do now to prepare for the possibility that offals (presumably specified offals) will need to be banned from pig and poultry feed.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn77" name="_ftnref77" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[77]</span></a>� It further stated that action would not be justified unless pigs were infected by the feed route. The minute was copied to Mr Capstick, Mr Meldrum, Mrs Attridge, Mr Griffiths and Mr Lowson.</div>
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46.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The House of Commons Agriculture Committee, Fifth Report on BSE was published on 10 July 1990.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn78" name="_ftnref78" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[78]</span></a>� The Committee heard evidence from a wide range of sources.� Amongst the evidence heard in respect of the enforcement of the SBO regulations was the following:</div>
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(a)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In its memorandum of evidence the IEHO raised concern over the</div>
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following slaughterhouse practices:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn79" name="_ftnref79" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[79]</span></a></div>
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(i)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Head splitting � due the danger of contaminating head meat which is removed for inclusion in human food.</div>
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(ii)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>MRM � concern was expressed about the possibility that significant quantities of spinal cord and nervous tissue would be contained in the final product.</div>
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(iii)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Carcase splitting � IEHO gave evidence that the spinal cord is usually severed, on occasions along its length, spreading cord tissue across the whole cut surface of the split carcase, the saw blade and the immediate environment.</div>
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(b)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The BVA memorandum of evidence stated:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn80" name="_ftnref80" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[80]</span></a></div>
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�MAFF should forthwith tackle the procedures, duties, standards and supervision of slaughterhouse practice�Veterinary ante mortem and post-mortem inspection should be extended to domestic slaughterhouses forthwith�Greater reassurance is needed that the removal of spinal cord from bovine carcasses does not present a problem in transferring some spinal material to meat.�</div>
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(c)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Gummer gave evidence in respect of the issues raised regarding</div>
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����������� slaughterhouse practices:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn81" name="_ftnref81" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[81]</span></a></div>
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��we have had an independent report on this which in general supports what we are doing but has some changes.� That has now gone to the Tyrrell Committee because I want them to look at this and say do they think this meets the requirements which they, with their much greater knowledge of BSE, would expect.�</div>
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In respect of the resources being made available for enforcement of the</div>
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controls he went on to say:</div>
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�As far as resources are concerned we have, of course, made the resources available for the sort of inspection which has to be done in any case both under European Community rules and under our own rules as far as this country is concerned. �There will be additional resources under the Food Bill to cover the extra, and as you know that is some �30 million which is additional resources and I emphasise that is what it is.� Therefore, I have not at the moment got any indication there are other resources which are necessary to meet this.� Of course, once the guidelines are put forward I shall be watching very carefully because I will now have power [under the Food Safety Act] to step in if resources are not provided and one of the things that a local authority would no doubt say to me is that it does not have the resources to do what it feels to be the right job.� I shall be watching that very craefully.�</div>
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(d)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr H C Oberst of the Meat & Liverstock Commission gave evidence concerning processing of bovine brains:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn82" name="_ftnref82" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[82]</span></a></div>
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�In only 33 abattoirs, representing less than 4 per cent of British cattle slaughterings, is brain removal attempted, and the methods employed vary. In only two cases was an attempt made to split the skull with a bandsaw, and that is a matter about which some concern has been expressed�.But we are satisfied that in what is happening now there is already no danger to human food�the cheekmeat certainly has a value and the recovery of the cheekmeat from the head should not be banned. The removal of the brain from the skull is another matter and if the skull and the brains within it were dumped, we believe that the loss to the abattoir would not exceed about 36p per animal. We suspect that the abattoir industry could accept that.�</div>
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(e)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The CMO, Sir Donald Acheson, gave the following evidence regarding the possible contamination of carcases with SBO material:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn83" name="_ftnref83" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[83]</span></a></div>
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�Then we get into the issue of contamination of bovine meat products by one or other of the materials, such as brains and the spinal cord.� I know that you have received evidence on that.� When we get into the technicalities of how carcasses are butchered I would have to turn to my colleague, the Chief Veterinary Officer, but in general we are talking about a degree of contamination which, if you take the total dose or theoretical dose that might be consumed in the material, will be very small.� It is tiny anyway because we know that the spongiform agent does not appear in meat in any case in tangible quantities.� On the matter of contamination I would simply say that from the public health point of view, if this is regarded as significant in any way it would be prudent to see what could be done to reduce it, but I am advised that currently there is not a significant public health problem due to this.� That would be my position.�</div>
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47.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The Report of the Agriculture Committee made the following recommendations regarding procedures in slaughterhouses:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn84" name="_ftnref84" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[84]</span></a></div>
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�50. This as we have already indicated, is an area of legitimate public concern. It is essential that action is taken, and seen to be taken, which makes the ban on specified offals as watertight as possible. Many of the horror stories which have been told, conveying a picture of brains being splattered indiscriminately about the slaughterhouse, are greatly exaggerated and bear no relation to normal practice. But there may be some scope for improvement in the present arrangements.</div>
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�</div>
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53. MAFF issued guidelines on abattoir practice on 14 June and the Tyrrell Committee is engaged in its own review which will no doubt lead in due course to supplementary guidance and, if necessary, regulatory powers. In those circumstances, and in view of our own fairly limited examination of the subject, it would not be appropriate to bring forward detailed proposals of our own. We do, however, feel in a position to <b>recommend that the practice of splitting the heads of cattle in abattoirs be outlawed</b>. It brings no significant benefits to anybody and is practically guaranteed to spread public alarm.</div>
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54. We were pleased to note that Dr Tyrrell voiced similar reservations about the latter practice.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn85" name="_ftnref85" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[85]</span></a> Recent MAFF guidelines also stipulate that �bovine head meat must be recovered from the intact skull before the brain is removed�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn86" name="_ftnref86" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[86]</span></a> This is a substantial step in the right direction, although we would like to see appropriate safeguards enshrined in legislation at an early opportunity.�</div>
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<span lang="EN-US">48.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">At a meeting to </span>discuss<span lang="EN-US"> the recommendations of the Select Committee on 25 July 1990 it was agreed to respond as positively as possible to the Select Committee�s recommendation on the need to legislate on brain removal.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn87" name="_ftnref87" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[87]</span></a>� The Bovine Offal (Prohibition) (Amendment) Regulations 1992 came into force on 12 March 1992.<o:p></o:p></span></div>
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<span lang="EN-US">49.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">The </span>recommendation<span lang="EN-US"> that the SBO ban should be extended to cover calves was rejected.� The note of the meeting stated:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn88" name="_ftnref88" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[88]</span></a><o:p></o:p></span></div>
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<span lang="EN-US">�In rejecting it, the Government could make it clear that we have indicated to Dr Tyrrell that if evidence emerged which led his committee to want to change any aspect of its advice then we were open to this.�<o:p></o:p></span></div>
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<span lang="EN-US">50.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">On a </span>further<span lang="EN-US"> point, not covered by the Select Committee, the note records that Mr Meldrum wondered whether it would be worth examining again the question of requiring the staining and sterilisation of obvious lymphatic tissues.� The Minister agreed that this should be done, with a view to taking any necessary action before the response to the Select Committee was published.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn89" name="_ftnref89" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[89]</span></a><o:p></o:p></span></div>
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51.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In August 1990, it was learned that BSE had been experimentally transmitted by direct inoculation to a pig.� On 23 August 1990, the CMO was informed of this development by a minute from Dr Pickles.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn90" name="_ftnref90" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[90]</span></a>� The minute informed him that a special meeting of SEAC had been arranged to discuss the issue. SEAC felt it would be prudent to exclude SBOs altogether from the pig diet. The occurrence of FSE in cats, even though it had not been demonstrated that there was any relationship with BSE, suggested that a cautious view should be taken. Thus SEAC concluded that SBOs should be excluded from the feed of all species.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn91" name="_ftnref91" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[91]</span></a></div>
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52.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 10 September 1990, Miss Bronwen Jones minuted Mrs Attridge about limiting statutory requirements regarding lymphatic tissue.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn92" name="_ftnref92" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[92]</span></a>� The minute was copied to Mr Meldrum, Mr Griffiths and Mr Lowson.� Miss Jones stated:</div>
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�In the eyes of the public lymphatic tissue is either safe to eat or it is not, and it would be difficult to draft legislation which did not draw attention to this difficult point�I am forced to conclude that we could only legislate on lymphatic tissue at the risk of creating further problems both for ourselves and for the industry, who would have more unsaleable waste to dispose of and would suffer from further � unnecessary � consumers� concern about the safety of carcase meat.�</div>
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53.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The BSE (No2) Amendment Order 1990 (SI 1930 of 1990) was brought into force on 25 September 1990.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn93" name="_ftnref93" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[93]</span></a>� Its main purpose was to extend the prohibition on the use of SBOs, or protein derived from SBOs, so as to exclude their use in feed for all animals and poultry.</div>
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54.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 25 September 1990, a letter was sent from Mr Crawford to all DVOs giving notice of the new Regulations.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn94" name="_ftnref94" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[94]</span></a>� The letter was copied to Mr Meldrum, Mrs Attridge and Mr Lowson.� The letter said:</div>
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�I would like you to take the following action:</div>
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Would you please contact the Local Authorities responsible for enforcing the disposal aspects of the [SBO Regulations] to ensure that they are fully aware of the legal position�</div>
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Would you also contact any rendering company in your area to advise them that you have been in touch with the Local Authorities to make clear to them what the legal position is.� Would you please ask the renderers to let you know if they have any evidence that the rules are being breached.</div>
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Clearly, if difficulties are arising, I would like to know so that we have a picture of the position throughout the country as a whole.</div>
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I am sorry to burden you with these additional tasks. �However, this is a very sensitive area, with health and environmental implications.� It is also an area which the media is quite likely to latch onto if major problems do arise.�</div>
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55.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 27 September 1990, Mr Lawrence minuted Mr M Stranks about identification of meat and bonemeal (MBM) derived from specified offal in animal feed.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn95" name="_ftnref95" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[95]</span></a>� Mr Lawrence explained that Mr Meldrum had asked whether any practical means existed for identifying MBM from specified offal in animal feed.� On the assumption that such a test did not exist, Mr Lawrence asked Mr Stranks whether it would be possible to incorporate a marker in the material which could be recognised visually or by some sort of test.� The minute was copied to Mr Meldrum, Mrs Attridge and Mr Lowson.</div>
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56.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 1 October 1990, UKRA wrote to all its members enclosing a letter which had been received from MAFF on 27 September 1990.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn96" name="_ftnref96" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[96]</span></a> The letter from MAFF stated that DVOs had been requested to contact any rendering company in their area to advise them that they had been in touch with the local authorities and to ask them (the renderers) to let DVOs know if they had any evidence that the rules regarding disposal of the specified offals were being breached.</div>
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57.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 4 October 1990, Mr Lawrence received a letter from DANI regarding the extension of the ban on the use of SBOs.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn97" name="_ftnref97" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[97]</span></a> The letter from DANI expressed concern over the apparent weakness in the audit trail on the use of meat and bone meal. The letter stated that unless a defensible audit was in existence, adverse consumer reaction could mount and do substantial damage to the meat industry. It went on to say:</div>
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��We are strongly of the view that action on this is necessary to prevent leakage of meat and bone meal back to bovines, as well as being seen to be securing consumer safety�.</div>
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58.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 8 October 1990, Mr Lawrence minuted Mr Lowson regarding the letter from DANI.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn98" name="_ftnref98" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[98]</span></a> Mr Lawrence said that MAFF were assessing the question of a marker for SBO material. However, discussions UKASTA had revealed that they felt a marker would be impractical. Mr Lawrence reported that UKASTA had suggested that, as part of their contractual arrangement with renderers that SBOs be excluded from meat and bone meal, they should make unannounced checks on abattoirs to ensure that proper separation was being achieved.</div>
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59.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 11 October 1990, Mr Maslin wrote to Ms Richmond of MAFF�s Legal Division, regarding errors in the BSE (No. 2) Amendment Order 1990.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn99" name="_ftnref99" title=""><sup>[99]</sup></a>� The minute was copied to Mr Meldrum and Mr Lowson.� He began, �Not surprisingly, in view of the haste and secrecy in which it was prepared, we have two errors in the above order pointed out to us�.� In respect of the first error Mr Maslin stated the following:</div>
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�It was our intention simply to re-enact the ban on ruminant proteins to ruminants in the amendment Order. Unfortunately the change to the definition of animal means that the definition of animal protein is wider than just ruminant protein. In practice this has had no effect since no rendering plant produces any animal protein from, say, just pig material. Nevertheless, we should put it right. Could I suggest something on the lines of adding �derived from ruminants� after �animal protein� in 8 (1) and 8 (2) of the BSE Order.�</div>
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60.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The second point related to the definition of �specified bovine offal�. As worded, it referred to offal from animals slaughtered in the UK. This appeared to exempt fallen stock and MAFF had received unconfirmed reports that renderers were taking advantage of this to make use of those fallen animals in processed feed.</div>
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61.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In October 1990 the IEHO made a submission to the Ministry regarding the illegal trade in unfit meat for human consumption.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn100" name="_ftnref100" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[100]</span></a>� With regard to the operation of the Meat (Sterilisation and Staining) Regulations and the Food Act 1984 the IEHO recommended that �careful consideration should be given to the effectiveness of the Meat (Sterilisation and Staining) Regulations and to seek changes where necessary�.� In particular IEHO noted:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn101" name="_ftnref101" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[101]</span></a></div>
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�The original report [IEHO report �The Illegal Trade in Unfit Meat for Human Consumption� 1981] called for changes in legislation available to enforcement authorities.� Yet subsequent changes in the Meat (Staining and Sterilising) Regulations and the Food Act 1984 failed to effectively control unfit meat.</div>
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There were no changes in the existing unsatisfactory system of meat marking.� The IEHO recommended a system of roller marking.</div>
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It is still not an offence to possess an unauthorised meat inspection stamp.</div>
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There has been no change in the reference to �for sale� in the Meat Inspection Regulations.� Constant enforcement problems are experienced when the �owner� insists that a carcase is not intended for sale for human consumption. (This will change with the inception of the Food Safety Act).</div>
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The BVA has introduced a new form for the Veterinary Certificate for Slaughterhouses Admission for Sick and Injured Animals, yet there is no legal requirement for proper documentation, and vets may continue to submit �back of the cigarette packet� certificates.� There are still instances where vets certify dead animals for admission to a slaughterhouse, although this is illegal.</div>
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There are no inspection requirements for knackers� yards, which may be adjacent to slaughterhouses and which should be under similar control.</div>
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Knacker activities at unfit meat places such as zoos and hunt kennels are still outside the scope of licensing requirements.</div>
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There are no requirements for the labelling of boxed meat at the wholesale stage despite stringent controls at the later, retail stage.�</div>
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62.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 29 October 1990, a meeting in MAFF was held to discuss the disposal of animal waste.� It was attended by the Permanent Secretary, Mr Lawrence, Mr Capstick, Mr Baker, Mr Maslin and Mr Davis.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn102" name="_ftnref102" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[102]</span></a> The meeting discussed EC proposals regarding the knacker industry, the fall off in knacker trade and the disposal of specified offal. The note of the meeting recorded that, in respect of the disposal of specified offal, the Ministry had received no indications of any problems from abattoirs or knackers, nor had any problems been observed by MAFF staff in domestic or export-approved slaughterhouses. The Permanent Secretary asked whether the Ministry should not carry out spot checks of slaughterhouses to see how this material was being processed, so that Ministers, if asked, could say that they were satisfied that none of it was going into animal feed. It was noted that renderers and knackeries were registered with the Ministry and received 20 days� inspection a year from veterinary and animal health officers for the purposes of salmonella control. However, the officers had no instructions to examine the way in which specified offals were being processed.� The Permanent Secretary asked Mr Lawrence to consider whether the remit of MAFF officers enforcing the Protein Processing Regulations in rendering plants should be extended to cover the inspection of specified offals and whether this remit should also be extended to cover knackeries.</div>
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63.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In their meeting on 1 November 1990, SEAC considered a paper prepared by MAFF on slaughterhouse practices. In its final form, the paper contained sections on carcase splitting, mechanically recovered meat, the use of pithing rods and possible research related to slaughterhouse practices.� In an introductory section, the paper made the following points:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn103" name="_ftnref103" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[103]</span></a></div>
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�Most of the offals covered by the ban can readily be removed in the slaughtering and dressing process.� However there is at least the theoretical possibility that some slaughtering practices could involve contact between material for human consumption and material covered by the Regulations, notably spinal cord and some nervous tissue.� It is important to bear in mind that, on the scrapie analogy, neuroinvasion is not likely to occur until about half way through the incubation process.� Thus the risk that these tissues will be infected is much less in animals killed for prime beef at about two years old than in cull cows.� Furthermore, assuming that BSE pathogenesis in cattle is like that of scrapie in mice, peripheral efferents are unlikely to be infected until clinical signs were visible.�</div>
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64.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>With regard to carcase splitting, the paper explained that it was normal for all bovine carcases to be split, apart from those of calves up to the age of six months, and that this was a requirement of EC rules governing the intra-Community trade in meat.� The paper also explained that:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn104" name="_ftnref104" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[104]</span></a></div>
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�The spinal cord will inevitably receive some damage during this operation, although it is often surprisingly intact.�</div>
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65.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The question of contamination of the carcase with spinal cord material was also addressed in the paper.� The following comments were made:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn105" name="_ftnref105" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[105]</span></a></div>
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�The concern that has been expressed regarding carcase splitting relates to the possible transfer of material from the damaged spinal cord onto the carcase.� The volume of material is likely to be small, in most cases no more than a few grams.� It will be concentrated around the cut surface of the spinal column, perhaps with some slight spill over onto exposed meat surfaces.� The routine washing of the carcases will, if done sufficiently promptly (as would be normal practice), remove the greater part of any gross particular matter.� However no data is available about the quantity of spinal cord tissue likely to come into contact or remain with material used for human consumption.� Such data could be obtained by comparing the mean weight of spinal cord collected after splitting with that obtained after necropsy using a standard procedure to account for the length of spinal nerve etc.�</div>
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66.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the possibility of sucking out the cord from the intact carcase, the paper said that this was unlikely to be practicable, as the shape of the carcase and the spinal canal and the attachments of the cord would all act against such a method.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn106" name="_ftnref106" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[106]</span></a>� It was pointed out that this and other possible methods of reducing the risk of spinal cord contaminating material used for human consumption were not in commercial use, and that some research and development would be required to determine their practicability and the extent to which they would in practice reduce such a risk.</div>
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67.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In the section specifically on mechanically recovered meat (�MRM�), the paper explained that there was currently no specific UK or EC legislation in force to regulate the use of MRM.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn107" name="_ftnref107" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[107]</span></a>� However, it was explained that by virtue of the Meat Products and Spreadable Fish Products Regulations 1984, MRM could not be used in uncooked meat products if it was obtained from certain specified parts of the carcase, including (amongst other organs and parts) brains, spleen, spinal cord and large and small intestines.� Reference was also made to the Bovine Offal (Prohibition) Regulations 1989, which prohibited SBO from all human food, and also to EC rules requiring that all visible lymphatic and nervous tissue be removed in the normal cutting process.</div>
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68.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The paper also pointed out that few meat products containing MRM were labelled as such and that the legal obligation to do so was disputed by the industry.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn108" name="_ftnref108" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[108]</span></a>� SEAC was informed that MAFF�s Food Science Division was embarking on a project to develop a method to detect the presence of MRM in meat products.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn109" name="_ftnref109" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[109]</span></a></div>
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69.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The paper then considered the implications regarding BSE.� It was pointed out that the vertebral column of bovine carcases, excluding the spinal cord, could be used in the manufacture of MRM.� The paper continued as follows:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn110" name="_ftnref110" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[110]</span></a></div>
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�Inevitably when bovine carcases are split through the centre of the vertebral column in the <span style="font-size: 12pt;">slaughterhouse</span> some nervous tissue can remain and some contamination of the vertebrae with central nervous system (CNS) tissue can occur.� This will be as a result of:-</div>
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(a)�� small pieces of spinal cord inadvertently remaining in the vertebral column;</div>
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(b)�� contamination from carcase splitting�; or</div>
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(c)�� the failure to remove nerves from between the vertebrae.</div>
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It is unlikely that lymph nodes and other nervous tissue associated with the muscle are left adhering to the bones, since only residual meat remains after the deboning stage.� However, there will probably be some peripheral nervous tissue still present within the vertebral column.� Therefore, any risk passed by MRM would seem to be by the transference of the BSE agent from nervous tissue to the MRM.� It is still not known however, if even where the spinal cord is removed cleanly, any risk exists from the remaining nervous tissue in the vertebral column.�<span style="font-size: 12pt;"><o:p></o:p></span></div>
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70.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In the section on possible research, the paper indicated a number of areas in which research and development could be useful.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn111" name="_ftnref111" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[111]</span></a>� These included:</div>
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(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>bioassay of MRM or potentially contaminated tissue from affected animals;</div>
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(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>the quantification of the extent of any residue of CNS tissue left with the carcase when the cutting process was complete;</div>
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(iii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>assessment of possible alternative methods of removing the spinal cord or cutting the carcase; and</div>
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(iv.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>methods of detection of CNS in MRM, and then determination of the presence of CNS tissue in MRM.</div>
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71.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>SEAC considered the paper provided by MAFF at its meeting of 1 November 1990.� Under the heading, �Slaughterhouse Practices�, the minutes of the meeting record the following:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn112" name="_ftnref112" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[112]</span></a></div>
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�Those members who had been involved in the slaughterhouse visit had noted that, if proper procedures were followed, specified offals could be satisfactorily removed at the slaughterhouse, and in particular that the spinal cord could be extracted from the carcase without difficulty.� The Committee therefore concluded that, provided all the rules were properly followed and supervised, there was no need to recommend further measures on the grounds of consumer protection (operator safety was a matter for HSE).�</div>
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72.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 8 November 1990, Mr Meldrum sent a minute to Mr Baker, stating that he wished to consider issuing advice to local authorities on checking protein processing plants on the disposal of SBOs as soon as possible, that DVOs should be contacted to ask them to ensure that slaughterhouses in their area were complying with the SBO regulations, and to ensure that VOs and AHOs visiting processing plants were checking on compliance with the SBO regulations.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn113" name="_ftnref113" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[113]</span></a>� The minute was copied to Mrs Attridge, Mr Crawford, Mrs Brown and Mr Lowson.� Mr Meldrum asked Mr Baker to arrange for the necessary instructions to be issued as soon as possible.�</div>
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73.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 9 November 1990, a meeting took place to discuss the issue of disposal of animal waste.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn114" name="_ftnref114" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[114]</span></a> It was chaired by Mr Meldrum and attended by MAFF personnel and representatives from DANI and DAFS (see minute dated 19 November 1990 prepared by Mr Maslin). There was some discussion at the meeting about how SBOs were being dealt with by the renderers.� Other than the issue of costs, there were no reports of slaughterhouses having major problems in disposing of SBOs.� In relation to abattoir waste it was agreed that changes in legislation were not necessary at the time.� It was however agreed that SVS field staff should visit rendering plants as soon as possible to check on the handling of SBOs, followed by routine monthly visits.� The possibility of the marking of SBOs was discussed.� It was agreed that a simple, cheap marker or test that could detect a dye in meat and bone meal was to be pursued with CVL by Mr Lawrence and Mr Taylor.� The CVO was concerned that the SBO order allowed those from fallen animals to go into meat and bonemeal for animal feed and asked that an amendment be made quickly.� Mr Lowson agreed to discuss hold ups in the Legal Department with Mrs Attridge.</div>
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74.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>A telex was issued by Mr Baker on 12 November 1990 to all DVOs in England, Wales and Scotland, instructing them to carry out monthly visits to rendering plants.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn115" name="_ftnref115" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[115]</span></a>� The telex asked that arrangements be made to establish monthly visits to rendering plants in order to establish:</div>
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<span lang="EN-US">(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span>awareness of BSE legislation in terms of specified offals;<span lang="EN-US"><o:p></o:p></span></div>
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<span lang="EN-US">(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span>how specified offals were identified;<span lang="EN-US"><o:p></o:p></span></div>
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<span lang="EN-US">(iii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span>how specified offals were kept separate;<span lang="EN-US"><o:p></o:p></span></div>
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<span lang="EN-US">(iv.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">how </span>specified<span lang="EN-US"> offals were processed and kept separate from other material during processing; and<o:p></o:p></span></div>
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<span lang="EN-US">(v.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">how processed material resulting from specified offals was disposed of.<o:p></o:p></span></div>
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75.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In respect of slaughterhouses, Mr Baker�s telex read as follows:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn116" name="_ftnref116" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[116]</span></a></div>
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�Specified Offals in Slaughterhouses</div>
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�In addition, we would like to know how slaughterhouses are handling specified offals.�� Unless the information is available from a recent visit a visit by a SAHO/AHO should be arranged.�� A return� - to Mr S C Hutchins, Tolworth Tower - on this subject is required by 17 December 1990.�</div>
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76.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 20 November 1990, Mr Webster, a veterinary officer in the Leeds area, wrote to a slaughterhouse which he had recently visited regarding deficiencies noted during his inspection.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn117" name="_ftnref117" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[117]</span></a> Amongst those deficiencies Mr Webster had noted the incomplete removal of spinal cord seen in the sides of two carcases, which had been inspected and passed as fit.</div>
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77.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 23 November 1990, Mr Lawrence circulated a minute setting out various suggestions for establishing a policing system to monitor the SBO controls.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn118" name="_ftnref118" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[118]</span></a>� The minute was copied to Mr Meldrum, Mrs Attridge, Mr Crawford, Mr Lowson and others.� Mr Lawrence said, �I hear on the grapevine that some specified material destined for renderers is not stained when it leaves the abattoirs�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn119" name="_ftnref119" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[119]</span></a>� His suggestions included monthly checks at rendering plants and checks at slaughterhouses for evidence that SBOs being collected by renderers had been stained before leaving the slaughterhouse.� As a possible additional check, Mr Lawrence suggested using calculations of the weight of SBOs that should arise to follow them through the production process.� Renderers would have to account for any discrepancies in the amount of material received and processed and the amount of meat and bone meal produced.� He also suggested random spot checks to supplement the annual visits of the SVS to knackers� yards. He added that the possibility of using a marker for SBOs was being pursued by Mr K Taylor and Mr Lawrence with Mr Shaw at CVL.</div>
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78.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 26 November 1990, Mr Hutchins responded to Mr Lawrence's suggestion to use weight calculations as a means of checking on the disposal of SBOs.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn120" name="_ftnref120" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[120]</span></a> Mr Hutchins pointed out difficulties in implementing this idea because of variable factors, such as the differing contents in SBO material collected from slaughterhouses, the presence of considerable amounts of water, problems of mixing loads and variations in weight during transporting due to fluid losses etc.� In addition, he queried whether there would be right of access to records of slaughterhouses and other premises for the purposes of making the necessary calculations. Mr Hutchins� minute was copied to the CVO, Mrs Attridge, Mr Crawford, Mr Lowson and others.</div>
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79.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Meldrum commented on Mr Lawrence�s minute of 23 November 1990 in his minute to Mr Crawford of 28 November 1990.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn121" name="_ftnref121" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[121]</span></a>� The minute was copied to Mrs Attridge and Mrs K J Brown and Messrs Baker, Taylor, Lowson and Lawrence.� Mr Meldrum asked:</div>
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�I would be grateful for advice from Mr Crawford on any increase in SVS visits to knackers yards.� I certainly support the suggestion that we should increase our visits and, in addition, persuade local authorities to do likewise.</div>
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On hunt kennels I was under the impression that they were being visited on a routine basis by VOs from the SVS.� Could Mr Crawford once again advise.�</div>
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80.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Crawford responded on 30 November 1990:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn122" name="_ftnref122" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[122]</span></a></div>
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�On 29<sup> </sup>August, I asked for returns on the development of problems in relation to the disposal of material from knackers and hunt kennels.� On 15 October the instructions were firmed up and the return is now required, via Regions, on a monthly basis.� In addition to the knackers and hunt kennels, the staff are also keeping under review the question of the removal of dead stock from farms.</div>
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Therefore, in answer to your questions, the knackers and hunt kennels are now receiving a much higher level of input from the SVS.� I am also asking RVOs to try to obtain an increased involvement by Local Authorities.�</div>
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81.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 18 December 1990, Mr Lawrence minuted Mr Hutchins concerning allegations against two slaughterhouses of contravention of the SBO regulations.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn123" name="_ftnref123" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[123]</span></a>� The particular nature of the allegations is unclear.</div>
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82.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the same day, 18 December 1990, Mr Crawford sent a telex to all territorial RVOs (England, Scotland and Wales) regarding the inspection of knackeries, hunt kennels and rendering plants.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn124" name="_ftnref124" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[124]</span></a> Mr Crawford referred to the numerous requests that had gone out to the field requiring staff to submit returns on various aspects of the rendering and knackery operations. In order to clarify the position, Mr Crawford said that he would hope to bring together the content of those requests in one circular letter in respect of hunt kennels and knackeries.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn125" name="_ftnref125" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[125]</span></a> Mr Crawford�s telex stated that these establishments should continue to receive a monthly visit by veterinary or technical staff to report on the removal of dead stock from farms. At these visits staff were also required to review the procedures for the disposal of waste material generally and of specified offals in particular. In respect of the rendering plants, Mr Crawford stated a monthly visit, preferably by a SAHO, should be made to rendering plants to obtain the following information:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn126" name="_ftnref126" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[126]</span></a></div>
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(a)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>how the specified offals were identified;</div>
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(b)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>how the specified offals were handled;</div>
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(c)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>how the specified offals were kept separate from other materials;</div>
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(d)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>how the specified offals were processed and kept separate from other material during processing; and</div>
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(e)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>how the processed material resulting from specified offal was disposed of.</div>
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Returns were to be submitted to Mr Hutchins at Tolworth.</div>
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83.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 18 December 1990, Mr Lowson minuted Mr Lebrecht with a background note for the Ministers� meeting the following day regarding disposal of fallen animals and animal waste.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn127" name="_ftnref127" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[127]</span></a> In his summary, Mr Lowson stated that it was not easy to quantify the extent to which farmers and others were by-passing conventional means of carcase disposal, but there was clearly a substantial incentive for them to do so. However, Mr Lowson stated that there was no justification for financial aids to the knackers� or renderers� running costs.</div>
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<a href="https://www.blogger.com/null" name="_Toc456173193">Events in 1991</a></div>
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84.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In a letter dated �January 1991� from Mr Lawrence to Mr Ian Anderson of DAFS, Mr Lawrence referred to difficulties that had been encountered by a rendering firm, Dundas Brothers Ltd, in ensuring that SBOs were kept out of the animal food chain.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn128" name="_ftnref128" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[128]</span></a></div>
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85.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 9 January 1991, the Senior Public Health Inspector of Wiltshire County Council wrote to Mr Maslin regarding problems which had emerged in respect of the Bovine Spongiform Encephalopathy (No.2 ) Amendment Order 1990.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn129" name="_ftnref129" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[129]</span></a> The letter drew attention to the error in the drafting of the Order which caused fallen animals to be effectively exempt from the SBO regulations and allowed the specified offals from fallen animals to be processed for inclusion in animal feeds.</div>
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86.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The results of the first set of returns from rendering plants were collated by Mr Hutchins in his minute of 12 January 1991 to Mr Crawford.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn130" name="_ftnref130" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[130]</span></a>� The minute recorded that there were no significant problems involved in the handling of SBO at rendering plants, and that general awareness of the legislation was good.� It was suggested that future returns should give details of the cleaning of shared processing equipment (namely, equipment that is used in the processing of both SBO material and other waste) and of the disposal of tallow.� The minute was copied to Mr Lowson and Mrs Attridge.</div>
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87.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>At the same time as the programme of SVS visits to rendering plants and collection centres was established, SVS staff were asked to start a<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn131" name="_ftnref131" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[131]</span></a>programme of monthly visits to knackers� yards and hunt kennels.� The summary of� the results of those visits was collated by Mr Hutchins in his minute of 17 January 1991.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn132" name="_ftnref132" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[132]</span></a> It was noted that hunt kennels were increasingly taking on the role of knackers, and that the potential for knackers to charge for collection might encourage farmers to dispose of carcases of sick animals to those involved in the �unfit meat trade.�� Some field staff had expressed concern about the level of input required for the monthly returns, and Mr Hutchins asked that consideration be given to reducing the frequency of visits to once every three months.</div>
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88.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 18 January 1991, Mr Crawford wrote to all RVOs regarding the results of the survey of the handling of SBOs in slaughterhouses which was made pursuant to Mr Baker�s telex of 12 November 1990.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn133" name="_ftnref133" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[133]</span></a>� Mr Crawford stated that the survey was of limited value owing to the variation in format and detail of the 36 returns received.� The minute noted that proformas had been prepared, so that future returns would be standardised.� The minute also asked that the returns from individual plants should not be sent to Mr Hutchins, but that he (Mr Hutchins) should receive instead a summary of the returns in each Division, prepared by the DVO.� The proforma asked whether brains were removed on site and �whether meat used for human consumption is at risk of contamination�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn134" name="_ftnref134" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[134]</span></a>�� It also asked whether intact skulls were sent to boning plants and whether SBOs were sterilised on site and further, about movement controls and the nature of any contraventions found.�� Mr Crawford asked for the forms to be completed and returned by 25 February 1991.</div>
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89.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 21 January 1991 Mr Meldrum minuted Mr Crawford regarding Mr Hutchins� 17 January summary of returns on the handling of specified offals at rendering plants.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn135" name="_ftnref135" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[135]</span></a>� He stated:</div>
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�2.� It is now important that we feed back information and advice to our staff arising from this return to ensure that we have uniformity of application of the relevant rules.</div>
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�3.� In particular, we need to cover the possibility of leakage from one bay to another (although this a comparatively minor problem) and the importance of ensuring that there is no deliberate mixing of the two types of offal.</div>
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�4.� We need further information on the time/temperature combination for all premises where the SBOs are being processed.� In the case of premises where the system is not �cleaned� we need further details and advice if necessary to the operator through the DVO.</div>
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�5.� We also need to know how tallow is being used.</div>
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�6.� On the general issue raised by Mr Hutchins I take the view that we do need to repeat visits and returns in view of the importance of this issue.�</div>
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90.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the same day Mr Meldrum minuted Mr Crawford about Mr Hutchins 17 January summary of returns from knackers yards and hunt kennels.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn136" name="_ftnref136" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[136]</span></a>� Mr Meldrum made the following comments:</div>
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�1.� You will have seen Mr Hutchins�s minute of 17 January which makes somewhat disturbing reading.</div>
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�2.� It is essential that this work continues, that the present programme of visits is maintained and that reports are submitted to Head Office regularly.� It indicates that our staff are not aware of the importance of this work if they are suggesting that the visits should suffice every 3 months.</div>
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�</div>
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�7.� Once again you will have to ensure that there is feed back to our staff on the problems that have been identified in the returns, not least to guarantee that all returns are dispatched as requested.�</div>
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91.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 21 January, Mr Crawford minuted Mr Hutchins regarding hunt kennels and knackeries.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn137" name="_ftnref137" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[137]</span></a>� He stated:</div>
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�You have expressed concern that some animals which may previously have been sent to knackeries are now going to abattoirs.� I should be grateful if Meat Hygiene Section, through RMHAs, would ask meat VOs to be vigilant and report back if they find evidence that there is an increase in unfit animals reaching the abattoirs.�</div>
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92.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 23 January 1991, Mr Hutchins replied to Mr Lawrence�s minute of 18 December 1990 and said that the SVO returns for those two plants alleged to have contravened the SBO regulations showed no evidence of wrong doing.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn138" name="_ftnref138" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[138]</span></a>� Mr Hutchins informed Mr Lawrence that he had written to the relevant RMHA in each case, to draw the allegations to their attention.� However, he suggested that the chances of coming across a problem by chance even at an unannounced visit �are remote�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn139" name="_ftnref139" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[139]</span></a>� The minute was copied to Mr Baker.</div>
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93.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 13 February 1991, Meat Hygiene Division sent out an Animal Health Circular (91/9) to all veterinary staff regarding returns on procedures at rendering plants and collecting centres.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn140" name="_ftnref140" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[140]</span></a> The circular enclosed a copy of a pro forma return on the handling of specified bovine offals at rendering plants and collecting centres. The circular also confirmed that visits should be conducted every two months and that the additional requirements did not alter the general requirement for monthly returns to be made on knackers� yards and hunt kennels.</div>
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94.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 21 February 1991, Mr Hutchins submitted a summary of the returns from rendering plants to Mr Crawford for the period ending in the second week of February.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn141" name="_ftnref141" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[141]</span></a>� The summary stated that there had been very few changes in the returns since those submitted for January.� Awareness of the regulations remained high and separation of SBO was good.� The previously reported problem of leakage from one bay to another was not recorded amongst the latest returns.</div>
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95.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 5 March 1991, Mr Lawrence minuted Mr Crawford, with copies to Mr Meldrum, Mr K Taylor, Mr K Baker, Mr Lowson, Mr D Taylor, Mr Hutchinson, Mr Maslin and Dr Matthews, attaching a note alleging wrongdoing in respect of SBO in certain abattoirs.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn142" name="_ftnref142" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[142]</span></a> Mr Lawrence explained that the problem was that if the reports are followed up by a VO or AHO, either by telephone or by a visit, there would simply be a flat denial. He added that �short of catching them in the act it is a pretty hopeless task�. Mr Lawrence made the following suggestion:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn143" name="_ftnref143" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[143]</span></a></div>
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�I still maintain that in certain cases the completion of the questionnaire may not be enough. I have suggested in the past that a more scientific approach would be to track the movement of raw material from abattoirs right through to the disposal of meat and bonemeal. I know that such an exercise is with difficulties (not least in trying to correlate the weight of the raw material to the finished product � as I am sure Steve Hutchins will remind me!) but the plain fact is that regular visits and the completion of the questionnaire won�t deter abuse. And persistent reports suggest that it is going on�� Is a possible approach to look at the records at rendering plants � perhaps during the PAPO visits or during visits to check on SBOs? At least if the news got round that MAFF were conducting more �in depth� checks it might deter some.�</div>
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96.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Crawford responded to Mr Lawrence on 7 March 1991.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn144" name="_ftnref144" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[144]</span></a>� He stated:</div>
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�I appreciate that confidentiality of the source of the information probably has to be observed but I would like to have a little more information.� It is possible that if we know how this information was obtained it may give us a lead on how to find the evidence.� The processors mentioned are reasonably widely distributed and there must therefore be a question of how one informant gained all of this information.� I would like to discuss this with you in a little more detail.</div>
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Although I agree that it will be difficult to catch these operators in the act, I would like to consider in more depth what action we can take and will take advice from colleagues over the next few days.� I will then agree a line of action with RVOs when they are in Tolworth next week.�</div>
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97.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 5 April 1991, Mr Hutchins produced a summary of returns from slaughterhouses.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn145" name="_ftnref145" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[145]</span></a>� The returns showed that there were two main methods of removing brains from skulls:</div>
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<span lang="EN-US">(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">removal of back or top of skull (without damaging brain); and<o:p></o:p></span></div>
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<span lang="EN-US">(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">splitting of the skull (brain being cut in two)<o:p></o:p></span></div>
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98.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Various methods were used, including saws, axes and cleavers.� One plant was reported to be using an air hose, and one a hydraulic cleaver and vacuum removal system.</div>
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99.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The summary further stated that there was little or no evidence of meat intended for human consumption being exposed to risk of contamination by brain material.� Head meat was generally removed prior to brain removal.� Heads were opened in parts of the premises where no meat for human consumption was present.� In the few cases where this was not the case, the undesirability of the practices was discussed with operators. Furthermore, <span lang="EN-US">in those few plants where contraventions were reported, contact had been made with the relevant local authorities to ensure that compliance would be achieved.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn146" name="_ftnref146" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[146]</span></a></span>�</div>
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100.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span><span lang="EN-US">The summary concluded that the overall picture appeared �quite encouraging. Brain removal does not appear to be causing any significant problems and there is generally a high degree of compliance with the legislation.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn147" name="_ftnref147" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[147]</span></a></span></div>
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101.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span><span lang="EN-US">The appendix to the summary provided the following breakdown of information received:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn148" name="_ftnref148" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[148]</span></a></span></div>
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�1.� Number of slaughterhouses��������������������������������� 570</div>
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�2.� Number of slaughterhouses where brains</div>
<div class="MsoNormal" style="font-size: 12pt; margin: 0cm 0cm 0.0001pt 56.9pt; text-indent: -56.9pt;">
���������� <span style="font-size: 11pt;">removed on site������������������������������������������������� 75 (13%)<o:p></o:p></span></div>
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�3.� Number of slaughterhouses sending intact</div>
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<span style="font-size: 11pt;">���������� skulls to specialist boning plants�������������������������� 256 (45%)<o:p></o:p></span></div>
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�4.� Number of slaughterhouses which sterilise</div>
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����� SBOs on site����������������������������������������������������� 11 (2%)</div>
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�5.� Number of slaughterhouses where</div>
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����� unsterilised SBOs were not stained pre-despatch��� 13 (2%)</div>
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�6.� Number of slaughterhouses where movement</div>
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����� permits were not obtained pre-despatch��������������� 13 (2%)�</div>
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102.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 8 April 1991, Mr Crawford minuted Mr Hutchins regarding the summary of returns from slaughterhouses contained in the minute of 5 April.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn149" name="_ftnref149" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[149]</span></a> Mr Crawford said that he was interested to note the comment about one slaughterhouse having a hydraulic cleaver and vacuum removal system. Mr Crawford requested further information. He also asked that Mr Hutchins follow up cases where unsterilised SBOs were not stained pre-despatch, and where movement permits were not being obtained. He further asked that staff should confirm whether their approaches to local authorities had the effect of correcting the contraventions.</div>
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103.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 15 April 1991, Mr Hutchins wrote letters to various Animal Health Offices noting that deficiencies in �certain aspects of the handling of specified bovine offals at some of the premises� had been reported.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn150" name="_ftnref150" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[150]</span></a>� He asked if the Animal Health Offices could �confirm that the steps taken to inform the local authority and plant management of these deficiencies have had the effect of correcting the contraventions.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn151" name="_ftnref151" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[151]</span></a></div>
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104.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 17 April 1991, Mr Crawford wrote to all territorial RVOs (England, Scotland and Wales) regarding the survey of compliance with the SBO regulations in slaughterhouses.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn152" name="_ftnref152" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[152]</span></a> Mr Crawford stated that the second and fuller return from slaughterhouses had now been reviewed, and that there were still a significant number of premises where the regulations were not being observed, �to a greater or lesser extent�. Mr Hutchins had asked those DVOs, in whose divisions the irregularities were recorded, to follow up with local authorities and report on the outcome of their action. Mr Crawford went on to say:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn153" name="_ftnref153" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[153]</span></a></div>
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��in view of the deficiencies noted, I feel that we can not let the matter drop without further action. To do so would be open to criticism. I would therefore ask RVOs to request their DVOs to organise a further round of visits, to all abattoirs which handle bovines, and to report on how the specified offals are being handled. The returns should be sent to Steve Hutchins, in the previously agreed format, <u>to arrive not later then the end of May</u>.�</div>
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105.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 24 April 1991, Mr Hutchins minuted Mr Crawford with a summary of returns from knackers� yards and hunt kennels. The position in respect of charges had not altered. The number of carcases being submitted to knackers continued to fall. The trend for hunt kennels to act as knackeries was less of a feature then in earlier reports. Dumping of carcases outside knackeries and hunt kennels remained a relatively frequently reported problem. The number of reports referring to carcases being left unburied on farms or at road sites had increased sharply in some areas. Compliance with the requirements of the Meat (Sterilisation and Staining) Regulations 1982 was recorded as being generally satisfactory. Occasional problems with the disposal of unsterilised waste were noted and were promptly taken up with operators and local authorities.</div>
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106.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In May DVOs began collecting information for the second survey of SBO controls in slaughterhouses. DVO, Trowbridge, A G McFarlane, reported to DRVO, Bristol, Mr Kirkham, that he had encountered resistance from an EHO:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn154" name="_ftnref154" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[154]</span></a></div>
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�At a recent very tight-lipped exchange about other matters with North Wilts Environmental Health Officer, Mr Bob Barrett, I was advised that as the [SBO] Regulations are made under the Food Act 1984 they are enforced by the District Authority and the Ministry of Agriculture have no statutory responsibility for observation or enforcement.�� I was asked why the State Veterinary Service felt they had to make approach to the slaughterhouses to review compliance rather than making direct contact with Environmental Health Officers concerned to obtain the information�.</div>
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107.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In his summary of 7 May 1991 of the returns from rendering plants and collection centres, Mr Hutchins noted that the quality of information had improved since the introduction of proformas.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn155" name="_ftnref155" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[155]</span></a>� Awareness of the legislation remained high.� Identification of SBO material was generally achieved by the use of separate bins but the staining of SBOs at abattoirs was also used as a means of identification.� Separation of SBO material was generally good, but the possibility of leakage across bays was noted.� In one plant, it was noted that the same tractor bucket was being used for SBO and non-SBO material.� Considerable variation was noted in the processing techniques being used to render the SBO.� The summary was sent to Mr Crawford and was copied to Mr Meldrum, Mrs Attridge, Mr Lowson and others.</div>
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<span lang="EN-US">108.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span>Mr Hutchins� summary went on to report that in plants where both SBOs and other offals were handled, cleaning procedures varied widely.� In some, careful consideration was given to the issue of cross-contamination; in others the issue did not appear to have been addressed at all. Various cleaning procedures identified included the following:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn156" name="_ftnref156" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[156]</span></a><span lang="EN-US"><o:p></o:p></span></div>
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<span lang="EN-US">(i)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">no cleaning;<o:p></o:p></span></div>
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<span lang="EN-US">(ii)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">physical sweeping or raking<o:p></o:p></span></div>
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<span lang="EN-US">(iii)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">steam cleaning and/or disinfection; and<o:p></o:p></span></div>
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<span lang="EN-US">(iv)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">treating the next load after an SBO load was also treated as being of SBO status.<o:p></o:p></span></div>
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109.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The summary described the uses of tallow which included edible tallow, animal feed, technical grade tallow, soap, poultry feed, fuel and sale to brokers.� There was little evidence that tallow from SBO was being treated differently from non-SBO tallow.</div>
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110.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The returns from collection centres indicated that awareness of the regulations was good.� Identification and separation was reported as being �generally satisfactory�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn157" name="_ftnref157" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[157]</span></a>� Occasional incidents were reported of indirect contact between SBOs and other offals, and advice was reported to have been given in these instances.</div>
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111.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In June 1991 MAFF and DH published a joint report entitled �Review of Fresh Meat Hygiene Enforcement in Great Britain.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn158" name="_ftnref158" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[158]</span></a> The report concerned a study and analysis of alternative management and enforcement structures in the area of meat hygiene. Under the sub-heading �Standards and motivation for improvements in plants� the report states:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn159" name="_ftnref159" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[159]</span></a></div>
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�SVS monitoring shows that there is room for improvement in standards, particularly in domestic plants, in Great Britain.�</div>
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112.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span><span lang="EN-US">On 3 June 1991, Mr Hutchins wrote to Mr Crawford reporting that further inquiries had been made and �it is now stated that no SBO-derived tallow is used in the preparation of human foodstuffs (apparently an error in the original report)�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn160" name="_ftnref160" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[160]</span></a>� Mr Hutchins went on to say that it did appear that SBO derived tallow was being used in animal feeds in some instances.</span></div>
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113.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The next summary of returns from abattoirs was produced on 19 June 1991 in a minute from Mr Hutchins to Mr Crawford.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn161" name="_ftnref161" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[161]</span></a>� The survey covered 581 slaughterhouses.� Mr Hutchins reported a slight decrease in the number of plants sending heads to specialist boning plants.� Concern about the possibility of contamination of meat for human consumption due to the method of brain removal was reported in only 6 plants.� It was said that this had been taken up with operators and local authorities.� 12 abattoirs were reported to be sterilising SBO on site.� In the remainder, 18 plants were identified as failing to stain SBO.� 13 sites were failing to obtain local authority movement permits for the removal of SBO. The summary identified that a variety of methods were being used to remove brains from skulls at slaughterhouses.� It was noted that where such methods gave rise to concerns about the risk of contamination of meat, the �undesirability� of those practices had been discussed with local authorities and slaughterhouse operators.�</div>
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114.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 24 June 1991 Mr Hutchins wrote to Mr Keir (VO at Carlisle Animal Health Office) regarding the failure of the Carlisle Animal Health Office to take action in relation to compliance problems identified in a Carlisle slaughterhouse.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn162" name="_ftnref162" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[162]</span></a></div>
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115.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 25 June 1991, Mr Meldrum minuted Mr Hutchins to ask when the amendments to the SBO regulations were coming into effect to ensure that head meat was removed before removal of the brain.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn163" name="_ftnref163" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[163]</span></a>� Mr Meldrum expressed concern about information he had received from �other sources� to the effect that little of the SBOs were being stained in slaughterhouses and asked that further advice be issued to local authorities through DVOs.�</div>
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116.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the same day (25 June 1991) Mr Hutchins minuted Mr Crawford about the handling of specified offals at rendering plants and collection centres.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn164" name="_ftnref164" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[164]</span></a>The report recorded that awareness of BSE legislation remained high, with operators reported to be fully aware of their legal responsibilities. Identification of specified bovine offals was achieved by the use of separate marked bins and containers in most cases. The summary recorded that the staining of SBOs at abattoirs was also used as a means of identification. Separation of specified offals was reported to be generally good, with clear separation being maintained between SBOs and other offals. However, in two premises the possibility was noted of indirect contact via tractor bucket used for both SBOs and other offals. It was recorded that in plants where both SBOs and other offals were handled, 11 used common preheating equipment and nine used common rendering equipment. The cleaning procedures which had been described varied widely from none, through physical sweeping or raking, to steam cleaning and/or disinfection. In a few cases, the next load through the system was also treated as being SBO status and was used to clean out the equipment. In respect of the use of tallow from SBOs, there had been no further development, and although SBO was not reported as being used in human food production, some was used for animal feeds. Fifteen collection centres had been identified, although it was recognised that this may well have represented an underestimate as it appeared likely that the smaller, non-dedicated premises, such as knackers� yards, had not been included under this heading.</div>
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117.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The summary of 25 June 1991 of returns from SVS visits to knackeries and hunt kennels reflected a similar situation as described in the report of 24 April 1991.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn165" name="_ftnref165" title=""><sup>[165]</sup></a>� Compliance with the Meat (Sterilisation and Staining) Regulations 1982 continued to be described as �satisfactory� at knackers� yards.� However, at hunt kennels the situation was �less satisfactory� with the same criticisms emerged as set out in the 24 April report.� The 25 June summary recorded that there had been no further developments on tallow and that some SBO derived tallow continued to be used in animal feed.</div>
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118.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 11 July 1991, Mr Crawford minuted Mr Hutchins regarding recent discussions he had had with Mr Meldrum.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn166" name="_ftnref166" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[166]</span></a> Mr Crawford reported that Mr Meldrum had received �information from a �reliable� source within the rendering industry� that significant quantities of SBOs were not being treated in accordance with the regulations. Mr Crawford asked Mr Hutchins to prepare a draft circular letter to DVOs, with copies to RVOs and RMHAs, asking them to discuss the regulations with their local authorities and to ensure that their staff made the occasional unannounced visit to abattoirs to view the handling of the SBOs.</div>
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119.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Animal Health Circular (�AHC�) 91/61 was circulated on 12 August 1991 to all DVOs in England, Wales and Scotland instructing them to arrange for occasional unannounced visits to be made to slaughterhouses to ensure compliance with the SBO regulations, with follow-up visits where problems were identified.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn167" name="_ftnref167" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[167]</span></a>� In addition, DVOs were instructed to remind local authorities with red meat slaughterhouses in their districts of the need for their staff to ensure that the regulations were being fully observed.� The AHC was also copied to all DRVOs, VOs (Meat Hygiene) and SVOs (RMHA). It stated:</div>
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�Although routine reports from Divisions indicate that the handling of specified bovine offals in slaughterhouses is satisfactory, information has been received in Headquarters from sections of the Industry that there are significant shortfalls in compliance with the Regulations.� It has been suggested that conditions seen during announced visits may not reflect the day to day situation.� In view of the widespread interest in the controls over specified bovine offals, it is essential that the Regulations are seen to be enforced evenly and effectively across the country�..Arrangements should therefore be made for occasional unannounced visits to abattoirs to ensure compliance with the Regulations..�Any deficiencies ... must be notified in writing to the Local Authority�.�</div>
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120.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 21 August 1991, a consultation letter was issued to organisations and interested parties regarding to proposed amendments to the SBO Regulations.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn168" name="_ftnref168" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[168]</span></a>� The letter explained that the proposed amendments were intended to give legislative force to the guidance, issued in June 1990, that meat for human consumption should be recovered from the intact skull before removal of the brain.� As an additional precaution, the proposed regulations required that, where the brain was being removed in an abattoir or specialist boning plant, this must take place in an area which is free from any material intended for human consumption.� The new regulations would also allow the movement, under permit, of intact bovine heads, once stained, to processors� premises.�</div>
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121.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 23 August 1991, Mr Simmons (who had succeeded Mr Hutchins as SVO in the Meat Hygiene Veterinary Section with responsibility for red meat premises) minuted Mr Crawford with a summary of returns from knackers� yards and hunt kennels for the period ending in the second week of August 1991.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn169" name="_ftnref169" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[169]</span></a> In respect of charges, no significant change was noted from the previous months other than one report from a Gloucester DVO that SBO loads from small through-put premises were being charged at up to �200 per tonne. The figures provided for through-put showed that there had been a decrease compared with the previous month in the figures for all categories including cattle, sheep and goats, pigs and horses. In respect of compliance with the Meat (Sterilisation and Staining) Regulations 1992, reports from most divisions were satisfactory. Where this was not the case staff were liasing with local authority officials to effect a remedy. Some hunt kennels were purchasing raw carcase meat from knackers in contravention of Regulation 12 of the 1990 Regulations; this had been brought to the attention of the relevant local authorities. Reports also indicated a marked reduction in the dumping of fallen stock.</div>
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122.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 2 September 1991, Mr Simmons minuted Mr Crawford with the summary of returns from rendering plants and collection centres for the period ending in the second week of August 1991.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn170" name="_ftnref170" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[170]</span></a> The report repeated the previous months statement that awareness of BSE legislation remained high in respect of the identification and separation of specified offals. Cleaning procedures continued to vary widely from none, through physical sweeping or raking, to steam cleaning and/or disinfection. Reports on the use of tallow made no mention of their use in animal feedstuffs which had been mentioned in previous reports. Fourteen collection centres had been identified, although, as with previous reports, it was stated that this figure may well have represented an underestimate of the total number of centres being used for collection purposes.</div>
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123.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 3 September 1991, Mr Meldrum sent a minute to Mr Crawford.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn171" name="_ftnref171" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[171]</span></a> He expressed concern about plants where both SBOs and normal offals were being rendered. In particular, he was concerned that in some situations there would be no purging of the system carried out between runs. Mr Meldrum requested that the relevant information be reviewed by Mr Simmons and that draft procedures be prepared for his consideration for the purpose of ensuring that there was no cross-contamination in the processing plants.</div>
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124.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 16 October 1991, Mr Simmons minuted Mr Crawford with the results of his review of methods used to prevent cross-contamination between SBO and other material at rendering plants.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn172" name="_ftnref172" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[172]</span></a> Mr Simmons stated:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn173" name="_ftnref173" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[173]</span></a></div>
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�There is potential for cross-contamination at all stages of the process described�but the risk appears greatest when common equipment is used to prepare the material prior to cooking. Machinery such as macerators and augers have a large number of moving parts and as a consequence they are difficult to clean. In general, attempts are made to clean the equipment before it is used for non SBO material but no plants are reported to dismantle equipment between batches. However, this type of machinery, particularly augers, is prone to �dead spots� in which material accumulates; this can only be removed if it is dismantled prior to thorough cleaning.</div>
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�</div>
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It is clear that the procedures are not wholly effective in preventing cross-contamination. The amount of infectious agent, if any, reaching susceptible animals through contamination of animal protein feed with SBO will be very small. However, it is important to avoid complacency; the risk may be impossible to quantify but that does not justify abandoning attempts to reduce it. Nevertheless, it is important that the risk is kept in perspective.�</div>
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125.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Simmons argued against the introduction of legislative controls to ensure separation between SBO and other material of rendering plants and favoured the issue of a code of practice to the rendering industry, including advice on methods and practices to reduce the risk of animal protein being contaminated with SBO.</div>
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126.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 12 November 1991, Mr Simmons minuted Mr Crawford with a summary of returns from knackers� yards and hunt kennels.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn174" name="_ftnref174" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[174]</span></a>� The situation was largely unchanged from the previous month.� However, Mr Simmons stated that one or two local authorities seemed reluctant to devote any effort to resolving consistent non compliance.� This point was picked up by Mr Meldrum in a minute of 14 November 1991 to Mr Crawford, in which he asked for the position to be rectified through the appropriate RVO.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn175" name="_ftnref175" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[175]</span></a></div>
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127.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 4 December 1991, Mr Simmons minuted Mr Crawford with a summary of returns from knackers� yards and hunt kennels.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn176" name="_ftnref176" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[176]</span></a> With regard to through-put, the figures showed a sustained fall in through-put in Scotland. However, the figures also indicated an increase in through-put of adult cattle and calf carcases in England and Wales. No significant changes were reported in charges for the collection of carcases. In respect of disposal and dumping of fallen stock, a slight increase in number of sheep carcases left unburied was reported. There were also reports of increasing use of burial pits; scepticism was expressed as to whether they were correctly sited. The licensing and cost of incinerator installation meant that plans were being shelved in many cases. Mr Simmons noted that �despite these adverse comments the tone of reports suggests that the majority of farmers are experiencing little problem with the disposal of fallen stock�. In contrast with the previous return on slaughterhouses of 19 June 1991, the 4 December 1991 report did not address the issue of proper separation and staining of waste and SBO material respectively.</div>
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128.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>A summary of results of MAFF monitoring of red meat and poultry meat premises in 1990/91 showed that of the 89 red meat premises visited, only 37 had satisfactory hygiene.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn177" name="_ftnref177" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[177]</span></a>� The table of results compared the figures with those for 1989-90 when 78 plants were visited and 57 had satisfactory hygiene standards; and in 1988-89 96 plants were visited and 60 had satisfactory hygiene standards.� A foot note to the entry on red meat premises stated:</div>
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�Method of assessing domestic plants has increasingly taken account of impending single market requirements.� The % drop in satisfactory domestic plants reflects, to a certain extent, this change to a stricter assessment.� The sharp drop in standards in 1990-91 may also be due to lack of commitment by plants who think that they will not continue in business after 1992.� However, the standard in domestic plants has consistently been lower overall.�</div>
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<i>CLARIFICATION:� The document from which this is quoted is an annex to a larger document.� However, the Inquiry has been unable to locate this larger document.� It is also unclear in what circumstances the document was produced.<o:p></o:p></i></div>
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<a href="https://www.blogger.com/null" name="_Toc456173194">Events in 1992</a></div>
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129.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 3 January 1992, Mr Metcalfe of Fats and Proteins (UK) Limited, a rendering company, wrote to Mr Sadler of UKRA regarding MAFF�s draft code of practice on the handling of SBOs.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn178" name="_ftnref178" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[178]</span></a> Mr Metcalfe made the following remarks:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn179" name="_ftnref179" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[179]</span></a></div>
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�How we as renderers can be expected to monitor both unstained and often very poorly segregated material defies me. We are expected to be able to judge every set of tonsils or intestines, etc are from an animal of 5 or 7 months of age and then take the appropriate action. We provide well identifiable containers and still the abattoirs can get the material mixed up.</div>
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The whole question of SBOs must also bring into question the actual meat that we eat. We know the extreme difficulty in removing totally the spinal cord. the juices of which does contaminate the carcase while being split. The removal of other organs is equally difficult to achieve 100% effectively and assured �best effort� is accepted by the enforcing bodies. If there is an element of risk from unsuspected animals, the practical way is to segregate the brain and for this to be disposed of and the responsibility to be the local authority or the relevant regulatory bodies under supervision of the meat inspector to ensure the brain is indeed handled correctly and disposed of via the nearest incinerator or supervised method.</div>
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I in no way wish to bring the above back into the public domain but the whole exercise on <u>non suspected</u> [sic] animals would appear to me to have been none other than a systematic exercise to appease the public. I feel it is now high time after three years to get the whole issue put straight in light of the evidence to date which I am satisfied in my opinion would be well accepted and save costs, also ensure maximise safety.�</div>
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<i>Clarification: the copy of the letter reproduced in the Inquiry�s yearbooks is not entirely legible.<o:p></o:p></i></div>
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130.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 9 January 1992, Mr Sadler wrote to Mr Meldrum attaching a copy of the letter that he had received from Mr Metcalfe.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn180" name="_ftnref180" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[180]</span></a> Mr Sadler asked Mr Meldrum to prepare his own comments in response to the points in Mr Metcalfe�s letter and to provide these to UKRA in writing prior to their forthcoming Technical Committee meeting on 30 January 1992.</div>
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131.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 13 January 1992 Mr Simmons reported on returns from knackers and hunt kennels. The report stated that a diminishing number of reports of non compliance were received every month in respect of the Meat (Sterilisation and Staining) Regulations.� In the main, these were resolved after reminders to the local authorities.� SVS staff in association with local authorities were actively engaged in resolving the few outstanding problems.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn181" name="_ftnref181" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[181]</span></a></div>
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132.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 27 January 1992 Mr Meldrum responded to Mr Sadler and briefly explained the background to the introduction of the SBO ban and the basis for the tissues included in the ban<span style="font-size: 13pt;">.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn182" name="_ftnref182" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[182]</span></a></span></div>
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133.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 2 March 1992, Mr Maslin wrote to Mr Sadler of UKRA regarding the code of practice produced by MAFF on the handling of SBO in rendering plants.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn183" name="_ftnref183" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[183]</span></a> Mr Maslin enclosed an amended code of practice which contained some minor changes to the version provided by Mr Saddler under cover of his letter of 12 February.� Mr Maslin explained that the Department would not be considering codes for other sectors �at the moment� but that this did not �mean that the legislation on SBO is being less strictly applied�.</div>
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134.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 5 March 1992, Mr Simmons minuted Mr Crawford with the summary of returns from knackers� yards and hunt kennels.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn184" name="_ftnref184" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[184]</span></a> Mr Simmons concluded that there was little of significance to report other than a slight increase in carcase dumping and a continuing reduction in the costs of collection of �other wastes�. In respect of the Meat (Sterilisation and Staining) Regulations 1982 no significant problems had been reported. Mr Simmons explained that, as in previous reports where deficiencies were identified, these were brought to the attention of the local authority.</div>
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135.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 12 March 1992 the Bovine Offal (Prohibition) (Amendment) Regulations 1992 came into effect, amending the SBO Regulations and banning the use of head meat after opening of the skull and requiring removal of the brain only in areas free at all times from any food intended for human consumption.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn185" name="_ftnref185" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[185]</span></a></div>
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136.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 10 April 1992, Mr Simmons reported on returns from SVS visits to renderers, noting that:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn186" name="_ftnref186" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[186]</span></a><o:p></o:p></div>
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�the situation remains relatively unchanged from previous summary reports.� Handling and processing appears to be carried out responsibly and separation of SBO from other material is satisfactory.� However, as pointed out in the review procedures vary considerably from plant to plant.� The code of practice on the handling of specified bovine offal at rendering plants, recently agreed by the UKRA, should clarify our policy with respect to the separation of the material in these plants, and should, where appropriate, facilitate exports of meat and bone meal where this is processed at the same plant.�</div>
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137.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The Code of Practice for the Handling of Specified Bovine Offals (SBO) at Rendering Plants was issued by MAFF in July 1992.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn187" name="_ftnref187" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[187]</span></a>� The Code stated that:</div>
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��renderers have a responsibility to ensure that their procedures for transportation, storage, handling and processing of SBO are correctly undertaken and thus minimise the risk of possible co-minglement with their other productions of animal proteins, particularly where both categories of material are processed on the same site�The purpose of this �Code of Practice� is therefore both to provide guidance and also set out acceptable methods that will best minimise any risk�.</div>
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138.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The Code advised that the best method of avoiding comminglement was by use of separate facilities for the processing of SBO material.� However, it was recognised that this would not be possible in many cases and advised the following specific measures:</div>
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(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>dedicated, easy to clean and clearly marked storage facilities for SBO should be used.� Where this was not possible, facilities needed to be thoroughly cleaned before being used for non-SBO material;</div>
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(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>during storage SBO must not be allowed to come into contact with any other materials.� Overfilling of SBO containers should be avoided;</div>
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(iii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>preferably, separate tools and mechanical equipment should be used for handling and processing SBO and the processed SBO;</div>
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(iv.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>equipment used solely for SBO should be clearly marked.� Where separate equipment could not be provided items should be thoroughly cleansed before use with other materials;</div>
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(v.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>in respect of cooking equipment, where separate facilities were not available equipment should be cleansed to remove all traces of SBO (this would involve dismantling the equipment) or purging it� twice with sufficient material to remove the traces of SBO.� All material used during the purging of the machines should then be treated as SBO; and</div>
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(vi.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>processed SBO should be stored in dedicated separate, leak-proof, easily cleanable facilities.</div>
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139.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In his statement to the BSE Inquiry, Mr Fleetwood commented as follows on the Code of Practice for renderers processing SBO material:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn188" name="_ftnref188" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[188]</span></a></div>
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�There was a code of voluntary practice in place in the industry about reducing possibilities for cross contamination in rendering plants. However, I knew from my experience with cross contamination in feed mills and rendering processes in relation to salmonella that, without dedicated plants, it was almost impossible to eliminate cross contamination risk.</div>
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Feed mills and rendering plants are complex plants handling material in multiple tonne quantities. They use automated equipment (such as screw conveyors and blow lines). It is very difficult, if not impossible, to remove all traces of previous material conveyed through the plant.�</div>
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140.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In oral evidence, Mr Fleetwood stated:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn189" name="_ftnref189" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[189]</span></a></div>
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�MR FLEETWOOD: At the time the code was written in 1991 they [the provisions of the Code of Practice] probably were sensible and practical, because you must remember that there was also a ruminant feed ban in place.� So this was a second tier of defence, the primary defence still being the ruminant protein ban.</div>
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MR MATOVU:� When the studies emerged showing that 1 gramme or perhaps even less of material was sufficient to transmit infection, do you think that this purging system would have been a sufficient �</div>
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MR FLEETWOOD:� No.� That is one of the bases, or one of the reasons for the decision being taken to require dedicated lines.�</div>
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141.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 30 July 1992, Mr Simmons minuted Mr Crawford regarding the handling of animal waste at knackers� yards and hunt kennels.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn190" name="_ftnref190" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[190]</span></a> In general, Mr Simmons stated that reports indicated a relatively unchanging picture but it was clear that the lot of the knacker had improved gradually over the past few months, partly because of the acceptance of charging and the reduction in the costs of waste disposal. There had been no reports of closures since January 1992. However, several reports indicated dismay at the costs of registration under the Environmental Protection Act 1990. In respect of compliance with the Meat (Sterilisation & Staining) Regulations 1982, again no significant problems were reported. In respect of the dumping of fallen stock, the summary reflected that �a few reports of the dumping of sheep and calf carcases were received but none were considered of particular significance�.</div>
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142.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 7 August 1992, MAFF distributed an Animal Health Circular 92/94 to DVOs for action and other veterinary and technical staff for information.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn191" name="_ftnref191" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[191]</span></a>� The Circular noted that MAFF had received reports from industry contacts alleging that in some instances SBO was not being kept separate from other material and as a result some meal derived from SBO was being incorporated into animal feed.� The Circular described changes to the controls on SBO which were to be introduced with immediate effect to ensure that protein derived from SBO did not enter the animal feed chain. The changes included extension of the movement licences for SBOs so as to provide similar information for the movement of SBOs from slaughterhouses and knackers� yards to renderers as was already provided in respect of the movement of SBO material from renderers to disposal. At rendering plants, checks were to be carried out �from time to time� to compare the weight of SBO raw material input and protein yield. The circular recorded that experts in the rendering industry estimated that the protein yield would be about 25% of the original weight. The circular also enclosed the revised code of practice for renderers on the handling of specified bovine offal.� DVOs were asked to distribute the code of practice to all rendering plants in their Division and during regular visits to plants ensure that the code was fully understood and applied by plant management and staff.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn192" name="_ftnref192" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[192]</span></a></div>
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143.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 2 October 1992, Judith Nelson of UKASTA sent a fax to Dr Cooke of Dalgety Agriculture Ltd attaching a note prepared from comments made at a recent meeting of UKASTA�s Scientific Committee.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn193" name="_ftnref193" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[193]</span></a>� The note was sent in preparation for a further meeting with MAFF officials to take place on 10 November and set out a number of hypotheses to explain the emergence of BSE in suspects born after 18 July 1988 (BABs).� In respect of cross-contamination, the note stated:</div>
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�It was noted that the MAFF were not concerned about cross contamination of feedingstuffs in mills because the dose rate of meat and bonemeal would be too low.�</div>
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<span lang="EN-US">144.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">A review of </span>hygienic<span lang="EN-US"> standards in slaughterhouses was established on 28 October 1992 by the Minister of Agriculture, Fisheries and Food.� The Review was to be carried out by Dr A M Johnston and Mr B J Spurr.� Its terms of reference were:<o:p></o:p></span></div>
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��to carry out an independent assessment of hygiene standards in a small sample of slaughterhouses which have applied for temporary derogations; to identify the extent to which structural deficiencies are contributing to hygiene problems and to assess whether the improvements required in the proposed work plan go beyond what is necessary to rectify the structure-related hygiene problems.� Two plants were selected from each of the five MAFF regions in England and from Scotland and Wales (a total of 14 plants).�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn194" name="_ftnref194" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[194]</span></a></div>
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145.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 28 October 1992, Mr Gummer appeared before the House of Commons Agriculture Committee to discuss progress on the British Presidency of the EU and other matters.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn195" name="_ftnref195" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[195]</span></a> In response to worries expressed by the Committee that the European Regulations to be imposed on slaughterhouses were excessively burdensome, Mr Gummer stated<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn196" name="_ftnref196" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[196]</span></a>:</div>
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�we have real problems with our slaughterhouses�I have decided to give an example or two of recent inspections�On Slaughter house A) it was reported: �Slaughter hall floor heavily soiled with blood, gut contents and other debris � no attempt to clean up between carcases. Car cleaning brush heavily contaminated with blood and fat being used to wash carcases. Knives and utensils not being sterilised. Offal rack and carcase rails encrusted with dirt. Window missing panes in roof � birds, flies and vermin entering.� Another slaughterhouse report: �Filthy equipment and surfaces � congealed and dry blood on offal racks. Effluent discharging across floor under dressed carcases � risk of contamination. Slaughtermen at cattle sticking point not sterilising knife. No sterilisers or washbasins in pig slaughterhall. No fly screening on open windows.�</div>
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146.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Gummer went on to explain his commitment to the introduction of the regulations as follows:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn197" name="_ftnref197" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[197]</span></a></div>
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�I say this to the Committee because I am as unbelievably enthusiastic about not having regulations if you do not need them but the truth is, and I discovered much of this when I had to face the BSE issue I needed to be able to stand up in front of the public and say when we suggest certain things that they do happen, they have to happen, in slaughterhouses. Those examples have been put right and our inspections get them put right. I cannot derogate from the general standards of the European Committee Rules because they are necessary to enable the public to have confidence.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn198" name="_ftnref198" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[198]</span></a></div>
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147.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 30 November 1992, the Prime Minister sent a letter to Mr Gummer stating.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn199" name="_ftnref199" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[199]</span></a></div>
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�As I said in my Party Conference speech I am absolutely determined to reduce the burden of regulation on business.� The regulatory burden we are imposing on business frustrates enterprise, innovation and growth. Regulations result in lost jobs, reduced international competitiveness and higher public expenditure.� We must change all this�. We � need to look at the new rules on meat hygiene which have caused alarm to local business, including butchers and village shops selling meat.� Do we go too far in bowing to EC pressure on such things?.. it is essential that all Departments put time and energy into developing their deregulation programmes now.� I am determined that we should have made major progress by the next Party Conference.�</div>
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148.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 2 December 1992, Mr Gummer produced a written answer to a question on slaughterhouses from Mr Nicholson MP.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn200" name="_ftnref200" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[200]</span></a> Mr Gummer broadly welcomed the EC Fresh Meat Directive before stating:</div>
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�My Department has this week issued further guidance to local authorities on the provision of veterinary supervision at slaughterhouses. This guidance, which has been placed in the Library, should reduce the estimated cost of the inspection service substantially at some plants. My Department believes that the cost to the industry as a whole should be reduced by some �2 million, compared with estimates made by independent consultants on behalf of MAFF earlier this year.</div>
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Local authorities have considerable flexibility to arrange provision of the inspection service in the way which is most appropriate to their local circumstances subject to the overriding need to achieve adequate veterinary supervision. Pending transfer for responsibility for meat inspection to the proposed National Meat Hygiene Service I shall monitor inspection charges very closely, and will continue to encourage plant operators to discuss with their local authority any possible options for reducing costs.�</div>
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149.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span><span lang="EN-US">On 9 December 1992, MAFF provided an Animal Health Circular (92/147) to all veterinary staff regarding the handling of animal waste at knackers� yards and hunt kennels.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn201" name="_ftnref201" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[201]</span></a> The circular confirmed that the frequency of visits and returns for knackers and hunt kennels had been reduced from monthly to every two months with effect from 1 January 1993. It also stated that visits could be carried out by Animal Health Officers.</span></div>
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150.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 16 December 1992 Mr Simmons reported on the handling of specified bovine offals at rendering plants and collection centres.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn202" name="_ftnref202" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[202]</span></a> Mr Simmons recorded his concern that MAFF Headquarters was not gaining a complete picture of SBO disposal. The returns from which the summaries were generated were based on Animal Health Circular 91/9 but there had been several changes in legislation and policy.� Mr Simmons proposed that new instructions should be issued to the field in the form of an AHC, calling for two monthly returns, covering the handling of SBO in the slaughterhouse through to the licensed disposal of SBO derived protein (�from cradle to grave�).� This would enable the ultimate destination of SBO derived protein to be determined.</div>
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151.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Simmons went on to say:</div>
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�In my opinion, such an instruction would not add to the workload of field staff as the information is already available from routine visits made for the purposes of AHC91/9 (every two months), sampling under the Protein Animal Protein Order (20 days sampling/year) or slaughterhouse visits (it is proposed to visit at least quarterly from 1 January 1993).� In any case, field staff are under instruction to check on SBO handling whilst making unannounced visits to slaughterhouses (AHC91/61) and to issue licenses under Article 9 of the BSE order 1991 (AHC92/94).�</div>
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<a href="https://www.blogger.com/null" name="_Toc456173195">Events in 1993</a></div>
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152.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 18 January 1993, MAFF distributed an Animal Health Circular 93/6 to RVOs, DRVOs, RMHAs and VOs (meat hygiene) in England and Wales for action and to all other Field Veterinary Staff in England, Wales and Scotland for information.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn203" name="_ftnref203" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[203]</span></a>� The Circular discussed the frequency of visits to licensed red meat and poultry slaughterhouses, cutting plants and cold stores, farmed game handling and processing facilities and meat product plants approved by the Agriculture Departments for export to third countries. Full throughput licensed slaughterhouses were to be visited at least once every three months; low throughput slaughterhouses were to be visited at least once a year; and unannounced visits were to be made if considered necessary.� The Circular also commented on the increasing types of slaughterhouses which were to receive visits (namely extending to poultry slaughterhouses).</div>
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<span lang="EN-US">153.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">In March </span>1993<span lang="EN-US"> Dr A M Johnston and Mr B J Spurr produced their report entitled �Review of Hygiene and Structural Requirements in a sample of Slaughterhouses which have applied for Temporary Derogations under the Fresh Meat (Hygiene and Inspection) Regulations�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn204" name="_ftnref204" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[204]</span></a>� The review had been established on 28 October 1992 by the MAFF Minister (see above).� The findings were summarised as follows:<o:p></o:p></span></div>
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�The plants we reviewed represented, as expected, a range in hygiene and structural standards.� There was considerable variability in the attitude and commitment of individual operators to improve standards.</div>
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�Overall we are of the opinion that the requirements being imposed by the State Veterinary Service do not go beyond those necessary to rectify structure-related hygiene problems, and that there is still a considerable way to go before many of these premises will be acceptable for licensing.</div>
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We found considerable confusion existed within the industry on many points. There was total apathy from some operators who still do not believe that the single standard (even in hygiene) will ever be achieved. It is clear that in many cases the State Veterinary Service/Meat Hygiene Division made, and is still making, every effort to assist plant owners and operators.</div>
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Unfortunately we also found instances where, in our opinion, the actions and advice given by the State Veterinary Service officer fell short of the same quality. A combination of these factors did appear to cloud the key issues relevant to hygienic slaughter, which was further compounded by misinformation circulating within the trade.</div>
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While the plants are operating under the three-month extension there is little, if any, evidence of any work in hand or planning at a sufficiently advanced stage to be able to agree their work plan for derogation prior to 18<sup>th</sup> April 1993. We urge the State Veterinary Service to make every effort to obtain the cooperation of individual operators to overcome that problem.</div>
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However, there was considerable variability in the way in which State Veterinary Service officials had processed applications and discussed with operators the improvements which should be undertaken. This appears to have contributed to the extent to which structural and hygiene problems have been allowed to persist. We will deal with each of these main headings separately.</div>
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<span lang="EN-US">154.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">In respect of the role of the State Veterinary Service, the report said:<o:p></o:p></span></div>
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We found wide variation in the approach which had been adopted by Veterinary Officers in discussing the future work plan requirements with individual operators. We have been told of instances where State Veterinary Service staff have used their own time, in excess of the normal working day, to assist in the development of a hygienic slaughter operation.</div>
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There had been instances of poor communication between State Veterinary Services and operators. Differences in approach included, for example, the level of written comment and confirmation of requirements between individual officers, and where the responsibility for producing work plans lay. In some cases, we found a greater emphasis on structural requirements and variation in interpretation of points of detail, when, in our opinion, there was a more pressing need to tackle basic hygiene problems.</div>
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Also of concern was the variation in the ability of individual operators and veterinary officers to discuss and resolve problems. This has been aggravated by variation in the approach taken by the State Veterinary Service officials to points of detail, which should be resolved before the licensing exercise is completed.</div>
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We are convinced that State Veterinary Service officers were not consistent and in some cases, firm enough in their requirements to plant owners and operators. We consider a very firm line should have been taken with all plants. Some plants should have been closed on 31<sup>st</sup> December 1992 as they fell far short of even the existing legislation.</div>
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We were surprised that a greater emphasis had not been placed on a fundamental hygiene requirement, for example, the need for stainless steel or food grade material hooks throughout the UK. We accept, however, that in many of the plants there were important issues in need of more urgent attention.</div>
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We note the action taken by MAFF to address these points and improve consistency.</div>
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<span lang="EN-US">155.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">In </span>respect<span lang="EN-US"> of the role of the Official Veterinary Surgeon the report said:<o:p></o:p></span></div>
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1.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span> <o:p></o:p></div>
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While not within our original remit, in all our visits the subject of provision, or in some cases the non-provision, of the Official Veterinary Surgeon service was raised.</div>
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We were very concerned to find little evidence, in most cases, of any attempt to provide an integrated meat inspector/veterinary service or to relate hours of attendance by Official Veterinary Surgeons to throughput and standard of hygiene or on an assessment of risk. In many cases, the Local Authority appeared disinterested and, in one case, most unhelpful in getting the veterinary service off to a reasonable start. These problems do not appear to exist in Scotland.</div>
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We see a real need for an integrated meat inspection/veterinary service to enforce the new Meat Hygiene Regulations. We are encouraged by the decision that the National Meat Hygiene Service will be established in 1995 and see this going a long way to improving matters. There is the potential for a real improvement. We see scope for the Meat Hygiene Headquarters and State Veterinary Service to take a stronger lead in managing the transition and encouraging better integration of the Official Veterinary Surgeon/Meat Inspector role in the hygienic operation of the plant in the interim. We suggest this could be done by bringing all relevant parties together at Regional or Divisional meetings where advice should be given on even application of hygiene and enforcement standards.</div>
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156.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 14 April 1993, MAFF distributed an Animal Health Circular 93/32 to DVOs and RVOs for action and other veterinary and technical staff for information regarding collection, handling and disposal of SBO.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn205" name="_ftnref205" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[205]</span></a>� The Circular reported that reports generated by the Animal Health Circulars, while providing valuable information, did not provide a complete picture of the collection, handling and disposal of SBO from the slaughterhouse through to ultimate disposal.� A new pro-forma had been produced (form MH6) to extend the scope of the return to cover all aspects of SBO disposal.</div>
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157.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 19 April 1993, Mr Simmons minuted Mr Crawford regarding the handling of animal waste at knackers� yards and hunt kennels. This was the first summary collated from the new two-monthly report forms which had been introduced by AHC 92/147.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn206" name="_ftnref206" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[206]</span></a> No problems were identified.</div>
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158.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 7 July 1993, the first report on handling and disposal of specified bovine offal from �cradle to grave� (pursuant to Mr Simmons� suggestion) was prepared.� The report stated that of the 320 slaughterhouses visited during the period, all were complying with the Bovine Offal (Prohibition) Regulations 1989.� Separation of SBO was reported as satisfactory.� In respect of collection centres, separation of SBO and other waste was reported as satisfactory in all but one plant.� In respect of rendering plants, all but one of the plants handling SBO were complying with the Code of Practice for handling SBO.� Minor infringements were noted and it was stated that the SVS were working with the local authority to resolve the problems.</div>
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159.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 8 July 1993, Mr Simmons minuted Mr Crawford regarding the handling of animal waste at knackers� yards and hunt kennels.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn207" name="_ftnref207" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[207]</span></a> In summary, Mr Simmons stated that the returns reported little of concern and indicated, in general, slow but steady improvement in trading conditions and the operation of knackers� yards and hunt kennels. The suggestion that knackers� yards were to be formally exempted from registration under the Prescribed Processes Regulations was expected to ease their circumstances further. Again, no problems were reported in respect of Meat (Sterilisation and Staining) Regulations 1982, but a few reports of dumping were received.</div>
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160.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The second report on the handling and disposal of SBO was produced on 5 October 1993.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn208" name="_ftnref208" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[208]</span></a>� It stated that, in general, returns indicated satisfactory practices at all stages.� Of the 342 slaughterhouses visited, all apart from four were complying with the Bovine Offal (Prohibition) Regulations 1989.� The infringements were described as being of a minor nature, (eg failing to stain all SBO, failing to identify SBO bins satisfactorily).� In all cases, it was reported that remedial action was taken by the local authorities once the problem was brought to their attention.� Separation of SBO from other material during transport from the slaughterhouse was said to be satisfactory.</div>
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161.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 5 October 1993, Mr Simmons minuted Mr Crawford with his summary of returns on the handling of animal waste at knackers� yards and hunt kennels.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn209" name="_ftnref209" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[209]</span></a> The second report identified no significant changes from the position in the first report.</div>
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162.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 7 December 1993, Mr Simmons minuted Mr Crawford regarding the collection, handling and disposal of SBOs.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn210" name="_ftnref210" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[210]</span></a> Mr Simmons stated that the reports indicated, in general, satisfactory practices at all stages. All slaughterhouses, apart from one, were reportedly complying with the regulations. The infringement reported was in a small slaughterhouse where two bovine heads were found in a bin of �other waste�.� Immediate remedial action was taken by the local authority once the problem was brought to their attention. Separation of SBO from other material during transport from the slaughterhouse was reported as satisfactory. At collection centres separation of SBO from other waste was reported as satisfactory in all but one plant.� A temporary delay in onward consignment of material meant a risk of co-minglement of �other wastes and SBO�. This had been resolved at the time of writing. All but one of the rendering plants handling SBO were reportedly complying with the code of practice for handling of specified bovine offal. The one plant which was not had been granted planning consent to build the wall that would ensure complete separation of unprocessed SBO from other waste.� It was recorded that construction had begun. In respect of tallow, the reports recorded that all tallow produced from SBO, other than a small amount that was incinerated, was sold to brokers.</div>
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<a href="https://www.blogger.com/null" name="_Toc456173196">Events in 1994</a></div>
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163.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 19 January 1994, Mr Simmons minuted Mr Baker regarding allegations that SBO had been disposed of incorrectly at two slaughterhouses. Mr Simmons stated:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn211" name="_ftnref211" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[211]</span></a></div>
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�If we continue to receive criticism about SBO disposal we may have to review our surveillance.� For example, we could initiate an audit of weight of SBO noted on the movement permit, compared with weight of SBO that would be expected to be produced from the kill period under investigation.� However, this is likely to meet some resistance from the LAs.�</div>
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164.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The note included a hand-written annotation, from Dr Matthews, dated 20 January 1994 which stated:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn212" name="_ftnref212" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[212]</span></a></div>
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�I think we should audit records at the renderers, however, compare total input of raw material in January 1994 versus January 1993 for example, and relate to output of finished SBO meat and bone meal for disposal � this would not require LA involvement.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn213" name="_ftnref213" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[213]</span></a></div>
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165.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In <span lang="EN-US">November</span> 1993 a consultation letter was issued to industry organisations on the proposed new Spongiform Encephalopathy (Miscellaneous Amendments) Order.� This related to the proposal, following advice from SEAC in October 1992, to bring the rules on the use of SBO-derived tallow for animal consumption in line with those applying to human consumption. In his statement Mr Meldrum notes that �(s)ome of the responses received from the industry raised concerns about failures by renderers to dispose of SBOs properly and that tallow produced from SBO might be finding its way into the human food chain. Meetings were set up with the industry to discuss these concerns, one with the feed fat industry on 18th January 1994 and another with UKRA on 21st January 1994�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn214" name="_ftnref214" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[214]</span></a></div>
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166.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Meldrum further notes in his statement that:</div>
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�As a result of the concerns that had been raised by the industry since the issue of the consultation letter in November 1993, and following reports from UKRA that SBOs were arriving at renderers unstained, Mr Crawford issued a minute dated 1 February 1994 to all RVOs in England, Scotland and Wales explaining the reports we had received from UKRA and other reports of inadequate separation and handling of SBOs and [instructed] that all plants processing SBOs should be visited unannounced during February 1994.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn215" name="_ftnref215" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[215]</span></a></div>
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Mr Crawford noted that some staff had been giving advance notice of intended visits and pointed out that this gave operators an opportunity to ensure that, at the time of the visit, everything was being done that should be.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn216" name="_ftnref216" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[216]</span></a></div>
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167.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 2 February 1994, Mr Bradley minuted Mr K Taylor regarding the policing of BSE controls.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn217" name="_ftnref217" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[217]</span></a> Mr Bradley stated:</div>
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�I, amongst others, have stressed the importance of ensuring that these controls are being effectively policed with particular respect to ruminant feed (RF) ban and the SBO ban. It has always been important to do this but any deficits will be more plainly revealed for all to see in the next few years and there could be serious financial implications re compensation and disposal, not to mention drains on veterinary resources.�</div>
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168.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>With particular reference to the SBO controls, Mr Bradley stated as follows:</div>
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�Hearsay reports have suggested that SBO and other offals are not as well separated as they might be�.I believe we are both of the opinion that whilst the RP ban was effective, though not completely so, after 18 July 1988 any infected RP getting through would be stopped by the SBO ban two and a bit years later. If the SBO ban itself is being abused then there is a weakness in this argument�The recent industry meetings have done little to allay the fears about SBO, rather the reverse, as we now know if we did not before, that tallow tanks at renderers may not adequately separate tallow from the two sources.</div>
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I believe we have to quickly and effectively reassess and if necessary, improve the policing of the controls both via MAFF and the local authorities. Any trickle of infected RP into the cattle feed chain could result in an unfortunate plateau of confirmed BSE cases in a couple of years which will be hard to deal with and may even prevent export of live breeding cattle, or reintroducing a ban if we are successful at having it lifted this year.�</div>
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169.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 23 February 1994, Mr Meldrum sent a minute to Mr Taylor asking, �as a matter of some urgency�, about any progress made on visits that had been conducted as instructed by Mr Crawford.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn218" name="_ftnref218" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[218]</span></a> Mr Meldrum commented that he was �becoming increasingly concerned that some of the provisions of our legislation are being circumvented�.</div>
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170.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 7 March 1994, Andrew Scott of ED & F Mann Ltd wrote to Mr Soames regarding an article which had appeared that weekend in <i>The Mail on Sunday</i>.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn219" name="_ftnref219" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[219]</span></a>� The letter made two particular allegations:</div>
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The first was that</div>
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�(i)�� Tallow from banned offal, including the brain, spinal cord and spleen is still being included and still allowed to be included in the food chain; and</div>
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(ii)�� Meat and bone meal from banned offal which is supposed to go into landfill is still finding its way into the food chain.��</div>
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Mr Scott argued that the financial incentive for abattoirs to flout the regulations was considerable.� The cost to the knacker of disposing of SBO material was �50.00 per tonne for removal to land fill but he would receive �150.00 per tonne for material which could be incorporated into meat and bone meal for pig and poultry feed.�</div>
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171.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 21 March 1994 Mr Meldrum minuted Mrs Ratcliffe, P/S Parliamentary Secretary, regarding preliminary results from the inactivation experiments.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn220" name="_ftnref220" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[220]</span></a>� The study had been undertaken by the UK government, the European Commission and the European Renderers Association to see whether BSE agent added artificially to raw material could survive processing in a range of rendering plants in the UK and Europe. Preliminary results already showed that the agent survived treatment in three systems which collectively provided �most of the British rendering capacity�.� Mr Meldrum stated:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn221" name="_ftnref221" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[221]</span></a></div>
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�The results support the hypothesis that BSE was caused by the presence of the agent in animal protein which was fed to cattle and underline the wisdom of the measures which have been implemented since July 1988 to prevent ruminant derived protein being fed to ruminant animals.</div>
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Although current control policies are vindicated, and no change is needed in response to these new findings, the results do raise questions about the advisability of continuing to export meat and bone meal containing ruminant protein.�</div>
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Mr Meldrum noted that only a small volume of meat and bone meal was being exported (only 40 tonnes in 1993) and said: �(h)owever we should recall that meat and bone meal produced in the United Kingdom would not contain material derived from specified bovine offals, which are in effect, destroyed.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn222" name="_ftnref222" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[222]</span></a></div>
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172.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>UKASTA were also increasingly concerned about the problem of cross-contamination.� According to Dr Cooke and Mr Clegg of Dalgety Agriculture Ltd three factors gave particular cause for concern during 1994, namely:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn223" name="_ftnref223" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[223]</span></a></div>
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(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>the realisation that the amount of SBO being processed did not correlate with the tonnage that would have been expected;</div>
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(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>EU-funded work on rendering processes, which revealed that there could be no guarantee that the infective agent would be completely inactivated, even under the best conditions of heat, duration and pressure; and</div>
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(iii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>the early results of the MAFF attack-rate experiment: �MAFF study on the feeding of 100g, 10g and 1g of infected brain tissue had indicated that 100g of infected material in one meal caused BSE.� However, from late 1994 through to 1995, information received from MAFF suggested first that 10g and then 1g of material might be enough to cause infection.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn224" name="_ftnref224" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[224]</span></a></div>
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173.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In his statement to the BSE Inquiry, Mr Fleetwood stated as follows:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn225" name="_ftnref225" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[225]</span></a></div>
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�In March 1994, results began to come on-stream from the first (BSE) phase of the rendering experiment.� These results provided the first direct experimental evidence that infectivity may survive some forms of rendering.� In my role as study sponsor, I communicated these interim results to MAFF staff (the CVO and Mr Eddy) and to the European Commission.</div>
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These results came as no surprise. They corroborated epidemiological evidence which suggested BSE had been present in MBM, having survived the rendering process. The particular concern, shared by all those involved including the industry, was that there was now definite evidence that BSE infectivity would survive certain processes, but no evidence of what processes would eliminate it.</div>
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However, to put this into context, it is important to note that eliminating BSE infectivity through the rendering process was a second line of defence - the first being the various legislative measures to cut off recycling of infection.�<o:p></o:p></div>
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174.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 22 March 1994 Mr Soames replied to Andrew Scott explaining the Government�s policies in relation to BSE.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn226" name="_ftnref226" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[226]</span></a>� Mr Soames� response explained the measures put in place to deal with BSE and drew a clear distinction between measures taken to protect animal health and those to protect human health. Mr Soames stated the Ministry�s �strong commitment to the maintenance of strict measures where BSE is concerned.�� He added:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn227" name="_ftnref227" title=""><span class="MsoFootnoteReference" style="vertical-align: super;"><span lang="EN-US">[227]</span></span></a></div>
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�I view with the utmost seriousness your allegation that some in the trade are not complying with the rules, and that material which should be going to landfill is entering the food chain. I am grateful to you for bringing these concerns to my attention, and am anxious that they should be properly investigated. To this end, I feel that it would be most useful if you could come into the Department and go over your evidence with my officials . . . I suggest that you contact Mr Eddy, the Head of Animal Health (Disease Control) Division, to arrange a mutually convenient date.�</div>
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175.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In respect of the use of tallow, Mr Soames stated:</div>
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�It is true that tallow can be used for animal feed.� This is because the Spongiform Encephalopathy Advisory Committee (SEAC) took the view that the infective agent would fractionate with the protein rather than the fat fraction in the rendering process.� More recently the Committee concluded that it would make sense to align the rules about the use of SBOs for animal feed with those relating to human consumption, and ban the feeding of all material derived from them to any species.� However, this would primarily be as a precautionary measure and not because of any major and significant disease risk.�</div>
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176.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 24 March 1994, Mr Eddy minuted Ms Wordley, PS/Minister, attaching a note on the handling of the interim results of the UK/EC rendering studies.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn228" name="_ftnref228" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[228]</span></a> The results were based on testing samples in mice and only the positive results were available.� Mr Eddy noted that no conclusions could be drawn on other systems because it was not certain that studies which were negative would not become positive in time.</div>
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177.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In this statement to the BSE Inquiry, Mr Simmons recalled: �(i)n February 1994, I was requested by Mr Crawford to collate and analyse a further one-off return that should be completed by SVS staff in relation to the efficiency of SBO disposal at rendering plants.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn229" name="_ftnref229" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[229]</span></a> Mr Simmons produced this report on 25 March 1994.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn230" name="_ftnref230" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[230]</span></a> The report concluded:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn231" name="_ftnref231" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[231]</span></a></div>
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�It is likely that a small but significant of the total amount of SBO processed, as a result of being inadequately separated and/or identified�, finds its way into � animal feedstuffs.�</div>
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178.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>�The report�s summary of findings was:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn232" name="_ftnref232" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[232]</span></a></div>
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�1.�� In general, SBO is removed from carcases correctly . . .</div>
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Compliance with staining requirements is patchy. In particular, intestines are frequently not stained . . .</div>
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Separation of SBO from �other waste� in the slaughterhouse is generally adequate . . .</div>
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There is evidence that separation of SBO from �other waste� is not always maintained after leading the slaughterhouse . . .</div>
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There is evidence that some local authorities are not sufficiently diligent in controlling movements . . .</div>
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�</div>
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At collection centres, separation is generally adequate but it is accepted that determining the constituents of the stored material is almost impossible . . .</div>
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At rendering plants, compliance with the Code of Practice was considered to be generally satisfactory.�� Again the operators must take the stated constituents largely on trust . There were a few reports of poor separation and inadequate identification of stored material awaiting processing.�</div>
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179.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 28 March 1994, Andrew Scott responded to Mr Soames� letter of 22 March by passing on a copy of a letter from David Howells of FF-Man Feed Products, which addressed the issues Mr Soames had raised.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn233" name="_ftnref233" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[233]</span></a> With regard to the abuse of SBO regulations, Mr Howells� letter stated that:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn234" name="_ftnref234" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[234]</span></a></div>
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�The evidence for the abuse is by implication only in that the tonnages of SBO by-products do not reconcile with theoretical prediction. That there is scope for abuse was self-evident in that:</div>
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The infected offals are not being permanently stained under Ministry supervision</div>
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SBO and non-SBO materials are transported on the same vehicles.</div>
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SBO and non-SBO materials are processed through the same plant.</div>
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SBO tallows are currently not governed by movement order legislation.</div>
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SBO tallows and non-SBO tallows are processed on the same oleochemical plant.</div>
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Tank bottoms from the oleochemical industry contained significant percentages of SBO protein and are disposed of without a licence.</div>
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In many of the above operations there is a substantial difference in price between the SBO product and non-SBO product. In the circumstances, it is not surprising that there is an apparent discrepancy between theoretical and actual tonnages of SBO products. It would seem more appropriate to query whether there is evidence that the tonnages of SBO derived meat and bone meal, and tallow matched the theoretical predictions.�</div>
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180.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 8 April 1994, Mr Meldrum chaired a meeting which was attended by Messrs Crawford, Baker, K. Taylor, D. Taylor, Simmons and Howard and Mrs Sadowski, to review MAFF's arrangements for disposal of SBOs.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn235" name="_ftnref235" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[235]</span></a>� Possible measures discussed included reviewing the SBO movement permits system to allow cross-checks between the weight of SBOs leaving slaughterhouses and arriving at rendering plants; requiring that SBOs be stained with a different dye to avoid confusion between different staining requirements; requiring dedicated plants for rendering of SBOs; making the MHS responsible, when it was launched, for enforcement of the SBO regulations at the slaughterhouse; increasing the surveillance of knackeries and hunt kennels; and prohibiting the use of spinal column for MRM production.� It was agreed that Mr Simmons would draft instructions to require the SVS to monitor SBO disposal at head boning plants and that a submission would be put to the Parliamentary Secretary outlining why the controls on SBO disposal were being reviewed and seeking a meeting with him to discuss possible measures that could be taken.</div>
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181.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 13 April 1994, Mr Simmons produced a plan for implementation over the following weeks of the various points which had been discussed at the meeting on 8 April 1994.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn236" name="_ftnref236" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[236]</span></a>� This included issuing an AHC increasing the frequency of visits to knackers� yards and hunt kennels and for further checks at rendering plants and collection centres (a draft being provided with the minute).� Mr Simmons stated he was �somewhat uneasy about the reaction of LAs to the introduction of these checks since it amounts, at slaughterhouses and head boning plants, to scrutiny of their enforcement effort�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn237" name="_ftnref237" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[237]</span></a></div>
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182.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 21 April 1994 Mr Soames responded to Mr Scott�s letter dated 28 March 1994. Mr Soames wrote:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn238" name="_ftnref238" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[238]</span></a></div>
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�(T)he issues which Mr Howells and others raised when they met officials in January, and those which you have set out in the letters to me, are being considered carefully.� In fact a paper is to be submitted to the Spongiform Encephalopathy Advisory Committee (SEAC) � about the use of tallow in animal feedingstuffs which was the main issue discussed at the January meeting.� Officials are at present considering the specific points about disposal of SBO material made by Mr Howells in his letter.�</div>
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183.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 25 April 1994, Mr Crawford responded to Mr Simmons earlier minute of 13 April 1994.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn239" name="_ftnref239" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[239]</span></a> Mr Crawford suggested some minor amendments and in respect of slaughterhouse visits stated:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn240" name="_ftnref240" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[240]</span></a></div>
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�If we are concerned to ensure the safe handling of SBOs (and to correct what is perceived to be a particular problem), two unannounced visits per year would seem to be rather infrequent. I would support more frequent visiting � say, quarterly. These could later be reduced in the light of experience.�</div>
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184.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 28 April 1994 Mr Meldrum chaired a further meeting to discuss SBO controls.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn241" name="_ftnref241" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[241]</span></a> Specific points of action were agreed following on from the matters discussed at the meeting on 8 April 1994:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn242" name="_ftnref242" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[242]</span></a></div>
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�1.�� Mr Simmons was asked to consider urgently the possibility of using a different colour heat resistant dye which would identify SBO, even after rendering.</div>
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�ACTION: Mr Simmons</div>
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The possibility of requiring the use of such a dye through the Identification and Movement Control Regulations would be considered.</div>
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ACTION: Mr McIntosh</div>
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RMHAs would be asked to remind OVSs and AMIs of the need to keep SBOs separate from other material in the slaughterhouse and the need for tight control over movements.�</div>
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ACTION: Mr Baker</div>
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There needs to be further consideration of the legislative loophole which allows SBO to come into contact with other by-products during transportation.�</div>
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ACTION: Mrs Brown</div>
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Mrs Brown was asked to speak urgently to Dr Cawthorne and Mr Eddy about knackers� yards which are not currently covered by the 1989 Regulations.� It is likely that an Animal Health Order will be necessary to introduce the necessary controls as the 1989 Regulations are made under the Food Safety Act and therefore relate to public health.</div>
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ACTION: Mrs Brown</div>
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The CVO said that a reason for introducing an Animal Health Order would be on the basis of the inactivation studies, and to complement the provisions of the new Identification and Movement Control regulations.� He also wanted SBO to be directed by LAs to plants authorised by MAFF with a dedicated line for processing SBO.� Mrs Brown was asked to liaise with Dr Cawthorne and Mr Eddy about introducing regulations under the relevant parent Act.�</div>
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ACTION: Mrs Brown�</div>
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185.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Simmons recalls in his statement:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn243" name="_ftnref243" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[243]</span></a></div>
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�Until 1st April, 1995, SBO was stained with Black PN before disposal.� SBO was stained to enable it to be identified, at a glance, as not suitable for human consumption.<b>� </b>However, the stain was easily broken down by microbial activity and was also confusing for the operators of premises since the stain was also used for other unfit carcase meat and offal.� In April 1994, I was instructed by Mr Meldrum to research an alternative stain: one that was distinctive, not destroyed by the heat of rendering and one that could be readily detected in the protein and fat fractions of the rendered material.� It was important that an approved colorant (ie with an �E� number) was selected since this was to be used in food premises such as slaughterhouses.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn244" name="_ftnref244" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[244]</span></a></div>
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186.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 29 April 1994, Mrs Sadowski of Meat Hygiene Division A minuted Mrs Brown regarding the Bovine Offal (Prohibition) Regulations 1989.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn245" name="_ftnref245" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[245]</span></a> She stated that Mr Gunatilleke of the Legal Division had looked at the Regulations and concluded that knackers� yards were not covered by the Regulations because the premises referred to in Regulation 12 were those in Regulation 7, which excluded knackers� yards. The minute also discussed that fact that under the regulations SBO material could be �sterilised�, which would avoid the necessity to stain. Mrs Sadowski said<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn246" name="_ftnref246" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[246]</span></a>�if it was decided that SBO must be processed in such a way as to inactivate the BSE agent, then we would need to remove the option to sterilise at the slaughterhouse�.</div>
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187.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 3 May 1994, Mr Eddy held a meeting with colleagues to discuss in detail the problems that had been identified with the separation, handling and disposal of SBO material and to try to provide proposals to overcome those difficulties and on which legal advice was required.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn247" name="_ftnref247" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[247]</span></a>� Present at the meeting were Messrs Fleetwood, Lackenby, Howard, Matthews, Simmons and Mrs Sadowski. The following action was recommended in respect of slaughterhouses:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn248" name="_ftnref248" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[248]</span></a></div>
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�(a)� introduce new stain (green was suggested) to mark and identify ALL SBO material.� Stain to be heat stable up to at least 135�C and probably higher, and to colour both protein and fat fractions (desirable but unlikely in view of other controls) after rendering;</div>
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SBO to be kept separate from non-SBO unless all material is to be treated as SBO and stained as such (including green offal);</div>
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permits for the movement of SBO to declare weights (or at least volume) and records required for quantities �in and out� at all stages.� This is likely to present problems as some premises will not have equipment for weighing or measuring volume which may necessitate declared weights/volumes from the renderers;</div>
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requirement for L/As to fill in details on the permits on the movement of material out of plant and not to rely on plant operators filling them in (or verify if operator has filled in details).� In 1995 the MHS will become responsible for enforcement in slaughterhouses and head boning plants and it may be more practical for this task to be devolved to them then but collection centres are likely to remain the responsibility of the 2<sup>nd</sup> tier LA;</div>
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requirement to license movement of SBO only to rendering plants or incinerators specifically licensed to receive SBO) (but taking account of collection centres);</div>
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records to be kept by recipients to reconcile permits to a centre with actual deliveries and movement out for processing/disposal.�</div>
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188.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>As regards the handling of SBO at slaughterhouses, it was also recommended that local authorities should be reminded of the need for proper separation and staining of SBOs and that:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn249" name="_ftnref249" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[249]</span></a></div>
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�(c) L/As to reconcile information from permits on quantities of SBO being moved particularly the regular checking that the completed SBO movement permit has been returned to them within a given period, following-up non returned permits;�</div>
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189.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In respect of knackers� yards and hunt kennels, the note of the meeting set out the legislative background before concluding that:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn250" name="_ftnref250" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[250]</span></a></div>
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�Against this background it is clear that the present and proposed new measures provide insufficient control of SBO through knackers� yards and similar premises.� It was agreed that some additional form of control is necessary and that secondary legislation is the most appropriate vehicle for this.�</div>
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190.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The recommended legislative changes in respect of the handling of SBO at knackers� yards and hunt kennels were:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn251" name="_ftnref251" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[251]</span></a></div>
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�(a)� requirement for the separate handling of SBO or if inadequate separation to treat all material as SBO;</div>
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(b)�� SBO to be stained using the new stain;</div>
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(c)�� permits required for all movement of both raw and sterilised SBO.� Permits to specify weights etc as for changes to slaughterhouse permits�;</div>
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(d)�� SBO in green offal to be covered by the same rules as other SBO and to be sterilised or stained using �new stain� for SBO, and covered by movement permits�.</div>
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191.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>It was also recommended that SVS visits to knackers (some unannounced) be increased from one every two months to one each month.� An AHC draft had been prepared for this purpose.</div>
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192.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In respect of the handling of SBO material at rendering plants, it was recommended that legislative changes be introduced to:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn252" name="_ftnref252" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[252]</span></a></div>
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�(a)� require rendering plants to be licensed (or approved) to handle SBO with dedicated plants or lines within plants.� All SBO treatment to be a standard which inactivates the BSE agent (or at least reduces infectivity to undetectable levels under the recent trial protocol);</div>
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although there is a requirement in the license under article 9 of the BSEO to keep records (for 2 years) of the weight of SBO before rendering and the quantity of material derived after rendering, a separate legislative requirement for the keeping of records is necessary so that reconciliation can be carried out;</div>
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we already have in train proposals to extend to tallow from SBO the ban on the use in animal feed already in force for protein meal derived from SBO.� This will require an extension of the meal licensing rules to tallow.� It may be simpler to introduce these changes at the same time.�</div>
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193.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>It was also proposed that consideration should be given to the industry code of practice, in particular to consider whether it was effective and should it remain voluntary.� Local authorities were to be encouraged to reconcile movement permits in order to avoid alleged problems where movement permits showed SBO movement to a plant which had never received it.</div>
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194.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>It was further agreed that provisions should be made for the separation of SBO from non-SBO material during transportation and for reconciliation of specified weights of SBO moved to and from the various recognised destinations.</div>
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195.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 5 May 1994, Mr Simmons minuted Mr Howard regarding proposals for changes to the controls on SBO disposals.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn253" name="_ftnref253" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[253]</span></a> Mr Simmons stated that it was his belief that requiring the consignee to declare weights or volumes of SBO would be a useful start to an effective audit trail.� However, he remained concerned about the practicalities of such a system, since not all premises would have equipment for weighing or measuring volumes. He suggested that it might pay to have discussions with the renderers to determine whether they had a system of charging for collection which relied on weights or volume. Mr Simmons further explained that before the issue of movement permits under the Bovine Offal (Prohibition) Regulations the local authority had to ensure that the proposed destination was suitable. This applied as much to collection centres as it did to rendering plants. Head boning plants were already licensed by the SVS under the Fresh Meat (Hygiene & Inspection) Regulations 1992, since these were defined as cutting premises. They were subject to supervision, �often intermittently�, by the second-tier local authority. Mr Simmons felt that further approval would be of doubtful value.� He believed that more efficient enforcement was required. The minute was copied to Mr Eddy, Mr Fleetwood, Dr Matthews, Mr Lackenby and others.</div>
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196.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 5 May 1994, Mrs S Sadowski of Meat Hygiene Division �A� minuted Mrs Brown regarding the meeting with the Legal Department that had been chaired by Mr Eddy on 3 May 1994.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn254" name="_ftnref254" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[254]</span></a> Mrs Sadowski was asked to produce two lists, one which highlighted immediate action, which could be taken without amendment to legislation, and one which highlighted measures which required changes to current or new legislation.</div>
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197.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The first list recommended that the Meat Hygiene Division should write to local authorities to �remind them of their responsibilities in enforcing the Regulations, in particular the need to:�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn255" name="_ftnref255" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[255]</span></a></div>
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�Ensure that all SBO is properly stained�;</div>
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Encourage consignors to compete Part II of the movement permit more accurately in respect of the quantity of material, the number of containers and the size and type of containers�;</div>
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Reconcile movement permits issued with the receipted copy returned by the rendering plant to ensure that material is not being diverted.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn256" name="_ftnref256" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[256]</span></a></div>
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198.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>It also proposed that the Animal Health Division should issue a circular to introduce �greater presence of SVS staff at slaughterhouses, head boning plants, knackers� yards and rendering plants.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn257" name="_ftnref257" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[257]</span></a></div>
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199.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 6 May 1994, Mr Simmons minuted Mr Crawford to inform him that his comments of 25 April had been incorporated into the draft AHC which was attached.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn258" name="_ftnref258" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[258]</span></a> In particular, he noted that the amendment as to the frequency of visits to hunt kennels and knackers� yards had been included.</div>
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200.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 9 May 1994, Mr Crawford replied to Mr Simmons.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn259" name="_ftnref259" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[259]</span></a> With regard to the need for weight checks, Mr Crawford stated that he acknowledged that comparisons between the consigned SBOs and recorded bovine kill could only be a rough guide.� However, he felt it would be useful to monitor this for a few months to establish whether it provided useable information.</div>
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201.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 9 May 1994 Mr Scott replied to Mr Soames� letter dated 21 April 1994 advising that he (Mr Scott) had asked Mr Howells to contact Mr Eddy and to pass on any positive evidence he should come across.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn260" name="_ftnref260" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[260]</span></a></div>
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202.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 17 May 1994, Mr Eddy minuted Mrs Davis and Mr Gunatilleke seeking advice on proposed legislative changes relating to the handling of SBO.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn261" name="_ftnref261" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[261]</span></a>� In particular, Mr Eddy remarked that �(t)he current arrangements are complex because they involve three policy Divisions at Tolworth and operate under the Food Safety and Animal Health Acts and therefore fall to two Divisions in the Legal Department.� To make matters worse the animal health aspects are implemented by County Council level local authorities and the Food Safety Act aspects by the District Council tier�.�</div>
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203.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 20 May 1994, Prosper De Mulder wrote to Mr Meldrum reiterating their concerns about various aspects of the SBO regulations, which they felt were not working as well as they should.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn262" name="_ftnref262" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[262]</span></a>� They commented that overall tightening up of all aspects of the SBO regulations was long overdue.</div>
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<span lang="EN-US">204.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">During the period from February to May 1994 European Commission </span>inspectors<span lang="EN-US"> visited temporarily and permanently derogated fresh meat establishments in the UK (referred to as �missions�).� Their findings were reported in a General Report on the position in the United Kingdom in relation to temporarily and permanently derogated Fresh Meat Establishments.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn263" name="_ftnref263" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[263]</span></a>� Amongst the findings were the following:<o:p></o:p></span></div>
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��Overall 68.5% of the derogated slaughterhouses inspected were of some concern. The 31.5% of the slaughterhouses falling in the �other� category were not without deficiencies but these shortcomings were estimates to be of less significance.</div>
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A further analysis shows that 25% of the permanently derogated slaughterhouses were of some concern whereas 80.7% of the temporarily derogated plants fell into this category. The vast majority of the latter were in England.</div>
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1.��� Poor overall standards</div>
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-����� 68.5% of the derogated establishments visited were classified as being of concern or of grave concern: this is of particular significance in England where 63.5% of the national kill takes place in the derogated establishments.</div>
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2.��� Inadequate veterinary supervision</div>
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OVSs are denominated by MAFF but employed by local authorities: MAFF does not have line control of OVSs, EHOs or AMIs.</div>
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OVSs were insufficient in number and in presence ie the slaughterhouses were not supervised in accordance with the Directive.</div>
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100% veterinary ante-mortem health inspection is no longer required or practised. In many cases this inspection is exclusively carried out by auxiliaries. Consequently, in many cases OVSs only see casualty or questionable animals.</div>
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OVS powers were quite limited in England � Wales: the OVS did not generally have any effective input in relation to inspection, cleanliness, maintenance or operational hygiene of the establishment. This poor input was often time-related eg only sufficient time to carry out the ante-mortem inspection.</div>
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OVSs/AMIs did not control the entry/exit of meat.</div>
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The system (non-centralised as described above, contractual, extremely limiting insofar as the official veterinarian is concerned) was clearly not working in an effective manner.</div>
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�</div>
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Many of these low-capacity slaughterhouses, which do not comply with the reduced structural requirements and which have been granted �derogations� until 31.12.1995, do not aspire to reach the full requirements.</div>
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�</div>
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8.��� Staff training programmes</div>
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These programmes do not appear to have been generally established.</div>
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9.��� Hygiene checks</div>
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Checks on the general hygiene of the establishments were not, for the most part, carried out.</div>
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�</div>
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11.�� Visibly contaminated carcases were health marked</div>
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SUPERVISION AND HYGIENE</div>
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As a general rule veterinary supervision in terms of numbers and presence was inadequate.</div>
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The OVS line-managers were non-veterinarians who themselves were not line-managed by the State Veterinary Service of MAFF;</div>
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AMIs and EHOs are not placed under the authority and responsibility of the OVS who is therefore not assisted by auxiliaries;</div>
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OVSs are employed by local authorities in such a way that their role is considerably reduced vis-�-vis the requirements of the Directive, and in some cases virtually confined to that of assessing certain animals at ante mortem inspection;</div>
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Since local authorities employ individual OVSs, practices containing OVSs or companies employing OVSs, there is no guarantee of continuity and there is little if any coherence in terms of veterinary control.</div>
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The individual reports attest to the fact that the general level of hygiene, in particular operational hygiene, was poor and was frequently of grave concern.</div>
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Derogations, in the case of temporarily derogated establishments, concentrated on physical absences or defects. Many quarterly reports seen did not refer to hygiene.�</div>
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205.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span><span lang="EN-US">At a meeting with UK Officials on 20 May 1994, t</span>he Commission Inspectors emphasized the general difficulties faced by the UK and in particular (among other things):</div>
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�(1)� the very low standard of the plants seen and the high/frequent occurrence of gross contamination;</div>
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�</div>
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(5)�� the system (non-centralised, contractual, extremely limiting� insofar as the official veterinarian [OV] is concerned) which was clearly not working in an effective manner.�</div>
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206.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The <span lang="EN-US">report</span> states that in response, the UK Officials:</div>
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�(1)� did not question the facts as reported on-the-spot, but disputed the significance of contaminated meat;</div>
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�</div>
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(5)�� in answer to the criticism of the present system, claimed that the advent on 1.4.1995 of the Meat Hygiene Service, which will be an agency of MAFF, (see Annex X) would resolve the difficulties as it would be centralised. The Chief Executive has been recently selected.�</div>
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207.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In respect of the forthcoming transfer of enforcement responsibility to the MHS, the EC inspectors� report stated:</div>
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�It is likely that some of the basic problems will not be resolved because the OVs will continue to be employed on a contractual basis, the small amount of time spent by OVs in the plants will hardly alter, it is unclear if regional managers will be veterinarians and the UK does not seem fully ready to achieve the objectives prescribed by the Directive.�</div>
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<span lang="EN-US">208.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">From 24 to 27 May 1994 the fourth European Commission mission took place in the United Kingdom in order to examine the implementation of EC legislation, including trade rules, regarding BSE and subsequent report prepared.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn264" name="_ftnref264" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[264]</span></a>� The mission noted that (amongst other things) in the slaughterhouses it visited �(t)he removal of obvious nervous and lymphatic tissue during the cutting process was performed adequately�.� The mission concluded that</span><a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn265" name="_ftnref265" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[265]</span></a><span lang="EN-US">:<o:p></o:p></span></div>
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�procedures applied in the UK provide sufficient guarantees for trade in calves and embryos.</div>
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�. Check and control procedures actually applied in Great Britain with regard to trade in bovine meat from the UK to Member States are in general satisfactory but need some improvement if they are to provide complete guarantees � with respect to the origin and identification of the slaughter animals��</div>
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<span lang="EN-US">209.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span>On 29 May 1994, Mr Bradley replied to Mr Meldrum�s request for suggestions for improving the policing of the existing SBO ban and ruminant feed ban.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn266" name="_ftnref266" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[266]</span></a>� Mr Bradley stated:<span lang="EN-US"><o:p></o:p></span></div>
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�There is hearsay evidence of skulls (with brains inside) entering rendering plants with non-SBO offal�. Even if abuse happening it would not be of tremendous animal health importance unless MBM derived from the SBO was diverted into cattle feed since non-ruminants so far have not succumbed to [spongiform encephalopathy] naturally or experimentally�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn267" name="_ftnref267" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[267]</span></a><span lang="EN-US"><o:p></o:p></span></div>
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<span lang="EN-US">210.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span>Mr Bradley went on to suggest �practical measures�, such as including bovine heads within the SBO ban, and specifying that visible nervous tissue and lymph nodes could not be used in the preparation of MRM.� As �less practical measures� he suggested investigating methods of carcase splitting other than sawing, training slaughterhouse workers to a common standard to maximise safety of carcase splitting and spinal cord removal, and including in the SBO ban tissues such as lymph nodes, nerves and the pregnant uterus and its contents.� In respect of carcase splitting techniques, Mr Bradley noted that several methods had been reviewed by SEAC and SEAC had pronounced them �safe�.� In conclusion, Mr Bradley identified various arguments against the �less practical measures�, such as the difficulty of policing them, increases in meat industry costs, lack of scientific evidence of aerosol formation and cross‑contamination of carcases, and the reduction in the number of infected cattle going into slaughterhouses.<span lang="EN-US"><o:p></o:p></span></div>
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211.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 15 June 1994 Mr Howard minuted Mr Meldrum, and widely throughout MAFF and the Territorial Departments, outlining discussions he had had with legal department about proposals to tighten the SBO controls.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn268" name="_ftnref268" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[268]</span></a>� The minute gave a detailed explanation of methods by which it was proposed that further human health and animal health measures be introduced by statutory instruments under the Food Safety Act 1990 and the Animal Health Act 1981. In particular, there was a discussion on enforcement of the SBO and BSE controls. Mr Howard highlighted that provisions made under the Food Safety Act 1990 were being enforced by District Councils (i.e. responsibility for slaughterhouses, head boning plants, collection centres, knackers yards etc.), whereas provisions under the Animal Health Act were being enforced by County Councils (i.e. responsibility for rendering plants and disposal of waste after rendering) and following the introduction of the MHS in April 1995, enforcement of controls at slaughterhouses and boning plants would be transferred from local authorities to the MHS. This would mean that the SBO controls would be enforced by three separate authorities and Mr Howard noted that, considering the importance of the controls, this was an aspect that needed further consideration.</div>
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212.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Meldrum replied to Prosper de Mulder�s letter of 20 May 1994 on 3 June 1994.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn269" name="_ftnref269" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[269]</span></a>� In the letter he stated that PDM were not the only ones to voice concern about the disposal of SBO and MAFF�s own investigations revealed that in a small number of cases the system was not working as well as it should adding: �(t)his is being addressed urgently.� All staff have been instructed to increase their vigilance and to target any perceived weaknesses in the system�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn270" name="_ftnref270" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[270]</span></a></div>
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213.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>An emergency meeting of SEAC was convened on 25 June 1994 to discuss the results of the pathogenesis study, which had revealed infectivity in the distal ileum of a calves killed six and ten months after exposure to the agent (but not in a calf killed two months after exposure).<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn271" name="_ftnref271" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[271]</span></a> The minutes note Mr Tyrrell�s concern regarding �the difficult position this placed the Committee in when they were expected to produce top class scientific opinions in a rush. This was an unrealistic expectation.� With respect to human health:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn272" name="_ftnref272" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[272]</span></a></div>
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�The Committee considered that the theoretical risk of infection of man via food derived from infected calves is minuscule if it occurs at all but information on calves is still very limited and as the experiment is still in progress and further information is expected it will be necessary to monitor these results carefully to see if this basic conclusion is correct and to see whether further action is needed.�</div>
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214.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The Committee further noted:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn273" name="_ftnref273" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[273]</span></a></div>
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�What was clear was that thymus and pancreas were used for human consumption and if either of those were remotely likely to harbour agent then action would need to be taken. The question was a difficult one and final conclusions could not be drawn at this stage in the ongoing experiment.�</div>
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215.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>It also noted that :<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn274" name="_ftnref274" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[274]</span></a></div>
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�at this stage one cannot give a definitive answer. There is a theoretical risk and Government could respond by a limited SBO ban for calves to exclude the intestines.�</div>
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216.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>During the meeting the Committee consider a draft paper by Mr Wilesmith and Mrs Hoinville and others on the case central study for calves born after the ruminant feed ban. The Committee concluded that:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn275" name="_ftnref275" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[275]</span></a></div>
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�The paper showed no good evidence of either maternal or horizontal transmission � Food contamination was likely to be the major source [of BAB cases] and the Committee expressed its concern that the later BAB cases suggested that there could still be some contaminated material slipping through the controls into animal feed through cross-contamination in mills producing ruminant and monogastric feed and through lax compliance with the SBO rules.�</div>
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217.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Meldrum explained in his statement that he, Mr Eddy and Mr Bradley� attended lengthy meetings over the following weekend with the CMO, Mr Calman. Mr Calman explained his concerns about the findings of the pathogenesis study and that the DH wished to get advice from SEAC. Mr Calman was anxious to make a statement as soon as possible and wished to avoid any suggestion of there being a delay in dealing with the information and taking any necessary action to protect public health.� He therefore went through the pathogenesis study in detail and reviewed the current knowledge of the epidemiology of BSE.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn276" name="_ftnref276" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[276]</span></a></div>
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218.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 28 June 1994, Ms Wordley minuted Mr Eddy concerning a series of meetings the Minister had held on 27 June 1994 to discuss the latest results from the BSE pathogenesis experiment.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn277" name="_ftnref277" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[277]</span></a> Ms Wordley noted there had been a brief discussion of the legal scope for action:</div>
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�Under the Food Safety Act, there were specific provisions covering what could be done and what had to be taken into account. Mr Attwood said that in order to use the emergency powers, it would need to be clear that emergency action was justified. Moreover, provisions would have to be notified under the Technical Standards Directive. The Minister agreed that the legal point would have to be discussed with the CMO, but legal niceties could not be used to justify lack of action if that was what the CMO recommended. Further examination of how quickly we could act under the legal powers was needed. The Minister noted that, in any event, as far as BSE was concerned, we had always gone a little further than the scientific evidence justified.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn278" name="_ftnref278" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[278]</span></a></div>
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219.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Animal Health Circular 94/106 was issued to all DVOs on 29 June 1994, replacing AHC 92/94 and AHC 93/32.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn279" name="_ftnref279" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[279]</span></a>� In respect of slaughterhouses, the instructions required that each cattle slaughterhouse must receive an unannounced visit every two months.� Two separate weeks� kill in the proceeding period should be selected and the movement permits should be compared to the kill for the period in question.� The amount of SBO consigned should be compared to the number of bovines killed.� Estimates of the expected yield of SBO should be checked against the records of cattle slaughtered.� At each of the visits, checks were to be made to establish that SBO remained separate from �other waste�.</div>
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220.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 30 June 1994, MAFF and DH made a joint announcement regarding preliminary results of an experiment to trace the biological routes through which BSE develops in cattle.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn280" name="_ftnref280" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[280]</span></a>� The preliminary results confirm that �following the feeding of calves with large doses of BSE-infected material, traces of the disease can be detected in the animals� small intestines.� Furthermore, (t)hese �results show that it is possible to transmit BSE to laboratory mice from intestines taken from young cattle when fed a substantial dose of brain material known to contain BSE.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn281" name="_ftnref281" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[281]</span></a></div>
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221.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The announcement also states that both SEAC and the CMO assessed the results and �(a)lthough they consider that the risk to human health is minuscule, the existing ban on the use of specified bovine offals is to be extended to include the intestines and thymus of calves under the age of six months��.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn282" name="_ftnref282" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[282]</span></a></div>
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222.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The announcement quotes extensively from a Parliamentary Written Answer to Dr Liam Fox MP, (Woodspring) by Gillian Shepard of MAFF, which states (among other things) �the Chief Medical Officer continues to advise that there is no evidence whatever that BSE causes Creutzfeld Jakob Disease (CJD) and, similarly, not the slightest evidence that eating beef or hamburgers causes CJD.�</div>
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223.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 8 July 1994, Mr Soames wrote to Paul Cheale, President of the Federation of Fresh Meat Wholesalers, concerning hygiene standards in slaughterhouses.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn283" name="_ftnref283" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[283]</span></a> Mr Soames stated:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn284" name="_ftnref284" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[284]</span></a></div>
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�I have been considering with officials of the State Veterinary Service and Meat Hygiene Division the results � of slaughterhouse inspections using MAFFs new Hygiene Assessment System.</div>
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The SVS inspectors are finding widespread deficiencies, � particularly in the areas of slaughter and dressing and personnel practices. Problems in these areas frequently resulted in cross contamination of the carcase�.</div>
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Those plants which received the lowest scores are being revisited and revocation of their licence will be considered if they fail to show a substantial improvement. But there is a real need for improvement in hygiene standards in the majority of premises inspected, not just in the worst cases.�</div>
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224.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>At a monthly management meeting Mr Haddon asked Dr Cawthorne to take over from Mr Eddy responsibility for progressing legislative changes to the SBO controls that had started in April 1994, and to prepare an action plan. One of the proposed changes was to limit the rendering plants that could handle SBO to those which had a processing line dedicated solely to SBOs and the separate collection of protein and tallow derived from them.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn285" name="_ftnref285" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[285]</span></a>�� Dr Cawthorne gave the task of taking this initiative forward to Mr Fleetwood.� At Dr Cawthorne�s request, Mr Fleetwood telephoned the major UK rendering plants in order to check capacity.� In the course of his telephone calls, he took the opportunity to obtain information about the quantities of SBOs that resulted, and the theoretical tonnages that ought to have been resulted, from slaughterhouse throughput.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn286" name="_ftnref286" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[286]</span></a> The results of Mr Fleetwood�s inquiries suggested that �SBO controls were not working�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn287" name="_ftnref287" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[287]</span></a> and indicated a �substantial shortfall in the estimated SBO which renderers were receiving compared with estimated SBO which ought to have been received by them.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn288" name="_ftnref288" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[288]</span></a></div>
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225.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>A report prepared by Dr Cawthorne was presented to Mr Haddon on 15 July 1994.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn289" name="_ftnref289" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[289]</span></a>� It highlighted the results of Mr Fleetwood�s telephone survey of renderers and referred to Prosper de Mulder�s view that since SBO was not being stained �some renderers may be diverting SBO for normal processing�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn290" name="_ftnref290" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[290]</span></a> Dr Cawthorne concluded that whilst staining might improve the situation by restricting opportunities for siphoning off at rendering plants, the long term solution demanded �effective policing of SBO separation, staining and storage at slaughterhouses�. Dr Cawthorne proposed the following changes to controls on SBOs:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn291" name="_ftnref291" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[291]</span></a></div>
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�We wish to monitor and control the collection and movement of all SBOs (including that from calves less than 6 months of age), from their premises of origin, (slaughterhouses, knacker yards, boning and cutting plants, hunt kennels, fur farms, zoos, etc) to Agriculture Department approved rendering/incineration plants via approved collection centres, and to ensure SBO material remains identifiable and separate from other material at all times.� We also want to ensure any protein or tallow derived from SBO does not enter the animal or human food chains by requiring its burial or incineration in the case of meat and bone meal, or chemical fractionation, in the case of tallow.� To this end, the following legal requirements are considered necessary:</div>
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�(a)� all SBO to be stained at the premises of origin with a water soluble, non toxic dye capable of withstanding the temperatures reached in rendering (130<span style="font-family: Symbol;">�</span>C). Ideally such a dye will be carried through to any meat and bone meal derived from processed SBO making it easily distinguishable from non-SBO derived material;</div>
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(b)�� <u>separate</u> handling, storage and transport of SBOs from non-SBOs at premises of origin, intermediate collection points and premises of final destination (rendering plants, incinerators); if this cannot be achieved, all non-SBO to be treated as SBO;</div>
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(c)�� all movements of SBOs between premises of origin, intermediate collection points and premises of final destination to be subject to movement permits issued by the local authority or the Meat Hygiene Service, when in place and where appropriate;</div>
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(d)�� all intermediate collection points to be approved by Agriculture Ministers, approval they have the necessary facilities to store and handle SBOs separately from other animal waste and that they keep records on SBO movements onto and off the premises as required;</div>
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(e)�� all SBOs to go to rendering plants/incineration plants approved/designated by Agriculture Ministers: approval would only be given if they have (a) the necessary facilities for the separate storage and handling of SBOs (b) a line dedicated solely to the processing of SBOs and the separate collection of protein and tallow derived from it� and (c) can meet the new EC standards for the processing of ruminant material;</div>
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(f)��� all greaves, meat and bone meal and tallow derived from SBO to be moved under Agriculture Minister licence to approved incinerators or burial sites, subject to a final decision being reached on SBO derived tallow;</div>
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(g)�� the owner or person in charge slaughterhouse, knackers yard etc, intermediate collection point or rendering/incineration plant to (a) record the weight of all SBO material originating from, leaving or arriving at his premises (b) keep such records for a minimum of two years and (c) make the records available to Agriculture Ministers or local authority on request. Ideally access to inspect records also required.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn292" name="_ftnref292" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[292]</span></a></div>
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226.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Cawthorne emphasised that a suitable dye needed to be identified and tested. A commercial scale trial of a candidate dye in a batch rendering operation (Dundas, Scotland)� was to take place on 25 July 1994<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn293" name="_ftnref293" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[293]</span></a> and was to be carried out by Animal Health Zoonoses Division and Meat Hygiene Division.</div>
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227.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In his statement to the BSE Inquiry, Mr Fleetwood explained that this task was transferred to Zoonoses Division following Dr Cawthorne�s recommendations in his 15 July 1994 action plan.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn294" name="_ftnref294" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[294]</span></a> Mr Fleetwood identified two practical problems which arose from staining SBOs with Black PN:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn295" name="_ftnref295" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[295]</span></a></div>
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�First, it made it difficult to distinguish SBOs stained according to the 1989 SBO regulations from offal stained according to the Meat and Sterilisation Regulations 1982 � Secondly, Black PN was not bio-stable. It tended to disappear as an identifiable stain after approximately 48 hours on offals.�</div>
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228.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 23 July 1994, Mr Meldrum received a minute from Dr Cawthorne with a draft submission for the Minister on the proposals to improve the controls on the collection, storage, transportation, processing and disposal of SBOs.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn296" name="_ftnref296" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[296]</span></a>� The minute was copied to Mr Haddon. The draft submission explained how evidence obtained from reports from SVS field staff indicated that there was some non-compliance with staining requirements; that separation of SBOs and non-SBOs was not always maintained during transport to rendering plants or collection centres; and that some local authorities were less diligent than others in controlling and reconciling the movement of SBO from slaughterhouses to renderers.� It was pointed out that as a result of these findings enforcement had been stepped up and SVS staff had been instructed to make unannounced visits every two months to all cattle slaughterhouses to check on the collection and separation of SBOs and the adequacy of the movement permits issued and that all shortcomings identified should be pursued.� The draft submission then set out each of the proposed changes designed to make it easier to identify SBOs and to make it more difficult to divert SBOs into meat and bone meal for incorporation into animal feedingstuffs.� In summary, the proposed changes were:</div>
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(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>to introduce a legal requirement for all SBO to be stained with a distinctive, non-toxic dye;</div>
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(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>to introduce a legal requirement for SBOs to be handled, stored, transported and processed separately from non-SBO material;</div>
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(iii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>to extend requirements for SBO movement permits to knackers� yards;</div>
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(iv.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>to require movement permits to contain additional information on the weight of SBOs moved;</div>
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(v.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>to require collection centres and rendering plants to be officially approved for dealing with SBOs; and</div>
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(vi.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>that slaughterhouses, knackers� yards, collection centres and rendering plants should keep records of all SBO material with which they deal.�</div>
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In addition, it was proposed that rendering plants should be required to process SBOs in a dedicated cooker or plant.� The feasibility and implications of these proposals would be clarified once the industry had been consulted.</div>
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229.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 2 August 1994, a revised draft of the submission to the Minister on the proposed changes to SBO controls was circulated by Dr Cawthorne for comment within MAFF.� It was also copied to SOAEFD, WOAD, DANI and DH.� Dr Cawthorne sent the finalised submission to the PS/Minister on 10 August 1994 which stated (among other things):<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn297" name="_ftnref297" title=""><sup>[297]</sup></a></div>
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�Recently there have been allegations that the SBO controls are not always adhered to, and that some SBO may be finding its way into animal feed stuffs.� Evidence to substantiate such claims is difficult to obtain, but analysis of available data suggests that a sizeable proportion is not being destroyed.� Reports from our veterinary field staff indicate that while SBO is in general correctly removed from carcases and compliance with staining requirements is, on the whole, fairly well observed, intestines are frequently not stained.� Separation of SBO from non-SBO material in slaughterhouses is generally adequate but this separation is not always maintained during transportation to rendering plants or collection centres.� Inadequate staining makes it more difficult to distinguish SBO from non SBO material, and provides opportunity for SBO to find its way into animal feedstuffs if mixed with non-SBO material.� There is also evidence that some local authorities are less diligent or less effective than others in controlling and reconciling the movement from slaughterhouses to renderers.�</div>
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230.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The submission also stated that the changes it proposed require careful presentation to avoid giving any impression that existing controls are not working and human health was being put at risk: �our primary concern is to minimise the possibility of material derived from SBO getting into animal feed�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn298" name="_ftnref298" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[298]</span></a></div>
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231.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 17 August 1994, Dr Cawthorne, Mr Howard and Dr Matthews met with UKASTA and CVL to discuss, amongst other things, the current and future controls on SBOs.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn299" name="_ftnref299" title=""><sup>[299]</sup></a> The note of the meeting stated:</div>
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�The CVL reiterated the finding known for some time that <i>(sic) </i>a single exposure to the BSE agent likely to cause the disease to develop.� There was no evidence of the occurrence to BSE resulting from a cumulative exposure.�</div>
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The BSE epidemic is consistent with a low dose exposure�.</div>
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A discussion took place on the implications to the feed industry if it was subsequently shown that a dose of 1g had caused BSE.� Setting aside considerations of the effectiveness of the SBO legislation and even though it was possible to try and minimise the risk of cross contamination between feeds for ruminants and those for monogastrics, the only protection for a feed manufacturer might be to stop using meat and bonemeal in any feedingstuff.�</div>
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232.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span><span lang="EN-US">The </span>consultation<span lang="EN-US"> letter on the changes which were proposed to the controls for the collection and disposal of SBO was sent out on 22 August 1994.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn300" name="_ftnref300" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[300]</span></a></span>It explained the current need for rationalisation in the light of the several pieces of existing legislation which regulated the collection, movement and disposal of SBO. It stated the overall aim was:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn301" name="_ftnref301" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[301]</span></a></div>
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��to combine in a single Order all the controls over the collection and disposal of SBO from where it is produced in slaughterhouses, knackers yards, hunt kennels or any other place through to its destruction in incinerators or if it is rendered, the final disposal of the protein and tallow produced.�</div>
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233.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 24 August 1994, Mr <span lang="EN-US">Meldrum</span> sent a minute to Mr Fleetwood saying that he felt it was essential that a dye be found before the regulations were introduced requiring the staining of SBOs with a new dye rather than having to introduce one at a later stage.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn302" name="_ftnref302" title=""><sup>[302]</sup></a>� He requested a progress report on any new dye that had been suggested for use.� In response, Mr Fleetwood informed him that new stains were being assessed and depending upon those results an industrial scale trial could be repeated for any potential stain.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn303" name="_ftnref303" title=""><sup>[303]</sup></a>� Mr Fleetwood remarked that he was �aware that this was taking longer than we would have liked, but the technical difficulties are considerable�.</div>
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234.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 8 September 1994, a meeting took place between MAFF, CVL and UKASTA.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn304" name="_ftnref304" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[304]</span></a>� The meeting was attended by Mr K Taylor, Mr Fleetwood, Mr Howard, Dr Matthews and Mr Wilesmith.� Mr Meldrum records in his statement that although he did not attend this meeting, Mr Howard provided him with a copy of a note of the meeting prepared by UKASTA. The issues discussed at the meeting were the BSE control measures, the ELISA test and a proposed questionnaire for feed compounders.� It was reported at the meeting that CVL had always considered that the infective dose of� BSE was relatively small and that, although not yet complete, the studies being undertaken on the oral exposure of cattle (the attack rate study) were indicating that a very low dose was sufficient to cause BSE. In addition, with completion of the case control study� it was the considered opinion of MAFF researchers that the potential for cross-contamination at feed mills was a cause of some concern.� UKASTA advised that under the circumstances the only way in which individual compounders could fully protect themselves against possible claims was by stopping the use of meat and bone meal altogether in mills where ruminant feeds were being manufactured. �MAFF representatives reported on the recently adopted European Commission Decision (94/382/EC) on heat treatment systems for processing ruminant meat and bone meal based on work undertaken on de-activation of the BSE and scrapie agents.� The Commission Decision (94/381/EC) banning the use of mammalian meat and bone meal in ruminant feedingstuffs was also discussed. MAFF representatives advised the meeting that the UK ruminant feed ban would not be lifted when the legislation implementing the Commission Decision on rendering processes was adopted.� It was also reported to the meeting that it was hoped that the ELISA testing facility at Luddington VI Centre would be expanded and that a commercial testing service would be available in due course.</div>
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235.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The finding that 1gram of infective material was or might be sufficient to transmit BSE came as a surprise to Mr Wells, who was the experiment leader at the CVL. In oral evidence to the BSE Inquiry, he said:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn305" name="_ftnref305" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[305]</span></a></div>
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�Yes, I think it was rather a surprise to us initially that 1 gramme of brain extract -- brain homogenate from affected cattle would affect another animal. It had implications that material that had gone through the rendering process and subsequently ended up in meat and bonemeal had to be in -- could be in very small quantities to result in infection.�</div>
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236.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Fleetwood minuted Mr Meldrum, among others, on 13 September 1994 informing him that Patent Blue had been identified as the most suitable new stain and recommending that a field trial for the stain.� Mr Meldrum agreed with this recommendation immediately.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn306" name="_ftnref306" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[306]</span></a></div>
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237.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 2 November 1994 the Bovine Offal (Prohibition)(Amendment) Regulations 1994 (SI No 2628) extended the Bovine Offal (Prohibition) Regulations 1989 to include intestines and thymus of calves under six months of age within the prohibition.� Specifically, Regulation 2(1) was amended to include the following definition:</div>
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�excluded matter� in relation to any bovine animal which has died or been slaughtered in the United Kingdom means any part of such an animal which does not consist of or contain any specified bovine offal;�</div>
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The definition of �specified bovine offal� was amended to mean the following parts of the bovine animals:</div>
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�i���� the brain, spinal cord, spleen, thymus, tonsils and intestines of an animal, more than six months of age, which has died or been slaughtered in the United Kingdom;</div>
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ii����� the thymus and intestines of an animal, two months or over but not more than six months of age, which has died or been slaughtered in the United Kingdom;</div>
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iii.��� the thymus and intestines of an animal, under two months of age, which has been slaughtered in the United Kingdom; and which no longer form part of the carcase of an animal.</div>
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238.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 2 November 1994, Mr Simmons produced his second report following the introduction of AHC94/106.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn307" name="_ftnref307" title=""><sup>[307]</sup></a>� Over 350 slaughterhouse visits were made during reporting.� No significant problems were reported in separation, staining and consignment of SBO at slaughterhouses. Some slaughterhouses did not separate SBO from other waste, but it was dispatched as a mixed consignment with all of the material being treated as SBO.� While this was an acceptable procedure, it was noted that it precluded the use of detailed weight checks.</div>
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239.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 21 November 1994, the outcome of the consultation exercise on the proposed changes to the SBO controls was circulated by Dr Cawthorne with a summary explaining the various responses received on each of the proposals and his conclusions as to what recommendations should be made to the Minister.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn308" name="_ftnref308" title=""><sup>[308]</sup></a>� Dr Cawthorne's conclusions were as follows:</div>
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(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>that the option of sterilising of SBOs on removal from carcases should be removed;</div>
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(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>that Patent Blue should be recommended for staining SBO;</div>
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(iii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>that it should be made a legal requirement to separate SBO from non-SBO material at all points and that mixtures should be treated as if they were SBO;</div>
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(iv.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>that although there was widespread agreement on the need for an improved system for auditing SBO movement, the consultation had identified a number of difficulties, and so the movement permit system needed to be thought through carefully before recommendations went to Ministers (with record keeping requirements to be considered in conjunction with this);</div>
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(v.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>that collection centres should be approved and preferably by MAFF rather than local authorities; and</div>
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(vi.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>that there were no �obvious barriers� to the approval of renderers for SBO processing.� Mr Meldrum had reported that there was a division of opinion on the issue of requiring SBOs to be processed in dedicated cookers or plants, and Dr Cawthorne recommended that this needed further consideration and discussion with the industry.</div>
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240.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 21 November 1994, Mr Packer minuted the Minister regarding a recent meeting he had attended with representatives of UKASTA.� Mr Packer stated:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn309" name="_ftnref309" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[309]</span></a></div>
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�The background is the development by MAFF of a test for ruminant protein in feed which is likely to be able authoritatively to detect small proportions (perhaps as low as 0.25%).� It is interesting that against this background the trade�s protestations that cross-contamination never occurred have been reversed; they are now more or less telling us that where the same mill is used for ruminant and non-ruminant feed some cross-contamination is inevitable, thought this is usually at low levels.�</div>
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241.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 22 November 1994, the PPS/Minister minuted the Permanent Secretary thanking him for his minute to the Minister of 21 November.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn310" name="_ftnref310" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[310]</span></a>� The Minister asked whether �in practice we believe that cross-contamination <u>has</u> been taking place: If it has, what consequences does this have and is there any action which the Ministry should take given the new judgment we now have of the possibility of cross-contamination having occurred, albeit at low levels�.�</div>
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242.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 28 November 1994, Mr K Taylor minuted the Permanent Secretary noting that the consequences of any cross-contamination depended on the amount of ruminant derived protein which had entered feed for ruminants after the ban and whether any of the ruminant-derived protein contained BSE infectivity.� The latter point depended in turn on whether the SBO ban had been effectively enforced, and whether the rendering method used was effective in inactivating the BSE agent.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn311" name="_ftnref311" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[311]</span></a></div>
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243.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 30 November the PS to the Parliamentary Secretary (Mrs Browning) commented that Mrs Browning understood �that as little as 1 gramme of ruminant protein from an infected animal is sufficient to transmit BSE.�� She therefore feels that if cross-contamination is detectable, the correct course of action would be to move, in consultation with the industry, to a situation in which separate production lines would have to be used for ruminant and non-ruminant feed�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn312" name="_ftnref312" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[312]</span></a></div>
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244.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 30 November 1994, Mr Packer, Mr Taylor and Mr Eddy met with UKASTA.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn313" name="_ftnref313" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[313]</span></a>� During the meeting, officials were asked whether, in their view, cross-contamination had been taking place in feed mills.� They responded that MAFF �strongly� suspected some cross-contamination had taken place.� In support they offered the following evidence:</div>
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(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>the born after the ban cases were proportionally greater in those parts of the country where the ratio of pigs and poultry numbers to cattle were the highest.� These were areas where one might expect the greatest risk of cross contamination of ruminant feed with ruminant protein; and</div>
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(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>the new ELISA test showed provisional positive results for two mills.� The detailed evidence implicated a contaminated ingredient in one case, and suggested a possible cross contamination in the other.� (Both mills had altered their arrangements and particular products which had been positive under the old arrangements were now negative.)</div>
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245.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The note of the meeting went on to state that the above tended to support MAFF�s thesis as to the main cause of the epidemic, �though if the animal health controls are shown not to have been 100% effective it will be necessary (but difficult) to explain that there is no necessary read across to the effectiveness of the public health controls�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn314" name="_ftnref314" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[314]</span></a></div>
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246.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 2 December 1994 Mr Packer minuted the Minister to answer the questions that Ministers had raised and report on the UKASTA meeting:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn315" name="_ftnref315" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[315]</span></a></div>
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�1� The main new point was that I was able to tell them that we were now confident that the new test for ruminant protein in feed was working properly and did not require recalibration . . .</div>
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2. Mr Cameron said that he would need to call a special meeting very soon to inform members of this development.� �He expected some companies to decide to stop using meat and bone meal in those pig and poultry feeds manufactured in plants in which ruminant feeds are also manufactured.� He estimated that as much as 70-80% of pig and poultry feeds were currently produced in such mixed mills.� He also expected the medium term larger companies would decide to reorganise production into ruminant only and monogastric (pig and poultry) only mills.� The single mill companies had less room for manoeuvre but could over time make improvements to reduce the possibility of cross-contamination.</div>
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3. It must be likely that there will be a short term decline in meat and bone meal usage.� But it now looks much less likely that UKASTA will issue a clear statement to their members <u>recommending</u> an end to <u>all</u> use of meat and bone meal as had been suggested initially. . . .</div>
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4. My only comment would be that it is a pity the industry did not take the steps now contemplated at an earlier stage.�</div>
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247.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the points that Ministers had questioned, the Permanent Secretary advised: �We strongly suspect that cross contamination has occurred in at least some feed mills�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn316" name="_ftnref316" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[316]</span></a>� He stated that the industry�s reaction �more or less confirms this�.� In addition, he drew the Minister�s attention to two new pieces of evidence:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn317" name="_ftnref317" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[317]</span></a></div>
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�(i)�� The number of �born after the ban� cases are proportionately greater in those parts of the country where the ration of pig and poultry numbers to cattle numbers is the highest.� These are where one might expect the greatest risk of cross-contamination of ruminant feed with ruminant protein.</div>
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(ii)�� The new test showed provisional positive results for two mills.� The detailed evidence implicates a contaminated ingredient in one case, and suggests a possible cross-contamination in the other.� (Both mills have altered their arrangements and particular products which had been positive under the old arrangements are now negative).�</div>
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248.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The Permanent Secretary also pointed out that �a number of significant improvements in the rules have been introduced in the past year�.�� These were the introduction of ELISA, impending new EU rendering standards and the consultation exercise on tightening up the handling of SBOs, and he continued, �I doubt if anything more is needed�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn318" name="_ftnref318" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[318]</span></a></div>
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249.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>He noted in conclusion that �one experiment has shown that 0.5gm of infected raw cow�s brain fed to sheep will cause �BSE�.�� There is however a lot of difference between raw brain from clinically infected cattle and meat and bone meal since all clinical BSE cases are incinerated, all brains from cattle over six months of age are classified as specified bovine offal and cannot be used for human or animal feed or spread as fertilisers and meat and bone meal has by definition been rendered�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn319" name="_ftnref319" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[319]</span></a>��</div>
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250.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 9 December 1994, Mr Meldrum, Mr Cawthorne and others attended a meeting with representatives of UKRA to discuss the proposed changes to the SBO controls.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn320" name="_ftnref320" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[320]</span></a>� The UKRA representatives were content with proposals for staining of SBO with Patent Blue and also with requiring separation of SBO from non-SBO material. There were concerns, however, that this should not extend to requiring use of dedicated vehicles as opposed to single compartmentalised vehicles on the grounds of cost.� They were not happy with the possibility of seals being introduced for loads of SBOs; this was an idea put forward by Mr Taylor, seals being applied to loads on despatch and broken on delivery, with movement permits recording the seal number.� There were no objections raised to the proposal of replacing movement permits with an obligation to record weights/volumes of SBO despatched and received.� Representatives were also content with proposals to approve rendering plants.� There followed a discussion of the possibility of requiring dedicated lines or plants for the processing of SBO material.� Several points against such action were put forward.� Dr Cawthorne felt that in light of the readiness with which some of the proposals had been accepted by UKRA, MAFF should not require dedicated processing of SBO and the use of seals for the time being.</div>
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251.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 15 December 1994, Mr Meldrum minuted Dr Cawthorne regarding a recent meeting between MAFF officials and representatives of UKRA.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn321" name="_ftnref321" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[321]</span></a> Mr Meldrum said that he remained adamant that �we must have a watertight system for the separation, staining and processing of SBOs that does not put the cattle industry at risk�.� He recognised that some of the proposals could cause some inconvenience and additional cost to the industry, but noted that �our objective is to reduce the exposure of cattle to the agent of BSE to negligible proportions and thereby ensure that the disease is eradicated from the UK�.� He also indicated his support for the use of seals on SBO containers in transit and for processing of SBOs in dedicated plants.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn322" name="_ftnref322" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[322]</span></a></div>
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252.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>From late 1994 the feed industry received information from MAFF to suggest that first 10g and then 1g of infective material might be sufficient to transmit the disease.� On 30 November 1994, UKASTA was informed that as little as 0.5g of infected cow�s brain transmitted BSE to sheep.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn323" name="_ftnref323" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[323]</span></a></div>
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<a href="https://www.blogger.com/null" name="_Toc456173197">Events in 1995</a></div>
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253.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 9 January 1995, the results of the consultation process on proposed changes for the collection and handling of SBOs were assembled by Dr R Cawthorne and submitted to Mrs Ratcliffe, PS/Parliamentary Secretary, for Ministerial agreement �to legislative changes aimed at strengthening existing controls�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn324" name="_ftnref324" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[324]</span></a> The submission was copied widely within MAFF, and to the Territorial Departments and the Department of Health.� Of the 70 or so organisations consulted, 30 replies had been received with a wide range of responses.� The submission stated that �(t)here was almost universal support for the proposal to remove the option of sterilisation and general support for the proposal that all SBO should be stained with a distinctive dye that would survive rendering and be detectable in meat and bone meal.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn325" name="_ftnref325" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[325]</span></a> The Parliamentary Secretary was requested to agree that the legislation be drafted:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn326" name="_ftnref326" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[326]</span></a></div>
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�(a) withdrawing the option of sterilising SBO at the place of its removal and requiring SBO to be stained with the dye Patent Blue V �;</div>
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(b) requiring the separation of SBO throughout the collection and disposal chain and for any mixed material to be regarded as SBO �;</div>
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(c) requiring slaughterhouses, collection centres, rendering plants and all those handling SBO to keep records of the weights of SBO handled, its place of origin and intended destination, and keep those records for two years �;</div>
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(d) removing the existing requirement for movements of SBO to covered by movement permits or accompanied by consignment notes �;</div>
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(e) requiring collection points to be approved for that purpose by Agricultural Departments �;</div>
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(f) requiring rendering plants wishing to process SBO to be approved for this purpose by Agriculture Departments on condition they can �</div>
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i)���� meet EU standards for processing ruminant material;</div>
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ii)��� have facilities dedicated solely to the processing of SBO and which allow the materials and the products resulting from it (meat & bone meal and tallow) to be kept separate from other meals and tallows at all times, �;</div>
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(g) prohibiting the use of SBO tallow in animal feed until after it has been processed by the oleochemical industry �;</div>
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(h) allowing slaughterhouses, cutting plants, knackers� yards,� hunt kennels etc the option of sending SBO direct to an incineration plant for destruction, such movements being controlled by Agriculture Departments �;�</div>
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<span lang="EN-US">254.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span>Dr Cawthorne�s submission set out the potential impact of the requirement for dedicated rendering lines as follows: �Four rendering companies, who between them process 80% of all the SBO produced in Great Britain, would install dedicated lines if Ministers decided this was necessary: others could, given time, though they would have to decide whether this was financially� worthwhile . . . The cost of installing new equipment is estimated at between �100,000 to �750,000 per plant . . .�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn327" name="_ftnref327" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[327]</span></a>�<span lang="EN-US"><o:p></o:p></span></div>
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<span lang="EN-US">255.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span>It was also recommended that industry organisations should be consulted on early amendments to the Bovine Offal (Prohibition) Regulations 1989 as amended and the Bovine Offal (Prohibition) (Scotland) Regulations 1990 as amended, so as to make it a legal requirement to stain SBO at the place of its removal with the dye Patent Blue.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn328" name="_ftnref328" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[328]</span></a><span lang="EN-US"><o:p></o:p></span></div>
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256.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 17 January 1995 Baroness Denton wrote to Mrs Browning to confirm that Northern Ireland would prefer:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn329" name="_ftnref329" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[329]</span></a></div>
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�to proceed with the uncontroversial proposed changes now but to have further discussions with our respective industries on the separate processing facilities.� I think we need much clearer assessment of the practical and economic consequences of this proposal before committing ourselves to making it a legal requirement�.</div>
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257.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 20 January 1995, Mrs Ratcliffe, PS/Mrs Browning minuted Dr Cawthorne regarding a meeting which had taken place the previous day to discuss proposed changes to the controls for the collection and disposal of specified bovine offal.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn330" name="_ftnref330" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[330]</span></a> The minute was copied to Mr Carden, Mr Meldrum, Mr Haddon, Mr Crawford, Mr K Taylor, Mr Baker and others.� Mrs Ratcliffe reported that at that meeting Mr Meldrum had explained that the further measures that were proposed were necessary to make the separation of SBO more enforceable. She stated:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn331" name="_ftnref331" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[331]</span></a></div>
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�He was convinced that there was some accidental �leakage� of SBO into non-SBO material, and hence into cattle feed. There had also been some evidence in the past year that the rules were not always followed. Action had already been taken on this, for example by increasing checking, but it was not possible to be there all the time. Contamination of ruminant feed with SBO-derived material had obvious implications for animal health. Mr Taylor noted that half of all BSE cases now appeared in animals which had been born after the ruminant feed ban.</div>
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Staining using the new dye could be rapidly implemented to ensure that SBO-derived products were identifiable as such. However, from the point of view of enforcement, the best way forward was to require separate lines to be used for SBO and non SBO material. It was essential to keep potentially infected material out of the feed, since comparatively small volumes of brain tissues could cause infection.�</div>
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258.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mrs Browning subsequently met Baroness Denton to discuss the issue of separate rendering lines.�� Lady Denton was accompanied by the NI CVO who argued that �it would be necessary to allow sufficient time for operators to buy and install new equipment�.�� The note of the meeting records that Dr Cawthorne now proposed that the requirement for separate rendering lines should be implemented �in May/June�, which, in the view of the NI CVO, �seemed rather early�.�� The meeting concluded that Baroness Denton should meet Northern Ireland renderers before decisions were announced and that �MAFF would await confirmation of the outcome of the meeting before proceeding further�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn332" name="_ftnref332" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[332]</span></a></div>
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259.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The problem of BABs and cross-contamination was discussed by SEAC at its meeting on 10 February 1995.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn333" name="_ftnref333" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[333]</span></a>� SEAC was very concerned that cross-contamination appeared to be the main reason for continuing cases of BABs.� It urged the development of the ELISA test for use on a large number of field samples.</div>
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260.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 28 February 1995, Mr Meldrum minuted Mr Packer regarding recent research findings.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn334" name="_ftnref334" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[334]</span></a>� With regard to the attack rate study, Mr Meldrum reported:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn335" name="_ftnref335" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[335]</span></a></div>
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�� it is becoming clear that calves in all groups are succumbing with little difference in incubation period.� This indicates that the amount of unprocessed brain needed to cause the disease is very small, and that the study may need to be repeated using smaller doses in order to determine the minimum infectious dose.� The findings may help to explain why the feed ban was less effective than intended, and they will certainly cause UKASTA some uneasiness.� This supports our view that we should tighten up our controls on the disposal of the specified bovine offals; an issue we have discussed with Ministers.�</div>
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261.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The minute also dealt with a comparison of the infectivity of tissues using cattle and mice.� In this respect Mr Meldrum stated:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn336" name="_ftnref336" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[336]</span></a></div>
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�The Secretary will recall that there has been criticism by Professor Lacey and others that bioassay of cattle tissues in mice is not as sensitive as bioassay in cattle, <u>because of the effect of the species barrier</u>.� We have tested a narrow range of tissues in both mice and cattle to try to compare the sensitivities of the two systems.� The preliminary results suggest that the mouse is not so sensitive to BSE as cattle but we cannot yet quantify the difference.� That can only be done when the experiment is more advanced.� However some would argue on that basis that some bovine tissues that have tested negative through mice are not necessarily negative.� This underlines the importance of our cautionary specified offal ban.�</div>
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262.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The next set of returns under AHC 94/106 was summarised by Mr Simmons in his minute of 2 March 1995.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn337" name="_ftnref337" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[337]</span></a>� Mr Simmons stated:</div>
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�I believe that, in general, the disposal of SBO has improved at all stages and that provided our current input is maintained, further improvements can be made.� However�I remain concerned about head boning plants.�</div>
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263.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The summary reported that 348 slaughterhouses were visited, of which only 10 were reported as showing deficiencies.� These related to absence of movement permits, inadequate staining and poor separation.� In each case, the reports either indicated prompt resolution or that the problem had been taken up with the relevant local authority.</div>
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264.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In respect of head boning plants, the summary stated that information derived from returns under AHC94/150 indicated that on current information it appeared that 60% of the heads from the weekly national kill were processed in 10 plants.� Mr Simmons observed:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn338" name="_ftnref338" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[338]</span></a></div>
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�Given the concentration and amounts of potentially infected material that these premises produce, there is a good case for close and regular supervision.� Most head boning plants are licensed cutting premises and will be supervised by the MHS.� However, in some cases, supervisory input by the MHS may be as little as 1 hour per month.� Given that most, if not all, of this time will be directed at hygiene, this input is inadequate to ensure proper disposal of SBO.�</div>
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265.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The returns from rendering plants and collection centres indicated that operators appeared to be complying with the relevant legislation.</div>
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266.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In his written evidence to the BSE Inquiry, Mr Meldrum explained the concern that arose in his mind, following receipt of the results from the attack rate study, which led him to take action on 7 March 1995 to introduce supervision of the disposal of bovine heads:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn339" name="_ftnref339" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[339]</span></a></div>
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�Having considered Mr Simmons� recommendations and in light of the recent results from the attack rate study indicating that the amount of unprocessed brain needed to cause disease was very small (see paragraph 135 of Section E), I decided that all head boning plants should be visited by MHS staff on a weekly basis to supervise the disposal of bovine heads (see minute dated 7th March, 1995 from Dr Cawthorne to Mr Gregg). (YB 95/3.7/2.1) In addition, I wanted a further change to the SBO controls to be implemented to ban the removal of the brain from skulls, requiring bovine heads (other than tongue and cheek meat) to be treated as brain which, of course, was a SBO.� This was suggested because of the difficulty in ensuring that all brain material had been removed from the skull before the latter was processed to produce meat and bone meal intended for use as feed for pigs and poultry.� Mr Eddy suggested that SEAC should be asked to advise on this issue and I agreed that this should be done as well as advising the DH of our intentions.� However, I did not feel that this needed to delay implementation of the legislation introducing the changes to the SBO controls.�</div>
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267.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In his oral evidence to the Inquiry, Mr Scott, General Secretary of the Federation of Fresh Meat Wholesalers, stated:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn340" name="_ftnref340" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[340]</span></a></div>
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�There was a watershed which I think is evidenced, certainly in the papers I have read, that in early to mid-1995 there were two major shifts in the perception of how BSE should be regarded.� One was the increasing seriousness with which the risk of specified bovine offals was treated.� And the other was the amount of infective material which would be necessary to create the disease.� That second one was a very serious shock to industry.�</div>
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2.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span> <o:p></o:p></div>
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3.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The other witnesses who appeared with Mr Scott agreed with this view.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn341" name="_ftnref341" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[341]</span></a></div>
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268.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 24 March 1995, a new Animal Health Circular (AHC 95/40) was produced advising that the Bovine Offal Prohibition (Amendments) Regulations 1995 would come into effect on 1 April 1995.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn342" name="_ftnref342" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[342]</span></a>� The new regulations provided for the transfer of enforcement responsibility in respect of SBO at slaughterhouses and head boning plants to the new National Meat Hygiene Service.� The new service would also be responsible for the day to day checks on SBO disposal at these sites.</div>
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269.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The new regulations also required that SBO be stained with a new distinctive food colour, Patent Blue V, instead of Black PN.� The staining requirements in the new regulations would also apply to SBO originating at knackers� yards and hunt kennels.� The covering letter sent out with the Animal Health Circular stated that the SVS officers must as a first priority visit all slaughterhouses and head boning plants in their area at which SBO may be expected to arise.� They should explain the requirements of the new regulations and ensure the new stain is brought into use without undue delay.� As a second priority, SVS staff were required to visit all knackers� yards and hunt kennels to ensure the same awareness and compliance with the new regulations as at slaughterhouses.�</div>
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270.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Additionally, SVS visits to head boning plants were increased to once monthly and SVS staff were assigned new checks during their visits to premises handling SBO.� Responsibility for auditing and directing SVS activity on SBO had passed to the SVO (Protein Processing) Tolworth to whom all inquiries were, thereafter, to be addressed.</div>
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271.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 31 March 1995, a submission prepared by the Meat Hygiene Division was put forward to the Permanent Secretary regarding the removal of bovine brain from the skull.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn343" name="_ftnref343" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[343]</span></a> It noted the results of the attack rate study and experiments in progress on eye tissue.� Although results from the latter were not yet available, it was considered prudent to include eyes in the SBO ban when the rules on skulls were being reviewed, in case there was a positive result.� It was noted that the issue of a ban on bovine eyes might give rise to criticism, particularly since when the issue had been considered previously, it had been decided that there was no need for a statutory ban as the industry had advised that eyes were not used in the production of food for human consumption.� The Minister was invited to agree a ban on the removal of brains and eyes from bovine heads and that SEAC should be notified.� As this was a tightening up of the controls, it was not considered necessary to seek advice from SEAC.� The Permanent Secretary forwarded the submission to the Minister on the same day and indicated that he supported the recommendation.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn344" name="_ftnref344" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[344]</span></a>� The Minister also agreed with the recommendations in the submission on bovine brains and eyes and commented that �this is an important issue on which we shall need to act swiftly�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn345" name="_ftnref345" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[345]</span></a></div>
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272.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The Bovine Offal (Prohibition) (Amendment) Regulations 1995 came into force on 1 April.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn346" name="_ftnref346" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[346]</span></a></div>
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273.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The MHS was launched as an Executive Agency of MAFF on 1 April 1995.� It took over responsibility from local authorities for meat inspection, supervision of licensed fresh meat premises and enforcement of the legislation relating to meat hygiene, BSE/SBO controls and animal welfare in these premises.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn347" name="_ftnref347" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[347]</span></a></div>
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274.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In his statement to the BSE Inquiry, Mr Soul said that, following the launch of the MHS on 1 April 1995, a major exercise was undertaken to �benchmark� standards in the meat industry.� This exercise was undertaken by �Hygiene Advice Teams� or �HATs�.� Teams of experienced Official Veterinary Surgeons and Senior Meat Hygiene Inspectors visited all full throughput abattoirs during 1995, and conducted a thorough and detailed inspection of hygiene and animal welfare standards and made an assessment of manning levels.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn348" name="_ftnref348" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[348]</span></a></div>
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275.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Swann, an OVS who led a hygiene advice team in visiting red meat slaughterhouses, explained in his statement to the Inquiry that a format for the audit was provided (HAT 1-4).� HAT 1 gave details of the meat plants through-put.� HAT 2 was a detailed check list of hygiene and welfare standards indicators.� HAT 3 was a written report which included recommendations for improvements and standards.� HAT 1-3 were sent to MHS Headquarters and to the meat plant operator in question.� HAT 4 was a confidential report to MHS Head of Operations, which commented on the meat inspection requirements of the plant as well as on the effectiveness of the inspection team.� HAT visits were announced, but commenced before the meat plant start up, usually between 4-6 am.� Audits took from 6-22 hours depending on plant shutdown times.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn349" name="_ftnref349" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[349]</span></a></div>
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276.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In his statement to the Inquiry, Mr Swann recorded that the HATs had found deficiencies in SBO control.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn350" name="_ftnref350" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[350]</span></a>� Specifically, incomplete removal of spinal cord, failure to remove thymus, failure to separate spleen, failure to stain SBO, failure to mark SBO containers, deficiencies in paper work and failure to remove SBO spillage from abattoir floors were all noted.� More than 40% of all plants showed some degree of non compliance with SBO regulations.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn351" name="_ftnref351" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[351]</span></a></div>
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277.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Swann further recorded that the HAT exercise had found deficiencies in the ability of some regulating staff to recognise irregularities in SBO control.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn352" name="_ftnref352" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[352]</span></a> Some OVSs were unable to identify bovine thymus and some MHIs were not aware of the importance of complete removal of spinal cord.� The HATs also noted the following reasons for non-compliance with SBO controls:</div>
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(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Physical reasons � some plants were designed in such a way that removal of SBO was difficult.� This specifically applied to spinal cord removal where inability to reach the caudal section of the spine resulted in retention of 4-6 inches of spinal cord in the lumber area.</div>
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(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Production speed � the speed of operation resulted in carelessness in disposal of SBO.� Large quantities of SBO were seen on the abattoir floor where the bins were misplaced or not emptied regularly.</div>
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(iii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Culture � many plant operators were convinced that BSE was a disease of cattle only, and that controls were of benefit to the farming community only.� Resentment at the cost of SBO controls was widespread.� The veterinary staff at meat plants were invariably of the opinion that BSE would be restricted to livestock, consequently SBO regulations were not always taken seriously.</div>
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278.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In his evidence, Mr Soul stated that it was clear that many local authority staff working in licensed abattoirs had not been trained in enforcement and had not had an enforcement culture instilled into them.� Most of these individuals transferred into the MHS on 1 April 1995 under the Transfer of Undertakings (Protection of Employment) legislation (TUPE).� Mr Soul stated that the MHS management was faced with a major challenge to change the culture of these same individuals in order to achieve effective enforcement of all the legislation not just the SBO Order. The cultural change was to be brought about by means of various training initiatives, better, clearer and more comprehensive instructions, more effective management, incentives in key areas, the introduction of quality systems and audit and a strict, firm but fair disciplinary code for all MHS staff.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn353" name="_ftnref353" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[353]</span></a></div>
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279.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 2 May 1995, Mr Hewson, SMHA in MAFF�s Meat Hygiene Veterinary Section minuted Mr Corrigan of the MHS, regarding information received that the majority of SBO was arriving unstained at rendering plants. The minute was copied to Mr Meldrum, Mr Baker, Dr Cawthorne, Mr Fleetwood and Mr Penny.� Mr Hewson stated that it was clear that local authorities were not implementing the staining requirements of the SBO regulations with the diligence that would have been expected. In many instances they appeared not to have been insisting SBO was stained and were not making following up enquiries when unstained SBO was received at its final destination. Mr Hewson suggested that the situation might have worsened since the old black dye was replaced by the more expensive Patent Blue V. Mr Hewson asked that MHC staff be urgently reminded of their responsibilities as comprehensively set out in chapter 10 of the MHS Operations Manual. He added that Mr Corrigan might wish to remind MHS staff that it was not their responsibility to do the staining themselves, as was understood to be happening at some premises.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn354" name="_ftnref354" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[354]</span></a></div>
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280.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 3 May 1995, Mr Fleetwood sent a minute to Mr Meldrum, with copies to Mr Haddon, Mr Crawford, Mr K Taylor, Mr Baker, Mr Eddy and Mrs Brown, concerning information from the rendering industry which suggested that not all SBO arriving at rendering plants was stained with the Patent Blue V dye.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn355" name="_ftnref355" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[355]</span></a>� Some appeared to be unstained, some fully stained and some stained with an inappropriate colour.� In addition, some material that was not SBO was being stained with the Patent Blue V dye.� Mr Fleetwood stated that �the allegations appear to suggest that local authorities have taken a lackadaisical approach to enforcement in recent times.�</div>
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281.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the same day, Mr Fleetwood minuted Dr Cawthorne, Mr K Taylor, Mr Baker, Mr Eddy, Mrs Brown, Mr Lackenby and Mr Simmons setting out in full the details of allegations about the non staining of SBO arriving at abattoirs.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn356" name="_ftnref356" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[356]</span></a>� He explained that he had received a telephone call from the renderers, Prosper de Mulder, on Friday 28 April.� In that call, the company had said that almost all of the SBO arriving at their plant for processing was unstained.� As this plant processed approximately 60-70% of the national SBO, this caused some concern.� By coincidence, staff from the Animal Health Office had been in the rendering plant concerned under Mr Fleetwood�s instructions, examining raw material and taking samples of greaves to be tested for the SBO stain.� The plant operators alleged that they had only received two consignments of SBO stained with the patent blue V since the regulations had come into force on 1 April, and that attempts by their buyers to ask for staining of SBO had been met with outright rejection.� The staff from the Animal Health Office were able to confirm that during their visit they saw no evidence of SBO arriving stained with patent blue V, although they considered it possible that some had been stained with the black PN stain.� However, this decomposed from SBO within two days and the staff were therefore unable to decide one way or the other.</div>
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282.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Fleetwood�s minute recorded that Peter Lackenby had made inquiries of the manufactures of Patent Blue V.� They were able to confirm that they had stocks available for immediate delivery, and that although some of them had received several enquiries from the operators of slaughterhouses, few orders for stain had been placed.� From this Mr Fleetwood concluded that non availability of stain was not an explanation for failure on the part of slaughterhouses to use it.</div>
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283.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Fleetwood said that he could not speak for what had gone on in the past, but current evidence seemed to suggest that SBO was not being stained as it should be.� He went on to say, that the problem seemed to be worse with the suppliers to de Mulders, which might have had something to do with their gut room contracts. However, the problems had not yet been detected by SVS staff, who continued to report that all was well.� Mr Fleetwood commented that he found this puzzling, but had a feeling that although staff were shown one thing when they visited the premises, something quite different might happen the moment they left.� There might also, he suggested, be an element of failure on their part to get on to the cutting room floor, and really look at things in detail.� Mr Fleetwood suggested that consideration be given to whether SVS staff should separately investigate the position of slaughterhouses and head boning plants by advancing and enhancing their programme of regular visits.� To this end, he had drafted an AHC for discussion with senior staff.</div>
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284.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 4 May 1995, Mr Crawford minuted Mr Fleetwood expressing surprise that there was a significant problem of SVO arriving unstained at rendering plants, and asking whether there was any way of assessing the extent of the problem.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn357" name="_ftnref357" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[357]</span></a>� The minute was copied to Mr Meldrum, Mr Haddon, Mr Taylor, Mr Baker, Mr Eddy and Mrs Brown.� Mr Crawford�s concern arose from the fact that SVS staff had been required to visit abattoirs and head boning plants every two months in order to inspect procedures for handling SBO material.� Those reports had not revealed the problem that was the subject of Mr Fleetwood�s earlier note, and Mr Crawford pointed out that Mr Fleetwood�s minute appeared to be contrary to the findings of SVS staff.� He asked whether the difficulties in staining might be due to the fact that local authorities no longer provided the service of staining and whether they were now seeing a reluctance by the plant operatives to provide and use the stain.�</div>
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285.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Fleetwood responded to Mr Crawford on 5 May 1995 reiterating what he had said in previous minutes.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn358" name="_ftnref358" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[358]</span></a>� In addition to those copied in on Mr Crawford�s minute, Mr Fleetwood added Dr Cawthorne. Mr Fleetwood stated:</div>
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�(Y)ou ask why we have had no indication of problems from field staff and � whether the introduction of MHS may have had an effect.� It is possible that the problem with staining is a new phenomenon in which case reports would not have started to filter through from the field. Possible reasons may include the fact that there are no longer tame LA meat inspectors to apply stain, and that the plant operators have to purchase a new stain (which is not more expensive than the old one).� However, I suspect that at least some of the problem is of longer standing duration in which case the lack of reported problems from the field is puzzling.� I suspect that the explanation is that although the staff are shown one thing when they visit a premises, something quite different happens the moment they leave.� We are addressing this problem by enhancing the checks that SVS staff make when they visit the premises and by making the checks at rendering plants which triggered this issue.�</div>
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286.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 5 May 1995, Mr Eddy put a submission to the Parliamentary Secretary with the consultation letter on the proposed changes to the Specified Bovine Offals Rules.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn359" name="_ftnref359" title=""><sup>[359]</sup></a> Mr Eddy stated that:</div>
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�We are particularly anxious to introduce these changes as soon as possible because of the research results on the infectivity of very small doses of BSE which make it important that we remove any risk from material being left behind in skulls�.The Secretary will wish to note that we have proposed only a three week consultation. This is because of the need to get these new controls in place quickly.�</div>
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287.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The Parliamentary Secretary responded �very quickly� that she was �happy with his (Mr Eddy�s) proposed presentation of the issues and that he should send out the consultation document as early as possible�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn360" name="_ftnref360" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[360]</span></a></div>
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288.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 9 May 1995, the consultation letter regarding changes to the controls for the collection and disposal of specified offal, was distributed to all relevant parties.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn361" name="_ftnref361" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[361]</span></a></div>
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289.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 10 May 1995, Mr Corrigan, Head of Operations at the MHS, wrote to inspection staff regarding �information received� indicating that the majority of SBO was arriving at rendering plants unstained.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn362" name="_ftnref362" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[362]</span></a>� The note confirmed that ensuring proper staining was now the responsibility of the MHS, but that it was not the responsibility of inspectors to apply stain.� The note also gave details of the companies which were supplying Patent Blue V dye.</div>
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290.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 17 May 1995, Dr Cawthorne wrote to Mr Corrigan about the problem of failure to stain SBO emanating from slaughterhouses and head boning plants.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn363" name="_ftnref363" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[363]</span></a>� The letter noted that further inquiries by SVS staff had confirmed that the bulk of SBO was arriving at rendering plants unstained, inadequately stained or stained with the wrong dye.� The SVS were now beginning to report similar problems at slaughterhouses and head boning plants. The letter explained that the proper separation and disposal of SBO was a key component of the Government�s measures for the control of BSE.� It was noted that Dr Cawthorne had asked SVS staff to bring forward the date of their next visit to slaughterhouses and head boning plants.� They were instructed, if they noticed any shortcomings, to notify the Official Veterinary Surgeon in writing, copying the letter to his or her regional manager.� The letter stated that:</div>
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�Naturally, SVS staff will not interfere directly in the operation of the plant as this is properly the responsibility of MHS staff where problems are encountered, however, SVS staff will make a second unannounced visit in the following two weeks.� If problems are still encountered, the MHS will be asked to consider taking a prosecution.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn364" name="_ftnref364" title=""><sup>[364]</sup></a></div>
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291.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 19 May 1995, an Animal Health Circular (AHC 95/74) was sent out, dealing with improper separation and staining of specified bovine offals.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn365" name="_ftnref365" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[365]</span></a>� The AHC said that a programme of regular visits to slaughterhouses and head boning plants provided for by Inset 25, section F, was to be supplemented by a period of national surveillance of all slaughterhouses and head boning plants handling SBO.� Every slaughterhouse and head boning plant known to handle bovine material was to receive an unannounced visit between 31 May and 23 June, even if the plant had only recently received a routine visit.� Each visit was to be undertaken by a VO, preferably accompanied by the AHO responsible for ongoing routine visits to that premise.� The AHC required that at each visit the VO should tour the premises, in the company of the Official Veterinary Surgeon, if he or she was present, and examine all aspects of the separation and staining of SBO, making checks as described in the new AHC insert.� In addition, they were to check for the following:</div>
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<span lang="EN-US">(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">that the plant possessed stocks of Patent Blue V and that it was being applied adequately and at the correct concentration, by a member of the plant�s staff;�<o:p></o:p></span></div>
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<span lang="EN-US">(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">that any SBO in storage awaiting transport had been stained properly.� This would give an indication of the quality of staining in the hours proceeding the visit;<o:p></o:p></span></div>
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<span lang="EN-US">(iii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">that Patent Blue V was only used to stain material that was SBO or was being mixed with SBO.<o:p></o:p></span></div>
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292.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Any premises at which it was found that SBO was not being separated or stained correctly was to receive a second unannounced visit by SVS staff, approximately 2 weeks later.� If defects were still found, a further letter was to be written to the OVS recommending that the MHS consider a prosecution of the plant operators.</div>
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293.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 24 May 1995, Dr Cawthorne minuted Mr Hewson and Mr Fleetwood regarding a recent meeting with Mr Meldrum to discuss whether skulls and vertebrae should be excluded from the production of gelatin destined for use in ruminant feed rations.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn366" name="_ftnref366" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[366]</span></a> Dr Cawthorne reported that Mr Meldrum was anxious to ensure that spinal cord was properly removed from vertebrae during the slaughtering process, that meat inspectors should take particular note of this operation and prevent carcases/parts of the carcase in which spinal cord was still in evidence in the vertebral column from entering the human/animal food chain. The amendment to AHC� 95/74, which was being prepared by Mr Fleetwood, required that in the course of their unannounced visits SVS staff should take particular note of whether spinal cord was being properly removed, and emphasised the need to ensure that all MHS staff understood the need for this to be carried out completely.</div>
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294.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 31 May 1995, Mrs Sadowski minuted Ms Heron of the Legal Division regarding requests from two councils for clarification on the scope of the Bovine Offal (Prohibition) Regulations 1989.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn367" name="_ftnref367" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[367]</span></a> The councils wished to know whether there was a requirement for SBO in knackers� yards and hunt kennels to be stained with the new blue stain and accompanied by a movement permit when moved. The minute reflected that the position continued to be complicated by the definition of premises referred to at regulation 12, which specifically excluded knackers� yards. In addition, the councils had raised the point that the 1989 Regulations defined SBO as deriving from a slaughtered animal, whereas hunt kennels took mainly fallen stock.</div>
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295.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 2 June 1995, Mr Hewson wrote to Mr Corrigan about the measures that could be taken to ensure that spinal cords were properly removed from the vertebral column of beef carcases.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn368" name="_ftnref368" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[368]</span></a>� Mr Hewson recognised that MHIs were ideally placed to check on proper removal of spinal cord, as the Fresh Meat (Hygiene and Inspection) Regulations 1995 required a carcase inspection after carcase splitting.� However, Mr Hewson did not believe that the same regulations could be used to withhold the health mark from carcases which were shown to have some spinal cord remaining.� He believed that MHIs should draw any incomplete removal to the attention of the plant operator, and ensure that the carcase did not leave the premises without proper removal of the spinal cord being carried out.</div>
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296.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 5 June 1995, Mr Corrigan sent a minute to all MHIs and OVSs drawing their attention to the relevant provisions of the Bovine Offal (Prohibition) Regulations 1989 and emphasising that MHIs should draw any incomplete removal of the spinal cord to the attention of the operator, and ensure that the carcase did not leave the premises without proper removal of the spinal cord.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn369" name="_ftnref369" title=""><sup>[369]</sup></a><sup></sup></div>
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297.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 12 June 1995, Mr Meldrum received a letter from Peter Carrigan, a consultant to the meat industry, regarding perceived gaps in the legislation controlling SBO.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn370" name="_ftnref370" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[370]</span></a>� Mr Carrigan stated:</div>
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�Put simply, people have cheated, and will continue to do so, because the legislation, updated though it may be, has gaps in it large enough to accommodate a horse and cart.� Because of that SBO will still be included in �meal� and the cycle remains unbroken.�</div>
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298.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In his letter, Mr Carrigan described practices which might be employed by �unscrupulous� abattoirs in order to evade the weight calculations designed to ensure, very approximately, that the correct amount of SBO material was being removed from slaughterhouses.� He commented that the remaining mesenteric fat (left after the necessary weight of SBO had been made up by unscrupulous methods) could be sold on the �black market�, thus defeating the system aimed at preventing SBO getting into the feed chain.</div>
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299.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 12 June 1995, Mr Eddy minuted the Parliamentary Secretary regarding concerns expressed Mr Meldrum about the possibility that there could be a loophole allowing SBO to enter the food chain for animals through knackers� yards and hunt kennels.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn371" name="_ftnref371" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[371]</span></a> Copies of the minute were provided to MAFF Ministers, Mr Carden, Mr Meldrum, Mr Haddon, Mr K Taylor, Mr Baker, Dr Cawthorne and Mrs Brown amongst others.� In particular, Mr Meldrum was concerned about the adequacy of the removal of spinal cord from the vertebral column.� The minute records that the spinal cord in animals over 6 months of age was an SBO and indeed the cervical spinal cord was one of the few tissues taken from clinically affected cattle in which BSE infectivity had been demonstrated. Mr Eddy stated that it was therefore important to ensure that none of this material could enter the food chain. Mr Eddy stated that in slaughterhouses MAFF were reasonably confident that the spinal cord was properly removed. The Meat Hygiene Service had clear instructions to give priority to ensuring that this was done. In knackers� yards and hunt kennels there was no routine presence and the main oversight was from a monthly visit from the State Veterinary Service. Mr Eddy explained that there was often difficulty in removing the tissues from animals if they had been dead for some time and had been allowed to decay. Mr Eddy stated that on balance, therefore, Mr Meldrum felt that it was necessary to extend the prohibition on skulls to a prohibition on the splitting of the vertebral column and removal of the spinal cord in animals being processed in hunt kennels or knackers� yards.</div>
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300.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 14 June 1995, Ms Heron of MAFF�s Legal Division minuted Mrs Sadowski.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn372" name="_ftnref372" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[372]</span></a> With regard to the question whether knackers� yards were covered by the Bovine Offal Prohibition Regulations, Ms Heron stated that �I think the most we could say is that we would hope that as a matter of good practice the regulations are observed in knackers� yards�. She also agreed that the requirement that animals to which the regulations were referred were slaughtered should be amended by the addition of the words, �or died�.</div>
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301.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 16 June 1995, Mr K Taylor minuted Mr Meldrum regarding his visit with Mr Bradley and Mr Simmons to a head boning plant.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn373" name="_ftnref373" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[373]</span></a> The visit was intended to assess the practicality of adopting a suggestion received in the course of the consultation, that removal of the front part of the skull be permitted in order to reduce the weight of the material which had to be treated as SBO. Having observed the skulls being cut in various places with a band saw, they were satisfied that the operation could be carried out without risk by making a single transverse cut starting not more then 1 inch behind the back molars and passing at least half an inch in front of the anterior rim of both orbits. This resulted in a 30% reduction of the weight. They were not, however, convinced that the procedure would be carried out satisfactorily without surveillance in every plant. They therefore suggested that plants should be licensed after a satisfactory veterinary assessment to carry out the operation and subject to regular unannounced inspections thereafter.</div>
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302.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 20 June 1995 Mr Anderson of the SOAEFD Meat Hygiene Branch, sent a letter to all interested organisations regarding changes to the controls for the collection and disposal of specified bovine offal.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn374" name="_ftnref374" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[374]</span></a> The letter stressed the importance of ensuring that spinal cord and in particular cervical spinal cord be properly removed so as to ensure that no such material could enter the food chain. The letter gave notice that it was now proposed that, as well as the prohibition on removing brain from skulls, the draft Specified Bovine Offal Order would include a prohibition on splitting of the vertebral column and removal of the spinal cord from bovine animals processed in hunt kennels or knackers� yards or in any place other than a slaughterhouse.</div>
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303.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 20 June 1995, Mr Corrigan sent an MHS Information Note to all staff advising that the HAT visits had identified failures in the controls on the disposal of SBO and in respect of BSE certification.� The note further stated that:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn375" name="_ftnref375" title=""><sup>[375]</sup></a></div>
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�It is imperative that plant based MHS personnel (in particular OVSs and SMHIs) liaise closely with plant management to ensure that all aspects of the detailed SBO disposal and BSE certification requirements as outlined in the Operations Manual are fully understood and implemented.�</div>
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304.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 21 June 1995, Mr Eddy, Dr Wight and Mr Lister attended the nineteenth meeting of SEAC.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn376" name="_ftnref376" title=""><sup>[376]</sup></a><sup> </sup>��Mr Eddy told the Committee that first reports from the audit of the MHS showed problems with SBO separation and that less than half the premises were staining properly.� The Committee were very concerned and felt that action should be taken as a matter of the highest priority. In discussion of the use of gelatin and blood in blood products in ruminant feedingstuffs, Dr Kimberlin stressed that the issue was really about SBO. He stated that �there should be no concern about gelatin, but the logic hinged on the proper removal of SBOs. If this was not being done satisfactorily, there was a risk�. Later, in discussing MRM, Dr Tyrrell noted that the key question was once again how effectively the SBO controls were being carried out. Dr Watson pointed out that the impact of prohibiting the use of spinal columns on the industry would be enormous. Dr Tyrrell concluded that, provided that in the slaughtering process the removal of the spinal cord was done properly, the MRM process was safe and there was no reason for the Committee to change its advice.</div>
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305.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In his minute of 26 June 1995 to Mr Taylor, Dr Cawthorne discussed the response to Mr Carrigan�s letter of 12 June 1995.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn377" name="_ftnref377" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[377]</span></a>� He stated:</div>
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�In replying, the problem is whether we ignore Mr Carrigan�s suggestion that we flush all bovine intestines, possibly leaving him to criticise us at a later date for not heeding his words or tackle the issue head on by saying we don�t see the need at this time.� I have chosen the latter course to minimise the chance of him coming back.�</div>
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306.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>However, Dr Cawthorne recognised that Mr Carrigan had a good point, and said that he had considered a number of measures which could be built into SVS/MHS standing instructions to counter the possibility of fraud.� The suggestions were as follows:</div>
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<span lang="EN-US">(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">check the non-SBO skip at slaughterhouses to ensure that no unstained bovine guts were present,<o:p></o:p></span></div>
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<span lang="EN-US">(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">inspect the SBO skip at slaughterhouses to check on staining and the extent to which guts were flushed or full,<o:p></o:p></span></div>
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<span lang="EN-US">(iii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">check for unstained bovine intestines in the non-SBO intake pits at rendering plants.<o:p></o:p></span></div>
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307.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Cawthorne�s minute ended:</div>
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�It goes without saying that we rely heavily on MHS staff to police the regulations in slaughterhouses.� If we can�t rely on them to enforce them and be alert to fraud, we will never get on top of the problem. I did not want to disclose these thoughts to Carrigan.�</div>
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308.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 27 June 1995, Dr Kimberlin wrote to Mr Eddy in his capacity as an independent MAFF consultant rather than as a member of SEAC.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn378" name="_ftnref378" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[378]</span></a>� Dr Kimberlin�s letter made his own suggestions for improving the monitoring of the SBO Regulations.� Dr Kimberlin�s advice was based upon the fact that the brain and spinal cord are considerably more infective than other tissues.� He suggested that monitoring of the SBO Ban concentrate on the measurement of the weight of brain and spinal cord material removed from carcases.� In conclusion he said:</div>
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�Neither I, nor anyone else would find it easy to justify a relaxation of the beef trade rules, without really sound data to indicate that the SBO ban is being implemented fully.� Good collection and staining records of spinal cords, the number of bovine heads, plus the combined weights of other offals would be an excellent way to address this problem.�</div>
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309.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 28 June 1995, Mr Meldrum responded to Mr Carrigan�s letter of 12 June 1995.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn379" name="_ftnref379" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[379]</span></a>� The letter placed the new auditing requirements of the SBO regulations in the context of a wider system of control.� It went on to say:</div>
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�We will seek to ensure that correct removal and storage of SBO at slaughterhouses will be rigorously enforced by the Meat Hygiene Service staff, and that MAFF State Veterinary Service staff carry out regular spot checks of all other points in the collection and disposal chain to monitor compliance.�</div>
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310.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Kimberlin�s letter of 27 June 1995 to Mr Eddy was copied to Mr Fleetwood by Dr Cawthorne. On 30 June 1995, Mr Fleetwood wrote to Dr Cawthorne saying that he believed that the proposed new SBO Order would adequately address concerns about bovine brains.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn380" name="_ftnref380" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[380]</span></a>� With regard to the spinal cord, he noted with interest the suggestion that its removal should be audited by virtue of a separate weight tally.� However, it was Mr Fleetwood�s view that the removal of spinal cord was the simplest matter for the SBO Regulations to deal with.� This was because the carcase would inevitably have to be inspected immediately after splitting by MHS staff, who had been instructed to ensure that all traces of spinal cord were removed.</div>
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311.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 4 July 1995, Mr Eddy minuted Dr Cawthorne about Mr Fleetwood�s comments regarding the auditing of spinal cord removal.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn381" name="_ftnref381" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[381]</span></a>� Mr Eddy stressed that he felt the problem associated with spinal cord did not end at the point at which it was removed from the carcase.� In his view, the public needed to be reassured about what happened to spinal cord after it had been removed.� His intention was to ensure that no spinal cord could be said to have entered the animal food chain, after the removal from carcases.�</div>
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312.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 4 July 1995, Mr Fleetwood minuted Mr Meldrum summarising the returns from the four week period of national surveillance that had been undertaken at slaughterhouses and head boning plants between 31 May and 23 June.<span class="MsoFootnoteReference" style="vertical-align: super;"> <a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn382" name="_ftnref382" title="">[382]</a></span> The survey supported observations from the field, that significant amounts of SBO had been leaving slaughterhouses and head boning plants, either inadequately or incorrectly stained, or not stained at all.� Some of the problems seemed to have arisen recently as a consequence of the requirement to change from black PN to patent blue V, but this did not seem to Mr Fleetwood an adequate explanation for those premises that were failing to stain at all.� Problems of separation of SBO were slightly less widespread and it was noted that no instances of failure to separate SBO from material intended for direct human consumption had been reported.� In conclusion, Mr Fleetwood stated that the overall impression of this snapshot view of the industry was that there was widespread and flagrant infringement of the regulations requiring staining of SBO.� Although the problems with separation were less extensive, there were grounds for suspecting that the highest risk tissues (brain and spinal cord) had been mixed with other by-products and processed for animal consumption.� He also expressed concern that some SBO might have been included in grade 2 tallow, which might have been incorporated into products subsequently used for human consumption.</div>
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313.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 6 July 1995, in the light of Mr Fleetwood�s earlier report, Mr Eddy minuted Mr Meldrum expressing concern at the results.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn383" name="_ftnref383" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[383]</span></a>� His minute was copied to Mr Haddon, Mr Taylor, Dr Cawthorne, Mrs Brown, Mr D Taylor, Mr Fleetwood and others.� Mr Eddy identified certain problems in respect of the funding of SBO enforcement.� MAFF had bid in the 1995 PES� for a sum of �150,000 for the MHS to cover the costs of SBO Enforcement, but there was no allocation in the current financial year.� Since this amounted to only about half an hour per month, Mr Eddy felt that it was possible that the MHS would argue that they needed more resources to be able carry out the operating instructions effectively.� However, Mr Eddy went on to suggest that in targeting the MHS activity they should concentrate on a programme of education of plant operators to ensure that they understood fully the requirements of the existing legislation.� Mr Eddy also suggested that it was necessary to ensure that the MHS had a clear order of priorities for enforcement of the SBO controls, paying attention first to the treatment of brains, then spinal cord, then guts.� Finally, he suggested that it might also be necessary, because of public health implications, to send SVS staff into slaughterhouses every few months to audit the arrangements, at least until they were satisfied that the SBO regulations were being properly applied and enforced by the MHS.�</div>
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314.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Cawthorne minuted Mr Eddy on 6 July 1995, copied to Mr Fleetwood and others, regarding Dr Kimberlin�s suggestion for improving the SBO audit.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn384" name="_ftnref384" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[384]</span></a>� Dr Cawthorne agreed that it was vital that brain and spinal cord were somehow singled out for particular� attention.� However, he was concerned that they should not deny the requirements of legislation where intestines were concerned, and felt that greater opportunities existed to circumvent legislative controls on their disposal.� He was most concerned to address the obvious fault detected in the recent survey of SBO collection and disposal in slaughterhouses through direct approaches to the MHS and follow up surveys by SVS staff.�</div>
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315.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 11 July 1995, Mr Crawford minuted Mr Meldrum regarding the results of the national survey on separation and staining of SBOs.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn385" name="_ftnref385" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[385]</span></a>� Mr Crawford expressed his concern that the picture painted in the report differed to such an extent from that painted by previous reports.� It was essential that the information was made available to ADsVFS (RVOs) so that they could carry out a detailed investigation to discover why there was such a difference.� This would be done as quickly as possible, but until the reports were received, it was difficult for him to make any meaningful comment.� Mr Crawford suggested that one possible explanation for the difference between this and earlier reports might be that the report was based on unannounced visits by VOs, instead of AHOs.� The introduction of the new stain might have had a contributory effect.� Finally Mr Crawford reported that it had been suggested by field staff that the MHS staff did not appear to be fully aware of the SBO requirements.� He suggested that if this were correct, MHS staff should be made aware of those requirements immediately.�</div>
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316.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 11 July 1995, Dr Cawthorne wrote to all DVOs, enclosing a new AHC 95/74, about follow ups from visits to slaughterhouses where problems had been found in respect of staining or separation of SBO material.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn386" name="_ftnref386" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[386]</span></a></div>
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317.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 12 July 1995, Mr Eddy put two submissions to the Permanent Secretary.� The first dealt with the new SBO controls implementing the proposals covered in the May 1995 submission, and the other reported on the failure of slaughterhouses to separate and stain SBO.� The second submission stated that these failures had no implications for human health, as the measures to ensure that infective material did not enter the human food chain were shown to be working effectively in that survey.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn387" name="_ftnref387" title=""><sup>[387]</sup></a></div>
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318.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 13 July 1995, Mr Packer sent a minute to the Minister and Parliamentary Secretary, attaching the two submissions which had been provided by Mr Eddy on 12 July:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn388" name="_ftnref388" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[388]</span></a></div>
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<span lang="EN-US">(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">on the reporting of the outcome of consultation on the draft Specified Bovine Offal Order, together with a revised draft Order for signature by the Parliamentary Secretary;�<o:p></o:p></span></div>
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<span lang="EN-US">(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">reporting the results of a special period of surveillance on the controls actually applied in respect of specified bovine offals in slaughterhouses and other premises.<o:p></o:p></span></div>
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319.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Packer stated that he thought the papers made a convincing case to the effect that measures already in place properly protected human health.� However, taken together they seemed to present real problems of presentation.� It might be regarded as unfortunate, for example, to be continuing to introduce more stringent requirements about the treatment of bovine skulls.� He said that they were aware now, which they were not previously, that a very small amount of infected brain could bring about the disease if fed orally, but even so, this explanation might not seem �overly convincing� to some who might consider that the situation should have been properly grasped long since.� He also commented that the unsatisfactory treatment of specified bovine offal in slaughterhouses reflected an unfortunate state of affairs, which had presumably existed for many years.� Finally, he suggested that they should institute a programme of random unannounced spot checks on compliance until further notice.</div>
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320.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In the final paragraph, Mr Packer discussed the presentational aspects:</div>
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�It is our well established policy in this area, as in others, which I commend, to be completely open on the facts.� This, however, leaves open whether a Parliamentary answer, as proposed, is the best way to proceed.� Also there is the question of our relationship with other departments, mainly the Department of Health, but also other Agriculture Departments.� The former, in particular need to be content with what is proposed; it is also vital they are prepared to agree that there is no risk to human health.� I suggest we need to consider these points also at an early meeting.�</div>
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321.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 13 July 1995, Mr Corrigan sent a memorandum to all MHS Regional Managers, all POVs, all OVSs, all MHIs and all ARMs, regarding the specified bovine offal controls.<sup> <a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn389" name="_ftnref389" title="">[389]</a></sup>�� Mr Corrigan included with his memorandum a copy of the SBO Control Responsibility Check List.� He requested that necessary steps be taken to ensure that each member of the Plant MHS Team, and relevant plant personnel, be made fully aware of the detail and requirements of the SBO controls, and to ensure that the controls were being fully complied with.</div>
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322.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 18 July 1995, Mr Hewson sent a minute to Mr Meldrum, Mr Crawford, Mr Haddon, Mr K Taylor, Dr Cawthorne, Mr D Taylor, Mr Eddy, Mr McNeill and Mr Corrigan, which recorded discussions held about control of the disposal of SBO in licensed fresh meat premises.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn390" name="_ftnref390" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[390]</span></a>� The meeting set out a system for an integrated approach to SBO enforcement as between the SVS and the MHS.�</div>
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323.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 18 July 1995, Mr Hewson wrote to Mr Meldrum regarding a meeting which had taken place between MAFF and MHS officials.� The meeting discussed the proposals which had been made to improve SBO control and monitoring.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn391" name="_ftnref391" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[391]</span></a> The minute noted that failure properly to stain and separate SBO had been identified by SVS staff in visits made pursuant to AHC 95/74.� The findings were confirmed at HAT visits made to a smaller sample of slaughterhouses by the MHS.� It was therefore agreed that a follow-up visit would be made and any deficiencies notified to MHS Head of Operation with copies to MHS Regional Manager.</div>
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324.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the same day, the Minister, Mr Hogg, held a meeting with Mrs Browning (the Parliamentary Secretary), Mr Packer, Mr Eddy, Mr Carden, Mr Meldrum, Mr Haddon, Mr Taylor, Mr Haslam (MAFF Director of Information), Mr Fleetwood, Miss Wordley and Miss A Evans.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn392" name="_ftnref392" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[392]</span></a> Amongst other things, they discussed the results of a survey on compliance with SBO controls. Of the 392 slaughterhouses and 43 head‑boning plants that were visited, failures to comply fully with the rules on SBO staining were found in 65% of plants, and failures to comply fully with the rules regarding the separation of SBOs from other materials to be sent for rendering were found in 14% of the plants.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn393" name="_ftnref393" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[393]</span></a> Mr Meldrum reminded the meeting that �there was no public health problem, there was not [sic] question of SBOs entering the human food-chain, the risk was of cross-contamination of animal feed�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn394" name="_ftnref394" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[394]</span></a> Mr Carden told the BSE Inquiry that the results �clearly reinforced the case for tighter rules and tighter enforcement�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn395" name="_ftnref395" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[395]</span></a>� The Minister �commented that were there to be any risk to human health it would be necessary to take immediate action . . . However, the costs of introducing these measures without a transitional period probably outweighed the nature and level of the risk to animal health�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn396" name="_ftnref396" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[396]</span></a></div>
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325.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>It was agreed at the meeting that several steps should be taken to publicise the newly agreed order and the slaughterhouse findings.�� These included a PQ, �a low-key background press briefing� by the CVO and letters to key MPs, �notably the Opposition Parties� spokesmen and the chairman of the Agriculture Select Committee�.�� The Minister also instructed that �it was important that the Department of Health were fully in the picture and that the Chief Medical Office (<i>sic</i>) would if necessary reiterate that there were no public health implications.�� It would also be important to notify the Commission and Germany�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn397" name="_ftnref397" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[397]</span></a></div>
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326.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Notification was sent to the Commission the day after the meeting.�� The letter explained the slaughterhouse findings at some length and informed the Commission that �in line with the Government�s policy of openness on BSE the unsatisfactory position has been announced to the UK Parliament and the Parliamentary Reply will be issued in the form of a Press Notice�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn398" name="_ftnref398" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[398]</span></a></div>
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327.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In the news release on the next day (19 July 1995), Mr Hogg announced a</div>
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�A strengthening of the rules for preventing tissue potentially infected with the BSE agent from entering the cattle feed chain � The Ministry has also indicated that there is room for improvement in the application of the current rules in some slaughterhouses and further action is under way to deal with this.</div>
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Mr Hogg emphasised that there were no implications for the human feed chain in these findings and that measures to protect human health were found to be working effectively in all cases.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn399" name="_ftnref399" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[399]</span></a></div>
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328.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>He further stated:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn400" name="_ftnref400" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[400]</span></a></div>
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�It is clear from the surveillance of slaughterhouses and head-boning plants that has been undertaken by my officials since the Government took over full responsibility for control of such premises in April this year, that current practice on the separation and staining of the specified bovine offals can be improved.� Most of the failings we have identified are comparatively minor in nature - for instance using the wrong stain - and plant operators have been given clear instructions on what they must do to put things right.� But some could have resulted in BSE infected material entering the animal feed chain.� Further follow up visits are being made to ensure that the faults have been rectified.� Where failings are not corrected we are prepared to bring prosecutions if necessary.�</div>
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329.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 19 July 1995, Mr Fleetwood wrote a short minute to Mr Meldrum setting out a progress report in respect of the second round of visits to slaughterhouses and head boning plants.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn401" name="_ftnref401" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[401]</span></a>� The minute recorded that in the vast majority of cases the problem had now been addressed. In 91% of premises where problems had been identified in respect of improper separation, the problems had been rectified. In premises where there had been problems with staining, 79% had now corrected the deficiencies.</div>
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330.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 25 July 1995, Mr K Taylor wrote to Mr Corrigan at the MHS regarding SBO compliance in slaughterhouses.� Mr Taylor reported that:<span class="MsoFootnoteReference" style="vertical-align: super;"> <a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn402" name="_ftnref402" title="">[402]</a></span></div>
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��despite our various control measures there have now been more than 20,000 cases of BSE confirmed in cattle born after the imposition of the ban on feeding ruminant protein to ruminant animals in July 1988.� The effectiveness of that ban should have been reinforced by the extension in September 1990 of the SBO ban from human to animal feed, which was intended to prevent transmission to non-ruminant species but should, incidentally, have reduced the effect of any contravention of the ruminant feed ban.� As at 30<sup>th</sup> June 1995 BSE had been confirmed in 468 cattle born after 30 September 1990.�</div>
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331.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Taylor stated that the EC Scientific Veterinary Committee in Brussels and SEAC were �increasingly reluctant to accept general statements of intent� about proper implementation of the controls, and were �beginning to demand some form of proof that what we say should happen actually does happen � not just sometimes but always�.</div>
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332.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 28 July 1995, Mr Fleetwood sent Mr Corrigan the results of the second round of SVS visits to slaughterhouses and head boning plants.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn403" name="_ftnref403" title=""><sup>[403]</sup></a><sup> </sup>�The report indicated that there were a number of outstanding problems. Mr Corrigan had advocated a progressive approach, concentrating on education in the first instance, and thereafter dealing with problems as they arose.� Mr Fleetwood and Mr K Taylor had discussed the results of the second round of SVS visits and concluded that a variety of different approaches might be needed.� Mr Fleetwood stressed the need for any premises, where a risk of contamination of meat for human consumption had been identified, to receive an immediate visit, so that the problem could be corrected by whatever means were necessary.� Problems such as the confusion as to which stain to use were considered to be less important, and in those instances Mr Fleetwood favoured a progressive approach.� Where �a bloody minded� attitude had been identified with slaughterhouse operators refusing to use the correct stain, Mr Fleetwood suggested that immediate steps should be taken to begin prosecution proceedings.� In conducting future visits, Mr Fleetwood thought it best that MHS take the lead on all visits, but he wanted SVS staff to be in attendance so that they could report back, and report on the outcome of any follow up visits.�</div>
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333.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 31 July 1995, Mr Corrigan sent a memorandum to all MHS Regional Managers, OVSs, MHIs and ARMs, concerning the revised Specified Bovine Offal Order, which was to come into force on 15 August 1995.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn404" name="_ftnref404" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[404]</span></a>� He stressed that the changes outlined formed a major part of the overall UK BSE controls which were being advised to the European Union.� He stated that it was imperative that they were distributed to the listed persons and effectively implemented in the very near future.� Mr Corrigan provided a copy of the SVS report form on SBO control arrangements so as to assist MHS staff in understanding the criteria which were to be used in assessing the effectiveness of the control measures.� The memorandum also recorded recent legal advice that suggested that paragraph 9 of Schedule 10 to the Fresh Meat Regulations permitted the residual presence of spinal cord being used as a reason for not health marking bovine carcases.</div>
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334.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 1 August 1995, Mr Eddy put a submission to the Parliamentary Secretary, Mrs Browning, reporting the early results of the second series of visits to slaughterhouses and head boning plants.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn405" name="_ftnref405" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[405]</span></a>� The minute was copied widely within MAFF and to the Territorial Departments.� Mr Eddy identified that two operators were found not to be separating SBO properly from material for human consumption.� These problems had not been found at the earlier visits to the two plants concerned.� In one plant, spinal cord was seen in one carcase and tonsils were not being properly removed from the heads.� In the other, brains were being removed from heads in a separate part of the plant, and the heads were then brought back for vacuum packing into the part of the factory processing meat for human consumption.� Mr Eddy stated that at first sight these were serious problems, particularly in the first plant, which if undetected could have led to SBO entering the food chain, though this needed to be carefully checked.� Mr Eddy reported that �State Veterinary Service staff gave on the spot advice to the operators to correct the problem.� Both plants are being visited� and we expect reports on those today�.� An article, which had appeared in Farming News on 28 July, had reported on the deficiencies mentioned in the recent Parliamentary Answer, suggesting that, if potentially contaminated material had been allowed to leak into the animal feed chain, it was likely that the same thing was happening in the human food chain.� Mr Eddy pointed out that the two instances reported in the recent survey meant that MAFF could not respond to that article in such robust terms as would have been possible on the basis of the first round of visits.�</div>
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335.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In his statement Mr Meldrum stated:</div>
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�I recollect that I was made aware of the spinal cord finding before I went on leave on 29th July, 1995 and, as a result, I left clear instructions that the slaughterhouse should be re-visited as soon as possible and attention should be directed at the satisfactory removal of spinal cord at all future inspection visits to other premises where SBOs were being removed from the carcase.� I also recollect that I was profoundly disappointed at this finding and expressed the hope that it would be a one off. Unfortunately this was not to be the case�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn406" name="_ftnref406" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[406]</span></a></div>
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336.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mrs Ratcliffe (P/S Mrs Browning) responded by manuscript note on 2 August that, �the Parliamentary Secretary has commented that <u>immediate</u> action is necessary to correct these problems.�</div>
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337.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 3 August 1995, an update on the results of the second round of visits to slaughterhouses and head boning plants was sent by Mr Fleetwood to Mr K Taylor and Mr Eddy.� The minute was copied to Mr Meldrum, Dr Cawthorne, Mr Soul, Mr Hewson, Miss Coales and Mr Lackenby. Mr Fleetwood reported that a third plant had been identified where problems of separation concerning food fit for human consumption had been identified.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn407" name="_ftnref407" title=""><sup>[407]</sup></a></div>
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338.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the same day (3 August 1995), Mr Eddy wrote to Mr Lister of the Department of Health regarding the results of the second round of visits to slaughterhouses.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn408" name="_ftnref408" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[408]</span></a> Mr Eddy described the three instances where SBO was not being separated adequately from material for human consumption. �Mr Eddy pointed out that �we can no longer be as robust as we were in the press notice about no infective material entering the human food chain.�� He went on to say that the problems were not such as to warrant a special announcement, or any special new measures other than the immediate action that was taken at the plants concerned.� Mr Eddy said that he was inclined to await the results from the third round of unannounced visits, which should be out in the autumn, before advising on any further announcements.� He said that he would welcome the views of the Department of Health.</div>
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339.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span><span lang="EN-US">On 4 </span>August<span lang="EN-US"> 1995, Mr Lister copied Mr Eddy</span>�s letter to Dr Wight, stating that Dr Calman and the Department of Health Ministers needed to be briefed on the findings. He said:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn409" name="_ftnref409" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[409]</span></a></div>
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�SEAC will clearly need to discuss the implications at the next meeting, but it comes down, as always, to the need for adequate policing of slaughterhouse practices. Once all the visits are completed � there is a third series to come in the Autumn � we will need to consider how the results affect our assurance to the public that, following the SBO ban, no potentially infective material can enter the human food chain.�</div>
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I agree with Tom that there is no need to consider a public statement until the third series of unannounced visits has been completed�.</div>
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340.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Calman became aware of these findings of non-compliance with the SBO regulations either at the time of Mr Lister�s minute to Dr Wight or shortly thereafter.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn410" name="_ftnref410" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[410]</span></a></div>
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341.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 4 August 1995, Mr G Hollis of MAFF�s Livestock Group minuted Mr Eddy regarding the early results of the second round of SVS visits to slaughterhouses.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn411" name="_ftnref411" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[411]</span></a>� Mr Hollis stated:</div>
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�Your minute of 1 August came as an unwelcome surprise, since it revealed that at least one plant has been cutting carcases so poorly that SBO could be entering the food chain.�</div>
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342.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hollis pointed out that the problems described in Mr Eddy�s letter of 1 August 1995 came to light as a result of unannounced visits by the SVS, despite the fact that the MHS had been asked to monitor SBO compliance.� He stated that the findings gave rise to the following questions:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn412" name="_ftnref412" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[412]</span></a></div>
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why had these problems not been detected by the Meat Inspectors/OVS at the plants?</div>
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what is the MHS going to do about this?</div>
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will disciplinary action be taken by the MHS?</div>
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is legal action being considered against the plant?</div>
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343.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In a minute of 4 August 1995, Mr Strang wrote to Mr Eddy about a recent briefing meeting with the Minister.� The Minister had expressed concern about the outcome of the second round of visits to slaughterhouses.� In particular �the case involving spinal cord could be very serious.� The Minister agreed that in general terms the approach outlined by Mr Carden should be pursued, namely:</div>
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<span lang="EN-US" style="font-size: 11pt;">�(i)�� tightening up the rules wherever there was evidence that action was needed;<o:p></o:p></span></div>
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<span lang="EN-US" style="font-size: 11pt;">(ii)�� tightening up enforcement, making prosecutions when companies repeatedly infringed the legislation.<o:p></o:p></span></div>
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<span lang="EN-US" style="font-size: 11pt;">(iii)� making prosecutions when companies repeatedly infringed the legislation.<o:p></o:p></span></div>
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<span lang="EN-US" style="font-size: 11pt;">The Minister commented that we should certainly not shrink from (iii)�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn413" name="_ftnref413" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[413]</span></a><o:p></o:p></span></div>
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344.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Eddy replied to Mr Hollis on 7 August stating (amongst other things that:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn414" name="_ftnref414" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[414]</span></a><o:p></o:p></div>
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�I think you will find that most of these questions have been answered in my minute to Mrs Browning.� In relation to the piece of spinal cord left behind in a carcase I think we have to keep this in proportion.�� We are talking about one carcase in an entire chillroom of carcases and also of course all the other meat plants which were checked had no problems with spinal cords.�� In this particular case we are told that there was a new operative on the line and the offending piece of spinal cord was removed before the carcase left the slaughterhouse.�� Nevertheless it had already been inspected and passed and I know that the Meat Hygiene Service are taking action to ensure that meat inspection does pay particular attention to this question of the spinal cord.�� In future meat will not be given its health stamp unless the inspector is absolutely sure that the spinal cord has been removed.�</div>
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345.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 7 August 1995 Mr Eddy minuted Mrs Browning� in response to her comment on his minute of 1 August that immediate action was necessary to correct problems found in slaughterhouses during the second round of SVS visits and also dealt with Mr Hollis� minute of 4 August to Mr Eddy.�He explained:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn415" name="_ftnref415" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[415]</span></a></div>
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�2.� The results of all the unsatisfactory visits have been taken up with the Meat Hygiene Service�to take immediate action to get the various problems corrected.� We asked for top priority to be given to immediate correction of the problems in the small minority of slaughterhouses where the risk of contamination of material for human consumption.� This has been done and those practices have been ceased.</div>
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3.� Turning to other plants which still had problems but only in relation to the animal feed chain.� Some premises had ordered but not yet received the new stain for specified bovine offals, and some were still genuinely confused about the rules.� The MHS are working with those plant operators to ensure that the right procedures are put in place as soon as possible and we expect these problems to be resolved quickly.� Three operators are however refusing to buy the new stain and we have told the MHS that immediate steps should be taken with a view to begin prosecution proceedings.</div>
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4.� A third round of unannounced visits to plants where it is not clear that all the problems have now been resolved will be undertaken shortly which will, if necessary, be used to collect evidence for prosecution.� The results of these visits will be available in September when an overall report will be made to Ministers.� No decisions on prosecutions will be taken without consulting Ministers.�</div>
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346.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mrs Browning responded to Mr Eddy by Mrs Ratcliffe�s manuscript note of 8 August, saying:</div>
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�Mrs Browning is keen to see para 3 implemented quickly, and has commented that she wishes to be alerted to any problems that arise with this or other BSE-related matters.�</div>
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347.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 8 August 1995, AHC 95/119 was circulated to all veterinary staff. The circular requested that visits be undertaken to all plants where deficiencies had been discovered during the second round of visits to slaughterhouses made under AHC 95/101.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn416" name="_ftnref416" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[416]</span></a> Mr Fleetwood wrote to Mr Soul of the MHS on the same day, endosing the new AHC stressing the need for �robust� action to be taken in respect of the deficiencies in SBO compliance.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn417" name="_ftnref417" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[417]</span></a></div>
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348.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 11 August 1995, Mrs Brown of the Meat Hygiene Division clarified a misunderstanding over the respective roles of her Division and Animal Health (Disease Control) Division under the new MHS Agency arrangements.� As a result, Animal Health (Disease Control) Division became the customer of the MHS for SBO work in the MHS Memorandum of Understanding, and Mr Eddy therefore became accountable for the public expenditure costs.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn418" name="_ftnref418" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[418]</span></a><span class="MsoFootnoteReference" style="vertical-align: super;"></span></div>
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349.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 15 August 1995, the Specified Bovine Offal Order 1995 came into force.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn419" name="_ftnref419" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[419]</span></a>� The Order, made under the Animal Health Act 1981, replaced and extended the previous SBO Regulations made under the Food Safety Act 1990 and the Animal Health Act respectively. It tightened controls on record-keeping, introduced dedicated lines for rendering plants processing SBO, prohibited the removal of brains and eyes so that the whole skull had to be disposed of as SBO, and prohibited the removal of spinal cord from the vertebral column apart from in slaughterhouses.</div>
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350.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 17 August 1995, Mr Jones of Eville and Jones wrote to Mr Corrigan at the Meat Hygiene Service.� Mr Jones set out a summary of the deficiencies found as at 1 April 1995 in the plants attended by Eville and Jones.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn420" name="_ftnref420" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[420]</span></a>� The deficiencies included, in the majority of areas, identification of incomplete removal of spinal cord. Deficiencies in respect of staining and separation of SBOs were noted in a number of cases, as well as poor control over movement. In some plants, obvious lymphatic and nervous tissue had not been removed during boning.� Bovine intestines had been included in bins of fat and not stained.� Pieces of intestine were removed with mesenteric fat and not treated as SBO.� The report ended by saying that most of the points outlined had undergone significant improvement over the five months since 1 April 1995.�</div>
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351.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 22 August 1995, Dr Cawthorne minuted Mr K C Taylor regarding the second round of SVS visits to abattoirs and head boning plants.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn421" name="_ftnref421" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[421]</span></a>� Dr Cawthorne reported that 272 premises were visited and in 198 separation and staining of SBO was found to be satisfactory.� Problems were found in 74 plants.� There was inadequate separation in five plants, ineffective staining in 59 plants and inadequate separation and staining in 10 plants.� In the three plants identified in Mr Fleetwood�s minute of 3 August 1995, the major problems with separation appeared to have been rectified. Dr Cawthorne reported that he had spoken to Mr Corrigan and MHS Regional Managers.� They had undertaken to provide a statement identifying for each of the 74 plants where inadequate separation and staining was detected (a) whether the inadequacies had been corrected, (b) if not, why not, identifying mitigating circumstances, and (c) those plants which were candidates for prosecution.</div>
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352.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 25 August 1995, Mr Meldrum wrote to Dr Metters at the Department of Health regarding Mr Eddy�s letter of 3 August to Mr Lister.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn422" name="_ftnref422" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[422]</span></a>� Mr Meldrum said that in his view Mr Eddy painted a more alarmist picture than was justified by the circumstances.� Although many faults had� been found, particularly relating to the staining of SBO, there was no risk to public health in any of the three cases because each was spotted and corrected.� He said:</div>
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�It is of course, true that there may be other undetected cases where SBO is not properly removed and destroyed, but this has always been the case and is still the case now.� The argument for strict enforcement is clear, the Meat Hygiene Service is aware of it, and the new SBO legislation that has just been introduced, although primarily directed to protecting the health of cattle, should simplify their task in some respect.� The Meat Hygiene Service has issued specific and detailed instructions to its staff on the checks that must be carried out to ensure compliance with the legislation.�</div>
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353.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Metters replied on 1 September that it was �helpful to have this amplification� and that, as Mr Meldrum�s letter had noted, �this strengthens the case for strict enforcement by the Meat Hygiene Service�.�� Dr Metters also noted that there were plans to report the latest results at SEAC�s next meeting and that �both our Departments will benefit from having an up-to-date comment from SEAC�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn423" name="_ftnref423" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[423]</span></a><o:p></o:p></div>
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354.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 8 September 1995, SEAC discussed the results of SVS visits to slaughterhouses.� Their discussions are recorded in Mr Eddy�s minute of 11 September 1995 to Mr Meldrum.� The minute was copied to Mr Haddon, Mr K Taylor, Dr Cawthorne, Dr Matthews, Mr Fleetwood, Mr Lackenby, Miss Coales, Mrs K Brown and Mr D Taylor.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn424" name="_ftnref424" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[424]</span></a> Mr Eddy said that Mr Fleetwood had given a very clear and convincing exposition of the findings from the final round of intensive visits to slaughterhouses.� The Committee were reassured by the progress from the first round of visits and by the fact that MAFF were continuing to visit on an unannounced basis.� Mr Eddy observed that:</div>
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�They accepted we now had a grip on this but the point was made that it would have been better to have done this five years ago and we will clearly have major problems with the Committee unless we can give them constant reassurance that we are keeping up the pressure and that there has been no back sliding.�</div>
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355.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Following his attendance at the SEAC meeting, Mr Fleetwood wrote to Mr Corrigan on 18 September 1995.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn425" name="_ftnref425" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[425]</span></a>� As a result of the concerns raised by SEAC, Mr Fleetwood asked that the MHS should draw to the attention of their staff in individual plants the need to ensure that fragments of spinal cord were removed, kept separate and included in the weight audit at all points along the production line.�</div>
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356.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 20 September 1995, Mr Corrigan sent a memorandum to all MHS staff with responsibilities under the SBO regulations.<sup> <a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn426" name="_ftnref426" title="">[426]</a></sup>� The minute reported that disposal of SBO had been discussed at a recent meeting of SEAC.� Mr Corrigan recorded that SEAC welcomed the efforts made by the MHS and progress made.� However, the Committee had drawn particular attention to the fact that fragments of spinal cord might become detached or be removed at a number of points along the process line. SEAC had asked that the MHS should draw this to the attention of inspectors at individual plants, asking them to ensure that all such fragments were collected together and included in the weight audit.</div>
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357.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 26 September 1995, Mr Corrigan sent a memorandum to all MHS Regional Managers about continued attention to ensure SBO compliance.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn427" name="_ftnref427" title=""><sup>[427]</sup></a>� The memorandum noted that the SVS second round of visits to licensed plants had been completed and that Mr Corrigan had been advised that any outstanding problems had been rectified.� Mr Corrigan reported that the SVS had been instructed to carry out further unannounced visits and therefore stressed the necessity of paying attention to SBO controls at all bovine plants within each region.</div>
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358.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 29 September 1995, MAFF distributed an Animal Health Circular ACH 95/148 to ADsVFS, the VHS at Pentland House (SOAEFD), RMHAs, MHAS� and VOs (MH) (for action) and other veterinary staff (for information).� It discussed the revised instructions on the meat hygiene duties of SVS staff following the inception of the MHS.� The instructions reiterated, with minor changes, the instructions on licensing and the revocation of licences in fresh meat and poultry meat premises, and introduced monitoring of MHS performance by the SVS.� Instructions on completion of temporary derogations and the approval of premises for export to third countries were included.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn428" name="_ftnref428" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[428]</span></a></div>
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359.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 6 October 1995 Mr Fleetwood minuted Dr Cawthorne about the outcome of SVS Surveillance of SBO.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn429" name="_ftnref429" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[429]</span></a> Mr Fleetwood enclosed a table outlining the reasons why certain premises inspection was found to be unsatisfactory and continued: �the results show a less than satisfactory outcome. I am particularly disappointed with the high failure rate at slaughterhouses, especially in view of the recent efforts made by the SVS�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn430" name="_ftnref430" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[430]</span></a></div>
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360.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>�On 11 October 1995 Dr Cawthorne minuted Mr Meldrum about a meeting which the latter was due to hold with MHS officials that evening.� The meeting was to discuss the slaughterhouse findings and hear the �action plan� which the MHS had drawn up to tackle the problems.�� The plan included �instructions to MHS staff in each abattoir to sign a log book at the end of each day indicating that checks have been carried out on SBO separation and staining and that all is in order.�� Principal OVSs will be asked to visit problem plants to be sure that MHS staff are doing their job properly: disciplinary measures will be instituted if necessary.�� Where problems rest with plant management, Investigation Branch will be invited to collect evidence for prosecution�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn431" name="_ftnref431" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[431]</span></a></div>
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361.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 12 October 1995, Mr Fleetwood minuted Dr Cawthorne<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn432" name="_ftnref432" title=""><sup>[432]</sup></a> confirming that the poor SBO results he reported on 6 October 1995 <a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn433" name="_ftnref433" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[433]</span></a> did, in fact, represent serious problems.� He stated:</div>
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�In my report of 6 October, I hinted that some of the poor results recorded at slaughterhouses in August/September may have arisen as a result of field staff applying exceptionally strict inspection criteria during their visits.� I understand that similar opinions have recently been voiced by the MHS.</div>
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�</div>
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��I have to report to you my opinion that some of the SVS results reflect genuine, continuing problems, some reflect differences of opinion which require a firm lead from us and some may reflect over-strict interpretation of the rules by the SVS.�</div>
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362.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In his evidence to the Inquiry, Mr Eddy commented that, with the benefit of hindsight, the fact that these allegations were made suggested that those directly involved in enforcement work in slaughterhouses might, until this point, had been applying a degree of tolerance of minor failings, which Mr Eddy did not believe was ever asked of them in their instructions.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn434" name="_ftnref434" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[434]</span></a>�</div>
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363.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 13 October 1995, Dr Cawthorne reported to Ministers on the further round of abattoir surveillance. Mr Eddy received a copy of the report.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn435" name="_ftnref435" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[435]</span></a>� The note suggested that there were differences of interpretation amongst veterinary field staff in some respects, but not on key issues.� The results were again �disappointing�. They are referred to in more detail in relation to Mr Soul�s minute of 18 October 1995 to MHS Regional Managers, which is described below.</div>
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364.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 18 October 1995, Mr Soul wrote to MHS Regional Managers asking them to identify those plants where there was genuine non-compliance and those cases which might warrant a prosecution.<sup> <a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn436" name="_ftnref436" title="">[436]</a></sup>� This information was to be passed to York Headquarters, so that letters could be written to the relevant individual plants.� At the same time, Mr Soul wrote to all MHS staff in beef plants about the most recent results of SVS visits. Mr Soul recorded that, while the second round of SVS visits were quite satisfactory, the results of the most recent round were quite disappointing.� In the latest round 52% of plants were found to have satisfactory controls in place, whilst 48% of plants failed to satisfy the reviewing SVS Veterinary Officer in some aspects of SBO controls.� The most recent failures included:</div>
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(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>inadequate separation of SBO;</div>
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(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>failure to stain SBO comprehensively;</div>
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(iii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>unsatisfactory record keeping of SBO by plant management;</div>
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(iv.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>consignment to inappropriate destinations.</div>
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365.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Soul stressed that it was imperative that plant management and MHS staff fully appreciated the importance of implementing SBO controls in full as part of the national effort to control SBO.� In addition, the MHS OVS was required to ensure that a daily entry was made by himself/herself or the SMHI/MHI in the MHS daybook at each plant, verifying that full compliance with SBO regulations had occurred on that day.�</div>
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366.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 20 October 1995, Mr Soul wrote to MHS Regional Managers informing them that he had received reports that SVS staff were continuing to find cases of health marked beef sides with pieces of spinal cord still present in the spinal canal.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn437" name="_ftnref437" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[437]</span></a> Mr Soul asked all plant-based staff to be made aware that they must not permit the health mark to be applied to beef sides until all the spinal cord had been removed.</div>
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367.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 20 October 1995, Mr Meldrum put a submission up to Mr Hogg and Mrs Browning (copied widely to other MAFF Ministers, officials and Territorial Departments) informing them about the first case of BSE in an animal born in 1993.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn438" name="_ftnref438" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[438]</span></a> He said that this was</div>
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�not surprising� It can readily be explained by our current thinking on the causes of BABs and no further action is needed in response to this case. The leakage out of our BSE control system and through our feed mills is thought to have continued beyond 1992, and so cases born in 1993 and later years can be expected.� <a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn439" name="_ftnref439" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[439]</span></a></div>
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368.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Meldrum noted that the animal was only 25 month old at clinical onset, and that the EC, �possibly prompted by the Germans�, might want to shorten the current restriction on exporting beef from cattle over 30 months old. He said that this �would make exports more difficult and we would try very hard to resist this��<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn440" name="_ftnref440" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[440]</span></a></div>
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369.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 20 October 1995 Mr Fleetwood minuted Dr Cawthorne in respect of the three occasions during September�s surveillance when SVS staff had noted that spinal cords were not being removed correctly from beef carcases (all of which had nevertheless received the health mark).<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn441" name="_ftnref441" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[441]</span></a>� Mr Fleetwood was pleased to report that in each case SVS staff had �followed their Inset instructions to the letter�.� In two of the cases problems had been resolved on the revisit and results were awaited on the third.</div>
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370.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 23 October 1995, Mr Meldrum wrote to Sir Kenneth Calman to report that the findings of the SVS staff�s bi-monthly audit of all abattoirs and boning plants were �disappointing�.� However, he said that �in all cases, an unannounced visit, approximately a fortnight later, showed that spinal cord was being removed correctly and in its entirety�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn442" name="_ftnref442" title=""><sup>[442]</sup></a><sup> </sup>Mr Meldrum�s letter was accompanied by a draft PQ which was still to be approved by Ministers. Mr Meldrum told Dr Calman that he was to have a meeting with the industry in order to �impress upon them the importance of compliance with the requirement to fully separate and dispose of SBO�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn443" name="_ftnref443" title=""><sup>[443]</sup></a> Though measures were being taken to correct the problem, Mr Meldrum said that such instances were inevitable to a certain degree as �no system operated by humans can deliver at 100% efficiency all the time.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn444" name="_ftnref444" title=""><sup>[444]</sup></a></div>
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371.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In evidence Mr Meldrum stated:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn445" name="_ftnref445" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[445]</span></a></div>
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�Lastly, I would just say I was a little bit surprised when he expressed his surprise in his statement about the letter I wrote to him on 23rd October 1995.� On its own, yes, I can understand his concern but there had been some earlier discussions with Sir Kenneth which he may have forgotten about for the moment when I expressed to him my personal concerns about the SBO controls prior to a meeting that took place with the Meat Hygiene Service on 11th October 1995, when, if you like, I expressed my extreme displeasure at the fact that there were significant problems with the SBO controls and I asked Johnston McNeill and Peter Soul to do everything they possibly could to achieve full compliance.� I had thought that Sir Kenneth was aware of that meeting and my concerns at that time.�</div>
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372.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In his statement to the BSE Inquiry, Sir Kenneth Calman said that, when made formally aware of these breaches:</div>
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�immediate action was taken to obtain the requisite assurances from MAFF that the SBO bans would be enforced rigorously to safeguard public health.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn446" name="_ftnref446" title=""><sup>[446]</sup></a></div>
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373.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Sir Kenneth stated that the Department of Health had �no enforcement responsibilities� in relation to compliance with the SBO regulations.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn447" name="_ftnref447" title=""><sup>[447]</sup></a>� They relied upon MAFF for current and accurate information. This position was supported by Dr Wight, who stated that MAFF not only had a �considerable amount of information about the state of the BSE epidemic�,<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn448" name="_ftnref448" title=""><sup>[448]</sup></a> and were �responsible� for communicating this information to DH and SEAC as required.�</div>
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374.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In evidence to the Inquiry Dr Rubery was asked about the DH involvement in monitoring the enforcement of meat hygiene legislation and representation on the MHS ownership board:</div>
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��[MAFF] would make the legislation in regard to meat hygiene, and I assume they give guidance which they may well consult us on, and any responsibility for monitoring and ensuring that guidance was implemented would lie with them and the local authorities who presumably employed those who inspected.<o:p></o:p></div>
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MR WALKER:� Suppose they were to revise their guidance, which part of the Department of Health would they consult with then?<o:p></o:p></div>
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DR RUBERY:� They would then consult with us in terms of asking if we were content with what was in the guidance, but we do not lead, we would then give advice to them.<o:p></o:p></div>
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MR WALKER:� You have mentioned, Dr Rubery, that you were on the board of the --<span style="font-size: 8pt;"><o:p></o:p></span></div>
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DR RUBERY:� Meat Hygiene Services Board, yes.<o:p></o:p></div>
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MR WALKER:� Why was that?<o:p></o:p></div>
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DR RUBERY:� For that reason, because we have an interest in the meat hygiene side of things being enforced in slaughterhouses and abattoirs, therefore it is important that we are aware of what is going on and we perform the useful function of reminding MAFF of the health implications of the work that they are supervising, but it is not our responsibility to lead, and that would be reflected by the fact that Mr Carden, Grade 2 in MAFF, was the Chairman of Meat Hygiene Services Board, and Meat Hygiene Services reported into MAFF rather than into the Department of Health.<o:p></o:p></div>
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MR WALKER:� Would it be right to describe it as a two way process, that on the board you would be able to contribute a Department of Health perspective, and equally, from your work on the board, you would be able to bring back to the Department of Health the Meat Hygiene Services perspective?<o:p></o:p></div>
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DR RUBERY:� Yes, and MAFF's perspective as well.� These perspectives are very different, because each part does� react with a different constituency, and it is very important when you are trying to make the best decision to be aware of all the pressures that are acting on all the different partners in that decision, so yes, I think� the Meat Hygiene Services Board is very useful in that context.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn449" name="_ftnref449" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[449]</span></a><o:p></o:p></div>
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375.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 23 October 1995, the Daily Mail reported the fourth case of CJD in a cattle farmer.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn450" name="_ftnref450" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[450]</span></a> The newspaper had �received a late draft of the statement when it was faxed incorrectly by a DH official and went to a private Fax number�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn451" name="_ftnref451" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[451]</span></a>� Later that day, SEAC released, via the Department of Health, their statement announcing the fourth (suspected) case of CJD in a cattle farmer. The statement said</div>
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�it was difficult to explain this as simply a chance phenomenon. There is a statistical excess of cases in cattle farmers compared with the general population but the absolute risk, even for cattle farmers, is extremely low at about 2 cases per million per year. There may be other explanations for such an association besides infection with BSE, and the Committee noted that there are no reported cases in other occupational groups such as veterinarians who might be expected to be similarly exposed. They also noted that surveillance of CJD elsewhere in Europe has shown a similar incidence of CJD in farmers, including dairy farmers��<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn452" name="_ftnref452" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[452]</span></a></div>
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376.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Skinner of the Department of Health told the BSE Inquiry that the information about a possible fourth case of CJD in a farmer, together with the slowly emerging information concerning breaches of the SBO ban, caused considerable unease.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn453" name="_ftnref453" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[453]</span></a></div>
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377.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 24 October 1995, Mr Lister minuted Dr Harvey, PS/CMO, concerning the draft PQ that Mr Meldrum had sent to Dr Calman on the day before. He said that the CMO �will wish to know that the removal of SBOs was discussed by SEAC on 8 September�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn454" name="_ftnref454" title=""><sup>[454]</sup></a> Mr Lister summarised the evidence presented in the PQ for Dr Harvey as follows:<sup> <a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn455" name="_ftnref455" title=""><span lang="EN-US">[455]</span></a></sup></div>
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������ continuing cases of BSE in animals born after the feed ban indicate that SBOs may well have got into animal feed because of inadequate controls at slaughterhouses. We cannot therefore rule out the possibility that SBO may have got into the human food chain. This concern is supported by evidence from the recent unannounced visits to slaughterhouses; <u>but</u></div>
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������ new MHS inspection system means that the situation is now being controlled and opportunities for contamination should become rare. However, we can�t yet say that the problem is resolved, and this concern is shared by the SEAC.�</div>
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378.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Wight and Mr Lister discussed the wording of a proposed CMO statement and proposed the following:</div>
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�In view of the uncertainty surrounding slaughterhouse procedures, it is impossible to give a complete assurance that Specified Bovine Offal has not entered the food chain. However, it is exceedingly unlikely that this has happened to any great extent and, importantly, I remain satisfied that there is no scientific evidence of a link between meat-eating and the development of CJD in humans.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn456" name="_ftnref456" title=""><sup>[456]</sup></a></div>
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379.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the same day (24 October) Dr Cawthorne minuted the Permanent Secretary with a background note to the SVS audit of SBO separation in abattoirs.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn457" name="_ftnref457" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[457]</span></a>� Dr Cawthorne summarised the results of the first and second round of visits and the subsequent bi-monthly unannounced audits of abattoirs.� He explained that the results for September revealed that problems were still in evidence and that,</div>
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�As a consequence, the CVO met the Chief Executive and senior managers of the MHS on 11 October and expressed his serious disquiet at what the SVS was uncovering in the course of their audits.� The point was made forcibly, that the responsibility for enforcing controls in abattoirs rested with MHS staff on-the-spot.� It was highly unsatisfactory that SVS staff should continue to identify faults which MHS inspectors should have picked up in the course of their duties.� The MHS were concerned at the results of these audits and expressed a commitment to ensuring that SBO separation and disposal was properly enforced in plants.�</div>
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380.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 25 October 1995, Mr Lister also wrote to Ms Woodeson, PS/Parliamentary Secretary (Lords), with a briefing. He outlined the current position of the Department of Health on the BSE epidemic. The brief stated that SBOs thought to contain infective agent and banned from use in human and animal food �may have been getting into animal feed because of poor controls at slaughterhouses.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn458" name="_ftnref458" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[458]</span></a> It also said that MAFF had addressed this problem �at least in part, by transferring responsibility for slaughterhouse inspections from local authorities to the Meat Hygiene Service.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn459" name="_ftnref459" title=""><sup>[459]</sup></a></div>
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381.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 25 October 1995, Dr Calman met Mr Packer for a more detailed discussion.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn460" name="_ftnref460" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[460]</span></a> In his evidence to the BSE Inquiry, Dr Calman summarised the meeting as follows:</div>
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�� I expressed a number of concerns I had as a result of the lapses in the SBO ban which had been identified. These were the continuing high number of BSE cases being reported, although this was declining, the high number of cases born after the feed ban which implied that controls in feed mills were inadequate and discovery that SBO had not always been properly removed in slaughterhouses and the fact that four farmers had contracted CJD. Despite the fact that I received assurances that enforcement of the SBO ban would be carried out vigorously in feed mills and slaughterhouses and that the Meat Hygiene Services would be left in no doubt of the high priority of this measure I requested an immediate meeting with the Minister.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn461" name="_ftnref461" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[461]</span></a></div>
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382.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Packer minuted the Minister regarding this meeting on 25 October.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn462" name="_ftnref462" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[462]</span></a>� The minute records that the Permanent Secretary said that the Department would pursue �with vigour� the following:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn463" name="_ftnref463" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[463]</span></a><o:p></o:p></div>
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�(i)�� proper liaison with DoH on matters such as PQs. Perhaps those to whom this minute is copied could ensure there are no hitches in this area in future;</div>
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(ii)�� continued monitoring of feed mills. I�ll be grateful if AHVG could report urgently on the monitoring in place and how this might be made more effective;</div>
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(iii)� the monitoring of adherence to the regulations in slaughterhouses and in particular the correct treatment of Specified Bovine Offals. I have said we will ensure that the Meat Hygiene Service were in no doubt whatsoever as to the priority to be accorded to this objective by a directive from new or some other means;</div>
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(iv)� BSE to take first priority on the R&D budget.</div>
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He also proposed that MAFF should �call in the slaughterhouse owners and, in effect, read the riot act�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn464" name="_ftnref464" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[464]</span></a>� The Minister read the Secretary�s minute �with concern� and asked for �an urgent meeting� with officials and a separate meeting with the CMO.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn465" name="_ftnref465" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[465]</span></a><o:p></o:p></div>
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383.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Packer arranged for Dr Calman to meet Mr Hogg on 7 November 1995.</div>
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384.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 27 October 1995, with the agreement of the CVO and senior colleagues, Mr Eddy recommended to Ministers that the SVS double the audit frequency of slaughterhouses, that they move more quickly to prosecutions and that the Minister write to the Chief Executive of the MHS to instruct him formally that appropriate steps should be taken to ensure that the MHS staff enforce the regulations properly.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn466" name="_ftnref466" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[466]</span></a></div>
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385.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 30 October 1995, the Minister and the Parliamentary Secretary (Mrs Browning) held a meeting on BSE with senior officials.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn467" name="_ftnref467" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[467]</span></a><span class="FootnoteReferencedfa" style="vertical-align: super;"> </span>The note of the meeting records that those present re-examined everything from �the origin of BSE� to the �increase in CJD cases, and in cases in unusually young people�.�� The Permanent Secretary described �the potentially very serious matter of cases where SBO matter - in particular spinal cords - had not been properly removed from carcases.�� We had to take and be seen to take all necessary action to put this right.�� He recommended that the Minister should call in the Chief Executive of the Meat Hygiene Service to stress that he attached the highest importance to strict enforcement of our provisions.�� The Minister agreed . . . The meeting should be followed by a formal letter�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn468" name="_ftnref468" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[468]</span></a><o:p></o:p></div>
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386.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The Minister also �agreed that the MHS should launch prosecutions where that was appropriate . . . [and] that he should call in, as a group, the key organisations, telling them clearly that the results of our inspections in September showed that they were not doing well enough . . . The Minister would also want to arrange a visit to a slaughterhouse . . . Mrs Browning should hold separate meetings with the knacker industry and the hunt kennels ��<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn469" name="_ftnref469" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[469]</span></a><o:p></o:p></div>
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387.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The Permanent Secretary said that �BSE research remained an absolute priority in the PES round . . . It was agreed that the Minister should invite in Dr Tyrrell for a valedictory meeting on these issues�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn470" name="_ftnref470" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[470]</span></a>�� �The Minister and Mrs Browning both expressed concern about reports of CJD among farmworkers.�� Mrs Browning added that �we should not be too dismissive . . . of the possible link between farming and CJD�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn471" name="_ftnref471" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[471]</span></a>��� On public presentation, �the Minister said that he would make plain that the September results of the surveillance exercise to monitor compliance showed that things were not as they should be�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn472" name="_ftnref472" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[472]</span></a>�� The meeting also agreed that it was �very important to liaise closely with the Department of Health and to keep Scottish and Welsh Offices informed�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn473" name="_ftnref473" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[473]</span></a><o:p></o:p></div>
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388.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 1 November 1995, the Meat and Livestock Commission wrote to the Minister expressing their concern about SBO controls. Mr Render prepared a draft reply for the Minister on 6 November 1995.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn474" name="_ftnref474" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[474]</span></a><span class="FootnoteReferencedfa" style="vertical-align: super;"></span></div>
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389.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 3 November 1995, Mr Hogg wrote to the Cabinet Sub-Committee, EDC(P), to inform them about the discovery of breaches of the SBO regulations.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn475" name="_ftnref475" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[475]</span></a></div>
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390.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 3 November 1995 Mr Render minuted Mr Strang enclosing a draft covering letter (addressed to the Deputy Prime Minister) for the EDC(P) paper on BSE.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn476" name="_ftnref476" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[476]</span></a>� The draft covering letter discussed the recent surveillance visits by the SVS to slaughterhouses stating that:</div>
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�[These visits] have revealed a number of failings in the handling of specified bovine offals (SBOs)�.</div>
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In the recent SVS audits we found four instances where small pieces of SBO (spinal cord in all cases), was left attached to carcases in slaughterhouses after dressing�.� This is a potentially serious failing, as it could risk exposing the public to SBOs ��</div>
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Where serious failings are found they [the MHS] will prosecute slaughterhouse operators�..� Given the potentially serious nature of some of the failings, I am minded to issue to the Chief Executive a formal instruction to ensure that his staff enforce the regulations rigorously.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn477" name="_ftnref477" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[477]</span></a></div>
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391.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 6 November 1995, Mr Hogg met Mr Johnston McNeill, Chief Executive of the Meat Hygiene Service (MHS).<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn478" name="_ftnref478" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[478]</span></a> Mr Hogg gave a formal instruction to the MHS regarding the enforcement of the SBO regulations and,</div>
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��stressed the importance of our controls on SBOs in our strategy for the control and eradication of BSE. He was very concerned about the results of the most recent SVS audit of SBO handling in slaughterhouses. Clearly there had been a number of failings. We had to consider together how to make the slaughterhouses do better.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn479" name="_ftnref479" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[479]</span></a></div>
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The minute continued:</div>
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�The Minister made clear that Mr McNeill should not hesitate, where appropriate to prosecute � [The] research findings implied that even a very small amount of BSE could have serious implications��</div>
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392.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr McNeill said he would immediately �issue instructions to MHS staff stressing the importance of 100% compliance�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn480" name="_ftnref480" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[480]</span></a> Mr Carden agreed that �we could not tolerate anything less than 100% compliance�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn481" name="_ftnref481" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[481]</span></a></div>
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393.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr McNeill said that, �in terms of the technology, there was no reason for non-compliance.� There were, however, operational implications.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn482" name="_ftnref482" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[482]</span></a>� These operational implications were likely to slow turnover significantly in some plants and to avoid this, more inspectors would be needed which would �in turn imply an extra cost for MAFF.� The Minister asked whether the MHS had access to sufficient staff.� Mr McNeill said that there was no problem in terms of recruitment and availability.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn483" name="_ftnref483" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[483]</span></a></div>
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394.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In evidence Mr Hogg stated:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn484" name="_ftnref484" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[484]</span></a></div>
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�If you take the Meat Hygiene Service, it was possible for Angela and myself to call in Johnston McNeill, which we did in November 1995, and give him formal instructions, which you will recall is set out in the papers, and I can take you to them if you want.� A formal instruction I gave to Johnston McNeill to say (a) you are to ensure 100 per cent compliance, (b) you are to prosecute and (c) if any of your officials do not do their jobs, they will face disciplinary action.�<o:p></o:p></div>
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Giving a formal instruction, which was under the framework agreement, which we will also find in the papers, is a very rare thing because it is a re-ordering of priorities.�<o:p></o:p></div>
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395.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 7 November 1995, Mr John Pratt, President of the Association of Meat Inspectors (GB) Ltd, wrote to all members stressing the importance of full compliance with the SBO regulations.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn485" name="_ftnref485" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[485]</span></a><span class="FootnoteReferencedfa" style="vertical-align: super;"></span></div>
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396.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>To help prepare Dr Calman for the meeting with Mr Hogg on 7 November, Mr Lister prepared a minute about a paper on BSE/CJD that had gone to the Cabinet Sub-Committee, EDC(P). The minute discussed the differences in wording proposed by DH and MAFF, which Mr Lister said was �indicative of the unwillingness of some MAFF officials to accept the lapses in SBO controls as an issue of genuine public health concern, as opposed to one about the undermining of public confidence in the safety of British beef�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn486" name="_ftnref486" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[486]</span></a></div>
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397.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 7 November 1995, Dr Calman and Dr Metters met Mr Hogg, Mrs Browning, Mr Packer and Mr Osborne. Mr Hogg informed Dr Calman of �the likely findings of the October SVS audit of the handling of SBOs in slaughterhouses: this merely confirmed the need to take decisive action�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn487" name="_ftnref487" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[487]</span></a></div>
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398.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Calman expressed his concerns. He said that the origins of the disease were not understood well enough. Although the science was reassuring, he was concerned about the cases in farmers with BSE in their herds and in young people, and the fact that cases of BSE were not dropping off as predicted.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn488" name="_ftnref488" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[488]</span></a> He was also worried about controls at the slaughterhouse and at the feedmill. The note of the meeting recorded his view that:</div>
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�Although he could continue to say with complete confidence that there was no evidence that British beef, that is meat as commonly understood, was not safe, it could not be said with confidence that no offal which might have been contaminated had entered the food chain. This reduced confidence that the public was being properly protected. If he was pressed on this point � and therefore by implication on the safety of food containing mechanically recovered meat � he would be in a difficult position; he would need to think very carefully about a suitable form of words. He reiterated that we should bear in mind that there remained no evidence of a link between CJD and BSE; the difficulty was that we might not know for sure for another year or two. We were therefore still talking about no more than a hypothetical risk. But it was easy to imagine how quickly the connection would be made in people�s minds.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn489" name="_ftnref489" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[489]</span></a></div>
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399.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Calman<span lang="EN-US"> felt that the processes to control SBOs which were now in place were satisfactory, but that those in the past had not been.</span> Dr Calman �found the attitude of the farming industry and slaughterhouses astonishing, particularly given the threat to the whole future of the sector�. Dr Metters said that he had noticed MAFF�s attitude change over the last six weeks: �there was now no inclination to tolerate any failure to remove SBOs�. Mr Hogg told of his meeting with Mr McNeill the previous day, that he had told Mr McNeill not to hesitate in prosecuting if the evidence justified doing so and that Mr McNeill had said that there were no technical reasons why the industry should not be able to comply with the regulations. Mr Hogg added that he would shortly be seeing representatives from the slaughterhouse industry, and that his message would be �uncompromising�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn490" name="_ftnref490" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[490]</span></a></div>
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400.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Calman told the BSE Inquiry:</div>
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�I recall informing the Minister that my concerns would have been greatly reduced but for the recent findings which led to my concluding that there was a potential for contaminated offal to have entered the food chain. By implication this led to concerns about the safety of food containing mechanically recovered meat.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn491" name="_ftnref491" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[491]</span></a></div>
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401.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hogg gave the following evidence to the Inquiry:</div>
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SIR NICHOLAS PHILLIPS: �It seems to me what Dr Calman is saying here is, �I am happy to say it is safe to eat beef. I am certainly not happy to say it is safe to eat offals, and what is worrying me is it looks as though some of these offals have been getting into the food chain�.</div>
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MR HOGG: It worried me too and that is why I took the action I did.</div>
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MR WALKER: Did you understand him to be saying that there was any change in his perception of the risk from SBOs, as opposed to the risk of SBOs getting into what humans eat?</div>
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MR HOGG: What you are putting to me I think is: was he changing his position on transmissibility? That is what you are putting to me, are you not?</div>
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SIR NICHOLAS PHILLIPS: Did he think the belt was being nibbled?</div>
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MR HOGG: Exactly. That is, I think, the question that is being put to me. I think the answer to that is no, not at that stage, but he was concerned about leakage of SBOs and I agreed with him. It was a serious matter.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn492" name="_ftnref492" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[492]</span></a></div>
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402.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 8 November 1995, Mr Soul wrote to all OVSs in the following terms:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn493" name="_ftnref493" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[493]</span></a></div>
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�It has come to my attention that some members of the profession may have adopted a somewhat <i>laissez-faire</i> approach.� They seem to believe that a <b>reasonable</b> level of compliance with the SBO Order is acceptable.� That is not the case.� <b>Only 100% compliance is acceptable</b>.� I am confident that the vast majority of OVSs realise just how important it is for farmers and the UK beef industry that we all strive to ensure that there are no deficiencies with respect to SBO controls in our plants.</div>
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I know that I do not need to remind you that there are perceived public health as well as actual animal health implications.� We have a duty to ensure that all potential risks to public health as well as all animal health risks are eliminated or minimised.�</div>
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403.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 8 November 1995, the Veterinary Public Health Association also wrote to all OVSs regarding the SBO controls.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn494" name="_ftnref494" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[494]</span></a><span class="MsoFootnoteReference" style="vertical-align: super;"> </span>Martin Cooke, President of the VPHA, wrote to lend his support to the actions being taken by the MHS to ensure fully effective control of the handling, separation and staining of SBO�s in licensed beef premises.</div>
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404.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 8 November 1995 Mr Hogg wrote to Mr McNeill to repeat his concerns at breaches of SBO regulations, and instructed him �in accordance with the provisions of paragraph 4.3 of the Meat Hygiene Service�s framework document, to ensure that appropriate steps are taken to see that your staff in slaughterhouses enforce the Specified Bovine Offal Order 1995 fully.�� Failure to comply with these regulations is an extremely serious matter.�� I must therefore ask you to make every effort to secure 100% compliance.�� In particular, your staff must ensure that all SBO is removed from a carcase before they give it a health stamp.�� Failure to do so should be viewed extremely seriously.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn495" name="_ftnref495" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[495]</span></a></div>
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405.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the same day, Mr McNeill wrote to all MHIs and SMHIs regarding the specified bovine offal controls.<span class="MsoFootnoteReference" style="vertical-align: super;"> <a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn496" name="_ftnref496" title="">[496]</a></span>� The letter stressed the importance of SBO controls, and ended by stating:</div>
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�YOU MUST NOT APPLY THE HEALTH MARK TO ANY BEEF SIDE YOU UNLESS ARE ABSOLUTELY CERTAIN THAT ALL THE SPINAL CORD HAS BEEN REMOVED.�</div>
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The letter also stressed that any failure on the part of MHIs to comply fully with their responsibilities would be dealt with as a serious disciplinary matter and could ultimately lead to dismissal.</div>
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406.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The letter further stated that if staff were obstructed in any way by plant management whilst carrying out their instructions, they were to record the incident in their day book, and report the matter to their OVS, who would be expected to note and act on the incident and report it to the Regional Manager as a matter of urgency.� Finally, the letter indicated that there had been discussion on these matters with Unison and the Association of Meat Inspectors, and that full agreement had been reached as to the actions which were to be taken.</div>
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<span class="FootnoteReferencedfa" style="vertical-align: super;"><span style="vertical-align: baseline;">407.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span></span>On 9 November 1995, Mr Fleetwood�s report to Dr Cawthorne on the October round of checks on SBO removal at slaughterhouses was circulated.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn497" name="_ftnref497" title=""><sup>[497]</sup></a><span class="FootnoteReferencedfa" style="vertical-align: super;"><span style="vertical-align: baseline;"><o:p></o:p></span></span></div>
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408.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span><span lang="EN-US">Also on 9 November 1995, Mr Hogg met representatives of slaughterhouse operators �to discuss some failings found in the handling of specified bovine offals.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn498" name="_ftnref498" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[498]</span></a>� The note of the meeting records that the Minister was,</span></div>
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�insisting on 100% compliance . . . The industry should be clear about this: prosecutions would be undertaken. There would be no further warnings.[The industry representatives] said that the Minister was preaching to the converted, [and acknowledged that] the system had not in the past always operated as it should have. However, there had been significant improvements since the MHS took over responsibility. [The industry] were right behind MAFF and would comply [but insisted that] it was not possible, with the best will in the world, to prevent very small amounts of SBO material passing unnoticed�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn499" name="_ftnref499" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[499]</span></a>.</div>
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The industry pressed for the costs of SBO removal to be borne by Government or by EU funds.�� The Minister continued to insist that compliance must be absolute and that it would be for the slaughterhouses to bear the costs, at least in the first instance.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn500" name="_ftnref500" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[500]</span></a></div>
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409.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In evidence <span lang="EN-US">Mr</span> Hogg recalled:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn501" name="_ftnref501" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[501]</span></a><o:p></o:p></div>
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I called them in.� It was a fairly sanitised report by Frank Strang.� It was a fairly tough meeting. I read the riot act.� It is all in the documents.� They were pretty hostile to what they were being told, and actually they were saying, broadly speaking, "We cannot give you 100 per cent compliance, do not be silly, only go for the serious cases".� I was saying, "That will not do at all.� I intend to prosecute, you will comply and I do not want any excuses, thank you very much".� It was a pretty rough meeting; I do not mind that, that was the way it was.<o:p></o:p></div>
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410.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span><span lang="EN-US">In the press release issued afterwards, he said:<span class="MsoFootnoteReference" style="vertical-align: super;"> <a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn502" name="_ftnref502" title="">[502]</a></span></span></div>
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�I said that I would only be satisfied with 100 per cent compliance with the rules and informed them that the Meat Hygiene Service would enforce the controls most rigorously.�</div>
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411.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 10 December 1995 Mr Robb sent two minutes to Dr Calman�s private secretary, copied to Dr Metters, Dr Wight and Mr Clark, about the possible CMO statement that Dr Wight and Mr Lister had drafted on 24 October.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn503" name="_ftnref503" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[503]</span></a> �Minor� amendments had been received from MAFF and incorporated.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn504" name="_ftnref504" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[504]</span></a> Dr Wight had suggested a revision be used as Press Office line over the weekend, if pressed.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn505" name="_ftnref505" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[505]</span></a> The revised draft said that it was impossible to be certain that SBO had,</div>
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�not entered the food chain. However, it is exceedingly unlikely that this has happened to any great extent and I am reassured by the steps taken to ensure that it does not happen in the future. I remain satisfied that there is no scientific evidence of a link between meat-eating and the development of CJD in humans.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn506" name="_ftnref506" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[506]</span></a></div>
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412.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 16 November 1995 Dr Wight wrote to Mr Eddy in relation to the recent� MAFF paper for EDC(P).� Dr Wight stated that the Department�s views had not been sought before the paper was sent to Cabinet and added:</div>
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I would like to register the CMO�s and Department�s concerns over the generally reassuring tone of the paper.� Perhaps this is best illustrated by reference to one or two specific points, for example:</div>
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3<sup>rd</sup> indent under �<u>Protection of public health�.</u>Surely it is an overstatement to say �All BSE suspect animals are killed��� Whilst most of those with disease are slaughtered and compensation given, it seems clear that not every single one is picked up.� Omitting the �All� would give a more accurate reflection of the situation.</div>
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1<sup>st</sup> three indents under �<u>Protection in Slaughterhouse�.</u>The potential significance of the inspection findings should have been emphasised, particularly as we are aware to date of ten instances of non-compliance with SBO requirements. This must cast doubts on the safety of some products for human (and animal) consumption.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn507" name="_ftnref507" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[507]</span></a></div>
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413.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 20 November 1995, there was a meeting between Mr Meldrum, Mr Taylor, Dr Matthews of MAFF, Mr Wells of the CVL and Drs Calman, Metters and Wight of the Department of Health. They discussed the progress of transmission studies. They also discussed MRM.� Mr Meldrum said the concern arose because of the possible inclusion of small residues of spinal cord. However, it was observed that �SEAC had visited slaughterhouses and had decided that it was not necessary to recommend a ban�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn508" name="_ftnref508" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[508]</span></a></div>
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414.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Meldrum discussed the audit checks which were being undertaken by MAFF in slaughterhouses, which had revealed �some problems related to spinal cord�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn509" name="_ftnref509" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[509]</span></a> The note of the meeting records that:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn510" name="_ftnref510" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[510]</span></a></div>
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�[It] was not possible any more to say that we could guarantee that potentially infectious material (spinal cord) could not get into the human food chain, albeit in small amounts.� Clearly we have improved the situation in the last year or so but we cannot be 100% certain, particularly with the risk of inclusion of some spinal cord in MRM produced from vertebral column which would be used in cheap food.� That is not to say we believe that any member of the public may necessarily have been exposed to an infective dose but in presentational terms there is certainly a problem.�</div>
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415.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Meldrum stated, and the CMO and Dr Metters agreed, that in risk assessment there was a difference between MRM produced from cull cows and that from young cattle, which was less of a risk.� However, it was agreed that MRM was an issue which needed to be revisited and this would be put to the SEAC at its meeting on 23 November.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn511" name="_ftnref511" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[511]</span></a></div>
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416.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 22 November 1995, Mr Hogg made public, by a response to a PQ, the results of the SVS�s unannounced visits to slaughterhouses. He said:<span class="MsoFootnoteReference" style="vertical-align: super;"> <a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn512" name="_ftnref512" title="">[512]</a></span></div>
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�In the most serious cases we found small pieces of spinal cord, ranging in size from 1 cm to one third of the spinal cord, left attached to the carcases after dressing. So far, we have found 17 such instances, including one found during preliminary visits in the summer and five found up to 10 November and one on 20 November in the latest round of visits�</div>
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417.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The Minister went on to outline the steps he had taken to ensure full compliance: he had asked the MHS to ensure �most rigorous� enforcement of the SBO Order and to prosecute failing slaughterhouses where it has sufficient evidence; he had asked the SVS to double the frequency of its unannounced visits; and he had met slaughterhouse operators on 9 November �to impress on them the need for full compliance with these controls�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn513" name="_ftnref513" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[513]</span></a></div>
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418.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 22 November 1995 Mr Eddy replied to Dr Wight�s letter dated 16 November 1995 concerning the MAFF paper for EDC(P).� Mr Eddy stated that it was not an overstatement to say, �All BSE suspect animals are killed�; since all reported animals which receive a preliminary diagnosis of BSE are slaughtered.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn514" name="_ftnref514" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[514]</span></a>� On the other hand, he stated it would be an overstatement to say �that all animals with BSE are killed since that would imply that we were picking up as suspects all animals at any stage of the disease, which clearly we cannot do before manifestation of any detectable symptoms�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn515" name="_ftnref515" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[515]</span></a>.� It is for this precise reason, he stated, that the SBO ban was in place, adding:</div>
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I accept that we do need to make sure that the slaughter policy and the SBO controls are closely allied in any presentation and that we have never, and would never, seek to suggest that the system for picking up disease in the animal is foolproof.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn516" name="_ftnref516" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[516]</span></a></div>
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419.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 22 November 1995, Dr Metters minuted Dr Wight about the meeting of SEAC on the following day.� The minute was copied to PS/Baroness Cumberlege, PS/Dr Calman, Dr Skinner, Mr Sutherwood, Mr Clark and Mr Robb. Dr Metters said that Ministers wanted advice from SEAC on three issues:<span class="MsoFootnoteReference" style="vertical-align: super;"> <a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn517" name="_ftnref517" title="">[517]</a></span></div>
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�a.�� in the light of the number of failures to remove [SBOs] in slaughterhouses, what is SEAC�s view about the potential risk to human health from MRM? Ministers wish CMO to have SEAC�s advice on this specific point in case he (CMO) is asked that particular question.</div>
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b.��� do SEAC have any further advice or explanation of the number of farmers with CJD. You will be aware that CMO is asked about the labelling of animal feeds. A further question relates to SEAC�s advice and comments on recent cases of CJD among teenagers.</div>
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c.���� arising from SEAC�s review of research, what further studies do they now recommend to Ministers.�<b><o:p></o:p></b></div>
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420.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The minute passed on Mr Dorrell�s emphasis that SEAC�s advice was for Ministers:<span class="MsoFootnoteReference" style="vertical-align: super;"> <a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn518" name="_ftnref518" title="">[518]</a></span></div>
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�It was essential that any conclusions reached were <u>not</u> communicated direct to the public, despite the fact that SEAC is known to be meeting tomorrow.�</div>
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421.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>At the SEAC meeting of 23 November 1995, Mr Eddy reported the results of the latest round of inspection visits, which included several reports of small quantities of spinal cord being left in carcases.� This was a worse result than those of the earlier surveys.� In his evidence to the BSE Inquiry, Mr Eddy reported that SEAC were �appalled� by this because they had been reassured about �this sort of thing�, and felt that they had been given assurances that the chances of this happening were very low.� Mr Eddy went on to say:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn519" name="_ftnref519" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[519]</span></a></div>
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�I told the Committee that a number of investigations were under way with a view to prosecution and reassured them that the assurances which I and my pre-decessor had given had been in good faith and on the basis of the information we had.� Personally I felt as disappointed as the Committee.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn520" name="_ftnref520" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[520]</span></a></div>
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422.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>SEAC�s advice regarding MRM was as follows:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn521" name="_ftnref521" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[521]</span></a></div>
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�Earlier in 1995 SEAC had concluded that �provided in the slaughtering process the removal of the spinal cord was done properly, the MRM process was safe and there was no reason for the Committee to change its advice.</div>
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In the light of the current audit reports showing failure to remove parts of the spinal cord in a small number of carcasses the Committee expressed its grave concern.</div>
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It noted the further tightening up of controls but felt that unless and until it was clear that the removal of SBO, particularly spinal cord, was now being undertaken properly in all cases it would be prudent, as a precaution, to suspend the use of vertebrae from cattle aged over six months, in the production of MRM.�</div>
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423.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Following the receipt of SEAC�s advice MAFF held meetings on 27 and 28 November 1995.� Discussion at these meetings concerned the introduction of an Order banning the use in food of mechanically recovered meat from the vertical column of cattle (to apply to MRM from all bovines; not just those aged over 6 months as in the SEAC recommendations).<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn522" name="_ftnref522" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[522]</span></a>� Consultation with industry representatives was also discussed.</div>
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424.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 30 November 1995 various MAFF personnel met with industry representatives concerning the latest advice from SEAC and introduction of an Order banning the use of vertebral column of a bovine animal (of any age) in MRM for human consumption.� The purpose of this meeting was to listen to the industry�s views.�</div>
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425.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 14 December 1995, Mr Swann of the MHS presented to the editorial group his draft report on the MHS HAT exercise in red meat plants.� It stated as follows:<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn523" name="_ftnref523" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[523]</span></a></div>
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�Meat Inspectors are frequently expected to trim visible contamination, remove SBO, expose kidneys and strip pleura.� It is recommended that, with the possible exception of bovine tonsil removal, all these practices should be the responsibility of the plant staff.</div>
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Spinal cord was not fully removed from all bovine carcases.� Bones containing spinal cord may be processed into animal feed, providing a possible source of infection to cattle��</div>
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����������� The draft report continued:</div>
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�Contamination on carcases awaiting despatch reflected poor dressing practices and debris on oil rails etc.� Inspection deficiencies included procedural irregularities and SBO retention, in a number of plants, especially those with fast line spreads.�<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn524" name="_ftnref524" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[524]</span></a></div>
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426.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>It was noted that the vast majority of plants do not mark waste buckets or bins in the cutting room �unfit for human consumption� or �SBO�, deficiencies which should be rectified.�</div>
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427.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The final published report, entitled �Review of the Hygiene Advice Team Audit of Licensed Slaughterhouses in Great Britain 1995�, makes no mention of SBO controls other than to say that �SBO removal in the slaughterhall was carried out in accordance with the legislation�.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn525" name="_ftnref525" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[525]</span></a></div>
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<a href="https://www.blogger.com/null" name="_Toc456173198">Events in 1996</a></div>
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428.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 4 January 1996, Mr Fleetwood minuted Dr Cawthorne with the third routine report on the outcome of SVS surveillance of SBO.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn526" name="_ftnref526" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[526]</span></a>� Mr Fleetwood commented:</div>
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�Once again, a significant improvement in SBO disposal has been recorded compared with the previous month.� Very few problems are now being recorded other than a few lingering defects in staining and record keeping.� The results for rendering plants appear poor at first glance, but with only three plants visited, a single failure has produced an unrepresentative result�</div>
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Looking at the results as a whole, I think that SVS field staff and MHS staff should be congratulated for their excellent performance which has resulted in significant improvements in the industry.�</div>
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429.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 20 March 1996, the MHS received a Ministerial Direction, which implemented the recommendations of SEAC to take all possible steps to ensure full and complete removal of SBM from beef carcases.� The Minister issued a new formal instruction in accordance with paragraph 4.3 of the MHS Framework Document<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn527" name="_ftnref527" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[527]</span></a>.� The instruction to the MHS was to take all possible steps to ensure full and complete removal of specified bovine offal from carcases, and in particular:</div>
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(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>There must be constant supervision at the point in the slaughter line where the spinal cord is removed, to ensure complete removal,</div>
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(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>MHS must ensure that where there was any evidence of contamination with SBO tissue, <span lang="EN-US">this</span> was removed by cutting off the contaminated tissue and disposing of it as SBO; and also</div>
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(iii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>MHS must ensure that all visible traces of spinal cord were removed with <span lang="EN-US">particular</span> care taken that no debris was left in the spinal canal or adjacent to the vertebral column.� It was concluded that carcases should be inspected more than once to achieve this.</div>
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430.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Estimates were requested from the Meat Hygiene Service of the cost of covering the stricter standard of operation called for in the Minister�s letter.� Costings were provided to Mr Richard Carden on 21 March 1996.<a href="https://web.archive.org/web/20000830210453/http://www.bse.org.uk:80/dfa/dfa15.htm#_ftn528" name="_ftnref528" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[528]</span></a></div>
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Terry S. Singeltary Sr.</div>
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Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-4687453285836897153.post-10101238610454541272017-08-26T15:20:00.003-05:002017-08-26T15:20:57.917-05:00DFA 14 Consideration of the Risk from Mechanically Recovered Meat (MRM) in 1989-1990<div class="Section1" style="page: Section1;">
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<span style="font-family: Arial;">DFA 14 ������ </span><span style="font-family: Arial; font-size: 10pt;"><img border="0" src="https://web.archive.org/web/20000830210922im_/http://www.bse.org.uk:80/dfa/bselogo.gif" /></span></div>
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<span style="font-size: 24pt;">Consideration of the Risk from Mechanically Recovered Meat (MRM) in 1989-1990<o:p></o:p></span></div>
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<span style="font-size: 11pt;">Draft Factual Accounts ������������������������������������������������������� 9 July 1999<o:p></o:p></span></h1>
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<span style="font-family: Arial; font-size: 11pt;">This is one of a series of documents intended to provide an account as at the date of publication of the factual evidence received by the Inquiry. The documents do not make any judgements about the implications of the facts or point to any conclusions. They are simply working drafts seeking in a neutral way to set out relevant evidence. They do not contain any expressions of opinions by the Secretariat or the Committee of the Inquiry. The series will only cover certain areas of the evidence.<o:p></o:p></span></div>
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<span style="font-family: Arial; font-size: 11pt;">The DFAs may contain inaccuracies and omissions. The purpose of publishing them is to invite corrections, additions and comments. The Inquiry has received suggestions for such corrections and additions in relation to DFAs already published. This is helpful in furthering the work of the Inquiry; all suggestions are considered and used to update the Secretariat�s working papers which will form the basis of the Committee�s Report in due course. The DFAs should not be treated as setting out a complete and accurate appreciation of the relevant facts.<o:p></o:p></span></div>
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<span style="font-family: Arial; font-size: 11pt;">You are invited to let the Secretariat know of any errors, inaccuracies or material omissions in this DFA. It would be helpful if you could distinguish suggested amendments to the DFA from more general comments which would not involve such amendment. Please write to:<o:p></o:p></span></div>
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<strong><span style="font-family: Arial; font-size: 11pt;">������������������ The Secretary<br />The BSE Inquiry<br />6<sup>th</sup> Floor<br />Hercules House<br />Hercules Road<br />London SE1 7DU</span></strong><span style="font-family: Arial; font-size: 11pt;"><o:p></o:p></span></div>
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<strong><span style="font-family: Arial; font-size: 11pt;">Email to : inquiry@bse.org.uk</span></strong><span style="font-family: Arial; font-size: 11pt;"><o:p></o:p></span></div>
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<span style="font-family: Arial; font-size: 11pt;">Responses should reach the Secretariat by 9 August 1999 for them to be of most assistance to the Inquiry.<o:p></o:p></span></div>
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<a href="https://www.blogger.com/null" name="_Toc456157468">Draft Factual Account 14 � Consideration of the Risk from Mechanically Recovered Meat (MRM) in 1989-1990</a></div>
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1.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The Bovine Offal (Prohibition) Regulations 1989 introduced a ban on the sale or use of specified bovine offal in food intended for human consumption.� The Regulations were made on 8 November 1989 and came into force on 13 November 1989.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn1" name="_ftnref1" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[1]</span></a>� They did not contain any specific measures concerning the manufacture or sale of mechanically recovered meat.</div>
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2.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 30 November 1989, Miss Jones of the Meat Hygiene Division in MAFF sent a minute to Mr Maslin of the Animal Health Division, with copies to Mr D Taylor, Mr K Taylor, Mr Hutchins, Ms Rimmington and to the Territorial Departments, regarding a call she had received from �a rather unhappy Environmental Health Officer from Carrick District Council (Cornwall)�.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn2" name="_ftnref2" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[2]</span></a>� The caller maintained that the Bovine Offal (Prohibition) Regulations were �unworkable�.� Miss Jones said that he would not go into details over the telephone, but that she had gathered that his chief concerns were over what he saw as unnecessary requirements for movement permits, and the danger of contamination of meat arising from the practice of splitting heads to remove the brain.� In respect of the former, Miss Jones said that she had invited him to let her have his observations in writing, preferably via the Institution of Environmental Health Officers (IEHO).� With regard to head splitting, Miss Jones asked Mr Maslin to consider whether it was necessary to amend the regulations.� Miss Jones set out her own view as follows:</div>
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�My own reaction to this is that we have never attempted to, nor can we, ensure that <u>all</u> of the risks from this material (minimal though they are) are eliminated.� I should have thought that the removal of the brain and other specified bovine offal by whatever means carries some unavoidable risk of cross-contamination.� However, I should be grateful for your advice on whether we should consider taking up this point in our amendments.�</div>
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3.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The issue of the use of heads for MRM processing has been raised on several occasions during the Inquiry hearings.� Mr Soul told the Inquiry that �heads are not really suitable for the production of MRM...because the enamel of the teeth was such as to damage the machine.�<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn3" name="_ftnref3" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[3]</span></a>� Mr Hibbett agreed with the Chairman that heads would go off for MRM production after removal of the brain; he had not come across the suggestion that �the machine could not cope with the teeth�.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn4" name="_ftnref4" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[4]</span></a>� Mr Oberst (MLC) thought that �if they went in at all it was in a very small number of cases.�<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn5" name="_ftnref5" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[5]</span></a>� Mr Clark (then a Deputy Senior Meat Hygiene Inspector for South Holland DC) told the Inquiry that �I believe that heads are not used in the production of MRM...As far as I am aware heads would damage the machinery...and they would not be used.�<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn6" name="_ftnref6" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[6]</span></a></div>
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4.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Maslin replied to Ms Jones on 12 December 1989 (copying to recipients of her minute), having discussed the matters raised with Mr K Taylor.� He explained that:</div>
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�On the splitting of heads, or spinal columns, we agree with your reaction.� Some contamination is bound to occur but we have already gone further than Southwood suggested in tackling an already remote risk from offals.� Through the prohibition we have taken all practical steps and an amendment to the Regulations is neither necessary nor practical.�<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn7" name="_ftnref7" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[7]</span></a></div>
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5.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 1 February 1990, the IEHO wrote to MAFF (Mrs C Goodson, AHD) setting out the views of its members regarding difficulties in the interpretation of, compliance with and enforcement of the SBO regulations.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn8" name="_ftnref8" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[8]</span></a>� The letter reported (amongst other things) that IEHO members were concerned about the speed with which the ban had been implemented.� Specific comments raised by the IEHO included the following issues (amongst others):</div>
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(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Many specialist boning plants would not under normal circumstances receive daily veterinary/EHO supervision.</div>
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(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Given that the spinal cord had been designated as SBO, the tail, from which it was �almost impossible� to remove the spinal cord, should also be regarded as prohibited offal.</div>
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(iii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In practice the spinal cord was often shredded and fragmented by the mechanical carcase splitting saw, not only contaminating the meat but also prohibiting effective removal as per the Regulations.</div>
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(iv.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Given the risk of contamination of meat from current slaughterhouse practices, the removal of brains should be prohibited in order to ensure that the risk of contamination was kept to a minimum.</div>
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(v.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Problems were encountered in obtaining information as to whether a calf was more or less than 6 months old (under the Regulations, offals from calves under the age of 6 months were exempted from the SBO ban).</div>
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6.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 6 February 1990, Mr Meldrum responded to a minute from Mr Baker of 2 February 1990. Mr Meldrum�s minute was copied to Mr Crawford, Mrs Attridge and Mr Griffiths.� Mr Meldrum asked whether it would be wise to draft instructions to local authorities on the implementation of the BSE sterilisation and staining regulations.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn9" name="_ftnref9" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[9]</span></a>�</div>
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7.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Baker�s manuscript reply included the following comments:<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn10" name="_ftnref10" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[10]</span></a></div>
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�The last guidance note (FSH Circular) was sent out when the Sterilisation and Staining Regs were amended in 1984.� No problems have come to our attention in implementing the Regulations.�� If we go back to Local Authorities offering guidance it might be wise to cover a number of topics rather than BSE alone as this will raise its profile yet again.� Perhaps �unfit meat� could be covered as well � a meeting with ADC/IEHO and others is mooted for 21 February & BSE could also feature on the agenda.� Any guidance might also have to cover brain removal, spinal cord, major nerve trunks and lymph nodes and MRM as these have come up as BSE related topics.� I suggest our approach to these needs careful consideration & probably a round table discussion.�</div>
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8.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mrs Attridge forwarded to Mr Lowson a copy of Mr Meldrum�s minute with Mr Baker�s manuscript comments.� In a manuscript note to Mr Lowson, Mrs Attridge said:</div>
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�I would welcome your views on presentation.� We need to be sure Local Authorities are enforcing the regulations.� The spread between divisions is awkward.�<span class="FootnoteReferencedfa" style="vertical-align: super;"> <a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn11" name="_ftnref11" title="">[11]</a></span></div>
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9.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 6 February 1990, Ms Rimmington wrote to Mr Hutchins on Mechanically Recovered Meat.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn12" name="_ftnref12" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[12]</span></a><span class="FootnoteReferencedfa" style="vertical-align: super;"> </span>�She said that:</div>
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�In a recent BBC radio programme (�Face the Facts�, Radio 4, 29.1.90), Mr Martin Cooke, OVS, was interviewed in connection with BSE.� He commented that bovine vertebrae were particularly high-yield sources of MRM and that since they would contain residual spinal cord which would then be incorporated into MRM-based meat products, neither he nor his family would in future be eating such products.�</div>
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10.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hutchins forwarded the minute� to Mr Baker on 7 February 1990 with the following hand-written annotation:</div>
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�Please see attached papers. I would welcome the opportunity to discuss. It is a situation which is in some ways analogous to head splitting, although the �risks� of neural tissue reaching the consumer seem greater with MRM�</div>
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11.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Baker responded on 9 February 1990, also by way of a hand written annotation:</div>
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�This is another subject for discussion refers advice to the industry. I do not concur with Mr Eames� views but let us await the outcome of our deliberations on related matters�.</div>
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12.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 9 February 1990, Mr Hutchins replied to Ms Rimmington on MRM.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn13" name="_ftnref13" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[13]</span></a>� He explained that:-</div>
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�I understand from the CVO that this question was discussed with DoH.� It was agreed that it did not pose a health risk and that a ban on the use of spinal columns for MRM production was not justified.�</div>
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13.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Matthew Taylor MP tabled a PQ for answer on 20 February 1990.� He asked if the Minister intended to �take steps to ensure that the process of stripping animal bones to obtain mechanically recovered meat entails no risk of spinal tissue being included in the final product.�� Mr Griffiths submitted a draft reply under a covering minute of 20 February 1990 (copied to PS/Perm Sec, Mr Meldrum, Mrs Attridge, Mr K Baker, Mr K Taylor, Mr Lowson, Miss Jones and Mr Maslin).<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn14" name="_ftnref14" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[14]</span></a>� He commented that:-</div>
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�There is a possibility that a small amount of residual material may be left on the vertebrae after the cord is removed.</div>
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However, the bovine offal ban is an ultra-precautionary measure which affects offal from healthy animals and we have no reason to suppose that this poses a risk.� Veterinary advice is that even if the animal were to be in the sub-clinical stages of BSE, the agent is unlikely to be present in the central nervous system.�</div>
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14.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The accompanying draft reply to the PQ stated that:-</div>
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�As an ultra-precautionary measure my Department introduced the Bovine Offal (Prohibition) Regulations 1989, which prohibit the use of spinal cord and other specified bovine offals in food for sale for human consumption.� In practice the spinal cord would be removed before recovery of MRM.� Animals displaying symptoms of BSE are required to be slaughtered and disposed of so that they do not enter the human food chain.�</div>
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15.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 9 April 1990, a meeting took place to discuss the comments in the letter of 1 February 1990 from the IEHO regarding difficulties associated with the Bovine Offal (Prohibition) Regulations 1989.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn15" name="_ftnref15" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[15]</span></a>� The meeting was attended by Mr Baker, Miss Jones, Mr Maslin and Ms Rimmington from MAFF, and Mr Corbally of the IEHO.� On the issue of timing, MAFF officials acknowledged that the time scale for the introduction of the Regulations had been unusually short and that this might initially have led to some enforcement difficulties.� However, officials stated that considerations of public health and awareness had necessitated the speed of action, which the IEHO accepted.� The IEHO offered help in disseminating such information as quickly as possible in the future.� In response to other concerns raised by the IEHO, MAFF officials made the following points (amongst others):</div>
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(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Removal of the tail need not incorporate any spinal cord.� It was necessary to adopt a practical approach to the removal of spinal cord from all parts of the carcase.</div>
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(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The main nerves of the carcase were not considered to represent a risk by specialist advisors. Practical difficulties would be met when trying to remove them.</div>
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(iii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>No evidence had as yet been found to suggest that BSE was congenital.� The 6 month cut off point for the offals ban is cautious since the disease showed itself in grown animals and on the scrapie analogy would be likely to manifest itself only at 10 months.� There is therefore a safety margin in determining which animals might be exempt.</div>
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(iv.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The IEHO�s opposition to head splitting was noted. However, veterinary studies of methods indicated the operation could be performed safely providing some basic principles were followed. Guidance on these principles was being considered.</div>
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16.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Corbally wrote to Mr K Baker on to thank him for the �informative and worthwhile discussion� held on 9 April.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn16" name="_ftnref16" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[16]</span></a>� Mr Corbally noted that �there are still a number of points that concern me�.� He said that he would be obliged to receive comments on the following:-</div>
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�Although the Ministry consider that the implementation of the Regulation is a prudent measure, minimising still further a risk that is believed to be very small, if not insignificant (according to present knowledge), do you consider that the continued use of mechanically recovered meat from bovines is acceptable?� I recall that during our discussion on the subject of removing the spinal cord you felt that the requirements had to provide a reasonable balance.� That is, while removal of the major parts of the spinal cord should be performed it was not considered necessary, nor indeed practical to remove fragments of the major nerves.� However, MRM could contain significant quantities of spinal cord nervous tissue.�</div>
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17.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 2 May 1990 Mr Griffiths wrote to PS/Mr Maclean (copied to Private Offices, Mr Capstick, the CVO, Mrs Attridge, Mr Wentworth, Mr K Baker, Mr Lowson, Miss Jones and others) regarding the question of head splitting and the possibility that the Bovine Offal (Prohibition) Regulations 1989 might be amended to ban the procedure.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn17" name="_ftnref17" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[17]</span></a>� He also noted that:-</div>
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��Amendment regulations would fuel debate on BSE generally and, inevitably, lead to demands for similar action on spinal cords. �This issue has already been raised in a recent PQ from Mr Matthew Taylor and in correspondence from Carrick District Council suggesting that there is a risk of contamination as a consequence of the splitting of bovine carcasses along the spine and from residual spinal cord.� On this, we are satisfied that the removal of all visible spinal cord is acceptable in health terms.� Slaughterhouses cannot handle whole carcasses and splitting is an EC requirement for intra-community trade.� A ban on splitting would have grave consequences for the industry and for the export trade.� Nor would it end with spinal cords.� Concern would then be directed at nerve trunks and lymph nodes, which cannot be removed from carcasses.�</div>
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18.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 3 May 1990 Mr Hill (PS/Mr Maclean) noted by way of annotation</div>
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�In the light of the Minister�s recent discussion with the Parliamentary Secretary� ( Mr Maclean) we have commissioned further advice on procedure for splitting heads. In the light Mr Griffiths� minute above, Mr Maclean has agreed that we ought not to ban the removal of brains before head meat is removed, or to legislate on the methods, but that we should strengthen the guidelines.</div>
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Does the Minister agree?�</div>
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19.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 15 May 1990 Mr Nick Hibbett (Chairman of the Meat Legislation Review Group of the Institution of Environmental Health Officers) was reported in the Financial Times as saying that the requirement to remove from bovine carcases the brain and specified offals deemed to carry BSE was �frankly not enforceable�.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn18" name="_ftnref18" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[18]</span></a></div>
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20.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Against a background of heightened concern in the media regarding the risk of transmission of BSE to humans from eating beef, the Minister and the Government Chief Medical Officer made public statements on 15 May and 16 May 1990 respectively regarding the safety of British beef.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn19" name="_ftnref19" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[19]</span></a> �The CMO�s statement had been approved by members of SEAC.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn20" name="_ftnref20" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[20]</span></a></div>
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21.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 18 May 1990, Miss Jones wrote to Mr Holmes of Carrick District Council regarding concerns he had raised about the Bovine Offal (Prohibition) Regulations 1989.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn21" name="_ftnref21" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[21]</span></a>� Miss Jones explained that independent experts had already assessed the risk to humans from BSE as remote.� She added that when results of investigations into the nature and transmissibility of the disease were available it would be possible to make a fuller appraisal of any risk, but that in the meantime, the offals ban ensured that those parts of the animal in which the BSE agent was most likely to be present did not enter the human food chain.� Miss Jones said that liaison was taking place with the IEHO with a view to ensuring that the Regulations work as �smoothly and effectively as possible�.� She asked Mr Holmes to inform her, either directly or through the IEHO, if he had any suggestions for improving the SBO controls.</div>
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22.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Briefing material was provided in readiness for a BSE debate in the House of Commons on 21 May 1990.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn22" name="_ftnref22" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[22]</span></a>� On MRM and splitting of carcases, the brief explained that:-</div>
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�Veterinary advice is that removal of the spinal cord from bovine carcases may be carried out in an acceptable manner.� Any transference of spinal material to meat can be minimised by exercise of due care and observance of established hygiene rules.</div>
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...The law requires that the spinal cord and other specified offals must be removed before the carcass leaves the abattoir.� The carcasses and bones used in the production of mechanically recovered meat will not therefore contain any specified bovine offal.�<span lang="EN-US"><o:p></o:p></span></div>
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<span lang="EN-US">23.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">On 2</span>1<span lang="EN-US"> May 1990, a meeting was held with representatives of the meat industry and retailers, attended by the Parliamentary Secretary (Mr Maclean), Mrs Attridge, Mr Meldrum, Mr Wentworth, Mr Smith and Mr Cowan.</span><a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn23" name="_ftnref23" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[23]</span></a><span lang="EN-US">� The issues of head splitting and MRM were raised.� The minute recorded that:<o:p></o:p></span></div>
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<span lang="EN-US">�some suggested that public fears might be laid to rest if heads were removed completely.� Mr Meldrum explained that, firstly only healthy animals� heads were used, secondly expert advice was that head splitting could be done safely, thirdly a change of policy would undermine our current position and finally the value of the cheek meat was not insignificant.� In any case the meat industry pointed out that the great majority of heads were not split near carcasses, but in specialist boning plants.� On MRM, they could not guarantee a 100% removal of all the specified offal, but Mr Meldrum explained that zero risk was an impossibility.�<o:p></o:p></span></div>
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24.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 22 May 1990, the Minister, Mr Gummer, discussed with the Permanent Secretary, Mr Andrews (amongst other things) the possibility of referring questions on slaughterhouse practices to SEAC.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn24" name="_ftnref24" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[24]</span></a> It was decided that SEAC should be invited to consider the new guidelines that had been drafted following the advice of Dr.A.M. Johnston, a senior lecturer at the College of Veterinary Surgeons.� It was also considered that SEAC had no expertise covering slaughterhouse practices, and that accordingly it would be appropriate to suggest that they involve Dr Johnston in their proceedings.� The Minister said that SEAC should also be invited to look into the issue of feeding animal protein to animals.� Mr Andrews acknowledged the case for requesting advice from SEAC in the circumstances.� However, he advised that the implementation of any measures arising out of SEAC�s advice would depend on the terms of the advice given by the Committee.� Mr Andrews advised that the question whether action was taken for health reasons or because of public sensitivity was crucial.</div>
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25.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The Minister said that he would convey the request for advice to Dr Tyrrell when he dined with him on the following evening.� He also said that he would invite Dr Tyrrell to bring forward SEAC�s discussion of both issues in order that recommendations could be made well before July, and any legislative changes that might be required following SEAC�s advice could be completed before the summer recess if possible.</div>
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26.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In June 1990, the MLC instigated work to develop a suction device to remove the spinal cord of cattle before splitting.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn25" name="_ftnref25" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[25]</span></a>� In his statement to the BSE Inquiry, Mr Colin Maclean, who was the technical director of the MLC at the time, stated that this was in response to supermarket interest in removing all contact of SBOs with meat and to remove any hypothetical risk to abattoir workers.� However, the project was technically unsuccessful and was terminated in August 1991.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn26" name="_ftnref26" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[26]</span></a></div>
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27.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span><span lang="EN-US">In</span> relation to the concern of supermarkets about the risk of contamination from sagittal splitting of carcases with saws, Mr Colin Maclean explained in oral evidence that:<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn27" name="_ftnref27" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[27]</span></a></div>
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�� we did not believe it was a threat at all I think is the honest answer at that stage.� But to deal with the perceived concern we started work on the sucking devices to try to suck the spinal <span lang="EN-US">cord</span> out of the column without sagittally [sic] cutting the carcass.� We spent a lot of time in our own workshops because we have cutting plant and cutting rooms in our own offices where we can obviously do that sort of work.� And we spent about a year and a half trying to achieve that in a way that could meet the line speeds, obviously.� It is not a matter of getting it out, it has to meet the commercial needs of the industry.� We did not succeed at that stage.� Therefore we stopped that work because I would not say the problem had gone away but the supermarkets had retreated from their area of concern as more knowledge had been disseminated in the industry that the concern associated with the sawing of carcasses had receded throughout the industry, and it remained so until probably 1994/1995 when it actually returned again.� So having not been able to succeed with that sucking device we actually -- well, kept the equipment and so on and so forth but retreated from the research.�</div>
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<span lang="EN-US">28.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span>In his statement to the Inquiry, Mr Hutchins of MAFF�s Meat Hygiene Veterinary Section recalled that in further investigations attempts to remove the spinal cord intact by cutting down either side of the spinal canal with a double-bladed saw were found to run the risk of damaging the vertebral column to the extent that it would have made it impossible for the half carcasses to be handled on existing dressing lines.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn28" name="_ftnref28" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[28]</span></a><span lang="EN-US"><o:p></o:p></span></div>
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29.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 4 June 1990, Mr Meldrum minuted Mrs Attridge (copied to Mr Crawford, Mr K Baker and Mr Lawrence) to provide �some notes on the major issues that could arise in the Scientific Veterinary Committee, the Standing Veterinary Committee or in Council on BSE.�<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn29" name="_ftnref29" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[29]</span></a>� On the subject of MRM, Mr Meldrum noted that:-</div>
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�Once again no MRM is known to be exported from red meat animals, nor indeed is the volume of production known.� Most of the MRM extraction plants are in export cutting plants where they have a significant throughput to make the operation financially viable.� Trade in MRM and indeed head meat is not covered at this time by a trade directive and therefore bilateral arrangements apply.� We in Tolworth are concerned at this practice because in the extraction of the MRM small fragments of nervous tissue would be sucked out and therefore it is difficult to argue that the resultant material could not be significantly contaminated.� So far as we are aware bovine heads are not used for the preparation of MRM.� We doubt whether this will be raised at the Scientific Veterinary Committee but it is an issue of some importance and sensitivity.�</div>
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30.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 7 June 1990, Ms Rimmington wrote to Mr Evans (DEHO, Pembrokeshire District Council).� Amongst other things, she explained that<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn30" name="_ftnref30" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[30]</span></a>:-</div>
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�When carcases are split, the spread of spinal cord tissue onto immediately adjacent carcase surfaces can be kept to an absolute minimum by exercising normal care during these operations.� This, taken with the assessment by independent experts that the risk for humans from BSE is in any case remote, indicates that the risk from contamination of meat by spinal cord tissue must be negligible.�</div>
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31.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 10 June 1990, an article appeared in the Sunday Times, in which it was stated that the BVA was intending to raise with the House of Commons Agriculture Committee, as part of its inquiry into BSE, concerns about the safety of meat products made from MRM.� On 11 June 1990, Mrs Attridge sent a minute to the PS/Minister advising the Minister on the background to the article and on the MRM process in general.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn31" name="_ftnref31" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[31]</span></a> Mrs Attridge explained that:-</div>
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�The background to this Sunday Times article is that Bill Riley was invited to a meeting which the BVA Policy Committee held to consider a number of points relating to their evidence to the House of Commons Committee.� The views which Bill Riley expressed were his own, they were not endorsed by the rest of the Committee, and I understand that in their evidence the BVA will simply indicate that MRM is a process which needs to be examined.�</div>
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32.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mrs Attridge explained that �When looked at [from] the hygiene point of view, it [MRM] was considered to be a safe process and it does require to be specifically labelled if it is used in meat products.�� Mrs Attridge advised that if steps were to be taken to ban MRM as a process for obtaining meat from beef carcasses, a scientific base for this would be needed and this in turn would require research.� She went on to say that since the spinal cord and other specified offal were removed from the bones before being used in the MRM process, �on the face of it the risks should be minimal�.� However, Mrs Attridge suggested that, if the CVO agreed, it would be worthwhile to find out precisely what parts of the carcase were used for MRM production, and in particular whether the head was used after removal of the brain. (�It would not be legal to send it with the brain still in it.�)It was suggested that a better assessment of risk (if any) could then be given to the Minister.</div>
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33.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 11 June 1990, Mr Maslin put forward a briefing and a line to take for the Prime Minister on the safety of UK sausages.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn32" name="_ftnref32" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[32]</span></a>� The minute was copied to Mr Meldrum, Mrs Attridge, Mr K Baker, Mr Lowson, Mr K Taylor, Mr Lawrence and Mr Griffiths; it drew on advice provided by Ms Rimmington on 11 June.� Amongst other things, the briefing noted that:-</div>
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3. The ban on certain bovine offals requires that they are removed before the carcass leaves the abattoir and not used in human food.� The carcass bones used in the production of mechanically recovered meat do not therefore contain any specified offal. �<u><o:p></o:p></u></div>
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<u>Background<o:p></o:p></u></div>
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1.� The Bovine Offal (Prohibition) Regulations 1989 provide for removal from the human food chain of those parts of all cattle over 6 months of age where the agent (if it is present) is most likely to occur. Those Regulations require that the spinal cord and other specified offal must be removed before the carcass leaves the abattoir. The carcass bones used in the production of mechanically recovered meat will not therefore contain any specified bovine offal.</div>
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2� The report in the Sunday Times (on 10 June) of the opinion of a veterinary surgeon on mechanically recovered eat (sic) has been investigated with the BVA by veterinary officials.� The BVA have confirmed that it does not represent their policy but constitutes the personal views of a private individual.�</div>
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34.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 12 June 1990, Mr Meldrum sent a minute to Mrs Attridge, copied to Mr Crawford, Mr Baker, Mr Griffiths and Mr Lawrence, explaining that he had �some difficulties with the concept of obtaining MRM from bovine carcasses and particularly from the vertebral column because of the risk of sucking out residual nervous tissue and causing contamination�.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn33" name="_ftnref33" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[33]</span></a>� He stated that �although we have accepted, so far, that the risk is minimal we do need to be guarded in any statement we make since this is an issue that will be considered by Tyrrell and may lead to a restriction on the derivation of MRM from some parts of the bovine carcase.�</div>
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35.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 13 June 1990, slaughterhouse practices were discussed at SEAC�s third meeting.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn34" name="_ftnref34" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[34]</span></a>� The Committee felt that precautions about the removal of the brain from bovine skulls were a common sense measure.� The following conclusions were also recorded in the minutes of the meeting in relation to the risk of contamination from spinal cord:</div>
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�Similar issues arose with spinal cord; if it makes sense to avoid contamination by brain tissue of meat for human consumption it appeared on the face of it to make equal sense to avoid the contamination of such meat with the spinal cord, which was just as likely to carry infection. Further information is needed on this�.</div>
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36.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In oral evidence to the BSE Inquiry, Mr Lowson was asked if the IEHO letter of 1 February 1990 was provided to SEAC when they were asked to give advice on slaughterhouse practices at their meeting on 13 June 1990.� Mr Lowson said:<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn35" name="_ftnref35" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[35]</span></a></div>
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�I probably would have remembered if it had been, and I do not think it was.�</div>
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37.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the same day (13 June 1990), a meeting took place between the Minister, Mr Gummer, and the Parliamentary Secretaries, Mr Maclean and Mr Curry, attended by Mrs Attridge, Mr Meldrum, Mr D Taylor, Mr Packer, Mr Wentworth and Mr Dugdale.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn36" name="_ftnref36" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[36]</span></a>� The Minister said that he would like guidelines on removal of lymph nodes, removal of head meat and the export of bone-in beef to be issued at the same time.� The draft guidelines needed to be amended to reflect that necessary action should be taken at both domestic and export approved plants.� On MRM, Mr Meldrum said that there �was a need for further work on possible contamination with nervous material�.� He said that Dr Tyrrell was not an expert on� the procedures involved and it would therefore be necessary for MAFF to prepare a paper on the technical issues. Mrs Attridge said that the possibility of controls of beef MRM opened the question� of MRM produced from other species: its production was a hygienic process and MRM was specifically labelled in meat products� The Minister concluded that MAFF should not take immediate action to introduce controls.� However, Mrs Attridge or Mr Meldrum was asked to take forward urgently the preparation of a detailed assessment of the possible hazard from MRM, as suggested in Mrs Attridge�s minute of 11 June.</div>
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38.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 14 June 1990, Mr Meldrum received a minute from Mrs Attridge on the issue of MRM.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn37" name="_ftnref37" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[37]</span></a>� Mrs Attridge suggested that the assessment of the possible hazard from MRM should take the form of a paper to SEAC.� She recommended that such a paper should take into account what the MRM production process was, and in particular how it dealt with parts of the vertebral column from which the specified offals had been removed; the quantity of MRM being produced and what it was used for; and some risk assessment of MRM in relation to other materials such as sheep and sheep products, lymph nodes and similar nervous tissue in meat which would not be affected by any restrictions, �bearing in mind that this material will be coming from clinically healthy animals and that increasingly animals slaughtered will not have been eating meat and bonemeal�.�</div>
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39.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mrs Attridge also suggested that the paper for SEAC might also need to consider what powers MAFF could use if the Committee suggested that any action should be taken.� She noted her understanding � which Mr Cockbill was asked to confirm - that current requirements stipulated that MRM had to be clearly identified as such when used in meat pies and similar products.� Mrs Attridge suggested that if this was the case, consumers had a choice whether or not to use MRM.� She advised that if the Minister decided that any action was appropriate, he would need to act on a rational basis, otherwise he would be subject to judicial review. She also emphasised that it was �particularly important that decisions should not be taken for presentational or other reasons, but be clearly based on science and on appropriate risk assessment�.</div>
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40.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mrs Attridge went on to say that she was copying her minute to the Food Standards and Food Science Divisions, those dealing with meat and meat products and also with the food industry as she felt that any action on MRM would have �serious repercussions in the meat product area�, because of the value of the material. She added that it would also be necessary to take into account the fact that �we would have no rational argument for prohibiting the importation of products using mechanically recovered meat and that butchers and others would still strip the meat from bones with a sharp knife � which may be effective in recovering the meat, but is not necessarily as hygienic a process as mechanical recovery�.</div>
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41.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Bremner replied to Mrs Attridge on 19 June 1990.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn38" name="_ftnref38" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[38]</span></a>� He explained that the CVO had already asked the SVS and Meat Hygiene Division to prepare a draft paper which would be circulated shortly to all interested parties, and would take into account the points that she had raised.</div>
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42.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 15 June 1990, the MLC produced a document entitled �Evidence to the Select Committee of Agriculture�s Enquiry on Bovine Spongiform Encephalopathy�.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn39" name="_ftnref39" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[39]</span></a>� Paragraph 19 dealt with abattoir practice.� It explained that:-</div>
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�Following dressing the carcase is split either by saw or by chopping and this involves exposure of and damage to the spinal cord.� At this stage it is possible that a very few fragments of spinal cord could be left on the carcase but these will be removed by wiping or washing as the carcase is processed.� The spinal cord is then removed under hygienic conditions and disposed of as �specified offal�.�</div>
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43.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Denner of the Food Science Division sent a minute to Mrs Attridge on 18 June 1990, which was copied to the PS/Minister, Private Offices, Mr Meldrum, Mr Capstick, Mr Crawford, Mr Baker, Mr Griffiths, Mr Lawrence and others.� In his minute, Dr Denner advised that the majority of beef MRM manufacturers adhered to the BMMA draft code of practice, which required the removal of the spinal cord and specifically excluded use of the long bones and head bones for the production of MRM.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn40" name="_ftnref40" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[40]</span></a>� He stated that there was no evidence to suggest that heads were used in MRM production.� Dr Denner also advised that his Division was embarking on a project to develop a method of detecting the presence of MRM in meat products and this could be used to enforce any ban on the use of MRM, or certain types of MRM, if necessary.� It was hoped to commission this work by the end of June.� Dr Denner ended by observing that if the risk of BSE from muscle meat was regarded as negligible, the use of MRM would not seem to add to that risk, provided that MRM was prepared in accordance with the BMMA�s draft code of practice.</div>
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44.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 19 June 1990, Mrs Attridge sent a manuscript minute to Mr Lowson, copied to Mr Meldrum and Mr Lawrence, in which she suggested that Dr Denner�s minute was useful and could be incorporated in any paper to be put to SEAC.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn41" name="_ftnref41" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[41]</span></a></div>
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45.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 20 June 1990, members of the Institution of Environmental Health Officers gave evidence to the Agriculture Select Committee.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn42" name="_ftnref42" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[42]</span></a> The memorandum submitted by the IEHO raised concerns about practical difficulties that were being encountered in applying and enforcing the SBO regulations, especially in the removal of the brain and spinal cord. The memorandum stated that:</div>
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�During carcase splitting a mechanical splitting saw travels down the spinal axis of the suspended carcase.� Whilst the spinal cord may be �pushed aside� by the blade of the saw, thus remaining virtually complete, this is not generally the case.� The spinal cord is usually severed, on occasions along its length, spreading cord tissue across the whole cut surface of the split carcase. The result is that both the carcase, the saw blade and the environment are contaminated, again potentially with the infective agent of BSE.�<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn43" name="_ftnref43" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[43]</span></a></div>
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46.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The memorandum from the IEHO to the Select Committee also stated that the Institution had received no reply from MAFF to questions that it had raised with respect to the continued use of mechanically recovered meat from bovines, especially with respect to the possibility that MRM might contain significant quantities of spinal cord and nervous tissue.� The memorandum stated that this formed �the basis of a letter to the Assistant Chief Veterinary Officer confirming the meeting on 9 April�.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn44" name="_ftnref44" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[44]</span></a></div>
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47.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>When giving oral evidence to the House of Commons Agriculture Committee on 20 June 1990, Mr Hibbert was joined by Mr Cracknell (Anglo Beef Processors Limited) and Mr Cawthorne (The Fresh Meat Company Limited), amongst others.� These two witnesses were giving evidence on behalf of the Association of British Meat Processors and The Federation of Fresh Meat Wholesalers<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn45" name="_ftnref45" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[45]</span></a>.� The issue of MRM was discussed:-</div>
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�...The Environmental Health Officers are concerned about mechanically recovered meat, I understand, and the possibilities of the agent being included in the bits and pieces that are flayed off the bones.� Do you think this is a significant risk or is it a risk that is perhaps worth avoiding, and what does the Association think about that?</div>
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(Mr Hibbert)� Can I answer first and say, whether it is a significant risk or not we are not scientists.� We do not have access to the kind of evidence we understand that is available.� All we know is that some one is saying there is a risk, and if there is a risk in the food chain our view is that that risk should be eliminated completely.� Our concern with mechanically removed flesh is that very often - and in particular may I refer to the point we have made in our evidence about splitting the animal through the spinal cord - in the very act of splitting an animal in half you destroy the spinal cord in many places, which means that parts of the spinal cord will be splashed over the carcase.� In particular it may be that the removal of meat by the mechanical process will actually pick up those fragments.� That is our concern�</div>
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�(Mr Cracknell)� I think [MRM] is a wider consumer issue really.� I am satisfied that in the abattoirs that I visit regularly in the act of splitting a carcase the saw moves backwards and forwards through the backbone and undoubtedly there is some raking of the spinal column.� That is then followed by a cleaning process.� The spine is actually hosed from the inside down, historically primarily to remove bone dust.� Clearly now that also removes any remaining pieces of spinal cord that the actual scraping process has failed to remove. �What is risk?� That is what this whole debate is about: nil risk and minimal risk. MRM has an economic part to play in our industry.� We sell bones to people.�</div>
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�But is it a normal practice to wash the bone dust away, and therefore you are likely to wash away any small quantity of spinal cord?</div>
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(Mr Cracknell)� Yes, that is vital to preserve the keeping qualities of the carcase.</div>
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(Mr Cawthorne)� I think it should be appreciated that the spinal cord has got all the strength and consistency of a skipping rope in some respects, and it is possible to account for the spinal cord, whether it has been split or whether it comes out whole.� In a great many cases - and I mean a great many - the spinal cord falls into the left-hand or right-hand side of the channel and can be taken out from neck to sternum in one piece and cut into bits.� That happens in most cases.�</div>
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48.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Concerns about the difficulty involved in� removing the spinal cord and possible resulting contamination were also expressed by the following organisations in letters and memoranda to the Agriculture Committee: North Yorkshire County Council, Consumers in the European Community Group, the Food Safety Advisory Centre, the British Veterinary Association, the Consumers� Association, the Institute of Biology, the British Medical Association and the British Federation of University Women.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn46" name="_ftnref46" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[46]</span></a></div>
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49.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Various individuals and organisations also made submissions to the Agriculture Committee expressing concern about or recommending a ban on the continued production of MRM from bovine carcases or vertebral columns.� They included the Consumers Association, the Consumers In the European Community Group, the National Consumer Council, the Food Safety Advisory Centre, the British Medical Association, the British Veterinary Association, Dr. G.I. Forbes, the Director of the Environmental Health (Scotland) Unit and the British Federation of University Women.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn47" name="_ftnref47" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[47]</span></a></div>
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50.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In his evidence to the Agriculture Committee on 20 June 1990, Sir Donald Acheson was asked the following question by the Committee:<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn48" name="_ftnref48" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[48]</span></a></div>
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�In your statement, Sir Donald, you made no distinction between solid cuts of meat and mechanically recovered meat.� We have had some evidence that mechanically recovered meat may well contain traces of the specified offal.� I wondered, with that in mind, if you still considered your statement applied to both solid cuts of meat and meat products containing mechanically recovered meat?�</div>
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51.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Sir Donald stated:-</div>
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�Yes.� The definition of beef, which is covered in my statement of the 16 May, is bovine material for human consumption, excluding the material banned under the Offal Order.� That includes any type of bovine material that is for human consumption, and it includes the type of meat that you refer to.�</div>
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52.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Sir Donald was asked whether that was still the case �even if that type of meat includes some of the banned offal you were referring to�:-</div>
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�Then we get into the issue of contamination of bovine meat products by one or other of the materials, such as brains and the spinal cord.� I know that you have received evidence on that.� When we get into the technicalities of how carcasses are butchered I would have to turn to my colleague, the Chief Veterinary Officer, but in general we are talking about a degree of contamination which, if you take the total dose or theoretical dose that might be consumed in the material, will be very small.� It is tiny anyway because we know that the spongiform agent does not appear in meat in any case in tangible quantities.� On the matter of contamination I would simply say that from the public health point of view, if this is regarded as significant in any way it would be prudent to see what could be done to reduce it, but I am advised that currently there is not a significant health problem due to this.� That would be my position.�</div>
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53.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 20 June 1990, Mrs Attridge minuted Mr Bremner on MRM.� She assumed that Dr Denner�s minute of 18 June would be taken into account in the paper being drafted by the SVS and Meat Hygiene Division.� The next stage would be to get an assessment of any possible hazards from MRM compared to more conventional recovery methods. Mrs Attridge said:<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn49" name="_ftnref49" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[49]</span></a></div>
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�It will obviously not be ready for the next meeting of the Tyrrell Committee but we will need to think of something for the subsequent meeting.�</div>
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54.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Meldrum wrote to Mrs Attridge on 20 June 1990.� He confirmed that:-</div>
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�We are preparing a paper on MRM for internal discussion prior to submission to the Tyrrell Committee.� Thereafter I have suggested to the Committee that they may consider seeking advice from Mac Johnston when they are discussing meat hygiene issues. I should add, however, that Mac does not have the full support of the whole industry since it is argued that he has insufficient background experience�.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn50" name="_ftnref50" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[50]</span></a></div>
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55.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 21 June 1990 Dr Pickles wrote to Ms Smart with comments on a draft Which? magazine report.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn51" name="_ftnref51" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[51]</span></a>� She copied her letter to Mr Maslin.� Amongst other things, Dr Pickles noted that:-</div>
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�You may be interested to read of Chief Medical Officer�s reassurances about mechanically recovered meat at the Agriculture Select Committee on the 20 June.�</div>
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56.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 21 June 1990, Mr Bremner minuted Mr K Baker, Mr D Taylor and Mr Griffiths on a visit by Mr Curry to Canvins Slaughterhouse and Cutting Room on 20 June 1990 to see the treatment of prohibited offal and the production of MRM.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn52" name="_ftnref52" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[52]</span></a>� Mr Bremner noted that:-</div>
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�Small pieces of spinal cord were being left in the sides of beef and Canvins suggested that the cords should be sucked out before the carcasses were split...There was very little contamination of carcase during the splitting as a saw with a band saw blade was being used.</div>
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Sales of beef MRM have declined and MRM was not being produced any longer as a routine.� A small demonstration was put on for Mr Curry.� All the bones from the carcase go into the MRM machine, some having been previously broken into smaller pieces.� Canvins thought it would be uneconomic to sort the bones prior to going into the machine.�</div>
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57.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 22 June 1990, the APS/Parliamentary Secretary (Mr Curry) sent a minute to Dr Denner, copied to Mr Capstick, Mr Meldrum, Mr Crawford, Mr Baker, Mr Griffiths, Mr Lawrence and others, in which he explained that at a demonstration of the MRM process which Mr Curry had seen at a slaughterhouse, traces of spinal tissue had been found in the product and as a result the Parliamentary Secretary was �very unhappy about MRM�.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn53" name="_ftnref53" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[53]</span></a>� A suggestion had been made to Mr Curry that an efficient method of removing the spinal tissue would be to apply a suction pump to the spinal canal after the head had been removed and before the carcase was split.� The Parliamentary Secretary asked for a short note on the feasibility of such a method.</div>
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58.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 25 June 1990, Mr Bremner sent a minute to Mr Meldrum, copied to Dr Denner, Mr Crawford, Mr D Taylor and Mr Griffiths.� Mr Bremner reported that he was �very surprised� that the Parliamentary Secretary had seen traces of spinal tissue in MRM and that �it is so unlikely that I suspect he was misinformed�.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn54" name="_ftnref54" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[54]</span></a>� Mr Bremner explained that what the slaughterhouse operators had said was that �they were not happy to sell MRM because of the risk of contamination of the vertebrae with the spinal cord.� Unfortunately not all the spinal cord was being removed by the meat inspectors although only small pieces were left�.� He went on to say that although the idea of using a suction pump was being pushed by the operators, he found it difficult to imagine how it would work, and that �my own view was that if the meat inspectors had done their job correctly, there would have been little risk and if the vertebrae were excluded from MRM, there should be no further risk�.</div>
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59.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In a manuscript minute dated 28 June 1990, Mr Meldrum asked Mr Bremner to find out from his trade contacts whether any suction pumps were actually available on the market.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn55" name="_ftnref55" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[55]</span></a></div>
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60.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Denner wrote to APS/Mr Curry on 26 June 1990 regarding the visit to Canvin International Ltd.� His minute was copied to PS/Minister, Private Offices, Mr Capstick, Mr Packer, Mr Meldrum, Mrs Attridge, Mr Wentworth, Mr Crawford, Mr Baker, Mr Griffiths and Mr Lawrence amongst others.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn56" name="_ftnref56" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[56]</span></a>� Dr Denner explained that:-</div>
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�There are two separate issues arising from the Parliamentary Secretary�s (Mr Curry) visit to the abattoir.� The first is the efficacy of removing spinal cord from the carcase, which is a mandatory requirement of the Bovine Offals (Prohibition) Regulations 1989.� This issue is related to other problems of abattoir practice such as the removal of the head meat and brains from cattle heads, and the prevention of cross contamination from spinal fluids and tissue during carcase dressing.</div>
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The second problem is the safety of MRM prepared from spinal column bones.� Since legislation already exists for the removal of spinal cord, any further consideration must stem from the risk posed by using spinal column with the spinal cord removed in MRM piston type machines.</div>
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Any policy decision on BSE must be based on the best technical evidence available to be consistent with previous MAFF policy.� The CVO is already organising a study to improve abattoir practice of splitting carcases.� The use of a suction tube for removal of spinal cord after splitting the carcase is an effective technique already in use in some plants producing MRM from lamb spinal column bones.� This may be one of several possible techniques that can be studied.</div>
<div class="Quote" style="font-size: 11pt; margin: 12pt 14.45pt 0.0001pt 14.2pt;">
I understand the Tyrrell Committee will discuss the use of spinal column in the preparation of MRM at their next meeting on 2 July.� Subject to their recommendation, Food Science Division would be prepared to commission a study into verifying whether central nervous system fluid or tissue is extracted into MRM during the preparation in piston type machines when spinal column with the cord removed is used.� The results of such a study would give Ministers the basis for any further action.�</div>
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61.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The APS/Mr Curry replied to Dr Denner on 2 July 1990<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn57" name="_ftnref57" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[57]</span></a>.� She explained that:-</div>
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�The MRM [at Canvins] was produced using a machine which used a piston under hydraulic pressure.� The traces of spinal tissue were identified by eye by Canvin�s vet.� However, Mr Bremner - who accompanied the Parliamentary Secretary on this visit - said that it was possible that the material in question could have been cartilage tissue.� Mr Bremner felt that the machine was not working properly as the MRM it produced was in larger pieces than normal.�</div>
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62.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 26 June 1990 Mr Andrews sent a minute to the Minister with a short paper summarising the �next steps� in respect of BSE.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn58" name="_ftnref58" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[58]</span></a>� The paper was copied to Mr Capstick, Mrs Attridge, Mr Meldrum, Mr Crawford, Mr Lowson, Mr Lawrence and Mr Gueterbock.� The following matters were mentioned (amongst others):</div>
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(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mechanically Recovered Meat � �A paper is being prepared for the Tyrrell Committee on this which will be submitted to you [the Minister] before it goes to the Committee�.</div>
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(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Slaughterhouse practices � �A paper is being prepared for the Tyrrell Committee on this subject.� Again this will come to you before being sent to the Committee�.</div>
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63.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 27 June 1990, Mr F Taylor circulated a draft paper on MRM.� The paper was intended to go forward to the Tyrrell Committee in due course.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn59" name="_ftnref59" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[59]</span></a>� Mr Meldrum commented to Mr Lowson on 28 June that he would prefer not to put a firm recommendation to the Committee in the paper.� He also pointed out that:-</div>
<div class="Quote" style="font-size: 11pt; margin: 12pt 14.45pt 0.0001pt 14.2pt;">
�One further option would be to design a suction machine to remove residual pieces of spinal cord from the vertebral column.�<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn60" name="_ftnref60" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[60]</span></a></div>
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64.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 28 June 1990, Mr Lawrence sent a minute to Mr Lowson, copied to Mr Meldrum, Mrs Attridge, Mr Crawford, Mr Baker, Mr Bradley, Mr Griffiths, Ms Jones and Mr Maslin.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn61" name="_ftnref61" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[61]</span></a>� The minute explained that he and Mr Maslin had recently visited abattoirs in the Sheffield area in the company of Peter Carrigan.� Mr Lawrence advised that there was considerable expertise available on slaughterhouse practices which could be made available to SEAC and suggested that David Leith, Director of the Institute of Meat at Langford, Bristol, be asked to advise on appropriate technical experts. Mr Meldrum replied on 28 June:-</div>
<div class="Quote" style="font-size: 11pt; margin: 12pt 14.45pt 0.0001pt 14.2pt;">
�I have suggested that the Tyrrell Committee should commission a �hygiene report� from the SVS and we will need to consult in preparing that report to ensure we take on board the advice of those who have relevant technical expertise.�<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn62" name="_ftnref62" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[62]</span></a></div>
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65.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Slaughterhouse practices were mentioned briefly at the fourth meeting of SEAC held on 2 July 1990.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn63" name="_ftnref63" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[63]</span></a> The minute of the meeting recorded that:</div>
<div class="Quote" style="font-size: 11pt; margin: 12pt 14.45pt 0.0001pt 14.2pt;">
�Mr Lowson reported that MAFF were working on a paper on slaughterhouse practices relevant to BSE for consideration at a future meeting. The committee agreed that after receiving this it would probably be necessary to see the slaughtering process at first hand before offering further advice.�</div>
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66.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>�On 5 July 1990 Mr Maclean sent a note to the Minister setting out what he regarded as the issues in respect of BSE which would require further action.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn64" name="_ftnref64" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[64]</span></a>� The minute was copied to Private Offices, Mr Gueterbock, Mr Capstick, Mr Meldrum, Mrs Attridge, Mr Lowson and Mr Lawrence.� In respect of MRM, Mr Maclean stated:</div>
<div class="Quote" style="font-size: 11pt; margin: 12pt 14.45pt 0.0001pt 14.2pt;">
�I am getting increasing media interest in MRM and I am not happy that we are watertight on two counts.� First, we have seen David Curry�s minute of his visit to Canvin International and Dr Denner�s minute suggesting further research to see if any spinal material gets into MRM.</div>
<div class="Quote" style="font-size: 11pt; margin: 12pt 14.45pt 0.0001pt 14.2pt;">
Dr Tyrrell is looking at this but even if he rules it perfectly safe, we will still have a massive lack of consumer confidence in a product which is universally disliked.� If he is ambivalent about it, or says that some aspects are unsafe, then it will be impossible to defend the �safe� aspects and we would, in all probability, lose the whole process.�</div>
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However, until he reports on its safety, we have a defence and I do not anticipate any special onslaught against MRM until then.�</div>
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The other problem about MRM is labelling.� It is clear that labelling is not satisfactory though it is almost impossible to label MRM satisfactorily and guarantee its accuracy.� Nevertheless, there are increasing demands for it to be labelled, which would effectively outlaw its use in British products, but not of course EC ones, thereby putting our industry at a great disadvantage.� I therefore recommend that we raise MRM labelling in the EC since this will remove the debate from our own forum.�</div>
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We should do this before Dr Tyrrell reports on safety since any questions he may raise on that score could also be addressed in an EC context.�</div>
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67.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Bremner sent Mr Meldrum, Mr D Taylor and Mr Baker, a copy of a minute dated 6 July 1990 from Mr Hutchins, explaining that following enquiries made of Regional Meat Hygiene Authorities (RMHAs), MLC and slaughterhouse equipment suppliers as to the availability of suction devices for removing spinal cord, �all are adamant that no such devices are commercially available�.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn65" name="_ftnref65" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[65]</span></a>� Mr Hutchins noted that one supplier produced a suction device for use on pig carcases, but that the sales manager of this company did not believe that it had been used for cattle.� Mr Hutchins also noted that the MLC had informed him that they were involved in a project to develop a commercial system, but that this was not yet operational.� He added that the MLC had agreed to keep him advised of developments.</div>
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68.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 9 July 1990 Mr Lowson wrote to Mr Lawrence regarding �BSE/Tyrrell�.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn66" name="_ftnref66" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[66]</span></a>� He copied his minute to Mr Meldrum, Mr Crawford, Mrs Attridge, Mr Griffiths, Dr Denner, Mr D Taylor, Mr K Taylor, Mr Bremner, Mr Bradley, Mr F Taylor and others.� Mr Lowson noted that he had already received a contribution from Mr F Taylor on MRM.� The key questions for the Tyrrell Committee would be:-</div>
<div class="Quote" style="font-size: 11pt; margin: 12pt 14.45pt 0.0001pt 14.2pt;">
�1.�� To what extent in (sic) there a risk that material from the �specified offals� particularly spinal cord, might contaminate MRM?</div>
<div class="Quote" style="font-size: 11pt; margin: 12pt 14.45pt 0.0001pt 14.2pt;">
2.��� If so, is it practicable to do anything about it? (e.g. exclude certain bones from the process, use apparatus that would reduce the problem).</div>
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3.��� If we wanted to do anything about it, what legal powers would be available?</div>
<div class="Quote" style="font-size: 11pt; margin: 12pt 14.45pt 0.0001pt 14.2pt;">
4.��� Is there any obvious research that could be done in addition to that mentioned in Dr Denner�s minute of 26 June (e.g. to design equipment that would reduce the problem, if any, of contamination).</div>
<div class="Quote" style="font-size: 11pt; margin: 12pt 14.45pt 0.0001pt 14.2pt;">
I would be grateful if Mr Taylor and his veterinary colleagues could look again at the paper with these points in mind.� Mrs Attridge has suggested that Mr Locke of the BMMA might be able to advise on the practice followed in the relatively small number of abattoirs involved in bovine MRM (which is of course all that we are interested in).� I will leave it to Mr Taylor to pursue the point as necessary.�</div>
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69.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 9 July 1990, a draft paper for SEAC on MRM, as amended by the Food Standards and Food Science Divisions, was circulated by Mr Cockbill under cover of a minute to Mr Lowson.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn67" name="_ftnref67" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[67]</span></a><span class="FootnoteReferencedfa" style="vertical-align: super;"> </span>�The paper was also copied to Mr Meldrum, Mr Crawford, Mrs Attridge, Mr Griffiths, Mr Bremner, Mr Lawrence and others. The minute said:</div>
<div class="Quote" style="font-size: 11pt; margin: 12pt 14.45pt 0.0001pt 14.2pt;">
�Mr Taylor sent me a copy of the proposed paper on this subject for the Tyrrell Committee with his minute of 27 June to you. Unfortunately the paper contained a number of omissions and inaccuracies in the area of the meat products and food standards law which applies to MRM and also on the food technology / food science side. Rather than suggest a whole series of drafting amendments it seemed better to us to rewrite the paper correcting those omissions and inaccuracies and we have done so in conjunction with Food Science Division.�</div>
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70.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The paper attached briefly explained the MRM process.� It also stated that the Meat Products and Spreadable Fish Products Regulations 1984 did not allow brains and spinal cord to be used in raw meat products, and that in the case of cooked meat products, their presence had to be declared on the label either specifically or under the generic term �offal�.� It was noted that few meat products containing MRM were labelled as such, and that it was disputed whether there was a legal obligation to do so.�</div>
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71.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The paper pointed out that:-</div>
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�The majority of beef MRM manufacturers adhere to the British Meat Manufacturers� Association (BMMA) draft code of practice regarding which bones can be used for MRM production.� This code requires the removal of the spinal cord and specifically excludes the use of the longer bones i.e. bones with higher marrow content, and also head, feet and tail bones.�</div>
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72.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The paper stated that �inevitably, when bovine carcases are split through the centre of the vertebral column in the slaughterhouse some contamination of the vertebrae with central nervous system (CNS) tissue can occur�.� Two major issues were identified, namely the question as to how spinal cord could be removed more efficiently from bovine carcases, and the question as to what risk was posed by the remaining nervous tissue in the vertebral column.� The paper advised that:</div>
<div class="Quote" style="font-size: 11pt; margin: 12pt 14.45pt 0.0001pt 14.2pt;">
�The following areas of investigation are being considered:</div>
<div class="Quote" style="font-size: 11pt; margin: 12pt 14.45pt 0.0001pt 50.2pt; text-indent: -36pt;">
(i)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>a study to improve abattoir practice of splitting carcases;</div>
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(ii)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>the use of a suction tube, as already used in some plants producing����� lamb MRM, for the removal of spinal cord; and</div>
<div class="Quote" style="font-size: 11pt; margin: 12pt 14.45pt 0.0001pt 50.2pt; text-indent: -36pt;">
(iii)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>to see if CNS tissue can be detected in MRM and whether it is transferred from spinal column bones during the manufacture of MRM.�</div>
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73.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The draft paper contained a section entitled �Possible course of action�, which set out four possible options for the Committee to consider:-�</div>
<div class="Quote" style="font-size: 11pt; margin: 12pt 14.45pt 0.0001pt 14.2pt;">
�In the absence of a wholly satisfactory method of removing nervous tissue from the vertebral column, the following courses of action might be considered to minimise the risk of meat and bones, contaminated with nervous tissue, being used in the manufacture of MRM:</div>
<div class="Quote" style="font-size: 11pt; margin: 12pt 14.45pt 0.0001pt 14.2pt;">
(a)�� issue guidance to the trade on how to minimise contamination of bovine carcasses from CNS tissue when splitting the carcase;</div>
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(b)�� request local authorities to ensure that, on inspection of the carcase, spinal cord material has been removed;</div>
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In addition, based on the results of research work outlined in section 9, the following options could be considered:</div>
<div class="Quote" style="font-size: 11pt; margin: 12pt 14.45pt 0.0001pt 14.2pt;">
(c)�� prevention of the use of any meat or bones from the vicinity of the spinal column, by excluding the use of the vertebrae, in the production of MRM;</div>
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(d)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>avoidance of all perceived risk by prohibiting manufacture of MRM from bovine carcases.�</div>
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74.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The paper concluded with a section entitled � Recommendations�:�</div>
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�There is the likelihood that options (a) and (b) would be seen as recognition that there was a need for further action without taking any enforceable steps to ensure its fulfilment<i>.<o:p></o:p></i></div>
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Option (d) would result in widespread opposition from a substantial number of MRM producers and users, with the accusation of wastage of perfectly good meat, a reduction in consumer choice, and increased costs.</div>
<div class="Quote" style="font-size: 11pt; margin: 12pt 14.45pt 0.0001pt 14.2pt;">
On the other hand option (c) would solve any perceived problem while allowing trade in acceptable meat to continue.�</div>
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<span lang="EN-US">75.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span>The fifth report of the House of Commons Agriculture Select Committee was published on 10 July 1990.� <span lang="EN-US">The comments and recommendations of the Select Committee included (amongst other things) the conclusion that:</span><a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn68" name="_ftnref68" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[68]</span></a><span lang="EN-US"><o:p></o:p></span></div>
<div class="Quote" style="font-size: 11pt; margin: 12pt 14.45pt 0.0001pt 14.2pt;">
<span lang="EN-US">�It is essential that action is taken and is seen to be taken to make the SBO ban as watertight as possible�[although some reports may give an exaggerated view of the poor state of abattoir practices] there may be some scope for improvement in the present arrangements.�<o:p></o:p></span></div>
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76.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In respect of slaughterhouse procedures and MRM, the Report stated:<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn69" name="_ftnref69" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[69]</span></a></div>
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�Since specified offals are now banned from human consumption (except those from calves under six months which are not regarded as a threat), this avenue of possible infection is now closed.� The only slight loophole is that�the offals could enter the food-chain through slaughterhouses failing to carry out the letter of the regulations and allowing possibly infected tissues to be included in mechanically recovered meat (MRM).� This is a process by which meat is recovered from the bone after the main cuts have been removed and then included in food products.� Concerns have been expressed that MRM could contain small amounts of spinal cord and steps must be taken to minimise this risk.� It is one thing to pass legislation prescribing that some parts of animals can be fed to humans and others cannot: it is another to ensure that such distinctions are rigorously enforced in practice.� We have received no evidence of an irresponsible approach to the regulations, but it cannot be assumed that they are watertight.</div>
<div class="Quote" style="font-size: 11pt; margin: 12pt 14.45pt 0.0001pt 14.2pt;">
This point is borne out by the memorandum submitted by the Institution of Environmental Health Officers, which gives an excellent account of the difficulties of implementing the legislation.� As will be clear from this and other evidence, a number of aspects of slaughterhouse practice give concern to experts and, now that the protein and offals bans are in force, this is the main area where some tightening of procedures may be necessary to maintain public confidence.� The Minister of Agriculture acknowledged that this is a legitimate source of concern and has asked the Tyrrell Committee to review slaughterhouse procedures.� We questioned a number of interested bodies on this specific issue and shall make recommendations arising from that evidence in later paragraphs.�</div>
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77.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In connection with paragraphs 28 and 29 of the Report, the Agriculture Committee concluded that:-</div>
<div class="Quote" style="font-size: 11pt; margin: 12pt 14.45pt 0.0001pt 14.2pt;">
�If the ban on the sale of specified cattle offals for human consumption is <b>properly policed in slaughterhouses</b>, full public confidence can be maintained.�</div>
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78.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The Agriculture Committee recommended that legislation should be introduced to prohibit the practice of splitting bovine heads in abattoirs.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn70" name="_ftnref70" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[70]</span></a>� However, no recommendation was made in relation to MRM. In this respect the committee stated:</div>
<div class="Quote" style="font-size: 11pt; margin: 12pt 14.45pt 0.0001pt 14.2pt;">
�All our witnesses were in agreement that the infectivity of the BSE agent is related to the quantity of the agent involved. Thus the brains of a subclinically affected animal would be less infectious than that of one in the final throes of the disease; a six-month old calf less infectious than one in whom the disease had been incubating for two years; a nerve at the periphery of the nervous system less infectious than the brain itself. Although, therefore, the authorities are right to address the possibility that infectious tissue from a sub-clinically affected animal might inadvertently be included with, or otherwise contaminate, meat sold for human consumption, such a possibility need not cause undue concerns because of the small quantities of the agent likely to be involved. This element in scientific arguments has a critical bearing on the food safety issue, but has been consistently ignored or understated by those wishing to present the risks to humans in their most dramatic light..�</div>
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79.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The MAFF Consumer Panel discussed labelling of MRM at its third meeting on 11 July 1990:-</div>
<div class="Quote" style="font-size: 11pt; margin: 12pt 14.45pt 0.0001pt 14.2pt;">
�Mr Bell believed that the rapid development of food production from farm to market place in recent years had taken place without the average consumer knowing what was happening.� As food scares arose, the public were becoming aware of certain farming practices and did not like what they saw.� This was leading to a general mistrust of farming practices and, as a result, the food produced.� He believed that a solution might be to label foods with information on how they were produced.� The Panel were critical of the practice of Mechanically Recovered Meat (MRM) particularly in the light of concern to consumers during the recent BSE scare.� Mr Maclean explained that MRM was used throughout the EC.� The labelling of meat products was currently under review within the EC.� The UK would be advocating that MRM should be required in the labelling of meat products but this would be dependent on the outcome of EC discussions.� Mr Dickinson added that food labelling regulations required the treatment of an ingredient to be included in ingredient lists where its omission could mislead the consumer; and the MAFF view that this applied to MRM was supported by magistrates.� There was no percentage below which MRM did not have to be declared.�<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn71" name="_ftnref71" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[71]</span></a></div>
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80.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Meldrum commented on the draft paper for SEAC in his minute dated 11 July 1990 to Mr F.B. Taylor.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn72" name="_ftnref72" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[72]</span></a>� In particular, he noted that some risk assessment needed to be introduced into the paper to explain that MRM was �being obtained from totally healthy cattle in which the agent could either be totally absent from the brain or spinal cord or present in very low quantities indeed�.� Mr Meldrum also noted an apparent inconsistency between Mr Hutchins� minute of 6 July 1990<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn73" name="_ftnref73" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[73]</span></a> and the revamped draft paper to SEAC where reference was made to the use of a suction tube in some plants producing lamb MRM. He asked Mr Hutchins to pursue� this lead. Mr Meldrum also suggested that the paper could include under �Possible Courses of Action� the development of a suitable hand held machine for removing residual traces of spinal cord.</div>
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81.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Meldrum felt that the section entitled �Recommendations� should be re-titled �Summary� and should not, at that stage, include any recommendations.� He felt it would not be true to say that options (a) and (b) were as negative as they were stated and were very positive in the respect that MAFF would be giving clear advice to the industry and local authorities as to how to reduce any possible contamination of MRM.� He considered that:<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn74" name="_ftnref74" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[74]</span></a></div>
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�Although presentationally option (c) is attractive, it still has significant difficulties since we have allowed MRM to continue to be obtained for so long and we could be criticised that we are seeking a lower risk assessment than the facts warrant.� We must not ignore the reality of the situation and that MRM is being obtained from healthy animals in which the agent is unlikely to be present at all and, if present, at very low concentrations indeed.� On balance therefore I would link (a) and (b) in a rather more positive fashion for consideration by the Tyrrell Committee.�</div>
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82.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 17 July 1990, Mr Bremner passed Mr Meldrum a copy of a minute from Mr Hutchins.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn75" name="_ftnref75" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[75]</span></a>� Mr Hutchins had been investigating the suction devices for removing residual spinal cord as requested in Mr Meldrum�s minute of 11 July.� Mr Hutchins provided details of apparatuses he had inspected.� He noted that:-</div>
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�As indicated in my earlier minute, there are apparently no commercially available devices for the removal of bovine spinal cords...Whilst the development of a device with sufficient power to remove the cord should not be difficult, lack of precision in the splitting operation might cause problems of usage.�</div>
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83.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Meldrum wrote to Mr Taylor on 19 July 1990 in the light of the advice provided by Mr Bremner and Mr Hutchins on suction removal of residual spinal cord.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn76" name="_ftnref76" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[76]</span></a>� He commented that:-</div>
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�I do feel that this is an issue that should be addressed in the paper you are preparing and that we should commission, if at all possible, some research work into development of suitable devices for this purpose.</div>
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Is it possible to include such a recommendation in the paper for the Tyrrell Committee?�</div>
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84.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 3 September 1990 Mr Meldrum wrote to Mr Lawrence (copied to Mr Crawford, Mr K Baker, Mr Griffiths, Mr Bremner, Mr Lowson, Mr Cockbill and Mr F Taylor) to air some concerns that he had about the draft paper for SEAC on MRM<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn77" name="_ftnref77" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[77]</span></a>:-</div>
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�We may be placing ourselves in something of a quandary with particular reference to further action.� If we go further than to offer advice then the Tyrrell Committee is going further than the action we have proposed within the SVS and presentationally it will appear as if our advice is faulty.� For that reason I would prefer there to be a comment in the paper as to what advice we have given so far to the industry on MRM production and, in particular, to Local Authorities on removal of spinal cord tissue.</div>
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�I assume that any regulation made under the Food Act would have to be based on the assumption that there was either a real or perceived public health hazard.� Is this so and, if so, would it cause problems for our lawyers, since any such risk is purely hypothetical?�</div>
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85.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In a minute of 6 September 1990 (to Mr Lawrence, copied to Mr Meldrum, Mr Crawford, Mr Baker, Mr Griffiths, Mr Bremner, Mr Lowson and others), Mr Cockbill set out a number of problems that might arise if it was decided to follow the route of legislating against MRM production.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn78" name="_ftnref78" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[78]</span></a>� Mr Cockbill ventilated difficulties with the introduction of legislation in EC terms, and pointed out that:-</div>
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�So far as I am aware there is no analytical capability currently available to distinguish between MRM that has been taken from the vertebrae and MRM that has been taken from other more acceptable bones.� Added to this I also believe that a fair amount of MRM is in fact not produced in slaughterhouses but taken to specific plants that specialise in MRM production.� Thus it could be necessary to set up some kind of inspection system at those plants before the MRM is produced to determine whether amongst the bones there are any vertebrae or perhaps any bones from bovine animals over six months of age.� I suspect that the logistics of setting up such an enforcement system are quite considerable.� We are already receiving suggestions that the �30m which the Government is giving through the revenue support grant to assist local authorities with the extra enforcement tasks that the Food Safety Act brings is not enough.� A proposal along the lines of 10(c) or 10(d) would add further weight to those who want further funds for food law enforcement from central Government.� So far as I know there are no funds available unless they are found from offsetting savings within the central Government Department concerned.</div>
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Whilst therefore the option of legislation should not necessarily be excluded from the considerations of the Tyrrell Committee I think that the paper leads the Committee to the conclusion that it is an easy option which could be simply followed.� I hope I have illustrated in this minute that it is not so easy and that even if it was followed I am far from certain that the problems which you would want to address would be solved by it.</div>
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I suggest therefore that the paper is far more tentative in its conclusions as regard (sic) possible legislation on the restriction of the bones from which MRM might be derived.� Perhaps it ought to develop rather more the rules and guidance and controls on ensuring that spinal cord material is properly removed from the carcass at the slaughtering stage without the risk of contamination of other material.� This would seem to me to address the problem far more directly at its real source.�</div>
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86.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Under cover of a minute dated 8 October 1990<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn79" name="_ftnref79" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[79]</span></a> Mr Lowson circulated for comment a paper on slaughterhouse practices (intended for consideration by SEAC). The minute went to Mrs Brown, Mrs Attridge, Mr Meldrum, Mr K Baker, Mr Bremner, Mr Hutchins, Mr Cockbill, Mr Suich, Dr Woolfe, Mr Lawrence, Mr Bradley, Mr Murray (DoH) and Mr F Taylor.� The paper took into account Mr Taylor�s draft material on MRM.� Recipients were asked to provide any final comments.� Inter alia, this version of the paper confirmed that over 70% of chilled beef MRM was produced according to the BMMA�s draft code of practice.� However, this particular point was dropped from the final version of the paper after being challenged by Dr Hargin (minute of 12 October 1990 to Mr Lowson)<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn80" name="_ftnref80" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[80]</span></a>.</div>
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87.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 11 October 1990 Mr Bradley wrote to Mr Lowson with comments on the draft paper on slaughterhouse practices.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn81" name="_ftnref81" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[81]</span></a>� He provided extensive comments on MRM aspects:-</div>
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�Para 5 The circular saw procedure is inadequately described. These may have running water cooling which is sprayed over a distance of several metres and may be contaminated. Aerosol is almost certainly produced and may contaminate the same adjacent carcasses. The latter could be protected by isolation of the carcase being split in a sealed cabinet ( like a shower cabinet). Guildford abattoir has a circular saw system.</div>
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Para 7 Add-�or which can be transferred with spray onto adjacent carcasses unless protected� at the end of the first sentence. 2<sup>nd</sup> sentence- is there scientific support (a reference) to �the few grams�. In any case a gram of infected cord could have a lot of infectivity. Last sentence- this data could be obtained by comparing the mean weight of spinal cord collected after splitting with that obtained after necropsy using a standard procedure to account for the length of spinal nerves etc.</div>
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Para 12.� The meat products and spreadable fish pdcts regs 1984 does not permit the use of specified bovine offals (except thymus which is regarded as meat) to be used in uncooked meat products.� Thus spinal cord is excluded.� There was however no restriction on their use in cooked meat products before the specified offals ban.� Community legislation states that steps must be taken to remove visible lymphatic and nervous tissue from meat before sale to the consumer.� Meat is defined as any part of the carcase that is eaten.� Therefore all nerve and lymphatic tissue must be removed before MRM is prepared (it would be impossible afterwards).� MRM from limb bones would probably be less likely to be �contaminated� than that prepared from the vertebral column.� These points are not brought out [in the paper].� There are possibilities for analysis of MRM to determine the amount of myelin lipids present which could suggest the degree (or absence) of nervous tissue contamination.� I have discussed this with Food Science Div - Dr M Wolfe.� Limb bones other than scapula and pelvis are prevented from use by the trade.</div>
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Because detectable neuroinvasion does not occur until about half-way through the incubation period and, assuming similar in cattle incubating BSE, prime beef cattle killed at two years would present minimal risk compared with cull cows in regard to nervous tissue.� However the thoraco-lumber chain of lymph nodes would likely be infected in an exposed animal even at 2 years of age.� We need to know not only if infectivity is present but how much is present.� This could be important to know for decision making particularly if MRM from different species was mixed (to dilute infectivity) before use - would it be effective.�</div>
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88.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the suggestion in paragraph 21(c) of the draft paper that contamination of the vertebrae with CNS tissue might occur through �the failure to remove nerves from between the vertebrae�, Mr Bradley thought that:-</div>
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������ �I doubt this is done in practice.�</div>
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89.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Bradley also commented on paragraph 22 of the draft paper which noted that �there will probably be some peripheral nervous tissue still present within the vertebral column.� Therefore, any risk passed by MRM would seem to be by the transference of the BSE agent from nervous tissue to the MRM.� It is still not known however, if even where the spinal cord is removed cleanly, any risk exists from the remaining nervous tissue in the vertebral column.�� In this context, Mr Bradley considered that:-</div>
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�Assuming pathogenesis in cattle with BSE is similar to that in mice with scrapie infection of the cord would be via autonomic nerves (centripetal).� Only after the cord was infected would peripheral efferents be infected (centrifugal).� This would [be] unlikely unless clinical signs were present - at least titres would probably be low.�</div>
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90.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Meldrum wrote to Mrs Brown on 12 October 1990 with comments on the draft paper for the Tyrrell Committee<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn82" name="_ftnref82" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[82]</span></a>:-</div>
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�On a number of occasions I have suggested that we should look at the possibility of a machine that would suck out residual parts of the spinal cord after the carcase has been split.� This would not be difficult technically and would be an improvement on the present manual extraction system.� I would be grateful if this could be incorporated into the draft.�</div>
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91.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mrs Brown replied to Mr Meldrum on 15 October 1990.� She confirmed that there was ongoing liaison with Dr MacOwan and IFR-Bristol on possible approaches to the issue.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn83" name="_ftnref83" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[83]</span></a></div>
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92.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 15 October 1990, Ms Pawlyn (Consumer Protection Division) circulated to Messrs Lowson, Cockbill and F Taylor the latest version of the BMMA�s definition of MRM, and its labelling advice for meat products and preparations in relation to the declaration of MRM.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn84" name="_ftnref84" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[84]</span></a></div>
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93.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In its final form, the paper prepared for SEAC<span lang="EN-US"> by MAFF officials contained sections on carcase splitting, mechanically recovered meat, the use of pithing </span>rods<span lang="EN-US"> and possible research.� In an introductory section, the paper made the following points</span>:<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn85" name="_ftnref85" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[85]</span></a></div>
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�Most of the offals covered by the ban can readily be removed in the slaughtering and dressing process.� However there is at least the theoretical possibility that some slaughtering practices could involve contact between material for human consumption and material covered by the Regulations, notably spinal cord and nervous tissue.� It is important to bear in mind that, on the scrapie analogy, neuroinvasion is not likely to occur until about half way through the incubation process.� Thus the risk that these tissues will be infected is much less in animals killed for prime beef at about two years old than in cull cows.� Furthermore, assuming that BSE pathogenesis in cattle is like that of scrapie in mice, peripheral efferents are unlikely to be infected until clinical signs were visible.�</div>
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94.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span><span lang="EN-US">With </span>regard<span lang="EN-US"> to</span> carcase splitting, it was explained to SEAC that it was normal for all bovine carcases to be split, apart from those of calves up to the age of six months, and that this was a requirement of EC rules governing the intra-Community trade in meat.� The paper also explained that:<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn86" name="_ftnref86" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[86]</span></a></div>
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�The spinal cord will inevitably receive some damage during this operation, although it is often surprisingly intact.��</div>
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95.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The question of contamination of the carcase with spinal cord material was also addressed in the paper.� The following comments were made:<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn87" name="_ftnref87" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[87]</span></a></div>
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�The concern that has been expressed regarding carcase splitting relates to the possible transfer of material from the damaged spinal cord onto the carcase.� The volume of material is likely to be small, in most cases no more than a few grams.� It will be concentrated around the cut surface of the spinal column, perhaps with some slight spill over onto exposed meat surfaces.� The routine washing of the carcases will, if done sufficiently promptly (as would be normal practice), remove the greater part of any gross particular matter.� However no data are available about the quantity of spinal cord tissue likely to come into contact or remain with material used for human consumption.� Such data could be obtained by comparing the mean weight of spinal cord collected after splitting with that obtained after necropsy using a standard procedure to account for the length of spinal nerve etc.�</div>
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96.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the possibility of sucking out the cord from the intact carcase, the paper said that this was unlikely to be practicable as the shape of the carcase and the spinal canal and the attachments of the cord would all act against such a method.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn88" name="_ftnref88" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[88]</span></a>� It was pointed out that this and other possible methods of reducing the risk of spinal cord contaminating material used for human consumption (e.g blowing out the cord from the intact carcase, or use of a double bladed saw) were not in commercial use, and that some R&D would be required to determine their practicability and the extent to which they would in practice reduce such a risk.</div>
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97.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In the section specifically on MRM, the paper explained that there was currently no specific UK or EC legislation in force to regulate the use of mechanically recovered meat.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn89" name="_ftnref89" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[89]</span></a>� However, it was explained that by virtue of the Meat Products and Spreadable Fish Products Regulations 1984, MRM could not be used in uncooked meat products if it was obtained from certain specified parts of the carcase, including (amongst other organs and parts) brains, spleen, spinal cord and large and small intestines.� Reference was also made to the Bovine Offal (Prohibition) Regulations 1989, which prohibited SBO from all human food, and also to EC rules requiring that all visible lymphatic and nervous tissue be removed in the normal cutting process.�</div>
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98.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The paper also pointed out that few meat products containing MRM were labelled as such and that the legal obligation to do so was disputed by the industry.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn90" name="_ftnref90" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[90]</span></a>And it explained the guidance that was available to manufacturers via the BMMA�s draft code of practice.� SEAC was informed that MAFF�s Food Science Division was embarking on a project to develop a method to detect the presence of MRM in meat products.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn91" name="_ftnref91" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[91]</span></a>The paper noted that it might be possible to use this method �to enforce a ban on the use of MRM, or certain types of MRM, should this be necessary.�</div>
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99.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The paper then considered the implications regarding BSE.� It was pointed out that the vertebral column of bovine carcases, excluding the spinal cord, could be used in the manufacture of MRM.� The paper continued as follows:<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn92" name="_ftnref92" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[92]</span></a></div>
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�Inevitably when bovine carcases are split through the centre of the vertebral column in the <span lang="EN-US" style="font-size: 12pt;">slaughterhouse</span> some nervous tissue can remain and some contamination of the vertebrae with central nervous system (CNS) tissue can occur.� This will be as a result of:-</div>
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(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>small pieces of spinal cord inadvertently remaining in the vertebral column;</div>
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(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>contamination from carcase splitting�; or</div>
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(iii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>the failure to remove nerves from between the vertebrae.</div>
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It is unlikely that lymph nodes and other nervous tissue associated with the muscle are left adhering to the bones, since only residual meat remains after the deboning stage.� However, there will probably be some peripheral nervous tissue still present within the vertebral column.� Therefore, any risk passed by MRM would seem to be by the transference of the BSE agent from nervous tissue to the MRM.� It is still not known however, if even where the spinal cord is removed cleanly, any risk exists from the remaining nervous tissue in the vertebral column.�</div>
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<span lang="EN-US">100.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">In </span>the<span lang="EN-US"> section on possible research, the paper indicated a number of areas in which R&D could be useful.� These included:<o:p></o:p></span></div>
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(a)bioassay of MRM or potentially contaminated tissue from affected animals;</div>
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(b)the quantification of the extent of any residue of CNS tissue left with the carcase when the cutting process was complete;</div>
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(c) assessment of possible alternative methods of removing the spinal cord or cutting the carcase; and</div>
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(d)methods of detection of CNS in MRM, and then determination of the presence of CNS tissue in MRM.</div>
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101.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The paper concluded:-</div>
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�The Committee is invited to consider on the basis of the available evidence whether any action or guidance is required in relation to slaughterhouse practices, and whether any new R&D is needed, and if so with what priority.�</div>
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<span lang="EN-US">102.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">SEAC considered the paper provided by MAFF at its meeting of 1 November 1990.� The minutes of the meeting do not record any specific discussion of MRM. Under the heading, �Slaughterhouse Practices�, the minutes of the meeting record the following:</span><a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn93" name="_ftnref93" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[93]</span></a><span lang="EN-US"><o:p></o:p></span></div>
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<span lang="EN-US">�Those members who had been involved in the slaughterhouse visit had noted that, if proper procedures were followed, specified offals could be satisfactorily removed at the slaughterhouse, and in particular that the spinal cord could be extracted from the carcase without difficulty.� The Committee therefore concluded that, provided all the rules were properly followed and supervised, there was no need to recommend further measures on the grounds of consumer protection (operator safety was a matter for HSE).�<o:p></o:p></span></div>
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103.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 9 November 1990 Mr Lowson minuted PS/Mr Maclean on the subject of slaughterhouse practices.� He explained that the Tyrrell Committee had now:-</div>
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�specifically consider[ed] the issues raised by carcase splitting, mechanically recovered meat and pithing rods.� This included visiting two slaughterhouses and seeing the slaughtering process at first hand.� In the light of these visits and of papers prepared in Tolworth the Committee concluded that so long as the rules were properly observed and proper supervision was maintained, there was no need to recommend further control measures on grounds of food safety.</div>
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The Committee does not intend to produce a formal document setting out this advice, but are aware that the Minister may choose to make some kind of public announcement. One possibility would be to cover the point in the response to the report of the Agriculture Committee on BSE. Paragraph 9 of the draft which the Minister sent to his ministerial colleagues says that the Government has asked the Tyrrell Committee to advise on slaughterhouse practices. If the Parliamentary Secretary is content this could� be revised as attached, and Mr Alderton could arrange to have the draft altered.�<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn94" name="_ftnref94" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[94]</span></a></div>
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104.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the question of publicising the Committee�s advice, the Parliamentary Secretary agreed with Mr Lowson�s suggestion that the point could be covered in the response to the Agriculture Committee on BSE.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn95" name="_ftnref95" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[95]</span></a></div>
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<span lang="EN-US">105.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span>When giving oral evidence to the BSE Inquiry, Mr Lowson was asked about the basis upon which SEAC had issued their advice on slaughterhouse practices.� He was asked whether he believed that, in making the proviso that practices were safe so long as the �rules were properly followed and supervised�, the Committee had been provided with any information regarding compliance with the regulations.� Mr Lowson replied that �<span lang="EN-US">they advised that way because they did not feel able to advise about the extent to which those provisos were met.</span>�<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn96" name="_ftnref96" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[96]</span></a><span lang="EN-US"><o:p></o:p></span></div>
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106.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In his evidence to the BSE Inquiry, Mr Meldrum was asked whether it was his view, at this time, <span lang="EN-US">that small parts of the spinal cord might in fact contaminate meat recovered mechanically from the spinal column of bovine carcases.� He said:</span><a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn97" name="_ftnref97" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[97]</span></a></div>
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<span lang="EN-US">�� we have always accepted that brain, spinal cord was the most dangerous part of the animal, particularly in those that are clinically affected, and under the SBO ban it was clear we wanted to ensure total removal of both brain and spinal cord.� Certainly when you split the carcass of an adult animal you would expect to get some contamination of the area around the saw cut, particularly on the bone.� To some extent this would be dealt with by the washing of the carcass, and it was certainly acknowledged by us that contamination of the bony surface of the spinal column could occur.� It was an issue that we considered, an issue that was considered by the Advisory Committee; and it was considered that so long as we removed the spinal cord that the other bovine products were safe�<o:p></o:p></span></div>
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<span lang="EN-US">I believed that the contamination problem would be on the bones. As you cut through the bone of the spinal column, on that cut surface you may get some contamination with spinal cord material, although in many cases when you split the spinal column the spinal cord will move to one side or the other and is not in fact damaged.� In some cases it could be damaged or cut through.� That contamination would occur on the bony surface.�<o:p></o:p></span></div>
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107.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In her written statement to the BSE Inquiry, Mrs Attridge explained that:-</div>
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�Because of adverse press comments on the production of mechanically recovered meat and concern that it was not being properly labelled, research had been commissioned by Food Science at Bristol which was completed in August 1989.� This studied the compositional differences between the mechanically recovered meat and hand de-boned meat.� This concluded that there were very few differences and that the majority of beef MRM manufacturers adhered to British Meat Manufacturers Association Draft Code of Practice regarding which bones can be used for MRM production.� The Code required the removal of the spinal cord and excluded the use of longer bones which would have a higher marrow content and also excluded head bones.� In the light of this there appeared no reason to prohibit the use of mechanically recovered meat (see Dr Denner�s minute to me of 18th June 1990 [paragraph 39, above] and my reply of 19th June [paragraph 40, above]).� The views of the Tyrrell Committee were sought on it.�<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn98" name="_ftnref98" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[98]</span></a></div>
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108.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>A number of industry representatives who gave evidence to the BSE Inquiry expressed the view that it was likely that bones used for the production of MRM would probably carry some spinal cord on them.� Mr Baker of the Federation of Fresh Meat Wholesalers said that most boning plants were using machines to recover meat at the time, and that a number of carcase bones that would go through the machines �would probably have some spinal cord in them�.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn99" name="_ftnref99" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[99]</span></a>� When Mr Carrigan of SpecialPack Limited, was asked about the possibility that spinal cord would be contained in MRM he stated that there was �no question� that it would.<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn100" name="_ftnref100" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[100]</span></a>�</div>
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<span lang="EN-US">109.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span>Mr Ridge, a quality assurance executive of Somerfield Stores, stated in his evidence to the Inquiry that they had excluded MRM from their products from 1990 onwards.� He explained that the reason for this involved fears about the microbiological standard of some MRM and concern that the process was �actually going to potentially extrude a certain amount of lymphatic and nervous tissues.�<a href="https://web.archive.org/web/20000830210922/http://www.bse.org.uk:80/dfa/dfa14.htm#_ftn101" name="_ftnref101" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[101]</span></a><span lang="EN-US"><o:p></o:p></span></div>
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Terry S. Singeltary Sr.</div>
Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-4687453285836897153.post-84094966654633946982017-08-22T12:09:00.001-05:002017-08-22T12:09:56.715-05:00BSE INQUIRY DFA 16 MID 1995 TO THE FINAL DAYS<div class="Section1" style="page: Section1;">
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<span style="font-family: Arial;">DFA 16 ������ ����</span><span style="font-family: Arial; font-size: 10pt;"><img height="131" src="https://web.archive.org/web/20001121091600im_/http://www.bse.org.uk:80/dfa/DFA16_files/image001.gif" v:shapes="_x0000_i1025" width="107" /></span><span style="font-family: Arial;"><o:p></o:p></span></div>
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�<span style="font-size: 28pt;">MID 1995 TO THE FINAL DAYS<o:p></o:p></span></div>
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<span style="font-size: 11pt;">Draft Factual Accounts ������������������������������������������������������� 7 July 1999<o:p></o:p></span></h1>
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<span style="font-family: Arial; font-size: 11pt;">This is one of a series of documents intended to provide an account as at the date of publication of the factual evidence received by the Inquiry. The documents do not make any judgements about the implications of the facts or point to any conclusions. They are simply working drafts seeking in a neutral way to set out relevant evidence. They do not contain any expressions of opinions by the Secretariat or the Committee of the Inquiry. The series will only cover certain areas of the evidence.<o:p></o:p></span></div>
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<span style="font-family: Arial; font-size: 11pt;">The DFAs may contain inaccuracies and omissions. The purpose of publishing them is to invite corrections, additions and comments. The Inquiry has received suggestions for such corrections and additions in relation to DFAs already published. This is helpful in furthering the work of the Inquiry; all suggestions are considered and used to update the Secretariat�s working papers which will form the basis of the Committee�s Report in due course. The DFAs should not be treated as setting out a complete and accurate appreciation of the relevant facts.<o:p></o:p></span></div>
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<span style="font-family: Arial; font-size: 11pt;">You are invited to let the Secretariat know of any errors, inaccuracies or material omissions in this DFA. It would be helpful if you could distinguish suggested amendments to the DFA from more general comments which would not involve such amendment. Please write to:<o:p></o:p></span></div>
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<strong><span style="font-family: Arial; font-size: 11pt;">������������������ The Secretary<br />The BSE Inquiry<br />6<sup>th</sup> Floor<br />Hercules House<br />Hercules Road<br />London SE1 7DU</span></strong><span style="font-family: Arial; font-size: 11pt;"><o:p></o:p></span></div>
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<strong><span style="font-family: Arial; font-size: 11pt;">Email to : inquiry@bse.org.uk</span></strong><span style="font-family: Arial; font-size: 11pt;"><o:p></o:p></span></div>
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<span style="font-family: Arial; font-size: 11pt;">Responses should reach the Secretariat by 7 August 1999 for them to be of most assistance to the Inquiry.<o:p></o:p></span></div>
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DFA 16: MID 1995 TO THE FINAL DAYS</div>
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MID 1995 TO THE FINAL DAYS.................................................. 3<o:p></o:p></div>
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Before July 1995.................................................................................................................... 3<o:p></o:p></div>
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1992.......................................................................................................................................... 3<o:p></o:p></div>
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Farmer 1.................................................................................................................................... 3<o:p></o:p></div>
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1993.......................................................................................................................................... 4<o:p></o:p></div>
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Farmer 2.................................................................................................................................... 4<o:p></o:p></div>
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1994.......................................................................................................................................... 5<o:p></o:p></div>
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Farmer 3.................................................................................................................................... 6<o:p></o:p></div>
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1995.......................................................................................................................................... 6<o:p></o:p></div>
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Teenager 1................................................................................................................................. 6<o:p></o:p></div>
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July 1995................................................................................................................................. 7<o:p></o:p></div>
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August 1995.......................................................................................................................... 10<o:p></o:p></div>
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Teenager 2.............................................................................................................................. 12<o:p></o:p></div>
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September 1995................................................................................................................... 15<o:p></o:p></div>
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SEAC Meeting 20.................................................................................................................. 15<o:p></o:p></div>
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Farmer 4.................................................................................................................................. 16<o:p></o:p></div>
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October 1995........................................................................................................................ 18<o:p></o:p></div>
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SEAC Meeting 21.................................................................................................................. 19<o:p></o:p></div>
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SBO entering the food chain................................................................................................. 27<o:p></o:p></div>
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Teenager 3.............................................................................................................................. 30<o:p></o:p></div>
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November 1995.................................................................................................................... 33<o:p></o:p></div>
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SEAC Meeting 22.................................................................................................................. 45<o:p></o:p></div>
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Ban on the use of vertebrae................................................................................................... 49<o:p></o:p></div>
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December 1995.................................................................................................................... 50<o:p></o:p></div>
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Contingency Planning............................................................................................................ 67<o:p></o:p></div>
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January 1996........................................................................................................................ 68<o:p></o:p></div>
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SEAC Meeting 23.................................................................................................................. 69<o:p></o:p></div>
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February 1996...................................................................................................................... 83<o:p></o:p></div>
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SEAC Meeting 24.................................................................................................................. 83<o:p></o:p></div>
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Early March 1996................................................................................................................ 93<o:p></o:p></div>
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Friday 8 March 1996.......................................................................................................... 94<o:p></o:p></div>
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SEAC Meeting 25.................................................................................................................. 94<o:p></o:p></div>
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Monday 11 March 1996...................................................................................................... 98<o:p></o:p></div>
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DH........................................................................................................................................... 98<o:p></o:p></div>
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SEAC Meeting 26.................................................................................................................. 99<o:p></o:p></div>
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Tuesday 12 March 1996................................................................................................... 100<o:p></o:p></div>
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MAFF.................................................................................................................................... 100<o:p></o:p></div>
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DH/ Contingency Planning................................................................................................. 101<o:p></o:p></div>
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Wednesday 13 March 1996................................................................................................ 107<o:p></o:p></div>
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Thursday 14 March 1996................................................................................................. 112<o:p></o:p></div>
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Friday 15 March 1996...................................................................................................... 113<o:p></o:p></div>
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Saturday 16 March 1996.................................................................................................. 114<o:p></o:p></div>
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SEAC Meeting 27................................................................................................................ 114<o:p></o:p></div>
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DH and MAFF...................................................................................................................... 117<o:p></o:p></div>
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Sunday 17 March 1996..................................................................................................... 118<o:p></o:p></div>
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Monday 18 March 1996................................................................................................... 120<o:p></o:p></div>
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Minute 1 (from Mr Hogg and Mr Dorrell)........................................................................ 120<o:p></o:p></div>
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Minute 2 (from Mr Hogg).................................................................................................. 120<o:p></o:p></div>
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Minute 1 is sent................................................................................................................... 125<o:p></o:p></div>
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DH......................................................................................................................................... 127<o:p></o:p></div>
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Minute 2 is sent................................................................................................................... 128<o:p></o:p></div>
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Cabinet.................................................................................................................................. 129<o:p></o:p></div>
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Tuesday 19 March 1996................................................................................................... 129<o:p></o:p></div>
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SEAC Meeting 28................................................................................................................ 131<o:p></o:p></div>
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Wednesday 20 March 1996.............................................................................................. 135<o:p></o:p></div>
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Mid 1995 to the final days</div>
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<i>This draft factual account is a narrative of the period from mid 1995, when the first cases of what was later identified as new variant CJD came to light, to the Government�s announcement of 20 March 1996 about possible links between this disease and BSE.</i><span style="color: blue; font-family: Arial;"></span><i><o:p></o:p></i></div>
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Before July 1995</div>
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1<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Some events before July 1995 are mentioned below.</div>
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2<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In the months before the announcement on 20 March 1996, there emerged several cases of CJD in farmers and in young people, which caused concern. Although the clustering of farmers� cases was the subject of some speculation, these did not turn out to be cases of what is now known as new variant CJD.</div>
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1992</div>
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Farmer 1</div>
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3<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 4 August 1992, Dr Ailsa Wight (DH, Health Aspects of the Environment and Food (HEF) Division) minuted her colleagues Dr Roger Skinner and Ms L Lockyer. She said that the CJD Surveillance Unit had informed her that a dairy farmer was suffering from probable CJD. The farmer had experienced a case of BSE in his herd. Dr Wight said she had discussed the case with Mr Thomas Murray (DH, SEAC Secretariat). Dr Wight noted that Dr (later Professor) Robert Will (Director, CJD Surveillance Unit, and member, later Deputy Chair of SEAC) felt that the existence of BSE on the farm and the farmer�s suffering from CJD was �probably a coincidence�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn1" name="_ftnref1" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[1]</span></a></div>
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4<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 13 August 1992, Dr Wight minuted the private secretary to Dr (later Professor Sir) Kenneth Calman (CMO) to inform him about the farmer.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn2" name="_ftnref2" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[2]</span></a></div>
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5<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 22 October 1992 Mr Murray minuted Mrs Virginia Bottomley, Secretary of State for Health, advising that on 15 October SEAC had discussed the case of CJD in a dairy farmer to the effect that the farmer had since died and that a diagnosis of typical CJD had been confirmed by pathology. SEAC had come to the conclusion that it seemed to be a typical sporadic case of CJD.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn3" name="_ftnref3" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[3]</span></a> The minute was copied to DH officials and Mr Lowson, Head of Animal Health Division, MAFF.</div>
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1993</div>
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6<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The case of the farmer was published in the <i>Lancet</i> in March 1993.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn4" name="_ftnref4" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[4]</span></a></div>
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7<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 11 March 1993, in response to media interest in the case, Dr Calman issued a statement reassuring the public about the safety of beef.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn5" name="_ftnref5" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[5]</span></a></div>
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Farmer 2</div>
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8<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In July 1993, Dr Will informed DH of a second case of CJD in a dairy farmer.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn6" name="_ftnref6" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[6]</span></a> On 12 July, Dr Wight minuted Dr Calman and Baroness Cumberlege (DH Parliamentary Under-Secretary (House of Lords) with responsibility for BSE/ CJD)<b> </b>to inform them about this case.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn7" name="_ftnref7" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[7]</span></a></div>
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9<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In a minute on 19 July 1993, Mr Kevin Taylor (Assistant CVO, MAFF) briefed the private secretaries to the MAFF Ministers with the details of the second case of CJD in a farmer. The minute was copied to numerous MAFF officials, Mr Charles Lister (DH, HEF Division, had replaced Mr Murray as SEAC Secretariat) and Dr Wight.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn8" name="_ftnref8" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[8]</span></a></div>
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10<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 19 July 1993, Professor Peter Smith (epidemiologist, London School of Hygiene and Tropical Medicine, and later a SEAC member) sent a fax to Dr Will.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn9" name="_ftnref9" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[9]</span></a> He had done some �rough calculations� on the statistical significance of the two farmers� cases. He said:</div>
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�I would agree with your conclusion that the observation of 2 cases in workers on dairy farms with BSE-affected herds is disquieting, but the evidence is insufficient at this stage to draw any definite conclusion or to recommend any specific public health action. The appropriate action, in my view, would be to continue the surveillance. Certainly, if 2 more cases arise in the first five years of the surveillance scheme the possibility of an association which is not due to chance must be given very serious consideration�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn10" name="_ftnref10" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[10]</span></a></div>
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11<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>This fax was among the papers considered at the SEAC meeting which was called at short notice, for 20 July 1993, to consider the two cases.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn11" name="_ftnref11" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[11]</span></a></div>
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12<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>At this 20 July meeting, SEAC decided that �no conclusions could be drawn from the available statistical information�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn12" name="_ftnref12" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[12]</span></a></div>
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13<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the same day, Dr Jeremy Metters (Deputy CMO) minuted Dr Wight and Mr Lister about newspaper reports on the second farmer. He expressed concern about �how MAFF and DH would respond to public concern generated if there are further CJD cases among farmers�. He said:</div>
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�4.�� Unwelcome, though it may be to [SEAC], I think they must be asked at their next meeting to give further thought to what they might advise the Department and MAFF if another farmer (or two) develops CJD. Or, if a butcher or abattoir worker develops the disease.</div>
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�5.�� Although the Committee were given plenty of advance warning about the second farmer, they may not be so fortunate next time round. Some contingency planning on the Committee�s response to a further case of CJD in a farmer seems essential. At the same time the Committee should consider if there are special risks to farmers, for example their historical habit of chewing cattle nuts, that might be implicated.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn13" name="_ftnref13" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[13]</span></a><b><o:p></o:p></b></div>
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14<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>At the SEAC meeting on 7 October 1993, members �agreed that if a third case of CJD in a farmer with BSE in their herd occurred, an immediate full Committee meeting would be required�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn14" name="_ftnref14" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[14]</span></a></div>
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1994</div>
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15<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In January 1994 there were media reports of a possible case of CJD in a teenager.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn15" name="_ftnref15" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[15]</span></a> This was 16-year-old Victoria Rimmer. Ms Rimmer died on 21 November 1997.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn16" name="_ftnref16" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[16]</span></a> Diagnosis had not been confirmed at the time that Mrs Beryl Rimmer, her grandmother, gave evidence to the BSE Inquiry in October 1998.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn17" name="_ftnref17" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[17]</span></a></div>
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16<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 8 September 1994 Dr Calman met Mr William Waldegrave, the MAFF Minister, to discuss BSE/ CJD. Among other items, Dr Calman �referred to the need to strengthen the clinical membership of SEAC�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn18" name="_ftnref18" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[18]</span></a> Mr Waldegrave endorsed �the need for a strong, effective committee�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn19" name="_ftnref19" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[19]</span></a> Dr Calman also noted that Dr David Tyrrell, the SEAC chair, �was in poor health and� his lack of vigour had affected his performance at times�. Dr Calman therefore wanted to find a replacement �fairly quickly�. Professor Pattison was a possibility. Mr Waldegrave suggested that DH also seek the views of the Royal Society.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn20" name="_ftnref20" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[20]</span></a></div>
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17<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Professor (later Sir) John Pattison, Professor of Medical Microbiology and Dean of the University College of London Medical School, was prepared to join SEAC. After this meeting Mr Lister drafted a submission for Ministers, recommending Professor Pattison�s appointment.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn21" name="_ftnref21" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[21]</span></a></div>
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Farmer 3</div>
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18<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In December 1994 the CJD Surveillance Unit informed DH of a possible third case of CJD in a farm worker. In a minute on 19 December 1994, Mr Lister informed the private secretary to Baroness Cumberlege about this third case. He copied the minute to Dr Calman�s private secretary, Mr Heppell, Dr Metters, Mr Bridges, Dr Jones, Dr Skinner, Dr Wight, Mr Cunningham, Mrs Sian Gordon-Brown (HEF, DH), Ms Kinghorn and Mr Tom Eddy (MAFF, Head of Animal Health (Disease Control) Division, and MAFF�s SEAC secretariat).<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn22" name="_ftnref22" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[22]</span></a> Mr Lister�s minute noted that there �has been local media interest in the case (before the man died) but nothing nationally, and there have been no enquiries to DH or MAFF press offices.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn23" name="_ftnref23" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[23]</span></a> Mr Lister suggested the following line to take in case of enquiries:</div>
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�We are aware of the case of a farm worker who died recently from <u>suspected</u> CJD. The case is being investigated by the CJD Surveillance Unit in Edinburgh, and the Department is being kept informed of developments. The Surveillance Unit�s third annual report (October 1994) concluded that there is no evidence of a link between occupational exposure to animals and animal products and risk of CJD.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn24" name="_ftnref24" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[24]</span></a></div>
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19<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Calman said this minute was when he first learned of the third farmer case.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn25" name="_ftnref25" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[25]</span></a></div>
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20<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 19 December 1994, Mr Eddy minuted the MAFF Ministers� private secretaries to inform them about the possible third case of CJD in a farm worker. He attached an �interim press statement� which DH had produced �for use if the story breaks�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn26" name="_ftnref26" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[26]</span></a></div>
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1995</div>
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Teenager 1</div>
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21<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In May 1995 the CJD Surveillance Unit received material from a patient who was later diagnosed with nvCJD. The material was from a brain biopsy performed on a teenager.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn27" name="_ftnref27" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[27]</span></a></div>
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22<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 21 May 1995 19-year-old Stephen Churchill died of what was later diagnosed as nvCJD.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn28" name="_ftnref28" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[28]</span></a></div>
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23<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 24 May 1995, the <i>Today</i> newspaper reported Stephen Churchill�s death under the headline �Human mad cow disease tests on dead teenager�. His identity was not revealed.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn29" name="_ftnref29" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[29]</span></a></div>
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24<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In a minute dated 24 May 1995, Mr John Howard (MAFF Animal Health Division, Head of Branch dealing with BSE policy) sent a minute to Mr Keith Meldrum (CVO), Mr Martin Haddon (Under Secretary responsible for the Animal Health Group), Mr Geoffrey Hollis (Head, MAFF Livestock Group), Mr K Taylor, Dr Cawthorne, Mr Raymond Bradley (Pathology Department, CVL) and Mr Webb (Press Branch). He copied it to Mrs Gurnhill and Mr Lister (DH). He said:</div>
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�1.�� Further to my earlier minute I have now had confirmation from DH of <u>their</u> line to take regarding the alleged case of CJD reported in today�s edition of Today is as follows [sic]:</div>
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��The report in the 24<sup>th</sup> May edition of Today is purely speculative and we are not prepared to comment further on individual cases.�</div>
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�2.�� Apparently the CMO has expressed views about not being pressed into commenting on individual cases reported in the press in order to protect patient confidentiality. As on previous occasions I suggest that any queries are referred to DH Press Branch.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn30" name="_ftnref30" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[30]</span></a></div>
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25<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The next mention of this teen-aged case in MAFF or DH files is at 1 August 1995; see below.</div>
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July 1995</div>
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26<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 5 July 1995, Mr Stephen Dorrell succeeded Mrs Bottomley as DH Secretary of State.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn31" name="_ftnref31" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[31]</span></a> On 6 July 1995 Mr Douglas Hogg succeeded Mr Waldegrave as MAFF Minister.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn32" name="_ftnref32" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[32]</span></a></div>
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27<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 14 July 1995, Mrs Dorothy and Mr David Churchill (Stephen Churchill�s parents) wrote a letter to Mr Michael Ancram, their Member of Parliament. The letter was copied to MAFF, DH, and their Member of the European Parliament. The letter indicated that they believed their son had become infected with CJD via the food chain. It said, �As this cause of death is avoidable we feel it imperative to prevent others being stricken by this dreadful disease.� They �demanded� that Mr Ancram pursue the matter on their behalf, and obtain answers to a set of questions on the incidences of CJD, BSE and scrapie, action taken to prevent infected meat getting in to the food chain, and research being carried out.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn33" name="_ftnref33" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[33]</span></a> Mr Ancram forwarded this letter to Mrs Angela Browning (MAFF Parliamentary Under-Secretary) on 19 July (see below).<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn34" name="_ftnref34" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[34]</span></a></div>
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28<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 18 July 1995 the European Commission introduced new measures on beef exports. The provision permitting export of meat from animals slaughtered in the UK that were born after 1 January 1992<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn35" name="_ftnref35" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[35]</span></a> was replaced with a requirement for the animals to be aged less than 2� years at slaughter. This was in response to the news that some cattle born in 1992 had developed BSE.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn36" name="_ftnref36" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[36]</span></a> Requirements for routine monitoring in feed mills were also introduced.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn37" name="_ftnref37" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[37]</span></a></div>
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29<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 18 July 1995 Mr Hogg held a meeting with Mrs Browning, Mr Richard Packer (MAFF Permanent Secretary), Mr Eddy, Mr Richard Carden (Head of MAFF�s Food Safety Directorate), Mr Meldrum, Mr Haddon, Mr Taylor, Mr Jonathan Haslam (MAFF Director of Information), Mr Fleetwood, Miss Wordley and Miss A Evans.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn38" name="_ftnref38" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[38]</span></a> Among other things, they discussed the results of a survey on compliance with SBO controls. Of the 392 slaughterhouses and 43 head‑boning plants that were visited, failures to comply fully with the rules on SBO staining were found in 65% of plants, and failures to comply fully with the rules regarding the separation of SBOs from other materials to be sent for rendering were found in 14% of the plants.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn39" name="_ftnref39" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[39]</span></a> Mr Meldrum reiterated that there was no public health problem, there was not [sic] question of SBOs entering the human food-chain, the risk was of cross-contamination of animal feed�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn40" name="_ftnref40" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[40]</span></a> Mr Carden told the BSE Inquiry that the results �clearly reinforced the case for tighter rules and tighter enforcement.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn41" name="_ftnref41" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[41]</span></a></div>
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30<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>A MAFF news release the next day (19 July 1995) announced the following:</div>
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�A strengthening of the rules for preventing tissue potentially infected with the BSE agent from entering the cattle feed chain� The Ministry has also indicated that there is room for improvement in the application of the current rules in some slaughterhouses and further action is under way to deal with this.</div>
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�Mr Hogg emphasised that there were no implications for the human feed chain in these findings and that measures to protect human health were found to be working effectively in all cases��<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn42" name="_ftnref42" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[42]</span></a></div>
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In answer to a written Parliamentary Question (PQ) from Edward Garnier MP (Harborough), Mr Hogg described the new SBO order that would be made. This was written in the Press Release. The Order is described at 15 August 1995 below.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn43" name="_ftnref43" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[43]</span></a></div>
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31<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The announcement was �welcomed� by the Meat and Livestock Commission (MLC) in a �position statement.� The position statement stated that a �dramatic fall� in the incidence of BSE (BSE had reportedly fallen by 70% from a 1992 peak to less than 3000 cases per week) indicated the �success of measures so far to control the disease�. However, the presence of BABs meant that �the integrity of the [feed] ban is not 100 per cent and we must now tighten up controls to ensure they are totally effective�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn44" name="_ftnref44" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[44]</span></a></div>
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32<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The position statement finished with the statement that:</div>
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�There are no implications for human health because:</div>
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�1.�� visibly infected cattle are totally destroyed,</div>
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�2.�� all specified offals from all cattle are removed and destroyed before the meat enters the human food chain and</div>
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�3.�� despite research there is no evidence whatever that BSE, or its human equivalent CJD, can be caught by man through eating beef�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn45" name="_ftnref45" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[45]</span></a></div>
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33<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 19 July, Mr Ancram forwarded the 14 July letter from Mr and Mrs Churchill to Mrs Browning. He said:</div>
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�As you will see, they raise a number of different points relating to this infection and feel that Stephen�s death could have been avoided had certain actions been taken by the relevant authorities in recent years. In view of the very sad circumstances of this case I would be most grateful if all the questions which they ask could be answered in full�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn46" name="_ftnref46" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[46]</span></a></div>
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34<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 19 July 1995 there was a meeting of the MRC�s Allen Committee on the Epidemiology of CJD. The meeting was chaired by Professor Ingrid Allen, and attended by Dr Jeanne Bell, Mr Bradley, Professor Jeremy Brockes (Ludwig Institute for Cancer Research), Dr Jack Cuzick, Dr Sheila Gore (MRC Biostatistics Unit, Institute of Public Health, Cambridge), Dr Skinner, Mr John Wilesmith (epidemiologist, CVL), and Mrs Meg Wilson (BBSRC). Apologies were received from two new members of the Committee and from Dr MacOwan (Veterinary Science Liaison Officer (VSLO), MAFF), Dr Wight and Dr Will.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn47" name="_ftnref47" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[47]</span></a></div>
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35<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Wilesmith updated the Allen Committee on BSE epidemiology, and Mr Bradley reported that �the law regarding feed production would be changed shortly as there was also some evidence that the feed ban since September 1990 was not totally effective.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn48" name="_ftnref48" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[48]</span></a></div>
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36<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Bell reported on CJD surveillance in Dr Will�s absence. She informed the Allen Committee of the fourth report of the CJD Surveillance Unit, which was still being drafted and was intended to be published in August (see below). The data was discussed in detail, including patients� genotypes and the epidemiological questionnaire.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn49" name="_ftnref49" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[49]</span></a> It was noted that �if a further questionnaire were to be developed to investigate potential occupational exposure to BSE, this would require staff with a knowledge of farming practices�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn50" name="_ftnref50" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[50]</span></a></div>
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August 1995</div>
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37<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 1 August 1995 Dr Wight sent a minute to the private secretaries to Dr Calman and Baroness Cumberlege about the first case of CJD in a teenager (a 19-year-old male) in the UK. The minute was copied to Dr Metters, Dr Eileen Rubery (Head of the HEF Division), Dr Skinner, Mrs Gordon-Brown, Mr Lister, Mr Gerald Robb (HEF1C), Dr Callaghan, Ms French, Miss Thompson and Mr Eddy (MAFF)<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn51" name="_ftnref51" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[51]</span></a>. The minute said �This case received some very limited press attention in May 1995� At that time the diagnosis had not been confirmed, but this has now been confirmed by histopathological examination�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn52" name="_ftnref52" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[52]</span></a></div>
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38<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The same minute discussed a �World in Action� programme to be screened on 14 August 1995 on CJD in teenagers and dairy farm workers.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn53" name="_ftnref53" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[53]</span></a></div>
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39<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Calman told the BSE Inquiry about his concern in relation to the death of the aforementioned 19-year-old:</div>
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�I recall being concerned primarily because of the age of the victim. Whilst sporadic CJD is very unusual it is not unheard of in teenagers. To date the cause of sporadic CJD was unknown. The CJD Surveillance Unit was set up in 1990 following the BSE epidemic in cattle so that any change in the pattern of human spongiform encephalopathy, CJD, that might be attributable to BSE, could be detected. At that point no link had been established between the consumption of beef products, or milk, and the development of CJD�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn54" name="_ftnref54" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[54]</span></a></div>
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40<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 1 August 1995, Mr Eddy informed MAFF Ministers of the case of CJD in the 19-year-old, and of the proposed �World in Action� programme.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn55" name="_ftnref55" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[55]</span></a> His minute went to the private secretaries of Mr Hogg, Mrs Browning, and Mr Packer, and to Mr Carden, Mr Haddon, Mr Meldrum, Mr Crawford, Mr Taylor, Mr Haslam (Information), Mr Bradley, Mr Gerald Wells (neuropathologist, CVL), Mr Wilesmith, Mr Rossington, Mr Paul Hayward (MAFF press officer with responsibility for BSE), Mr Fleetwood, Miss Mary Coales (MAFF Animal Health (Disease Control)), Mr Matheson (SOAFD), Mr Podmore (WOAD), Mr Pat Toal (DANI) and Mr Lister (DH).</div>
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<span lang="EN-US">41<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">On 3 August 1995 Mr Eddy wrote to Mr Lister about the results of a second round of unannounced visits to slaughterhouses and head-boning plants.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn56" name="_ftnref56" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[56]</span></a>According to Mr Eddy, the second round of visits �revealed three instances where SBO was not being separated adequately from material for human consumption�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn57" name="_ftnref57" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[57]</span></a> Mr Eddy wrote<o:p></o:p></span></div>
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<span lang="EN-US">��We can no longer be as robust as we were in the press notice about no infective material entering the human food chain, but the problems are not such as to warrant a special announcement or any special new measures other than the immediate action that was taken at the plants concerned� I am inclined to await the results from the third round of unannounced visits, which should be out in the Autumn, before advising on any further announcements. I do not see it as necessary to issue press statements at every stage in what is a three stage process. I would welcome DH�s views.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn58" name="_ftnref58" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[58]</span></a><o:p></o:p></span></div>
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42<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span><span lang="EN-US">On 4 August 1995 Mr Lister copied Mr Eddy</span>�s letter to Dr Wight, stating that Dr Calman and the DH Ministers needed to be briefed on the findings. He said</div>
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��SEAC will clearly need to discuss the implications at the next meeting, but it comes down, as always, to the need for adequate policing of slaughterhouse practices. Once all the visits are completed � there is a third series to come in the Autumn � we will need to consider how <span lang="EN-US">the</span> results affect our assurance to the public that, following the SBO ban, no potentially infective material can enter the human food chain...�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn59" name="_ftnref59" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[59]</span></a></div>
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43<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Calman became aware of these findings of non-compliance with the SBO ban either at the time of Mr Lister�s minute to Dr Wight or shortly after.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn60" name="_ftnref60" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[60]</span></a></div>
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Teenager 2</div>
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44<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In August 1995 a second teenager was referred to the Surveillance Unit after a brain biopsy confirmed the diagnosis of CJD.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn61" name="_ftnref61" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[61]</span></a> This was 17-year-old Gulcan Hassan.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn62" name="_ftnref62" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[62]</span></a></div>
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45<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 9 August 1995 Dr Wight informed Dr Calman�s private secretary of the possible second case of CJD in a young person (the 17-year-old).<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn63" name="_ftnref63" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[63]</span></a> The minute was copied to Drs Metters, Rubery, and Skinner, and Mr Lister.</div>
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46<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In a 9 August 1995 minute to Dr Calman and Baroness Cumberlege, Mr Lister noted that �World in Action� were aware of the third case of CJD in a dairy farm worker. The minute said:.</div>
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��Apart from an article in �The Cornishman� in December 1994, this case has so far received no publicity within the UK. The WHO, the EC Scientific Veterinary Committee and the German Government were informed of the case earlier in the year��<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn64" name="_ftnref64" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[64]</span></a></div>
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47<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 11 August 1995 Mrs Browning sent Mr Ancram a detailed reply, on behalf of MAFF and DH, to the letter of 14 July from Mr and Mrs Churchill.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn65" name="_ftnref65" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[65]</span></a>Among other things, she said:</div>
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�SEAC is satisfied that no causal link between BSE in cattle and CJD in humans has been shown. The UK�s CJD Surveillance Unit has reported that there is no evidence of any change in the epidemiological characteristics of CJD following the advent of BSE and CJD is no more prevalent in the UK than in other parts of the EU. Nevertheless, the ultra precautionary measures described above have been put in place on the assumption that BSE could theoretically infect humans.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn66" name="_ftnref66" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[66]</span></a></div>
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48<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mrs Browning enclosed a copy of the �most recent� (September 1994) CJD Surveillance Unit annual report, which, she said, �concluded that there was no conclusive evidence of any change in CJD that can be attributable to BSE�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn67" name="_ftnref67" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[67]</span></a></div>
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49<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Ancram followed up with a letter to Mr Gerald Malone (DH Minister of State (Commons)) on 8 September 1995 (see below).</div>
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50<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 11 August Dr Wight minuted her colleagues in the DH Information Division (ID) about an embargoed press release from the Alzheimer�s Disease Society, announcing the launch of their CJD Support Network and information booklet. She wrote that she thought that the Society was a �responsible group� and that �without seeing the booklet, I think a �cautious welcome� to the initiative is in order�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn68" name="_ftnref68" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[68]</span></a></div>
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51<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 11 August 1995 Miss Coales minuted Mr Haslam with a briefing to use in response to the �World in Action� programme on 14 August. She copied it to MAFF Ministers, Mr Packer and others in MAFF, CVL, Scottish, Welsh and Northern Irish Offices and Mr Lister at DH.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn69" name="_ftnref69" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[69]</span></a></div>
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52<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 14 August 1995, the front page of <i>Today</i> newspaper reported that Mr and Mrs Churchill were calling for a public inquiry into their son Stephen�s death on 21 May. They wanted to know if his death from CJD was linked to BSE.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn70" name="_ftnref70" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[70]</span></a></div>
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53<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In relation to the <i>Today</i> article, Mr Eddy minuted Mr Smith (INF) and Ms Saunders (Press Office). He copied the minute to Mr K Taylor, Mr Lister, Miss Coales and Mr Wilesmith. He said that the article had mentioned that Stephen Churchill� had had several holidays in the past on a dairy farm�. The farm had been disbanded in 1986 and because ear tags had not been retained, MAFF were �unable to confirm whether or not any of the cattle sold in the dispersal sale subsequently went on to develop BSE�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn71" name="_ftnref71" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[71]</span></a></div>
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54<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Stephen Churchill�s case was a focus of the �World in Action� programme on television that night.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn72" name="_ftnref72" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[72]</span></a></div>
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55<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 14 August 1995, the Alzheimer�s Disease Society launched its CJD Support Network.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn73" name="_ftnref73" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[73]</span></a></div>
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56<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 15 August the SBO Order 1995<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn74" name="_ftnref74" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[74]</span></a> took effect. It tightened controls on record-keeping, introduced dedicated lines for rendering plants processing SBO, prohibited the removal of brains and eyes so that the whole skull must be disposed of as SBO, and prohibited the removal of spinal cord from the vertebral column apart from in slaughterhouses.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn75" name="_ftnref75" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[75]</span></a></div>
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57<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 16 August 1995 Mr Mark Clark (DH Press Office) informed Dr Wight that the front page of that day�s <i>Sunderland Echo</i> detailed a �doomed mothers anguish� [sic]. This was about a 38-year-old whom an �expert� from Edinburgh had confirmed was �98% sure� to have CJD. Mr Clark asked if Dr Wight was content that Press Office use the �lines we have taken to date?�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn76" name="_ftnref76" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[76]</span></a></div>
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58<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 18 August 1995 Miss Coales minuted Messrs Carden, Meldrum, Haddon and Mrs Gurnhill, and copied the minute to Mr Eddy and Mrs Townsend. She said that the �World in Action� programme had been �based, as expected, around the 19 year old CJD case. It was fairly balanced in approach, although much was made of the transmissibility of BSE to cats, and there was no mention of the various ways that CJD can be transmitted�. She noted that there had been no immediate upsurge in public interest � �indeed, the [MAFF] Press Office has had no enquiries at all, much to their surprise�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn77" name="_ftnref77" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[77]</span></a></div>
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59<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In a minute dated 18 August 1995 Dr Wight informed Dr Metters that a brain biopsy had confirmed the diagnosis in the second teenager, and that the two teen-aged cases would be discussed at the next SEAC meeting on 8 September.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn78" name="_ftnref78" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[78]</span></a> She said she had informed Mr Kevin Taylor (MAFF) by telephone, who was to inform Mr Meldrum �next week�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn79" name="_ftnref79" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[79]</span></a> The minute was copied to Dr Calman�s private secretary, Dr Rubery, Mrs Gordon-Brown and Mr Lister.</div>
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60<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 22 August 1995, Mrs Gordon-Brown minuted Dr Calman�s private secretary to say that the second teenage case was confirmed.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn80" name="_ftnref80" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[80]</span></a> She copied the minute to Drs Metters, Rubery, Skinner, Wight, and Callaghan, Messrs Lister, Robb and Wilson (ID), and Baroness Cumberlege�s private secretary. She sent a separate minute to Dr Wight, copied to Messrs Lister and Robb, detailing the clinical history of the teenager.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn81" name="_ftnref81" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[81]</span></a></div>
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61<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Calman told the BSE Inquiry that �given the unremarkable histories of both victims these cases were treated as sporadic incidences of CJD. Both were referred to the CJD Surveillance Unit for consideration�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn82" name="_ftnref82" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[82]</span></a> He said</div>
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�What we had was one case, then two cases. At that stage it is quite important to remember that the CJD Unit and particularly Dr [James] Ironside had not come to any conclusions about a differing pathology, it was the same pathology. That I think said well, maybe it is just young people with classic CJD. It was later on, about December, January, February, that there was a shift in the thinking about the pathology, not in the August, September time.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn83" name="_ftnref83" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[83]</span></a></div>
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<span lang="EN-US">62<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span lang="EN-US">On 25 August 1995 Mr Meldrum wrote to Dr Metters (DH) regarding Mr Eddy�s letter to Mr Lister about the breaches that had been found of SBO regulations (see 3 August above). Mr Meldrum wrote:<o:p></o:p></span></div>
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<span lang="EN-US">�In my view this letter paints a more alarmist picture than is justified by the circumstances: although many faults were found, particularly related to the staining of SBO, there was no risk to public health in any of the three cases identified because each was spotted and corrected. It is of course, true that there may be other undetected cases where SBO is not properly removed and destroyed, but this has always been the case and is still the case now. The argument for strict enforcement is clear: the Meat Hygiene Service is aware of it, and the new SBO legislation has just been introduced, although primarily directed to protecting the health of cattle, should simplify their task in some respect. The Meat Hygiene Service has issued specific and detailed instructions to its staff on the checks that must be carried out to ensure compliance with our legislation.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn84" name="_ftnref84" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[84]</span></a></span></div>
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63<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In August 1995 the Fourth Annual Report of the CJD Surveillance Unit expressed concern over an apparently high incidence of CJD in farmers, particularly in three dairy farmers who had had BSE in their herds.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn85" name="_ftnref85" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[85]</span></a> The report was released to the public on 5 October 1995.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn86" name="_ftnref86" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[86]</span></a></div>
<div class="Heading3-Section" style="font-family: Arial; font-size: 14pt; font-weight: bold; margin: 24pt 0cm 0.0001pt; text-align: justify;">
September 1995</div>
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64<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 8 September 1995 Mr Ancram wrote to Mr Malone to ask further questions in follow-up to the letter that Mrs Browning had sent on 11 August for Mr and Mrs Churchill.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn87" name="_ftnref87" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[87]</span></a> He raised three issues. First he asked Mr Malone to check the CJD reporting system �to see if there should be clearer criteria for reporting deaths from CJD to ensure that there is a greater awareness of the symptoms of the disease and also more confidence in the figures of the incidence of the disease�. Secondly, he asked why there was not going to be a public inquiry into the death of Stephen Churchill. Thirdly, he asked whether SEAC co-ordinated SE research. His letter was replied to on 20 October 1995 (see below).</div>
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SEAC Meeting 20</div>
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65<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>At its meeting on 8 September 1995, SEAC discussed the information on enforcement of the SBO ban.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn88" name="_ftnref88" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[88]</span></a></div>
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66<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>SEAC also discussed the teenage cases, and decided that they could not draw any conclusions on these. They said:</div>
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�...the presentation of CJD in adolescents is exceptional but not without precedent. CJD has occurred in adolescents in other countries which are free from BSE and it would therefore be premature to conclude that its occurrence in a teenager in the UK was indicative of transmission of BSE. The Committee agreed that these cases should be studied in great detail and it should consider whether they had any implications for the cure or management of the disease�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn89" name="_ftnref89" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[89]</span></a></div>
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SEAC released a statement to this effect at the end of October (see below).<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn90" name="_ftnref90" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[90]</span></a><b><span style="font-size: 13pt;"><o:p></o:p></span></b></div>
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67<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 22 September 1995 Mr Eddy (who had attended the SEAC meeting) informed Mr Hogg about CJD in the second teenager, the 17-year-old girl.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn91" name="_ftnref91" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[91]</span></a></div>
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68<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr (later Sir) Graham Hart (DH Permanent Secretary) told the BSE Inquiry that in September 1995 he</div>
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�became aware that, as well as more cases of CJD in farmers, there was one and possibly two cases of CJD in young people. I accepted the expert advice that such cases were not unprecedented, but I recall discussing the matter with the CMO. We agreed that it was vital that the CJD Surveillance Unit was monitoring the situation very carefully�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn92" name="_ftnref92" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[92]</span></a></div>
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69<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>He further commented:</div>
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�we did not know and I suppose we still do not know for sure how accurate ascertainment had been in the past. There is always a danger, the possibility, when you are starting up a new particular kind of hunt as it were for a particular syndrome, condition or whatever, you will find cases that in the past would have been undetected�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn93" name="_ftnref93" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[93]</span></a></div>
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70<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>He also said:</div>
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�I made a judgment that the world had not, you know, as it were changed catastrophically at that point. One obviously had at the back of one's mind at this time that there was a possibility here; still relatively remote, but real, but we had not reached the point at which, you know, one's balance of judgment tips over into it looks as though it is really bad news�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn94" name="_ftnref94" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[94]</span></a></div>
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Farmer 4</div>
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71<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 28 September 1995 Dr Wight minuted Dr Calman�s private secretary about a probable fourth case of CJD in a beef farmer who had had a case of BSE in his herd four years earlier.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn95" name="_ftnref95" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[95]</span></a> She copied the minute to Dr Metters, Dr Rubery, Dr Skinner, Mr Lister, Ms French (ID) and Mr Eddy (MAFF). Dr Wight noted:</div>
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�2.�� If he is confirmed as suffering from CJD, this brings the total number of cases in farmers in the UK to four. CMO will recall that earlier advice the SEAC had from Professor Peter Smith� was that the occurrence of a fourth case (in a dairy farmer) would be of serious concern�</div>
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�3.�� �The CJD Unit hope to visit tomorrow� more details will be available then.</div>
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�4.�� There is some urgency in dealing with this as the case is already in the public domain � BBC Wales are making a programme which refers to this case. In addition, the <i>Lancet</i> articles on the third UK farmer and on the European situation are to be published tomorrow. Together, these factors are very likely to provoke wider interest.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn96" name="_ftnref96" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[96]</span></a></div>
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72<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In a minute the same day, Mr Eddy informed the MAFF Ministers about the fourth farmer.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn97" name="_ftnref97" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[97]</span></a> He said that DH would �take the lead in handling any media enquiries�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn98" name="_ftnref98" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[98]</span></a> He noted that the local media were aware of the case and �we understand will be running an item on it today. This could stimulate further media interest�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn99" name="_ftnref99" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[99]</span></a></div>
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73<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Eddy�s minute recalled the (July) 1993 advice from Professor Peter Smith that �if four cases of CJD occurred in farmers over a five year period then �the possibility that the association was not due to chance had to be given very serious consideration��.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn100" name="_ftnref100" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[100]</span></a></div>
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74<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Calman met DH staff the next day (29 September) to discuss �the latest findings in research and any further safety measures which should be taken to minimise the risk to humans�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn101" name="_ftnref101" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[101]</span></a> An emergency meeting of SEAC was scheduled for the next week, on 4 October.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn102" name="_ftnref102" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[102]</span></a></div>
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75<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 29 September 1995 Mr Lister minuted Baroness Cumberlege�s private secretary, and copied the minute to the private secretaries of Mr Packer and Dr Calman, and to Drs Metters, Rubery, Skinner, Wight, and Callaghan, Mr Jobson, Mrs French (ID), Mr C K McIntosh (SHHD), Ms Liz Jones (WO), Mr T Robinson (DHSS NI) and Dr Render (MAFF). He invited Baroness Cumberlege to agree on a publication date for the CJD Surveillance Unit�s Annual Report, and he advised her of a fourth case of BSE in a farmer whose herd had suffered from BSE. He said that a special SEAC meeting had been called to discuss the case, and that the line to take in the meantime was �We are aware of the case. The necessary investigations are underway, and we cannot comment further at present�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn103" name="_ftnref103" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[103]</span></a></div>
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76<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 29 September 1995 the press reported the third case of CJD in a dairy farmer.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn104" name="_ftnref104" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[104]</span></a> This information was from a letter which had been published in the <i>Lancet, </i>dated 30 September 1995. The letter said:</div>
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�The occurrence of CJD in another dairy farmer with a potential occupational exposure to BSE is clearly a matter of concern. Statistical analysis indicates that the probability of discovering three or more dairy farmers with CJD by chance since 1990 in England and Wales ranges from 0.09 to 0.0002��<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn105" name="_ftnref105" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[105]</span></a></div>
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77<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In the same issue of the <i>Lancet, </i>there was a publication of the European statistics for CJD in farmers. It concluded that �there is no differential increase in the risk of CJD to farmers in the UK through potential occupational contact with cases of BSE�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn106" name="_ftnref106" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[106]</span></a> Dr Wight explained to the BSE Inquiry that on the continent there was also a �slight excess� of CJD cases arising in farmers.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn107" name="_ftnref107" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[107]</span></a> Dr Will said it indicated that in the UK, CJD in farmers had �probably not� been transmitted from BSE.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn108" name="_ftnref108" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[108]</span></a></div>
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78<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Skinner (DH) told the BSE Inquiry that when he was advised at the end of September of the possible fourth case of CJD in a farmer, this information together with the slowly emerging information concerning breaches of the SBO ban, caused considerable unease.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn109" name="_ftnref109" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[109]</span></a></div>
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October 1995</div>
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79<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 3 October 1995 there was a meeting between MAFF and DH Permanent Secretaries. Present from MAFF were Mr Packer, Mr Carden, Mr Meldrum and Mr Dickinson, and from DH, Mr Hart, Dr Calman, Dr Skinner and Mr Lister.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn110" name="_ftnref110" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[110]</span></a></div>
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80<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The DH files show some notes about this meeting. The notes identified two teen-aged cases of CJD, in a 19- and a 17-year-old, the second of which was not public �and should be treated as confidential�. It was noted that CJD had been �described previously in two adolescents in the USA �which is free of BSE and one adolescent in France at a time when it too was free of BSE�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn111" name="_ftnref111" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[111]</span></a></div>
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81<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>DH�s minutes of the meeting record that DH and MAFF</div>
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�noted a suspected new case of CJD in a cattle farmer who had had BSE in his herd. There was no conclusive evidence that recent cases of CJD were linked to BSE, but it was agreed that it was important to keep the issue under close review, particularly in view of the long incubation period of CJD.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn112" name="_ftnref112" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[112]</span></a></div>
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82<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Packer�s private secretary wrote to DH on 24 October 1995 suggesting some changes to these minutes, including deletion of the word �conclusive� (see 24 October below).<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn113" name="_ftnref113" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[113]</span></a></div>
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SEAC Meeting 21</div>
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83<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>SEAC�s emergency meeting to discuss the fourth farmer was held on 4 October 1995.</div>
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84<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>SEAC reached the following main conclusions at the meeting:</div>
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�there had been a worrying number of cases in farmers exposed to cattle with BSE. However, if there were an occupational link, there would be other occupations that might be expected to be at greater risk, and there was no evidence for this;</div>
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�the stage was being reached where it was difficult to explain the cases as a chance phenomenon. However, although significant, the absolute risk remained extremely low;</div>
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�the evidence in the current case was exposure to BSE for a short period. There was also the likely presence of meat and bonemeal fed to poultry before 1990;</div>
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�it was unclear whether the potential risk factor might be association with animals with BSE or the food given to them (it was known that some farmers ate small amounts of calf and cattle feed but not whether they also ate pig and poultry feed). It was suggested that there might be a problem with dust from feed but that this should be more of a problem with dust compounders;</div>
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�given that there was a problem relating the case to a causal link, the transmission studies were particularly important;<b></b></div>
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�it was still necessary to make a final diagnosis of CJD in the possible 4<sup>th</sup> case.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn114" name="_ftnref114" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[114]</span></a></div>
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85<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>At the meeting,</div>
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�Dr Will summarised recent cases of sporadic CJD in young people. There were currently two cases in teenagers � a 19 year old and a 17 year old. The case in the 17 year old had unusual pathology, although this could be related to age. There were also other cases in their 30s and 40s, which was unusual. However, although this was a change from previous experience, it was difficult to relate to BSE.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn115" name="_ftnref115" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[115]</span></a></div>
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86<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also at the meeting, Dr Wight �invited members to make a fairly clear statement on how they viewed the significance of a fourth case. She also invited the Committee to consider whether they were satisfied that nothing else needed to be done in terms of practical measures.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn116" name="_ftnref116" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[116]</span></a> Dr Wight told the BSE Inquiry �I do not think that SEAC any more than anybody else had any idea of how to make sense of this at that stage�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn117" name="_ftnref117" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[117]</span></a></div>
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87<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In response to Dr Wight�s invitation, SEAC �agreed to draw up a statement which the Department of Health could issue in response to media enquiries�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn118" name="_ftnref118" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[118]</span></a></div>
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88<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The statement, attached to the minutes, said that SEAC had �not altered their advice to Government on the precautions necessary to protect either the public health [sic], including farmers, or animal health.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn119" name="_ftnref119" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[119]</span></a></div>
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89<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The statement said that SEAC had</div>
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�...also noted that surveillance of CJD elsewhere in Europe has shown a similar incidence of CJD in farmers, including dairy farmers, in countries with no or very few cases of BSE. They [SEAC] therefore felt that it was �important to undertake further epidemiological studies to detect any particular risk factors which might be involved, and reiterated their advice that the UK cases of CJD in cattle farmers and the strain of the agent recovered from them should be studied in detail.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn120" name="_ftnref120" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[120]</span></a></div>
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90<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>This was Dr Tyrrell�s last SEAC meeting because he was retiring. Professor Pattison was taking over the SEAC Chair.</div>
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91<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>That day (4 October), after the meeting, Mr Eddy minuted the MAFF Ministers to alert them of the outcome of SEAC�s meeting. He copied his minute to a number of officials, including Mr Bradley (CVL), Mr Lister (DH) and Mr Huws (Welsh Office). He said that the CJD Surveillance Unit had</div>
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�downgraded the case from a �probable� to a �possible� which reflects some uncertainty about the diagnosis now that the symptoms have been examined in more detail by the experts but final confirmation will depend on further tests and ultimately the post mortem.</div>
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�SEAC concluded that, if the fourth case were confirmed, it would be worrying, especially as all four farmers with CJD would have had BSE cases on their farms. It was difficult to calculate accurately the likelihood of this being due to a series of random events; but looking at all male farmers and farm workers in England and Wales the chance of four CJD cases occurring randomly since 1990 was around 5/100; the chances of four cases of CJD occurring randomly in farmers with BSE in their herds was very much lower, around 3/10,000. The Committee therefore concluded that <u>it was difficult to explain the incidence as a chance phenomenon.</u> This is a change to the Committee�s position; it had said that the most likely explanation of the three previous cases of CJD in dairy farm workers was that they were chance phenomena...�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn121" name="_ftnref121" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[121]</span></a></div>
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92<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Eddy advised that SEAC had not recommended �any changes to the measures currently in place to protect human and animal health, including that of farmers and others handling cattle and BSE suspects�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn122" name="_ftnref122" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[122]</span></a></div>
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93<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The same day (4 October), Mr Eddy minuted Dr Danny Matthews (MAFF, technical adviser to SEAC) about discussions during the SEAC meeting. He copied the minute to Mr Keith Meldrum (CVO) and others. At the SEAC meeting, Dr William Watson, Director of the Central Veterinary Laboratory (CVL), had briefly listed four possible routes of infection �although neither he nor anyone else� felt any of them were particularly plausible�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn123" name="_ftnref123" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[123]</span></a>Mr Eddy listed them:</div>
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(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>�that cattle were excreting the agent in some form � there is no evidence for this least of all from the epidemiology of BSE in cattle;</div>
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(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>�that farmers may be exposed through meat and bonemeal in cattle feed � again it was felt that if feed, rather than the cattle themselves, were a problem then there should be a similar excess of cases in pig and poultry farmers where more ruminant material would be in feed;</div>
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(iii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>�from normal food as for the rest of the population but it was unclear why this should discriminate in favour of cattle farmers;</div>
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(iv.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>�through contact with animals � possibly animals killed on the farm and possibly with BSE suspects.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn124" name="_ftnref124" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[124]</span></a></div>
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1.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The last point entailed discussion of the slaughter procedures for BSE-suspect cattle and Mr Eddy suggested putting together a short note for SEAC to cover this point.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn125" name="_ftnref125" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[125]</span></a></div>
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2.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Matthews wrote a paper for presentation at SEAC�s next meeting on 23 November.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn126" name="_ftnref126" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[126]</span></a></div>
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94<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In a press release dated 5 October 1995, DH announced the Fourth Annual CJD Surveillance Unit report.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn127" name="_ftnref127" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[127]</span></a> The report showed an increase in the number of deaths from CJD in 1994. The press release quoted Dr Calman saying:</div>
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�I continue to be satisfied that there is currently no evidence of a link between meat eating and development of CJD and that beef and other meats are safe to eat. However, in view of the long incubation period of CJD, it is important that the Unit continues its careful surveillance of CJD for some years to come.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn128" name="_ftnref128" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[128]</span></a></div>
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95<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The press coverage the following day was extensive. Newspapers ran headlines on the increase in deaths from CJD throughout Britain for the year 1994. <i>The Independent</i> mentioned the deaths of the 19-year-old and three dairy farmers. <i>The Daily Telegraph</i> quoted the CMO�s statement from the press release.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn129" name="_ftnref129" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[129]</span></a></div>
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96<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 5 October 1995 Mr Meldrum minuted Dr Matthews about Mr Eddy�s minute of 4 October on possible routes of infection for farmers. He asked, �Is there any possibility that infectious agent could appear on the anterior surface of the eyeball and be picked up by the farmer when he was treating an animal�s eye or giving an injection for New Forest disease?�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn130" name="_ftnref130" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[130]</span></a></div>
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97<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Matthews responded on 10 October 1995:</div>
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�...I should like to make the following limited observations. I say limited because the amount of information available to us relating to the farms where farmers have been affected by CJD is restricted to that contained in the original epidemiological reports on their cattle, and information made available by Dr Will.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn131" name="_ftnref131" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[131]</span></a></div>
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98<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>He commented that to date he did not have the names and addresses of the farms where the four farmers were from. However, a list had been requested.</div>
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99<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>He said that he was �conscious that:</div>
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(v.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>�we have had no input into the medical epidemiological investigations in order to be confident that all opportunities of exposure have been considered (assuming that we know all potential routes of exposure). In effect the questioning by the Surveillance Unit staff may not have been informed by the knowledge of agricultural and veterinary practice.</div>
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(vi.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>�we have not re-assessed the epidemiology on farm relating to the risk to owners. Nor have we re-assessed the epidemiology in relation to the cases identified and their sources. In other words, given the sensitivity of the circumstances, we have not specifically re-visited the farms to review risk after we became aware of the diagnoses in the farmers...�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn132" name="_ftnref132" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[132]</span></a></div>
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100<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Matthews also said �We are aware of the need to amend our epidemiological questionnaire to force VOs to ask questions about areas of risk that have of necessity been of lower priority in recent years�� He said, �While [the questionnaire] might also prove an ideal mechanism for gathering data on practices that might put handlers at risk, this might be considered too sensitive an issue to approach in such a way�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn133" name="_ftnref133" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[133]</span></a></div>
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101<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In answer to the question about eyeballs, posed by Mr Meldrum�s minute, Dr Matthews did not believe this risk to be zero but felt that there were other practices that were of greater risk. He noted that</div>
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(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>infectivity from the bovine retina was known about but not the optic nerve or other tissue including the cornea;</div>
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(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>the Advisory Committee on Dangerous Pathogens� (ACDP) Precautions for work with human or animal TSEs includes eye in Category A (highest risk) along with brain, spinal cord, thymus etc, placenta and membranes;</div>
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(iii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>treatment for an eye condition in cattle would involve holding the animal by the snout, horn or ear. Excretion via nasal mucosae could lead to contamination of the hands;</div>
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(iv.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>direct contact with or aerosol transmission from placenta at calving time would also be a more likely route of transmission to man.</div>
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(v.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>other routes of transmission to consider were faeces, blood, milk, contact with organs post-mortem or during on-farm surgery, and consumption of SBO from home-killed animals. �It would be nice to know whether the Surveillance team interview the farmer�s veterinary practitioners for historical evidence of diseases and procedures on farms�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn134" name="_ftnref134" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[134]</span></a></div>
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102<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Matthews commented that the presence of only a small number of affected cattle in the herds of the affected farmers was a puzzle. �Might one not expect risk due to association with cattle to be greater in herds with many cases of BSE?�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn135" name="_ftnref135" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[135]</span></a> He also considered that consumption of meat and bone meal (MBM) in animal feed and accidental ingestion or inhalation of SBO-derived fertiliser were also real possibilities.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn136" name="_ftnref136" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[136]</span></a></div>
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103<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Matthews noted that Mr Ray Bradley (Head of Pathology, CVL) had suggested that there might be sub-strains of BSE which presented lesser or greater risk to man. Dr Matthews said that MAFF was still not in a position to evaluate the options as there was insufficient information about the herds and risks concerned. He said that the planned transmission studies of the brains from the farmers� cases might help.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn137" name="_ftnref137" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[137]</span></a></div>
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104<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 10 October 1995 Mr Lister forwarded Mr Eddy�s minute of 4 October to Dr Wight, with the suggestion that �we brief DH Minister and CMO once SEAC have agreed the statement�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn138" name="_ftnref138" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[138]</span></a></div>
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105<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 13 October 1995, Mr Ancram wrote a second letter to Mr Malone about his 8 September letter about the Churchills� concerns. He said:</div>
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�I really would be most grateful for an answer as soon as possible as Mr and Mrs Churchill are continuing to pursue this and have contacted Tony Blair about their case. It would also be most helpful to have details of the latest research currently being conducted into this disease which was recently announced in the Press.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn139" name="_ftnref139" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[139]</span></a></div>
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106<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 20 October 1995 Mr Meldrum informed Mrs Browning and Mr Hogg (copied widely to other MAFF Ministers, officials and territorial departments) about the first case of BSE in an animal born in 1993.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn140" name="_ftnref140" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[140]</span></a> He said</div>
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�The fact that BSE occurs in an animal born in 1993 is not surprising, indeed we have said all along that we expected born after the ban cases (BABs) in animals from later years than 1992. It can readily be explained by our current thinking on the causes of BABs<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn141" name="_ftnref141" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[141]</span></a> and no further action is needed in response to this case. The leakage out of our BSE control system and through our feed mills is thought to have continued beyond 1992, and so cases born in 1993 and later years can be expected...�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn142" name="_ftnref142" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[142]</span></a></div>
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107<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Meldrum noted that the animal was only 25 month old at clinical onset, and that the EC, �possibly prompted by the Germans,� might want to shorten the current restriction on exporting beef from cattle over 30 months old. He said that this �would make exports more difficult and we would try very hard to resist this��<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn143" name="_ftnref143" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[143]</span></a> On making the case public, Mr Meldrum said:</div>
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�...we will shortly have to make details of it public in reply to a PQ put down by Mr David Hinchliffe MP (whose questions may be inspired by Professor Lacey) to ask the Minister:</div>
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��how many BSE cases born in each month since July 1988 were subsequently confirmed.�</div>
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�We could simply let the information become public in response to that question. However, that might leave us open to claims that we were reluctant to make such �difficult� news public, and that it had been �dragged out of us�. This could lead to attempts to discredit our policy of openness on BSE, and conceivably thereby create difficulties with the Germans...�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn144" name="_ftnref144" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[144]</span></a></div>
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He recommended making the 1993 BAB public in response to a �low key� arranged PQ the next week, and at the same time, informing the EC and the German Government about the case.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn145" name="_ftnref145" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[145]</span></a></div>
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108<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 20 October 1995, Mr Thomas Sackville (DH Parliamentary Under-Secretary (Commons)) replied to Mr Ancram�s letter to Mr Malone of 8 September and 13 October, about some concerns of Mr and Mrs Churchill.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn146" name="_ftnref146" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[146]</span></a> Mr Sackville enclosed a copy of the CJD Surveillance report which had been released earlier that month. He responded to the three issues that Mr Ancram�s letter had raised. First, he noted:</div>
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�We share your concern that the monitoring of CJD in the UK should be as effective as possible. That is why we set up the National CJD Surveillance Unit in 1990. The monitoring system used by the Unit is kept under constant review by the Department and we are satisfied that the level of ascertainment of CJD is very high�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn147" name="_ftnref147" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[147]</span></a></div>
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109<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Second, he stated that DH did not consider a public inquiry into Stephen�s death was necessary:</div>
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�The question of a public inquiry into the death of Mr and Mrs Churchill�s son was first raised by the Today newspaper in articles published on 14 and 15 August. Copies are enclosed for your information. The Department�s refusal of a public inquiry was in response to questions from the newspaper. We felt such an inquiry to be unnecessary because we have already established the independent Spongiform Encephalopathy (SE) Advisory Committee (SEAC) with a remit to advise Government on all matters concerning SEs, including CJD.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn148" name="_ftnref148" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[148]</span></a></div>
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110<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>He added that �CJD in young people, although extremely rare, is by no means unique�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn149" name="_ftnref149" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[149]</span></a></div>
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111<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The third question had been whether SEAC co-ordinated SE research:</div>
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�The role of the SEAC in research is to advise the Ministry of Agriculture, Fisheries and Food (MAFF) and the Department of Health on all aspects of research into SEs, including research priorities, new work required, and advice on work in progress. MAFF and the Department of Health have responsibility for the co-ordination of that research.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn150" name="_ftnref150" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[150]</span></a></div>
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112<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 23 October 1995 the <i>Daily Mail</i> reported the fourth case of CJD in a cattle farmer.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn151" name="_ftnref151" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[151]</span></a> The newspaper had �received a late draft of the [SEAC] statement when it was faxed incorrectly by a DH official and went to a private Fax number�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn152" name="_ftnref152" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[152]</span></a></div>
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113<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 23 October 1995 Mr Lister sent a minute to Mr Dorrell�s private secretary. He copied it to the private secretaries of Baroness Cumberlege and Dr Calman, and to Dr Rubery, Dr Skinner, Dr Wight, Mr Sutherwood, Dr Render, Ms George, Mr Robinson and Mr McIntosh. He attached the statement approved by SEAC on possible CJD in a cattle farmer and a list of �bull points� including:</div>
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�SEAC have not altered their advice to Government on the precautions necessary to protect the public health;</div>
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�There remains no current scientific evidence to link meat eating with the development of CJD. The Chief Medical Officer has advised that beef and other meats � and milk � are safe to eat.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn153" name="_ftnref153" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[153]</span></a></div>
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114<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Later that day, SEAC released, via DH, their statement announcing the fourth (suspected) case of CJD in a cattle farmer. The statement said:</div>
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�...it was difficult to explain this as simply a chance phenomenon. There is a statistical excess of cases in cattle farmers compared with the general population but the absolute risk, even for cattle farmers, is extremely low at about 2 cases per million per year. There may be other explanations for such an association besides infection with BSE, and the Committee noted that there are no reported cases in other occupational groups such as veterinarians who might be expected to be similarly exposed. They also noted that surveillance of CJD elsewhere in Europe has shown a similar incidence of CJD in farmers, including dairy farmers��<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn154" name="_ftnref154" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[154]</span></a></div>
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SBO entering the food chain</div>
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115<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 23 October 1995 Mr Meldrum wrote to Dr Calman informing him of incidences of non-compliance with the SBO ban. At the third round of bi-monthly unannounced inspections, State Veterinary Service (SVS) staff had found four cases where spinal cord was still attached to bovine carcasses. Dr Calman had become aware of the problems arising from previous rounds of inspection at the time of, or shortly after, Mr Lister�s minute to Dr Wight on 4 August.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn155" name="_ftnref155" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[155]</span></a> Dr Calman told the BSE Inquiry that although</div>
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�primary responsibility for compliance with the relevant legislation lay with those owning and operating slaughterhouses, cutting rooms and cold stores, the Department of Health and others including SEAC had always proceeded, (after the introduction of the legislation), on the basis that such bans were both in place and effective. Enforcement of all legislation relating to animal health fell within MAFF's jurisdiction.</div>
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�My concerns related to the fact that until the end of October 1995 I, the Department of Health, and others including SEAC had repeatedly made statements in relation to the consumption of beef and its risks to human health and BSE based upon the fact that:</div>
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�(1)� Legislative bans on potentially infected tissue were in place and effective</div>
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�(2)� There was currently no scientific evidence of a link between meat eating and the development of CJD.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn156" name="_ftnref156" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[156]</span></a></div>
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116<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Packer�s private secretary wrote to DH on 24 October 1995 suggesting some changes to the minutes of the MAFF/ DH Permanent Secretaries� meeting on 3 October (see above). Suggestions included deletion of the word �conclusive� because �there is <u>no</u> evidence�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn157" name="_ftnref157" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[157]</span></a></div>
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117<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 24 October, after discussion with Dr Wight, Mr Lister minuted Dr Calman on the subject of SBO removal. He said that BSE in animals born after the introduction of the feed ban meant that SBOs �may well have got into animal feed because of inadequate controls at slaughterhouses�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn158" name="_ftnref158" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[158]</span></a> He included a draft CMO statement that he and Dr Wight had drafted.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn159" name="_ftnref159" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[159]</span></a></div>
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118<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>For Dr Calman, this �confirmed as a possibility� the question of SBOs getting into human or animal food. He was �extremely concerned at this report and discussed... [his] concerns with Baroness Cumberlege and Mr Packer�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn160" name="_ftnref160" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[160]</span></a></div>
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119<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 25 October, Dr Calman met Mr Packer for a more detailed discussion.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn161" name="_ftnref161" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[161]</span></a> Dr Calman summarised the meeting to the BSE Inquiry as follows:</div>
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�I expressed a number of concerns I had as a result of the lapses in the SBO ban which had been identified. These were the continuing high number of BSE cases being reported, although this was declining, the high number of cases born after the feed ban which implied that controls in feed mills were inadequate and discovery that SBO had not always been properly removed in slaughterhouses and the fact that four farmers had contracted CJD. Despite the fact that I received assurances that enforcement of the SBO ban would be carried out vigorously in feed mills and slaughterhouses and that the Meat Hygiene Services would be left in no doubt of the high priority of this measure I requested an immediate meeting with the Minister.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn162" name="_ftnref162" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[162]</span></a></div>
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120<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Packer arranged for Dr Calman to meet Mr Hogg on 7 November 1995.</div>
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121<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 25 October 1995 Dr Calman wrote down his thoughts on BSE.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn163" name="_ftnref163" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[163]</span></a> He noted that �the evidence so far, suggests that there is <u>no</u> scientific evidence that BSE causes human disease�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn164" name="_ftnref164" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[164]</span></a> He went on to say that new information had become available over the last four months, necessitating review of the existing evidence. He cited four areas that the new information related to:</div>
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A.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>�The CJD Surveillance Unit providing information on the incidence, age, geography, food and occupation (including farmers)�,</div>
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B.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>lack of rapid decline in BSE, and BABs;</div>
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C.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>evidence of SBOs getting into the food chain; and</div>
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D.<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>greater understanding of the science.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn165" name="_ftnref165" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[165]</span></a></div>
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122<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>He continued:</div>
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�4.�� These findings taken together do not give grounds for complacency and are not entirely reassuring. The uncertainty remains, and may even have increased. In view, in particular of the problems uncovered in the slaughterhouse procedures, it is impossible to give complete assurance that SBOs have not entered the food chain. However, it is exceedingly unlikely that this has happened to any great extent, and importantly there remains no scientific evidence of a link at present between the eating of meat and the development of CJD in humans. These conclusions have been confirmed by SEAC. The long incubation period needs to be remembered.</div>
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�5.�� The issue remains however, that the uncertainty has increased, rather than decreased. Urgent action is required to reassure the public that all steps are, and have been taken, to minimise any possible risk. It will be difficult to continue to provide complete reassurance unless food manufacturing plants; [sic]</div>
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�A.�� Action at farms, food manufacturing plants and slaughterhouses is effective;</div>
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�B.�� No new findings emerge from the surveillance and transmission studies.�<span class="MsoFootnoteReference" style="vertical-align: super;"> <a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn166" name="_ftnref166" title="">[166]</a></span></div>
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123<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 25 October 1995 Mr Lister sent a briefing on BSE to Baroness Cumberlege. She had requested it after the previous day�s discussion with Dr Calman. The briefing gave statistics on the epidemic and described the SBO ban. It said that MAFF had explained the BABs as being a result of</div>
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�continued infection in feed. At first this was said to be due to supplies of infected feed stored on farms from before the ban. But it now seems likely that SBO� may have been getting into animal feed because of poor controls at slaughterhouses. MAFF have addressed this, at least in part, by transferring responsibility for slaughterhouse inspections from the local authorities to the Meat Hygiene Service.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn167" name="_ftnref167" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[167]</span></a></div>
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124<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In a minute dated 25 October 1995, Mr Eddy informed MAFF Ministers of �the formal announcement later in the week of two cases of CJD in adolescents.� The announcement was to be made in advance of the publication of two letters in the <i>Lancet</i> on Friday 27 October.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn168" name="_ftnref168" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[168]</span></a> The minute also stated:</div>
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�4.�� This article is likely to raise further media interest in BSE and its possible relation to CJD, following the announcement of the possible fourth case of CJD in a farmer at the beginning of the week. Two other announcements to be made this week, of the first 1993 born after the ban case and of the findings of small amounts of specified bovine offal material being left attached to carcases after dressing in slaughterhouses, may well lead to sustained media pressure.�</div>
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125<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>A briefing on the recent media coverage of CJD in farmers was provided for the Prime Minister on 25 October 1995.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn169" name="_ftnref169" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[169]</span></a><b> </b>This was to help Mr Major prepare for his regular �Prime Minister�s Questions� slot in Parliament.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn170" name="_ftnref170" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[170]</span></a> The background note attached to the briefing said that �SEAC�s statement makes it clear that they are not advising Government that extra precautions are needed to protect human health. Neither this case, nor the Committee�s statement, changes our fundamental advice that beef is safe to eat.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn171" name="_ftnref171" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[171]</span></a> The background note also brought the Prime Minister�s attention to the two confirmed cases of CJD in teenagers which were to be published in the <i>Lancet</i> that week (see 27 October below).</div>
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Teenager 3</div>
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126<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In October 1995 a third young patient was referred to the CJD Surveillance Unit after a brain biopsy. Similar to the previous cases, plaque deposition was one of the pathological features in this case.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn172" name="_ftnref172" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[172]</span></a></div>
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127<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In a minute dated 26 October 1995, Dr Render informed MAFF Ministers about a third case of CJD in a young person:</div>
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�DH also learnt today of a case of <b>CJD in a 28 year old man</b>. This has been confirmed by brain biopsy, although the man is still alive. It is unusual to see sporadic CJD in someone so young; apart from the two adolescents the Minister is aware of, the previous youngest sporadic CJD sufferer in the UK was 34 years old. Details of this case are not publicly known.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn173" name="_ftnref173" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[173]</span></a></div>
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128<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In a minute titled �CJD in young people� dated 26 October 1995, Mr Lister informed Baroness Cumberlege�s private secretary of the two letters to be published in the <i>Lancet</i>.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn174" name="_ftnref174" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[174]</span></a> He attached a SEAC statement �which we will issue in response to media enquiries�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn175" name="_ftnref175" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[175]</span></a></div>
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129<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In addition, the minute informed Baroness Cumberlege that</div>
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�4.� The CJD Unit are also investigating a confirmed case of CJD in a 29 year old from London. The patient is still alive, and the diagnosis has again been confirmed by brain biopsy. <u>This case is not yet public.</u> There is also a probable case of CJD in a 38 year old woman � which is still young for CJD � which has attracted media attention.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn176" name="_ftnref176" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[176]</span></a></div>
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130<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>This minute was copied to Dr Calman�s private secretary, Dr Metters, Mr Roy Sutherwood (ID), Mr Clark, Dr Rubery, Dr Skinner, Dr Wight, Mr Robb, Mr W Jobson (HEF1C), Dr Timothy Render (Animal Health (Disease Control) Division, MAFF), Mr McIntosh (Scottish Home and Health Department), Mr Robinson (Northern Ireland DHSS), and Ms George (Welsh Office).</div>
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131<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 26 or 27 October 1995<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn177" name="_ftnref177" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[177]</span></a> SEAC released, via DH, a statement on the two adolescent cases. It said:</div>
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�We note that two cases of CJD have been diagnosed in adolescents in the UK. It is not possible to draw any conclusions from this as confirmed cases of CJD have been found in the same age group in other countries. In addition, the two cases had no exposure to risk factors for CJD and no contact with BSE. It is essential, however, to study the patients in greater detail and consider whether there are any implications for the cause or management of the disease.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn178" name="_ftnref178" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[178]</span></a></div>
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132<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 27 October 1995, Jan Mackenzie of the CJD Surveillance Unit sent two faxes to DH. One was to Mr Robb and it contained a table listing the numbers of referrals of suspected CJD by year, and the number of deaths per year.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn179" name="_ftnref179" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[179]</span></a> This table was to assist in answering a PQ.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn180" name="_ftnref180" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[180]</span></a><b></b></div>
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133<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The other fax was to Dr Wight: �I enclose a table of ranges from 1980-1984 England and Wales and 1989-Present for the UK. I have given the two youngest sporadic cases and the two oldest cases for each year�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn181" name="_ftnref181" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[181]</span></a></div>
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134<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Appended to these tables was a list of �those still alive�. This gave the ages of 6 patients (ranging from teen-aged to 42) and their status (two definite, one probable, one possible and two �?Other�). A seventh patient was added to this table (presumably by DH) in handwriting. Also appended to the tables was a list of age ranges for France, Italy and Netherlands.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn182" name="_ftnref182" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[182]</span></a></div>
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135<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>A submission dated 27 October 1995 from Mr James Brown (Assistant Secretary, Scottish Office Public Health Policy Unit) to the private secretary of Lord Selkirk (Scottish Office Minister of State) informed him of the two letters that were to be published in the <i>Lancet</i>, and gave information about the two cases of sporadic CJD in teenagers in the UK.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn183" name="_ftnref183" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[183]</span></a> The submission was copied to Mr (later Sir) Michael Forsyth (Scottish Secretary of State), Lord Lindsay (Scottish Parliamentary Under-Secretary), the Scottish Health and Agriculture Departments, Dr Robert Kendell (Scottish CMO) and others. The submission reproduced SEAC�s recent statement on CJD in adolescents. It also noted that before 1995, the youngest case of sporadic CJD in the UK had been in a 34 year old. Those cases of sporadic CJD in teenagers known about in other countries were: a 16 year old in the USA in 1978, a 19 year old in France in 1982, a 14 year old in Canada (of UK origin) in 1988, and three cases aged 19, 23 and 27 in Poland, who were identified retrospectively in a study published in 1991. The submission also noted that Creutzfeldt�s first patient in 1920 was aged 23.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn184" name="_ftnref184" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[184]</span></a></div>
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136<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 27 October, the 28 October 1995 edition of the <i>Lancet</i> was published. It contained 2 letters (by numerous authors) about teen-aged CJD victims. One was about a 16-year-old (this was Gulcan Hassan) and the other was about an 18-year-old (Stephen Churchill).<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn185" name="_ftnref185" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[185]</span></a></div>
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137<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>That day, Dr Render minuted Mr Hayward on CJD in the 17-year-old (ie. Gulcan Hassan). He noted that it was reported in the <i>Lancet</i> that she could have eaten cow�s brain in Cyprus. He said that Britain had not exported offals to Cyprus.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn186" name="_ftnref186" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[186]</span></a><b></b></div>
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138<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 30 October 1995 MAFF Ministers and officials met to discuss BSE. Mrs Browning and Mr Hogg expressed concern at the farmers� cases. In discussion of SBO breaches, Mr Packer:</div>
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�referred in particular to the potentially very serious matter of cases where SBO matter � in particular spinal cords � had not been properly removed from carcases. We had to take and be seen to take all necessary action to put this right. He recommended that the Minister should call in the Chief Executive of the Meat Hygiene Service to stress that he attached the highest importance to strict enforcement of our provisions�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn187" name="_ftnref187" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[187]</span></a></div>
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This meeting was later arranged for 6 November. Also at the meeting on 30 October Mr Hogg agreed that representatives of the slaughterhouses should be invited to a meeting, and this was arranged for 9 November.</div>
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139<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 30 October 1995 a briefing was provided to the Prime Minister on CJD in the four farmers and two teenagers. The briefing repeated the advice in the 25 October briefing that there was no reason to be alarmed, because there was �currently no scientific evidence to link BSE in cattle with the development of CJD in humans�. It noted that SEAC�s advice had not changed, and that SEAC had not been able to draw conclusions on the teenagers, because CJD had been found in teenagers in other countries and the teenagers had no exposure to risk factors.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn188" name="_ftnref188" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[188]</span></a><b> </b>Mr Major told the BSE Inquiry</div>
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�I understood the phrase �it was not possible to draw conclusions� to mean that the two cases did not add any additional information to what was already known about BSE and did not provide any evidence of a link between BSE and CJD�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn189" name="_ftnref189" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[189]</span></a></div>
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140<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 31 October 1995 Professor John Collinge, head of the Neurogenetics Unit at St Mary's Hospital, Imperial College, London, visited Dr Calman to relay his fears about the new cases of CJD in young people.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn190" name="_ftnref190" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[190]</span></a> Professor Pattison was present. Following these discussions, Dr Calman asked Professor Collinge if he would be willing to serve as a member of SEAC.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn191" name="_ftnref191" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[191]</span></a></div>
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141<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 31 October 1995, DH received a table entitled �Cases of suspected sporadic CJD in young people notified to CJD Surveillance Unit in 1995�. The table listed information on 7 patients, including their age and location, date notified to the Surveillance Unit, and other notes.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn192" name="_ftnref192" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[192]</span></a></div>
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November 1995</div>
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142<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 1 November 1995 Mr Ancram wrote again to Mr Malone<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn193" name="_ftnref193" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[193]</span></a> (see 20 October above). He informed Mr Malone that a further two cases of CJD had been found in the locality where the Churchills lived. He said:</div>
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�I am conscious that it is important not to draw rash conclusions from this, but the fact of a geographical cluster is bound to cause concern, and reassurance is needed. The causes of CJD are unknown or unproven, as I understand it, which if anything causes greater concern.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn194" name="_ftnref194" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[194]</span></a></div>
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143<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 3 November 1995 Mr Hogg wrote to the Cabinet Committee EDC(P) to inform them about SBO breaches that had been found.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn195" name="_ftnref195" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[195]</span></a></div>
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144<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 3 November 1995 Dr Wight sent a minute to the DH Press Office, noting that the fourth case of CJD in a farmer �has now been confirmed by the CJD Surveillance Unit�. She said that the family had been informed of the diagnosis, and the case was likely to be reported in the medical literature. There was �no merit in DH withholding information on the diagnosis until then if the Press appear to know anyway�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn196" name="_ftnref196" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[196]</span></a></div>
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145<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 4 November 1995 Maurice Callaghan died of what was later diagnosed as nvCJD. He had been referred to the CJD Surveillance Unit in September.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn197" name="_ftnref197" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[197]</span></a></div>
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146<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 5 November 1995 Mr and Mrs Churchill wrote to Mr Ancram with comments on Mr Sackville�s letter of 20 October.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn198" name="_ftnref198" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[198]</span></a> They raised similar issues to those Mr Ancram had raised on 1 November. They advocated the establishment of an �independent� inquiry into the death of their son, and said</div>
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�There are now compelling reasons for such an inquiry as there are now three �clusters� of CJD concurrently:-</div>
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������ �1. Three teenagers, the most ever in one country.</div>
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������ �2. Four � Six members of the farming community.</div>
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������ �3. One confirmed and two suspected cases in a small geographical area � Devizes.</div>
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�These clusters and cases are only the ones we are aware of and we are sure that SEAC and CJD Unit will be aware of others.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn199" name="_ftnref199" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[199]</span></a></div>
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147<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Ancram forwarded this letter to Mr Sackville on 15 November<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn200" name="_ftnref200" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[200]</span></a>, and Mr John Horam (who was to replace Mr Sackville as Parliamentary Under-Secretary (Commons) for Health<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn201" name="_ftnref201" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[201]</span></a>) answered it on 7 December 1995; see below.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn202" name="_ftnref202" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[202]</span></a></div>
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148<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 6 November 1995, Mr Hogg met Mr Johnston McNeill, Chief Executive of the Meat Hygiene Service (MHS).<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn203" name="_ftnref203" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[203]</span></a> Mr Hogg</div>
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�stressed the importance of our controls on SBOs in our strategy for the control and eradication of BSE. He was very concerned about the results of the most recent SVS audit of SBO handling in slaughterhouses. Clearly there had been a number of failings. We had to consider together how to make the slaughterhouses do better.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn204" name="_ftnref204" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[204]</span></a></div>
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149<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>To help prepare Dr Calman for the meeting with Mr Hogg on 7 November, Mr Lister prepared a minute about a paper on BSE/ CJD that had gone to a Cabinet sub-committee, EDC(P). MAFF and DH had differed in on how to word the paper, and Mr Lister said that MAFF�s position was:</div>
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�indicative of the unwillingness of some MAFF officials to accept the lapses in SBO controls as an issue of genuine public health concern, as opposed to one about the undermining of public confidence in the safety of British beef�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn205" name="_ftnref205" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[205]</span></a></div>
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150<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 7 November 1995, Dr Calman and Dr Metters met Mr Hogg, Mrs Browning, Mr Packer and Mr Osborne.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn206" name="_ftnref206" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[206]</span></a> Dr Calman had requested this meeting on 25 October. Mr Hogg informed Dr Calman of �the likely findings of the October SVS audit of the handling of SBOs in slaughterhouses: this merely confirmed the need to take decisive action�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn207" name="_ftnref207" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[207]</span></a></div>
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151<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The minutes record that: <a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn208" name="_ftnref208" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[208]</span></a></div>
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�Mr Calman said that he was concerned. We simply did not understand well enough the origins of the disease. He was less confident now than he had been a year ago that things were moving in the right direction. Much of the science itself was reassuring. Work done by Dr Collinge with mouse assays had so far suggested that BSE might not be transmissible to humans. However this was as yet confirmed [sic]. Comfortingly, analyses of the brains of CJD victims tended to point in the same direction. However other developments were less encouraging. The results of the CJD surveillance � based on much more sophisticated data than in other countries � were worrying, since the four cases in farmers had all occurred in producers with dairy herds which had had BSE. The increased incidence in young people was also worrying. Finally, he was disappointed that the BSE epidemic in cattle had failed to drop off as we had predicted, with cases occurring of animals born in 1993. His earlier confidence about the human health implications had been based partly on reassurances that BSE was itself a short-term problem.�</div>
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�Mr Calman continued that, in respect of our controls, there were clearly two critical points at the slaughterhouse and in the feedmill. If controls at these points were perfect potential problems and worries would be significantly less.�</div>
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�Although he could continue to say with complete confidence that there was no evidence that British beef, that is meat as commonly understood, was not safe, it could not be said with confidence that no offal which might have been contaminated had entered the food chain. This reduced confidence that the public was being properly protected. If he was pressed on this point � and therefore by implication on the safety of food containing mechanically recovered meat � he would be in a difficult position; he would need to think very carefully about a suitable form of words. He reiterated that we should bear in mind that there remained no evidence of a link between CJD and BSE; the difficulty was that we might not know for sure for another year or two. We were therefore still talking about no more than a hypothetical risk. But it was easy to imagine how quickly the connection would be made in people�s minds�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn209" name="_ftnref209" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[209]</span></a></div>
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152<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Calman told the BSE Inquiry:</div>
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�I recall informing the Minister that my concerns would have been greatly reduced but for the recent findings which led to my concluding that there was a potential for contaminated offal to have entered the food chain. By implication this led to concerns about the safety of food containing mechanically recovered meat�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn210" name="_ftnref210" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[210]</span></a></div>
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153<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span><span lang="EN-US">The hypothesis that the farmers may have been exposed by eating or tasting cattle feed was discussed at length, and Mr Hogg wondered about issuing a warning on the handling of animal feed. </span>Dr Metters said that in theory, this should not be necessary because ruminant feed was not being fed to ruminants. And �any warning would imply that we accepted that there really was <span lang="EN-US">significance</span> in the surveillance conclusions�. Also, Sir Richard Southwood had not thought there was cause for concern (although the issue of human consumption of cattle feed was not mentioned in his (1989) report).<span lang="EN-US"> Dr Calman added that there might well be a problem with compliance with any such warning. It was decided to consult SEAC on this and possibly other questions.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn211" name="_ftnref211" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[211]</span></a></span></div>
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154<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Calman<span lang="EN-US"> �implied� that if he were pressed on the point he would say that the processes to control SBOs which were now in place were satisfactory, but that those in the past had not been.</span> Dr Calman �found the attitude of the farming industry and slaughterhouses astonishing, particularly given the threat to the whole future of the sector�. Dr Metters said that he had noticed MAFF�s significant attitude change over the last six weeks: �there was now no inclination to tolerate any failure to remove SBOs�. Mr Hogg told of his meeting with Mr McNeill the previous day, that he had told Mr McNeill not to hesitate in prosecuting if the evidence justified doing so and that Mr McNeill had said that there were no technical reasons why the industry should not be able to comply with the regulations. Mr Hogg added that he would shortly be seeing representatives from the slaughterhouse industry, and that his message would be �uncompromising�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn212" name="_ftnref212" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[212]</span></a></div>
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155<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In discussion about research, Dr Calman thought that the Government was �probably not� doing enough, though it was difficult to decide where more resources were needed, and that this should be pursued with SEAC.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn213" name="_ftnref213" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[213]</span></a></div>
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156<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The BSE Inquiry asked Mr Hogg about this meeting:</div>
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SIR NICHOLAS PHILLIPS: �It seems to me what Dr Calman is saying here is, "I am happy to say it is safe to eat beef. I am certainly not happy to say it is safe to eat offals, and what is worrying me is it looks as though some of these offals have been getting into the food chain".�</div>
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MR HOGG: �It worried me too and that is why I took the action I did.�</div>
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MR WALKER: �Did you understand him to be saying that there was any change in his perception of the risk from SBOs, as opposed to the risk of SBOs getting into what humans eat?�</div>
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MR HOGG: �What you are putting to me I think is: was he changing his position on transmissibility? That is what you are putting to me, are you not?�</div>
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SIR NICHOLAS PHILLIPS: �Did he think the belt was being nibbled?�</div>
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MR HOGG: �Exactly. That is, I think, the question that is being put to me. I think the answer to that is no, not at that stage, but he was concerned about leakage of SBOs and I agreed with him. It was a serious matter�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn214" name="_ftnref214" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[214]</span></a></div>
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157<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also at this meeting, Dr Calman suggested that Mr Hogg have a meeting with Professor Pattison. He also advised that additional members be appointed to SEAC in order to provide further clinical expertise.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn215" name="_ftnref215" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[215]</span></a> Dr Calman told the BSE Inquiry, �I believed that there was a need for greater human health input to the Committee and this view was shared by others including Professor Pattison, the Chairman of SEAC�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn216" name="_ftnref216" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[216]</span></a> He had first raised this issue, along with �the need to appoint a new Chairman of SEAC� in September 1994, with Mr Waldegrave, the MAFF Minister.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn217" name="_ftnref217" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[217]</span></a> However:</div>
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�First of all there needed to be some discussion first of all in terms of membership and secondly who the Chairman might be. Secondly, Dr Tyrrell, who had done a tremendous amount of work in terms of where SEAC had got to, wished to complete the report, and that happened in October 1995 and that was the time that change took place. There are no other reasons I can think of�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn218" name="_ftnref218" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[218]</span></a></div>
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158<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>DH and MAFF discussed recommendations for appointments of experts in the areas of human and related animal diseases, public health, human epidemiology and statistics and virology and immunology.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn219" name="_ftnref219" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[219]</span></a> The new appointees were announced on 14 and 20 December 1995 (see below).</div>
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159<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hogg�s private secretary circulated his note of the 7 November meeting to Mr Eddy, the private secretaries of Mr Tony Baldry (MAFF Minister of State), Mrs Browning and Mr Boswell (MAFF�s two Parliamentary Under-Secretaries), and Mr Packer, and to Mr Osborne, Mr Carden, Mr Meldrum, Mr Haddon, Mr K Taylor, Dr Cawthorne, Mr Haslam, Dr Render and Mr Davidson. It was also copied to Mr Hart�s private secretary, Dr Metters and Dr Wight.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn220" name="_ftnref220" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[220]</span></a></div>
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160<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 8 November 1995 Mr Hogg wrote to Mr McNeill:</div>
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�I welcome the steps you are taking. However, given the importance of the SBO controls in our strategy on BSE, and especially for the protection of public and animal health, we agreed that I should formalise my instructions to you on this matter. I am, therefore, by this letter, formally instructing you, in accordance with the provisions of paragraph 4.3 of the Meat Hygiene Service�s framework document, to ensure that appropriate steps are taken to see that your staff in slaughterhouses enforce the Specified Bovine Offal Order 1995 fully. Failure to comply with these Regulations is an extremely serious matter. I must therefore ask you to make every effort to secure 100% compliance. In particular, your staff must ensure that all SBO is removed from a carcase before they give it a health stamp. Failure to do so should be viewed extremely seriously. I have discussed this with the Secretaries of State for Scotland and Wales and know that they fully share my concerns.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn221" name="_ftnref221" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[221]</span></a></div>
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161<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the morning of 9 November 1995 Professor Pattison was interviewed on the radio programme <i>Today</i>. He had discussed this with Dr Wight the day before, and on 9 November she faxed him an outline of the likely main issues and responses. She copied the outline to the DH Information Division (ID).<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn222" name="_ftnref222" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[222]</span></a> She said that the interest had been prompted by families of CJD sufferers. She noted that �3 further cases� in Devizes (the Churchills� town) were �unsubstantiated�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn223" name="_ftnref223" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[223]</span></a></div>
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162<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span><span lang="EN-US">On 9 November 1995 Mr Hogg met representatives of slaughterhouse operators �to discuss some failings found in the handling of SBOs�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn224" name="_ftnref224" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[224]</span></a> In the press release afterwards he said: �I said that I would only be satisfied with 100% compliance with the rules and informed them that the Meat Hygiene Service would enforce the controls most rigorously�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn225" name="_ftnref225" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[225]</span></a></span></div>
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163<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 9 November <i>The Times</i> newspaper reported that the incidence of CJD �looks set to fall when the figures for 1995 are revealed�. The article said that there had been �fewer referrals� to the CJD Surveillance Unit. It said that �Dr Will confirmed yesterday that the figure for 1995 looks set to be substantially lower than 1994, although the final figure is not due to be published until mid-1996. �It looks very much as if there will be fewer cases, which is reassuring.��<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn226" name="_ftnref226" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[226]</span></a><o:p></o:p></div>
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164<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In a further article in <i>The Times</i> on 9 November 1995, it was reported that �despite all the work on CJD surveillance, �no evidence of a link between CJD and �mad cow� disease has been found so far�, and because of the long incubation time another 10 to 15 years of surveillance were needed. Dr Will was quoted as saying:<o:p></o:p></div>
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��My expectation is that we will not find any definite link� I still believe that very firmly, but I do think it will be years before we can be sure. Proving a definite association is a very difficult thing to do with a rare disease unless there is a major change. We have not had a major change.�</div>
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������������������ He believed that the two recent cases in teenagers was a reflection of better case ascertainment,<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn227" name="_ftnref227" title=""><span class="MsoFootnoteReference" style="vertical-align: super;"><span style="color: black;">[227]</span></span></a> and pointed out that CJD had been found in teenagers in other countries.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn228" name="_ftnref228" title=""><span class="MsoFootnoteReference" style="vertical-align: super;"><span style="color: black;">[228]</span></span></a></div>
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165<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the statistical links between CJD and consumption of venison and veal, the article said Dr Will thought they were �unlikely to be meaningful. �I still enjoy beef,� he says, pointing out that there have been several cases of lifelong vegetarians contracting CJD�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn229" name="_ftnref229" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[229]</span></a><o:p></o:p></div>
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166<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 10 November 1995, Mr Robb sent an urgent fax to Dr Zeidler (in Dr Will�s absence) at the CJD Surveillance Unit.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn230" name="_ftnref230" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[230]</span></a> He said that after yesterday�s article in <i>The Times, </i>Dr Calman had asked for the following information:<o:p></o:p></div>
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�1.�� The number of sporadic cases from January 1994 to October 1994 inclusive; and</div>
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�2.�� The number of sporadic cases from January 1995 to October 1995 inclusive.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn231" name="_ftnref231" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[231]</span></a><b><o:p></o:p></b></div>
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167<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Zeidler telephoned Mr Robb that day with the information: there were 42 cases from 1 January to 31 October 1994, and 21 cases from January to October 1995.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn232" name="_ftnref232" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[232]</span></a> Mr Robb sent this information in a minute to Dr Calman�s private secretary, copied to Dr Metters, Dr Wight and Mr Clark (Press Office).<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn233" name="_ftnref233" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[233]</span></a> He added that �Although the 1995 figures and the 1994 figures (at the time) are both <u>provisional</u>, there is evidence of a marked decrease�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn234" name="_ftnref234" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[234]</span></a></div>
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168<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 31 October 1995, DH had been sent a table of information on 7 cases of suspected sporadic CJD in young people. An eighth patient was added to this table in handwriting from information received from Dr Zeidler on 10 November.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn235" name="_ftnref235" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[235]</span></a></div>
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169<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 10 November, <i>Today</i> newspaper reported that a Belfast father-to-be had died of CJD.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn236" name="_ftnref236" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[236]</span></a> Mr Robb copied this report to Dr Wight and Mr Jobson.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn237" name="_ftnref237" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[237]</span></a></div>
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170<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Again on 10 November, Mr Robb minuted Dr Calman�s private secretary, copied to Dr Metters, Dr Wight and Mr Clark (ID). He said:</div>
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�1.�� The <i>TODAY </i>newspaper today reported two suspected CJD cases: a 30 year old male who has recently died in Belfast, and a 42 year old male in Liverpool who we understand is currently in a nursing home.</div>
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�2.�� The CJD Unit is looking into these cases but has not yet completed its investigations. Our usual line in such cases is appropriate:</div>
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�We are aware of these cases. The necessary investigations are underway and we cannot comment further at this stage.��<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn238" name="_ftnref238" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[238]</span></a></div>
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171<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Robb sent two further minutes that day to Dr Calman�s private secretary, copied to Dr Metters, Dr Wight and Mr Clark, about the possible CMO statement that Dr Wight and Mr Lister had drafted on 24 October.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn239" name="_ftnref239" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[239]</span></a> �Minor� amendments had been received from MAFF and incorporated.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn240" name="_ftnref240" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[240]</span></a> Dr Wight had suggested a revision be used as Press Office line over the weekend, if pressed.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn241" name="_ftnref241" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[241]</span></a> The revised draft said that it was impossible to be certain that SBO had</div>
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�not entered the food chain. However, it is exceedingly unlikely that this has happened to any great extent and I am reassured by the steps taken to ensure that it does not happen in the future. I remain satisfied that there is no scientific evidence of a link between meat-eating and the development of CJD in humans�.<b><o:p></o:p></b></div>
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172<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 13 November there was extensive newspaper coverage of BSE, in advance of a television programme that night (see below). It was estimated that 600 infected animals each week were entering the human food chain. <i>The Times </i>said it had asked Mr Meldrum about a calculation that there were two subclinical cases for each one reported. He was quoted: �Yes, that is a calculation that's been made, that there are a significant number of cattle that could be going in for slaughter that could be incubating the disease�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn242" name="_ftnref242" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[242]</span></a> Also reported was a survey, which had found that 23 per cent of Britons had stopped eating beef because of BSE fears.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn243" name="_ftnref243" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[243]</span></a><o:p></o:p></div>
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173<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 13 November 1995 Dr Will sent a fax to Dr Wight at DH. The fax enclosed a table that had been researched by the CJD Surveillance Unit, entitled �Young Cases 13/11/95�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn244" name="_ftnref244" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[244]</span></a> The table listed 8 �suspect cases of CJD aged <50 a="" href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn245" name="_ftnref245" title="" years=""><span class="MsoFootnoteReference" style="vertical-align: super;">[245]</span></50></div>
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Dr Zeidler of the Surveillance Unit had first assembled this table on 27 September 1995, listing 5 such cases.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn246" name="_ftnref246" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[246]</span></a><div class="MsoNormal" style="font-size: 12pt; margin: 12pt 0cm 0.0001pt 57pt; text-align: justify; text-indent: -57pt;">
174<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Wight copied the table to Mr Robb, who copied it to Mr Jobson.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn247" name="_ftnref247" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[247]</span></a></div>
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175<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>That evening, there were two television programmes on BSE and CJD: �Watchdog� and �World in Action�. Mr Colin Maclean (MLC Director General) told the BSE Inquiry that the programmes suggested a �link between BSE and CJD and that the certification controls for export were being abused�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn248" name="_ftnref248" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[248]</span></a> Mr Meldrum, who had been interviewed for the �World in Action� programme, had earlier that day minuted Mr Hayward about the �hostility� of the programmers.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn249" name="_ftnref249" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[249]</span></a></div>
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176<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>There was newspaper coverage in the next few days.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn250" name="_ftnref250" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[250]</span></a> The <i>Daily Express</i> reported that the �World in Action� programme had claimed that up to 600 BSE-infected cows �are being eaten every week� [MAFF] admits the situation could be that two infected cows are eaten for every one that is diagnosed and destroyed�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn251" name="_ftnref251" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[251]</span></a> Mr Taylor later told Mr Meldrum that this was based on a paper that MAFF had published, which included the calculations that for each sick animal that is diagnosed and destroyed, there may be two sub-clinical animals entering the food chain, and that this paper had been discussed with the World in Action team.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn252" name="_ftnref252" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[252]</span></a></div>
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177<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In a minute for MAFF�s Press Office dated 14 November 1995 Mr Meldrum summarised the �five main issues� from the �World in Action� programme �which you may care to use if questions are asked by the press�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn253" name="_ftnref253" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[253]</span></a> They related to sub-clinically and clinically affected cattle entering the human food chain, infectivity in liver, �why can�t cattle be tested at slaughter for BSE�, and SBO removal.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn254" name="_ftnref254" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[254]</span></a> On sub-clinical animals entering the food chain, he said �To some extent the number of cattle incubating the disease is immaterial because our precautionary measures are intended to meet just that situation�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn255" name="_ftnref255" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[255]</span></a> On SBO enforcement he noted that</div>
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�prosecution will follow when public health is jeopardised as a result of failure to meet the requirement to remove spinal cord from the split spinal column. The removal of spinal cord from the spinal column is relatively easy (as could be seen in the World in Action film) and there should be no splashing of material onto the carcase�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn256" name="_ftnref256" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[256]</span></a></div>
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178<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In an urgent minute on 14 November 1995, Mr Toal informed Baroness Denton (Northern Ireland Parliamentary Under-Secretary), who had just returned from abroad, that BSE had �taken on a much higher profile in the media�. He informed her of the previous evening�s television programmes. He also said the recent death from CJD of a Belfast man would be the focus of another programme later in the week (this was Mr Callaghan).<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn257" name="_ftnref257" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[257]</span></a>Baroness Denton was informed of the �line to take�:</div>
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�1.�� no evidence of any link between BSE and CJD;</div>
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�2.�� no evidence of risk to humans from eating beef (This is not just the Government line but is based on the findings of a completely independent scientific advisory committee.);</div>
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�3.�� Controls on BSE in Northern Ireland remove any risk to humans. The Veterinary Services operates a centralised meat inspection system. There is no evidence of any breakdown in slaughterhouses in Northern Ireland in the removal and proper disposal of Specified Bovine Offal</div>
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�4. If asked about sub-clinical disease the Minister should say:</div>
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�This is not relevant to the risk factor. BSE is only found in certain offals and <b><u>all</u></b> Specified Bovine Offal is removed from all animals both for human and animal consumption.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn258" name="_ftnref258" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[258]</span></a></div>
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179<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 15 November 1995 Dr Wight minuted Mr Eddy at MAFF to arrange a meeting with the CMO to discuss research. She added that Dr Calman had:</div>
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�identified a need to establish what products are made from MRM for human consumption, as the DH view is that MRM poses a potentially greater risk than other bovine meats. I would be grateful if MAFF could indicate what types of products contain MRM�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn259" name="_ftnref259" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[259]</span></a></div>
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180<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 15 November 1995 Mr Ancram forwarded to Mr Sackville the Churchills� letter of 5 November.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn260" name="_ftnref260" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[260]</span></a> Mr John Horam (who was to replace Mr Sackville as Parliamentary Under-Secretary (Commons) for Health<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn261" name="_ftnref261" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[261]</span></a>) answered it on 7 December 1995; see below.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn262" name="_ftnref262" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[262]</span></a></div>
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181<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 16 November 1995 Mrs Browning met Mr Ashworth, from the Licensed Animal Slaughterers and Salvage Association, to discuss the handling of SBOs. The note of the meeting records that Mrs Browning said �Nothing less than 100% compliance was acceptable�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn263" name="_ftnref263" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[263]</span></a></div>
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182<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 20 November 1995 there was a meeting between Mr Meldrum, Mr K Taylor, Dr Matthews, and Mr Wells and Drs Calman, Metters and Wight. They discussed the progress of transmission studies. They also discussed MRM. The minutes record that Mr Meldrum said the concern arose because of the possible inclusion of small residues of spinal cord.</div>
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183<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Meldrum</div>
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�made it clear that if all the rules were complied with then cattle cake should not be infectious to farmers or to cattle but born after the ban cases clearly indicated that there had been a problem. Because of the ruminant feed ban, if feed was a risk to humans then pig and poultry feed should, if anything, be a greater risk than cattle feed. There were no reported CJD cases in pig and poultry farmers�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn264" name="_ftnref264" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[264]</span></a></div>
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184<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Calman</div>
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�took the view that if there was a genuine increased risk of CJD in cattle farmers it could be thought to be reassuring if feed was the possible cause because this might indicate an alternative source of infection which did not directly involve cattle, and could suggest that meat was not a risk�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn265" name="_ftnref265" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[265]</span></a></div>
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185<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Taylor raised the point that CJD rates were higher in other European farmers. Dr Metters responded that �they were now querying these figures �much depended on which population of farmers you looked at and if you looked at cases in farmers with BSE in their herds then there was clearly a very marked excess in the UK and in the UK only�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn266" name="_ftnref266" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[266]</span></a></div>
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186<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Eddy, who wrote the minutes for MAFF, added: �This is news to us � the figures came from DH�s surveillance unit.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn267" name="_ftnref267" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[267]</span></a></div>
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187<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The minutes continue:</div>
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�10. Mr Taylor said that animal feed was not labelled to say that it should not be eaten by people and pig and poultry food containing ruminant protein was not labelled to say that it must not be fed to cattle. The CMO said that Southwood said that the HSE [Health and Safety Executive] should be asked to advise on human health risks from BSE and the CVO said that they had done so. Dr Matthews made the point that the precautions already in place in abattoirs to protect meat from possible contamination by abattoir workers would also protect abattoir workers from possible risks from meat and that farmers already had an advisory leaflet. I [Mr Eddy] said that we had revised the leaflet for farmers and that the SEAC on 23 November would discuss the draft leaflet and be asked whether farmers should be given further advice. I also made the point that if we thought that animal feeds were a risk then� we should be warning pig and poultry farmers as well as cattle farmers�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn268" name="_ftnref268" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[268]</span></a></div>
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188<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In discussion of SBO breaches, it was �agreed that we could not guarantee 100% removal of spinal cord although that was the target that had been set to the industry and the Meat Hygiene Service�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn269" name="_ftnref269" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[269]</span></a></div>
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189<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>It was noted that MRM was mainly produced from young animals. It was agreed that �MRM was an issue which needed to be revisited and this would be put to the SEAC at its meeting on 23 November�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn270" name="_ftnref270" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[270]</span></a></div>
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190<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In response to a PQ on 22 November 1995, Mr Hogg announced the results of the SVS�s unannounced visits to slaughterhouses. He said that</div>
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�In the most serious cases we found small pieces of spinal cord, ranging in size from 1 cm to one third of the spinal cord, left attached to the carcases after dressing. So far, we have found 17 such instances, including one found during preliminary visits in the summer and five found up to 10 November and one on 20 November in the latest round of visits�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn271" name="_ftnref271" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[271]</span></a></div>
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191<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>He went on to outline the steps he had taken to ensure full compliance: he had asked the MHS to ensure �most rigorous� enforcement of the SBO order and to prosecute failing slaughterhouses where it has sufficient evidence, he had asked the SVS to double the frequency of its unannounced surveillance visits, and he had met slaughterhouse operators on 9 November �to impress on them the need for full compliance with these controls�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn272" name="_ftnref272" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[272]</span></a></div>
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192<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 22 November 1995 Mr Hogg visited a slaughterhouse.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn273" name="_ftnref273" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[273]</span></a></div>
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193<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 22 November Dr Metters minuted Dr Wight about the next day�s SEAC meeting. He copied the minute to Baroness Cumberlege�s private secretaries, Dr Calman�s private secretary, Dr Skinner, Mr Sutherwood, Mr B Clark and Mr Robb. He said that Ministers wanted advice from SEAC on three issues:</div>
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�a.�� in the light of the number of failures to remove [SBOs] in slaughterhouses, what is SEAC�s view about the potential risk to human health from MRM? Ministers wish CMO to have SEAC�s advice on this specific point in case he (CMO) is asked that particular question.</div>
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�b.�� do SEAC have any further advice or explanation of the number of farmers with CJD. You will be aware that CMO is asked abut the labelling of animal feeds. A further question relates to SEAC�s advice and comments on recent cases of CJD among teenagers.</div>
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�c.�� arising from SEAC�s review of research, what further studies do they now recommend to Ministers.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn274" name="_ftnref274" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[274]</span></a><b><o:p></o:p></b></div>
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194<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The minute passed on Mr Dorrell�s emphasis that SEAC advice was for Ministers: �It was essential that any conclusions reached were <u>not</u>communicated direct to the public, despite the fact that SEAC is known to be meeting tomorrow�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn275" name="_ftnref275" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[275]</span></a></div>
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195<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 23 November 1995 Dr Calman�s private secretary minuted Mr Robb, attaching embargoed copies of scientific articles that were to appear on that week�s edition of the <i>BMJ.</i> She asked Mr Robb to inform the Press Office and herself, and provide a line to take, if the articles were �likely to stimulate any press interest�. There were 6 articles about CJD and links with BSE.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn276" name="_ftnref276" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[276]</span></a></div>
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SEAC Meeting 22</div>
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196<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 23 November 1995, SEAC�s 22<sup>nd</sup> meeting was held.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn277" name="_ftnref277" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[277]</span></a> This was the first meeting chaired by Professor Pattison. SEAC were concerned at the information about SBO breaches.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn278" name="_ftnref278" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[278]</span></a> After discussion they agreed on a statement:</div>
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�Earlier in 1995 SEAC had concluded that �provided in the slaughtering process the removal of the spinal cord was done properly, the mechanically recovered meat (MRM) process was safe and there was no reason for the Committee to change its advice. In light of the current audit reports showing failure to remove parts of the spinal cord in a number of carcases the Committee expressed its grave concern. It noted the further tightening up of controls but felt that unless and until it was clear that the removal of SBO, particularly spinal cord, was now being undertaken properly in all cases it would be prudent, as a precaution, to suspend the use of vertebrae from cattle aged over six months, in the production of MRM.� <a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn279" name="_ftnref279" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[279]</span></a></div>
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197<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also at the meeting Professor Collinge gave a presentation on his work with transgenic mice.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn280" name="_ftnref280" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[280]</span></a> Also discussed were CJD and blood transfusions, and a MAFF advisory note to farmers. SEAC �noted� a paper that Dr Matthews had written entitled �CJD in cattle farmers � possible health risks associated with MAFF procedures for slaughter and disposal of BSE suspects.� Dr Wight had discussed with Dr Gore a questionnaire to study changes in practices which might put farmers at risk. Professor Pattison asked Dr Wight to pursue this. He said that SEAC �needed more data on farmers as soon as possible and did not want the matter delayed because of difficulties of implementation�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn281" name="_ftnref281" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[281]</span></a></div>
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198<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 24 November, Dr Wight minuted Dr Calman�s private secretary with the main points from the SEAC meeting. She copied the minute to Baroness Cumberlege�s private secretary, Dr Metters, Mr Robb and Mr Sutherwood. She quoted and discussed the statement on MRM that SEAC had agreed at the meeting<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn282" name="_ftnref282" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[282]</span></a> and summarised the other issues that had been discussed. As SEAC had not had time to discuss all the issues on their agenda, Dr Wight added that research priorities, MAFF�s transmission studies, and �an update on the CJD situation following the two recent cases in teenagers, will be discussed at a further meeting to be held in January�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn283" name="_ftnref283" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[283]</span></a></div>
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199<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Towards the end of 1995, Sir Donald Acheson, who had been CMO from 1983 to 1991, began to get �concerned about a cluster of cases of CJD in young people�. Dr Calman agreed that Sir Donald could visit DH for a briefing with officials,<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn284" name="_ftnref284" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[284]</span></a> and he met Dr Wight in November.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn285" name="_ftnref285" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[285]</span></a> (See also 22 January below.)</div>
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200<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 25 November 1995 Michelle Bowen died of what was later diagnosed as nvCJD. She had been referred to the CJD Surveillance Unit earlier that month.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn286" name="_ftnref286" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[286]</span></a> Mrs Bowen�s death was reported in the newspapers on 27 and 28 November 1995.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn287" name="_ftnref287" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[287]</span></a></div>
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201<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 27 November 1995 Dr Calman and Mr Packer met, to prepare for a meeting between Mr Dorrell and Mr Hogg the next day. The meeting was �useful in clarifying a number of issues.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn288" name="_ftnref288" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[288]</span></a>They proposed that the next afternoon, Mr Hogg should announce a ban on the use in food of MRM made from the �vertical column� of cattle.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn289" name="_ftnref289" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[289]</span></a> They noted that for practical and enforcement purposes the ban would be for all cattle � not just those over 6 months old as recommended by SEAC. This was because it was hard to age spinal columns accurately.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn290" name="_ftnref290" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[290]</span></a></div>
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202<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>They also recommended that Dr Calman issue a detailed statement at the same time as Mr Hogg�s announcement: �this will make it clear that all beef products, including pies, sausages etc, are safe�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn291" name="_ftnref291" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[291]</span></a> In addition, Mr Hogg should �minute the Prime Minister tomorrow about what is intended immediately after [Mr Hogg�s] meeting with Mr Dorrell�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn292" name="_ftnref292" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[292]</span></a></div>
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203<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hogg agreed with these proposals at a meeting later that day.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn293" name="_ftnref293" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[293]</span></a> On consultation, Mr Packer suggested a meeting later that week with interested parties. This was later arranged for 30 November 1995. Mr Hogg agreed and said he would take the meeting, and that he would indicate then that he intended to make the Order a week after that.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn294" name="_ftnref294" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[294]</span></a></div>
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204<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Later that day, Mr Haddon minuted Mr Hogg�s private secretary, copied to the private secretaries of Ministers and to numerous officials. He attached a draft letter for Mr Hogg to send to the Prime Minister, explaining SEAC�s recommendation to ban the use of vertebral columns in MRM,</div>
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�immediately following his meeting with the CMO tomorrow morning. The proposed plan, as I understand it, is that the Minister should hold a Press Conference later tomorrow at which he will announce a short period of consultation on the proposed legislation banning the use of bovine vertebral columns for mechanically recovered meat as a precautionary measure�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn295" name="_ftnref295" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[295]</span></a><span class="FootnoteReferencedfa" style="vertical-align: super;"></span></div>
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205<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>He also attached a draft PQ answer for Mr Hogg.</div>
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206<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Copies of the draft letter to the Prime Minister and the PQ answer were sent to Mr Dorrell�s private secretary.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn296" name="_ftnref296" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[296]</span></a></div>
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207<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In the morning of 28 November, Mr Dorrell and Mr Hogg met.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn297" name="_ftnref297" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[297]</span></a> Mr Packer, Mr Meldrum, Dr Calman, Dr Metters and others were present.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn298" name="_ftnref298" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[298]</span></a> Mr Dorrell said that �we had to make very clear in our public statements that the potential source of infectivity was very narrowly defined�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn299" name="_ftnref299" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[299]</span></a> It was said that SEAC had referred to the proposed ban as a �prudent precaution,� therefore �the issue was not unduly urgent: there would be no problem with making the Order around 7 December�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn300" name="_ftnref300" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[300]</span></a> Dr Calman �repeated that he would be welcoming this particular step as closing a minor loophole. We had done all that was needed to safeguard public health. Beef continued to be safe�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn301" name="_ftnref301" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[301]</span></a></div>
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208<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 28 November 1995 Mr Hogg minuted the Prime Minister, copied to other Cabinet members and Sir Robin Butler (Cabinet Secretary), to tell him about the action he was taking on MRM. He quoted from the SEAC advice that had been received. He said that after discussion with Mr Dorrell and Dr Calman, they had agreed to act quickly on the advice, and to introduce legislation banning the use of bovine vertebral column in the manufacture of MRM. He explained why the ban would be for all cattle, including those under 6 months.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn302" name="_ftnref302" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[302]</span></a></div>
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209<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hogg identified that the economic impact of the ban would be �quite small� at around �2 million a year. He said �in such a potentially serious area the economic aspect must be outweighed by the need to protect the public as advised by SEAC�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn303" name="_ftnref303" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[303]</span></a></div>
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210<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the handling of the announcement, he noted that it</div>
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�could spark renewed fears about the safety of beef and meat products on the shelves despite the reassuring statement that the CMO will issue with mine. However, SEAC specifically said at its meeting that they were content that beef, including cuts containing parts of the backbone� was safe. I will obviously stress this point, and the precautionary nature of the new measures�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn304" name="_ftnref304" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[304]</span></a></div>
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211<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 28 November, a briefing on BSE /CJD was provided to the Prime Minister to help him prepare for Prime Minister�s Questions in Parliament.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn305" name="_ftnref305" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[305]</span></a> The briefing noted the recent death of a young mother from CJD, and the four farmers and two teenagers. It stated that �there is currently no scientific evidence that BSE can be transmitted to humans or that eating beef causes CJD in humans�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn306" name="_ftnref306" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[306]</span></a><b></b></div>
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Ban on the use of vertebrae</div>
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212<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Following a PQ in which Mr Hogg announced a ban on the use of any cattle vertebrae in the production of MRM, there was a press release on 28 November. <a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn307" name="_ftnref307" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[307]</span></a> Mr Hogg said:</div>
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�I am grateful for SEAC�s advice and have acted upon it as quickly as possible. This removes the risk of spinal cord tissue entering the human food chain. The new measures, like the others in place, are precautionary. They are designed to protect public health from any remote theoretical risk of BSE. I would reiterate that we have no evidence of any link between BSE and the similar human disease, CJD.</div>
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�These new measures are a consequence of the failings in the handling of SBOs we have found in slaughterhouses. They do not reflect any concerns about the MRM process itself. I have previously expressed my grave concern about the failings found in slaughterhouses, and taken steps to address them. I look to slaughterhouse operators now to deliver 100 per cent compliance with the SBO controls.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn308" name="_ftnref308" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[308]</span></a></div>
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213<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The same press release contained a statement from Dr Calman:</div>
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�There is currently no scientific evidence that BSE can be transmitted to humans or that eating beef causes CJD.</div>
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�Specifically, all the studies to date on transmission have shown that beef is safe. There is no epidemiological evidence of transmission from beef to humans or of transmission when muscle (meat) from cattle clinically affected with BSE is injected into mice.</div>
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�The SBO ban introduced in 1989 was intended to remove from the food chain all tissues that might have contained the BSE agent. Since that ban there has been a very remote risk based solely on rare accidental failure to remove small amounts of one of the SBOs, the spinal cord, from the vertebral column which may have been used to produce mechanically recovered meat (MRM).</div>
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�I welcome the new restrictions banning the use of bovine vertebral column in the production of MRM. These are a prudent precaution to eliminate any risk from this source, however small. I also welcome the Minister for Agriculture�s emphasis on the need for vigorous enforcement. This further extends the precautionary measures already in place to protect human health against any remote risk from BSE.</div>
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�I repeat my previous assurances that if any new evidence comes to light that BSE could transmit to humans, I will bring this to the attention of the public.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn309" name="_ftnref309" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[309]</span></a></div>
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214<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hogg was quoted in <i>The Daily Telegraph</i> on 28 November as saying that he could not give �a 100 per cent categorical guarantee� that mad cow disease could not spread to people, following several reported breaches of the SBO legislation.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn310" name="_ftnref310" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[310]</span></a></div>
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215<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 29 November 1995 Mr John Horam replaced Mr Sackville as Parliamentary Under-Secretary (Commons) for Health.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn311" name="_ftnref311" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[311]</span></a> Responsibility for BSE/ CJD at this level remained with Baroness Cumberlege in the House of Lords until 31 January 1996.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn312" name="_ftnref312" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[312]</span></a></div>
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216<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 30 November 1995 Mr Hogg convened a meeting with representatives of the meat industry, retailers and food manufacturers, to hear their views on SBO enforcement. Mr Carden recalls this as a �very difficult discussion, at which some of the industry representatives became very heated at the impact that the proposed ban would have on their businesses�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn313" name="_ftnref313" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[313]</span></a> Mr Hogg defended the public health need for his decision and stated that �The risk [to humans from consumption] was small but we were not prepared to take any chances�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn314" name="_ftnref314" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[314]</span></a></div>
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217<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Some industry representatives initiated litigation, and leave was obtained to pursue a judicial review of the decision to ban the use of vertebrae.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn315" name="_ftnref315" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[315]</span></a></div>
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218<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The ban on the use of vertebrae came into effect on 15 December 1995 (see below).</div>
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December 1995<span style="font-weight: normal;"><o:p></o:p></span></div>
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219<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 1 December 1995 Professor Sir Bernard Tomlinson (Emeritus Professor of Pathology, University of Newcastle upon Tyne) appeared on BBC Radio Four�s �You and Yours� Programme. He said<o:p></o:p></div>
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�Until we can say quite positively there really is no evidence now that BSE transfers to humans, until we can say that, I believe we�ve got to pay that price and all offal should be kept from public consumption. But I certainly don�t eat any longer beef pies, for instance, or puree, I wouldn�t eat a burger�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn316" name="_ftnref316" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[316]</span></a></div>
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220<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>He presumed that �everybody in the country over about the age of fifteen would have already been exposed to BSE�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn317" name="_ftnref317" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[317]</span></a><o:p></o:p></div>
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221<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The same day, the <i>Daily Star </i>reported that Sir Bernard �last night vowed NOT to eat beefburgers for fear of mad cow disease� [He] said: �I wouldn't eat a burger at the moment in any circumstances.��<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn318" name="_ftnref318" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[318]</span></a> The <i>Daily Express </i>ran a similar story.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn319" name="_ftnref319" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[319]</span></a><o:p></o:p></div>
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222<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Haslam told the BSE Inquiry that the BBC established a �help-line�</div>
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�for listeners to call for advice about how they should react. The Meat and Livestock Commission discovered that the advice given by the �help-line� included the suggestion that meat stock-cubes were unsafe. This was a matter of great concern to companies such as Oxo, whose product was derived from South American sources. I made a telephone call complaining to the BBC. However, damage to public confidence had resulted. This lead to the reaction from schools with many declaring that they would take beef off their menus�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn320" name="_ftnref320" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[320]</span></a><b><o:p></o:p></b></div>
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223<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 3 December the <i>Sunday Times</i> reported that Mr Hogg was asked whether he thought beef was �perfectly safe� to eat. He replied</div>
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��Yes, I do�. Questioned about the mounting concern of scientists, however, he admitted, �I cannot on the evidence before me give a categoric [sic] guarantee that it cannot be transmitted. We believe it cannot be and the scientific evidence suggests it cannot be��.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn321" name="_ftnref321" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[321]</span></a><b><o:p></o:p></b></div>
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224<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 3 and 10 December 1995, the MLC issued two newspaper advertisements to reassure British consumers on the safety of eating British beef. They listed a series of �fictions� and �facts� about British beef, and quoted supporting comments from Drs Calman and Will respectively.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn322" name="_ftnref322" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[322]</span></a></div>
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225<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The advertisements stated the following �facts� in response to �fictions� that it listed:</div>
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(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>�BSE is a disease which affects only cattle. CJD affects only humans. There is no evidence whatsoever of any link between them�.</div>
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(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>BSE cases were on the decline.</div>
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(iii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>CJD cases had �remained stable for as long as records go back�.</div>
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(iv.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>�CJD has been recorded in vegetarians as well as meat eaters, and occurs at pretty much the same rate in countries where BSE is not even present�.</div>
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226<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The 3 December advertisement (only) said:</div>
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(v.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>�<b><u>Fiction</u></b>: There must be some truth in the scare otherwise they wouldn�t be taking so many control measures.</div>
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(vi.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>�<b><u>Fact</u></b>: No, the truth is that the control measures are implemented to reassure the public�</div>
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227<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Both advertisements continued:</div>
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(vii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>�<b><u>Fiction:</u></b> Control measures are just an empty gesture.</div>
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(viii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>�<b><u>Fact</u></b>: Far from it. British veterinary and abattoir regulations, along with their enforcement, are as strict as the strictest in the world. Altogether, eight separate controls are in place embracing the farm, auction market and meat plant. With such stringency, even the remotest perceived risk is avoided.</div>
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(ix.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>�<b><u>Fiction</u></b>: They talk about beef being safe but some forms of beef are probably safer than others.</div>
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(x.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>�<b><u>Fact</u></b>: Beef is beef is beef. Be it prime cuts, mince, burgers, pies or sausages. All play a key role in providing the nation with a healthy, balanced diet. Enjoy it, just as you have always done.</div>
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(xi.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>�<b><u>Fiction</u></b>: The weight of opinion suggests beef is not safe.</div>
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(xii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>�<b><u>Fact</u></b>: Not at all. British beef has been endorsed by independent scientists, world health organisations, and government authorities, both in the UK and European Union�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn323" name="_ftnref323" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[323]</span></a></div>
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228<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The 3 December advertisement finished with a quote from Dr Calman: �British beef is perfectly safe to eat�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn324" name="_ftnref324" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[324]</span></a></div>
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229<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In an interview on London Weekend Television on 3 December 1995, Mr Dorrell agreed with the interviewer that there was no �conceivable risk� of anyone eating beef being infected with BSE:</div>
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�I had been invited onto the programme to discuss the National Health Service, but in view of the topicality of BSE Mr Dimbleby commenced the interview by asking about the government�s assessment of the risk that BSE could be transmitted to humans in the form of CJD. I said that science suggested that there was no link, but even if science was wrong on that subject, government had removed from the human food chain the organs that could conceivably be linked to a transmission. Mr Dimbleby said �So, there is you are saying no conceivable risk from what is now in the food chain; that�s the position?� and I responded �that is the position.� I regretted that response because Mr Dimbleby�s summary of my words went further than the words of the Chief Medical Officer. As a consequence of this interview, I was reported in some newspapers the next day as having said that there was no conceivable risk from eating beef.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn325" name="_ftnref325" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[325]</span></a></div>
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230<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span><i>The Times </i>on 4 December 1995 reported that Mr Dorrell and Dr Calman had �issued the assurance in the face of growing doubts by eminent scientists about the safety of beef�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn326" name="_ftnref326" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[326]</span></a></div>
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231<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Dorrell told the BSE Inquiry:</div>
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�Well, the only basis on which we felt, I felt, my colleagues felt free to say �beef is safe� is on the basis that these safeguards were in place and being enforced. So beef is safe given these safeguards. Clearly if the safeguards were not being enforced, then we had -- we could not, on the evidence of -- on the advice available to us, have felt that beef was in the normal meaning of the word safe.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn327" name="_ftnref327" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[327]</span></a></div>
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232<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 4 December 1995 Dr Metters faxed Mr Carden at MAFF to complain about an advertisement by the MLC that had appeared in the Sunday (3 December) newspapers. The advertisement had misquoted Dr Calman as saying that British beef was �perfectly safe�. Dr Calman had not used the phrase �perfectly safe�. Dr Metters said that it was in neither the MLC�s nor DH�s interests �for the CMO�s words to be manipulated so that he has no alternative but to issue a public clarification of his position�. Mr Metters copied his fax to nine colleagues.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn328" name="_ftnref328" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[328]</span></a></div>
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233<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Carden responded on 5 December that the MLC had assured him it had not intended to distort the CMO�s words, and that it would aim to avoid doing so in future.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn329" name="_ftnref329" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[329]</span></a></div>
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234<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Diana Walford, Director of the Public Health Laboratory Service (PHLS), told the BSE Inquiry that since her appointment in January 1993, she had been in periodic communication with DH, offering the services of the PHLS in relation to the epidemiology and surveillance of CJD, insofar as it might be helpful to, and supportive of, the work of the CJD Surveillance Unit. However, she was advised that there was no requirement for PHLS involvement in SEs:</div>
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�I was deeply concerned that my repeated offers of assistance by the PHLS were rebuffed on each occasion. This exclusion of the PHLS from a role that appeared to fall squarely within its corporate purpose of protecting the population from infection caused dismay and frustration amongst our staff. It also elicited adverse criticism from those outside the Service of the perceived inaction by the PHLS in an area in which is might reasonably have been expected to play a significant, if not a leading, role.�<span class="MsoFootnoteReference" style="vertical-align: super;"><a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn330" name="_ftnref330" title="">[330]</a></span></div>
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235<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>When the report of a small number of cases of CJD in young people became known in November 1995, Dr Walford again became concerned that the PHLS was not involved in prion work. She contacted Dr Will to ask him if there was any epidemiological assistance that the CJD Surveillance Unit would welcome from the PHLS.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn331" name="_ftnref331" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[331]</span></a> On 5 December 1995 Dr Walford noted the outcome of her conversation with Dr Will in a memorandum to Dr Chris Bartlett, Director of the Communicable Disease Surveillance Centre (CDSC). Her note stated:</div>
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�At first, Dr Will seemed slightly wary of my approach, appearing to believe that we were questioning the basis of CJD surveillance within the neurological community. I hastened to assure him that this was not so and that my sole purpose in making this informal contact was to offer any additional expertise in either surveillance or in analytical epidemiology that his Unit might find helpful. He seemed reassured by this and was grateful for the approach. His Unit is receiving epidemiological advice from Professor Peter Smith of the London School of Hygiene and Tropical Medicine together with Dr Simon Cousins also, I believe, at the LSHTM. I mentioned to Dr Will the recent cases of CJD in teenagers and said that I was aware that the BPASU was interested in including paediatric CJD in its surveillance programme. Dr Will became quite animated at this point and said that he believes that paediatric CJD may well have been misdiagnosed in the past and classified as subacute sclerosing pan-encephalitis [SSPE]. He also mentioned another condition which I think he called Alper�s syndrome. He is therefore keen to see the paediatric surveillance initiated. I left it that I would contact Peter Smith to see whether he would value any additional input from CDSC at the moment. In any case, our offer to assist in ways appropriate to our statutory function, is now firmly on the table.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn332" name="_ftnref332" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[332]</span></a></div>
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236<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Walford contacted Professor Smith. The agreement was that a meeting should be arranged, early in the new year, for two or three key PHLS experts to meet Dr Will with Professor Smith or his colleague, Dr Simon Cousens, another epidemiologist at the London School of Hygiene and Tropical Medicine.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn333" name="_ftnref333" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[333]</span></a> Dr Walford informed Dr Calman of her discussions with Dr Will on 14 December 1995 (see below).</div>
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237<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 5 December a briefing on BSE and CJD was provided for the Prime Minister to help him prepare for Prime Minister�s Questions.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn334" name="_ftnref334" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[334]</span></a> It said that Sir Bernard Tomlinson had caused �unnecessary and unjustified alarm about the safety of beef products such as burgers and pies. We have invited him to submit any new evidence� for SEAC to consider.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn335" name="_ftnref335" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[335]</span></a> It said that Sir Bernard had been unaware of the MRM controls announced on 28 November.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn336" name="_ftnref336" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[336]</span></a> An additional briefing from MAFF stated that the number of BSE cases had �fallen dramatically in the past couple of years�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn337" name="_ftnref337" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[337]</span></a>It also stated that changes in rendering practices in the 1980s were not due to changes in regulation, but to changes in commercial practice.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn338" name="_ftnref338" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[338]</span></a></div>
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238<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 5 December 1995 Dr Metters wrote to the Editor of <i>The Times</i> about �increased recent speculation� of a causal link between BSE and CJD. He said that the CJD Surveillance Unit and SEAC were established to advise on this, and that the CMO �has consistently stated that if he became aware of evidence [of such a link] he would immediately advise the public. There is, however, no current scientific evidence that BSE can be transmitted to humans�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn339" name="_ftnref339" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[339]</span></a></div>
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239<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 7 December 1995 Mr Horam replied to Mr Ancram�s letter of 15 November 1995 about the Churchills� concerns. He said that the CJD Surveillance Unit had reported that there was no cluster of �definite or likely� CJD cases in the Devizes area. Nor had it found any �conclusive evidence of space time clustering�. He said it would not be appropriate to set up �another independent inquiry� because �the Government already receives independent expert advice from SEAC�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn340" name="_ftnref340" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[340]</span></a></div>
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240<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>He said that SEAC had advised it was not possible to draw conclusions on the teen-aged cases because CJD had been found in teenagers in other countries, also �the cases had no exposure to risk factors for CJD and no contact with BSE�. He said that SEAC had asked for more information. He added that �there are only two cases of CJD in teenagers in the UK�. The Churchills, in their letter of 5 November, had said there were three teenagers.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn341" name="_ftnref341" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[341]</span></a></div>
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241<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>He said that SEAC had also asked for more information on farmers. He said they had not found increased incidence �in other occupational groups such as veterinarians, who might be similarly exposed, whilst other groups, for example, vicars, who have no reason to be exposed to BSE, show a greater excess than farmers.� SEAC had also noted a higher incidence in farmers elsewhere in Europe.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn342" name="_ftnref342" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[342]</span></a></div>
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242<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 7 December 1995 Mr Hogg, Mrs Browning, Mr Packer, Mr Osborne, Mr Carden, Mr Meldrum, Mr Haslam, Mr Kent and Dr Render met �to discuss the latest state of play on BSE�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn343" name="_ftnref343" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[343]</span></a> It was agreed that Messrs Meldrum and Carden discuss with Professor Pattison �the sort of points which he might cover in a letter to the papers�, and Mr Hogg said that �he had not ruled out the possibility of paying for space, possibly to publicise the SEAC paper�. It was also agreed that Mr Hogg put a set of questions to SEAC with a view to publishing the answers. Mr Packer told the meeting that Dr Calman �had come forward with names of three doctors who might be appointed� to SEAC. It was agreed that Mr Hogg hold a press briefing on 14 December 1995, accompanied by Professor Pattison, Dr Calman and Mr Meldrum; and that MAFF Ministers write to leading parliamentarians setting out the latest position in full.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn344" name="_ftnref344" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[344]</span></a></div>
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243<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 7 December 1995 the Prime Minister was sent a briefing for Prime Minister�s Questions on BSE and CJD.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn345" name="_ftnref345" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[345]</span></a><b> </b>The briefing explained that existing MRM products would not be withdrawn from the shelves unless the CMO or SEAC advised otherwise. It also noted that the CMO had �confirmed his previous assurances that if any new evidence comes to light that BSE could transmit to humans he would bring this to the attention of the public�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn346" name="_ftnref346" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[346]</span></a> It also said there was no need for a Royal Commission because SEAC was an independent group.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn347" name="_ftnref347" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[347]</span></a></div>
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244<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>That day (7 December), there was a Cabinet meeting at which Mr Hogg raised the renewed media interest over the past week in CJD, �fuelled by doubts expressed by a number of eminent scientists�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn348" name="_ftnref348" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[348]</span></a> He said that he had issued draft orders that day banning the use of bovine vertebral column in MRM manufacture. He put forward the proposals discussed at the earlier meeting that day.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn349" name="_ftnref349" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[349]</span></a> The points were made that it might be wiser to issue a statement sooner than 14 December, and that discussion on BSE should remain open and non-partisan. The credibility of the NFU and MAFF were not high, so it was important to get independent scientific opinion. The possibility was mentioned that Sir Bernard Tomlinson might be invited to offer a further view �but he might still feel obliged to register some qualification which would leave doubt in the public mind�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn350" name="_ftnref350" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[350]</span></a> It was noted that the CMO and the CVO</div>
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�ought to be by far the most convincing spokesmen for the Government on the key question of whether BSE could be transmitted to humans from infected meat. Their assurances on that point might, however, be undermined if they could not give unqualified advice that meat products currently on sale, which had been produced prior to the orders banning the use of vertebral column in MRM, were safe to eat. Such meat currently held in deep storage could be prevented from entering the food chain but it would be going a considerable step further to withdraw all meat products containing such meat from retail outlets. To do that would carry the danger of precipitating a degree of panic among the public with devastating effects for the livestock industry and a strong possibility of claims for compensation which the Government might find it extremely difficult to resist�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn351" name="_ftnref351" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[351]</span></a></div>
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245<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Major summed up the discussion at the end of the meeting:</div>
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�there was a disturbing degree of public anxiety over BSE once more and that the Government must be ready with an immediate and coherent response. The key element in that response should continue to be the assurance from the Government�s chief professional advisers that there was no evidence that the disease could be transmitted to humans. It would be essential, however, to clarify what should be said about the safety of meat products already on sale, bearing in mind the potential impact on the livestock industry and the possibility of claims for compensation. He therefore invited the Lord President of the Council to meet urgently with the four Agriculture Ministers, the Secretary of State for Health and the Chief Secretary, Treasury with the Chief Medical Officer and Chief Veterinary Officer in attendance to concert a public statement and to convey it immediately to Cabinet colleagues in order to maintain the credibility of the Government�s stance on this sensitive issue.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn352" name="_ftnref352" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[352]</span></a></div>
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This action was agreed by Cabinet.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn353" name="_ftnref353" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[353]</span></a></div>
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246<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 7 December 1995, Ms Heather Robinson (DANI) sent a minute explaining the process of MRM to the private secretaries of Baroness Denton and Mr Ancram. She copied the minute to Mr John Murray (DANI Permanent Secretary), Mr Elliott (Northern Ireland DHSS), Mr David Carnson, Mr Ron Martin (Northern Ireland CVO), Mr Toal and Mr Sinclair. Baroness Denton had requested the minute. It explained that MRM was made by crushing bone and allowing the meat and bone marrow to escape through a fine mesh. Spinal column was a principle ingredient of MRM.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn354" name="_ftnref354" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[354]</span></a> The minute noted that MRM was not produced in Northern Ireland although it was imported and used in production processes.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn355" name="_ftnref355" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[355]</span></a> It identified the �line to take: Beef is safe to eat� The new measures proposed are precautionary and designed to eliminate any remote theoretical risk from BSE�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn356" name="_ftnref356" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[356]</span></a></div>
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247<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 7 December 1995 Dr Kendell (Scottish CMO) issued a statement in response to media interest and reports that schools and caterers were starting to remove beef from menus.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn357" name="_ftnref357" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[357]</span></a> The statement said:</div>
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�The Government�s independent scientific advisers are saying consistently that there is no evidence at all that eating beef or other foods derived from beef is dangerous. My general advice to people is therefore to carry on eating what you want to eat as you were before.</div>
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�We have no evidence of any connection between BSE and CJD. However, both conditions are being closely monitored and studied by scientists, in this country and abroad, as there is much about both that is still unknown.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn358" name="_ftnref358" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[358]</span></a></div>
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248<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Kendell told the BSE Inquiry, �I was not trying to say beef is safe but to say that we have no good evidence to believe that it is unsafe� I do not know whether I expected it to be reassuring or not. I wanted it to be accurate.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn359" name="_ftnref359" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[359]</span></a></div>
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249<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The same day (7 December), Dr Kendell minuted Scottish Ministers to inform them of his action. After quoting his public statement, he said:</div>
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�The core of the dilemma is there is no evidence of any connection between BSE and CJD, but on the other hand neither I nor anyone else can give a cast iron guarantee that eating beef or beef products from UK farms does not carry any risk of transmitting the causal agent of CJD, a disease which is invariably fatal. Worse still, this uncertainty may last for 10 years or more.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn360" name="_ftnref360" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[360]</span></a></div>
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250<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Forsyth (Scottish Secretary of State) thought that Dr Kendell had probably discussed the statement with him beforehand.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn361" name="_ftnref361" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[361]</span></a> He added that �[Dr Kendell] in that statement actually, I thought, produced a very balanced statement of the facts as they were known at the time.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn362" name="_ftnref362" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[362]</span></a></div>
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251<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 7 December 1995 Sir David Naish (President, National Farmers� Union, England and Wales) sent a letter to Mrs Gillian Shephard (Secretary of State for Employment and Education), copied to Mr Dorrell and Mr Hogg. The letter proposed that the Department</div>
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�ensure that all the facts are placed before local education authorities and schools, citing the evidence an [sic] statements of the Chief Medical Officer, so that all those involved in deciding menus for children�s lunches can come to a reasoned decision.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn363" name="_ftnref363" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[363]</span></a></div>
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252<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 7 December 1995, McDonald�s Restaurants circulated a statement to MPs outlining the �strict quality control standards� that McDonald�s took with its food.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn364" name="_ftnref364" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[364]</span></a></div>
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253<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In an article for <i>The Independent</i> on 8 December 1995 Dr Will said</div>
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�there is a risk of over-interpreting small numbers of cases, and statistical analysis may be unreliable�</div>
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�There are limitations in the epidemiological study of a rare disease as it may be impossible to assess the significance of minor changes, although continued surveillance of CJD will allow any major change to be identified, particularly if comparisons with other countries without BSE continue�</div>
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�No link between BSE and CJD has been established, but the possibility of such a link cannot be excluded for many years because of the long incubation period in these diseases. In my view, the possibility of such a link remains theoretical, but even if the BSE agent were a risk to man, oral transmission would require exposure to high levels of infectivity, as in kuru.</div>
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�That is why the SBO ban is so important and why I believe the risk from eating beef is negligible� I do not believe it is reasonable to conclude that there is significant risk from eating beef. I have therefore not altered my consumption of beef or beef products, and neither have any of my colleagues at the CJD Surveillance Unit�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn365" name="_ftnref365" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[365]</span></a><b></b></div>
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254<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 8 December Professor Pattison and Dr Will sent a letter to <i>The</i> <i>Times </i>that was almost identical to their open letter of 13 December (see below). Professor Pattison faxed a copy of the letter to Dr Wight.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn366" name="_ftnref366" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[366]</span></a></div>
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255<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the invitation of Mrs Browning, Sir Bernard Tomlinson wrote a letter to Professor Pattison dated 8 December 1995.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn367" name="_ftnref367" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[367]</span></a> He said he believed it was �unjustifiable, in the light of knowledge� to state that BSE could not transmit to humans �under any circumstances�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn368" name="_ftnref368" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[368]</span></a> He said</div>
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�If scrapie has transmitted to cattle it demonstrates with alarming clarity the dangers of assuming that the species barrier will totally protect humans who ingest beef tissues infected with BSE. That would be so even without the plentiful evidence that the TSE�s [sic] in most species can be transmitted to other species.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn369" name="_ftnref369" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[369]</span></a><b><o:p></o:p></b></div>
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256<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>He was concerned about recent cases of CJD in farmers and young people, and asked what evidence SEAC would need before proposing further precautionary measures.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn370" name="_ftnref370" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[370]</span></a> He was also concerned about SBO from cattle under 6 months old,<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn371" name="_ftnref371" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[371]</span></a> liver,<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn372" name="_ftnref372" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[372]</span></a> and SBO regulation enforcement.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn373" name="_ftnref373" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[373]</span></a></div>
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257<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Professor Pattison replied on 15 Dec, and sent a copy to DH (see below).</div>
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258<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 9 December 1995 in <i>The Independent, </i>Professor Pattison �refused to support� Mr Dorrell�s 3 December statement that there was �no conceivable risk� of BSE spreading to humans. He was quoted as saying �I freely admit that we cannot yet give anyone absolute guarantees�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn374" name="_ftnref374" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[374]</span></a><b></b></div>
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259<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In an article for <i>The Sunday Telegraph</i> on 10 December 1995, Dr Calman said there was �no need for more safeguards� I remain satisfied that human health is properly protected�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn375" name="_ftnref375" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[375]</span></a></div>
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260<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 10 December 1995, the MLC issued a newspaper advertisement on the safety of beef. It is described at 3 December above. It finished with a quote from Dr Will: �I do not believe there is a significant risk from eating beef and I have therefore not altered my consumption of beef or beef products, neither has any of my colleagues at the CJD Surveillance Unit�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn376" name="_ftnref376" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[376]</span></a></div>
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261<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In a column for the newspaper <i>News of The World </i>on 10 December 1995 Mr Hogg answered �the 64,000 dollar question � is beef safe to eat?�:</div>
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�Yes. Professor Pattison says so. The members of his committee say so. The Chief Medical Officer, Dr Kenneth Calman says so� I spoke to him this week and he told me: �I am satisfied that any beef or beef product allowed by the regulations is safe to eat.��<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn377" name="_ftnref377" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[377]</span></a></div>
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262<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span><i>The Daily Telegraph</i> on 11 December published an article headed �Public urged not to panic over beef�. It quoted from a statement by Professor Pattison and Dr Will that was almost identical to their letter of 13 December (see below).<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn378" name="_ftnref378" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[378]</span></a></div>
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263<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In a �Dear Colleague� letter dated 11 December 1995, Mr Hogg informed Conservative Members of Parliament of �the new steps I will be taking to protect public health from the very remote risk from BSE and to reassure the public that British beef is safe�. Mr Hogg outlined the slaughter and compensation scheme, the SBO regime, the use of vertebral column in MRM, the decline in number of cases of BSE and research funding. Under a final subheading, he stated:</div>
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�A Policy of Openness</div>
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�The Government is pursuing a policy of complete openness on BSE and CJD. All new findings are put into the public domain as quickly as possible. I invite those scientists who have raised public fears about the safety of beef to submit any new evidence they have for consideration by our independent expert advisory committee, SEAC.</div>
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�I will continue to give Parliament regular updates on the action we are taking to protect the public and eradicate BSE. On Thursday, I will be placing in the library of the House of Commons our regular comprehensive progress report on BSE.</div>
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�At the risk of repeating myself, let me give you this final assurance. British beef is safe. It is safe for school children and it is safe for adults. That is not simply my view. It is the view of the Chief Medical Officer, the World Health Organisation, the international veterinary organisation, the OIE, and the European Commission.</div>
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�My first duty is to protect the public. You can be sure that I will not allow anything to put public health at risk.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn379" name="_ftnref379" title=""><span class="FootnoteReferencedfa" style="vertical-align: super;">[379]</span></a></div>
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264<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 11 December 1995 Dr Calman�s private secretary minuted Dr Wight, copied to Dr Metters, asking her to provide the other UK CMOs, Dr Kendell, Dr Hine and Dr Campbell with key documents on BSE. She said �All the CMOs are coming under increasing pressure to respond to the media, and feel that they require a steer from us as to the most up to date line�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn380" name="_ftnref380" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[380]</span></a></div>
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265<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 12 December 1995, Dr Render minuted Mr Eddy, copied to Mr K Taylor, Dr Matthews, Dr Wight and Mrs Gurnhill.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn381" name="_ftnref381" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[381]</span></a> He suggested a standard information paper for use in replying to the large amount of correspondence that was being received. He attached a note that he had drafted, and asked for comment by 13 December. He circulated a final copy on 17 December; see below.</div>
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266<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In a letter dated 13 December 1995, Professor Pattison and Dr Will wrote to Mr Dorrell and Mr Hogg, answering the �many questions [that had been asked during the last two weeks] about BSE, CJD, the public health and British beef�. The letter said</div>
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�On the basis of the measures taken SEAC had a high degree of confidence that the beef reaching the shops is safe to eat. We are equally confident that offal which is not included in the ban, for example liver, is safe to eat because no BSE infectivity has been found in liver, either from infected cows or from experimentally infected calves.</div>
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�The restrictions on the use of bovine offal have been strengthened since they were first introduced in 1989 and, through inspections, the application of these bans is being much more rigorously applied. If there was any risk to human health from BSE, and there may be none, then we have no doubt that risk is very much less in December 1995 than it has ever been. There is therefore no need to take extreme measures with respect to the British beef that is allowed to enter the human food chain.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn382" name="_ftnref382" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[382]</span></a></div>
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267<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>This letter was given to reporters at a press conference on 14 December 1995, given by Mr Hogg, Mrs Browning, Dr Calman and Professor Pattison.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn383" name="_ftnref383" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[383]</span></a></div>
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268<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>At the press conference Mr Hogg announced the appointments of four new members to SEAC, and the fifth was announced on 20 December. They were Professors Collinge, Peter Smith and Jeffrey Almond (School of Animal and Microbial Sciences, University of Reading), Dr Michael Painter (consultant in Communicable Disease Control) and Mr Bradley (formerly of the CVL).<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn384" name="_ftnref384" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[384]</span></a></div>
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269<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 14 December 1995 Dr Walford telephoned Dr Calman to let him know of her discussion with Dr Will (see 5 December above), and that she had invited Dr Will to the PHLS at Colindale in order to give him access to the PHLS database on cases of sub-acute sclerosing pan-encephalitis (SSPE, a chronic measles condition).<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn385" name="_ftnref385" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[385]</span></a> She followed this up with a letter on 22 December (see below).</div>
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270<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 15 December, <i>The Daily Telegraph</i> reported Mr Hogg as saying<i> </i>�the Government was acting with an abundance of caution even though he [Mr Hogg] and his team of expert advisors, viewed beef as �wholly safe��.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn386" name="_ftnref386" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[386]</span></a></div>
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271<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The newspaper also reported that Professor Pattison had said �that it could take �decades� to provide �the final proof� scientifically that BSE could not spread to people.� Nevertheless, Professor Pattison was �sure that beef was safe in the light of the increasing amount of scientific evidence that was building up.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn387" name="_ftnref387" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[387]</span></a></div>
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272<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The newspaper also quoted Dr Calman as saying that there were no financial constraints on BSE research. Dr Calman added:</div>
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�It is understandable why the public are concerned. That is not unreasonable. What we need to do is to reassure them, as much as we can, that beef is safe�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn388" name="_ftnref388" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[388]</span></a></div>
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273<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 15 December 1995, the SBO (Amendment) Order 1995<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn389" name="_ftnref389" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[389]</span></a> took effect. The Order prohibited the use of the bovine vertebral column in the manufacture of MRM and also in the production of some other products for human consumption, and required all plants producing bovine MRM to register with MAFF.</div>
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274<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 15 December 1995, Professor Pattison responded to Sir Bernard Tomlinson�s letter of 8 December.</div>
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�You ask what epidemiological data concerning CJD would lead the committee to re-examine the regulations with respect to cattle offal. In principle we are seeking to identify a significant and sustained deviation from the expected in relation to CJD in the UK compared to Europe which can be correlated with BSE. You rightly draw our attention to the difficulties with statistical analyses of small numbers and to the recent paper by Sheila Gore, who has of course attended SEAC to advise it on two recent occasions. We monitored the apparent rise in overall incidence of CJD in the UK between 1990 and 1994. This is a general trend in other countries as well, and we ascribe it to better identification of cases. The UK rise will not be sustained in 1995. However the unusual events this year are the occurrence of the fourth case in a cattle farmer and the two teenage cases. As Sheila Gore point out there is a higher incidence of CJD in dairy farmers in other European countries and this does not correlate with BSE in their herds. Clearly we need to pursue this association further in respect of cattle farming practices and the personal diet and habits of the farmers but we recognise the great difficulty of this.</div>
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�The other unusual and tragic events of 1995 are the two cases in teenagers. Cases of CJD in teenagers in other countries have been described previously and again there is no link to BSE in these other countries. Mis-diagnosis in young people of illness that turned out to be CJD has been described and there have also been the occasional unexplained small clusters of cases in the past. We have not defined a specific number of teenage cases that will lead us to re-examine our conclusions because we reconsider the situation after every single new case in young people (or farmers).�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn390" name="_ftnref390" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[390]</span></a></div>
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275<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Professor Pattison also explained the science relating to the SBO ban in under-6-month-old cattle. Experiments had not found transmissibility in the organs permitted from these cattle.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn391" name="_ftnref391" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[391]</span></a> He said that with the current enforcement regime SEAC were satisfied that the current list of SBOs did not need to be extended. He said,</div>
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�As scientists we do still have to be properly cautious in our statements. We lack the knowledge on many important aspects of SEs in general and BSE and CJD in particular. The duration of experiments is usually measured in years, there is no simple test of infectivity and the strain-typing methods so crucial in the control of any transmissible disease are not as rapid as we would like ideally. Thus it is proper at this stage to continue to say �there is no evidence.� However I am struck by the fact that every time we receive new experimental data or pass a new milestone in the pathogenesis experiment the data reinforces the adequacy of the current controls rather than the opposite. I do think that human health considerations are paramount and that the Government is taking all the necessary steps to protect it.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn392" name="_ftnref392" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[392]</span></a><b><o:p></o:p></b></div>
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276<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The previous day, Professor Pattison had sent Sir Bernard�s letter and his own draft reply to Mr Carden for comment. Mr Carden had circulated the letters to Mr Meldrum, Mr Eddy, and the private secretaries to Mrs Browning and Mr Packer.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn393" name="_ftnref393" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[393]</span></a></div>
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277<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 15 December 1995 Mr Eddy minuted Dr Wight, copied to Mr Meldrum, Mr Haddon and Dr Render. He said</div>
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�1.�� I have been thinking about ways in which we can try to get across to people just how small the risk from CJD currently is. Clearly the one in a million mortality rate does not seem to get through. I wonder whether we could look at it in another way.</div>
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�2.�� My back of the envelope calculations suggest that about 800,000 people a year die of which 50, ie. 1 in 16,000, die of CJD. I would quite like to draw up a table with the real figures if you could get hold of them from somebody in DH on mortality rates for different diseases showing, say, for 1994, total number of deaths, total number from CJD, total number from cancer, heart disease, road accidents and total number believed to be related to smoking and to drinking and possibly to other avoidable risks if you can think of any. We could then perhaps use this as another way of trying to get people to look at this particular issue in a more balanced context. Do you think this is a good idea and could you try and get hold of the necessary figures?�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn394" name="_ftnref394" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[394]</span></a><b><o:p></o:p></b></div>
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278<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 15 December 1995 Mr Peter Grimley (MAFF Animal Health (Disease Control) Division) invited various consumer and catering groups to a meeting on Monday 18 December, to discuss BSE. Attached to the invitation was a �short paper which sets out the Government�s perspective on this question which you may find helpful�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn395" name="_ftnref395" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[395]</span></a></div>
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279<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 16 December 1995 <i>The Guardian</i> published an interview with Dr Calman. In discussion of beef, Dr Calman said</div>
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�We say that beef is safe. That is not to say, please go and eat beef. All we say is that, on all the evidence, we believe it is safe. Safe, that is, up to a point. We take the science and stretch it as far as we can and then give the best possible advice we can.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn396" name="_ftnref396" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[396]</span></a></div>
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280<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 17 December 1995 Dr Render circulated a Q&A note for use in replying to the large number of letters on BSE. He sent it to Mrs Browning�s private secretary, and copied it to the private secretaries of Messrs Hogg and Packer, and to Messrs Osborne, Carden, Haddon, Meldrum, K Taylor, Eddy and Haslam, and Dr Wight.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn397" name="_ftnref397" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[397]</span></a> The note included questions on BSE control and statistics, CJD, the safety of beef, SBO enforcement and SEAC.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn398" name="_ftnref398" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[398]</span></a>On the question of whether beef was safe, the note read:</div>
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�Yes. This is the clear advice of the Government�s Chief Medical Officer and the independent Spongiform Encephalopathy Advisory Committee (SEAC), which advises the Government on all matters to do with BSE and CJD. They and other international bodies, such as the World Health Organisation, consider that the control measures that the Government has put in place are sufficient to protect the public�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn399" name="_ftnref399" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[399]</span></a></div>
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281<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The note went on to describe the measures that the Government had put in place to �protect the public from any remote theoretical risk from BSE�: the slaughter policy and the SBO regulations.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn400" name="_ftnref400" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[400]</span></a></div>
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282<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 18 December MAFF held a meeting with various consumer and catering groups to discuss BSE.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn401" name="_ftnref401" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[401]</span></a></div>
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283<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 20 December 1995 Dr Wight forwarded Mr Eddy�s minute of 15 December to Mr W R Hageman, and copied it to Mr Robb. She asked him to provide the mortality statistics that Mr Eddy had outlined for comparison to CJD deaths.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn402" name="_ftnref402" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[402]</span></a><b></b></div>
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284<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 21 December 1995 Mr Forsyth wrote a letter about BSE to Mr Hogg. He copied it to Mr William Hague (Secretary of State for Wales), Mr (later Lord) Patrick Mayhew (Secretary of State for Northern Ireland), Mr Dorrell and Mr (later Baron) Ian Lang (President of the Board of Trade<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn403" name="_ftnref403" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[403]</span></a>). He suggested that SEAC be encouraged to �set out publicly their scientific opinions� so putting the Government in a �strong position to argue that our policy on BSE is similarly based on the best available scientific and medical advice�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn404" name="_ftnref404" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[404]</span></a></div>
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285<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Secondly, he pointed out that there were �persistent rumours that the total scientific effort on BSE is being weakened. It is coupled with the unfounded assertion that we have something to hide.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn405" name="_ftnref405" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[405]</span></a> He noted that this was not helped by organisational and funding difficulties in the BBSRC/ MRC Neuropathogenesis Unit (NPU). Mr Forsyth told the BSE Inquiry:</div>
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�it was becoming more and more difficult to fend off allegations that information was being suppressed and things of that kind. That underlines how difficult it is to deal with a public health issue in the context of normal politicals and the media. One of the suggestions I made� which I think is quite important, and I am in no way criticising either the Prime Minister or the then leader of the Opposition, but it would have been so much better if in dealing with this we could have had an all party approach�</div>
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�So one of the lessons I take from this is that it is extremely difficult to deal with these very sensitive public health issues in the context where people are wanting for other reasons to present Ministers as being driven by a considerations which will lose them support. I think that is the most difficult thing. And if we -- if your Inquiry were to encourage people in the future to develop that kind of approach, I think it would be a very much more sensible way to go about our business.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn406" name="_ftnref406" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[406]</span></a></div>
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286<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hogg replied to Mr Forsyth on 17 January 1996 (see below).<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn407" name="_ftnref407" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[407]</span></a></div>
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287<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 21 December 1995 Dr Wight minuted Dr Calman�s private secretary about a suspect case of CJD in an abattoir worker. She copied the minute to Dr Metters, Dr Rubery, Mr Robb and Mr Clarke. �If confirmed�, she said, �this would be the first such case� There will be an opportunity for SEAC to consider possible implications, if necessary in the light of the [CJD Surveillance] Unit�s investigations, on 5 January.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn408" name="_ftnref408" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[408]</span></a></div>
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288<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 22 December 1995 Dr Wight provided more information about the abattoir worker. In a minute (to the same people), she noted that the case had been reported in the <i>Guardian </i>newspaper.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn409" name="_ftnref409" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[409]</span></a> She said she had spoken to Dr Will who said that it must be regarded as a �possible� case. She said that SEAC would �pick up� the case at their next meeting. There was a second case mentioned in the newspaper but the CJD Surveillance Unit did not know about this.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn410" name="_ftnref410" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[410]</span></a></div>
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289<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 22 December 1995 there were various newspaper reports of an abattoir worker being admitted to hospital with symptoms of CJD.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn411" name="_ftnref411" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[411]</span></a></div>
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290<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 22 December 1995, Dr Walford wrote to Dr Calman to tell him what had transpired after an afternoon that Dr Will had spent at the PHLS examining the SSPE database. She informed Dr Calman of a proposed informal meeting between herself, Dr Will, Professor Smith, and �one or two� PHLS consultant epidemiologists, �to exchange ideas about possible study designs�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn412" name="_ftnref412" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[412]</span></a> Dr Calman responded on 12 January 1996 (see below).</div>
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Contingency Planning</div>
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291<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Rubery told the BSE Inquiry that the cases of CJD reported towards the end of 1995 alerted her to the fact that �the evidence base for the policy was changing�. <a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn413" name="_ftnref413" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[413]</span></a> By the end of 1995, she felt that if more cases of CJD in teenagers were identified �this would further undermine the evidence base for SEAC�s advice about the absence of a relationship between BSE and CJD�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn414" name="_ftnref414" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[414]</span></a></div>
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292<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Around November 1995, Dr Rubery had therefore discussed the situation with Mr Hart (DH Permanent Secretary). They agreed that Dr Calman had a leading role to play and that Dr Rubery and her staff needed to continue to support him as fully as possible. They also agreed that Dr Rubery needed to be able to support Mr Dorrell if a greater need developed for advice beyond the medical aspects.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn415" name="_ftnref415" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[415]</span></a></div>
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293<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>At the end of 1995 or the beginning of 1996,<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn416" name="_ftnref416" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[416]</span></a> Dr Rubery spoke over the telephone to Mr Carden to discuss forward planning:</div>
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�I did say to him, �It looks to me as if it is conceivable that if another case turns up of CJD in a teenager, then it is going to be difficult for SEAC to continue to say there is no link; should we meet to develop a plan and see how we should take things forward in the longer term?�, but he was adamant we could not do that. He felt that if anybody discovered that we were meeting, if the press got wind of this, that this would cause problems and also it would be difficult to get information from the relevant people they needed on the MAFF side to plan the consequences.</div>
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�So I did not do anything more on that side. I did continue to think about what we should do from the point of view of the Department of Health side, but most of the actions that we needed to take on that side were really relatively short-term, they were to take action once we had got the cases and therefore there was nothing more that I felt we needed to do in terms of long-term planning�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn417" name="_ftnref417" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[417]</span></a></div>
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��Because I have managed Chernobyl, I know how bad it can be to have to deal with these crises, so it did seem to me a bit of forward planning would be useful, but MAFF were clearly not keen on doing that. As most of the planning one needed to do was for them rather than us, it did not seem to me it was worth pushing it, if he was clear he did not want to do that.�<span class="MsoFootnoteReference" style="vertical-align: super;"> <a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn418" name="_ftnref418" title="">[418]</a></span></div>
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January 1996</div>
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294<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 3 January 1996 Mr Taylor circulated the World Health Organisation�s �just published� report on public health issues related to human and animal TSEs<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn419" name="_ftnref419" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[419]</span></a>, to 14 MAFF colleagues plus Dr Wight at DH. He said that its conclusions and recommendations</div>
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�are not unhelpful. The decline in the UK BSE epidemic is recorded, and there is a useful statement that �Current control policies are considered adequate to minimise the risk of exposure to BSE of all species, including humans.� The statement� that �tallow does not appear to be a risk for human and animal health� is also helpful.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn420" name="_ftnref420" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[420]</span></a><b><o:p></o:p></b></div>
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295<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 3 January 1996 Mr Eddy sent a minute to Mr Hogg�s private secretary.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn421" name="_ftnref421" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[421]</span></a> The minute was written in response to Mr Hogg�s request for advice on some of the German L�nder (Regional Governments) voting to ban the import of British beef.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn422" name="_ftnref422" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[422]</span></a> Mr Eddy noted the possible courses of action that Germany might take, and what responses Britain could take: �The question is whether there is anything that we or the Embassy in Bonn can do at this stage to encourage the German Government to reach [the] conclusion [that would avoid any problems in Europe]. I do not think that there is.� However, if Germany introduced a law banning the import of UK beef, then MAFF should lobby the EC Agriculture Commissioner, Mr Franz Fischler at once to take legal action. Mr Eddy concluded that the British Embassy in Bonn should continue to monitor the situation closely.</div>
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296<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 3 January 1996, Mr Don Curry, Chair of the MLC, wrote to Dr Rubery with an MLC �briefing paper�, which Mr Curry hoped she might �find useful when addressing this and related issues�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn423" name="_ftnref423" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[423]</span></a> The briefing paper began �British beef is safe to eat.� It went on to quote from various scientists, and quoted Sir Kenneth Calman as being satisfied that �there is no scientific evidence of a link between meat eating and CJD and that beef and other meats are safe to eat�.</div>
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297<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Mike Skinner (DH, HEF1C Division, had replaced Mr Lister as SEAC Secretariat) drafted a reply for Dr Rubery on 15 January 1996 (see below).</div>
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SEAC Meeting 23</div>
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298<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 5 January 1996 SEAC held its 23<sup>rd</sup> meeting.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn424" name="_ftnref424" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[424]</span></a> This was the first SEAC meeting for several new members.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn425" name="_ftnref425" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[425]</span></a> Present were Professor Pattison, Dr Will, Professors Almond, Brown, Collinge and Smith, Messrs Bradley and Pepper, and Drs Hueston, Kimberlin, Painter, and Watson. Observing were Dr Matthews (MAFF) and Dr Wight (DH), and from the Secretariat were Messrs Eddy (MAFF) and Skinner (DH). �In attendance� were Mrs M Wilson (BBSRC), Dr Dukes (MRC), Mrs Gurnhill (MAFF) and Mrs Townsend (MAFF).</div>
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299<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>A number of items were discussed, including publicity and dealing with the media, gelatin, MRM, tallow, a paper that had been written by Dr Stephen Dealler (a consultant microbiologist at Burnley General Hospital), blood transfusions, update on the CJD situation, human growth hormone and scrapie, an MRC workshop, research update and priorities, and the questions that had been put to SEAC by MAFF.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn426" name="_ftnref426" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[426]</span></a></div>
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300<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Will �reaffirmed that the incidence of CJD in dairy farmers in Europe showed an excess over the incidence for the population as a whole except in the Netherlands�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn427" name="_ftnref427" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[427]</span></a> He also �confirmed that there is now a CJD suspect in a 52 year old� who had a history of having been an abattoir worker�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn428" name="_ftnref428" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[428]</span></a> Professor Smith commented that</div>
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�taking into consideration the affected farmers as well, and even though the abattoir worker was in an apparently relatively low risk category, the �box� of �at risk� occupations was getting full compared to expectation on pure chance, and could not be dismissed�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn429" name="_ftnref429" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[429]</span></a></div>
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301<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In addition, Dr Will reported that he was worried about the number of cases in those aged under 30, over a very short period:<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn430" name="_ftnref430" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[430]</span></a></div>
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�Between 1970 and 1989 there had been no cases under 30 except for those due to growth hormone treatment. Since 1990 there have been four definites and one possible. These comprised the 17 and 19 year olds which were already published, a 29 year old diagnosed on the basis of cerebral biopsy, a 29 year old diagnosed post mortem and a 29 year old who was still alive and classified as no more than �possible�. There were also a 30 and 38 year old confirmed and a 35 year old suspect, who now looks unlike CJD. In one of the 29 year olds and the 30 year old the pathology is unique with very extensive plaques in both the cerebellum and cerebral cortex and Dr Will considered there is a very high chance that these two are genetic.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn431" name="_ftnref431" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[431]</span></a></div>
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302<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Kimberlin asked whether the lack of previous cases had been due to misdiagnosis. Dr Will thought this unlikely because the �the disease was unusual in the young�. He had ruled out the possibility of misdiagnosis as sub-acute sclerosing pan-encephalitis (SSPE): he had �checked through 35 cases of suspect but negative SSPE and had found none which looked like CJD��<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn432" name="_ftnref432" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[432]</span></a></div>
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303<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Will reminded the Committee that if two of the cases in young adults were genetic then the figures were perhaps not so worrying at this stage, given the fact that there had been two in France although over a 15 year period and two in Japan and other cases reported in the Netherlands and Australia under 30.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn433" name="_ftnref433" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[433]</span></a></div>
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304<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Professor Collinge was �extremely worried at the occurrence of this number of young cases in such a short period, which could suggest a link to BSE. He requested that a formal statistical analysis be carried out to assess this further.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn434" name="_ftnref434" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[434]</span></a></div>
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305<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>SEAC concluded that �the situation demanded the continuation of the intensive monitoring of CJD�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn435" name="_ftnref435" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[435]</span></a></div>
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306<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>As a result of the December 1995 media interest in BSE and CJD, Mr Hogg had put nine questions to SEAC, mostly relating to the safety of beef.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn436" name="_ftnref436" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[436]</span></a><b></b>Members agreed that �individual members might be asked to give some thought to individual questions with a view to circulating draft replies� before a further meeting at the end of January�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn437" name="_ftnref437" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[437]</span></a> These were in fact discussed at the next meeting on 1 February 1996.</div>
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307<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>That day (5 January 1996), Ann Richardson died of what was later diagnosed as nvCJD.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn438" name="_ftnref438" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[438]</span></a></div>
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308<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 9 January 1996 Dr Wight minuted the private secretary to Sir Kenneth Calman (he had now been knighted) about the SEAC meeting of 5 January.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn439" name="_ftnref439" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[439]</span></a> She copied the minute to Dr Metters, Dr Rubery, Mr Skinner and Dr Skinner. She summarised �the main agenda items discussed.� First was</div>
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�<b>CJD Update</b> � There have been 5 definite and one possible case of CJD in individuals aged 30 years or under in the last 4 years (though two of these may be genetic cases). Although this is a significant increase over the incidence in the UK in this age group during the preceding surveillance period, it is not without precedent worldwide. The Committee will be provided with a more definite statistical analysis, from Professor Smith, at its next meeting.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn440" name="_ftnref440" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[440]</span></a></div>
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309<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>She also summarised the two other main agenda discussions: a theory about human Growth Hormone (hGH) and scrapie, and research priorities.</div>
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310<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 9 January 1996 Mr Skinner minuted Baroness Cumberlege�s private secretary about a Parliamentary debate on BSE and CJD which was to be held on 10 January. He copied the minute to Mr Horam�s private secretary, Dr Wight, Dr Render and Mr Robb. He attached a Q & A briefing for use during the debate. It was addressed to Mrs Browning, and covered CJD (general), Government action on CJD (including research), CJD incidence and surveillance, BSE and CJD risks to human health, and CJD deaths in four farmers and two teenagers and an abattoir worker.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn441" name="_ftnref441" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[441]</span></a></div>
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311<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the possibility of a CJD epidemic, the answer was that the</div>
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�CJD Surveillance Unit will need to continue for a number of years before producing conclusive results. There is no evidence to date of an emerging CJD epidemic. The CJD Surveillance Unit has so far found no evidence of any change in CJD that can be attributable to BSE, nor is there any other current scientific evidence that BSE can be transmitted to humans�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn442" name="_ftnref442" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[442]</span></a><b><o:p></o:p></b></div>
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312<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The briefing went on to state the measures that were in place to protect public health: the slaughter of suspected cattle, destruction of their milk, and the SBO ban. The briefing said that these �were in line with, or more restrictive than, the WHO and OIE recommendations and have been approved by the European Commission�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn443" name="_ftnref443" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[443]</span></a></div>
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313<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>It also said, that there was �no current scientific evidence� BSE could be transmitted to humans or that eating beef causes CJD.</div>
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�Specifically, all the studies to date on transmission have shown that beef is safe. There is no epidemiological evidence of transmission from beef to humans or of transmission when muscle (meat) from cattle clinically affected with BSE is injected into mice.</div>
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�The Chief Medical Officer has recently reiterated previous assurances that if any new evidence comes to light that BSE could transmit to humans, he will bring it to the public�s attention�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn444" name="_ftnref444" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[444]</span></a><b><o:p></o:p></b></div>
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314<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the four farmers, two teenagers and the abattoir working, the briefing stated that it was not yet possible to reach conclusions.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn445" name="_ftnref445" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[445]</span></a></div>
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315<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>At a meeting on 9 January 1996, the UK CMOs discussed BSE and CJD �lines to take�. Under the heading �CJD and teenagers� the note of the meeting stated:</div>
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�It is not possible to draw conclusions about the cases of two teenagers recently reported in the <i>Lancet</i> because cases of sporadic CJD in teenagers, although rare, have been found in other countries before the appearance of BSE and the two cases had no exposure to risk factors for CJD and no contact with BSE�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn446" name="_ftnref446" title=""><span class="MsoFootnoteReference" style="vertical-align: super;"><span style="color: black;">[446]</span></span></a></div>
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316<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 10 January 1996, Mrs Richardson�s death was reported in the press as �suspected CJD�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn447" name="_ftnref447" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[447]</span></a></div>
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317<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 10 January 1996, Dr Metters wrote a minute to Dr Calman in relation to Dr Walford�s letter dated 22 December 1995. Dr Metters said that Dr Walford�s letter �contained the broad hint that PHLS should be brought in to advise the CJD Surveillance Unit and SEAC on the epidemiological studies of CJD�. He continued:</div>
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�This is not the first time Dr Walford has sought to involve PHLS in Spongiform Encephalopathy research. Yet the experience of recent weeks has shown how important it is for the Government to have a single source of independent scientific advice. With this in mind I have drafted the attached reply which is slightly stronger than Dr Wight�s initial draft.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn448" name="_ftnref448" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[448]</span></a></div>
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318<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 12 January 1996 Sir Kenneth Calman responded to Dr Walford�s letter of 22 December 1995.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn449" name="_ftnref449" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[449]</span></a> On the proposed epidemiological meeting, he said:</div>
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�When we previously corresponded about the Government�s sources of scientific advice on prion disease, I emphasised the importance to DH and MAFF of having, in SEAC, a single source of independent advice. Given that SEAC�s membership has been specifically strengthened epidemiologically by Peter Smith�s appointment, I think it would be preferable for SEAC to decide whether it requires further help over study design before an informal meeting is arranged between any of your consultant epidemiologists, Bob Will and Peter Smith.</div>
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�You may also know that SEAC have been asked to take stock of their research recommendations. This will provide an opportunity for the Committee to review the human epidemiological data provided for them by Bob Will�s unit.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn450" name="_ftnref450" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[450]</span></a></div>
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319<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Walford therefore cancelled the meeting (see 19 January below).</div>
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320<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 12 January 1996 Mr Packer, Mr Carden, Mr Hollis and Mr Hayward met Mr Maclean (MLC) and Mr Glyn Howells (MLC Marketing Manager). They discussed recent statistics showing a drop in beef sales, and market analyses that had been done.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn451" name="_ftnref451" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[451]</span></a></div>
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321<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The MLC �felt that urgent PR action was required�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn452" name="_ftnref452" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[452]</span></a> In addition to �conventional� promotion (advertising), they said that the �strategy on putting positive messages into the public domain was more complex�. The MLC proposed �a seminar to educate a range of scientists on BSE and the risks�, �a more proactive approach to schools through the Local Education Authorities [LEAs], especially those which had banned beef�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn453" name="_ftnref453" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[453]</span></a>, and �mechanisms to educate GPs�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn454" name="_ftnref454" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[454]</span></a> Mr Packer �told Mr Maclean that he would write to the Minister explaining the MLC�s position and that he was prepared to consider the seminar and a fresh approach to the schools. It was, of course, important to monitor the situation in the next few weeks�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn455" name="_ftnref455" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[455]</span></a></div>
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322<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Later that day Mr Packer minuted Mr Hogg on three issues, and copied the minute to Mrs Browning, Mr Hadley, Mr Carden, Mr Hollis, Mr Meldrum, Mr Haddon, Mr McNeill, Mr Eddy and Dr Render. First, he informed Mr Hogg that the Government of Ireland �wanted to run an advertising campaign for beef in the UK (without any differentiation of origin of the product)�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn456" name="_ftnref456" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[456]</span></a> Second, he informed the Minister about the meeting earlier that day with the Director General of the MLC.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn457" name="_ftnref457" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[457]</span></a> Third, he alerted him to �new evidence of seemingly widespread fraud over BSE status by slaughterhouses producing beef for export from cull cows.� (A cull cow is an old or poor quality dairy cow which is removed from the herd and sold for slaughter.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn458" name="_ftnref458" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[458]</span></a>) Mr Packer said</div>
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�This is likely to hit the newspapers soon, causing both a renewed spate of press interest in BSE, as well as firing concern in Europe. I cannot say I am surprised. The existing EC rules on UK beef virtually constitute an incentive for fraud. So do Irish national rules. Fraud in both the UK and Ireland is therefore not unexpected. However, the discovery of fraud now is very awkward especially as the profile of BSE was fading somewhat.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn459" name="_ftnref459" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[459]</span></a></div>
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323<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 15 January 1996 Mr Skinner drafted for Dr Rubery a letter to Mr Curry, in response to the MLC letter of 3 January 1996. In his covering note to Dr Rubery, Mr Skinner noted that the MLC paper �takes a very strong pro-safety of beef line and overstates the weight of interim conclusions from current scientific evidence.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn460" name="_ftnref460" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[460]</span></a> He said that the paper mentioned Professor Pattison, Dr Will and Professor Collinge</div>
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�in a way which appears to associate them with the conclusions in the paper. We do not feel these are altogether legitimate and they may well agree. The best way forward would be to let them have copies of the briefing paper and invite them to comment.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn461" name="_ftnref461" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[461]</span></a><b><o:p></o:p></b></div>
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324<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Skinner recalled that the MLC had</div>
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�misquoted CMO�s advice to their advantage in a newspaper advert before Christmas for which they subsequently sent CMO written apologies. They have misquoted him again and also relied on an announcement which has since been superseded�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn462" name="_ftnref462" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[462]</span></a><b><o:p></o:p></b></div>
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325<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Rubery sent the response to Mr Curry on 18 January.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn463" name="_ftnref463" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[463]</span></a> Mr Skinner sent the MLC paper for comment to Dr Will and Professors Pattison and Collinge on 12 February 1996.</div>
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326<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 16 January 1996, Mr Hogg met Mrs Browning, Mr Packer, Mr Meldrum, Mr Eddy, Mr Osborne, Mr Carden, Mr Hollis, Mr Haddon, Mr Taylor, Mr Kent, Mr McNeill, Mr Soul, Mr Corbett and Dr Render.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn464" name="_ftnref464" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[464]</span></a> In discussion of the possible fraud in slaughterhouses, Mr Hogg:</div>
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�3.�� �agreed that our initial line should be to say that if the police had any evidence of fraud, they should ensure that that [sic] evidence was passed on to the appropriate authorities. We should not interfere in the process in any way. We could add that it would be helpful if we were informed of any decisions on this matter taken by the police or other relevant authorities.</div>
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�4.�� On our current controls, Mr McNeill said that OVSs [Official Veterinary Surgeons] took great care to check the validity of declarations. However, this was a very difficult task. Mr Haddon said that it had been agreed to have a thorough look at our checks to see whether they could be tightened up. You said that we would almost certainly have to be able to show the Commission and the Germans that we had introduced some substantive changes. Mr Meldrum said that we might be able to do more to ensure that ear-tags and declarations matched up or to trace back the declarations themselves. We were discussing this with the MHS. In the meantime, we would step up our checks on ear-tags. The Minister agreed that we had to address these issues. He asked for a package of proposals to be put forward to Mrs Browning, including advice on how to handle the Germans and the Commission and on the line to take in public in the meantime (Action: Mr Eddy). Mr Haddon commented that we would also need to address the question of who would bear the costs of any additional checks.</div>
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�5.�� It was agreed that we would not call in the industry for a meeting, at least until the police and others had followed through their current inquiries. Mr Meldrum commented that our increased checks on ear-tags would themselves convey a message to the industry.</div>
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�6.�� Mrs Browning said that there were signs that the prime beef industry was becoming increasingly irritated by problems which were largely the fault of the cull cow trade. Mr Taylor said that some would argue that cull cows should not go for human consumption. [Mr Eddy] stressed the importance of this trade for the economics of the dairy industry and the heavy cost of taking all cull cows off the market at taxpayers� expense. [Mr Packer] said that there would also be considerable difficulties with the disposal of large volumes of carcases.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn465" name="_ftnref465" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[465]</span></a></div>
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327<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In discussion of the MLC�s proposals, the Ministers did not want to back a seminar for scientists.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn466" name="_ftnref466" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[466]</span></a> They agreed that contacts with LEAs should be followed through with further written material and oral briefings if necessary.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn467" name="_ftnref467" title=""><sup>[467]</sup></a> �Mr Hogg concluded as follows:�</div>
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�(i)�� [MAFF�s] principal role was to put factual information into the public domain. We should take opportunities to repeat the press conference we had held in December. This could be done, for example, at the launch of the next six-monthly report, or when we published the answers to our questions to SEAC;</div>
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�(ii)� we should not be involved with the MLC campaign. However, we should be prepared to support a bid to Brussels for EU money;</div>
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�(iii) we should prepare an up-to-date pack of written briefing material. [Mr Eddy] should discuss this with the Information Division;</div>
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�(iv) we should identify nationally particular groups where briefing would bear fruit. This would include both written material and oral briefing. The team for the latter might be Mr Kimberlin, Mr Bradley, Mr Taylor and possibly, a CJD expert. [Mr Eddy] should submit to Mrs Browning a list of the groups we should target;</div>
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�(v)� at the local level, we should, at least initially, concentrate on the LEAs. We did not for the time being have the resources necessary to provide anything other than written material for other groupings.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn468" name="_ftnref468" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[468]</span></a></div>
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328<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 16 January 1996 there was a regional television programme from Harlech TV, alleging a cluster of CJD cases in Devizes. MAFF and DH were aware of the programme.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn469" name="_ftnref469" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[469]</span></a> Mr Robb had spoken to the CJD Surveillance Unit who said they were aware of one possible case in the area.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn470" name="_ftnref470" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[470]</span></a> He attached to a minute to Miss Thompson (ID) the line to take in response to media enquiries:</div>
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�The National CJD Surveillance Unit is aware of a possible case of CJD in the Devizes locality and is obtaining information about it. If the case should subsequently be confirmed, the occurrence of two cases in a locality would not be unusual or necessarily significant�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn471" name="_ftnref471" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[471]</span></a></div>
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329<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 17 January 1996 Mr Hogg replied to Mr Forsyth�s letter of 21 December. He noted:</div>
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�It seems that the media furore over BSE has now died down, in part at least as a result of our efforts to ensure that a clear and detailed explanation of the scientific information was available. The willingness to give interviews and the comments of the Chairman of SEAC, Professor Pattison, was I think particularly helpful. This seems to have bought a more balanced and considered approach from at least some in the media.</div>
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�I agree with you that we need to maintain a strong scientific base to all our BSE policies. This applies both to the advice we receive, where the newly appointed members of the SEAC will increase that Committee�s breadth of skills and knowledge, and in our research programme. Let me reassure that research on BSE remains one of MAFF�s highest priorities. This is shown by the fact that we are increasing our funding in this area by �1 million to �6.4 million next financial year.</div>
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�I also agree that the Neuropathogenesis Unit in Edinburgh is one of the leading laboratories in the UK working in the BSE field. It will, no doubt, be a strong contender to bid for more funds for research next financial year from the extra we will have available, although, of course, I cannot make any commitments at this stage as all project proposals will have to be evaluated in the normal way. I appreciate that the changes to the BBSRC�s funding arrangements for this Unit have caused some concern, although I am told that there will be no job losses among the scientific staff there. I also recognise that the shift in MRC funding practices might create difficulties in due course. I know that SEAC value highly the CJD strain typing which the NPU is doing, funded by the MRC, and hope to see this important work expanded. No doubt Ian Lang will be able to provide more information on the actions and plans of the two research councils over the NPU.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn472" name="_ftnref472" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[472]</span></a></div>
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330<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 18 January 1996 Mr Eddy minuted MAFF�s Deputy Chief Press Officer Mr Smith and his colleague Mr Wagstaff. He copied the minute to Mr Carden, Mr Meldrum, Mr Haddon, Mr K Taylor and Dr Render.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn473" name="_ftnref473" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[473]</span></a> He said</div>
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�It is clear from the meeting which we had with the Minister earlier this week that we need to produce a document aimed at the intelligent layman on BSE. One potential audience would be local authority education committee members who we need to persuade to drop bans on beef in schools. Very roughly I think we are talking about aiming at Telegraph rather than Times readers and at people who have an interest but not a scientific background or the inclination to wade through a large amount of technical detail.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn474" name="_ftnref474" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[474]</span></a></div>
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331<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>He said the information pack might include: �a new version of the document �BSE and the Protection of Public Health�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn475" name="_ftnref475" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[475]</span></a> which Mr Taylor had drafted, which again is probably a little long and upmarket for the more general reader.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn476" name="_ftnref476" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[476]</span></a></div>
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332<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Eddy asked for the Press Office�s views on</div>
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�(a) what might go in an information pack, (b) whether we should produce such a note. There seems to be a general view amongst senior management that we should (c) if so, how do we go about doing it and (d) in conjunction with the CVO and Mr Haddon�s Groups, what it should cover.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn477" name="_ftnref477" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[477]</span></a></div>
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333<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 18 January Dr Rubery sent her response to the MLC�s briefing paper of 3 January, saying that it was �in line with current Government advice� on the safety of beef. �However,� she said,</div>
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�you have misquoted the Chief Medical Officer. The statement you quote is taken from our press notice of 5 October 1995 (copy attached) and should have read �I continue to be satisfied that there is <u>currently</u> no scientific evidence of a link between meat eating and the development of CJD and that beef and other meats are safe to eat.� In our view, the reference should continue to be to current scientific evidence until the results of further research and surveillance become available and this may not be for some years. However, I need to also point out to you that CMO has revised his advice since 5 October 1995 and this is now set out in the MAFF press notice of 28 November 1995. Again I enclose a copy and you will see the relevant section reads: �There is currently no scientific evidence that BSE can be transmitted to humans or that eating beef causes CJD.��<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn478" name="_ftnref478" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[478]</span></a><b><o:p></o:p></b></div>
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334<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 19 January 1996, Dr Render minuted Mr Boswell�s private secretary with a �line to take on the allegation that BSE had arisen as a result of changes to regulations as a result of the Government�s deregulatory policies� He copied the minute to the private secretaries of Mr Hogg, Mr Baldry, Mrs Browning, Lord Lucas, Mr Packer, Mr Osborne, Mr Carden, Mr Haddon, Mr Meldrum, Mr K Taylor, Mr Eddy, Mr Haslam and Mr Haywood.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn479" name="_ftnref479" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[479]</span></a></div>
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335<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Render said that it was one of the many myths that BSE was due to regulatory changes. He suggested the following line for Ministers to take:</div>
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�The contamination of ruminant feed in the early 1980s which led to the BSE epidemic was not the result of any regulatory changes introduced by the Government. A number of changes to the rendering process were introduced for commercial reasons. It is thought that these allowed the infections agent to remain active in meat and bovine meal.�</div>
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�It was not possible at that time to foresee the impact of what appeared to be relatively minor technical changes to the rendering process.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn480" name="_ftnref480" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[480]</span></a></div>
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336<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Render noted that the changes in rendering included �a reduction in the time and temperature of rendering and also the elimination of an organic extraction step�, which had been removed for health and safety reasons.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn481" name="_ftnref481" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[481]</span></a></div>
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337<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 19 January 1996, in response to a request by Mrs Browning for a background note on BSE and CJD to circulate to MPs, Dr Render sent her a set of Questions and Answers plus a draft cover letter from Mrs Browning.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn482" name="_ftnref482" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[482]</span></a> He copied it to the private secretaries of Mr Hogg and Mr Packer and to Mr Osborne, Mr Carden, Mr Haddon, Mr Meldrum, Mr K Taylor, Mr Eddy, Mr Haslam, Miss Evans, Mr Skinner and Mr Comport (Department for Education and Employment). The Qs & As were based on the note that Dr Render had circulated for use in replying to letters from members of the public (see 17 December above).</div>
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338<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The note now quoted from Professor Pattison�s and Dr Will�s letter of 13 December: �If there was any risk to human health from BSE, and there may be none, then we have no doubt that that risk is very much less in December 1995 than it ever has been�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn483" name="_ftnref483" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[483]</span></a></div>
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339<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>As a result of Dr Calman�s 12 January letter, Dr Walford wrote to Professor Smith on 19 January 1995 to cancel the plans for an epidemiology meeting,<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn484" name="_ftnref484" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[484]</span></a> and on 22 January she wrote to Sir Kenneth Calman accepting that, in light of his request, the proposed meeting should be deferred until SEAC requested additional help over the design of epidemiological studies.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn485" name="_ftnref485" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[485]</span></a></div>
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340<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 22 January 1996, Sir Donald Acheson, who had visited DH in November, wrote to Professor Pattison (who was Dean of the University College Medical School at which Sir Donald now worked part time<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn486" name="_ftnref486" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[486]</span></a>).<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn487" name="_ftnref487" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[487]</span></a> The letter was copied to Sir Kenneth Calman. Sir Donald said he had now had a chance to study the recent reports of the CJD Surveillance Unit (August 1995), the ACDP (1994) and SEAC (1994). He had also re-read the Southwood Report. He said:</div>
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�The principal point I want to make is that subsequent events have shown that the assumption made in the summary of the Southwood report in 1989� that the BSE epidemic is due to the presence of the scrapie agent in meat and bone meal fed to cattle is now less secure than it was then.</div>
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341<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Sir Donald then quoted from the Southwood Report<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn488" name="_ftnref488" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[488]</span></a>:</div>
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�The epidemiological evidence suggests this new disease has appeared as a result of contamination of meat and bone meal derived from sheep offal and fed to British cattle from the early 1980s. <u>Contamination has arisen because modern rendering practices failed to destroy the agent of scrapie, the endemic Spongiform Encephalopathy of sheep.</u>�</div>
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342<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>He continued his letter:</div>
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�At that time the basis for the reassurance that we gave the public (�beef is safe�) rested on the analogy with scrapie. Thus, this condition, although it had been endemic in sheep since 1732 and sheeps� brain and offal had been freely available for human consumption; had not led to spongiform encephalopathies in man. Nor did the global distribution of scrapie bear any relation to the distribution of CJD.</div>
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�In the interim, however, it has become clear that the agent of BSE either did not originate from scrapie material in sheep or, if it did, changed in passage through cattle. Two lines of evidence point in this direction. In the first place, while there is no evidence of scrapie having transmitted to the domestic cat it became clear late in 1991 that BSE had transmitted by the alimentary route [ie. orally] to the domestic cat. Later, evidence emerged of transmission to various exotic cats in captivity. In other words the inter-species transmissibility pattern of BSE differs from scrapie�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn489" name="_ftnref489" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[489]</span></a></div>
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�The second line of evidence comes from experiments using the mouse model. These confirm that there are differences between the scrapie and BSE agents. Various experiments have shown that unlike scrapie BSE appears to act as a single strain, appears to be more heat resistant and produces a different and consistent pattern of disease and incubation period in mice.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn490" name="_ftnref490" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[490]</span></a></div>
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�While this does not necessarily mean that BSE is any less innocuous to man than scrapie it means that much of the reassurance which the scrapie analogy afforded and on which the original policy was based has unfortunately fallen away. Happily the potentially serious implication of the successful transmission by cerebral inoculation of BSE to primates (marmoset) in 1993 is offset by the fact that scrapie has also been transmitted to marmosets.</div>
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�In the circumstances, and bearing in mind that the small number of pathogenesis experiments using tissue from cattle provide at best a weak negative, it seems appropriate for DH and MAFF to review once more its policies in relation to BSE to see whether any further steps should be taken to protect the health of the public. The elimination of calf brain and other offal and of beef liver from food permitted for human consumption including baby food would seem to be matters for reconsideration, and there may be others�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn491" name="_ftnref491" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[491]</span></a></div>
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343<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 24 January 1996, at the 25<sup>th</sup> meeting of MAFF�s Consumer Panel, MAFF tabled a paper called �BSE: the Government�s Perspective�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn492" name="_ftnref492" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[492]</span></a> It presented a brief history and description of TSEs, and discussed BSE in relation to human and animal health. It stated that:</div>
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�There is clearly no question of determining by experiment whether or not BSE can transmit to humans. It has been transmitted experimentally by brain inoculation to marmosets, a type of primate, but the incubation period is longer than for sheep scrapie which suggests that it is less easily transmitted to marmosets than scrapie, which we already know does not affect man. BSE does transmit to certain strains of experimental mice and experiments are now underway with recently developed strains of mice which have human genes as well as, and in some cases, instead of their normal mouse genes for the proteins believe to be involved in this disease. The first results of these experiments will be published shortly.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn493" name="_ftnref493" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[493]</span></a></div>
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344<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The paper continued:</div>
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�More than two centuries� experience with scrapie in sheep indicated that there is no link whatsoever between CJD and eating sheep meat. Indeed CJD has been known to occur in lifelong vegetarians and occurs at the same rate in the UK as in countries like Australia which are free of scrapie and BSE. Equally there is no evidence of any link between beef eating and CJD. All cases of CJD in the UK are intensively studied by the CJD surveillance Unit which publishes an annual report each summer. The number of cases fluctuates from one year to another, but early data for 1995 shows that the number of cases will be lower than in 1994. It has been suggested that one reason for the lack of correlation between scrapie and CJD in humans has been that sheep brains are not regularly consumed, but this is not the case as can be readily established by anyone with any experience of culinary practices in France and the Middle East. There is no excess of cases of CJD in countries such as France where sheep�s brains and eyeballs are often consumed as part of the diet. At one time there was a suggestion that there was an excess of CJD cases in one Middle Eastern country, attributed to the consumption of sheep�s eyes, but further work by Israeli scientists has established that this was due to a pocket of genetic disease in an extended family of Sephardic Jews who had emigrated to Israel from Libya�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn494" name="_ftnref494" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[494]</span></a></div>
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345<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The paper described the two control measures that had been taken in response to BSE: the slaughter policy and the SBO ban.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn495" name="_ftnref495" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[495]</span></a> It referred to the recent cases of CJD in four farmers and two teenagers, and noted that SEAC had not changed its advice in the light of these cases.</div>
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346<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The paper also discussed breaches of the SBO ban, and said</div>
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�we published the results of unannounced audit visits to slaughterhouses, which are undoubtedly disappointing in that they show that a very small number of slaughterhouses have not fully removed the spinal cord in each and every case. Ministers have made it clear that this level of performance is not good enough and that they must be able to guarantee 100% removal of spinal cord in all cases. The policing of the controls has been tightened up considerably and the industry and the enforcement authorities are in no doubt about the standard expected of them�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn496" name="_ftnref496" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[496]</span></a></div>
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347<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>It went on to explain the ban on the use of vertebral column that SEAC had recommended.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn497" name="_ftnref497" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[497]</span></a> It continued:</div>
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�18. The Chief Medical Officer said in November last year that there is no scientific evidence that BSE can be transmitted to humans or that eating beef causes CJD. But he welcomes the new restrictions as a prudent precaution to eliminate any risk from this source, however small. He also welcomed the Minister of Agriculture�s emphasis on the need for vigorous enforcement and noted that this further extended the precautionary measures already in place to protect human health against any remote risk from BSE. The Chief Medical Officer went on to repeat his previous assurance that if any new evidence comes to light that BSE could transmit to humans he will bring this to the attention of the public.</div>
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�19. The Chairman and Deputy Chairman of SEAC, who are both leading medical doctors, have written an open letter to Ministers to make their views clear. A copy is attached�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn498" name="_ftnref498" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[498]</span></a></div>
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348<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>After discussing animal health measures, the paper concluded:</div>
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�This paper has been written to explain the control measures taken to protect animal and public health in the light of independent advice and a substantial ongoing research programme. Government has made it very clear that its overriding priority must be the protection of human health. Economic considerations are secondary. The control measures which have been taken are consistent with this stance.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn499" name="_ftnref499" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[499]</span></a></div>
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349<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr John Godfrey of the Consumer Panel wrote a response to the MAFF paper.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn500" name="_ftnref500" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[500]</span></a> His final paragraph stated:</div>
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�5.�� However, these cases demand most careful consideration. CJD is a disease of the old. If BSE proves to have been able to jump the barrier species to man it can be expected to present as CJD, or a CJD-like encephalopathy, May I suggest a few initial thoughts?</div>
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������ -These cases will probably prove to have been a cluster of no discernible significance. The history of epidemiology is largely, a history of clusters that demanded attention, but deserved eventual dismissal.</div>
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������ -The putative importance of these cases has to be judged on the strength of the evidence that they are the first ones here, and among very few worldwide. If numerous cases have died without being diagnosed there is not much to worry about. This is a matter of clinical judgement, that I lack. The authors of the papers quoted write: ��it seems unlikely that CJD, and particularly cases with typical clinical presentation and histology, would have been previously missed in teenagers.� It seems likely that this statement is intended to apply only to countries with an advanced health service. That all the cases have been reported from Europe and North America may well be due to failure to diagnose other cases that died unrecognised elsewhere.</div>
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������ -If the tiny cluster is due to people having been infected, further cases are likely, perhaps many of them. It seems best for government to plan now for this highly improbable possibility. This should include: (a) taking statistical advice on what will be taken as significant evidence, leading to action (did R. A. Fisher work on an efficient test for very small samples?); (b) what advice should be given to consumers. It should the aim to get advice across to us before the predictable reactions to what would be major tragedy, but also a major news story; (c) what action should be taken, in this hypothetical situation, to make the beef that could be eaten by consumers in the future safe again. This would obviously cost a lot, and be technically difficult, but possible.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn501" name="_ftnref501" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[501]</span></a></div>
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350<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 29 January 1996 Miss Jill Wordley (MAFF Consumers & Nutrition Policy Division) minuted Mr Eddy with her thoughts on �groups to be briefed about BSE�. She mentioned consumer organisations and the MAFF Consumer Panel, the disadvantages of relying �too heavily on the MLC�: �It seems to me that as far as the general consumer is concerned, the MLC are perceived as being in the �save the meat industry� camp. A better impression of impartiality might be given if MAFF organised as much as possible itself.� She also mentioned scientists, food and health writers, the internet and schools.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn502" name="_ftnref502" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[502]</span></a></div>
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351<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Eddy told the BSE Inquiry, �I don�t recall this exercise [ie. publicity] progressing further and believe that it was simply overtaken by the aftermath of the nvCJD announcement.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn503" name="_ftnref503" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[503]</span></a></div>
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352<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Baroness Cumberlege was �concerned about the possibility that she might be perceived to have a conflict of interest in dealing with BSE issues because of her husband�s involvement in dairy farming�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn504" name="_ftnref504" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[504]</span></a> On 31 January 1996, therefore, she handed over the BSE/ CJD part of her portfolio as Parliamentary Under-Secretary for Health to Mr Horam, her counterpart in the House of Commons.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn505" name="_ftnref505" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[505]</span></a></div>
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February 1996</div>
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SEAC Meeting 24</div>
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353<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 1 February 1996 SEAC held its 24<sup>th</sup> meeting. Present were Professor Pattison, Dr Will, Professors Allen, Almond, Collinge, and Smith, Messrs Bradley and Pepper, and Dr Kimberlin. Messrs Eddy and Skinner provided the Secretariat, observing the meeting were Drs Matthews and Wight, and �in attendance� were Mrs M Wilson (BBSRC) and Mrs Townsend (MAFF). Apologies were received from Dr Heuston, Dr Painter, Dr Watson and Dr Havercroft.</div>
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354<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Will updated SEAC on the suspect CJD case in a 52-year-old who had worked in an abattoir for 18 months from 1989, and who was reported to have sustained an injury while working there. He had in fact been kicked by a steer and had received no hospital treatment�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn506" name="_ftnref506" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[506]</span></a> Dr Will �had been advised of one possible case of CJD in a German who had worked in a abattoir for 10 years, 30 years prior to death, and of one confirmed case in France in 1995 in a man aged 59 who had worked for 36 years in an abattoir�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn507" name="_ftnref507" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[507]</span></a></div>
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355<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Will reported that</div>
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�the 1995 incidence of CJD appears to be about 20% down on the 1994 level and updated SEAC on the now 5 pathologically confirmed individuals under 30 years of age. Three of these patients have died and 2 remain alive. Genotyping is incomplete� Two cases of CJD have been confirmed by pathology in 30-39 year olds and a further patient in this age group has pathology suggestive of GSS [<span lang="EN-AU">Gerstmann-Str�ussler-Scheinker syndrome, a r</span>are familial form of CJD]. Dr Will also reported a further confirmed case of CJD in a 41 year old.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn508" name="_ftnref508" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[508]</span></a></div>
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�2.1. In all of the cases mentioned above (except the GSS case and one where results are incomplete) there was extensive plaque formation in the cerebral cortex, cerebellum and spinal cord. An extensive and unusual pattern of PrP deposition was an unexpected finding. Dr Will reported Dr Ironside�s view that it is premature to decide that these cases are linked with BSE. Cerebellar and spinal cord plaques are evident in hGH cases. Recent findings suggested that there are 2 subsets of sporadic CJD: those with an extended duration of illness with plaques in the spinal cord and cerebellum and those with a short duration of illness which do not show these plaques. Dr Will said there were no apparent environmental factors identified, except that 5 of the 9 spinal cord positive cases had had abdominal surgery, in three cases in the 1950s/60s. None of the spinal cord negative cases had had abdominal surgery.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn509" name="_ftnref509" title=""><sup>[509]</sup></a></div>
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356<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Will said that</div>
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�the crucial issue is not simply the young age or pathology of recent cases but the short time scale in which 5 cases in individuals under 30 years of age had occurred� dates of onset of symptoms were February 94, May 94, June 94, January 95 and April 95��<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn510" name="_ftnref510" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[510]</span></a></div>
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357<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Professor Pattison �concluded that the unusual data on young cases is of greater concern than the cases in farmers which appeared to be classical sporadic cases with typical pathology.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn511" name="_ftnref511" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[511]</span></a> Professor Collinge was of the opinion that �5 cases in people under 30 years old in little over a year must be very significant in statistical terms�. Professor Smith agreed.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn512" name="_ftnref512" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[512]</span></a></div>
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358<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Professor Collinge told the BSE Inquiry that it seemed to him that �these young cases showed a unique and remarkably uniform disease pattern. This would be consistent with their being exposed to the same prion strain. I again reiterated my concerns that this was likely to represent BSE transmission to humans�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn513" name="_ftnref513" title=""><sup>[513]</sup></a></div>
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359<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Will informed SEAC that he intended to publish the genetic and clinico/pathological data of the young cases soon. He agreed to show SEAC a proof copy of the paper, but it was to remain confidential and would not be for amendment by SEAC.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn514" name="_ftnref514" title=""><sup>[514]</sup></a></div>
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360<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>SEAC decided to invite Dr Ironside to make a presentation at their next meeting.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn515" name="_ftnref515" title=""><sup>[515]</sup></a></div>
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361<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hogg�s questions to SEAC<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn516" name="_ftnref516" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[516]</span></a> were discussed. Professor Pattison confirmed with Mr Eddy that Mr Hogg wanted �the Committee�s views, in a publishable form to issue as a press release�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn517" name="_ftnref517" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[517]</span></a> SEAC went through five of the questions, but time ran out and the last four questions were postponed to the next meeting.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn518" name="_ftnref518" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[518]</span></a></div>
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362<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The same day (1 February), Anna Pearson died of what was later diagnosed as nvCJD.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn519" name="_ftnref519" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[519]</span></a></div>
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363<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 2 February 1996 Dr Wight minuted Sir Kenneth Calman�s private secretary about points raised at the 1 February SEAC meeting.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn520" name="_ftnref520" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[520]</span></a> She copied the minute to Mr Horam�s assistant private secretary, Dr Metters, Dr Rubery, Mr Skinner, Mr Sutherwood and Mr Jobson. Under the heading �CJD Update� she advised:</div>
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�(i)�� There are now 5 confirmed cases in the UK in patients under 30 years of age, all presenting in the last two years. It is likely that these will be sporadic rather than familial cases. This is clearly unusual compared with earlier data on age distribution of disease.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn521" name="_ftnref521" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[521]</span></a></div>
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364<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>After describing the features of the disease in these cases, she continued:</div>
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�The detailed findings will be submitted for publication later in the year, and although it is premature for any conclusions to be drawn, clearly the media could make much of this in terms of BSE being responsible for a �new� type of disease pattern.</div>
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�(ii)� A paper is currently in preparation by the CJD Surveillance Unit which describes variations in the degree and site of plaque formation in a subset of cases of sporadic CJD. Again, this could be interpreted by some as signalling an aetiological link with BSE.</div>
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�Further, there are some loose similarities between the appearances in this subset and in the young onset cases, and that found in hGH recipients, where there is a peripheral route of exposure as would be the case if there was any link with sporadic disease to BSE. This could add to the possibility of misleading deductions being made when these various findings are published.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn522" name="_ftnref522" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[522]</span></a></div>
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365<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Wight went on to summarise SEAC�s discussions on research priorities.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn523" name="_ftnref523" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[523]</span></a></div>
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366<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 6 February Mr Sutherwood responded to Dr Wight�s minute of 1 February. He said:</div>
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�Sounds as if we had better get together to discuss the handling of the publication of the latest data on the five UK cases under 30 years of age and relevant international comparative findings sooner rather than later!</div>
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�Pat Wilson is visiting the Surveillance Unit on 14/15 February to discuss media relations and, in particular, the merits of having someone with a full or part-time liaison role on the media front in Edinburgh�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn524" name="_ftnref524" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[524]</span></a></div>
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367<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 6 February 1996, Mr Eddy circulated the information from SEAC�s 1 February meeting to the private secretaries to Mr Hogg, Mrs Browning, and Mr Packer, and to Mr Osborne, Mr Carden, Mr Meldrum, Mr Haddon, Mr Hollis, Mr K Taylor, Mr Smith, Mr Cowan, Dr Cawthorne, and Dr Render. He said that the meeting focussed mainly on research priorities and on answers to Mr Hogg�s list of questions. However, SEAC had not reached a final conclusion on the questions, and they would continue to answer them at their next meeting on 8 March.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn525" name="_ftnref525" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[525]</span></a></div>
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368<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Eddy said that Dr Will was preparing two papers for publication, the first of which</div>
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�3.�� �describes the fact that using modern biological techniques, they have identified two distinct subsets of Creutzfeldt-Jakob Disease. In one form the disease appears restricted to specific parts of the brain. In the other form disease is more widespread and is found in the spinal column, and shows similarities to CJD in recipients of growth hormones. The conclusion which some of our critics will draw, although there is no evidence, is that the form of CJD with the widespread spongiform appearance represents the kind of disease which can be �caught� and that those who have this form of disease and have not had any form of medical intervention may have caught it from cattle. Dr Will�s paper will not say that but others will try to interpret it in that way.</div>
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�4.�� The second paper which has not yet been drafted, looks at the five cases of CJD which have now been confirmed in patients aged under 30. All five cases look the same under the microscope, with extensive plaques in both the cortex and cerebellar parts of the brain and in the spinal cord, which is an unexpected finding, and may relate to age of onset. Again, the analogy will be drawn by our critics between these cases and those described in the first paper with more extensive spongy appearance in the spinal cord and the suggestion is likely to be made that the five young cases again represent a new form of the disease which, by extension, can be �caught� and was no doubt caught from cattle. These are major leaps of logic but cannot be ruled out on the basis of the available evidence. It is far too premature to draw any conclusions and much work needs to be done on previous cases in the UK and on cases from abroad��<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn526" name="_ftnref526" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[526]</span></a></div>
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369<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Eddy said that SEAC would give Agriculture and Health Ministers a formal opinion on the implications of the second paper, probably in the Spring.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn527" name="_ftnref527" title=""><sup>[527]</sup></a></div>
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370<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hogg told the BSE Inquiry that he believed that at this time he was already aware of two cases of CJD in young people.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn528" name="_ftnref528" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[528]</span></a> He does not recall discussing SEAC�s concern with DH.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn529" name="_ftnref529" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[529]</span></a></div>
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371<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mrs Browning told the BSE Inquiry that she and Mr Hogg �were concerned [at Mr Eddy�s minute] but clearly there was more scientific work needed to give specific advice to Ministers�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn530" name="_ftnref530" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[530]</span></a></div>
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372<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Carden said that for more than a month after Mr Eddy�s minute of 6 February 1996, the tentative indications from SEAC's meeting on 1 February were all that officials had to go on.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn531" name="_ftnref531" title=""><sup>[531]</sup></a> Mr Eddy did not update the 6 February information until his minute on 12 March 1996 (see below).</div>
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373<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Carden said that those who received Mr Eddy's 6 February minute</div>
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�were aware that we could be on the edge of a very far-reaching change in the picture we had of BSE. My recollection is that from then on until SEAC reached a concluded view on 20 March 1996, we felt in a state of high alert. We - I am referring to myself and the circle of people within Government to whom the news at that stage was deliberately confined - paid extremely close attention to each new indication from the leading experts. But for more than a month the tentative indications from SEAC's 1 February meeting were all we had to go on. The hints of bad news remained tentative, and we lived in suspense�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn532" name="_ftnref532" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[532]</span></a></div>
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374<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Carden said that from about 6 February 1996 MAFF officials were �thinking closely about the worst case� with Ministers.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn533" name="_ftnref533" title=""><sup>[533]</sup></a> This thinking did not take a concrete form because �there was not much basis for thinking, usefully, about things that would have to be done if the worst case conclusion was reached.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn534" name="_ftnref534" title=""><sup>[534]</sup></a></div>
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375<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 8 February 1996, Peter Hall died of what was later diagnosed as nvCJD.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn535" name="_ftnref535" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[535]</span></a></div>
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376<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 12 February 1996 Mr Skinner forwarded to Dr Will, Professor Pattison and Professor Collinge the briefing paper that the MLC had sent to Dr Rubery on 3 January. In his cover letter, Mr Skinner summarised Dr Rubery�s response of 18 January to the MLC, in which she said that their paper was in line with current Government advice on the safety of beef and that the quote from Sir Kenneth Calman should have read �there is currently no scientific evidence that BSE can be transmitted to humans or that eating beef causes CJD�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn536" name="_ftnref536" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[536]</span></a> Dr Will replied on 23 February 1996; see below.</div>
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377<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 14 February 1996 Mr Baldry met the Mauritian Minister of Agriculture. He received a briefing at the meeting dated 12 February from Mr D V Orchard of MAFF�s International Relations & Export Promotion (IREP) Division, copied to Mr Packer�s private secretary, to Mr Hadley, Mr Hepburn, Ms F Proctor (ODA), Miss A Blackburn (STOP), Dr Render, Mr Roberts (IREP) and Mr Griffin (IREP).<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn537" name="_ftnref537" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[537]</span></a> The �line to take� included the statement that �British beef is safe to eat. There is no scientific evidence which suggests that British beef is a risk to human or animal health�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn538" name="_ftnref538" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[538]</span></a></div>
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378<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In a 14 February submission from Mrs Jane Brown (head of Meat Hygiene Division, MAFF), Mrs Browning was invited to sign the proposed Fresh Meat (Inspections for the Treatment of Specified Bovine Offals)(Charges) Regulations 1996, requiring the meat industry to pay for enforcement of the SBO controls. Mrs Brown noted that these proposals were opposed by the industry.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn539" name="_ftnref539" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[539]</span></a></div>
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379<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Peter Hall�s death was reported in the newspapers on 15 and 16 February.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn540" name="_ftnref540" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[540]</span></a></div>
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380<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 15 February 1996 Dr Wight minuted Mr Clark (ID) about another young case of CJD. She copied the minute to Dr Metters, Mr Skinner, Mr Robb and Mr Jobson. She said that</div>
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�1.�� A 30 year old man has been confirmed as having died from CJD in Belfast. Apparently the parents are very upset and, according to MAFF sources, are driving a publicity campaign. There is to be an inquest imminently, at which the coroner may be sympathetic to the parents� concerns and take the opportunity of raising various issues (re: BSE?) publicly.</div>
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�2.�� There are no factors of note in the man�s history (though he spent two days observing abattoir practices 9 years ago as part of his training as a food engineer).</div>
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�3.�� SEAC will be considering fully the recent cluster of young onset cases at their next meeting (this man is not one of the five under 29-year-olds referred to in my minute of 6 February). I hope that we will then be in a position to draw on SEAC�s advice with respect to the significance of cases in this age group and any public health implications.</div>
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�4. � In the meantime there is not much we can say, other than that the case is being fully investigated, and offering sympathy to the family�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn541" name="_ftnref541" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[541]</span></a><b><o:p></o:p></b></div>
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381<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In a minute dated 16 February 1996, Mr Skinner informed Mr Horam�s private secretary of the death of Peter Hall, and of the involvement in his case of the CJD Surveillance Unit and Dr Harash Narang (a scientist formerly of the Public Health Laboratory Service (PHLS)). The minute said that diagnosis �may take up to 10 weeks� because of the time needed to fix the brain tissue. The minute was copied to the private secretaries of Mr Dorrell and Sir Kenneth Calman, Dr Metters, Dr Rubery, Dr Skinner, Dr Wight, Mr Wilson (ID) and Mr Eddy (MAFF).<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn542" name="_ftnref542" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[542]</span></a></div>
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382<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The same day, Mr Eddy minuted Mrs Browning�s private secretary with some background about the case. He copied the minute to the private secretaries of Mr Hogg and Mr Packer, and to Mr Osborne, Mr Carden, Mr Haddon, Mr Meldrum, Mr Taylor, Mr Smith (Press Office), Dr Cawthorne, Dr Matthews, Dr Render and Dr Wight.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn543" name="_ftnref543" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[543]</span></a></div>
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383<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 17 February 1996, Alison Williams died of what was later diagnosed as nvCJD.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn544" name="_ftnref544" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[544]</span></a></div>
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<span style="letter-spacing: -0.15pt;">384<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span style="letter-spacing: -0.15pt;">On 20 February 1996 the Parliamentary Food and Health Forum held a meeting at the House of Commons.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn545" name="_ftnref545" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[545]</span></a> The topic of discussion was �BSE and CJD � The Current Situation�. Speakers were Dr Will and Dr Dealler. Mr K Taylor from MAFF was present.<b> </b>Dr Will<o:p></o:p></span></div>
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�opened by saying that the theoretical risk of BSE to the human population was judged to be remote by the Southwood committee in 1989� current evidence did not suggest any definite change in the pattern of CJD that could be attributable to BSE, but it would be many years before such a change could be finally excluded�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn546" name="_ftnref546" title=""><span class="MsoFootnoteReference" style="vertical-align: super;"><span style="letter-spacing: -0.15pt;">[546]</span></span></a></div>
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<span style="letter-spacing: -0.15pt;">385<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span style="letter-spacing: -0.15pt;">In discussion of CJD Surveillance, Dr Will said that<o:p></o:p></span></div>
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�5.�� �there was no overall change in the age-specific incidence of CJD in the UK, and that the incidence of CJD amongst farmers showed no mechanism for the transference of BSE�</div>
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�6.�� �while current information was reassuring, any risk to man from BSE might not be evident for some years, although there was currently no proof of a link between CJD and BSE�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn547" name="_ftnref547" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[547]</span></a></div>
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<span style="letter-spacing: -0.15pt;">386<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span style="letter-spacing: -0.15pt;">Dr Dealler spoke next, about BSE and the risk to humans. He said that there was a 70% chance of BSE being transmitted to humans.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn548" name="_ftnref548" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[548]</span></a> When asked about this, Dr Will said that �the 70% was important, and that there was confusion between methods of transmission � transmission between species required a large dose of infectivity�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn549" name="_ftnref549" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[549]</span></a><o:p></o:p></span></div>
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387<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 20 February 1996, Mrs Browning met Mr Hogg to discuss Mrs Brown�s submission of 14 February. They expressed their concern that the Regulations (to charge the industry for enforcement of SBO controls) might cause difficulty when laid before Parliament, because of �widespread opposition� to them.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn550" name="_ftnref550" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[550]</span></a> They decided to examine the consequences of not proceeding with the Order.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn551" name="_ftnref551" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[551]</span></a></div>
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<span style="letter-spacing: -0.15pt;">388<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span style="letter-spacing: -0.15pt;">On 22 February 1996 Mr Colin Smith, MLC Press and Industry Relations Manager sent a �BSE News Update� to �All Industry Organisations�, to �bring� you up-to-date with recent MLC activity to defend the industry against damaging BSE publicity�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn552" name="_ftnref552" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[552]</span></a> In his covering letter, he said that he had attended the meeting on 20 February, where Dr Will<o:p></o:p></span></div>
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�gave a reassurance that beef is safe to eat. He confirmed that CJD cases were lower in 1995 than 1994, that there is no evidence that CJD is linked to occupation or diet and that the two confirmed cases of CJD in young people in the UK are not unique. There are, in fact, eight other known cases in teenagers around the world, including three in Poland��<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn553" name="_ftnref553" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[553]</span></a></div>
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<span style="letter-spacing: -0.15pt;">389<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span style="letter-spacing: -0.15pt;">On 23 February 1996 Dr Will replied to Mr Skinner�s letter of 12 February about the MLC�s briefing paper. He said:<o:p></o:p></span></div>
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�My view is that there is a remote theoretical risk that BSE in cattle might cause disease in humans. The risk from beef and beef products is likely to be negligible provided statutory measures are fully enforced. I would also agree with the statement that there is currently no scientific evidence that BSE can be transmitted to humans or that eating beef causes CJD.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn554" name="_ftnref554" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[554]</span></a></div>
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390<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 23 February 1996, Mr Hogg�s private secretary informed the Cabinet sub-committee ECD(P) about the regulations discussed on 20 February, and MAFF�s public line that �it is quite proper for the industry to pay for the enforcement of these controls, which are essential for the maintenance of public confidence in British beef�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn555" name="_ftnref555" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[555]</span></a></div>
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391<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Packer told the BSE Inquiry that �the possibility of charging was overtaken by the events following 20 March 1996�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn556" name="_ftnref556" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[556]</span></a></div>
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392<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span><span style="letter-spacing: -0.15pt;">On 23 February Dr Render circulated a revised version of his Q&A note for use in answering correspondence. He sent it to </span>MAFF Regional Directors and to the State Veterinary Service (SVS) throughout the country �to allow them to use as they saw fit in response to public enquiries on BSE they might face�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn557" name="_ftnref557" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[557]</span></a> The note was similar to the one described at 19 January above.</div>
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<span style="letter-spacing: -0.15pt;">393<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span style="letter-spacing: -0.15pt;">On 27 February 1996 Mr Robb faxed Dr Will about the CMO�s report for 1995.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn558" name="_ftnref558" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[558]</span></a> He asked him for any further comments on the contribution to the report on the National CJD Surveillance Unit. This was followed up by Mr Skinner on 29 February, when he visited the Unit. Mr Skinner told Mr Robb that Dr Will was content with the contribution �provided report covers up to 31/12/95 only�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn559" name="_ftnref559" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[559]</span></a> The contribution said:<o:p></o:p></span></div>
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�In 1995, there were 34 deaths from CJD (29 sporadic cases and 4 iatrogenic cases � see Table [ ]). The number of sporadic cases represents a significant decrease on the 1994 figure of 59 cases although this remains provisional until the 1995 data is finalised. The make up of cases recorded included the fourth farmer and the first teenager to have died from CJD in the UK. A second case of CJD in a teenager was confirmed in 1995, but the patient remains alive. These cases are unusual but not outside the bounds of probability�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn560" name="_ftnref560" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[560]</span></a></div>
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<span style="letter-spacing: -0.15pt;">394<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span style="letter-spacing: -0.15pt;">Dr Will followed this up with a fax to Mr Robb on 4 March 1996 (see below).<o:p></o:p></span></div>
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<span style="letter-spacing: -0.15pt;">395<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span>In February 1996 MAFF reissued two booklets that had been revised, called �BSE and the Protection of Human Health�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn561" name="_ftnref561" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[561]</span></a> and �BSE and the Protection of Animal Health�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn562" name="_ftnref562" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[562]</span></a> <span style="letter-spacing: -0.15pt;">Mr Kevin Taylor had originally drafted these booklets in August and October 1994, respectively.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn563" name="_ftnref563" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[563]</span></a> According to Mr Taylor, �the original impetus for writing these was my perception that some practising veterinary surgeons had little understanding of the measures which were being taken or the rationale for those measures�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn564" name="_ftnref564" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[564]</span></a> The Animal Health booklet had been revised in April 1995<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn565" name="_ftnref565" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[565]</span></a> and both had been appendices to the May 1995 Progress Report to Office International de Epizooties (OIE).<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn566" name="_ftnref566" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[566]</span></a> They had now both been revised again, at the request of Dr Render.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn567" name="_ftnref567" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[567]</span></a><o:p></o:p></span></div>
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396<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span><span style="letter-spacing: -0.15pt;">Mr Taylor told the BSE Inquiry that the booklets were �withdrawn from general use after the events which followed the announcement about nvCJD in March 1996�. See 13 March below.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn568" name="_ftnref568" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[568]</span></a></span></div>
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397<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 29 February 1996, Dr Wight minuted Dr Metters, copied to Mr Horam�s assistant private secretary, Sir Kenneth Calman�s private secretary, Dr Rubery, Dr Skinner and Mr Skinner. She said:</div>
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�1.�� Dr Rubery, Mr Skinner, and I met MAFF officials yesterday and one item we discussed was how to address public concerns about BSE.</div>
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�2.�� MAFF have produced a detailed �information note� for consumers, industry, food writers etc., which the Department has had an opportunity to comment on and which takes account of comments made by the MAFF Consumer Panel.</div>
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�3.�� The attached leaflet is a distillation of the main points for easy consumption, and intended for wide distribution. We considered there was some merit in the leaflet being issued jointly by both Departments��<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn569" name="_ftnref569" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[569]</span></a></div>
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398<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The attached draft leaflet was entitled �British Beef and BSE: The Facts�. On its front page it stated:</div>
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�Two facts should be made absolutely clear at the outset:</div>
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�Fact 1�������� There is currently no scientific evidence to indicate a link between BSE and CJD.</div>
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�Fact 2�������� The independent expert committee set up to advise the Government on all aspects of BSE is satisfied that British beef is safe to eat.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn570" name="_ftnref570" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[570]</span></a></div>
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399<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The draft leaflet went on to list a series of questions and answers about BSE.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn571" name="_ftnref571" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[571]</span></a></div>
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400<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Carden told the BSE Inquiry that the work on publicity material was concluded in the early part of 1996 and went to Ministers �on the precise day when the first report suggesting there was new variant CJD came through and it was overtaken�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn572" name="_ftnref572" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[572]</span></a></div>
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Early March 1996</div>
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401<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 1 March 1996, Dr Metters minuted Dr Wight expressing his concerns about MAFF�s proposed publicity information on BSE.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn573" name="_ftnref573" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[573]</span></a> He copied the minute to Mr Horam�s assistant private secretary, Sir Kenneth Calman�s private secretary, Dr Rubery, Dr Skinner and Mr Skinner. He was �not in favour of DH being co-authors of the documents�. He said</div>
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��some statements are too definite and in time may be seen to be wrong. We should not follow MAFF�s hyperbole of reassurance. We must leave DH Ministers and CMO in particular, an escape route if any of these categorical statements turns out to be <b>WRONG</b>.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn574" name="_ftnref574" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[574]</span></a></div>
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402<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>At the end of November 1995, MAFF had announced its decision to ban the use of vertebrae in the manufacture of MRM (see above). Around 1 March 1996 a food company<b> </b>obtained leave to seek a judicial review of this decision.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn575" name="_ftnref575" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[575]</span></a> The MAFF Press Office was getting enquiries. Mr Eddy informed them of the line to take (that he had agreed with MAFF�s Legal Department) and copied it to MAFF Ministers and officials and territorial officials:</div>
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��The decision to introduce this legislation was based on independent advice from [SEAC]. It is intended to protect consumers against any possible risk which might arise a as result of the use of bovine vertebrae in the production of MRM if small pieces of spinal cord were not fully removed from those vertebrae. The Ministry is confident that the action it has taken is fully proportionate reasonable and legal both in terms of UK and EC law.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn576" name="_ftnref576" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[576]</span></a></div>
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403<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 4 March 1996 Dr Will faxed Mr Robb with a table for inclusion in the CMO�s 1995 report. The table showed the incidence of sporadic, iatrogenic and familial CJD, and GSS, for each year from 1985 to 1995. In his covering letter Dr Will said �I take it that the CMOs report [sic] addresses data in 1995 because there have been developments in 1996 which may alter the conclusions particularly in relation to young cases�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn577" name="_ftnref577" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[577]</span></a></div>
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Friday 8 March 1996</div>
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SEAC Meeting 25</div>
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404<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 8 March 1996 SEAC met. Present were Professor Pattison, Dr Will, Professor Almond, Mr Bradley, Professor Collinge, Dr Hueston, Dr Kimberlin, Dr Painter, Mr Pepper and Professor Smith. Dr Matthews (MAFF) and Dr Wight (DH) were observers. Messrs Eddy and Skinner were there (MAFF and DH Secretariat). Also attending were Dr P Dukes (MRC), Dr P Grimley (MAFF), Dr Ironside (CJDSU), Mr Jobson (DH), Mr Robb (DH), Dr Rubery (DH), and Mrs Wilson (BBSRC). Apologies were received from three members: Professor Allen, Dr Fred Brown and Dr Watson.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn578" name="_ftnref578" title=""><sup>[578]</sup></a></div>
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405<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The meeting was largely taken up with a presentation by Drs Will and Ironside about the �new variant� CJD cases.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn579" name="_ftnref579" title=""><sup>[579]</sup></a> Dr Will</div>
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�drew the Committee�s attention to the 12 confirmed or possible cases of CJD in people under the age of 40. 9 of these cases had been confirmed� All these cases had onset dates since 1994 except one which had an onset date of 1991. Apart from one case in the 1960s, there had been no confirmed cases of sporadic CJD in people under 30 before 1995. Over the last six months, there had been five such cases. The duration of illness in these cases in young patients had been more prolonged than in previous sporadic cases. The EEGs in all except one case were unusual. There was genetic evidence in 7 cases of which all except one [were] negative for genetic mutation��<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn580" name="_ftnref580" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[580]</span></a></div>
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406<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Ironside distributed his paper on the neuropathology of eight<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn581" name="_ftnref581" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[581]</span></a> of the cases. The paper said</div>
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�A subset of adults with CJD has been identified with the following features:</div>
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<span style="font-family: Symbol;">�<span style="font-family: "Times New Roman"; font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span>�Young age at onset</div>
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<span style="font-family: Symbol;">�<span style="font-family: "Times New Roman"; font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span>�Tendency to a long duration of illness</div>
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<span style="font-family: Symbol;">�<span style="font-family: "Times New Roman"; font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span>�No PrP gene mutations (Most are MM at codon 129)</div>
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<span style="font-family: Symbol;">�<span style="font-family: "Times New Roman"; font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span>�Characteristic neuropathology with �florid� plaques throughout the brain � not previously identified by the CJD Surveillance neuropathology project</div>
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<span style="font-family: Symbol;">�<span style="font-family: "Times New Roman"; font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span>�Extensive PrP deposition with multiple plaque morphologies combined with pericellular and diffuse deposition � not previously identified in the CJD Surveillance neuropathology project�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn582" name="_ftnref582" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[582]</span></a></div>
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407<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The paper raised the question whether these cases constituted �a new or hitherto unrecognised variant of CJD�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn583" name="_ftnref583" title=""><sup>[583]</sup></a></div>
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408<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Ironside told the BSE Inquiry that the evidence he presented to SEAC emphasised that although florid plaques are characteristic of �nvCJD�, they are not the only unique pathological features. Other features, particularly pericellular PrP deposition, were also said to be characteristic and unique to �new variant� CJD.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn584" name="_ftnref584" title=""><sup>[584]</sup></a></div>
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409<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Will told the meeting that the Surveillance Unit had found that</div>
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�there appeared to be two distinct subsets of sporadic CJD cases. The first with extended duration of illness with plaques in the brain and spinal cord, and the second with a short duration of illness which did not show these features. The presence of plaques in the spinal cord might be related to the extended duration of illness which allowed time for centrifugal spread of PrP down the spinal cord.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn585" name="_ftnref585" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[585]</span></a></div>
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410<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Will reported that the Surveillance Unit had compared the young cases with the 17 cases that had been found worldwide since 1965 in patients under 30 years old. �The clinical features and the duration of illness were variable� There were no plaques recorded except in the case of a 27 year old� which could have been GSS�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn586" name="_ftnref586" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[586]</span></a></div>
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411<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Drs Will and Ironside concluded that the young cases in the UK �could be� a new form of CJD. They preferred the results to remain confidential until they were published (in a peer-reviewed journal), but they �would be prepared for them to be made public now should the Committee and Government consider that necessary�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn587" name="_ftnref587" title=""><sup>[587]</sup></a></div>
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412<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Ironside left the meeting after lunch and was not party to SEAC�s further discussions.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn588" name="_ftnref588" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[588]</span></a></div>
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413<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>After discussion, SEAC expressed the following views:</div>
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(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Professor Collinge said that �the findings suggested that there was a new risk factor for CJD which may be BSE, and that the existing public health precautions should be reviewed�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn589" name="_ftnref589" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[589]</span></a></div>
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(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>�Several members queried whether these cases could have been identified because of increased ascertainment [ie. increased referrals because of increased awareness] and whether this new form of CJD could have been present, but unidentified, in the population for some time�. Dr Will did not believe so �because there had been growing awareness of CJD among neurologists over a number of years and in some of these cases identification had not been straightforward and mainly by neuropathology�. Dr Ironside noted that the pathology here was different to the young cases abroad.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn590" name="_ftnref590" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[590]</span></a></div>
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(iii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Kimberlin suggested the need for a �quantitative risk assessment based on information from the meat industry about the extent to which [SBO] had entered the human food chain since the advent of BSE and possible risk exposures of these young CJD cases�. It was said that �one new control measure might be to prohibit tissues from older cattle, which were known to have higher titres of BSE in the central nervous system, from entering the food chain�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn591" name="_ftnref591" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[591]</span></a></div>
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(iv.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Several members said that �young cases of CJD should be investigated further to identify any other potential risk factors such as pharmaceuticals, for example, and indicated concern about sheep which had been fed the same infective feed as cattle� The Secretariat should commission a paper on the use of meat, offal and other tissues from sheep and lambs in the human food chain��<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn592" name="_ftnref592" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[592]</span></a></div>
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(v.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>High priority should be given to strain typing.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn593" name="_ftnref593" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[593]</span></a></div>
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414<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>At the end of the discussion, Professor Pattison confirmed that SEAC would keep the information confidential pending publication. He would inform the CMO and the CVO of the findings. �It would be for Ministers to decide whether or not they should be put into the public domain now.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn594" name="_ftnref594" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[594]</span></a> He told the BSE Inquiry that he did not inform Dr Metters and Mr Meldrum personally, but that the secretariats from DH and MAFF informed their respective chief officers of the findings, and that SEAC would have asked for a review by other neuropathologists. �I think the CVO and CMO were willing to wait until Dr Will and Dr Ironside had finished those consultations and reported back to us before taking it any further.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn595" name="_ftnref595" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[595]</span></a></div>
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415<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>SEAC were due to meet again on Monday 11 March for a visit to an abattoir.</div>
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416<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 8 March 1996 Mr Skinner minuted the private secretaries of Mr Horam and Sir Kenneth Calman. He copied the minute to the private secretaries of Mr Dorrell and Sir Graham Hart, and to Dr Rubery, Dr Wight, Mr Eddy and Mr Wilson. The minute advised recipients about the presentation to SEAC by Drs Will and Ironside. It said</div>
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�In the opinion of the Unit all this indicates that these cases have been subject to some new factor which has precipitated the disease. If incubation periods similar to other spongiform encephalopathies have occurred the exposure would have taken place some 8 � 10 years ago. It is of course not possible to link this positively to exposure to BSE in the 1980s but, after SEAC had considered the data, it considered that this is a likely explanation, although other possibilities have to be considered.� <a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn596" name="_ftnref596" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[596]</span></a></div>
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417<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Meldrum told the BSE Inquiry that he was made aware of the new findings �a few days� before the 8 March SEAC meeting.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn597" name="_ftnref597" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[597]</span></a></div>
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418<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hogg found out about the results of the SEAC meeting from Mr Packer:</div>
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�there was one meeting between me and Mr Packer, Richard Packer, which is not referred to in this statement, which is about this time. I suspect it was after 8th March, but I am not sure about that. One night -- I mean to say between 6.00 and 7.00, but that is broadly speaking right -- Richard came into my office, I said that he often came in. This was late in the evening; Frank Strang may have been there, he was my Private Secretary, but he came in and said something like -- the language is not right, but this is the substance of it: "There is a very dark cloud on the horizon, which is that SEAC think, or are coming to the view, that BSE is transmissible". I said, "This is a very serious state of affairs". He said something like, "They have not come to that view yet, but they may come to that view". I said something like this, "You had better keep very close to Pattison so we can see how this thing is developing". I remember saying to him, "But what you must not do is in any way try and shape their deliberations or conclusions, but what you must do is to keep as close as possible, so we understand what is happening and you must keep me fully posted".</div>
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�That is not a meeting which is recorded. It was an entirely informal meeting, he just came into the office, and I suspected -- I have tried to date it in my own mind, it was probably about ten days before the announcement, and my bet is it was after the meeting of SEAC on 8th March, but I cannot be more precise.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn598" name="_ftnref598" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[598]</span></a></div>
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�</div>
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�My suspicion is that I did not at that moment talk to Angela [Browning] or my Ministerial colleagues.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn599" name="_ftnref599" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[599]</span></a></div>
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Monday 11 March 1996</div>
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DH</div>
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419<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Sir Kenneth Calman became aware on 11 March 1996 of the outcome of SEAC�s 8 March meeting.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn600" name="_ftnref600" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[600]</span></a> He called a meeting that morning with Dr Rubery, Dr Metters, Dr Wight and Mr Skinner.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn601" name="_ftnref601" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[601]</span></a></div>
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420<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>These officials noted that in light of the confirmatory work to be done, publication of the new findings was �unlikely for a month�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn602" name="_ftnref602" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[602]</span></a> It was noted that Sir Kenneth would call a meeting with MAFF and Professor Pattison that day (later postponed until Wednesday 13 March), with the possibility of further meetings of officials on 21 March, about 28 March, and during the week of 8 April.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn603" name="_ftnref603" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[603]</span></a></div>
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421<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also discussed at this meeting was MAFF�s proposed publicity material about BSE.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn604" name="_ftnref604" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[604]</span></a> A note of the meeting recorded �It was agreed that in the light of the new information available to the DH and MAFF on Friday it would be sensible to delay further progress on the leaflet�� <a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn605" name="_ftnref605" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[605]</span></a></div>
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422<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>After the meeting Sir Kenneth Calman wrote to Mr Packer to say that, in view of the new findings, �it would seem very unwise to disseminate information which could later be seen as falsely reassuring�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn606" name="_ftnref606" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[606]</span></a></div>
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423<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Sir Kenneth later met Mr Dorrell to discuss the new findings<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn607" name="_ftnref607" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[607]</span></a>.</div>
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424<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Later that day, at Sir Kenneth�s request, Dr Rubery spoke to the Chief Executive of the Medicines Control Agency (MCA) �to request a paper on pharmaceutical aspects of the new information for CMO and Ministers urgently�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn608" name="_ftnref608" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[608]</span></a> She also spoke to a DH official with responsibility for vaccines, �to alert him to the issue in relation to vaccines�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn609" name="_ftnref609" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[609]</span></a></div>
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425<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The same day (11 March), Sir Dai Rees of the MRC (whose representative Dr Dukes had attended the SEAC meeting on 8 March) wrote to Sir John Cadogan, Director General of the Research Councils, Office of Science and Technology (OST), with a summary of the new information. He said,</div>
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�You should know that new findings, while not proving such a connection are consistent with one, and will undoubtedly have major implications. One can reliably predict a major health scare and a potentially devastating effect on the meat and livestock industry.� <a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn610" name="_ftnref610" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[610]</span></a></div>
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426<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Sir John Cadogan forwarded this letter to Mr Lang (President of the Board of Trade)<b> </b>on the same day.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn611" name="_ftnref611" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[611]</span></a></div>
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SEAC Meeting 26</div>
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427<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 11 March 1996, members of SEAC visited a slaughterhouse. Present were Professor Pattison, Mr Bradley, Dr Kimberlin, Dr Painter, Mr Pepper and Professor Smith. Mr Eddy (MAFF Secretariat) and Mr Skinner (DH Secretariat) were there, as was Dr Matthews (MAFF observer). Dr Rubery, Dr Render and Mrs Townsend were there, and Mr Meldrum attended during the latter part of the visit.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn612" name="_ftnref612" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[612]</span></a> Apologies were received from Dr Will, Professor Allen, Dr Brown, Professor Collinge, Dr Watson, Professor Almond, Dr Hueston, and Dr Wight.</div>
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428<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>After the visit, members discussed the presentation given by Drs Will and Ironside at the last meeting. They called for</div>
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�[i] Peer review to ensure that this was indeed was a distinct variant of CJD;</div>
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�[ii] a review of the literature by experts to ensure that this presentation was new and had not been seen, possibly in an unidentified form, in earlier years;</div>
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�[iii] review of overseas cases to see whether this variant was unique to the UK or had been observed overseas.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn613" name="_ftnref613" title=""><sup>[613]</sup></a></div>
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Tuesday 12 March 1996</div>
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MAFF</div>
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429<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 12 March 1996 Mr Eddy minuted the private secretary of Mr Packer, and copied the minute to Mr Carden, Miss Kate Timms, Mr Meldrum, Mr Haddon, Mr Hollis, Mr K Taylor, Mr Blakeway, Mr Cowan and Dr Render.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn614" name="_ftnref614" title=""><sup>[614]</sup></a> Mr Eddy�s minute summarised the information presented by Drs Will and Ironside on 8 March 1996 and said that the Surveillance Unit �have now firmed up their views� on the emergence of a subtype of CJD in younger people.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn615" name="_ftnref615" title=""><sup>[615]</sup></a> It said</div>
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�The cases are confined to younger patients ranging from 18 to 42. Depending on medical tests still underway there could be as many as 8 or 9 such cases all dating from the past 2 years. Cases in young patients are unusual but not unknown. But we have had more in the past 2 years than in the previous 10 and more than in other countries. Furthermore the disease looks different both clinically and under the microscope where there are �plaques� which are not found in normal CJD.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn616" name="_ftnref616" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[616]</span></a></div>
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430<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The minute said that the Surveillance Unit were �confident� when �probed� by SEAC that �the disease really was new�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn617" name="_ftnref617" title=""><sup>[617]</sup></a> SEAC had been �extremely concerned and noted that a possible explanation of this new form of the disease occurring apparently only in the UK was that it was related to BSE�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn618" name="_ftnref618" title=""><sup>[618]</sup></a> Another concern was that �some sheep would have been fed with the same contaminated feed as cattle in the 1980s and could have contracted BSE unrecognised because it might look like normal scrapie�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn619" name="_ftnref619" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[619]</span></a></div>
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431<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The minute also mentioned the likely period of inoculation of the victims of the new disease:</div>
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�there is� no reason to believe that they were not potentially exposed before the SBO controls were introduced in November 1989. It is unlikely in logic that these cases reflect exposure post 1989 given the long incubation period of the disease and the expectation that exposure would be lower after the SBO ban than before; but this is not easy to prove. One of the SEAC members, Dr Kimberlin, will be doing a formal risk analysis calculation to assess the likely risk prior to the SBO ban and since. This will take time but will be important in considering the implications in SEAC and in presenting them to outside scientists. In essence he will be able to calculate odds to help answer the question �do these cases tell us that BSE <u>was</u> a risk to humans or that BSE still <u>is</u> a risk despite the precautions taken�.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn620" name="_ftnref620" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[620]</span></a></div>
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432<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Eddy explained the genotypes of the young victims:</div>
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�all of the cases of the new subtype of CJD have the same amino acid, methionine, at a particular place in their PrP protein� In humans there are two forms of the protein, one with methionine and one with valine. People can have either all methionine (MM) (because they have inherited methionine from both parents) all valine (VV), or half methionine and half valine � one from each parent (MV). In the Caucasian population as a whole these occur in a ratio of 37%MM: 51%MV: 12%VV. There is an excess of MM and VV genotypes over the MV genotype in human cases of CJD, most sporadic cases (around 80%) are MM and most iatrogenic forms are VV. All, so far, of these special cases tested are methionine only (MM).�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn621" name="_ftnref621" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[621]</span></a></div>
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433<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Eddy detailed the areas identified by SEAC on 11 March as requiring extra work before publication of the findings.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn622" name="_ftnref622" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[622]</span></a> He also commented that �the mood of the meeting on 11 March was less bleak than that of 8 March and rather more sceptical of the CJD Unit�s findings, but some of the leading medical members of SEAC, including the head of the CJD Unit, were not present�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn623" name="_ftnref623" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[623]</span></a></div>
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DH/ Contingency Planning</div>
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434<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 12 March 1996 Dr Rubery minuted Sir Kenneth Calman�s private secretary, copied to Drs Metters, Skinner and Wight and Mr Skinner, with her own notes from SEAC�s meeting the previous day.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn624" name="_ftnref624" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[624]</span></a> She noted that SEAC had concluded that �in light of the information provided by Bob Will and John Ironside [sic] on Friday and their visit to the abattoir today there was no need to change their advice on the SBO bans��<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn625" name="_ftnref625" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[625]</span></a> She also noted that</div>
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�The data are consistent with BSE causing a subset of CJD which is clinically atypical, with an unusual EEG and amyloid plagues [sic] on PrP staining but:-</div>
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�(1)� This could also be identification of a disease previously unidentified but present<o:p></o:p></div>
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�(2)� The description of the new disease is not necessarily evidence for a causal relationship to BSE exposure of the population, although this is a possible explanation.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn626" name="_ftnref626" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[626]</span></a><o:p></o:p></div>
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435<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>She noted several points that would be followed up by DH, if the new variant was related to BSE: �It will be important to investigate the likely levels of exposure at different times in the past.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn627" name="_ftnref627" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[627]</span></a> She noted that information would be needed on feline spongiform encephalopathy (FSE), the consumption of brain, MRM, intestines, catgut, vaccines, cheek meat, and abattoir workers.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn628" name="_ftnref628" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[628]</span></a></div>
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436<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 12 March 1996, Dr Rubery minuted Sir Kenneth Calman with a �status� paper.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn629" name="_ftnref629" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[629]</span></a> She summarised SEAC�s discussion on 8 March 1996, then set out 11 �next steps� required �to address the hypothesis of a causal link with BSE and to determine the actions necessary�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn630" name="_ftnref630" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[630]</span></a> These steps were</div>
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(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Obtaining advice from MAFF on the likely timing of exposure, assuming that the route was via beef and beef products.</div>
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(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Obtaining all available data on incubation periods of TSEs that might be relevant.</div>
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(iii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>MAFF needed to consider ways to further protect the human and cattle food chains.</div>
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(iv.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>MAFF and DH needed to consider the same question in relation to BSE in sheep.</div>
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(v.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Consideration by the CMO of what advice he needed to give and when on public health, political and creditability grounds.</div>
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(vi.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The setting up of a predictions group to plot out the likely future of the epidemic (with Professors Peter Smith and Roy Anderson involved).</div>
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(vii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Consideration of other routes of exposure, such as catgut, vaccinations and gelatine capsules.</div>
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(viii.)Consideration of other possible causes of the new disease, for example recreational drugs.</div>
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(ix.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Consideration of how the disease might be present in older people.</div>
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(x.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Urgent assessment of future resource needs for surveillance and research.</div>
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(xi.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Urgent development of a communication strategy and a helpline once the announcement was made. Dr Rubery noted a number of ways in which information could be passed to GPs and other doctors, members of the NHS and Environmental Health Officers, and recommended that SEAC�s policy on communication with members of the public be �sorted out.� She suggested considering the issuing of a press statement after each SEAC meeting, like the Advisory Committee on the Microbiological Safety of Food.</div>
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437<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Rubery told the BSE Inquiry that she could not recall how she devised this list of �next steps�, but she thought that it would have been based upon the discussions in SEAC, conversations with the secretariat of SEAC and her staff responsible for the area, and her previous experience of handling public health related episodes (such as Chernobyl and other food-related issues such as salmonella).<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn631" name="_ftnref631" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[631]</span></a> She said that she would have sent the paper in draft form for comment to others in the HEF Division before she finalised it.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn632" name="_ftnref632" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[632]</span></a></div>
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438<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In addition to Sir Kenneth Calman, the status paper went to Sir Graham Hart, Dr Metters, Dr Skinner, Dr Wight and Mr Skinner. Dr Rubery said that it subsequently served as a helpful <i>aide memoire </i>for her and others to refer to at meetings held over the following few days.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn633" name="_ftnref633" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[633]</span></a></div>
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439<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>She also discussed the paper with Dr Metters before he went on sick leave on 12 March. She forwarded the various points that arose from this discussion in a minute to Dr Wight, copied to Sir Kenneth�s private secretary, Dr Metters, Dr Skinner and Mr Skinner. The points were about advising clinicians, the use of gelatin, foetal calf serum used in vaccines, dates of likely human exposure, and information on hGH and kuru cases.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn634" name="_ftnref634" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[634]</span></a></div>
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440<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Rubery told the BSE Inquiry that she thought that the timing of her 12 March 1996 action plan was �about right�, and that while it was rushed, the CMO took forward the issues that she identified �largely within the timeframe�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn635" name="_ftnref635" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[635]</span></a> In her view there was nothing obvious that needed to be done before this time. Referring to her action plan, she said:</div>
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�Most of those issues are things that really you can only put into place once you know you have a problem. They are not issues � you cannot start to set up a predictions group until you have some cases you need to follow. You cannot really do the communications strategy until you have something to communicate, and all the links in the communication strategy were there, one knew that the CMO has a good communication network out and so on.</div>
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�So in terms of forward planning for the Department of Health � you cannot actually set up the research either on the cases until you actually have cases to inject into mice, so until we actually knew there were cases, there did not seem to me to be any issues that we needed to do more on than we had done. It seemed to me there might be issues that MAFF could usefully forward plan. That was why I raised it with Mr Carden. His view was we could not do all the planning on that side, therefore I let it lie�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn636" name="_ftnref636" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[636]</span></a></div>
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441<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Carden talked generally about whether he was aware of any thinking about a contingency plan.<b> </b>He said</div>
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�We did not have a file marked �contingency plan�. We were certainly thinking more and more actively from autumn 1995 onwards about what might follow if ... and there were two strands to the thinking. Measures that might need to be taken to protect public safety and measures that might need to be taken to handle the drop in demand of beef that would inevitably follow if there was evidence of a link between BSE and CJD. That of course came about.</div>
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�We did not take our contingency thinking into very great detail down either of those tracks, for different reasons. It would have been very difficult to have developed a contingency plan on the human health side for any new measures that might need to be taken� With the development in February, March 1996 we were looking to SEAC for guidance, we, the Government Ministers and officials were all looking to SEAC for a view on what they felt needed to be done�</div>
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�It would not, I would suggest, have been sensible for us to try to draw up a blueprint in abstract of measures of that kind. We needed scientists' advice. As to the collapse in the beef market and what should have been done about that, plenty of suggestions after March 1996 that that should have been planned out in detail beforehand. The difficulty there, I think, was quite different. It did not take long to work out that if the news that had come through had come through, you would get a collapse in the consumption of beef.</div>
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�We did some assessments of the order of drop in demand that might take place and some very sketchy thinking about measures that could be needed to react to that. But to take that thinking into any great detail we would have needed to discuss with authorities outside the Intervention Board, the Meat and Livestock Board, the European Commission in Brussels, had we done that there would have been very high risk of that becoming public knowledge; and in the climate of the time I think had that become public knowledge it would have produced the event we were contingency planning for, without the backing of science that we had come March 1996��</div>
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MR WALKER: ��When you say, �We were thinking from autumn 1995 onwards�, who were the people turning their minds to this?�</div>
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MR CARDEN: �A very small number of people. Discussions that I had about this were with the Permanent Secretary primarily as to the collapse in the market and what might need to be done about that. I had one or two discussions with the, I think, with the Head of the Beef Division, Richard Cowan�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn637" name="_ftnref637" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[637]</span></a></div>
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442<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Calman told the BSE Inquiry:</div>
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�I think Dr Rubery raising it with MAFF is perhaps inappropriate because MAFF would not have picked up the human consequences, which is why particularly around the time of the human growth hormone issue the real question for me, and indeed within the Department, and I discussed this with the NHS Executive side, was if the number of cases build up and if there is no treatment available, both of which remain could be true, how was the service going to cope with that? That was the contingency issue. It was the planning for looking after people, together with the research and funding more treatment. That would have been the implication. Therefore I had a number of discussions with the Executive about how we would deal with that in terms of contingency planning.�</div>
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MRS BRIDGEMAN: �You had already as it were begun the shadow planning for the worst?�</div>
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SIR KENNETH CALMAN: �But again assuming this would build up slowly rather than rapidly. I do not know the answer to that either, there would have been time to think about that. But the implications for neurology services, diagnostic services, pathology services, nursing care, all very considerable, and therefore we had taken that into account and had been thinking about that. That I do not think is a MAFF issue. That is very much a National Health Service issue which is where it would be appropriately discussed.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn638" name="_ftnref638" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[638]</span></a></div>
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443<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the subject of making contingency plans, Mr Dorrell told the BSE Inquiry:</div>
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�I think it is very hard, is the answer, to make contingency plans for this because what we are talking about is how should we care for patients who are diagnosed as having this disease or having a form of spongiform encephalopathy related to BSE? Now, clearly the National Health Service had traditionally cared for CJD victims as we still believe unrelated to BSE cases previously. Any contingency planning would have required assessment of how many cases were likely to arise, whether the condition was different from CJD or whether the clinical treatment of it needed to be the same, and no doubt a range of other factors as well. And I am all in favour of people thinking about contingencies, but the range of options that would have been potentially open if somebody had asked that question in the autumn of 1995 seems to me so wide that I am not sure a useful policy conclusion could have flowed.�</div>
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MR FREEMAN: �Do you think a centralised care plan could have been formulated earlier than March 1996 and indeed ought to have been formulated?�</div>
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MR DORRELL: �I think the question of how doctors care for patients is something that is best handled through the leadership of the medical profession. I think that the Department of Health and the National Health Service has a role to play as a catalyst for discussion between senior doctors on which experience is best; but my experience of the medical profession is that particularly with this kind of relatively unusual condition, doctors caring for patients that suffer from these kind of diseases do share their experiences and do seek to learn from each other.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn639" name="_ftnref639" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[639]</span></a></div>
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444<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Packer was asked about his attitude to contingency planning:</div>
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MR WALKER: �To what extent had you given thought before March 1996 of what should be done if they were to find what they were seeking?�</div>
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MR PACKER: �Did we have a contingency plan?�</div>
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MR WALKER: �Yes.�</div>
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MR PACKER: �No we did not, and rightly so. But it is appropriate to deal with the two separate aspects. One is what would we do as regards reassurance of the public in the public health domain, and what would we do vis a vis support for the beef industry.�</div>
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445<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the first aspect, he said:</div>
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�We had emerging two disquieting features. One was the CJD in dairy farmers which for a prolonged period was of more concern than was the second, which was CJD in adolescents. It is evident that any contingency plan for dealing with -- or any plan for dealing with CJD in dairy farmers would differ in kind enormously from dealing with CJD in adolescents, because CJD in dairy farmers, presumably the route of exposure is by some means other than food. And that would require different response and it is apparent that we would need to seek scientific advice from SEAC and indeed possibly more widely. That is one point.</div>
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�The nature of the end result is not known, the fact that there has been a dramatic development does not mean in the past you can predict what it is actually going to be. Therefore you cannot make a contingency plan for it. There are a whole host of other objections to contingency plans of that sort, like the sheer difficulty of drawing them up. They would necessarily involve the very people who are engaged in actually setting policy and dealing with the ongoing work on the crisis. You devise a framework. Events never fit into the framework, you waste a lot of time trying to force developments into the framework you have made which is of no use.</div>
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�I am going on, but there are so many objections. We have spent billions of pounds on BSE since 20th March 1996. Any committee which looked at the subject would have had to have a member of the Treasury. No member of a Treasury would ever agree to a contingency plan which involved pending billions of pounds. He just would not do it. Furthermore, my experience of Ministers is that they would be very wary of having such a committee, having justified fears that if existence of it would leak, it would precipitate the very event it is designed to set a contingency about. There are a whole host of objections to that sort of contingency plan which to my mind are wholly overwhelming.</div>
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�</div>
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�SEAC eventually came up with a recommendation that we should debone beef from animals over 30 months. No one predicted that would be their final recommendation up to and including the day before. Given it is SEAC's recommendation, that is what one would expect to have been forced to do. In the event we did something else. So that the scale of movement suggests to me that contingency plans would -- the effort devoted to devising a contingency plan would not have been valuable.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn640" name="_ftnref640" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[640]</span></a></div>
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446<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the second aspect of contingency planning, dealing with shops and industry, Mr Packer said:</div>
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�By 20th March 1996 we were already well aware of what that would have to consist of�</div>
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�that is a much simpler aspect because you have to keep the essential lines flowing, which is the rendering industry, the slaughterhouses, farmers. All that is sort of less difficult, because obviously one can define there what needs to be done. It is in the protection of the public, where you do not know what the final finding is going to be, nor what the recommended way of dealing with it would be. I would defy anybody to, unless shortly before 20th March, to have concluded (a) that deboning beef over 30 months was going to be a significant part of the conclusion, and (b) that the exclusion of them between the feed chain would be...�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn641" name="_ftnref641" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[641]</span></a></div>
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Wednesday 13 March 1996</div>
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447<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Packer, Sir Kenneth Calman, Professor Pattison, Mr Meldrum, Dr Rubery, Dr Wight, Mr Eddy, Dr Skinner, Mr Carden, Mr Haddon, Mr Taylor, Mr Hollis, Dr Matthews, Mr Blakeway and other officials met at MAFF at 10:30am<b> </b>on 13 March.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn642" name="_ftnref642" title=""><sup>[642]</sup></a> Sir Kenneth and Mr Packer agreed on the need to be �absolutely sure� the data was right before it was published, because of the �possibly immense implications� of the new findings.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn643" name="_ftnref643" title=""><sup>[643]</sup></a></div>
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�Taking all things into account, the CMO still envisaged that a sub-type of CJD in younger patients was likely to be identified. He needed to plan on the basis that there was a new risk, there was a new form of spongiform encephalopathy, and that the likely source was BSE in cows. He also had to assume that the whole population had been exposed over a 10 year period��<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn644" name="_ftnref644" title=""><sup>[644]</sup></a></div>
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448<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Professor Pattison told the meeting that SEAC�s slaughterhouse visit on Monday had �reassured members that the SBO ban could be made to work effectively.� Mr Meldrum said he was �more confident today than before April last year that the rules were being applied�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn645" name="_ftnref645" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[645]</span></a></div>
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449<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In discussion of what new controls might be introduced, Professor Pattison said that SEAC could consider �tweaking the SBO ban to remove more potentially infective organs, but this would not be rational�, and �removing cows over 2 or 2� years from the human food chain. However, this was a very complicated question in view of the economic consequences�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn646" name="_ftnref646" title=""><sup>[646]</sup></a></div>
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450<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Professor Pattison �confirmed that SEAC would meet in the next few weeks� (this was later set for 16 March).<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn647" name="_ftnref647" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[647]</span></a> He asked for guidance on the limits of SEAC's considerations. Mr Packer advised that</div>
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�SEAC should consider what it thought appropriate, although comments on how the situation might have arisen would be helpful. If SEAC made a recommendation, the Government was likely to follow it. Although economic consequences were secondary, clearly any recommendations should be balanced. As evidence came forward, it changed the balance of reasonableness of what we were doing; however, any changes to the rules had to be proportionate. It did not follow from the worst case scenario that the <i>current rules</i> needed to be changed.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn648" name="_ftnref648" title=""><sup>[648]</sup></a></div>
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451<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Meldrum asked Professor Pattison to �bear in mind the logistical effects of any recommendations, and to consider the wider uses of products such as bonemeal eg. for pig rations�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn649" name="_ftnref649" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[649]</span></a></div>
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452<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Sir Kenneth had drafted a press statement dealing with publication of the research, which he read out to the meeting.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn650" name="_ftnref650" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[650]</span></a></div>
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453<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On MAFF�s publicity information, Mr Packer told the meeting</div>
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��It would be inappropriate for MAFF to issue any more copies of the reassuring publications. Where commitments had been made to send out such publications, these should not be honoured. The briefings planned with local authorities and so on should also be cancelled.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn651" name="_ftnref651" title=""><sup>[651]</sup></a></div>
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454<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Packer told the BSE Inquiry that</div>
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�following the developments at the end of 1995 we thought it appropriate to change the literature, because there were statements that were incorrect�</div>
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�And like, for instance -- well, there were statements that were incorrect. And this took some time and it was being revised constantly. Of course, inevitably the emerging conclusions of SEAC were, and I hasten to add legitimately kept confidential for a period, so that they may well have been worked on by someone who was not aware of what was happening. I think I am right in saying that the revised version never came forward for approval�</div>
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�But in any event, as my statement here records, it was clearly well beyond the point where anything that had been issued previously could be issued and we needed to start from scratch.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn652" name="_ftnref652" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[652]</span></a></div>
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455<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Sir Kenneth pointed out that the <i>Lancet</i> was published on a Friday, �the wrong day for taking proactive action.� He suggested that they make the findings public and set out what they proposed to do, before they were published in the journal. Professor Pattison thought the article would be published in the <i>Lancet</i> within two weeks. Later publications could give rise to leaks. <a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn653" name="_ftnref653" title=""><sup>[653]</sup></a></div>
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456<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Packer �thought it would be difficult to go public other than on the basis of a recommendation from SEAC on further action�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn654" name="_ftnref654" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[654]</span></a></div>
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457<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>After this meeting Mr Packer held a �wash-up meeting� with Mr Eddy, Mr Carden, Mr Meldrum and Mr Haddon.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn655" name="_ftnref655" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[655]</span></a> Mr Packer �had some reservations. For example, why were only young people going down with this form of CJD?�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn656" name="_ftnref656" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[656]</span></a> Mr Eddy answered that �Professor Will�s explanation was that younger people were more disposed to buy hamburgers�. Mr Packer �did not find this convincing�,<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn657" name="_ftnref657" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[657]</span></a> and he followed up his reservations afterwards in a letter to Sir Kenneth Calman and Professor Pattison (see below).</div>
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458<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also at this �wash-up meeting�,</div>
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�It was agreed that it would be helpful if the work by Kimberlin was completed before publication. The Secretary suggested we offer to pay him to work on this full time. We could also offer to provide a statistician if that would help, unless this might be thought to compromise the findings. In the meantime, we should take the line that SEAC should not make recommendations for the sake of it if they were confident that the controls were adequate. We should also make contingency plans in terms of market support and disposal of carcasses�.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn658" name="_ftnref658" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[658]</span></a></div>
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459<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>After the (first) meeting, Dr Rubery spoke again to the MCA, to ask what line DH could take on the effectiveness of current measures on pharmaceuticals, and for details about the possible exposure from medical products manufactured before the current measures were put in place. Dr Rubery also arranged to meet Dr Painter (one of the new SEAC members, and a Consultant in Communicable Disease Control, Manchester) and Eileen Smith (from the CMO�s office) to devise a communications strategy.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn659" name="_ftnref659" title=""><sup>[659]</sup></a></div>
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460<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Packer wrote to Professor Pattison shortly after the meeting with further thoughts. He noted the �very considerable political and economic damage� that might be caused by an announcement, and wondered whether it was prudent to suggest a link between nvCJD and BSE unless it followed the same pattern as BSE, rising steadily with decreasing intervals between cases. He also said they needed to discuss why the new variant had been found only in young people.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn660" name="_ftnref660" title=""><sup>[660]</sup></a></div>
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461<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Packer recalls that �both Professor Pattison and the CMO telephoned to say that they regarded the points I had made to them as valid considerations�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn661" name="_ftnref661" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[661]</span></a></div>
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462<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Later that day (13 March), Mr Packer minuted Mr Hogg about �developments on BSE and possible links with CJD which are potentially extremely serious.� He summarised SEAC�s discussions and the meeting earlier that day,<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn662" name="_ftnref662" title=""><sup>[662]</sup></a> and said that SEAC had �recognised that given the seriousness of the implications of any statement from an authoritative source to the effect that BSE might well cause CJD, it behoves them to clear that Dr Will�s claims on singularity are accurate�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn663" name="_ftnref663" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[663]</span></a> He said that MAFF needed to plan on a �worst case� basis.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn664" name="_ftnref664" title=""><sup>[664]</sup></a> He continued:</div>
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��if BSE/CJD transmissibility does exist then it is highly probable that cases seen so far result from exposure before any measures were taken against BSE in the middle 1980s. Moreover... measures and enforcement have been progressively tightened up. Accordingly, whatever the position on transmissibility, it does not follow that any further measures would need to be introduced now. I said as much to Professor Pattison since elements in SEAC are apparently thinking in terms of recommending a ban on the consumption of beef from animals over two years old and it is far from clear that the cost of such a measure would be proportionate to any reduction in risk.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn665" name="_ftnref665" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[665]</span></a></div>
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463<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Packer went on to say that he was sure that the public and market reaction to an acknowledgement of the possibility of BSE transmission to humans �would be such that the political and economic effects would be a disaster of unparalleled magnitude so far as UK food scares are concerned. The consumption of beef would be likely to fall immediately to a small proportion of its former level��.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn666" name="_ftnref666" title=""><sup>[666]</sup></a></div>
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464<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On timing, Mr Packer noted that Sir Kenneth Calman was �very anxious that all this should be pushed forward as rapidly as possible, not least to avoid leaks�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn667" name="_ftnref667" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[667]</span></a> He commented that �it is even more important not to rush into public announcements before we are clear that there is a genuine cause for concern�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn668" name="_ftnref668" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[668]</span></a></div>
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465<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hogg agreed with this. He told the BSE Inquiry:</div>
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�In early December or very late November, there had been a series of television programmes about the unsafety of beef. That did have a very serious though short lived impact on the consumption of beef. In a sense therefore we were very alert to how febrile public confidence was and therefore I would not have wanted to have run the risks of leaks until such time as I had something positive to say, because I knew what the consequences would be. We had been through it, in a very played down form, in the latter part of 1995.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn669" name="_ftnref669" title=""><span class="MsoFootnoteReference" style="vertical-align: super;"><span style="color: black;">[669]</span></span></a></div>
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466<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mrs Browning told the BSE Inquiry:</div>
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�One of the ways which SEAC was verifying Dr Will's theory on the link between BSE and nvCJD was to speak to overseas scientists, to see if they had seen such new variant cases before. This was a necessary exercise, although it caused particular concern, because by discussing a possible link between nvCJD and BSE with other scientists, there was a increased risk that this link would be leaked to the press before the Government had had time to consider its response, and before SEAC had had time to make sensible recommendations. Since the emergence of Dr Will's theory, it had been a very tense time for Government. We were extremely anxious to have advice from SEAC as soon as possible. We did not feel that we could go to the public with an announcement that BSE and nvCJD might be linked, but without any recommendations as to how to deal with it. We therefore needed SEAC to give firm advice as soon as possible.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn670" name="_ftnref670" title=""><span class="MsoFootnoteReference" style="vertical-align: super;"><span style="color: black;">[670]</span></span></a></div>
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467<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>13 March 1996 was the day of the Dunblane tragedy, Scotland. A man shot and killed 16 children and their teacher while they were in school.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn671" name="_ftnref671" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[671]</span></a></div>
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Thursday 14 March 1996</div>
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468<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 14<sup> </sup>March, Dr Rubery attended a meeting with Sir Kenneth Calman and Dr Wight. Dr Wight had spoken to Professor Pattison, who had heard from Drs Kimberlin, Ironside, Will and Professor Collinge that the pathology of the new variant CJD cases had been confirmed by three other neuropathologists. The new disease �seemed to be real�. Sir Kenneth concluded that SEAC should meet again on 16 March, to advise Mr Dorrell. It was agreed that some form of statement would probably need to be made the following week. After the meeting, Dr Rubery updated Mr Dorrell�s private office on BSE/ CJD.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn672" name="_ftnref672" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[672]</span></a></div>
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469<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Packer and Mr Hogg spoke several times on 13 and 14 March to discuss Mr Packer�s minute of 13 March. They agreed that a public statement could not be made until SEAC had advised on the accuracy of Dr Will�s claims and the steps which the Government should take.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn673" name="_ftnref673" title=""><sup>[673]</sup></a> They also agreed that they should �avoid seeking to influence in any way the conclusions to which SEAC itself would come�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn674" name="_ftnref674" title=""><sup>[674]</sup></a> Mr Hogg noted the need to �get clear advice from the Committee as to the facts and the steps which the Government should take�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn675" name="_ftnref675" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[675]</span></a></div>
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470<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>As a result of these discussions, Mr Hogg wrote to Professor Pattison asking him to submit SEAC�s views to the Government as soon as SEAC was �in a position confidently to do so�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn676" name="_ftnref676" title=""><sup>[676]</sup></a></div>
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471<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Packer and Mr Hogg also discussed the possibility that after SEAC�s meeting on (Saturday) 16 March, Mr Hogg might need to write to the Prime Minister on 18 March. Mr Dorrell had informed MAFF that he would be content with this procedure.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn677" name="_ftnref677" title=""><sup>[677]</sup></a></div>
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472<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In the afternoon of 14 March 1996 there was a pre-arranged meeting of the four UK CMOs: Sir Kenneth Calman (DH), Dr Henrietta Campbell (Northern Ireland), Dr (later Dame) Deirdre Hine (Wales), and Dr Kendell (Scotland).<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn678" name="_ftnref678" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[678]</span></a> Dr Campbell told the BSE Inquiry that Sir Kenneth:</div>
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�showed Dr Hine, Dr Kendall and myself a sheet of paper which set out the 9 cases of CJD which showed a different presentation and pathology to CJD as it normally occurred. We were profoundly struck by the significance of these figures and discussed the implications deep into the night. Sir Kenneth was heavily involved in meetings with the Cabinet and we were aware of the overwhelming sense of shock within Whitehall. The next day I returned to Belfast to brief my own Minister and to await the statement in the House�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn679" name="_ftnref679" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[679]</span></a></div>
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473<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Hine recalled that Sir Kenneth told them that the most likely explanation of the �new variant� was</div>
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�exposure to BSE before the introduction of the Bovine Offal (Prohibition) Regulations in 1989. I was party during the next 24 hours with my fellow CMOs to detailed discussions which explored the implications of this information in preparation for a statement to be made to Parliament by the Minister for Agriculture and the Secretary of State for Health the following week. In view of the gravity and sensitivity of the new information I decided to return to the Welsh Office on Friday 15th March 1996 to brief the Permanent Secretary, Mr. Michael Scholar, and the Secretary of State for Wales, Mr. William Hague MP, orally, which I did in the late afternoon of that day�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn680" name="_ftnref680" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[680]</span></a></div>
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Friday 15 March 1996</div>
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474<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 15 March 1996 Mr Skinner drafted a minute entitled �Spongiform encephalopathy in humans: latest developments� to the private secretaries of Sir Kenneth Calman and Mr Dorrell, copied to Mr Horam�s private secretary, Dr Metters, Dr Rubery, Dr Skinner, Dr Wight, Ms Christopherson and Mr Wilson.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn681" name="_ftnref681" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[681]</span></a> Mr Skinner informed recipients that the CJD Surveillance Unit had discussed their findings with three neuropathologists in Glasgow, one CJD expert in Oxford and one in the USA: �All confirm that the pathological features identified are closely similar in all cases and quite unlike any others encountered previously either in practice or in literature. It now seems clear that we are dealing with a clinical entity which has not been identified before�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn682" name="_ftnref682" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[682]</span></a></div>
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475<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Skinner said �In the event that we were forced to conclude that BSE could not be ruled out as a possible cause this would change the whole approach to the protection of public health which has proceeded so far on the basis that the risk to the human population is only theoretical�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn683" name="_ftnref683" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[683]</span></a> He said that SEAC needed to give advice on �any further action which needs to be taken to protect the public health�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn684" name="_ftnref684" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[684]</span></a></div>
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476<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>He noted that an announcement could be either be made �in the next few days� and promise further information and advice when the significance of this has been clarified�, or it could be deferred �until we have built up as complete a picture as possible and are ready to announce any new public health measures; this might take four to six weeks�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn685" name="_ftnref685" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[685]</span></a> He discussed the benefits and disadvantages of these actions.</div>
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477<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Skinner concluded by noting that in the event of any �disclosure�, the line to take was that SEAC had received a report from the CJD Suveillance [sic] Unit on which it �has not reached any conclusions and has asked for further work to be done�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn686" name="_ftnref686" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[686]</span></a></div>
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478<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 15 March 1996 Sir Kenneth �received information from SEAC indicating that they were convinced at the possibility that there was a new disease�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn687" name="_ftnref687" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[687]</span></a> He discussed this with the Welsh, Scottish and Northern Irish CMOs.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn688" name="_ftnref688" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[688]</span></a></div>
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479<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also that day, a minute was circulated to MAFF officials and Mrs Browning of the discussions between Mr Packer and Mr Hogg the previous day.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn689" name="_ftnref689" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[689]</span></a></div>
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Saturday 16 March 1996</div>
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SEAC Meeting 27</div>
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480<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>An emergency meeting of SEAC was held on 16 March 1996. Present were Professor Pattison, Dr Hueston, Dr Will, Professor Smith, Professor Almond, Mr Bradley, Dr Kimberlin, Dr Painter, Mr Pepper and Professor Collinge, and the Secretariat (Messrs Eddy and Skinner). Observing were Dr Matthews, Dr Wight, Mrs Wilson (BBSRC) and Mr Dukes (MRC). �Also in attendance� were Dr Render and Mrs Townsend (both MAFF).<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn690" name="_ftnref690" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[690]</span></a></div>
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481<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>First, Dr Will described what he and Dr Ironside had discovered about the new variant of CJD:</div>
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�initial clinical presentation was in younger patients than normal for CJD and with psychiatric or behavioural problems which then developed to neurological problems and eventually dementia. The disease had a comparatively long incubation period, had abnormal EEG and showed distinct histopathology, with large distinct plaques�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn691" name="_ftnref691" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[691]</span></a></div>
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482<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Will reported that since the 8 March meeting, another case had been described in a 31-year-old. Annex 1 to the minutes was two tables, showing details of nine �confirmed� and three �suspect� cases of CJD in young patients.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn692" name="_ftnref692" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[692]</span></a> Members discussed other young cases of CJD in the UK<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn693" name="_ftnref693" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[693]</span></a> and in other countries.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn694" name="_ftnref694" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[694]</span></a></div>
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483<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The data had been examined by three independent neuropathologists in Glasgow, who considered that this was a �distinct entity unlike any previously seen form of CJD�. These experts had felt that pathologists in the 1970s and 80s would have been able to describe the plaques even without the new technique of immuno-staining. They noted that it was usual [sic] for young patients not to be given a biopsy or post-mortem.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn695" name="_ftnref695" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[695]</span></a></div>
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484<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Will had discussed the findings with Professor Walter Matthews, Professor Emeritus of Oxford University. Professor Matthews, a leading authority on CJD, had supervised Dr Will�s early CJD surveillance work. He had commented that �The evidence cannot� be regarded as conclusive and I am not wholly convinced that such cases might not have been overlooked in the past�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn696" name="_ftnref696" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[696]</span></a> However, Dr Will told the meeting that the cases he mentioned had not been of this new variant of CJD.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn697" name="_ftnref697" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[697]</span></a></div>
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485<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>SEAC felt that the new cases could not be explained by ascertainment bias. No cases had been reported before 1994 (and a significant number of cases had been seen only in the last 8 months) despite widespread interest in BSE/CJD throughout the 1990s.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn698" name="_ftnref698" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[698]</span></a></div>
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486<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>SEAC also noted that of the six patients who had been genetically analysed, all were methionine only (MM).<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn699" name="_ftnref699" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[699]</span></a></div>
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487<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Will explained that geographically, the cases were spread across the UK although it was hard to draw conclusions with the small number of cases.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn700" name="_ftnref700" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[700]</span></a>He also confirmed the absence of hormone treatment or neurosurgery in the medical histories of all of the cases.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn701" name="_ftnref701" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[701]</span></a>A review of the patients� medical records and genetic analysis to eliminate other possible causes �suggested that exposure to a previously unidentified risk factor was as likely an explanation as any other of the cause of these cases�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn702" name="_ftnref702" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[702]</span></a></div>
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488<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Professor Pattison reported MAFF�s advice that SEAC should not be constrained by economic or practical considerations when making recommendations for action, although if their recommendations were impractical MAFF might come back for SEAC�s opinions on other options. �However, it was clear that the responsibility for taking decisions on the way forward rested with politicians�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn703" name="_ftnref703" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[703]</span></a></div>
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489<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>SEAC concluded that the new variant was a distinct entity, and that it could be linked to a new risk factor. SEAC agreed that they �must take very seriously the possibility that this new risk factor was BSE, although it was noted that the data did not allow this conclusion to be drawn firmly. Similarly, the fact that other specific risk factors could not be described in detail did not mean they did not exist�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn704" name="_ftnref704" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[704]</span></a></div>
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490<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>SEAC recommended that all necessary steps be taken to ensure that the SBO ban was rigorously enforced.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn705" name="_ftnref705" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[705]</span></a></div>
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491<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>SEAC discussed risks of infectivity from eating beef. Different tissues had different levels of infectivity (eg brain was more infective than muscle meat). Oral transmission between species (eg. cow to mouse) was less effective than within species. Younger animals were less likely to be infected, and if they were, the infectivity of their tissues was lower than in affected older animals (over 2� years). It was agreed that �more detailed figures� were necessary for �this sort of risk analysis�.</div>
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492<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>They decided that the time had come to extend the ban on mammalian protein in ruminant rations to include all farm animals to avoid any possibility of perpetuating the BSE epidemic through cross contamination either in feed mills, in transit or on farms.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn706" name="_ftnref706" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[706]</span></a></div>
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493<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>They also considered but did not reach a conclusion on the need for further action in relation to SBOs. They discussed a complete ban on cattle over 2� years old in the food chain. Mr Bradley commented that this would be tantamount to saying the SBO ban was not effective. As an alternative, they discussed a requirement that animals over 2� years old should be completely de-boned and their obvious nervous and lymphatic tissue, which was likely to be the next most infectious tissue after central nervous system, removed. SEAC decided to give this issue further thought.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn707" name="_ftnref707" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[707]</span></a></div>
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494<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>SEAC also concluded that it was important for the HSE and ACDP to review the significance of the new findings and �if necessary issue new guidance as quickly as possible�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn708" name="_ftnref708" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[708]</span></a></div>
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495<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Late on 16 March, in response to Mr Hogg�s letter of 14 March requesting formal advice<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn709" name="_ftnref709" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[709]</span></a>, SEAC �agreed a statement�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn710" name="_ftnref710" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[710]</span></a> that the CJD Surveillance Unit had</div>
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�identified a previously unrecognised and consistent disease pattern� This is cause for great concern. On current data and in the absence of any credible alternative the most likely explanation at present is that these cases are linked to exposure to BSE before the introduction of the SBO ban in 1989� The Committee are actively seeking further data from both the UK and abroad to help assess the full significance of the Unit�s findings� The Committee emphasise that it is imperative that current measures to protect the public health are fully enforced and are considering the need for further measures.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn711" name="_ftnref711" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[711]</span></a></div>
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DH and MAFF</div>
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496<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>This statement was discussed on the evening of Saturday 16 March, at a meeting between Mr Dorrell, Mr Hogg, Mrs Browning, Sir Kenneth Calman, Mr Packer, Mr Meldrum, Mr Carden, Dr Rubery, Dr Wight, Ms Christopherson and Mr Blakeway.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn712" name="_ftnref712" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[712]</span></a> Mr Hogg said that he intended to make a statement to the House of Commons on Wednesday (20 March). He proposed</div>
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(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>to announce a judicial inquiry into the Government�s reaction to BSE;<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn713" name="_ftnref713" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[713]</span></a> and</div>
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(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>to ban the sale of beef and beef products derived from UK animals over the age of 2� years, the manufacture of products from bovine material from the same category of animals, and the export of such beef and beef products. The 2� year age limit was already used in the context of EU exports and only about 84 out of a total of around 160,000 cases of BSE had been in animals below this age.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn714" name="_ftnref714" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[714]</span></a></div>
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497<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hogg told the BSE Inquiry that he had begun to formulate these proposals after his informal discussion with Mr Packer on (approximately) 8 March.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn715" name="_ftnref715" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[715]</span></a> Mr Hogg also said, �I suspect there were discussions between the 10<sup>th</sup> and 13<sup>th</sup> in my room on a very private basis as to what happens if SEAC does say this, but I may be wrong about this. I cannot explain it� I am clear as to the conclusions but not quite as to the process�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn716" name="_ftnref716" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[716]</span></a></div>
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498<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The proposals on animals over 2� years would be an interim measure until recommendations were received from SEAC, which was due to meet again the next Saturday (23 March). The record of the meeting stated that</div>
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�According to indications received so far from SEAC�s chairman, Professor Pattison, the proposed measures fell �within the spectrum� of what SEAC would think necessary, though probably at the pessimistic end of the scale. However, SEAC was unlikely to recommend anything less than these measures once the Government had already announced them. Mr Hogg felt strongly that his measures represented the minimum that the Government could defensibly do�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn717" name="_ftnref717" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[717]</span></a></div>
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499<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Sir Kenneth Calman outlined the consequences for DH of SEAC�s statement. He said they would have to investigate the safety of non-food products such as vaccines, medicine, gelatin and tallow. They would also have to investigate risks to abattoir workers. DH would need to brief doctors and NHS staff to help them deal with the �likely flood of enquiries�. DH would need to consider setting up a helpline and running advertisements. It could also respond �positively� to SEAC�s recommendations for urgent research.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn718" name="_ftnref718" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[718]</span></a></div>
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500<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Instead of a helpline, Mr Dorrell preferred putting extra staff on existing DH/NHS lines. Mr Dorrell agreed that advertisements and information to GPs should go out by Thursday morning.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn719" name="_ftnref719" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[719]</span></a></div>
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501<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hogg asked about compensation for the victims of nvCJD. Mr Dorrell �felt strongly that the Government could not accept responsibility for compensation. The Government had at all stages followed the advice of SEAC and its predecessors��<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn720" name="_ftnref720" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[720]</span></a></div>
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502<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>It was suggested that Mr Hogg�s statement might be followed by a separate one from Mr Dorrell, then by a joint press conference with Dr Calman, Mr Meldrum and Professor Pattison. It was also noted that �the handling of the announcements would need further consideration in the course of the next day�, and that collective agreement would need to be sought on the contents of the announcement.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn721" name="_ftnref721" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[721]</span></a></div>
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503<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Carden told the BSE Inquiry that SEAC�s desire to give further thought to the need for new measures caused acute difficulty over the following three days, in the run-up to the announcement. At meetings over the next few days, Mr Hogg, Mr Packer and officials explored with Professor Pattison what SEAC's likely recommendations might be, but it became clear that SEAC could not reach a final view until it had fully assessed all the options.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn722" name="_ftnref722" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[722]</span></a></div>
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Sunday 17 March 1996</div>
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504<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On 17 March, a meeting was held between Mr Packer, Sir Kenneth Calman, Mr Meldrum, Professor Pattison, Dr Rubery, Dr Wight, Dr Skinner, Mr Carden, Mr Haddon, Dr Matthews, Dr Render, and Mr Eddy.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn723" name="_ftnref723" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[723]</span></a> Professor Pattison briefed those present on the lines along which SEAC was thinking. It was noted that at its meeting the next weekend, SEAC would consider recommendations that covered �the whole range of possibilities from doing nothing (except reinforcing the current controls) to the destruction of the national herd�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn724" name="_ftnref724" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[724]</span></a> It would also consider the implications for sheep (including the possibility of an ovine offal ban).<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn725" name="_ftnref725" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[725]</span></a> Mr Packer considered it necessary to make a public announcement within three to four days to forestall a leak, which was becoming increasingly likely as the information was by then widely known.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn726" name="_ftnref726" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[726]</span></a></div>
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505<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Sir Kenneth asked Professor Pattison whether it was safe to eat beef. Professor Pattison said that SEAC did not feel they should ban eating beef:</div>
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�If the SBO ban was fully implemented, meat which reached the market for human consumption, especially from young animals, was very likely to be risk free. However, the Committee could not give a 100% guarantee; it estimated the risk to the individual as between [one in] 3 x 10<sup>10</sup> and 3 x 10<sup>16</sup>. The question for today was whether it was safe to eat beef in 1996, whereas the likely exposure was in the mid-1980s. However, unfortunately, this distinction was likely to get blurred.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn727" name="_ftnref727" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[727]</span></a></div>
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506<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Sir Kenneth ran through the text of �a proposed statement� which concluded that there was no evidence that �eating beef <i>today</i>� caused CJD.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn728" name="_ftnref728" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[728]</span></a></div>
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507<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Packer had drafted a minute for Mr Hogg to send to the Prime Minister<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn729" name="_ftnref729" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[729]</span></a> which was �discussed and agreed� at this meeting.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn730" name="_ftnref730" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[730]</span></a> (The minute went to Mr Major the next day, and is described in detail below.)</div>
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508<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>After the meeting, Mr Packer sent Mr Hogg the draft minute for the Prime Minister.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn731" name="_ftnref731" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[731]</span></a> Attached to the minute was SEAC�s statement of 16 March.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn732" name="_ftnref732" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[732]</span></a> In his covering note, Mr Packer said �I deduce alternative hypotheses [to explain the new variant] have been seriously tested and no plausible one identified�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn733" name="_ftnref733" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[733]</span></a> He noted that the CMO and Professor Pattison were �content with the terms� of the draft statement.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn734" name="_ftnref734" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[734]</span></a></div>
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509<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>He also said that there were �vast implications� for MAFF:</div>
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�not merely is it probable that we will need to propose schemes of support for the beef industry likely to run into hundreds of millions of pounds per annum, but the organisation of it all will also have a cost. We, therefore, face some weeks of turmoil in which difficult decisions will have to be taken.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn735" name="_ftnref735" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[735]</span></a></div>
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510<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 17 March, Sir Kenneth telephoned Mr Dorrell to tell him of SEAC�s 16 March findings. A meeting was arranged for the following afternoon.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn736" name="_ftnref736" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[736]</span></a></div>
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Monday 18 March 1996</div>
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511<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Frank Strang (Mr Hogg�s principal private secretary) commented that �18 March was a busy day�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn737" name="_ftnref737" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[737]</span></a> In the course of the day, two minutes were submitted to the Prime Minister.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn738" name="_ftnref738" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[738]</span></a></div>
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Minute 1 (from Mr Hogg and Mr Dorrell)</div>
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512<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The first minute was from Mr Hogg and Mr Dorrell, informing Mr Major of SEAC�s 16 March advice.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn739" name="_ftnref739" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[739]</span></a> It was based on Mr Packer�s draft of the previous day.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn740" name="_ftnref740" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[740]</span></a> Mr Dorrell approved it over the telephone because he was engaged in constituency matters that morning.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn741" name="_ftnref741" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[741]</span></a> It was sent at lunchtime (and is described below).</div>
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Minute 2 (from Mr Hogg)</div>
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513<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hogg, Mrs Browning, and Mr Baldry met Mr Packer and other MAFF officials at 9:30am on 18 March 1996.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn742" name="_ftnref742" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[742]</span></a> Mr Hogg said that it was not enough to say �whether or not beef was safe�. He considered it necessary to set out the positive steps being taken. He proposed a ban on the sale of beef from cattle over 2 years old, the withdrawal of meat products and the establishment of an Inquiry, and asked for a (second) minute to the Prime Minister to be prepared putting forward these proposals.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn743" name="_ftnref743" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[743]</span></a></div>
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514<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Packer did not support either suggestion. He objected to the ban. He said that the legal basis for taking such steps would be difficult. He considered that �The key point here was proportionality. The proposals which the Minister had in mind would have very severe cost implications. We would need the recommendations of scientists before taking such steps�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn744" name="_ftnref744" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[744]</span></a> Mr Baldry agreed that they should wait for the advice of SEAC.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn745" name="_ftnref745" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[745]</span></a></div>
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515<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hogg responded that he was concerned that the effectiveness of the SBO regulations could not be guaranteed: �We no longer had our belt and braces�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn746" name="_ftnref746" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[746]</span></a> Mr Hogg told the BSE Inquiry:</div>
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��once the belt had gone [ie. the absence of evidence of transmissibility], I did not think it was responsible or proper, as we were dealing with the serious issue of public health, to rely on the abattoir controls, because I did not believe they would be implemented fully and therefore I was determined to find another belt and the belt that I had found, which I had obviously found before this, was the 30 month rule, so I was determined to reinstate both and I was not going to be persuaded to take a different view because I thought it was my duty to put in place as comprehensive a set of public health controls as I could. And Mrs Browning I am glad to say agreed with me.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn747" name="_ftnref747" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[747]</span></a></div>
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516<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Packer also questioned whether an Inquiry was necessary, as MAFF �had given a full account to Parliament in relation to the 1990 Select Committee Report�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn748" name="_ftnref748" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[748]</span></a></div>
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517<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>It was agreed, however, that Mr Packer would draft a note to the Prime Minister with Mr Hogg�s two proposals.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn749" name="_ftnref749" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[749]</span></a></div>
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518<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>After this meeting, Mr Hogg, Mrs Browning, Mr Packer and Mr Carden discussed with Mr Meldrum, Mr Middleton and Mr Eddy the practical implications of Mr Hogg�s proposals.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn750" name="_ftnref750" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[750]</span></a> Mr Meldrum noted that there was a danger that Mr Hogg�s proposals might be seen as disproportionate to SEAC�s advice. �More generally, this would be the first time we had ever pre-empted the conclusions of the scientific experts.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn751" name="_ftnref751" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[751]</span></a> Mr Hogg said he wanted MAFF to be ready to introduce his measures, that it was important to be able to deal �with the situation which arose until such time as SEAC had given its considered advice�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn752" name="_ftnref752" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[752]</span></a> In regard to the age limit, Mr Meldrum noted that very few BSE cases had been found in under-2�-year-olds, and that the levels of infectivity of organs in those cases was low. It was also easy to identify cattle at this age from their teeth.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn753" name="_ftnref753" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[753]</span></a> Mr Hogg also said he was inclined to the option of withdrawing products from the market.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn754" name="_ftnref754" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[754]</span></a></div>
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519<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>After these meetings, Mr Packer submitted a draft minute for Mr Hogg to send to the Prime Minister (or Cabinet colleagues) on �extra measures� that would have to be taken to protect human health.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn755" name="_ftnref755" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[755]</span></a><b> </b>This draft included the suggestion that it was �essential� to adopt these extra measures �even though SEAC has not yet made definite recommendations�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn756" name="_ftnref756" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[756]</span></a> Mr Packer explained in his covering note that the draft followed the earlier discussions, save in one particular. Mr Packer thought that in relation to the plan �of removing all beef products from the food chain� the difficulties are almost insuperable and the potential cost enormous�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn757" name="_ftnref757" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[757]</span></a> Mr Packer said these difficulties seemed to render this element of the proposed interim response �disproportionate to an extent that it is not acceptable�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn758" name="_ftnref758" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[758]</span></a>.</div>
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520<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Details of the plan that Mr Packer was referring to, and the difficulties involved, were explained in more detail in a minute dated 18 March 1996 by Mr Hollis.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn759" name="_ftnref759" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[759]</span></a> Mr Packer had asked him for a �rapid assessment� of the implications of a ban on �the sale for human consumption of all beef from UK cattle of more than 2� years of age, including meat products�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn760" name="_ftnref760" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[760]</span></a> In his minute, Mr Hollis described the difficulties involved in recalling such meat.</div>
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�Small retailers, caterers and wholesalers will not know the age of their meat. The major supermarkets have sophisticated systems which permit them to know this information and most of their fresh meat comes from young animals. In theory they should not therefore be adversely affected in this area, but the strong likelihood is that they would withdraw all meat from their shelves, whatever the age of the animal from which it came. Customers may well return all the beef in their freezers. In practice it would be impossible to refuse the return of any meat or meat product because there would be no way of saying how old was the animal from which it came.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn761" name="_ftnref761" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[761]</span></a></div>
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521<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hollis� �conservative guess� of the costs involved in such a recall was �at least �1 billion�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn762" name="_ftnref762" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[762]</span></a></div>
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522<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>He also estimated the cost of compensation to producers for cull cows compulsorily slaughtered to be of the order of �350m per year plus a further �200m for slaughter and disposal costs.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn763" name="_ftnref763" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[763]</span></a> Mr Carden told the BSE Inquiry that the latter proved to be a reliable estimate of the costs involved in the �Over Thirty Month� (OTM) scheme that was implemented after 20 March 1996.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn764" name="_ftnref764" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[764]</span></a></div>
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523<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hogg had further discussions with Mr Meldrum which Mr Meldrum followed up with a minute the next day.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn765" name="_ftnref765" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[765]</span></a></div>
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524<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>At 1:00pm on 18 March<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn766" name="_ftnref766" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[766]</span></a>, Professor Pattison briefed Mr Hogg, Mr Boswell, Mrs Browning, Mr Packer and others on the background to SEAC�s 16 March advice.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn767" name="_ftnref767" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[767]</span></a> Professor Pattison told the meeting that</div>
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�It was clear that a new form of CJD had developed in the 1990s and � assuming it had not arisen spontaneously � that the relevant event had taken place in the mid to late 1980s. Although it was possible that there was some other factor, the Committee had concluded that the most likely explanation was BSE (Professor Pattison put the likelihood at 60%)�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn768" name="_ftnref768" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[768]</span></a></div>
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525<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Asked about the likely spread of the new disease, Professor Pattison said that:</div>
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��it was possible that the 9 cases were in some way special and that there would be no more. Alternatively, the disease might spread as with BSE in cats, with a number of cases � say, 4 or 5 � each year � its spread is unlikely be like that of BSE itself. The fact that cattle had been fed back to cattle had inevitably amplified that disease. However, it may be conceivable that humans might be particularly susceptible.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn769" name="_ftnref769" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[769]</span></a></div>
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526<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>He said that it would be clear �within about a year� how the disease would develop.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn770" name="_ftnref770" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[770]</span></a></div>
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527<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hogg asked what SEAC was likely to advise by way of response measures. Professor Pattison outlined a range of ideas but said that SEAC would not be in a position to advise until their meeting at the weekend (23-24 March). He said that some members felt that existing SBO controls would suffice �provided they were enforced in 99.9% of cases�, but that others were not sufficiently confident in the controls. Professor Pattison stressed the relative degrees of risk in cows older and younger than thirty months.</div>
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��on the worst case scenario, we could expect around 5,000 older cows (i.e. over 2 years) which were incubating the disease to reach the foodchain (although, of course, the SBO material would have been removed). Unfortunately, we could also expect around 24,000 infected young animals to reach the foodchain. However, older animals were likely to be at least 10 times more infectious than younger ones� Action on older animals was therefore likely to take out at least half the potential problem. Such action might involve either removing the animals from the foodchain altogether or insisting that the meat be boned out, with all lymphatic nodes and nerves being removed.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn771" name="_ftnref771" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[771]</span></a></div>
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528<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hogg said he was minded to take interim measures, including the prohibition on the sale of meat from cattle over 2 years of age, withdrawal of all beef products from the shelves and a ban on the export of such goods.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn772" name="_ftnref772" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[772]</span></a> Professor Pattison �was not at all surprised at the Minister�s intentions and understood his wish for a bigger margin of safety�. He described this option as �justifiable, logical and not irrational� and said �SEAC was likely to be debating conclusions of this very nature�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn773" name="_ftnref773" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[773]</span></a></div>
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529<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hogg was also minded to ban the use of MBM in all feed. Professor Pattison agreed, �particularly given the continuing risk of cross-contamination�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn774" name="_ftnref774" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[774]</span></a></div>
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530<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hogg told the BSE Inquiry</div>
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�I had come to a firm view and SEAC had not, but I wanted to be sure that it was in the spectrum of what Pattison thought that SEAC would be recommending and did not lie outside the spectrum. I did not think they would recommend anything more dramatic, but I did not want to be doing anything which was manifestly silly, so I was saying to Sir John [Pattison], "This is what I have in mind, I would like to test it with you". The phrase, as you can see at the top of the next page, "justifiable, logical and not irrational", was I was asking him whether I was subject to judicial review if I did it. I put the test to him as I understood it. That is how that conversation went�</div>
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�we had lost our belt. I knew therefore that there was a risk of transmissibility, or at least SEAC thought there was a risk of transmissibility and I was not going to depart from that view. I knew full well that the SBO controls were not adequate in my judgment. Therefore I had to put something else in place. I was testing out on him whether the 30 month rule was something that he thought was sensible, whether it fell within the spectrum of what he judged sound, and it did, he said so.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn775" name="_ftnref775" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[775]</span></a></div>
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Minute 1 is sent</div>
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531<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>After this meeting, at �around lunchtime�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn776" name="_ftnref776" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[776]</span></a>, the first minute to Mr Major was sent, from Mr Hogg and Mr Dorrell.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn777" name="_ftnref777" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[777]</span></a></div>
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532<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The submission alerted Mr Major to �a very serious development on BSE�. It explained that the CJD Surveillance Unit �appears to have identified a new variant� of CJD in young people in the UK, and that SEAC had �<u>concluded that exposure to BSE is the most likely explanation</u>�. Exposure �almost certainly� had been in the middle 1980s.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn778" name="_ftnref778" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[778]</span></a></div>
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533<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The note included an outline of DH and MAFF responsibilities:</div>
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DoH Responsibilities</div>
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<span style="font-family: Symbol;">�<span style="font-family: "Times New Roman"; font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span>Reassure public anxiety about the current safety of beef.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn779" name="_ftnref779" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[779]</span></a></div>
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<span style="font-family: Symbol;">�<span style="font-family: "Times New Roman"; font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span>Ask the Health and Safety Executive (HSE) to look at worker safety as a matter of urgency.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn780" name="_ftnref780" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[780]</span></a></div>
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MAFF Responsibilities</div>
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<span style="font-family: Symbol;">�<span style="font-family: "Times New Roman"; font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span>MAFF acknowledged that it faced a major crisis of confidence in British beef. The financial implications of that for individuals, companies and the Government would be severe. The beef industry�s output was valued in 1995 at �2 billion. It also accounted for investments probably running into the billions and the export market for calves (currently at 500,000 p.a.) would disappear.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn781" name="_ftnref781" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[781]</span></a></div>
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<span style="font-family: Symbol;">�<span style="font-family: "Times New Roman"; font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span>It was noted that MAFF�s responses would depend partly</div>
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�on SEAC�s recommendations and policy conclusions that will flow from them. We may, for example, even have to prevent cattle over the age of 2 [sic] from entering the human food chain. Some consequences are predictable: the reduction in consumption is likely to lead to large sales of beef from younger animals into intervention. Older ones� most of which are currently exported in the form of various cuts of beef, and which could be thought to present a greater risk of transmitting BSE� will become virtually unsaleable and we could face major problems of carcass disposal. The export market for calves (currently running at some 500,000 p.a.) could disappear. There are implications for slaughterhouses and other types of business. The financial implications for individuals, for companies and for [the Government] could be severe�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn782" name="_ftnref782" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[782]</span></a></div>
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<span style="font-family: Symbol;">�<span style="font-family: "Times New Roman"; font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span>�The milk industry is considerably bigger than the beef industry and because there is no reason to doubt the safety of milk, it is essential and right that nothing is said which undermines the confidence in the product.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn783" name="_ftnref783" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[783]</span></a></div>
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534<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The note suggested that a leak was increasingly possible and that there should be an announcement to the House and the public in next day or two.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn784" name="_ftnref784" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[784]</span></a></div>
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535<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>At 4:00pm,<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn785" name="_ftnref785" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[785]</span></a> Mr Hogg met Mr Michael Heseltine (Deputy Prime Minister).<b> </b>Mr Heseltine had seen the first submission from Messrs Hogg and Dorrell to the Prime Minister.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn786" name="_ftnref786" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[786]</span></a> He �asked about the implications� of slaughtering the entire national herd.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn787" name="_ftnref787" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[787]</span></a> Mr Hogg told the BSE Inquiry that he did not take this as Mr Heseltine�s considered view or suggestion, merely as a question that he �threw� out as a possibility�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn788" name="_ftnref788" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[788]</span></a></div>
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536<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Major had not yet seen the minute from Messrs Hogg and Dorrell. Mr Heseltine told the BSE Inquiry</div>
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�I took the unusual step of interrupting a meeting that the Prime Minister was holding and provided him with a summary of the information that had been provided to me by Mr Hogg. I drew Mr Major�s attention to the minute that had been prepared by Mr Hogg and Mr Dorrell�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn789" name="_ftnref789" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[789]</span></a></div>
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537<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Later on 18 March, Mr Packer submitted to Mr Hogg a revised draft of the second minute for the Prime Minister.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn790" name="_ftnref790" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[790]</span></a> The draft said that Mr Hogg proposed taking interim measures in advance of SEAC advice.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn791" name="_ftnref791" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[791]</span></a> It set out �the very minimum we can do�, which was to ban beef, beef products, the manufacture of products and exports from cattle over 2� years old.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn792" name="_ftnref792" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[792]</span></a></div>
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538<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In contrast to the earlier version,<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn793" name="_ftnref793" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[793]</span></a> the revised draft now included the proposal for the possible withdrawal of all beef products. It said that Mr Hogg favoured this proposal though he acknowledged the �enormous financial and other implications� and that a collective decision would be needed.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn794" name="_ftnref794" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[794]</span></a></div>
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539<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The revised draft minute also identified the possibility that Mr Hogg had discussed earlier with Mr Heseltine: that �the announcement we are about to make will finish the UK cattle industry for decades and we might as well accept the fact and order a complete slaughtering and restocking�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn795" name="_ftnref795" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[795]</span></a></div>
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540<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In his covering note to Mr Hogg, Mr Packer said that he regarded this measure, and �to a lesser extent� the beef withdrawal proposal, as �disproportionate and unjustified�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn796" name="_ftnref796" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[796]</span></a> Mr Packer told the BSE Inquiry that he viewed this as a �possible prelude to my seeking an Accounting Officer Direction if such a policy were decided upon�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn797" name="_ftnref797" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[797]</span></a> As the Accounting Officer for MAFF, Mr Packer was responsible for the Ministry�s spending. To seek such a Direction would mean that he was advising against the expenditure and would not implement it without a specific instruction to do so from the Minister.</div>
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541<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The revised draft also now included the recommendation for a formal Inquiry into the BSE issue by a High Court judge.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn798" name="_ftnref798" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[798]</span></a></div>
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542<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>This draft note was similar to the version that Mr Hogg eventually sent to Mr Major in the evening of 18 March.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn799" name="_ftnref799" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[799]</span></a></div>
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543<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The same day (18 March) Mr Packer minuted Mr Hogg about the implications of a �possible collapse of the beef market�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn800" name="_ftnref800" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[800]</span></a> He attached a note that had been prepared by Mr Cowan, discussing �arrangements for supporting the beef market under current EC rules and analysing what the implications might be for the situation with which we are likely to be faced�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn801" name="_ftnref801" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[801]</span></a> The note discussed various options for supporting the beef market, including intervention buying, a calf slaughter scheme, and an over 30 month slaughter scheme.</div>
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DH</div>
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544<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the same day in the Department of Health, Sir Kenneth Calman held a meeting of health officials. Dr Rubery telephoned David Salisbury about vaccines, Jenny Bacon, Chief Executive of the Health and Safety Executive (HSE) about occupational aspects, Drs Jones and Jefferys at MCA, Professor Swales� office about research needs and the Medical Research Council (MRC) about their input. The Medical Devices Agency (MDA) were also informed.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn802" name="_ftnref802" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[802]</span></a></div>
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545<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Rubery and Sir Kenneth between them identified the persons they regarded as important medical professionals who should be informed in advance about the latest findings. These included Dr Tyrrell, Sir Richard Southwood and Sir Donald Acheson<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn803" name="_ftnref803" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[803]</span></a>.</div>
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546<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In the afternoon, Mr Dorrell met Sir Kenneth, Sir Graham Hart, Dr Rubery and others. At 7:15pm<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn804" name="_ftnref804" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[804]</span></a> they were joined by Mr Hogg and MAFF officials.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn805" name="_ftnref805" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[805]</span></a> Mr Hogg set out his proposals for a ban on beef older than 2� years, and an Inquiry into the Government�s response to BSE. Sir Kenneth set out the consequences for DH of the findings, which included investigations into the safety of non-food beef products (for example, vaccines) and communication with health professionals so that information could be passed on to the public. Mr Dorrell repeated his views that there was no need for a separate �helpline� to be set up but that existing lines be bolstered by extra staff, and that there should be no compensation for nvCJD victims because the Government had all times followed the advice of its committees.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn806" name="_ftnref806" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[806]</span></a></div>
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Minute 2 is sent</div>
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547<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>After this meeting, the second minute to the Prime Minister was submitted.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn807" name="_ftnref807" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[807]</span></a> In it, Mr Hogg proposed taking interim measures in advance of SEAC advice:</div>
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�The balance of probability concerning the transmissibility of BSE to man has been fundamentally altered by the SEAC statement. It is right to act now to protect and be seen to protect the public further. The likely Parliamentary and public perceptions point the same way. I would propose to explain to the House that such measures were interim and awaited definitive SEAC advice before being confirmed or amended. Obviously though it would be sensible to work with the trend of the discussions in SEAC. This, following a conversation I have had with Professor Pattison, I have sought to do in the following proposal.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn808" name="_ftnref808" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[808]</span></a></div>
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548<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>He proposed �the very minimum we can do�:</div>
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�(i) banning the sale of beef and beef products derived from animals from UK herds and from animals over 2� years of age;</div>
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�(ii) banning the manufacture of products from bovine material from animals from UK herds and from animals over 2� years of age;</div>
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�(iii) banning the export of such beef and beef products�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn809" name="_ftnref809" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[809]</span></a></div>
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549<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The minute proposed the possible withdrawal of all beef products. It said that Mr Hogg favoured this proposal though he acknowledged the �enormous financial and other implications� and that a collective decision would be needed.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn810" name="_ftnref810" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[810]</span></a></div>
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550<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hogg estimated that compensation for owners of cattle over 2� years old �could amount to somewhat in excess of �500m.p.a.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn811" name="_ftnref811" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[811]</span></a></div>
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551<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The minute also identified �a much more cataclysmic view. On this basis the announcement we are about to make will finish the UK cattle industry for decades and we might as well accept the fact and order a complete slaughtering and restocking�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn812" name="_ftnref812" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[812]</span></a></div>
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552<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The minute also recommended a formal Inquiry into the Government�s reaction to BSE, chaired by a High Court judge.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn813" name="_ftnref813" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[813]</span></a></div>
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Cabinet</div>
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553<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In the late evening of Monday 18 March, Mr Hogg and Mr Dorrell met the Prime Minister, other members of Cabinet, and officials to discuss the two minutes that had been circulated that day.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn814" name="_ftnref814" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[814]</span></a> Among other things, Mr Hogg pointed out that �Once one admitted the possibility of transmissibility to humans, then one had equally to admit that controls were ineffective. Controls had been tightened in 1995 but those controls continued to be breached�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn815" name="_ftnref815" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[815]</span></a></div>
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Tuesday 19 March 1996</div>
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554<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the morning of 19 March, Mr Dorrell met Sir Kenneth Calman and Dr Rubery before attending a meeting chaired by the Prime Minister.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn816" name="_ftnref816" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[816]</span></a></div>
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555<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also before the meeting, Mr Kenneth Clarke, Chancellor of the Exchequer, who was not present at the meeting, minuted Mr Major with his views. He said �the Government should make public as rapidly as possible the full facts it has at its disposal�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn817" name="_ftnref817" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[817]</span></a><b> </b>He said that any action which the Government took must be proportionate to the risk to public health: �We want to be in a position in 4 weeks time whereby intelligent people can look back and say that the Government�s actions were measured and sensible, and not an absurd over-reaction which made things worse�. He noted that the �behaviour of the Government following the salmonella and listeria crises [when he was Secretary of State for Health] are widely seen to have been foolish and excessive, causing lasting damage to British agriculture�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn818" name="_ftnref818" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[818]</span></a> He compared the risk to other risks such as smoking, and said</div>
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�I would regard a complete ban on beef products, or the culling of the beef and dairy herds, as completely over the top. Moreover, I suspect the general public would soon take a similar view, faced with endless media coverage of burning cattle piled high on funeral pyres�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn819" name="_ftnref819" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[819]</span></a></div>
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556<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Clarke emphasised that his perspective was �not based simply on the potential public expenditure implications,� but on his view that �the duty of the Government is to give a responsible and calm lead to public opinion in the face of disturbing events�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn820" name="_ftnref820" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[820]</span></a></div>
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557<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Major chaired a �large and long�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn821" name="_ftnref821" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[821]</span></a> meeting of Ministers, with Professor Pattison present. Mr Hogg presented his proposals:</div>
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��we had to date adopted a belt and braces approach. The belt being that there was no risk of transferability from cattle to humans, the braces being that SBO controls were in place should such an unlikely event occur. Now that there was thought to be the likelihood of a link between cattle and humans, the belt had been removed leaving only the braces� The panic which would ensue from any statement would destroy the beef industry� It might be possible to save it if a firebreak could be erected and he had offered the best advice he could. He commented that the difficulty was that we knew that SBO controls were not wholly adequate and in the changed circumstances of the new information this made the Government�s position untenable.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn822" name="_ftnref822" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[822]</span></a></div>
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558<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Major said that taking drastic action in advance of further advice would �make the Government look silly and would open it to significant legislation [sic] if premature action was taken�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn823" name="_ftnref823" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[823]</span></a> Mr Hogg�s proposals were rejected by the meeting. Mr Hogg accepted the collective decision.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn824" name="_ftnref824" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[824]</span></a></div>
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559<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Professor Pattison explained SEAC's conclusions but would not be drawn into giving advice in advance of SEAC's meeting scheduled for the weekend, on the wide range of measures which might be introduced in response to this development. Ministers agreed that any statement had to include substantive recommendations and an early meeting of SEAC was therefore �encouraged�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn825" name="_ftnref825" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[825]</span></a></div>
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SEAC Meeting 28</div>
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560<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>After that meeting, Dr Rubery went to assemble as many SEAC members as could be found at such short notice. The meeting started at 4:00pm. A number of members who could not be present were kept in telephone contact with the discussions.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn826" name="_ftnref826" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[826]</span></a> Present in London were Professors Pattison, Almond and Smith. Dr Will and Professor Collinge were there �for part of the meeting�. Mr Bradley and Dr Kimberlin participated via a telephone link to Paris. Observing were Drs Matthews and Wight. Messrs Eddy and Skinner (Secretariat) were there. �In attendance� were Dr Kendell, Mr Robb, Mr G Ross (MAFF), Dr Rubery, and Mr Wilesmith. Sir Kenneth Calman and Mr Meldrum attended for part of the meeting.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn827" name="_ftnref827" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[827]</span></a></div>
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561<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Professor Pattison explained that the meeting would focus on the adequacy of existing control measures to protect animal and human health. SEAC agreed that matters requiring detailed consideration in the light of new information would need to be dealt with at the meeting on 23 March.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn828" name="_ftnref828" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[828]</span></a></div>
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562<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Will said that a 10<sup>th</sup> case had been confirmed, in a 20-year-old.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn829" name="_ftnref829" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[829]</span></a></div>
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563<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>SEAC felt there was no evidence that milk could act as a vehicle for BSE or other TSEs. Also, slaughtering the entire UK beef herd was not considered a justifiable course of action in the light of scientific evidence.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn830" name="_ftnref830" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[830]</span></a></div>
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564<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Information from Mr Wilesmith indicated that �onset� of BSE in cattle under 2� years old was extremely rare. Professor Smith calculated that there could be a possible 500-fold reduction in risk if cattle over 2� years old were removed from the food chain.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn831" name="_ftnref831" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[831]</span></a></div>
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565<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The option of de-boning beef was also discussed.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn832" name="_ftnref832" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[832]</span></a></div>
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566<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 19 March, Mr Baldry sent Mr Hogg two minutes, copied to Mr Boswell, Mrs Browning and Mr Packer. The first expressed his view that MAFF should not act without the advice of SEAC. He said there was no reason to announce more than that the Government were expecting further recommendations from SEAC on which they would seek to act:</div>
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�I� feel very strongly that for Ministers to indicate action now in advance of any SEAC recommendation has every possibility of being �over-reaction� and to lead to much more draconian consequences than in the event are necessary, for which the government and Ministers will attract opprobrium�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn833" name="_ftnref833" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[833]</span></a></div>
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567<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>In his second minute Mr Baldry gave his opinion on the legal implications of three matters that Mr Hogg had raised with him. On the first, compensation, he advised that at �the very minimum, it should be full market value compensation for cattle which cannot otherwise be sold, but there is no way in this situation that we can just compensate farmers and no-one else�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn834" name="_ftnref834" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[834]</span></a></div>
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568<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>On the question of a BSE Inquiry, Mr Baldry considered that this would be �likely to undermine confidence in SEAC�. It was best to invite members of certain Royal Colleges to examine �whether the right terms of reference have been given to SEAC i.e. are they sufficiently broad�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn835" name="_ftnref835" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[835]</span></a> He noted that setting up any other kind of Inquiry �would almost certainly imply political acceptance of fault on the part of MAFF. As we have fully complied with all scientific advice so far this seems unnecessary, setting us off on the back foot�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn836" name="_ftnref836" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[836]</span></a></div>
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569<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Thirdly, Mr Baldry �strongly� recommended that MAFF should not make an Order until they knew SEAC�s recommendations. This was because laying an Order under the Food Safety Act</div>
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�requires asserting imminent risk of injury to health. That immediately would signal that we have no confidence in the existing control measures, goes way beyond what SEAC has said and runs the risk of MAFF being involved in litigation for some very considerable time�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn837" name="_ftnref837" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[837]</span></a></div>
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570<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Just before a 6:30pm meeting (below), Mr Hogg had a brief meeting with his junior Ministers, Mr Packer, Mr Carden, Mr Haddon, Mr Taylor and Mr Blakeway.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn838" name="_ftnref838" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[838]</span></a> They discussed Mr Baldry�s minute. Mr Baldry stressed that �it would be a mistake to pre-empt SEAC�,<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn839" name="_ftnref839" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[839]</span></a> and Mr Boswell �stressed the need not to lead SEAC in any way�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn840" name="_ftnref840" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[840]</span></a> Mr Carden noted the need not to place SEAC under �unreasonable time pressure�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn841" name="_ftnref841" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[841]</span></a><b></b></div>
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571<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>At 6:30pm Mr (later Lord) Anthony Newton (Lord President of the Council) chaired a meeting with Ministers including Mr Dorrell, Mr Hogg, Mrs Browning, Mr Forsyth and Mr Hague. They agreed that there would be an announcement in the House the next day. They also agreed that SEAC should be asked to provide urgent advice by 10:30 the next morning.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn842" name="_ftnref842" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[842]</span></a></div>
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572<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The notes of this meeting record that Mr Fischler had already been �warned� and that he would be telephoned again before the statement was made in the House.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn843" name="_ftnref843" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[843]</span></a></div>
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573<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Robert Lowson (formerly Head of the Animal Health (Disease Control) Division of MAFF) was now the �Agriculture Minister� at the UK Permanent Representation to the European Union in Brussels (UKRep). On 19 March, two officials (Mr Cameron (SOAFED) and Ms Kate Timms (a MAFF Deputy Secretary)) told him about the imminent announcement, but added that they had no authority yet to inform the European Commission. Mr Lowson said</div>
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�This was the first I had heard of this; UKRep had not been involved in any discussion of handling at European level. I spoke to MAFF (Mr Carden) to emphasise the importance of ensuring that the Commission had advance warning and reported accordingly to senior colleagues in UKRep.�<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn844" name="_ftnref844" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[844]</span></a></div>
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574<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Rubery relayed requests for further advice from the meeting chaired by Mr Newton back to the SEAC meeting.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn845" name="_ftnref845" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[845]</span></a> She also went to No. 10 Downing Street at about 10:00pm to brief Mr Major about the latest developments. He wanted to know what conclusions SEAC appeared likely to reach.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn846" name="_ftnref846" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[846]</span></a></div>
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575<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Heseltine telephoned Mr Dorrell that evening. He felt that given the concern about health, it was time to break with precedent and that tomorrow�s statement should be made by the Health Secretary, not by the Agriculture Minister.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn847" name="_ftnref847" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[847]</span></a><b></b></div>
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576<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>At 10:30pm SEAC had not reached final conclusions on all issues. Members agreed to reconvene at 8:00 the next morning.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn848" name="_ftnref848" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[848]</span></a></div>
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577<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>A number of other matters also occurred on 19 March 1996:</div>
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578<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Meldrum advised Mr Hogg that the proposed ban on beef from cattle more than 2� years of age should be described as interim because SEAC might take the view that the meat from such cattle could safely be put on the market for human consumption, provided it was first deboned. Mr Meldrum favoured �the banning of head meat from all cattle�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn849" name="_ftnref849" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[849]</span></a></div>
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579<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hollis (Livestock Group) estimated the cost of slaughtering the entire national herd. Mr Heseltine had asked Mr Hogg about this option the previous evening. The estimate was based principally on the value of milk that would be lost (value of milk production per year multiplied by 5, this being Mr Hollis� estimate of the number of years it would take milk production to return to normal). Mr Hollis remarked that the cost of such a slaughter programme would seem likely to �comfortably exceed �20 billion in the dairy section alone�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn850" name="_ftnref850" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[850]</span></a></div>
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580<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 19 March, Dr Rubery and other officials met with representatives of the MLC to discuss the �consequences and how one might handle things on 20 March�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn851" name="_ftnref851" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[851]</span></a></div>
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581<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr S M Ludgate of the MCA minuted Dr Wight with the point that: �Animal tissues and substances of animal origin derived from cattle, used in medical devices in the Health Service, are all sought from animals located outside the UK, predominately Australia and America�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn852" name="_ftnref852" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[852]</span></a></div>
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582<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Dr Painter sent a fax on 19 March to Dr Wight with a detailed set of questions and answers, presumably to be used in dealing with the media.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn853" name="_ftnref853" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[853]</span></a> Also, Mr Robb faxed a (different) set of questions and answers to Mr Skinner, with Dr Render�s comments in manuscript.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn854" name="_ftnref854" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[854]</span></a></div>
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583<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also that day, Mr Packer drafted a statement for Mr Hogg to make to Parliament. It left open the question of new protective measures pending the imminent advice from SEAC.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn855" name="_ftnref855" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[855]</span></a></div>
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Wednesday 20 March 1996</div>
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584<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Fears that the news would leak were realised on the morning of 20 March 1996, with newspapers reporting that Mr Dorrell was expected to announce today that there might be a risk of humans contracting a form of BSE from infected meat. The <i>Daily Mirror </i>said</div>
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�Humans could catch Mad Cow Disease from eating infected beef, the government will admit today.</div>
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�Health Secretary Stephen Dorrell will accept for the first time that the brain wasting disease may have been passed to people from infected animals.</div>
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�The U-turn by Ministers � who for 10 years have insisted it was impossible � will spark calls for tough new curbs on suspect meat��<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn856" name="_ftnref856" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[856]</span></a><b></b></div>
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585<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>That morning Sir Kenneth Calman prepared a first draft of his statement before attending the resumed meeting of SEAC.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn857" name="_ftnref857" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[857]</span></a></div>
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586<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>SEAC recommenced its meeting at 8:00am. Present in London were Professors Pattison, Almond, Smith and Collinge, Mr Pepper and Dr Painter. Dr Kimberlin and Mr Bradley were to return from Paris that morning, but the flight was cancelled.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn858" name="_ftnref858" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[858]</span></a> The telephone link to Paris was re-established at 8:45am. Dr Will had gone back to Edinburgh and he too participated by telephone, from 8:50am.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn859" name="_ftnref859" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[859]</span></a> Dr Matthews continued as an observer. Messrs Eddy and Skinner (Secretariat) were there. In attendance were Dr Rubery, Mr Wilesmith, Lord McColl (Mr Major�s private secretary) and Dr Render. Sir Kenneth Calman and Mr Meldrum attended for part of the meeting.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn860" name="_ftnref860" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[860]</span></a></div>
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587<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>SEAC resumed their discussion of the deboning option as �the best way forward�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn861" name="_ftnref861" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[861]</span></a> They also considered the option of removing from the food chain materials which would have been banned from human consumption, and decided against this �in view of the extreme precautionary nature of [SEAC�s] recommendations�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn862" name="_ftnref862" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[862]</span></a> On their 16 March recommendation to ban all MBM in farm animal feed,<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn863" name="_ftnref863" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[863]</span></a> they decided there was no need to ban MBM in pet foods or fertilisers.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn864" name="_ftnref864" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[864]</span></a> They also discussed worker safety.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn865" name="_ftnref865" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[865]</span></a></div>
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588<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>At 9:30am Mr Hogg was �informed of initial (but still uncertain) indications � received by telephone � of SEAC�s likely advice�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn866" name="_ftnref866" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[866]</span></a></div>
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589<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>SEAC finished their meeting and produced their final statement at 9:30am.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn867" name="_ftnref867" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[867]</span></a> The statement emphasised that �it is imperative that current measures to protect the public health are properly enforced and [we] recommend constant supervision to ensure the complete removal of spinal cord.� It also recommended:</div>
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�a.�� that carcasses from cattle aged over 30 months must be deboned in licensed plants supervised by the Meat Hygiene Service and the trimmings must be classified as SBOs.</div>
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�b.�� a prohibition on the use of mammalian meat and bonemeal in feed for all farm animals.<b><u><o:p></o:p></u></b></div>
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�c.�� that HSE and ACDP, in consultation with SEAC should urgently review their advice in the light of these findings.<b><u><o:p></o:p></u></b></div>
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�d.�� that the Committee urgently consider what further research is necessary�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn868" name="_ftnref868" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[868]</span></a><b><u><o:p></o:p></u></b></div>
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590<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>After this, Sir Kenneth redrafted his statement.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn869" name="_ftnref869" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[869]</span></a></div>
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591<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hogg discussed the recommendations briefly with Mr Packer and Mr Carden. He said that �we should do no more and no less than SEAC was recommending�. It was noted that the orders would not be under the emergency provisions of the Food Safety Act and would therefore need to be consulted on.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn870" name="_ftnref870" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[870]</span></a></div>
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592<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hogg also noted that since there was no product recall, there would be no need to decide immediately on issues around compensation. �We would, however, need to consider the mechanisms for providing for MAFF-approved plants for deboning�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn871" name="_ftnref871" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[871]</span></a></div>
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593<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Major convened a meeting of Cabinet Ministers at No. 10 at around 10:45am which lasted until after noon. Sir Kenneth and Professor Pattison attended for the first part of the meeting and presented SEAC�s advice.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn872" name="_ftnref872" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[872]</span></a> After they had left, Cabinet discussed and accepted SEAC�s advice. They decided that Mr Dorrell should make the opening statement and Mr Hogg should follow with a statement on the agricultural implications. They also decided that the Opposition should be offered a briefing from Sir Kenneth, and Sir Robin Butler was asked to arrange this.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn873" name="_ftnref873" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[873]</span></a></div>
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594<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>At lunchtime, Mr Packer, Sir Kenneth, and Sir Robin Butler briefed the Opposition spokespeople on health and agriculture on the background to the announcements to be made that afternoon. Mr Packer was concerned when Sir Kenneth �speculate[d]� during the briefing that, despite SEAC�s official advice, some members of SEAC might prefer their own children and grandchildren not to eat beef. Mr Packer inferred that this was Sir Kenneth�s own position. Mr Packer noted that Ms Harriet Harman�s (Opposition spokesperson on Health) interest was attracted by this comment.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn874" name="_ftnref874" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[874]</span></a></div>
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595<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>After the Cabinet meeting Mr Dorrell went to his office to prepare his statement. Dr Rubery and other DH officials helped him. Mr Dorrell told the BSE Inquiry that in the course of preparing his statement,</div>
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�I was reminded of speculation in the press that children were at particular risk of infection from BSE. I asked the Chief Medical Officer what his advice was. He told me that he did not feel qualified to respond. Since it was clear that I would be (and indeed was) asked the question, I asked the CMO to ensure that SEAC considered this specific question at the further meeting which they planned to hold over the weekend�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn875" name="_ftnref875" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[875]</span></a></div>
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596<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Sir Kenneth also prepared a further redraft of his statement.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn876" name="_ftnref876" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[876]</span></a></div>
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597<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Packer had the previous day prepared a statement for Mr Hogg to make to Parliament.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn877" name="_ftnref877" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[877]</span></a> Following the decision that Mr Dorrell should make the main statement, Mr Packer drafted an alternative version for Mr Hogg which was delivered broadly as drafted (see below).<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn878" name="_ftnref878" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[878]</span></a></div>
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598<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>A note was sent from the Prime Minister�s office to MAFF, copied to DH, outlining two points that Mr Major wanted to see brought out in any statements that were made that day. The first was that there was no <i>proven</i> link between BSE and CJD. All that had happened was that �the balance of probabilities has now shifted in the light of new evidence. The Prime Minister feels it is important to emphasise this so as to explain earlier statements about there being no scientific evidence of such a link�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn879" name="_ftnref879" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[879]</span></a></div>
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599<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>The second point was that the scientists whose advice the Government had received should be named. �The Prime Minister feels that simply to say �we are advised� will sound very weak when there will be other scientists prominently saying �we told you so��.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn880" name="_ftnref880" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[880]</span></a></div>
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600<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hogg told the BSE Inquiry that he did not remember this note. He did not use the particular phrasing in it. He made his statement to the House in his own words.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn881" name="_ftnref881" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[881]</span></a></div>
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601<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Earlier in the morning of 20 March, Mr Carden had telephoned Mr Lowson (UKRep) and the UK Embassy at Bonn to brief them about the breaking story.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn882" name="_ftnref882" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[882]</span></a> Later, he faxed the text of Mr Hogg�s statement to Mr Lowson, and followed this up with a telephone call.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn883" name="_ftnref883" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[883]</span></a></div>
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602<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>UK Embassies at Paris and Dublin were also informed individually.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn884" name="_ftnref884" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[884]</span></a> Other UK Embassies were sent a telex via the Foreign and Commonwealth Office (FCO).<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn885" name="_ftnref885" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[885]</span></a></div>
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603<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>It was Mr Hogg�s intention to inform Mr Fischler, who had earlier been warned of the developments,<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn886" name="_ftnref886" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[886]</span></a> by telephone.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn887" name="_ftnref887" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[887]</span></a> He did so at 2:30pm.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn888" name="_ftnref888" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[888]</span></a></div>
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604<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Dorrell made his statement in Parliament at 3:30pm. Mr Hogg�s statement followed.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn889" name="_ftnref889" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[889]</span></a></div>
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605<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Dorrell�s statement reported the new findings of the CJD Surveillance Unit and the view that SEAC had reached on those: �the most likely explanation at present is that [the 10 cases of CJD� identified in people aged under 42] are linked to exposure to BSE before the introduction of the specified bovine offal ban in 1989�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn890" name="_ftnref890" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[890]</span></a></div>
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606<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>He went on to explain the recommendations that SEAC had made on research and on food safety: �the Committee has concluded that the risk from eating beef is now likely to be extremely small and there is no need for it to revise its advice on the safety of milk�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn891" name="_ftnref891" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[891]</span></a></div>
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607<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Dorrell said that the CMO would write today to all doctors. He quoted from the CMO�s statement, in which Sir Kenneth said that he would continue to eat beef �as part of a varied and balanced diet�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn892" name="_ftnref892" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[892]</span></a></div>
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608<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Dorrell then referred to the particular question that had �arisen about the possibility that children are more at risk of contracting CJD.� He said he had asked for specific advice from SEAC on this issue.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn893" name="_ftnref893" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[893]</span></a> He told the BSE Inquiry that he referred to this issue because he was aware of speculation in the press that children were at particular risk of infection from BSE.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn894" name="_ftnref894" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[894]</span></a></div>
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609<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>After Mr Dorrell�s statement, Mr Hogg in a shorter statement explained SEAC�s recommendations for action by the agriculture departments, namely that:</div>
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(i.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>carcasses from cattle aged over 30 months must be deboned in specially licensed plants supervised by the MHS, and the trimmings kept out of any food chain; and</div>
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(ii.)<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>mammalian MBM be banned in feed for all farm animals.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn895" name="_ftnref895" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[895]</span></a></div>
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610<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hogg confirmed that the Government had accepted these recommendations and would put them into effect as soon as possible; and that with immediate effect he had instructed that existing controls in slaughterhouses and other meat plants and feed mills should be more vigorously enforced. He did not refer to a beef withdrawal scheme.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn896" name="_ftnref896" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[896]</span></a></div>
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611<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Mr Hogg also pointed out that �the Government�s Chief Medical Officer advises us that there is no scientific evidence that BSE can be transmitted to man by beef�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn897" name="_ftnref897" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[897]</span></a></div>
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612<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>That day, statements were released by SEAC<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn898" name="_ftnref898" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[898]</span></a> and by Sir Kenneth Calman.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn899" name="_ftnref899" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[899]</span></a></div>
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613<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>There was a press conference at 5:30pm. At the same time, Mrs Browning held a meeting with industry representatives to discuss the announcement.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn900" name="_ftnref900" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[900]</span></a></div>
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614<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>Also on 20 March 1996, Mr Hogg wrote to the German Health Minister to advise him of that day�s announcements and to �let you know that I am keen we should continue to keep you fully informed�.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn901" name="_ftnref901" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[901]</span></a></div>
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615<span style="font-size: 7pt; font-stretch: normal; line-height: normal;"> </span>SEAC met again on the weekend of 23-24 March to give advice on children in the light of the research findings and on several other issues.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn902" name="_ftnref902" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[902]</span></a> Mr Dorrell made a further statement on the safety of beef for children on 25 March 1996.<a href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn903" name="_ftnref903" title=""><span class="MsoFootnoteReference" style="vertical-align: super;">[903]</span></a></div>
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Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-4687453285836897153.post-63546105144246129202017-08-01T16:18:00.001-05:002017-08-04T11:10:05.201-05:00BSE INQUIRY DFA 17 Medicines and medical devices<div style="font-family: arial; font-size: 13.3333px;">
DFA 17<br />
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� Medicines and medical devices<br />
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Draft Factual Accounts<br />
������������������������������������������� ���������<br />
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6 October 1999<br />
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This is one of a series of documents intended to provide an account as at the date of publication of the factual evidence received by the Inquiry. The documents do not make any judgements about the implications of the facts or point to any conclusions. They are simply working drafts seeking in a neutral way to set out relevant evidence. They do not contain any expressions of opinions by the Secretariat or the Committee of the Inquiry. The series will only cover certain areas of the evidence.<br />
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The DFAs may contain inaccuracies and omissions. The purpose of publishing them is to invite corrections, additions and comments. The Inquiry has received suggestions for such corrections and additions in relation to DFAs already published. This is helpful in furthering the work of the Inquiry; all suggestions are considered and used to update the Secretariat�s working papers which will form the basis of the Committee�s Report in due course. The DFAs should not be treated as setting out a complete and accurate appreciation of the relevant facts.<br />
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You are invited to let the Secretariat know of any errors, inaccuracies or material omissions in this DFA. It would be helpful if you could distinguish suggested amendments to the DFA from more general comments which would not involve such amendment. Please write to:<br />
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������������������<br />
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The Secretary</div>
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The BSE Inquiry</div>
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6th Floor</div>
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Hercules House</div>
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Hercules Road</div>
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London SE1 7DU</div>
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Email to : inquiry@bse.org.uk<br />
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Responses should reach the Secretariat by 6 November 1999 for them to be assistance to the Inquiry.</div>
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Medicines and medical devices</div>
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Introduction............................................................................................................................ 4</div>
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A summary of the legislative requirements for medicinal products and medical devices����� 4</div>
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Legislation on medicinal products.................................................................................... 6</div>
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European regulation................................................................................................................. 7</div>
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UK Regulation before January 1995...................................................................................... 9</div>
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The licensing authority............................................................................................................ 9</div>
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The Medicines Commission and other bodies under the 1968 Act.................................. 10</div>
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Product licences.................................................................................................................... 14</div>
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Products requiring a product licence - �medicinal products�............................................. 15</div>
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Granting, renewing, suspending, revoking and varying licences........................................ 19</div>
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Confidentiality....................................................................................................................... 21</div>
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Provision of information....................................................................................................... 21</div>
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UK Regulation since January 1995...................................................................................... 22</div>
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Legislation relating to medical devices......................................................................... 23</div>
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Legislation relating to homoeopathic products........................................................... 26</div>
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The Joint Committee on Vaccination and Immunisation (JCVI).............................. 27</div>
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Structure of agencies with responsibility for medicines and medical devices...... 28</div>
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Medicines Division/ Medicines Control Agency............................................................... 28</div>
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Function.................................................................................................................................. 28</div>
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Structure of the Medicines Division/MCA � administrative and professional staff, their roles and responsibilities............................................................................................... 28</div>
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Relationship between the Medicines Division/MCA and the Advisory Committees...... 35</div>
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Communication with Ministers............................................................................................ 37</div>
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Relationship between the Medicines Division/MCA and the Chief Medical Officer..... 40</div>
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Supplies Technology Division/Medical Devices Directorate/Medical Devices Agency 41</div>
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Function.................................................................................................................................. 41</div>
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Structure of the Supplies Technology Division/Medical Devices Directorate/Medical Devices Agency - their roles and responsibilities.............................................................................. 41</div>
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Veterinary Medicines Directorate....................................................................................... 43</div>
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Structure of the Veterinary Medicines Division � administrative and professional staff, their roles and responsibilities............................................................................................... 43</div>
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Chronology of events.......................................................................................................... 47</div>
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Early Consideration............................................................................................................... 48</div>
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1988........................................................................................................................................ 56</div>
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March 1988............................................................................................................................ 59</div>
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First reactions........................................................................................................................ 59</div>
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Southwood Committee: first meeting.................................................................................. 69</div>
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Medicines Division Review.................................................................................................. 78</div>
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Southwood Committee: second meeting........................................................................... 104</div>
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Southwood Committee: third meeting............................................................................... 111</div>
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1989...................................................................................................................................... 114</div>
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Joint CSM/VPC Guidelines considered............................................................................ 115</div>
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Southwood Committee: fourth meeting............................................................................ 126</div>
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Prelude to publication of the Southwood Report............................................................. 127</div>
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Cabinet consideration.......................................................................................................... 145</div>
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The Southwood Report........................................................................................................ 146</div>
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The Joint Guidelines............................................................................................................ 149</div>
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Issue of guidelines to holders of licences for human medicinal products..................... 151</div>
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Issue of guidelines to holders of licences for veterinary medicines.............................. 153</div>
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Issue of guidelines regarding medical devices.................................................................. 154</div>
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The Tyrrell Committee........................................................................................................ 157</div>
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Response to questionnaire.................................................................................................. 160</div>
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Risk to humans..................................................................................................................... 173</div>
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The BSE Working Group (on human medicinal products): first meeting...................... 180</div>
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1990...................................................................................................................................... 198</div>
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BSE Working Group: second meeting............................................................................... 200</div>
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Other routes of transmission (SEAC: first meeting)....................................................... 204</div>
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Agriculture Select Committee........................................................................................... 206</div>
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BSE Working Group: third meeting................................................................................... 209</div>
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Spongiform Encephalopathy in a pig.................................................................................. 212</div>
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BSE Working Group: fourth meeting................................................................................ 214</div>
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1991...................................................................................................................................... 218</div>
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1992...................................................................................................................................... 220</div>
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BSE Working Group: fifth meeting................................................................................... 221</div>
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1993...................................................................................................................................... 224</div>
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1994...................................................................................................................................... 224</div>
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1995...................................................................................................................................... 225</div>
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1996...................................................................................................................................... 225</div>
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<br />
Introduction<br />
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1. This draft factual account details certain aspects of the story relating to BSE and medicines, in particular:<br />
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(i.) Initial notification of BSE to Department of Health and Medicines Division<br />
<br /></div>
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(ii.) Action taken by those responsible for the safety of human medicines, veterinary medicines, and medical devices, in response to the emergence of BSE, leading to the issue of joint CSM/VPC guidelines.<br />
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(iii.) Medicines aspects of the report of the Southwood Working Party.<br />
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(iv.) Medicines aspects of the first interim report of the Tyrrell Committee.<br />
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(v.) Action taken by MD/MCA, VMD and MDD to ensure compliance with the guidelines by manufacturers, including in relation to existing stocks.<br />
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(vi.) The actions and recommendations of the CSM�s BSE Working Party.<br />
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(vii.) Medicines and the introduction of the specified bovine offal ban.<br />
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It also includes sections summarising the relevant legislation, departmental structures, and bodies and individuals involved.<br />
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Many meetings dealing with BSE involved discussion of a variety of issues.� In this draft factual account, the aspects of meetings that have been highlighted focus on medicines and medical devices, even if other issues were discussed.<br />
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A summary of the legislative requirements for medicinal products and medical devices<br />
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2. Before 1 January 1995, the essential framework for regulating medicinal products in the UK was set by the Medicines Act 1968[1] (�the 1968 Act�). Central to the 1968 Act is a licensing system. In summary, that system inter alia prohibits the sale or supply of a medicinal product, except in accordance with a licence (referred to as a �product licence�), prohibits the manufacture of a medicinal product, except in accordance with a licence (referred to as a �manufacturer�s licence�), and prohibits the distribution by way of wholesale dealing of medicinal products, except in accordance with a licence (referred to as a �wholesale dealer�s licence�).<br />
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3. The licensing requirements of the 1968 Act relate to medicinal products, that is substances or articles for use wholly or mainly by being administered to human beings or animals for medicinal purposes.[2] Medicinal purposes are:<br />
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�a) treating or preventing disease;<br />
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b) diagnosing disease or ascertaining the existence, degree or extent of a physiological condition;<br />
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c) contraception;<br />
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d) including[3] anaesthesia;<br />
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e) otherwise preventing or interfering with the normal operation of a physiological function�.� [4]<br />
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4. Examples of medicinal products that come in solid dose form are: tablets; capsules; lozenges; and pastilles. Other medicinal products include: creams; lotions; ointments; patches; liniments; drops; pessaries; suppositories; and vaccines.[5] The definition of a medicinal product also includes herbal remedies.[6]<br />
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5. In addition, the 1968 Act and regulations made under it place (or placed in the period covering the Inquiry�s terms of reference) licensing requirements on certain other substances. These include: surgical ligatures; sutures; contact lenses; intra-uterine contraceptive devices; and a wide range of substances, such as heparin, that are used as ingredients in the manufacture of medicinal products.<br />
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6. Various products fall on the borderlines between foods and medicinal products, between medical devices and medicinal products or between cosmetics and medicinal products, for example vitamin supplements. There are regulations governing whether such products are to be treated as medicinal products (principally, if they are sold with indications) or not. The Medicines Control Agency (MCA) offers advice on their status in cases of doubt.The Medical Devices Agency (MDA) offers similar advice about the status of medical devices.<br />
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7. Certain products and substances are excluded from the licensing requirements of the 1968 Act, the main ones being herbal remedies and medical devices.<br />
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8. The MCA has stated to the Inquiry that the distinction between medicinal products and medical devices lies in the way in which the product achieves its principal intended action.<br />
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�The action of a medicinal product is typically achieved by pharmacological, immunological or metabolic means. In the case of a medical device, the principal intended action is typically fulfilled by physical means. A medical device may contain a material which would normally be regarded as a medicinal substance�if that substance has action ancillary to the principal action of the device�.[7]<br />
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9. Before 1993 there were no product specific regulations for medical devices. Those devices that were not treated as medicines were covered by general product safety legislation. However, the Procurement Directorate (PD) and the Medical Devices Directorate (MDD) operated the Manufacturers Registration Scheme (MRS), which was voluntary. Each manufacturer was able to decide whether to join the scheme.� There were no statutory controls of the MRS.� Purchasers (mainly the NHS) were advised to buy devices only from manufacturers registered on the scheme.[8]<br />
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10. Separate regulation of medical devices began with the Active Implantable Medical Devices Directive 90/385/EEC as implemented in the UK by the Active Implantable Medical Devices Regulations 1992[9] (SI 1992, 3146 as amended).[10] Separate regulation of most other medical devices (with the exception of in vitro diagnostic medical devices e.g. pregnancy and HIV test kits and blood grouping reagents) began with the Medical Devices Directive 93/42/EEC, as implemented in the UK by the Medical Devices Regulations 1994.<br />
<br />
[11]<br />
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11. Herbal remedies are regarded as medicinal products but are exempt from the licensing requirements of the 1968 Act under certain conditions. A herbal remedy is defined in section 132 as:</div>
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�a medicinal product consisting of a substance produced by subjecting a plant or plants to drying, crushing or any other process, or of a mixture whose sole ingredients are two or more substances so produced, or of a mixture whose sole ingredients are one or more substances so produced and water or some other inert substance.�<br />
<br />
[12]<br />
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Legislation on medicinal products<br />
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12. Medicines in the United Kingdom, both human and veterinary, are regulated for their safety, efficacy and quality in accordance with the Medicines Act 1968 and relevant European Community Directives and Regulations.� Since 1965 there has been an increasing body of European legislation which has applied to the UK since accession to the EC in 1973.� The interaction between the European and the UK legislation is summarised below.<br />
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European regulation<br />
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13. European regulation of medicinal products was introduced with the adoption of Council Directive 65/65[13].� The system was based on the grant of a marketing authorisation by the competent authority of the Member State in question (i.e. a decentralised system).� It provided that no product within the scope of the Directive could be placed on the market in a Member State unless an authorisation had been issued by the competent authority of that Member State.[14]�<br />
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14. The Directive seeks to harmonise the requirements to be fulfilled by those seeking authorisation and the provisions relating to the granting of authorisations.� It provides grounds upon which authorisation to market a medicinal product is to be refused.[15]� It also specifies grounds upon which a marketing authorisation may be suspended or revoked, including where the product proves to be harmful in the normal conditions of use.[16]� A Member State is not permitted to refuse, suspend or revoke an authorisation to market a medicinal product except on the grounds set out in the Directive.[17]</div>
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<br />
15. Originally only �proprietary medicinal products� were subject to the European regulatory system[18].� �Medicinal product� and �proprietary medicinal product� are defined by Article 1 of Directive 65/65/EEC:</div>
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<br />
�1. Proprietary medicinal product:</div>
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Any ready-prepared medicinal product placed on the market under a special name and in a special pack.</div>
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<br />
2. Medicinal product:</div>
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Any substance or combination of substances presented for treating or preventing disease in human beings or animals.</div>
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<br />
Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals.�[19]</div>
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<br />
16. No specific action was taken at the time the UK joined the EC to implement Directive 65/65/EEC.� In practice, therefore, the competent authority of the UK for the purposes of the Directive was the Licensing Authority, and such products were dealt with under the Medicines Act 1968.</div>
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<br />
17. Articles 2 and 3 of Directive 65/65/EEC were amended by Directive 89/341/EEC[20] to bring within the scope of the European system industrially produced medicinal products previously excluded. Exceptions were provided for medicinal products prepared on the basis of a magistral or officinal formula; medicinal products intended for research and development trials; and intermediate products intended for further processing by an authorised manufacturer.� Member States may also, in accordance with legislation in force, exclude specials (i.e. medicinal products specially prepared or imported to order for a particular patient).[21]�</div>
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<br />
18. In the UK the Medicines Act 1968 (Amendment) Regulations 1992 gave effect to these changes with effect from 3 April 1992, by way of amendment to the Medicines Act 1968.[22]�</div>
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<br />
19. Comprehensive provision was made implementing the Community legislation in UK law by the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994, with effect from 1 January 1995.� As of that date section 7 of the 1968 Act ceased to apply to those medicinal products for human use to which Chapters II to V of Council Directive 65/65/EEC apply; instead, they are regulated by the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994.[23]</div>
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<br />
20. The Regulations provide for applications for marketing authorisations to be made, and considered by the licensing authority, in accordance with the relevant Community provisions[24].</div>
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<br />
21. In 1975 Council Directives 75/318[25] and 75/319[26] were adopted to continue the process of approximation of Member States� legal, regulatory and administrative provisions relating to medicinal products.� Directive 75/319[27] set up the Committee for Proprietary Medicinal Products (CPMP), in order to facilitate the adoption of common decisions by Member States on the authorisation of medicinal products for human use on the basis of the scientific criteria of quality, safety and efficacy.</div>
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<br />
22. The introduction to the Annex to Directive 75/318 states that, in assembling a dossier for application, applicants for a market authorisation of a new product shall �take into account� Community guidelines relating to the quality, safety and efficacy of medicinal products for human use published by the Commission.[28]�</div>
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<br />
23. In addition to the decentralised system, Council Regulation 2309/93[29] introduced a central Community procedure for authorisation and supervision of medicinal products. This provides a single marketing authorisation to market a product in all Member States of the European Union and is administered by the European Medicines Evaluation Agency.� The procedure is compulsory for technologically advanced medicinal products listed in part A of the Annex to the Regulation, and is optional for the novel medicinal products listed in part B of the Annex, for instance products developed by innovative biotechnological processes, products containing new active substances not authorised in any Member State, and new products derived from human blood.�<br />
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UK Regulation before January 1995</div>
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<br />
24. Prior to 1 January 1995, the Medicines Act 1968[30] (�the 1968 Act�) was therefore the primary legislation providing the structure for the regulation of medicinal products in the UK.� Much of the detailed legislation in this area is provided by delegated legislation under the 1968 Act.</div>
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The licensing authority</div>
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<br />
2<span style="font-size: 13.3333px;">5. The �licensing authority� is responsible for the grant, renewal, variation, suspension and revocation of licences.� Section 6(1) of the 1968 Act defines �the licensing authority� as the �body of Ministers� listed in section 1(1) of the Act.� These are �the Health Ministers� and �the Agriculture Ministers,� i.e. the Secretary of State for Health, the Minister of Agriculture, Fisheries and Food and the corresponding Ministers in Northern Ireland, Scotland and Wales.�</span></div>
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<br />
26. Under section 6(2) of the 1968 Act, any one of the above Ministers may perform the functions of the licensing authority.� By virtue of section 6(3), where one of the Ministers does act alone he acts as the licensing authority and not on behalf of the other Ministers.� In practice, the functions of the licensing authority in relation to medicines for human use in the UK have throughout the period 1985-96 been performed by the Secretary of State for Health.[31] Similarly, the functions of the licensing authority in relation to medicines for animals have been performed by the Minister of Agriculture, Fisheries and Food.</div>
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<br />
27. Licences granted pursuant to sections 7 and 8 may contain such provisions as the licensing authority considers appropriate (section 20(1)(a));[32] certain standard provisions are found in the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971[33].</div>
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The Medicines Commission and other bodies under the 1968 Act</div>
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<br />
28. The 1968 Act provided for the establishment of the Medicines Commission, and laid down requirements as to its composition and role. By virtue of section 3 of the Act, the Medicines Commission are required to advise the Health and Agriculture Ministers on matters relating to the execution of the Act, the exercise of powers conferred by it, and otherwise relating to medicinal products.� They are to do this where either the Commission consider it expedient, or they are required by the Minister(s) in question to do so. Section 2 of the Act provides that the Medicines Commissioners should number no fewer than eight, and should include at least one person having �wide and recent� experience in, and have shown capacity in, the following activities:</div>
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<br />
(i.) the practice of medicine (other than veterinary medicine);</div>
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<br />
(ii.) the practice of veterinary medicine;</div>
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<br />
(iii.) the practice of pharmacy;</div>
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<br />
(iv.) chemistry other than pharmaceutical chemistry;</div>
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<br />
(v.) the pharmaceutical industry.</div>
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<br />
29. The Medicines Commission is obliged to send to the Ministers an annual report with respect to the performance of its functions.[34]</div>
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<br />
30. Section 4 of the 1968 Act empowers Ministers to establish committees (often referred to as �section 4 committees�) for any purpose connected with the execution of the 1968 Act or the exercise of any power conferred by it, including:<br />
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(i.) giving advice with respect to safety, quality or efficacy;<br />
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(ii.) promoting the collection and investigation of information relating to adverse reactions for the purpose of enabling such advice to be given.<br />
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31. Ministers appoint members of the section 4 committees,[35] and are obliged when establishing them to have regard to recommendations made by the Medicines Commission as to their number, function and membership.[36] Each of these committees is required to send an annual report with respect to the performance of its functions to the Commission and the Ministers.[37]<br />
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32. A section 4 committee may, with the approval of the Ministers, appoint one or more sub-committees.[38]</div>
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<br />
33. There are a number of section 4 committees, which provide specialist advice on particular areas.</div>
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Committee on Safety of Medicines (CSM)</div>
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<br />
34. The CSM was established for the purposes of �giving advice with respect to safety, quality and efficacy, in relation to human use, of any substance or article (not being an instrument, apparatus or appliance) to which any provision of the [Medicines] Act [1968] is applicable� and �promoting the collection and investigation of information relating to adverse reactions, for the purpose of enabling such advice to be given.�[39]</div>
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<br />
35. Professor Asscher said that during his time as Chairman, the CSM met once a month for meetings which lasted for one or two days.[40]� He also stated that the Chairman bears ultimate responsibility for the advice given.[41]� In addition, he said that the CSM is an expert advisory committee and officials generally remain silent at its meetings[42] but:�<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�I should make it clear that the Chairman of the CSM played no part in and had no responsibility for setting the agenda for CSM meetings.� The first knowledge that members of CSM had about the issues that were due to be considered at meetings came from reading their blue bags for that meeting.� However, it was my practice to receive the blue bags for each of the CSM�s subcommittees and, as a result, I would at a slightly earlier stage have had some idea what issues would be coming up at the next CSM meeting.� However, I would not be in a position, at that stage, to influence the agenda for the CSM meeting; nor would I need to because every item considered by a CSM subcommittee is also considered at the following meeting of the CSM.� I did, however, on first assuming the chairmanship of the CSM, bring my influence to bear on subcommittee chairmen to minimise the number of hearings (presentations by industry) at CSM meetings by the introduction of pre-hearing procedures.� This resulted in a considerable saving of committee time.�[43]</div>
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<br />
36. Mr Hagger has said in his statement to the Inquiry:</div>
<div style="font-family: arial; font-size: 13.3333px;">
��during the period 1984-1990, I had responsibility for administrative issues relating to the CSM.� Although the Secretary to the Committee was the grade 7 in MB1C, I was not responsible for the work of the bulk of the secretariat of the Committee who were professional staff, comprising physicians, pharmacists and scientists.�[44]</div>
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<br />
37. The Biologicals Sub-Committee (BSC) and BSE Working Group (BSEWG) were established by, and reported to, the CSM. The role of the BSE Working Group was different from that of the Biologicals Sub-committee with which it was associated. The Working Group did not have to deal with applications for products, but rather its role was to advise the section 4 committees on the possible hazards to man of human medicinal products, with special reference to BSE.[45]</div>
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<br />
38. Professor Collee (with regard to the CSM Biologicals Sub Committee) talked about the role of officials in his Statement to the Inquiry.� He said:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�After the meeting there was a Chairman�s debriefing session with officials.� This would last about half an hour and was used to prepare a draft of the minutes with officials.� I often amended the draft minutes.� The purpose of the debriefing meetings was to ensure that officials fully understood the committee�s advice and had accurately minuted that advice.� The actual implementation of advice was carried out by officials.�[46]</div>
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The agenda for meetings was set by officials from within the Medicines Division (and later the Medicines Control Agency) who, in doing so, would bear in mind the current timetable of the CSM.</div>
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<br />
39. Mr Hagger�s statement notes:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�In general, senior administrators would only get involved following a CSM meeting if it was clear that an issue dealt with there required a Ministerial decision, appeared to have wider implications and/or was likely to become public and attract press interest.� In these circumstances both the Head of the Division and the Professional Head would usually have leading roles.�[47]<br />
<br /></div>
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Committee on Dental and Surgical Materials (CDSM)<br />
<br /></div>
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40. The CDSM was established to exercise the same functions as the CSM, in respect of:</div>
<div style="font-family: arial; font-size: 13.3333px;">
�(i) substances or articles which are for dental or surgical use, being �<br />
<br /></div>
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(a) instruments, apparatuses or appliances to which any provision of the Act is applicable, or</div>
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<br />
(b) medicinal products or other substances or articles (not being instruments, apparatuses or appliances) to which any provision of the Act is applicable and in respect of which neither the Committee on Safety of Medicines nor the Veterinary Products Committee is the appropriate committee within the meaning of section 4(6) of the Act,<br />
<br /></div>
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whether or not used in conjunction with any other such substance, article, instrument, apparatus or appliance;<br />
<br /></div>
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(ii) the substances and fluids described in paragraph 2 of Schedule 1 to the Medicines (Specified Articles and Substances) Order 1976 (substances and fluids for use with contact lenses or blanks).�[48]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
41. The CDSM was abolished in 1994.[49]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
Veterinary Products Committee (VPC)<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
42. The VPC was established in 1970 with the following terms of reference:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�a)�� To give advice with respect to safety, quality and efficacy in relation to the veterinary use of any substance or article (not being an instrument, apparatus or appliance) to which any provision of the Medicines Act 1968 is applicable.<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
b)��� To promote the collection of information relating to suspected adverse reactions for the purpose of enabling such advice to be given.�[50]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
43. The VPC is very similar to the CSM.� As its name implies, it is concerned with veterinary products that were serviced by MAFF.[51] Like the CSM, the VPC also had a Biologicals Sub-Committee (BSC) which was established by it and reported to it.[52]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
Committee on the Review of Medicines (CRM)<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
44. The CRM was established[53] to advise on the safety, quality and efficacy of substances and articles that were on the market before the 1968 Act came into force and which had been granted licences of right[54].� Provision was made by s 25 of the 1968 Act for the grant of licences of right in respect of such medicinal products. Some 39,035 Product Licences of Right were granted for those products already on the market at that time.[55] The Order establishing the CRM provides:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�Without prejudice to the Committee on Safety of Medicines, in connection with the review by the licensing authority of the safety, equality and efficacy of substances or articles in respect of which product licences granted under Part II of the Act are in force, there shall be established a committee to be called the Committee on the Review of Medicines for the purpose of considering and giving advice with respect to the safety, quality and efficacy, in relation to human use, of any substance or article to which any provision of the Act is applicable.�<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
45. The work of the CRM was completed in 1991 and it was abolished.[56]</div>
<div style="font-family: arial; font-size: 13.3333px;">
The British Pharmacopoeia Commission (BPC)<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
46. The BPC is responsible for preparing new editions of the British Pharmacopoeia and the British Pharmacopoeia (Veterinary) and for keeping those up-dated. It is also responsible for maintaining liaison with the European Pharmacopoeia Commission and for the publication of British approved names under Section 100 of the Medicines Act.[57]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
Product licences<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
47. Until 1 January 1995, product licences were governed principally by section 7 of the 1968 Act, which prohibits the sale, supply or export of (or procurement of the sale, supply or export of) a medicinal product except in accordance with a product licence granted for the purposes of section 7.� Similarly, procuring the manufacture or assembly of such a product for sale or supply is prohibited save in accordance with a product licence. From 1 January 1995, section 7 of the 1968 Act ceased to apply to those medicinal products for human use to which Chapters II to V of Council Directive 65/65/EEC apply; instead, they are regulated by the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994.[58]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
48. There are a number of exemptions to the prohibition set out in section 7, including exemptions relating to:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(i.) anything done in accordance with a clinical trial certificate or animal test certificate (i.e. where medicines are used in clinical trials)[59];<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(ii.) medicines made, or imported, to order, for a particular patient (sometimes referred to as �specials�);[60]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(iii.) homoeopathic medicinal products which have been granted a certificate of registration (since 13 February 1994).[61]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
49. Section 8 of the 1968 Act governs manufacturers� and wholesale dealers� licences.</div>
<div style="font-family: arial; font-size: 13.3333px;">
Products requiring a product licence - �medicinal products�<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
50. A �medicinal product� is defined by the 1968 Act as �any substance or article (not being an instrument, apparatus or appliance) which is manufactured, sold, supplied, imported or exported for use wholly or mainly � by being administered to one or more human beings or animals for a medicinal purpose.� The definition also includes any substance or article (not being an instrument, apparatus or appliance) used as an ingredient in such a substance or article, where such use as an ingredient is in a pharmacy or hospital, by a practitioner or in the course of a business including the retail sale (or supply in circumstances corresponding to retail sale) of herbal remedies.[62]�<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
51. Therefore, only products to be administered for a �medicinal purpose� are medicinal products within the meaning of the 1968 Act.� �Medicinal purposes� are defined[63] as follows:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�(a) treating or preventing disease;<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(b) diagnosing disease or ascertaining the existence, degree or extent of a physiological condition;<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(c) contraception;<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(d) including[64] anaesthesia;<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(e) otherwise preventing or interfering with the normal operation of a physiological function � .�<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
52. Section 130(9) of the 1968 Act provides that �administer�:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�means administer to a human being or an animal, whether orally, by injection or by introduction into the body in any other way, or by external application, whether by direct contact with the body or not; and any reference in this Act to administering � a substance or article is a reference to administering � it either in its existing state or after it has been dissolved or dispersed in or diluted or mixed with, some other substance used as a vehicle.�<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
53. The position of certain substances and appliances is clarified by other provisions in the 1968 Act.<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
Dental fillings, bandages and surgical dressings<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
54. Section 130(5) of the 1968 Act expressly provides that medicinal products shall not be taken to include the substances used in dental surgery for filling dental cavities; and bandages and other surgical dressings.[65]� However, �medicated dressings� have been, since 1 January 1995, expressly included within the meaning of medicinal products if �their medication has a curative function which is not limited to sterilising the equipment� and the dressing does not fall within the scope of certain European regulations relating to medical devices.[66]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
Other specified articles<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
55. By virtue of sections 104 and 105 of the 1968 Act[67] the Ministers have power to make an order applying certain provisions of the Act to categories of substances which would otherwise not be categorised as medicinal products. Although many of the orders have now been amended, orders made under sections 104 or 105, have enabled sections 7 and 8 of the 1968 Act to be applied inter alia to the following substances:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(i.) Surgical ligatures and sutures prepared from any animal tissue for use in surgical operations upon the human body; surgical ligatures and sutures and absorbent or protective material for use in surgical operations upon the human body capable of being absorbed by body tissues.[68]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(ii.) Contact lenses, contact lens solutions and intra-uterine contraceptive devices.[69]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(iii.) A wide variety of substances used as ingredients in the manufacture of medicinal products, including, for example, heparin and preparations of the pituitary when used as an ingredient in a medicinal product for parenteral injections, insulin, sera and vaccines;[70] and any substance wholly or partly derived from animals not specified elsewhere in the schedule to the relevant Order when used as an ingredient in a medicinal product for administration to animals.[71]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
From 1 January 1995, a number of orders made under sections 104 and 105 of the Act were modified by the Medical Devices (Consequential Amendments � Medicines) Regulations 1994 so that the Act ceased to apply to a number of products that were treated as medical devices under Community law.� These included certain surgical ligatures, surgical sutures, absorbent and protective materials, intra-uterine contraceptive devices, substances associated with contact lenses, and contact lenses.[72]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
Herbal Remedies<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
56. Certain categories of herbal remedies are exempted from the restrictions imposed by sections 7 and 8 of the 1968 Act by section 12, which provides:[73]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�12� (1) The restrictions imposed by sections 7 and 8 of this Act do not apply to the sale, supply, manufacture or assembly of any herbal remedy in the course of a business where �<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(a)�� the remedy is manufactured or assembled on premises of which the person carrying on the business is the occupier and which he is able to close so as to exclude the public, and<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(b)�� the person carrying on the business sells or supplies the remedy for administration to a particular person after being requested by or on behalf of that person and in that person�s presence to use his own judgment as to the treatment required.<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(2) Those restrictions also do not apply to the sale, supply, manufacture or assembly of any herbal remedy where the process to which the plant or plants are subjected in producing the remedy consists only of drying, crushing or comminuting, and the remedy is, or is to be, sold or supplied �<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(a)�� under a designation which only specifies the plant or plants and the process and does not apply any other name to the remedy, and<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(b)�� without any written recommendation (whether by means of a labelled container or package or a leaflet or in any other way) as to the use of the remedy.�<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
Borderline products - cosmetics and foods<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
57. The Medicines (Exemption from Licenses) (Foods and Cosmetics) Order 1971 exempts (subject to certain qualifications explained below) from the restrictions imposed by sections 7 and 8 of the 1968 Act, medicinal products wholly or mainly for use by being administered to human beings, which are to be for sale either for oral administration as a food or for external use as a cosmetic.[74]� The Order contains the following definitions:[75]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�(2)� In this order, unless the context otherwise requires -<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�</div>
<div style="font-family: arial; font-size: 13.3333px;">
�cosmetic� means any substance or preparation intended to be applied to the various surfaces of the human body including epidermis, pilary system and hair, nails, lips and external genital organs, or the teeth and buccal mucosa wholly or mainly for the purpose of perfuming them, cleansing them, protecting them, caring for them or keeping them in condition, modifying their appearance (whether for aesthetic purposes or otherwise) or combating body odours or normal body perspiration;<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�food� includes beverages, confectionery and articles and substances as ingredients in the preparation of food and includes any manufactured substance to which there has been added any vitamin and which is advertised (within the meaning of Section 92 of the Act) as available and for sale to the general pubic as a dietary supplement;<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�medicinal product� includes articles or substances specified in orders made under section 104 or section 105 of the Act which are for the time being in force �<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�mineral salts� means salts of any one or more of the following, iron, iodine, calcium, phosphorus, fluorine, copper, potassium, manganese, magnesium or zinc;<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�vitamin preparation� means any medicinal product the active ingredients of which consist only of vitamins or vitamins and mineral salts;<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�vitamins� means any one or more of the following, vitamins A, B1, B2, B6, C, D and E, biotin, nicotinamide, nicotinic acid, pantothenic acid and its salts, biflavonoids, inositol, choline, para-aminobenzoic acid, cyanocobalamin or folic acid; � .�<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
58. By virtue of the Order, the exemption to the requirements of sections 7 and 8 does not apply to a medicinal product sold with written particulars specifying its curative or remedial function in relation to a disease specified;[76] to a medicinal product for oral administration as a food, being a vitamin (or other) preparation falling within one of the descriptions in the schedule to the Order;[77] to a medicinal product being a cosmetic containing antibiotic, hexachlorophane, any hormone in a proportion in excess of 0.004% or resorcinol in a proportion in excess of 1%;[78] or to any other medicinal product sold with written particulars specifying the dosage relevant to its medicinal purpose.[79]� Further, the exemption does not apply to medicinal products in respect of which there are, or are to be, directed to practitioners advertisements or representations of the nature and in the manner described in section 96 of the 1968 Act.[80]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
59. The Medicines Control Agency offers advice on the status of products in cases of doubt.� In looking at borderline products the MCA will consider ��the ingredients and function of the product as well as how it is presented to the public through labelling, packaging, advertising and promotion.�[81]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
Granting, renewing, suspending, revoking and varying licences<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
60. Applications for the grant of product licences were, until 1993, governed by the Medicines (Applications for Product Licences and Clinical Trial and Animal Test Certificates) Regulations 1971[82]. Paragraph 12 of schedule 1 to those regulations requires the applicant for a licence to give the licensing authority particulars of all active constituents, all colouring matter, flavouring agents and perfumes and all other constituents.� Paragraph 16 requires a description of the method of manufacture or assembly of the medicinal product, substance or article; and paragraph 17 requires a description of the method of manufacture of each active constituent.�<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
61. These regulations were replaced by the Medicines (Applications for Grant of Product Licences - Products for Human Use) Regulations 1993[83] in respect of medicinal products for human use.</div>
<div style="font-family: arial; font-size: 13.3333px;">
<br />
62. The 1968 Act provides that in dealing with an application for the grant of a product licence the licensing authority shall in particular take into consideration several factors including �the safety of medicinal products of each description to which the application relates�.[84]� The licensing authority may[85]:</div>
<div style="font-family: arial; font-size: 13.3333px;">
<br />
(i.) grant a licence containing such provisions as it considers appropriate;</div>
<div style="font-family: arial; font-size: 13.3333px;">
<br />
(ii.) if, having regard to the provisions of the Act and any Community obligation, it considers it necessary or expedient to do so, refuse to grant a licence.<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
63. Before refusing to grant a licence on any grounds relating to �the safety, quality or efficacy of medicinal products� the licensing authority is obliged to consult the �appropriate committee� or (if there is no such committee) the Commission.[86]�� The �appropriate committee� means any committee established under section 4 for giving advice with respect to safety, quality or efficacy, or for promoting the collection and investigation of information relating to adverse reactions for the purpose of enabling such advice to be given.[87]�<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
64. A licence expires at the end of a period of 5 years from the date upon which it was granted or last renewed, or at the end of any shorter period specified in the licence.[88]�� The licence holder may apply for the licence to be extended for a further period of 5 years from the date upon which it would otherwise expire.[89]� The licensing authority may:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(i.) renew the licence, with or without modifications;<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(ii.) grant a new licence containing such provisions as the licensing authority consider appropriate;<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(iii.) if, having regard to the provisions of the Act, it considers it necessary or expedient to do so, refuse to renew the licence or grant a new licence.<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
65. Before refusing to renew a licence on any grounds relating to �the safety, quality or efficacy of medicinal products� the licensing authority is again obliged to consult the �appropriate committee� or (if there is no such committee) the Medicines Commission.[90]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
66. By virtue of section 28 of the 1968 Act the licensing authority may suspend, revoke or vary the provisions of a product licence on the grounds set out in section 28(3), which include:[91]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
��(g) that medicinal products of any description to which the licence relates can no longer be regarded as products which can safely be administered for the purposes indicated in the licence, or can no longer be regarded as efficacious for those purposes;<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(h) That the specification and standards to which medicinal products of any such description are manufactured can no longer be regarded as satisfactory��<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
67. Except for suspension in the case of urgency under Section 2 of the Act, where the licensing authority propose to suspend, revoke or vary a product licence on any of the grounds specified in section 28(3)(g) or (h), they may not do so except after consultation with the appropriate committee or, if there is none, with the Medicines Commission.[92]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
68. Where the appropriate Committee or the Medicines Commission are consulted in relation to the proposed refusal, suspension, variation or revocation of a licence, and they have reason to think (in the case of refusal) that they may be unable to advise the licensing authority to grant the licence, or to grant it unless it contains provisions otherwise than in accordance with the application, or (in the case of suspension, variation or revocation) that they may have to advise the licensing authority that the product licence ought to be suspended, revoked or varied, they must afford to the applicant/licence holder a right to make written or oral representations prior to their giving such advice to the licensing authority.[93]</div>
<div style="font-family: arial; font-size: 13.3333px;">
<br />
69. Any reference in the 1968 Act to safety or the interests of safety is to be construed in accordance with section 132(2), which provides that considerations of safety, in relation to any substance or article, shall be taken to include inter alia consideration of the extent (if any) to which the substance or article if used without proper safeguards, is capable of causing danger to the health of the community.�<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
Confidentiality</div>
<div style="font-family: arial; font-size: 13.3333px;">
<br />
7<span style="font-size: 13.3333px;">0. Section 118 of the Medicines Act 1968 provides that a person shall be guilty of an offence if he discloses to any other person-</span><br />
<span style="font-size: 13.3333px;"><br /></span></div>
<div style="font-family: arial; font-size: 13.3333px;">
(i.) any information with respect to any manufacturing process or trade secret obtained by him in premises which he had entered under the right of entry provided by section 111 of the Act;<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(ii.) any information obtained by or furnished to him in pursuance of the Act;<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
unless the disclosure was made �in the performance of his duty�.<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
Provision of information<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
71. Section 44 of the Medicines Act provides that where an application has been made to the licensing authority for a licence the licensing authority:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�Before determining the application, may request the applicant to furnish to the licensing authority such information relating to the application as the licensing authority may consider requisite: and, where any such request has been made, the licensing authority shall not be required to d<span style="font-size: 13.3333px;">etermine the application until either-</span></div>
<div style="font-family: arial; font-size: 13.3333px;">
a) the information requested has been furnished to them, or<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
b) it has been shown to their reasonable satisfaction that the applicant is unable to furnish the information�<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
72. Subsection 3 states that the licensing authority may request information of the holder of a clinical trial certificate or animal test certificate where it is considered:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�That circumstances exist by reason of which it is necessary to consider whether the licence or certificate should be varied, suspended or revoked; and the information required by such a notice shall be such as appears to the licensing authority, or is represented to them by the Commission or by the committee, to be requisite for considering that question.�<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
73. Subsection 4 states that this does not have effect in the case of a licence of right or of a certificate issued in pursuance of section 37(4) of the Medicines Act 1968:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�Whether the licence or certificate has been renewed or not; and, in the case of such a licence or certificate, a notice under this section may be served at any time and may require any information which, in the opinion of the licensing authority, would be relevant if-<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
sections 25 and 37(4) of this Act had not been enacted, and <span style="font-size: 13.3333px;">the licensing authority were then dealing with an application, by the person who is the holder of the licence or certificate, for the grant or issue of a licence or certificate containing the same provisions as those contained in the licence or certificate in question.�</span></div>
<div style="font-family: arial; font-size: 13.3333px;">
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
UK Regulation since January 1995<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
74. As noted above, from 1 January 1995 section 7 of the 1968 Act ceased to apply to those medicinal products for human use to which Chapters II to V of Council Directive 65/65/EEC apply; instead, they are regulated by the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994.[94] Section 7 of the 1968 Act is now limited to a residual category of products which require UK product licences but do not require marketing authorisations for the purposes of Community law.� Section 8 remains applicable.� Other provisions of the 1968 Act, including the continued operation of the Medicines Commission and its section 4 committees, remain in force.<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
Legislation relating to medical devices<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
75. Instruments, apparatuses and appliances are excluded from the licensing requirements of the 1968 Act, as they do not fall within the definition of a medicinal product. One category of such items is medical devices.<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
76. There were no product-specific regulations for medical devices before 1 January 1993.� Those that were not treated as medicines were covered by general product safety legislation.� The Procurement Directorate (PD) and later the Medical Devices Directorate (MDD) operated the Manufacturers Registration Scheme (MRS), membership of which was voluntary.� There were no statutory controls of the MRS.� Purchasers (mainly the NHS) were advised to buy devices only from manufacturers registered on the scheme. (With the introduction of European legislation the scheme was gradually wound down and finally ceased in June 1998.)[95]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
77. Before 1993, if there was a need to remove an unsafe medical device from the UK market, the Consumer Protection Act 1987 could have been used (and later the General Product Safety Regulations 1994). In addition, a member of the MRS failing to meet the requirements of the scheme could be removed from the register. A reporting system also operated to encourage manufacturers and users to report details of any adverse incidents involving medical devices.[96]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
78. Separate regulation of medical devices began with regulation of �active� implantable devices.� From 1 January 1993 the Active Implantable Medical Devices Directive 90/385/EEC, as implemented in the UK by the Active Implantable Medical Devices Regulations 1992[97] came into force. There was a transition period that lasted until 31 December 1994.� These regulations apply to active (i.e. relying on a source of power other than that generated by the human body or gravity) implants, partial or whole, left in the body, including pacemakers.[98]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
79. Regulation 2 included the definition of an �active implantable medical device�:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
��instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any accessories or software necessary for its proper functioning, which -<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(a) is intended by the manufacturer to be used for human beings �<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(i)��� in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury;<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(ii)�� in the investigation, replacement or modification of the anatomy or of a physiological process, or<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(iii)� in the control of conception;<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(b) does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic means, even if it is assisted in its function by such means;<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(c) relies for its functioning on a source of electrical energy or a source of power other than that generated directly by the human body or by gravity; and<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(d) is intended to be totally or partially introduced into the human body�and which is intended to remain in the human body after completion of the surgical or medical procedure during which it is introduced;</div>
<div style="font-family: arial; font-size: 13.3333px;">
even if it is intended to administer a medicinal product as defined in the Medicines Act 1968 or incorporates as an integral part a substance which, if used separately, would be a medicinal product as so defined; �[99]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
80. Regulation of certain other devices (excluding in vitro diagnostic medical devices) was introduced with the implementation in the UK of the Medical Devices Directive 93/42/EEC, by the Medical Devices Regulations 1994.[100] The transition period lasted until 14 June 1998.� For the purposes of those regulations, a medical device is defined as follows:[101]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�� an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which -<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(a) � is intended by the manufacturer to be used for human beings for the purpose of -<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(i)��� diagnosis, prevention, monitoring, treatment or alleviation of disease,<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(ii)�� diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(iii)� investigation, replacement or modification of the anatomy or of a physiological process, or<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(iv)� control of conception; and<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(b) � does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means, even if it is intended to administer a medicinal product as defined in Council Directive 65/65/EEC or incorporates as an integral part a substance which, if used separately, would be a medicinal product as so defined and which is liable to act upon the body with action ancillary to that of the device; ��<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
81. There are a number of express exceptions to which the Medical Devices Regulations 1994 do not apply.[102] These include in vitro devices, active implantable devices covered by Council Directive 90/385/EEC as amended (implemented into UK law by the Active Implantable Medical Devices Regulations 1992 (SI No 3146)), transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable, and non-viable products derived from animal tissue.[103]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
82. Both sets of medical devices regulations are made pursuant to sections 11 and 27(2) of the<br />
Consumer Protection Act 1987and section 2(2) of the European Communities Act 1972.� They require the devices in question to comply with the relevant essential requirements.<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
83. Under the Directives, Member States of the EU have the right to withdraw from their territory any product that they consider endangers public health.[104]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
84. The responsible authority to enforce these directives in the UK is the Secretary of State for Health acting through the MDA, although local authorities have some enforcement responsibilities for medical devices that are also consumer goods.� The MDA�s duties include ensuring compliance and evaluating adverse incident reports provided by manufacturers and users under a statutory duty.[105] The Regulations provide for a vigilance system whereby information concerning serious incidents in the UK must be notified by the MDA to the EU and other Member States, so that any necessary action can be taken at European level.[106] The MDA said it has received no reports of adverse incidents associated with infection involving medical devices that incorporate material of animal origin. Finally the MDA assesses notifications for clinical investigations.[107]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
85. Independent accreditation bodies, known as Notified Bodies, are used to check manufacturers� claims of conformity for everything except the lowest risk devices.� These bodies are monitored by the MDA.[108]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
86. In January 1995 the Medical Devices Directive came into force[109] which covered, inter alia, devices containing or consisting of non-viable animal tissues, with a transitional period until 14 June 1998.</div>
<div style="font-family: arial; font-size: 13.3333px;">
Legislation relating to homoeopathic products<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
87. Homoeopathy is a school of medicine based on the theory that where large doses of drugs produce symptoms of a disease in healthy people, when administered in small amounts those drugs will cure the same symptoms.� The smaller the amount, the greater the paradoxical effect.� Homoeopathic drugs are therefore diluted to a concentration of approximately 10-30. At this dilution, there may not be a single molecule of active ingredient left in the preparation.[110]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
88. Prior to 1994 homoeopathic medicinal products that satisfied the definition of medicinal product in the 1968 Act were subject to its licensing requirements.[111] In fact in 1971 there would have been many product licences of right for homoeopathic products.[112]� A new homoeopathic product with no indications might escape the controls of the 1968 Act.� One with indications, which was subject to the licensing regime, would be unlikely to satisfy the ground of efficacy necessary to obtain a licence.[113]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
89. A special, simplified registration procedure was introduced by the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994,[114]which implement in part Council Directive 92/73/EEC.[115]� They make provision for the grant by the licensing authority of a certificate of registration for homoeopathic medicinal products, which authorises the placing on the market of the product in question[116].� The exception to the requirements of section 7 of the 1968 Act was introduced to correspond with the coming into force of these regulations on 14 February 1994.� The Directive and Regulations are concerned with quality and safety, rather than clinically proven efficacy, recognising that there are many users of these products regardless of their clinically proven efficacy, and that there is therefore a need for regulation.</div>
<div style="font-family: arial; font-size: 13.3333px;">
<br />
90. Homoeopathic medicinal product is defined for the purposes of the Regulations as �a medicinal product (which may contain a number of principles) prepared from products, substances or compositions called homoeopathic stocks in accordance with a homoeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by any pharmacopoeia used officially in a Member State.�[117]� The definition is taken from Council Directive 92/73/EEC article 1. �Article 2[118] provides exceptions for homoeopathic medicinal products prepared in accordance with a magistral or officinal formula and for those satisfying the exclusions set out in Articles 1(4) and 1(5) of Directive 65/65/EEC.�</div>
<div style="font-family: arial; font-size: 13.3333px;">
<br />
91. The Advisory Board on the Registration of Homoeopathic Products[119] was established in February 1995 for the purpose of giving advice with respect to the safety and quality of homoeopathic medicinal products.[120]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
The Joint Committee on Vaccination and Immunisation (JCVI)<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
92. The JCVI is a Non-Departmental Public Body. It is a statutory expert Standing Advisory Committee established in England and Wales under the NHS Act 1977 (section 6(3)) and NHS (Standing Advisory Committees) Order 1981 (Schedule, part II) as the Standing Advisory Committee on Vaccination and Immunisation. It is also a Sub-Committee of the National Professional Advisory Council covering Scotland. The JCVI is a statutory body in England and Wales but not in Scotland or Northern Ireland.[121]</div>
<div style="font-family: arial; font-size: 13.3333px;">
<br />
93. The JCVI�s terms of reference, prior to April 1995[122] were:</div>
<div style="font-family: arial; font-size: 13.3333px;">
�To advise the Secretaries of State for Health, Scotland, Wales and Northern Ireland on matters relating to the prevention of communicable disease through immunisation.�</div>
<div style="font-family: arial; font-size: 13.3333px;">
<br />
94. After April 1995[123] new terms of reference were agreed by Ministers. These were:</div>
<div style="font-family: arial; font-size: 13.3333px;">
�To advise the Secretaries of State for Health, Scotland, Wales and Northern Ireland on matters relating to communicable diseases, preventable and potentially preventable, through immunisation.�</div>
<div style="font-family: arial; font-size: 13.3333px;">
<br />
95. The terms of reference were changed following a general review of the JCVI, its workings and membership. There was recognition of the fact that the JCVI may on occasion be called upon to give advice on other related aspects of communicable disease as well as immunisation, and needed to have the flexibility to advise as new vaccines became available.[124]</div>
<div style="font-family: arial; font-size: 13.3333px;">
<br />
96. The JCVI is not responsible for issues of vaccine safety. It makes recommendations to Ministers on the use of vaccines that have already been licensed for use in the UK. It is the CSM that has overall responsibility for advising Ministers on the safety of medicines.[125]</div>
<div style="font-family: arial; font-size: 13.3333px;">
Structure of agencies with responsibility for medicines and medical devices</div>
<div style="font-family: arial; font-size: 13.3333px;">
Medicines Division/ Medicines Control Agency�<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
Function</div>
<div style="font-family: arial; font-size: 13.3333px;">
<br />
97. The function of the Medicines Division (MD), and later the Medicines Control Agency (MCA), was, inter alia, to ensure that all medicinal products met acceptable standards of quality, safety and efficacy. It was the executive arm of Government responsible for regulating the pharmaceutical sector and implementing policy in this area.[126]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
Structure of the Medicines Div<span style="font-size: 13.3333px;">ision/MCA � administrative and professional staff, their roles and responsibilities</span><br />
<span style="font-size: 13.3333px;"><br /></span></div>
<div style="font-family: arial; font-size: 13.3333px;">
98. Until the creation of the Medicines Control Agency on 11 July 1991, the Medicines Division was organised in three parallel structures. One consisted of medical staff, another pharmaceutical staff and another administrative staff.[127] Responsibility for staff in these structures was essentially dividedbetween the professional staff and the administrative staff, with the professional staff reporting to the Senior Principal Medical Officer (SPMO) or the Chief Pharmaceutical Officer and the administrative staff reporting to the Under Secretary.[128]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
99. Over the period 1984-89 the Medicines Division employed some 300 people, 200 of whom were administrative staff and 100 of whom were professionals (20 doctors and 80 pharmacists).[129]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
100. In the medical structure the SPMO, Dr Gerald Jones over the period 1986-91, was responsible for all professional work concerning drug regulation, new drug applications, adverse reactions, review of existing products, advertising, legal status and the servicing of all the advisory committees.� In addition he states that he had responsibility for policy formulation and advice to ministers.[130] The SPMO had three Principal Medical Officers (PMOs) reporting to him. He in turn reported to the Deputy Chief Medical Officer (DCMO).[131]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
101. Dr Gerald Jones notes in his statement to the Inquiry that:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
��my task was of an overall supervisory role rather than to intervene in the scientific judgments of the individual expert committees.� [132]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
102. The PMOs headed three medical branches. These were:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(i.) MB3A: New drugs and biological products � Dr Jefferys from September 1986 to 1990;<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(ii.) MB3B: Review of medicines and the CDSM � Dr WJ Jenkins from 1987 to September 1988 and Dr Adams from September 1988 to May 1990; and<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(iii.) MB4: Adverse reactions and post marketing surveillance � Dr Mann from 1986 to 1988 and Dr Wood from 1989-90.[133]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
103. In his Statement to the Inquiry Dr David Jefferys gave an indication of how the Medicines Division operated up until 1991. He said that he worked closely with Mr David Hagger the Grade 5 Assistant Secretary of MB1 whose main responsibilities were policy co-ordination, the administrative secretariat of the Committee of Safety of Medicines (CSM), and information services. Mr Hagger reported to the Under Secretary in the Division, Mr Norman Hale until 1987 and then Mr C Wilson. Dr Jefferys also worked with pharmaceutical colleagues who operated through a separate reporting structure to the Deputy Chief Pharmaceutical Officer, Mr Sandy Stewart, and on to the Chief Pharmaceutical Officer, Dr Brian Wills.[134]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
104. Dr Jefferys has also commented on how BSE was dealt with in the structure of Medicines Division.� He said:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�The issues raised by BSE did not naturally fall within the remit of MB3A or any other single group within Medicines Division. Indeed BSE never became the responsibility of MB3A or any other single group. Instead BSE was always handled on a team basis across the Division as a whole. Those involved in handling BSE were drawn from all parts of the Division and no single individual had the lead on handling the issues raised by BSE. In fact the issues raised by BSE predominantly fell to be considered by pharmacists rather than to toxicologists or physicians because BSE was primarily a pharmaceutical issue although it required medical input.�[135]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
105. Dr Wills explains the relationship between Pharmacy Division and Medicines Division:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�As Chief Pharmacist, I headed the Pharmacy Division (PH), which dealt with the practice of pharmacy; pharmacy in the NHS and international pharmacy.� Everybody within that division ultimately reported to me.� The Inquiry should understand that the Pharmacy Division was entirely separate from Medicines Division and the pharmacists within the Medicines Division did not report to me.� I was however professional head of all the 100 or so pharmacists who worked within different divisions of the Department of Health.�[136]</div>
<div style="font-family: arial; font-size: 13.3333px;">
<br />
106. In her Statement to the Inquiry Dr Frances Rotblat, a Senior Medical Officer (SMO), said she reported to Dr Jefferys from August 1986. She was one of a number of SMOs reporting to Dr Jefferys, the only one specialising in biologicals. She said that she worked closely with Dr John Purves, a Superintending Pharmacist in MB5A. Dr Rotblat was the medical assessor to the CSM Biologicals sub-committee.[137]</div>
<div style="font-family: arial; font-size: 13.3333px;">
<br />
107. In the pharmaceutical structure, the Chief Pharmaceutical Officer (Grade 4 level) was responsible for professional and pharmaceutical aspects of the Medicines Act, the Medicines Inspectorate and the British Pharmacopoeia Commission. Over the period 1986-91 this was Dr Wills. Prior to June 1990, the Chief Pharmaceutical Officer was not within the Medicines Division. After June 1990 he was in the Medicines Division, reporting to the Under Secretary of Medicines Division.[138]</div>
<div style="font-family: arial; font-size: 13.3333px;">
<br />
108. The Chief Pharmaceutical Officer had two Deputy Chief Pharmaceutical Officers (Grade 5 level) reporting to him. They were responsible for the professional and pharmaceutical aspects of the Medicines Act and the Medicines Inspectorate respectively. The Deputy Chief Pharmaceutical Officer with responsibility for the professional and pharmaceutical aspects of the Medicines Act had a Grade 6 working to him. This was Dr Purves who had the lead responsibility for biologicals and was the pharmaceutical assessor to the CSM<br />
<br />
Biologicals sub-committee.[139]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
109. Dr Purves comments in his statement to the Inquiry:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�The role of the pharmacists is to evaluate the acceptability of the quality of the product, the manufacturing process and materials used in manufacture.�� When there are issues of concern the advice of experts is sought through the various Sub-committees, which reported to the CSM.�[140]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
110. During this period, the co-ordination of BSE issues was handled by the administrative staff with professional support from the various branches of the Medicines Division.[141]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
111. The recommendation to create the Medicines Control Agency (MCA) came from the Evans-Cunliffe Report. The Report was published on 26 January 1988 and the Government�s response to the recommendations was given in April 1988. Considerable resources and attention were directed during the second half of 1988 and the whole of 1989 to the introduction and establishment of the new MCA to replace the Medicines Division.[142]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
112. The Evans and Cunliffe Report was commissioned in 1987.[143]� The terms of reference for the report outlined by Ministers were:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�To examine the issues for DHSS arising from the increases in licence applications and other work under the Medicines Act and to recommend ways of dealing expeditiously with this work, while maintaining adequate standards for the safety, efficacy and quality of human medicines in the United Kingdom.�[144]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
113. Under the heading �Ways of Improving� the Report stated:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�There is chronic difficulty in recruiting the best professional staff, and computing support is antediluvian.� The complex organisational structure prevents effective management, and overall the Division is unduly constrained from without and lacks resilience within.�[145]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
114. The Report made the following observations about the technology at the disposal of the Medicines Division:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�The thousands of current and previous licence applications are moved around the office in cardboard folders, the so-called gold files.� It is astonishing that that there is no reliable way of finding files within the building.� Some months ago, DHSS introduced a file tracking system in which staff read-off bar codes into a central computer, but it is not yet comprehensive nor fully operational.� File-tracking is an essential tool not only for finding and linking files but also for monitoring the transit of work through the organisation.� We RECOMMEND that a high priority be given to completing and developing the file-tracking system.�[146]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
115. On staffing the following comments were made:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�The other principal area of difficulty relates to staff: because civil service salaries for pharmacists and doctors are uncompetitive and there is too little secretarial and other support, it is difficult to recruit experienced professional staff for this highly specialised work and � once trained and experienced � they leave for posts in industry.� Other rigidities compound the problem, for example the control of staff numbers by arbitrary headcount, and the dilatory procedures for filling vacancies.�[147]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
116. In his oral evidence to the Inquiry Dr G Jones commented on staffing in the Medicines Division:</div>
<div style="font-family: arial; font-size: 13.3333px;">
�There was, unfortunately, a considerable turnover of staff.� We were recruiting almost permanently.� The board recruiting doctors from outside, I called it virtually a standing committee; it had to meet � which I served on � virtually every 3 months.� As soon as you were able to appoint a doctor you found that someone had moved on within the Department.� The Division stood at about 20 or 25 doctors at that time.�[148]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
117. Dr Jefferys also commented on staffing levels in Medicines Division:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�At that stage [1988], there were only 5 physicians in MB3A, one of whom was working full time on the Opren litigation. For most of this period we were actively recruiting for a sixth physician. In addition, there were 3 toxicologists in the group. However, for much of this period only one toxicologist was working full time because both the other toxicologists were on extended maternity leave.<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
By contrast, there are now 27 medical assessors, 8 toxicologists and 4 statisticians in the Licensing Division and 26 physicians in the Post-Licensing Division (including Pharmacovigilance activities). In total there are now approximately 550 staff within the Medicines Control Agency. In 1988 the figure was closer to 220.�[149]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
118. Dr Jefferys outlined the effect this had on resources in Medicines Division:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�In summary, I would estimate that over the last 10 years the volume of work carried out by the physicians within MB3A and its present day equivalent has increased by a little more than 100%. But in the same period, the number of physicians has increased six or sevenfold and the quality of the support services for those physicians has also greatly improved. In short, MB3A along with the rest of Medicines Division was, in 1988, in my view severely overstretched. This was a point expressly made in the Evans/Cunliffe Report. The position was not helped by the fact that, at that time, the Medicines Division was required to operate under both head count and pay restraints.<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
These resource difficulties inevitably had implications for the work of the Division. For example, in 1988, renewals of product licences were handled purely administratively without input from physicians because of the staff shortages. In addition, the processing of abridged licence applications was subject to a two year backlog. By summer 1989 the position had started to improve in that the number of physicians within MB3A had increased to 7 and the work on the Opren litigation had decreased, but the major improvement only occurred in the early 1990s with the full establishment of the MCA.�[150]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
Later he said:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�It is worth noting that the issues of prioritisation and resources were contemporaneously being addressed by the Evans/Cunliffe review which, when it reported, highlighted the serious resource limitations and the difficulties posed by a lack of functional organisation. These were the major changes which were addressed in the creation of the Medicines Control Agency (MCA).�[151]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
119. Sir Christopher France, in oral evidence to the Inquiry, said that the MCA was:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
��in many ways a continuation of the Medicines Division.� What was different was that instead of being as it were a core part of the Department of Health [DH], it became one of the so-called next steps agencies and therefore was given certain operational freedoms that it would not have had as part of the Department.� But it is -- its core function of controlling medicines remained the same as between the 31st March and 1st April.�[152]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
120. The establishment of the MCA reorganised the business of the Medicines Division along multi-disciplinary functional lines. On 11 July 1991 the MCA became an Executive Agency of the Department of Health.�� The freedoms of Agency status were intended to help it meet the challenges of new developments in medicine; of completion of the EC single market; and of a European system for regulating medicines.[153]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
121. Dr Keith Jones says in his statement to the Inquiry:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�The aim was to replace the Medicines Division with an Executive Agency of the Department of Health to be called the Medicines Control Agency.� Although the MCA would still be part of the Department of Health, it would have greater managerial autonomy than a Division and would be self-financing.�[154]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
122. In place of the old structure of the Medicines Division, the new MCA had several Business Groups. Management lines were reorganised and the professional and medical staff integrated.[155] The new Business Groups were in place by June 1990, although the reporting lines remained as under the Medicines Division until July 1991[156].<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
123. �These Business groups were:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(i.) Business A: New drugs and European Licensing;<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(ii.) Business B: Abridged licensing;<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(iii.) Business C: Pharmacovigilance business;<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(iv.) Business D: Inspection and enforcement;<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(v.) Business E: Executive support business; and<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
(vi.) Business F: British Pharmacopoeia.[157]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
124. The Agency was headed by a Director or Chief Executive, Dr Keith Jones, and each Business group by a Business Manager (of Grade 4 level) who reported to the Chief Executive. The Chief Executive was fully responsible and accountable to the Secretary of State for Health for the efficient management, overall performance and future development of the Agency. Ministers and the DH were not involved in the day to day management of the MCA.[158]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
125. Dr Keith Jones clarifies his role in his statement to the Inquiry:<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�On my appointment as Director of the MCA all staff within the Medicines Division nominally reported to me.� However, in practice the existing lines of command continued and I reported jointly to the Deputy Secretary responsible for medicines policy and to the Deputy Chief Medical Officer (DCMO) until MCA became a Next Steps Agency in 1991.[159]<br />
<br /></div>
<div style="font-family: arial; font-size: 13.3333px;">
�<span style="font-size: 13.3333px;">When the MCA became an executive agency on 11 July 1991, my title changed to that of Chief Executive, and I became responsible and accountable directly to the Secretary of State for the efficient management, overall performance and future development of the MCA.� My role is primarily that of a medically, scientifically informed manager: I am there to oversee the running of the MCA and since July 1991, to advise Ministers on matters of medicines control.�[160]</span><br />
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126. Dr Jefferys said in his Statement to the Inquiry that under the new structure he was given wider responsibility as the Business Manager for Business A: New Drugs and European Licensing. He was responsible for the medical, scientific and pharmaceutical staff involved in the assessment of new drugs including biological products. In addition he was responsible for the secretariat to the CSM and for the Biological and Biotechnological Unit that was headed by Dr Purves. Dr Jefferys reported to Dr Keith Jones.<br />
<span style="font-size: 13.3333px;">[161]</span><br />
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127. Dr Rotblat said in her Statement that a separate Biological and Biotechnological Unit was set up shortly after the MCA became operational. In late 1990 Dr Purves was appointed unit manager and Dr Rotblat was the SMO. Initially she was the only SMO in the unit but later another post was created because of the high workload. After Dr Purves was appointed unit manager, Dr Rotblat�s involvement with BSE became more limited as Dr Purves took over the responsibility for the work on BSE. To begin with Dr Purves reported to a Group Manager, Dr Ritchie, but after about one year, Dr Ritchie left the MCA and was not replaced. After that Dr Purves reported directly to Dr Jefferys who in turn reported to the Chief Executive.[162]<br />
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128. In the Autumn of 1994, there was a further reorganisation into the MCA[163] with the five following divisions:<br />
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(i.) Licensing Division;<br />
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(ii.) Post Licensing Division;<br />
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(iii.) Inspection and Enforcement Division;<br />
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(iv.) Executive Support Division;<br />
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(v.) Finance Division.<br />
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129. The Agency was still headed by the Chief Executive, Dr Keith Jones, and each Division by a Grade 4 Business Manager.[164]<br />
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Relationship between the Medicines Division/MCA and the Advisory Committees<br />
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130. Mr Wilson says in his statement to the Inquiry that �[t]he Division provided, amongst other things, the Secretariat and professional support for the Committee on Safety of Medicines (CSM) and the Medicines Commission��[165]<br />
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131. Dr Jefferys has also said:<br />
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��Medicines Division was inevitably dependent on its advisory committees whose members were highly distinguished scientists and clinicians. The committees met according to fixed timetables. For example, the CSM and SEAR met once per month and the Biologicals subcommittee met once every two months. It would have been very difficult to have altered the timetable of these committees� meetings save in a case of emergency.�[166]<br />
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132. Dr Jefferys said in his Statement that there was a very close relationship between the Medicines Division/MCA and the medicines advisory committees (set up under the Medicines Act 1968). There was almost daily contact between the Chairman of the CSM and senior members of the Medicines Division/MCA. There was also frequent contact between the Medicines Division/MCA and other prominent members of the CSM between committee meetings. On a matter of such importance as BSE, the Chairmen of the committees and subcommittees would be kept very closely informed on all developments.[167]<br />
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133. Dr Jefferys also stated that medicines required a considerable number of decisions to be made. Many of them could be taken by the Medicines Division/MCA, as the executive arm of the Licensing Authority, without referring them to expert advisory committees. However many others did need to be referred to the advisory committees and certain types of decision were required to go before the CSM under the requirements of the Medicines Act. The CSM was also consulted on matters of general policy.[168]<br />
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134. Dr Jefferys gave the following example of the interaction between the Medicines Division/MCA and the CSM[169]. Before each CSM meeting there were a number of other meetings, the first of which was an agenda and pre-briefing meeting. This meeting was held on the Tuesday of the week of a CSM meeting and was only attended by officials from the Medicines Division/MCA. It was used to identify in advance any political issues that might need to be communicated to Ministers, the CMO or other officials in DH. The meeting was also used to decide what issues should be placed before the CSM at future meetings.<br />
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135. On the Wednesday of the week of a CSM meeting, there was a lunch time meeting attended by the Chairman of the CSM (and possibly the Vice-Chairman), the Secretary to the CSM and its principal assessors (from the Medicines Division/MCA). Principal assessors might be from either the medical or pharmaceutical structure and were more senior than a medical or pharmaceutical assessor. This was followed in the afternoon by a full briefing meeting for the Chairman and Vice-Chairman at which other officials were present.<br />
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136. The CSM itself met on Thursdays although the meetings sometimes continued into Friday.<br />
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137. Dr Jefferys has commented on prioritisation of work within Medicines Division:<br />
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�The Division obviously had to, and did, prioritise its work. However, it is important to understand that there were considerable limitations on our ability to prioritise our work since most was demand led. First, EC and national legal timeframes applied to much of the work with the result that it would not have been possible for us to have ceased carrying out that work. For example, legal timeframes applied in EC multistate and Concertation procedures and cases where a hearing date had been set for a company to argue its case before one of Medicines Division�s advisory committees. There were also deadlines for getting applications before committees and we were sometimes threatened with legal action when we risked missing deadlines. In addition, at that time, MB3A was responsible for clinical trials which took up about 40 � 50% of one physician�s time and probably 50% of one toxicologist�s time. The Licensing Authority was required to determine a CTX within 35 days if it had any objections failing which it was assumed to have approved the application.�[170]<br />
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Communication with Ministers<br />
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138. The administrators within Medicines Division/MCA were primarily responsible for reporting to Ministers on matters relating to medicines. Before 1991 Mr Hagger, who was responsible for the CSM�s secretariat, would send submissions to Ministers, including any on BSE and medicines. An administrator considering whether and what to report to Ministers would discuss the matter with the Head of the Administrative Division (Mr Hale and subsequently Mr Wilson) and/or the Head of the Medical Division (Dr G Jones). There was no formal framework for deciding what matters (in particular those flowing from the recommendations of the CSM) should be referred to Ministers.[171]� Dr Jefferys states that �[o]fficials had to apply their own judgement when deciding what matters to refer to Ministers.�[172]<br />
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139. Mr Hagger has commented to the Inquiry:<br />
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�The bulk of my normal work comprised such things as considering courses of action to meet actual or anticipated licensing issues; preparing reports; briefings and occasional submissions for senior officers or ministers��[173]<br />
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140. In oral evidence to the Inquiry Dr G Jones said that on the vast majority of routine business the Minister would not be involved:<br />
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�If it were something highly controversial, well in some cases Ministers had to be consulted of course, especially on orders, but if it were not quite as drastic as that but still highly controversial, then senior officers and Ministers would be consulted anyway as a matter of common sense and courtesy. But it would be rare.�[174]<br />
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141. Dr Jefferys� approach to this issue was that if he was ever in doubt about whether a matter should be referred to Ministers, he would discuss it with senior colleagues in the Medicines Division/MCA including the SPMO or Chief Executive. Other officials in DH such as the DCMO or those in the Minister�s private office might also be consulted. At the end of that process, if he was still in doubt he would err on the side of recommending referring the matter to Ministers.[175]� Dr Jefferys also notes:<br />
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�A large number of issues are in fact referred to Ministers, partly because a considerable number of PQs are tabled on medicines based issues. In addition, Ministers sometimes ask the CSM to advise on a particular issue and then inform Parliament that they have asked the CSM to advise and that they are awaiting that advice.�[176]</div>
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142. Professor Asscher has stated</div>
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�The CSM reported to the Licensing Authority. Ministers are, as a matter of law, the Licensing Authority. However, my understanding of the arrangement was that decisions were de jure taken by Ministers; but were de facto taken by the Medicines Division/Medicines Control Agency.</div>
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I should emphasise that the CSM did not report directly to Ministers. As far as I can recall, I never wrote directly to Ministers during the whole of my time as Chairman of the CSM�.[177]�</div>
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He also says that he �had no meetings with either Ministers or the Chief Medical Officer (CMO) over BSE.�[178]</div>
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143. Ms Edwina Currie, Minister of Health between September 1986 and December 1988, told the BSE Inquiry that :[179]</div>
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�� I would not dream of overruling people who were on the various senior medical committees, the Committee on Safety of Medicines existed exactly to advise Ministers on what was and was not safe.</div>
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The system worked extremely fast. I could be informed within hours if a problem had arisen, for example, with a batch of vaccines. I would not be asked for my permission to withdraw it from the market; the Committee had the power, with the pharmaceutical industry, to act extremely quickly in the public interest. I would be told, if necessary I would give my retrospective approval; and then I would find myself facing press enquiries about it.�</div>
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It generated considerable confidence, amongst Ministers, in the approach that was being taken by the Committee on Safety of Medicines. I believe the technical responsibility lay with the Chief Medical Officer, who of course, he is not just an official like any other official he is a senior person who would feel himself, I am sure and I hope, obliged to take action first in the public interest and get hold of Ministers and tell them as soon as possible afterwards. In some cases the CMO would then answer for his actions in public, and in some cases Ministers would.�</div>
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144. When questioned about whether she would have looked to the CMO for advice on medicines and pharmaceuticals, Mrs Virginia Bottomley, Secretary of State for Health from April 1992 to July 1995, replied that the CMO:</div>
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��had a role in relation to medicines and pharmaceuticals, but essentially the [MCA] was established in 1989�The [CSM] actually advised the [MCA] on the safety, quality and efficacy of medicines and they had a range of expertise across the necessary sciences, which obviously was broader than the Chief Medical Officer�s area of expertise, so had I been unhappy about the reports back from the Medicines Control Agency, certainly I might have raised it with the Chief Medical Officer or one of his staff��[180]</div>
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145. When Mr Dorrell, Secretary of State for Health from July 1995 to May 1997, was questioned about who he would look to for advice on medicines, and particularly in relation to BSE, he replied</div>
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�There is a clear statutory framework laid out as I understand it.� That is that the Medicines Control Agency is responsible for marshalling and preparing the evidence which then goes to the Committee for Safety of Medicines and the Committee for Safety of Medicines�reaches conclusions based on the evidence submitted to it by the MCA and, on the basis of those conclusions, offers advice to Ministers as the Licensing Authority�</div>
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The Chief Medical Officer in that context is an independent source of advice, if you like, to the Secretary of State, or to Ministers to the Licensing Authority, on how they should react to advice that comes from the CSM.� But it is, I think -- it certainly did not happen in my time that the CMO expressed a different view from the CSM.� I think it is extremely unlikely that he would do that, much more likely that if he felt that action needed to be taken, he would act by changing the machinery rather than by commenting on the advice that came out of the machinery.�[181]</div>
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Relationship between the Medicines Division/MCA and the Chief Medical Officer</div>
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146. The Chief Medical Officer (CMO) is a second Permanent Secretary in the Department of Health (DH). The CMO works closely with the Permanent Secretary in the DH and advises the government generally on matters affecting public health.� The CMO is the professional head of the DH�s medical staff, and represents the UK on health matters in the EU and internationally.[182]</div>
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147. Sir Donald Acheson says in his statement to the Inquiry:</div>
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�The Chief Medical Officer is the principal adviser on medical and public health matters, not only to Ministers in the Department of Health but to the Ministers in other government departments and to the Government as a whole.� It follows that the field over which the CMO is required to provide advice extends far beyond his own personal professional experience.� It is therefore necessary for him to be supported by an extensive advisory machinery.�[183]</div>
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148. At the beginning of the period in question the DH administrative staff reported to the Permanent Secretary and the medical and scientific staff reported to the CMO.� As the person managerially accountable for the medical staff, the CMO could therefore address his responsibility for the quality of medical advice within the DH.[184]</div>
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149. Before the creation of the MCA the SPMO in the Medicines Division reported to the Deputy Chief Medical Officer (DCMO) and therefore the CMO[185].</div>
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150. Sir Donald Acheson, the CMO from January 1985 to October 1991, said in oral evidence to the Inquiry that the</div>
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��Medicines Division�seemed to have a slightly different line of accountability.� All the doctors in the Department in my day were accountable to me, which was, I believe, essential.� It guaranteed my independence.� Now, the Senior Principal Medical Officer in the Medicines Division also had to deal with the Medicines Act�.</div>
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And he had a line of accountability of some sort to the Medicines Commission, which was appointed by the Medicines Act. Now in practical terms the way this affected me and my colleagues was that we were told that a number of the things that we wanted to discuss were confidential in the commercial sense under the Act, and that they could not discuss them with us. Now, I do not want to make too much of that because --� I think it is part of the background, but having said that they were as receptive as they could be to my various interventions�.[186]</div>
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151. After the introduction of the MCA in July 1991 the reporting arrangements changed, and the Chief Executive reported directly to the Secretary of State for Health. There was no formal relationship between the Chief Executive and the CMO, although the CMO was routinely kept informed on MCA issues pertaining to public health.[187]</div>
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152. The CSM was not responsible under the relevant legislation to the CMO, although the practice on all sensitive public health issues was, and is, for officials to minute the CMO at the same time as minuting Ministers.[188]</div>
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Supplies Technology Division/Medical Devices Directorate/Medical Devices Agency</div>
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Function</div>
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153. The main function of the MDA (in its various forms) is to ensure that medical equipment and devices used in the UK meet appropriate standards of safety, quality and performance[189] and that these standards comply with the relevant Directives of the European Union[190].���</div>
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Structure of the Supplies Technology Division/Medical Devices Directorate/Medical Devices Agency - their roles and responsibilities</div>
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154. Until the creation of the Medical Devices Agency (MDA), responsibility for ensuring the safety of medical devices rested with the Supplies Technology Division (STD) and then the Medical Devices Directorate (MDD).[191]</div>
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155. The STD existed up until 1 August 1990 and was a part of the NHS Procurement Directorate. The NHS Procurement Directorate was managed by a Grade 3, and the STD by a Director, Mr Gordon Higson, at Grade 4 level. The function of the STD was to promote and investigate safety for a wide range of medical devices and equipment, and to provide scientific and technical services including quality audits of medical device manufacturers, some research and development, and technical evaluations of some products.[192]</div>
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156. Within the STD there were three areas which had responsibility for aspects of bovine products used in medical devices. These were: implants; sterilisation; and the Manufacturer Registration Scheme (MRS). The job responsibilities in these areas were considerably wider than just considering the use of bovine products in medical devices. It appears that after November 1987 both the implants and sterilisation areas were headed by the Grade 5, Miss Marilyn Duncan. Prior to that they had been headed by Miss Duncan but at a Grade 6 level. Until July 1988, Miss Duncan reported to the Director of STD and thereafter to the Director of the NHS Procurement Directorate. She had two Grade 6 and two Grade 7 staff members reporting to her on both the issues of implants and sterilisation. Technical responsibilities for the MRS were devolved throughout the organisation.[193]</div>
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157. In August 1990 the Procurement Directorate was re-organised: the procurement role was removed from the STD and transferred to the newly created NHS Supplies Authority. The STD was renamed the Medical Devices Directorate. The Procurement Directorate continued to be managed by a Grade 3, and the MDD was managed by a Director, Mr Alan Barton, at Grade 4 level. Mr Barton reported to Dr Jeremy Metters, the Deputy Chief Medical Officer.[194]� Two Grade 5 and four Grade 6 staff reported to Mr Barton, as well as two Senior Medical Officers.� The function of the MDD was to ensure that a wide range of medical devices and equipment met acceptable standards of safety, quality and effectiveness and that these standards complied with EC Directives.� It was also responsible for the evaluation of devices and equipment.[195]</div>
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158. Under this new structure the same three areas were responsible for aspects of bovine products used in medical devices. The implants and sterilisation areas continued to be headed by Miss Duncan, a Grade 5, with two Grade 6 and two Grade 7 staff members working to her. Miss Duncan reported to the Director of the MDD. In June of 1992 a technical area was set up with responsibility for the MRS. This was headed by a Grade 6 and had one Grade 7 staff member.[196] The area headed by Miss Duncan was known as Safety and Quality until September 1992 and then as Device Technology and Safety.</div>
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159. On 27 September 1994 the MDD was replaced by the MDA. It was managed by a Chief Executive, Mr Alan Kent, at Grade 4 level, who had been appointed in October 1993 in expectation of Agency status. He was responsible for the day to day running of the Agency and was supported by a senior management team and a total of 170 staff, many of whom had professional and technical qualifications.[197] The staff were organised in several businesses, four of a functional nature, one of a medical and nursing nature which supported the functional areas, and two administrative areas. These were detailed in the 1995 Civil Service Yearbook as:</div>
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(i.) European business and standards;</div>
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(ii.) Device technology and safety;</div>
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(iii.) Device evaluation and publications;</div>
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(iv.) Manufacturer Registration Scheme;</div>
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(v.) Medical and Nursing;</div>
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(vi.) Corporate management;[198] and</div>
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(vii.) Corporate finance (added after the Civil Service Yearbook was compiled).</div>
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160. The Chief Executive was directly accountable to the Secretary of State for Health and fully responsible for the efficient management, performance and future development of the Agency. The Secretary of State was answerable to Parliament for all matters concerning the Agency, but Ministers would only expect to intervene in the running of the agency in exceptional circumstances. If, exceptionally, Ministers needed to intervene, the effects of such intervention on the Agency�s targets would be made explicit.[199]</div>
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161. The areas responsible for aspects of bovine products used in medical devices continued to be implants; sterilisation; and the MRS. The first two of these areas came under the �Device Technology and Safety� business unit and were headed by Dr Eamonn Hoxey, a Grade 5. He reported to the Chief Executive and had two Grade 6 and two Grade 7 staff concerned with implants and sterilisation.</div>
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Veterinary Medicines Directorate</div>
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Structure of the Veterinary Medicines Division � administrative and professional staff, their roles and responsibilities</div>
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162. Before the creation of the Veterinary Medicines Directorate (VMD) in 1989 three bodies in MAFF undertook regulation of veterinary medicines. These were:</div>
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(i.) Animal Health Division III/Animal Medicines Division (MAFF Animal Health Group) which was responsible for policy matters relating to veterinary medicines. The Division was managed by a Grade 5, Mr K Wilkes between 1986-87, and Mr F Scollen between 1988 and April 1989. The Grade 5 reported to the Head of Animal Health Group, Mr J Hepburn between 1986-87 and Mr Cruickshank between 1988 and April 1989.</div>
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(ii.) Medicines Unit (Central Veterinary Laboratory (CVL)) which was responsible for the assessment of non-biological products and administrative staff who formed the Veterinary Products Committee (VPC) secretariat. It was managed by Mr Alastair Kidd and staffed by veterinary surgeons and scientists;</div>
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(iii.) Biological Products and Standards Department (BP&S), also part of CVL, which was responsible for the assessment of applications for immunological veterinary medicines and inspections of their manufacturing premises. It was managed by Dr Denise Thornton and staffed by veterinary surgeons and scientists.[200]</div>
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163. The formal channel of communication and co-ordination between the Animal Medicines Division and the two areas responsible for veterinary medicines in CVL was from the Grade 5 managing the Animal Medicines Division, to the Director of the CVL, Dr Watson.[201]</div>
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164. Dr Rutter�s statement to the Inquiry outlines the relationship between the VMD and the Department of Health:</div>
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�From the time the VMD was set up, its staff had regular contact with officials from the Department of Health through attendance of Department of Health officials at the Scientific Secretariat and the VPC.� In addition, Dr. Lee served as the VMD representative on the BSE Working Group of the Biologicals Sub Committee of the CSM from September 1989, which enabled the updating and sharing of information between the VMD and its equivalent in the Department of Health, the Medicines Control Agency (MCA).� VMD staff attended meetings of the Medicines Commission and I met the Chief Executive of the MCA at various meetings.�[202]</div>
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165. Dr Thomas Little, Deputy Director of the CVL from 1986-1990, said in his Statement to the Inquiry that he had specific responsibility for veterinary medicines and in particular for the Medicines Unit and the Biological Products and Standards Department.� He had fairly frequent contact with the Animal Medicines Division in the Animal Health Group, who were responsible for policy and administration side of veterinary medicines. He also briefed the Chairman of the Veterinary Products Committee (VPC) before meetings and attended meetings of the VPC.� When necessary,� he attended meetings of the Medicines Commission and various other committees which dealt with human medicines.[203]</div>
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166. Professor Armour outlined the role of the VPC:</div>
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�The Committee advised on applications for test licences and product licences for individual veterinary products and general policy, including guidelines for registration of veterinary medicines.� During my chairmanship, it also had the task of reviewing all pharmaceutical products given a Licence of Right when the Medicines Act was introduced in 1968 and all other licences awarded prior to 1984; this was to conform with European regulations (see EC Directives 81/851 and 81/852.�[204]</div>
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167. On 1 April 1989 the Animal Medicines Division merged with the Medicines Unit and part of the Biological Products and Standards Department to form the VMD. The VMD was responsible for licensing and control of animal medicines and medicated feedstuffs, and control of veterinary residues. It was a part of the Pesticides, Veterinary Medicines and Emergencies Group and was headed by a Director of Grade 4 level, Dr J Rutter. Two Deputy Directors of Grade 5 level, one responsible for professional matters (Mr Kidd) and one responsible for administrative matters (Mr Scollen), reported to him.[205]</div>
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168. With the establishment of the VMD, the work was allocated between three multi-disciplinary professional and administrative teams, each headed by a professional (Grade 6 level) and administrative (Grade 7 level) team leader reporting to the appropriate Deputy Director. The three teams which reported to the Deputy Directors, were:</div>
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(i.) Pharmaceuticals � responsible for assessing applications and administering product licences for pharmaceutical products. Also responsible for international and European aspects of market authorisations and legislation for these products. This team co-ordinated VMD interests on policy developments relating to these matters;</div>
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(ii.) Biologicals and recombinant products � responsible for assessing applications and administering product licences for biological and recombinant products. Also responsible for administering the Suspected Adverse Reactions scheme for all veterinary products. This team also co-ordinated VMD interest in policy developments relating to biologicals and recombinant products. The administrative staff in this team provided the secretariat services to the Veterinary Products Committee; and</div>
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(iii.) Feed additives- responsible for assessing applications and administering product licences for all veterinary medicinal products administered in feed or drinking water with the exception of oral vaccines. Also responsible for co-ordinating VMD interests in policy developments relating to these matters. The Finance team reported to the Head of Administration in this team.[206]</div>
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169. The VMD became an Executive Agency on 2 April 1990. It was responsible for all aspects of licensing and control of animal medicines and medicated feedstuffs including the protection of the consumer from potentially hazardous residues in food.</div>
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170. As an Executive Agency it was headed by a Director, or Chief Executive. The Director, Mr Rutter, was responsible for the day to day running of the VMD and as before had two Deputy Directors reporting to him (on professional and administrative matters). The work of the VMD continued to be allocated between three multi-disciplinary professional and administrative teams, each headed by a professional and administrative manager. The roles and responsibilities of these teams remained as they had been, but Finance became a separate branch and the IT branch was created. These areas both reported to the Deputy Director for Administration (now Mr C Lawson).[207]</div>
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171. The Minister was not involved in the day to day running of the VMD, but had the right to issue directions to the Director (Chief Executive) on matters relating to priorities, resources and general policy.[208]</div>
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172. The VMD was a service provider for MAFFs policy divisions, and as such had to provide services under the policy of �value for money�. The VMD and MAFF agreed on the services to be provided and any changes in requirements or priorities were made following the agreement of the Chief Executive.[209]</div>
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173. This structure remained in place until the 1992 Review of the Organisation and Management of VMD, which was implemented in April 1993. As a result of the review, two Director positions (at Grade 5 level) were created. One was the Director of Licensing, and the other the Director of Policy and Finance. These were essentially the same as the Deputy Director positions before the reorganisation, except that they had different responsibilities.[210]</div>
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174. The Director of Licensing, Dr K Woodward, was responsible for all technical matters relating to the assessment of product licences and other applications. He was also responsible for all administrative work relating to their issue, inspection of UK and overseas manufacturers of immunological products, inspection arrangements, the Suspected Adverse Reactions Surveillance Scheme, and the VPC Secretariat. The Teams reporting to the Director of Licensing were:</div>
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(i.) Pharmaceuticals and Feed Additives � with a Grade 6 Licensing Manager, Mr J O�Brien;</div>
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(ii.) Immunologicals and Suspected Adverse Reactions � with a Grade 6 Licensing Manager, Dr A Lee; and</div>
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(iii.) Licensing Support � with a Senior Executive Officer Head of Branch, Ms H Oliver. This team was responsible for the VPC Secretariat.</div>
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175. The Director of Policy and Finance, Mr C Lawson, was responsible for all licensing policy matters and the distribution of veterinary medicines. He also had responsibility for supporting the UK delegation to the European committee (CVMP), the review of veterinary medicines, and homoeopathics. General administrative, finance and IT matters were also dealt with in this section. The teams reporting to the Director of Policy and Finance were:</div>
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(i.) Licensing Policy � with a Grade 7 Head of Branch, Mr A Harvey;</div>
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(ii.) European and Information Policy � with a Grade 7 Head of Branch, Mr A Taylor;</div>
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(iii.) Residues and Office Support - with a Grade 7 Head of Branch, Mr C Bean;</div>
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(iv.) Finance - with a Grade 7 Head of Branch, Mr M Addison; and</div>
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(v.) IT - with a Grade 7 Head of Branch, Mr N Paterson.[211]</div>
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176. This structure remained in place until 1996 when a Business Unit was set up under a Grade 6, Mr J FitzGerald. This Unit took over responsibility for general administrative, finance, and IT matters, which left the Director of Policy responsible exclusively for policy matters relating to veterinary medicines.[212]</div>
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Chronology of events</div>
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177. In June 1983 MAFF prepared a reference document on use of substances of animal origin in the manufacture of veterinary vaccines. In the section headed �a guide to current practice� it said:</div>
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�Restrictions are placed upon the use of substances of animal origin in order to minimise the risk associated with pathogens which may be present in these materials. Unless there is a risk from a heat resistant pathogen such as the scrapie agent, no restrictions are placed on substances sterilised by autoclaving provided that the complete mass is held at a minimum of 115OC for at least 15 minutes. Restrictions on the use of substances that can not be sterilised by autoclaving vary according to the target species, the species of origin, the country of origin and whether the substance undergoes at any stage treatment which will inactivate contaminating agents.�[213]</div>
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178. In 1985 Dr A G Dickinson, the Director of the Neuropathogenesis Unit in Edinburgh, contributed to a paper in the Lancet which discussed concerns over the possibility of infection of human growth hormone with CJD. The paper said that the main concern was the risk of �cross-contamination between stages of the process. This will arise from a lack of appreciation of the extreme aseptic standards which are necessary.�[214]</div>
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Early Consideration</div>
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179. In his Statement to the Inquiry Mr John Sloggem said that in July 1987 he was asked in his capacity as a Pharmaceutical Officer in Medicines Division, to process a CTC (Clinical Trial Certificate) application for a drug that was a bovine brain extract containing phospholipids. The reason that the company was applying for a CTC was that its application for a CTX (Clinical Trial Exemption) had been refused in January 1984. One of the reasons for rejecting the 1984 application was that the company had not been able to satisfy Medicines Division about its freedom from transmissibility of transmissible agents, including virus particles.[215] Mr Sloggem also notes that �[t]he company had at that time been advised that if it wished to proceed to a clinical trial, a CTC would be required, necessitating an application for a CTC which would be formally considered by CSM and its Sub-Committees.�[216]</div>
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180. Mr Sloggem also said[217]:</div>
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�In the file I found a copy of a letter of 4th April 1984 from the Medicines Division, responding to a letter from the company which had asked for clarification of the type of viruses concerned. This letter of 4th April 1984 confirmed that, in relation to the issue of virus infection, evidence would be needed in view of the bovine brain source to satisfy the Committee [CSM] that slow virus contamination was not a problem.</div>
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As I have said, I had previously been aware of CJD and sheep scrapie.� I had not, until I read this letter, been aware of any slow virus issue relating to bovines. In light of the terms of the letter of 4th April 1984 I read the rest of the CTX file where I found a manuscript reference to the question of a slow virus associated with bovines possibly having been raised by Dr John Griffin who was then the Professional Head of Medicines Division�.</div>
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�In� light of this reference I decided that I should inquire into the situation further. In July 1987 I telephoned Dr Taylor with whom�I had previously worked professionally and discussed HGH and CJD issues, and he told me that a bovine encephalopathy had recently been recognised, I sent him some information about the production methodology in outline so that he could comment on the possibility of �bovine slow virus� transmission.�</div>
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181. On 24 August 1987 Dr David Taylor of the Neuropathogenesis Unit (NPU) wrote to Mr Sloggem in reply to earlier correspondence, about the �scrapie-like disease which is occurring in bovines�. He stated:</div>
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�Regarding the scrapie-like disease which is occurring in bovines, the results of transmission studies are not available yet but the histopathology is identical with sheep scrapie, and scrapie-associated fibrils (SAF) have been detected (SAF have only been seen in preparations from transmissible scrapie-like diseases although other neurological diseases have been investigated). The disease seems to be occurring in Friesians, particularly those which have been improved by imported Holsteins.� I believe that there was talk of its occurrence in the United States at the recent International Congress of Virology held in Edmonton but no details were known.</div>
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As far as the product procedure is concerned, exposure to the solvents would be likely to lead to approximately a two log loss of infectivity. Other unquantifiable losses are likely to occur not through inactivation but by mechanical removal, for example by precipitation, filter absorption etc. Infectivity could survive through to the end-product because the scrapie-associated protein has a co-valently linked glycolipid at its carboxyl terminus (see enclosed reference).� This could result in the co-fractionation of at least some infectivity.�[218]</div>
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182. On 31 August 1987 Dr Taylor wrote a further letter to Mr Sloggem in which he summarised the position about oral transmissibility of scrapie, Kuru and CJD.� Mr Sloggem had asked for his opinion because the product in question was for oral administration.[219]</div>
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Note:� The Committee for Safety of Medicines Biologicals Sub-Committee meeting on 9 September 1987 (below) is dealt with further in RFA 5 � The Early Days (and update).</div>
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183. The Committee for the Safety of Medicines (CSM) Biologicals Sub-Committee met on 9 September 1987.[220]� Professor Gerald Collee, Chairman of the Biologicals Sub-Committee, chaired the meeting, which was also attended by several senior members of the Department of Health and Social Security�s (DHSS) Medicines Division, including Dr David Jefferys, as Medical Assessor, Dr J Purves, as Pharmaceutical Assessor, Dr Paul N Adams and Dr Frances Rotblat.</div>
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184. Dr Little, Head of MAFF�s Medicines Unit, also attended this meeting. He recalled in his Statement to the BSE Inquiry that at that meeting he discussed BSE in the context of medicinal products, both human and veterinary.[221] Dr Little said:</div>
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�One of the products discussed during the meeting was composed of human dura mater.� This was under review at the meeting because of a case of CJD associated with its use.� The official from the Department of Health presenting the case was Dr Adams.</div>
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Although the minutes of the meeting make no reference to it, I made a mention at the meeting of the occurrence of BSE in cattle.� I believe (although I cannot now be sure) that I mentioned BSE during the course of the formal meeting.� I can remember that a discussion of scrapie resulted from my mention of BSE.� Professor Collee impressed me with his knowledge of scrapie.� It may be that my mention of BSE and Professor Collee�s comments on scrapie arose during discussion on Dr Adams� paper on the dura mater products.</div>
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Although I am uncertain about the precise context in which I raised BSE, I am certain that Professor Collee and Dr Adams were present when I mentioned BSE.�</div>
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185. Dr Little expanded on this statement in oral evidence to the Inquiry:</div>
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��I believe that what I have said was that there had, following some mention of scrapie, which I think I can explain, that there was a similar condition in cattle that we were investigating; and I did not go beyond that. I made a very simple statement, that there was a similar condition in cattle, BSE, which we, CVL, were involved in investigating.�[222]</div>
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186. The minutes of the meeting on 9 September 1987 make no reference to BSE.[223]</div>
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187. Drs Adams, Purves and Rotblat do not recall BSE being raised at the meeting.[224]� Professor Collee, in his Statement to the Inquiry, states that human dura mater was discussed at the meeting, as was the transmission of microbial agents, including what were known at the time as the �slow viruses.�� He also says:</div>
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�I am asked by the Inquiry whether I have any recollection of Dr Little mentioning BSE to me at this meeting, whether formally or otherwise, I have no such recollection and I am as confident as I can be that no such mention was made to me�.[225]</div>
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188. Dr Jefferys said in his statement:</div>
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�I understand that there has been a suggestion that the issue of an emerging problem with BSE might have been drawn to the attention of DHSS at a meeting of the Biologicals subcommittee held in Market Towers in September 1987. I have no recollection of this. There is no mention of it in the minutes of the meeting, nor in subsequent minutes of the CSM to whom the subcommittee reported� If mention was made of an emerging problem in the margins of the meeting, one would still have expected this to have been followed up with a formal letter. In addition, if it was raised at the meeting I would have expected its omission to have been corrected in the minutes or at subsequent meetings of the Biologicals subcommittee or the CSM. However, it is not mentioned in the minutes of subsequent meetings of either of those committees.�[226]</div>
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189. Dr Little also recalls that he had an informal discussion on the subject of BSE at the end of the meeting.[227]</div>
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190. Dr Little has given further evidence on this informal discussion at his oral hearing. He was asked about who was present for the discussion about the specific product, and the implications of BSE to it. He replied:</div>
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�The real answer is I cannot remember.� At the end of the meeting I spoke to Gerry Collee, and when I spoke to him about it -- and I spoke to Paul Adams.� We were all congregated at the end of the table. Whether they overheard the conversation with whoever it was about the product or not I could not be certain at this point in time.�We were all together at the end of the table, at the end of the meeting, having a discussion.� They may not have heard.� It is quite possible they did not.� They may have left.�[228]</div>
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191. In relation to the BSC meeting on 9 September 1987, Dr Little also says:</div>
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�I recall that after the meeting was formally concluded, but before everyone had dispersed, someone approached me from the Department of Health ("DoH"), whom I now deduce must have been Mr Sloggem.� He informed me that a product consisting of an extract of bovine brain was currently under review and that he was aware of the BSE problem, and had concerns about it in relation to this product.� He also told me that someone from DoH would be writing to MAFF about these concerns.�[229]</div>
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192. Mr Sloggem has said that he was interested in the discussion of possible transmission of CJD by dura mater products because of his previous work in connection with human growth hormone and transmission of CJD.[230]� He comments:</div>
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�I do not recall Dr Little contributing to that discussion or mentioning BSE during any such discussion. I had not met Dr Little prior to 9.9.87 and until my attention was drawn to the minutes of the BSC meeting of 9.9.87, did not recall that he had attended that meeting.</div>
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Before receiving the Inquiry�s letter of 9.7.99 with the enclosed copy transcript of Dr Little�s oral evidence given on 7.7.99 and his second supplementary statement I had no recollection of any discussions at the 9.9.87 BSC meeting.� Having now read the minutes and these documents I only recall matters as indicated above.� Certainly if there had been a discussion of the kind Dr Little suggests took place I believe that what he has said about it would have jogged my memory.</div>
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My comments above about my lack of recollection of what Dr Little describes need to be placed in context.� I note, in particular, that he said in his evidence that he recalled a specific discussion about a bovine brain product and the risk from BSE in relation to it.� I note also that while in oral evidence he said that somebody said �they� would be writing to MAFF, in his supplementary statement he said first that I said to him that �someone from DH� would be writing to MAFF about BSE concerns in relation to the product I was assessing (paragraph 19) and secondly that I said I personally would contact MAFF in relation to my concerns (paragraph 22).� I believe that I would have said none of these things.</div>
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If I had discussed with anyone the bovine brain extract product which I was then assessing with input on BSE from Dr David Taylor at NPU, it would have been with my line manager, Mrs Glenda Sylvester, who also attended the BSC meeting on 9.9.87 and with whom, as the product file demonstrates, I had discussed the product on 24.7.87.� I had no authority to say that I or anyone else within DH would write to MAFF about a general scientific issue.� In connection with my assessment of the bovine brain extract product I was already, by 9.9.87, communicating with Dr Taylor on the issue of �bovine slow virus��</div>
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�</div>
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On 9.9.87 there was no reason for me to talk to Dr Little, whom as I say I had never met, about the product I was assessing.� I had obtained the information about the bovine slow virus which I needed directly from Dr Taylor.</div>
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�</div>
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It seems to me that communication within NPU could have led to the fact of my concerns about bovine slow virus, in relation to the product I was assessing, becoming known to Dr Little and others in MAFF.� Certainly the BSC itself was not, by 9.9.87, aware of the bovine brain extract product I was assessing and which was presented to it for the first time in January 1988.</div>
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�</div>
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I had, by 9.9.87, formed the impression from my contact with Dr Taylor that the bovine slow virus issue was a matter which was not widely known and should not be publicised.� I do not believe that I would, therefore, have felt it open to me to approach someone I had not met before,� ie Dr Little, to tell him about what I knew.� Neither, as I have explained above, would it have been open to me to suggest that either I or someone else within DH would write to MAFF about the subject in general.� I had already involved NPU and obtained the information I needed from Dr Taylor to put the issue to BSC in my paper on the bovine brain extract.�Furthermore I agree with Dr Little that an issue of this significance would have been expected to have been dealt with at a more senior inter-departmental level.�[231]</div>
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193. On 10 September 1987 Dr Bill Watson, Head of Central Veterinary Laboratories (CVL), wrote to Mr Rees the Chief Veterinary Officer (CVO)� [232]saying, in relation to BSE, that the CVO would wish to consider the addition of the following information in a submission to the Minister of which he had previously submitted a draft:</div>
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�DHSS are aware of the problem. Concern is being expressed about the possible human health risks due to products for human use which contain an emulsion of bovine brain.�</div>
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The minute went on to say:</div>
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�This matter was discussed by Dr Little with DHSS colleagues attending the Committee of Safety of Medicines Sub-Committee Biological Products on Wednesday, 9 September, and I understand that they will be writing to us.�</div>
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194. Dr Little comments in his supplementary statement:</div>
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�I have seen a minute from Dr Watson to Mr Rees dated 10th September, 1987. I believe the minute accurately reflects what I told Dr Watson. It was my understanding that someone from the Department of Health would be writing or otherwise getting in touch with MAFF to discuss their concerns.�[233]</div>
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195. On 14 September 1987 a meeting took place at the NPU between Dr Watson, Dr Dickinson, Dr Kimberlin and Dr Hope.� A file note prepared by Dr Watson on 16 September 1987 records:</div>
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�Obtained details of the brain treatment with lecithin prior to use orally in treating patients with neurological disease.</div>
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The following day briefly discussed matter with Peter Biggs.�[234]</div>
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196. On 1 October 1987 Dr G Wood signed a commercial in confidence paper about �the possibilities of contamination of hormone preparations, produced by genetic engineering, by unconventional slow viruses (spongiform encephalopathy agents)�.[235] The paper said, on page 2:</div>
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�Having considered spongiform encephalopathy agent contamination purely in the context of genetic engineering and its products, there remains the broader likelihood of contamination by such agents in any product incorporating substances of animal origin in their production or formulation, including genetically engineered products (for instance, possible serum components in bacterial culture media).</div>
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To avoid the possibility of contamination by unconventional slow viruses, the following suggestions may be of value.</div>
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1.��� Do not use material direct from animals (particularly from neural tissues).</div>
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2.��� If using genetic engineering, take only the information from the animal, not the informational molecule, and construct the gene sequence from the amino acid sequence of the purified natural product.</div>
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3.��� Do not use substances of animal origin in growth media for novel host organisms when producing substances by genetic engineering unless they can possibly be avoided.</div>
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4.��� Do not use animals, particularly mammals, as the novel host organism.</div>
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�</div>
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There are, apparently, still some barriers to free exchange of information and queries with the companies involved or with their suppliers.� Eventually, when fuller information can be obtained, it may be possible to be more assured of the safety or otherwise of these products w.r.t. contamination by pathogens.�</div>
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197. In December 1987 Mr Peter Luff, from the Biological Products and Standards (BPS) Department in the Central Veterinary Laboratory (CVL), prepared a document entitled �bovine spongiform encephalopathy � implications for biological products�. The paper was based on the assumption that BSE was caused by an unconventional scrapie-like agent which had spread within the UK cattle population and that the most likely source was meat and bonemeal containing sheep by-products incorporated into cattle and in particular calf feed. Mr Luff set out what he saw as the three main approaches to containing the potential BSE threat, of which he considered only the third to be viable. The approaches were as follows:</div>
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�1.�� Everything derived from cattle represents a potential BSE threat. The use of such substances is not permitted unless they have undergone a process to inactivate this agent. The only acceptable treatment is two cycles of autoclaving at 126 C (20 psi) for 30 minutes with cooling to [less than] 35 C in between.</div>
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This will effectively stop the use of bovine serum and cell cultures in vaccine production, and the use of therapeutic bovine anti-serum. Serum albumin will also be adversely affected.</div>
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2.��� Tracing techniques could be used to designate acceptable sources for bovine products.</div>
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At the present state of the epidemic this approach is unusable as the picture is changing almost daily. Even if sufficient data were available, the logistics of collecting serum, for instance, would be unworkable in practice.</div>
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3.��� Risks should be assigned to particular products or groups of products, and action taken against these as necessary in light of the knowledge about the scrapie agent in natural and experimental hosts. There is a risk involved with this approach as there may be subtle differences between the distributions of BSE and scrapie agents, and knowledge of scrapie is anyway incomplete. However, the risks associated with reliance on imported substances are probably greater. As a general rule, the harvesting of any substance from suspected or confirmed cases should not be allowed. Also, it should be remembered that there is no possibility of testing production components or final product for the presence of BSE agent.�[236]</div>
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198. The paper prepared by Mr Luff then considered particular bovine products and their associated risks. He made the following points[237]:</div>
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�a)�� SERUM AND SERUM PRODUCTS: There is no evidence that serum from scrapie infected animals contains any infectious agent, although many attempts have been made. It seems reasonable to assume that the use of these substances is not associated with a risk of BSE agent contamination.</div>
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It may not be unreasonable, though, for manufacturers to use for anti-serum production only animals with the lowest risk of exposure to the BSE agent. At the present time this means those derived from suckler herds not feeding concentrates, and with no history of contact with BSE.</div>
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b)��� OTHER TISSUES: Tissue distribution of scrapie infectivity is uneven. Maximum titres occur in neural and �lymphoid� tissues. Lower amounts occur in placenta, salivary and adrenal glands, pancreas, liver (from work in sheep and goats), lung, kidney, intestine and uterus (from additional work on mice). The use of these tissues should be firmly discouraged. If such use is necessary, then the product should be treated as 1 above.</div>
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Traces of scrapie agent have also been isolated from muscle late in the incubaation (sic) period of the disease. This constitutes a smaller risk, given the low titre and short duration of its presence. A single cycle of 126 C for 30 mins is probably adequate treatment for such products, which tend to be the somewhat diverse �peptones� used in bacteriological media and sometimes as freeze-drying stabilizers.</div>
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There are two special cases to consider � hormones and similar extracts, and cell cultures.</div>
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HORMONES etc: Although the extraction processes involve the use of various organic solvents, which tend to have a deliterious (sic) effect on scrapie infectivity, extracts must be considered to be potentially contaminated � indeed Creutzfeld-Jackob disease has been transmitted by the use of human growth hormone extracted from cadaver pituitaries. It is therefor (sic) not possible to regard bovine gland extracts as deserving special consideration; they must be autoclaved as above. Such products are not likely to be effective after such treatment. The use of pituitary extracts for super-ovulation is not apparently controlled under the Medicines Act. This is an anomaly which requires urgent reconsideration.</div>
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CELL CULTURES: Primary cell cultures could transmit an unconventional agent mechanically. Their use should not be permitted. Given the probability of vertical transmission, it is not possible to set up �SPF� herds to get around this problem. Cell lines are a different matter. No unconventional agent has been grown in cell culture. It seems reasonable to assume that the agent of BSE will not replicate in cell cultures either. There is also no evidence that whatever constitutes a �genome� in these agents can integrate into host cell genome, so the danger in the use of cell lines is again one of mechanical transmission. With the number of passages required to produce a validated cell line there seems to be no real need to impose any general BSE-related requirements. This is, of course, a theoretical argument. Given that the risk, regardless of its absolute size, will be related to the degree of contamination of the original tissue, the use of cells derived from tissues that could carry a high burden of infectivity (neural and �lymphoid�) should not be allowed.</div>
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c)��� SECRETIONS and EXCRETIONS: Scrapie agents have not been isolated from any natural secretions or excretions. This includes saliva, milk, urine and faeces. It seems reasonable to regard these materials as not constituting a BSE-related risk. However, it is assumed that one way that scrapie is spread is through the ingestion of infected placentae, with the agent passing through the gut and being excreted in faeces. It may be possible to question the use of bovine faeces, or at least products derived from them. This has implications for lung worm vaccines. Calves, though, are not major consumers of placentae, and they are maintained in quarantine for a period before use, so there doesn�t seem to be an appreciable risk.</div>
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The situation with bile may not be so straightforward. I don�t know that bile has ever been looked at for scrapie infectivity. One could argue that the absence of agent in faeces suggests that it isn�t present in bile, but that there must be a considerable dilution effect. It is probably better to err on the safe side and a require a single 126 C, 30 min cycle for this substance.</div>
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d)��� OVA and SPERM: The situation here is uncertain, but of no direct concern for biological products in Medicines Act terms. However, the areas of AI and embryo transfer require some investigation.�</div>
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1988</div>
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199. Dr Rotblat said in her Statement to the Inquiry that she first became aware of a scrapie-like disease in cattle around January 1988. She said that:</div>
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�At around this time the Biologicals subcommittee was considering a Clinical Trial Certificate (CTC) application for an oral medical product containing an extract of bovine brain. I did not handle this application which was dealt with by Dr Hilton amongst others. The CTC was refused and the company later withdrew the application. However, for the purposes of considering the application my pharmaceutical colleague, Mr Sloggem, had previously enquired of the Edinburgh Neuropathogenesis Unit whether there was a bovine equivalent of scrapie and had been told that there was. Mr Sloggem mentioned this to me informally at around this time in the course of discussions about the CTC application. The impression which I received was that the scrapie-like disease was a long standing albeit rare disease in cattle; I did not get the impression that it was a new disease. Dr Taylor�s short letter was subsequently included in the papers that went before the Biologicals subcommittee. It should be noted that Dr Taylor�s letter did not specifically refer to BSE and contained very little scientific information about the nature of the scrapie-like disease.� [238]</div>
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200. On 6 January 1988 the CSM Biologicals Sub-Committee met.[239] The minutes of the meeting show that an application by G[240] was considered. This was the product that contained animal brain that Mr Sloggem had corresponded with Dr Taylor about in July and August 1987. The minutes do not record any discussion of BSE.� At its meeting on 25 February 1988, the CSM considered the Biologicals Sub-Committee�s conclusions and agreed with the BSC in advising against the issue of a CTC for the product.[241]</div>
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201. Professor Collee said in his Statement to the Inquiry that he remembers the Committee on Safety of Medicines (CSM) Biologicals Sub-Committee considering a product containing emulsion of animal brain on 6 January 1988. He states</div>
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�From the record of product applications made to the Biologicals Sub-Committee I note that on 6th January 1988 an application for a clinical trial certificate was submitted in respect of certain capsules. The paper which accompanied that application, prepared by John Sloggem, contained a reference to recent reports of a slow virus type syndrome in cattle and referred to the issue of slow virus transmission which this type of syndrome in cattle might raise. I believe that this reference was the first that I had seen to the condition that subsequently came to be known as BSE.</div>
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The product itself was unusual in that it contained bovine brain phospholipids as an active constituent. This would have given rise to concerns about its use on grounds that were distinct from any question of slow viruses. Any preparation that used animal brain as an active constituent would require meticulous scrutiny so as to ensure that appropriate safeguards against potentially contaminating conventional infectious agents were in place. Brain components are protective against sterilising agents and it would be difficult to sterilise an emulsion of bovine brain without destroying at least some of its supposed biological properties.</div>
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In relation to this product, the Sub-Committee were asked to advise whether viral inactivation studies should be carried out with specified organisms and whether slow virus transmission was considered a problem.</div>
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The Sub-Committee�s advice was to the effect that it was concerned about possible infection with transmissible agents and that validation of the extraction process to show the removal of slow virus derived from the starting material should be undertaken and the results reported when available. The Sub-Committee considered that studies using suitable hardy viruses and spiking experiments should be undertaken and reported. The product was refused a clinical trial certificate because of these concerns and for several other reasons as well.� [242]</div>
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202. In relation to the product considered at the 6 January meeting, Dr Jefferys says:</div>
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�The product under consideration was already both widely available and used in many parts of Europe at the time. It was never even allowed for Clinical Trials in the United Kingdom, but subsequently ran into adverse reaction problems and was withdrawn in other parts of Europe.� All this was well recorded in the public literature.� I make this point because I think it can be seen that Mr. Sloggem had very diligently made an assessment and raised a matter of concern which was thoroughly debated and endorsed by the Biologicals Sub Committee and by the CSM.�[243]</div>
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203. On 6 January 1988 there was also a meeting of the Veterinary Products Committee (VPC) Biologicals Sub-Committee. The minutes indicate that the following was discussed:</div>
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�8.2 Bovine Spongiform Encephalopathy</div>
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1)��� A draft paper from BP&S entitled Bovine Spongiform Encephalopathy � implications for biological products was tabled.</div>
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2)��� After a brief discussion it was agreed that an amended paper should be distributed to all members for discussion at the next Biologicals meeting.�[244]</div>
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204. On 3 February 1988 the VPC Biologicals Sub-Committee considered a paper on the implications of BSE for Biological products (prepared by Peter Luff, from BPS CVL, and referred to at paragraphs 197 and 198 above, but subsequently amended) [245]. The minutes of the meeting show:</div>
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�7.4 The paper outlined three options:</div>
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1. All vaccines containing bovine products should be heat treated for 2 cycles of 126�C for 30 minutes. This was considered a severe untenable option as it would affect virtually all product licence holders;</div>
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2. Vaccine manufacturers would only use bovine products from herds, certified as free of clinical disease.</div>
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This option was considered a satisfactory option by some members of the committee.</div>
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3. All bovine tissues should be assigned to different risk groups and each group would be treated separately.� The suggested groups were based on work that had been generated using the scrapie agent. There was concern about the use of brain, neural and lymphoid tissue and pituitary. (It was noted with concern that hormone extracts could be manufactured by a veterinary surgeon for administration to animals under his care without any Medicines Act control). Use of these products should be discouraged. Conversely serum products were considered to be of little concern.</div>
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This option was considered the most appropriate by some members of the committee.</div>
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7.5 After considerable discussion it was agreed that no action be taken at present but that the situation should be reviewed again in six months time unless any new developments within that time required urgent action.�</div>
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March 1988</div>
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205. On 2 March 1988 the Biologicals Sub Committee of the CSM met.[246]</div>
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206. On 3 March 1988 Mr Derek Andrews, the Permanent Secretary of MAFF wrote to Sir Donald Acheson, the Chief Medical Officer (CMO), telling him about BSE.[247] Sir Donald in his Statement to the Inquiry said this was the first time that he was told about BSE.[248]</div>
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First reactions</div>
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207. On 17 March 1988 Dr Watson and Mr Alastair Cruickshank, Under Secretary of MAFF, attended a meeting with the CMO and senior medical officials at the DHSS to discuss BSE.[249] The minute of the meeting records:</div>
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�6.�� Biological products were produced of bovine origin and this applied to a significant proportion of insulin despite genetically manufactured sources.� In addition, cell cultures for many vaccines used a bovine serum medium.� Dr Harris undertook to speak to the Director of NIBSC about biological products.</div>
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�</div>
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13.�� Mr Cruickshank thought it necessary to assess the risk in humans in order to justify the cost of any control measures taken by MAFF.� Although it would be possible to monitor diabetics, it could take 20 years or more before we would be able to assess whether any risk existed from bovine insulin.� In the meantime, with some 40 or so new cases in cattle a month, the disease would become newsworthy and it was important that both government departments arrange appropriate action before this happened.</div>
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14.�� In conclusion it was agreed that urgent advice was necessary on biological products and the disposal of sick animals.� The options would be outlined to Ministers (of both government departments) and they would be asked to agree the setting up of an expert advisory group.�</div>
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208. A note on the meeting written by Mr Cruickshank states:</div>
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��After some discussion of the data provided by CVL, it became clear that all those present found it very difficult to give any clear advice on the subject. The meeting appeared to be tending towards the view that there is probably no risk in drinking milk or eating flesh from animals affected with BSE, but that the position was much less clear in relation to brains, spleens and other organs. This raised questions about the safety of human vaccines prepared using bovine material.�</div>
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The CMO concluded the meeting saying that �he suspected there was no risk, but that it could take 30 � 40 years to prove this.�[250]</div>
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209. It was agreed that urgent advice was necessary on biological products and the disposal of sick animals.[251] It was thought that Ministers should be advised to set up an expert committee who �should meet two or three times and examine all the information available�, and provide advice to Agriculture and Health Ministers. The minute stated that the Committee �might be asked as a priority to advise on the use of bovine material in manufacturing vaccines...�[252]� The CMO later recommended that the working party should be chaired by Sir Richard Southwood, Professor of Zoology at Oxford University.[253]�</div>
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210. On 21 March 1988 the CMO briefed Health Ministers on BSE. In his oral evidence to the BSE Inquiry Sir Donald recalled that it was Lord Newton, Minister of Health, who received this briefing.[254]� Later in his oral evidence he explained,� ��I was concerned about biologicals from the beginning and that is indicated in my minute to the Minister after my meeting on 17 March, it was specifically mentioned.�[255]�� In this minute the CMO said:</div>
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�Their [officials from MAFF, PHLS & DHSS] unanimous view, with which I concur, is that, although a risk to human health through the consumption of milk or meat from infected cattle or through the use of bovine tissue-based biologicals in the pharmaceutical industry is likely to be low, in view of the lethal nature of the virus and the uncertainties, further expert advice is needed as soon as possible.�</div>
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The CMO sought agreement from Ministers for the setting up of an expert group advising on the implications of BSE for human health and any preventative action that could be taken as a result of its findings.[256]� The Minister agreed.</div>
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211. On 24 March 1988 the CSM held a meeting.[257]</div>
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212. On 4 April 1988 Mr Hagger sent Dr Jefferys a copy of the CMO�s submission to Ministers.[258]</div>
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213. On 11 April 1988 Mr Wilson, Grade 3 Administrative Head of Medicines Division, minuted Dr Jefferys on the subject of BSE.[259]</div>
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214. On 13 April 1988, Dr Jefferys replied to Mr Wilson.� He concluded that he �would be happy to look into the matter further if you wish but my view at present is that we should await the deliberations of the proposed expert group�[260] before taking any further action on the matter of bovine tissue based biologicals in the pharmaceutical industry. In coming to this view he wrote:</div>
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�I would have thought that the risk of infection and the transmission of BSE from the use of bovine tissue based biologicals in the pharmaceutical industry is likely to be less than that from infected food products. I base my views on the facts that much smaller quantities of biological materials are used in pharmaceuticals than would be ingested, and secondly that since the virus particles are resistant to heat, then they will not be inactivated by cooking, etc. For recent products we have taken a very stringent view on the quality control to avoid the risk of transmitting infection. We have demanded �spiking� studies with hardy viruses (these are rather similar to the scrapie virus).</div>
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There are still a significant number of older products which are subject to the review procedure.� I understand that these are likely to be reviewed in the next year.� It might be worth asking Dr Wood to comment on the approach that will be taken to the review of these products.� [261]</div>
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215. Dr Jefferys notes in his statement to the Inquiry that in Medicines Division �the agreed approach was to await the findings and report from the Southwood Working Party before finalising our advice on BSE and medicines.�[262]</div>
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216. In paragraph 5 of the 13 April minute Dr Jefferys said� �A further final thought is that recently we have required certificates that the animals from which biological products are derived are healthy.�� In his Statement to the Inquiry Dr Jefferys said that[263]: �I believe that it is likely that the certificates mentioned in paragraph 5 of my minute would have been certificates from veterinary practitioners verifying that the animals from which biological materials were derived were healthy�. He was unable to recall what would have constituted a healthy animal. A handwritten minute from Mr Wilson to Dr Jones on the face of this minute, says� �You will wish to see and perhaps show to Dr Wood.� Subject to that I would go along with 6 below� (which said that the Medicines Division should await the deliberations of the proposed expert group.)[264]</div>
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217. On this paragraph Dr Jefferys also notes:</div>
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�Paragraph 5 of my minute was intended to inform Mr. Wilson, at that time the senior administrator of the Medicines Division, of a requirement which was being made by pharmacist colleagues in Medicines Division in conjunction with outside experts. �As stated in paragraph 60 of my witness statement, (WS No 419) this minute was �an immediate and initial response� to a request from Mr. Wilson and should be read as such.� In addition, I should emphasise that within Medicines Division this issue would have been handled by pharmacists and the Pharmaceutical Secretariat to the Biologicals subcommittee rather than physicians because it concerned the quality of the materials used in the manufacture of medicines.� [265]</div>
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218. In his Statement to the Inquiry Dr Jefferys stated that at this time,� �work was commissioned from across the Division to determine the extent of usage of bovine material both as an active ingredient and as an excipient or as an intermediate in the manufacturing process.�[266]</div>
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219. Dr Jefferys has commented further:</div>
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�Although I have no recollection now of discussions and meetings that took place during this period, I am as sure as I can be that BSE would have been discussed at a senior management level within the Division. It seems to me highly probable that it featured at the monthly Divisional management group meetings co-chaired by the SPMO (Dr Gerald Jones) and the Grade 3 administrative head of the Division (Clive Wilson) part of the purpose of which was to consider emerging issues. Certainly I think the divisional view was that BSE raised highly technical issues on which specialist expert advice would be required and that we should await such advice.�[267]</div>
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220. On 28 April 1988 the CSM met.[268]</div>
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221. On 4 May 1988 the Biologicals Sub-committee of the CSM met.[269]</div>
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222. On 16 May 1988 the National Institute for Biological Standards and Control (NIBSC) held a preliminary meeting on the subject of BSE and biological medicinal products for human use.[270] Mr Wilesmith, the epidemiologist from CVL who was investigating the origins of BSE, and Dr Richard Kimberlin, an expert in TSEs from the Neuropathogenesis Unit (NPU), attended.</div>
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223. Dr Little explained the role of the NIBSC in his supplementary statement to the Inquiry:</div>
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�The NIBSC operates under the Biological Standards Act 1975 and the National Biological Standards Board (Functions) Order 1976. It reports to the Department of Health and is the body responsible for research and statutory testing of biological products for human use. Its aim is to safeguard and enhance public health through the standardisation and control of biological substances used in medicine.�[271]</div>
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224. A note of the 16 May 1988 meeting records that those present concluded:</div>
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�Bovine spongiform encephalopathy presents features suggesting that it is caused by a scrapie like agent although this is not yet unequivocally proven. The incidence varies geographically with a lower incidence in the North. In the absence of data on transmission the properties of the agent are expected to be similar to those of the causative agents of scrapie and Creutzfeldt-Jakob disease, which are, in practical terms, undetectable by existing technology and cannot be selectively destroyed, although they may be removed. If BSE is held to be a problem, the only option is to ensure that bovine materials for manufacture of biological medicinal products are derived from cattle in areas free of the disease.</div>
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It is possible that transmission to humans many not be readily effected under existing conditions. This statement is based on experience with scrapie which is unlikely to cause a disease in humans under natural conditions, and in particular has been shown to be epidemiologically unlinked to Creutzfeldt-Jakob disease. There is no evidence for transmission of scrapie to occupational groups such as shepherds and veterinarians which have high exposure to sheep and scrapie infected sheep.� This is true for research workers and abbattoir [sic] workers or butchers, where there may be exposure to brain tissues. The tissue distribution of infectious agents may also act against ease of transmission. In particular serum is a poor source of infectivity in animals infected by scrapie. Vertical transmission of acquired Creutzfeldt-Jakob disease, kuru or BSE has not been demonstrated. Transmission of scrapie from infected ewes to their lambs occurs with relatively high frequency, however, implying possible transplacental spread or transmission via milk. It is thus possible that BSE poses no real threat to human health provided the main exposures are either as a contaminant of food stuffs which will be minimised by inspection of animals, or from products which are not contaminated with nervous tissue. The information on which to base a decision is however extremely sparse.�[272]</div>
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225. Those at the meeting recommended further action to be taken in this area. It was agreed that studies should �be set up involving NIBSC and Wellcome Biotechnology and other parties to attempt to demonstrate the presence of scrapie-like agents in calf serum by inoculation into mice and hamsters and other species.� It was acknowledged that such experiments would be very lengthy. It was also agreed that �Consideration should be given to a survey of licensed products in respect to the use of bovine or ovine material in their manufacture, and the origin of the bovine or ovine materials.�[273]</div>
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226. On 19 May 1988, the issue of bovine products in pharmaceuticals was raised at a meeting between Sir Derek Andrews, Permanent Secretary at MAFF, the CMO and Sir Richard Southwood, proposed chair of the working party on BSE. The CMO thought Sir Richard�s committee should consider, � The risks inherent in using bovine material in the preparation of biologicals.��� He went on to comment that� ��urgent advice on the question of the manufacture of biologicals from cattle material.� would be needed.[274]</div>
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227. The minutes also record that Sir Richard indicated to the CMO that he hoped to be able to come forward with an interim report by early October. The CMO said that he would want advice as soon as possible on whether there were any steps that needed to be taken to safeguard human health.</div>
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228. On 20 May 1988, Dr Pickles minuted Mrs J Alderman[275].� The minute said:</div>
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�2.�� The tissues most likely to be affected are brains.� Are there any licensed products for human or veterinary use made from bovine or sheep or goat brains?� What about rabies vaccines, or some of the unreviewed homoeopathies?</div>
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3. There is the wider question of whether other tissues could carry the agent.� After brain, the next most likely tissues are lymph nodes or placenta.� Again, what licensed products for human or veterinary use are there made from bovine or sheep lymph nodes/placenta?</div>
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4. I do not know how sophisticated your record system is these days, but would it be feasible to list those products that involve bovine tissue during manufacture, eg bovine serum albumin in vaccine production?�</div>
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229. On 20 May, Dr Pickles minuted Dr Jefferys[276] in the following terms:</div>
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�Bovine Spongiform Encephalopathy</div>
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1.��� I believe you know that there is a joint MAFF-DHSS group looking at this problem. I have now been roped into the secretariat.</div>
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2.��� We would like to be sure that possible transmission through medicinal products can be ruled out for both humans and animals. Some positive evidence that it appears not to have been so transmitted would be nice. Since we know so little about BSE, we may have to look at scrapie, which is endemic in UK sheep. Is this a problem you should put before biologicals sub-committee?</div>
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3.��� Questions for them might be:-</div>
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������������� -��� are there any products prepared from bovine or sheep brain which need to be looked at? If rabies vaccine has been made using sheep/goat brain, are there adequate human follow-up data to be sure no viral infections might have been transmitted?</div>
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������������� -��� Can we assume that the �dose� of any infectious agent administered in non-parenteral medicinal products would have been so small in comparison with doses from food that such products need not be considered further</div>
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������������� -��� Are there any bovine (or sheep) materials used in production processes of parenterals that might be capable of introducing an infectious agent (eg bovine serum albumin in vaccine production, or bovine insulin)?</div>
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4.��� We have no evidence that BSE can be a risk to humans. If, however, we could identify a group of people who might have received parenteral �BSE agent� through medicinal products then they would be a group that might warrant special study.</div>
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5.��� I note in your minute of 13 April you take some reassurance from recent requirements that animals used in production of biological products should look healthy and be certified as so. With a long-incubation infection (currently thought to be 2 to 6 years) lack of physical signs cannot be taken to signify freedom of disease. So we cannot be sure.</div>
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6.��� May be [sic] you would like to discuss this with me. If you do put the problem to Biologicals Sub-Committee, please involve me if you can.�</div>
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230. On 23 May 1988, Mrs Alderman replied to Dr Pickles� letter of 20 May stating that she had been able to retrieve two computer printouts of products from the database because the constituents had the word �bovine� in their names.� She continued, �This was, unfortunately, the only way to do it.�[277]</div>
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231. On 24 May 1988 Dr Jefferys replied to Dr Pickles.[278] He said that the CSM Biologicals Sub-Committee had not formally discussed the matter but had done so informally whilst assessing an individual application: �For some months now the Sub-Committee have been regularly requiring appropriate �spiking� studies to be undertaken with hardy viruses and these would include bovine products.� Therefore he felt �reasonably confident about taking appropriate action for the new products.� He thought that �the major concern here is with the parenteral products.�</div>
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232. His minute continued:</div>
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�4. With regard to previously licensed products, then we have no evidence of hazard, but clearly we cannot provide reassurance given the timescale for possible incubation and infection.</div>
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5. As you will be aware from your previous work with the Review, many of the older products are PLRs (since many of the biological PLRs still have not been reviewed). I am therefore copying this minute to Dr Wood since she will need to take account of this during the review of these products.</div>
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6. Oral Products</div>
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As I previously stated, I would have thought the risk from oral medicinal products must be very small in comparison to the risk from food. I base this on the assumption that the infectious agent is probably not heat-sensitive and therefore will not be removed by normal cooking.</div>
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7. Parenteral Products</div>
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I accept that there may be a different consideration of parenteral products. I presume that the major agents would be bovine insulin, and bovine serum albumen in vaccine production. If you were looking for a group of people to study, then I would have thought those who have received bovine insulin might be the most appropriate group. I suppose it might be possible to undertake a retrospective study comparing those who have received bovine insulin versus those who have received porcine or ideally human insulin. I presume the endpoint would have to be the development of an encephalopathic syndrome. The danger in constructing such a study would be the scientific risks of confounding, etc. and the political risk of worrying large numbers of diabetic patients.</div>
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8. These thoughts are very preliminary ones.� It also occurs to me that this is more of a long term issue and that it may well involve William Jenkins since this is rather more an ADR problem than a New Drugs Group issue.� I am therefore copying your minute to him.� It may be appropriate for Sue Wood, William and I to have a discussion with you at a mutually convenient time.�</div>
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233. In his Statement to the Inquiry Dr Jefferys commented on his minute of 24 May 1988:</div>
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�In my minute, I set out some preliminary thoughts on the issues raised. I focused primarily on previously licensed products and said that with respect to them, we had no evidence of hazard, but I recognised that we could not provide reassurance given the timescale for possible incubation and infection. I thought that the risk from oral medicinal products would be very small in comparison to the risk from food. The major concern was with parenteral products, the major agents being bovine insulin and the use of foetal calf serum and bovine serum albumen in vaccine production (although neither foetal calf serum nor bovine serum albumen were used as active ingredients in vaccines). This reply reflected the consideration which had been given to this matter during the months of April and May.�[279]</div>
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234. On 25 and 26 May 1988 the CSM met.[280]</div>
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235. On 2 June 1988, Dr Pickles responded to Mrs Alderman requesting a further database search and asking about bovine insulin, which was not on the list of products, although licensed.� She also asked about the species used in the manufacture of any licensed rabies vaccines.[281]</div>
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236. Mrs Alderman replied on 3 June 1988, listing products containing� bovine insulin and noting there were two rabies vaccines listed but the species used in manufacture was not shown.[282]</div>
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237. On 6 June 1988 Mr Lawrence wrote to Sir Richard Southwood and enclosed some brief answers to the questions that had been tabled at the meeting on 19 May.[283] In relation to Q6, which asked �What is meat and other material from scrapie infected sheep used for - does it include pet food and material for biological products?� Part of the answer stated:</div>
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�There has been one instance of inadvertant [sic] transmission of the scrapie agent to sheep through louping ill vaccine (Gordon, Bronlee and Wilson 1939). One of the three batches of vaccine made in 1935 at the Moredun Institute contained the scrapie agent resulting in 7% of the recipients of the 18, 000 doses in the batch developing scrapie. This vaccine was made from formalin-inactivated sheep brain, and brought to the attention of research workers that formalin, at a concentration of 0.35% for at least 3 months, which inactivated conventional viruses, did not totally inactivate the scrapie agent.</div>
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It would appear that companies producing biological products take sensible precautions to exclude the use of tissues and fluids from scrapie infected animals.�</div>
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Answers to other questions also included references to biological products.</div>
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238. On 7 June 1988 the VPC Biologicals Sub-Committee met. The minute of the meeting records that on the issue of BSE members noted �the disease would become a notifiable disease from 1 July 1988� and agreed that the BP&S document, first discussed at the January 1988 VPC Biologicals Sub-Committee meeting, should be re-examined and a set of guidelines drawn up for the industry. A meeting between Medicines Unit, BP&S and CVL experts on the disease would be arranged as soon as possible to discuss guidelines.[284]</div>
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239. On 8 June 1988 a meeting was held between the Medicines Unit in MAFF, Biological Products and Standards Department(BP&S), and CVL to discuss the implications of BSE for biological products containing bovine extracted material.[285] Dr Little chaired the meeting, and also present were Mr Bradley, Mr Dawson, Mrs Evans, Mr Gray, Mr Kidd, Mr Luff, Dr Thornton, and Mr Wilesmith. The meeting discussed bovine biological products and the following bovine tissues used in biological products: serum; peptone/meat digest; pituitary extract; beef brain and brain infusion broths; tissue cultures derived from bovine tissues; ox bile and faeces. The recommendations of the meeting were as follows:</div>
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�Recommendation</div>
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The greatest concern was the use of pituitary gland products. It was agreed that the Medicines Unit should prepare a paper to advise Animal Medicines Division, Tolworth on the course of action to be taken.</div>
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It was agreed that BP&S should draw up a full list of all the tissues involved in biological products. Medicines Unit would produce a list for pharmaceutical products. A chart of risk assessment should be made for each of the tissues in relation to the products, together with appropriate treatments for each tissue.</div>
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It was agreed that some form of guidance should be given to companies at the next NOAH meeting of 11 July.�</div>
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240. On 10 June 1988 Dr Little, Deputy Director of CVL sent a minute to Mr Kyle, a Veterinary Surgeon at MAFF, about the use of bovine tissue in veterinary medicines.[286]� He said �We are urgently reviewing all users of bovine tissues, sera, etc. in veterinary medicines to determine what risks exist in relation to BSE, what action we need to take under the Medicines Act and what advice we can offer to manufacturers.� He also noted �[s]ome veterinary surgeons are quite legally using this exemption from the Medicines Act contained in Section 9(2) to prepare gonadotrophins from pituitary glands from various species, including cattle.�</div>
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241. Mr Wilkes replied to Dr Little�s minute of 10 June 1988, which he was copied, on 13 June 1988.[287] He pointed out that there was a small loophole that could allow the use of uncontrolled bovine pituitary extract.� He concluded:</div>
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�We might be able to block that loophole by a ban on sale or supply on grounds of safety�but I would think that you would want statutory provisions to bite on either collection of material or on administration of the product.� For that purpose animal health legislation might provide a better bet.�</div>
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242. Mr Kyle replied to Dr Little on 14 June 1988.[288]� He noted that animal health legislation was unlikely to assist and suggested that advice be taken from the Legal Branch. If they could not provide a solution, voluntary compliance should be sought from veterinary surgeons.</div>
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Southwood Committee: first meeting</div>
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Note:� Further information on this topic is available in RFA 1 � The Southwood Working Party (and update).</div>
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243. On 20 June 1988, the Southwood Working Party met for the first time. The members of the Southwood Committee were Professor Sir Richard Southwood, Professor Epstein, Dr Martin and Sir John Walton. Mr Wilesmith attended as an expert advisor. The joint secretariat was Dr Pickles from DHSS and Mr Lawrence from MAFF. Bovine material in pharmaceuticals was discussed.[289]� It was noted that cattle material had been used thus far instead of sheep because of scrapie. The laboratory use of foetal calf serum was also mentioned as a potential health risk. It was agreed that Dr Pickles would make enquiries into the use of bovine materials in pharmaceuticals.</div>
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244. On 20 June 1988, Dr Pickles minuted Dr Lewis, at the time Private Secretary to the Chief Medical Officer, telling her that Dr Martin, who was also a member of the Medicines Commission, would be raising the matter informally with Medicines Division. She advised that since the next meeting was a long way off she had promised to make further enquiries into the use of bovine materials in pharmaceuticals. She also noted that she had written again to Medicines Division suggesting formal discussion of the problem at CSM or a sub-committee.� She said that because much of the relevant information was protected by the Medicines Act, there were limits to what she could do herself.[290] She said in paragraph 4:</div>
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�The next move was for Sir Richard to write to Andrews (copied to CMO) with the preliminary views.</div>
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������������� i)�� known affected cattle should not be allowed to enter the human food chain, nor to be processed for pet food.[ A compensation scheme would be needed to optimise compliance]</div>
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������������� ii)� additional transmission experiments are clearly needed, for example using meat and bone meal from scrapie sheep and using scrapie milk.</div>
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������������� iii) an expert working party, preferably under the auspices of the MRC, should be set up to look at a research programme to answer the questions we have identified.</div>
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������������� iv) additional action might be needed to prevent farmers destroying all offspring of affected cows and spoiling natural experiments on vertical transmission.�</div>
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Dr Pickles also noted:</div>
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�An approach was to be made to the MRC asking for information about their reports on CJD and about the research programme they fund in Edinburgh. (I am also writing to Dr Metters to let him know what is going on, in case this comes up in MRC-DHSS discussions).�</div>
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The final paragraph of Dr Pickles� minute[291] said:</div>
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�The next meeting was planned for 10 November and Sir Richard was talking of a first report early next year. This is a more leisurely timetable than I had in mind, but maybe we do not need to wait formal meetings of the group to see some action. It will be many months before we can expect any substantial new data. The letter proposed in paragraph 4 above asks that attention is directed to the most urgent matters.�</div>
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245. On 21 June 1988� Dr Pickles wrote to Dr Gerald Jones, Medical Head of Medicines Division[292], copied to Dr Harris (DCMO), Mr Wilson, Dr Jefferys and Mr Lister, with silent copies to Dr Martin and Mr Lawrence. The minute said:</div>
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�BSE, Spongiform Encephalopathies and Medicinal Products</div>
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1.���������� You will have heard of this new disease of British cattle which is thought to be due to scrapie agent, introduced via sheep offal in cattle feeding stuffs. I am part of the secretariat of a working party, chaired by Sir Richard Southwood, which is looking into the implications of this disease. This group had its first meeting yesterday.</div>
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2.���������� We are clearly concerned that �BSE-agent� may be transmitted in medicines. Whilst the epidemiology does not suggest that the current cases in cattle are causally linked with the use of veterinary products, we are concerned about veterinary as well as human medicines in case we facilitate yet more species jumps. Much of the relevant information about ingredients and production processes is not accessible to us so we will look to the section 4 committees (and the Biological sub committee) to review this problem. All of them, including the VPC and CDSM, might have an interest. Dr Martin is a member of Sir Richard�s working party, and might raise the problem informally at a Commission pre-meeting.</div>
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3.���������� I have been in correspondence with Dr Jeffreys and others about this. I understand the pharmaceutical industry are also concerned: they had been using bovine not sheep products in various processes because scrapie is endemic in British sheep. Now they need to worry about possible dangers to their workers handling bovine materials as well as possible infection in their final products.</div>
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4.���������� Questions we might want to have answered are:</div>
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������������� -��� the highest risk would be from parenterals prepared from brain (eg rabies vaccine). Any species in which transmissible spongiform encephalopathies have been described would be suspect (�natural� infections in sheep, goats, cattle, deer, mink, but can be transmitted to hamster, mouse, guinea-pig etc). Are sterilisation processes adequate for the most resistant strain of scrapie agent or for CJD agent? Should companies be asked to include investigation for inclusion of scrapie agent (eg mouse innoculation [sic]) in at least some batches?</div>
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������������� -��� If BSE behaves like scrapie, then we might expect other nervous tissue, spleen, lymph nodes and placenta to be contaminated. Infection has been described in other tissues too, eg gut wall, and we can not [sic] be sure blood is free. Do we know what bovine materials are used in which products, both as the active ingredient and in production? Bovine active ingredients in human products include insulin, vasopressin, bone, immune globulins, fibrin, dermal collagen, albumin. Bovine serum albumin and fetal calf serum must be used in preparation of very many products. For each of these products would any �BSE agent� be destroyed or eliminated in processing? If not, and the product is administered parenterally or topically into an open wound, might there be a risk? [For oral products, there would only be a trivially increased load on top of that taken in food in omnivores/carnivores including man. But for some herbivores, this might allow the agent to be introduced into yet another species].</div>
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������������� -��� Would it be appropriate to arrange for monitoring of cases who have received any of these suspect products in the past? Could studies be undertaken in recipients of bovine insulin without causing alarm. Would recipients of collagen or fibrin implants be another group for study? Perhaps some animal recipients of suspect products should also be studied.</div>
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������������� -��� Should we restrict our concern to products manufactured in the UK, since BSE has not been described elsewhere?</div>
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������������� -��� Should we step up the physical examination of animals involved in medicine production, ensuring a neurological assessment is included and only healthy animals are used</div>
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������������� -��� Pending results of further investigations, should we insist all ruminants used for the production of human or veterinary products are not fed any time since birth supplementary animal protein as in meat and bone meal? Should the same rules apply to any other animals involved in production of human or veterinary medicines? This seems to me to be an easy option for the industry (assuming bovine serum albumin can be bought in from countries overseas where such supplementation is not used) and would be a responsible step. It would provide reassurance if, as I suspect, it is not possible to come up with answers to the other questions.</div>
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5.���������� Is this a topic you will want to raise with the FDA at the forthcoming Tripartite?</div>
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6.���������� As you know, BSE is of particular concern to CMO. He has asked me to keep him fully posted as to progress. Following yesterday�s meeting of the working party, I have let him know I am writing to you to suggest this potential problem is discussed by your expert committees. Please let me know if there is any further information I could provide for you. I would value the chance to be present as an observer when the issue gets discussed in committee.�</div>
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246. Dr G Jones said in his Statement to the Inquiry that:</div>
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�While I have no direct memory, no doubt upon receiving this letter I would have picked up the phone to Dr Jeffreys (who had been copied in the letter) and I [sic]ascertained that the review process was by then well in hand. I knew that Dr Jeffreys had already been involved because Dr Pickles in her third paragraph explicitly refers to this.�[293]</div>
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247. Commenting on this minute in his Statement to the Inquiry Dr Jefferys said:</div>
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�Dr Pickles clearly felt that BSE should be considered by the Biologicals subcommittee at the first available opportunity.� The Biologicals subcommittee met once every two months.� By 21st June, the papers for the next meeting (which would have been held in the first week in July) would already have been prepared and sent out to subcommittee members and thus, in practice, the first available opportunity would have been the September meeting.� I believe that it was in fact decided to work towards preparing a paper for the November meeting of the Biologicals subcommittee.� At its September meeting, the subcommittee was informed of the emergence of BSE and the fact that a paper was being prepared on the subject for consideration at the November meeting.�[294]</div>
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248. Dr Jefferys has said that the practicalities of preparing a paper:</div>
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��required the allocation of a Senior Medical Officer and Pharmacist to carry out the necessary work of summarising what was then known about the disease and identifying the potential issues to which the disease gave rise. I am sure that decisions as to who should do the work must have been arrived at after discussion between the various branches of Medicines Division. I would have needed to allocate a medical officer and, I think from recollection Mr Stewart would have needed to allocate a pharmacist. Questions of availability over the summer period together with the current workload of individual medical officers and pharmacists would undoubtedly have played a part in our discussion.�[295]</div>
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249. Dr Rotblat commented on the initial view of BSE and medicines in her Statement to the Inquiry:</div>
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�During the summer of 1988, I was involved in discussions in Medicines Division about how to deal with the potential problem posed by BSE for the safety of medicines.� A difficulty was that very little information was available to us at that time.� However, we knew that the Government had established the Southwood Working Party and we consequently felt that only limited action could be taken until we had seen and considered the report of the Working Party.� Nevertheless, some preliminary consideration could be given to the issues raised by BSE for the safety of medicines and a considerable amount of such work was done within Medicines Division before the views of the Southwood Working Party became available to Medicines Division.�[296]</div>
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250. On 30 June 1988 the CSM met.[297]</div>
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251. On 3 July 1988, Dr Martin responded to Dr Pickles� minute of 21 June 1988 (which Dr Pickles had copied to him). He said:</div>
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�I mentioned the problem, of BSE and scrapie agents in relation to the use of vaccines and pharmaceutical products, at the pre-meeting of the Medicines Commissioners. It seems that the appropriate information on the use of animal products could be obtained. At some stage I believe someone will have to look closely at this aspect.</div>
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Without condemnation of the carcase of BSE cases, the risk of tissues etc from such animals being used by the pharmaceutical industry will not be reduced, and the number of cases seems to be increasing. It seems unlikely that the Minister of Agriculture will ever consider paying compensation for affected animals. It will thus not be in the farmer�s interest to report such cases if he can avoid doing so. No farmer will admit to having or seeing scrapie in his flock and I image (sic) BSE may be the same way.</div>
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However it is likely that any possible horizontal and lateral transfer will not multiply the number of cases as much as by ingestion of contaminated feed. The new Order should certainly help in that respect, both with BSE and scrapie.�[298]</div>
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Dr Pickles copied this minute to Mr Lawrence for information.</div>
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252. On 5 July 1988 the VPC Biologicals Sub-Committee held a meeting and discussed draft guidelines prepared by Mr Wood of CVL and the minutes of the meeting held on 8 June 1988.[299] The following points were made in relation to Mr Wood�s paper:</div>
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�5.3 �.</div>
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1)��� The greatest concern was over the use of pituitary gland extracts by veterinary surgeons. However, this use was correct within the terms of the Medicines Act (Section 9.2). It had been agreed that individual letters, indicating the hazard of using these products, would be sent to the vets concerned.</div>
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2)��� At least 16 pituitary based products had Product Licences of Right. It was agreed that for these products and those containing extracts of adrenal, pancreas and thyroid glands, letters should be sent to the licence holders asking for further information on the sources of gland, methods of manufacture, etc.</div>
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3)��� Other hormone based products would be considered under the hormone review for which guidance notes were being prepared.</div>
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4)��� Neural or lymphoid tissue including brain infusion broths, from the UK, were unacceptable unless heated at 136 oC for 18 minutes, which would probably render the tissues unusable. Pigs or horse brains tissue or non-UK tissues might be acceptable.</div>
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5)��� Foetal calf serum and new born calf serum collected without prior brain penetrative stunning were considered to be acceptable for use.</div>
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6)��� Several treatments were proposed for other tissues including peptone meat broths. The more acceptable method for the tissues, was considered to be heat treatment at 126 oC for 2 cycles of 30 minutes each with cooling in between. A higher temperature of 136 oC for 18 minutes was considered preferable, but it would probably lead to the treated tissues being unable to support optimal growth.</div>
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7)��� Horse meat was often used for peptone meat broths and this could be used as an alternative to bovine meat.</div>
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8)��� Bile could not be heat treated at 126 oC without denaturation. Although bile was not essential the companies considered that it improved growth. It was suggested that a controlled source could be used for bile.</div>
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9)��� All manufacturers who currently use brain material should be asked to consider alternative materials or methods.</div>
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5.4 �������� It was agreed that an amended version of the BSE document�should be tabled at the forthcoming NOAH meeting. The amended paper would also be presented to DHSS and NIBSC.</div>
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It was considered that the DHSS should be kept informed of any developments with BSE.�</div>
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253. On 6 July 1988, following the meeting of 5 July, Mr Wood prepared a revised paper[300] about �BSE and Biological Products�. It covered a number of proposals for control of UK origin bovine derived substances to be used for veterinary purposes.</div>
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��Proposals for such controls follow, along with some discussion of reasons.</div>
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1.��� No product obtained from an animal suspected or confirmed to be BSE affected is acceptable for use. This point applies to, and where necessary overrides all of the following.</div>
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2.��� Only serum collected without prior brain-penetrative stunning is acceptable for use�.</div>
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3.��� Neural and lymphoid tissue is unacceptable unless it is first held at 136 oC for 18 mins. This applies, for instance, to Brain/Heart infusion broth. Alternatives would be to use bovine material of non-UK origin or to substitute, eg equine brain for bovine.</div>
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4.��� For other tissues, alternatives for consideration at this meeting are:</div>
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a) 136 oC for 18 mins</div>
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or</div>
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b) 126 oC for 2 cycles of thirty minutes with cooling between</div>
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or</div>
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c) 126 oC for 1 cycle of thirty minutes�.</div>
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5.��� Milk and milk products are acceptable for use�.</div>
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6.��� Primary cell cultures are not acceptable�.</div>
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7.��� Cell lines are acceptable provided they are not derived from neural or lymphoid tissue or cells�.</div>
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8.��� Faeces are acceptable for use provided they are obtained from a controlled source herd with no signs of infection that is not fed on offal derived concentrates�.</div>
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9.��� Bile is acceptable if obtained from a controlled source as in 8�.</div>
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10.�� Hormones derived from bovine tissues should not be used�.�</div>
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254. On 6 July 1988 the Biologicals Sub Committee of the CSM met.[301]</div>
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255. On 11 July 1988 there was meeting between the VPC Biologicals Sub-Committee and NOAH. A note of the meeting recorded that Mr Wood introduced his paper setting out the conditions under which material of bovine origin may be used in biological products. It was recognised by parties at the meeting that some of the requirements might cause difficulties to individual companies in their existing production processes. It was agreed that companies would consider the implications and send comments to BP&S as soon as possible. Mr Cook also agreed to obtain information from NOAH members on pharmaceutical products which contained bovine material from UK sources. In addition NOAH would formulate their response to the June bovine guidelines paper and forward it to MAFF in September after which a meeting would be arranged to discuss outstanding points.[302]</div>
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256. On 11 July 1988, Dr Pickles wrote to Dr Minor, Head of Virology at the National Institute for Biological Standards and Control (NIBSC), in the following terms:</div>
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�As we discussed today on the phone, I have lead responsibility for BSE here in DHSS. For your information, here is a copy of the note I have prepared for our press office. Also, in confidence, a note about the implications of BSE for biological products I sent to Dr Jones[dated 21 June 1988]. You had better not let Medicines Division know you have seen this, but there will be no excuse for not having a proper discussion at the next Biologicals Committee. Perhaps you could let me know if it does not appear to be on the agenda when you receive the papers.�[303]</div>
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257. On 11 July 1988, Dr Minor wrote to Dr Jefferys of the Medicines Division and enclosed a copy of the Report of a meeting on BSE held at NIBSC on 16 May 1988 (apparently incorrectly referred to as 4 May 1988 in a handwritten note on the face of the letter). Dr Minor said �the Report was mentioned briefly at the last biological sub-committee [of NOAH] and it was suggested that I send it to you for circulation�.[304] Dr Wood sent a copy of the same report to Drs Harris, Pickles and Rotblat and it was sent on to Mr Lawrence.</div>
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258. On 14 July 1988 Professor Collee replied to a query from Mrs Baker, at the Pharmaceutical Secretariat of the Medicines Division, concerning a collagen product that was to be considered by the CDSM.[305]� He said that his knowledge of the BSE agent was scanty and that he was influenced by the recent paper by Holt and Phillips.� Following a summary of publications on inactivation studies and iatrogenic infection, Professor Collee suggested that Dr Kimberlin could be approached for an update and advised that Mrs Baker should seek assurances from the manufacturers concerning the efficacy of their sterilisation techniques and their batch control of the radiation procedure.� He expressed the hope that:</div>
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��in future, products of this nature will be submitted to CSM (Biologicals).� It is not really satisfactory to try to deal with them on an ad hoc basis�but I hope that my comments are helpful. Of course, I shall defer to my specialist virological colleagues on CSM(B) who may find my bacteriological views on virus-like agents a little quaint.�[306]</div>
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His letter was copied to Professor Banatvala, Dr Schild and Dr Tyrrell.</div>
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259. On 16 July 1988 a letter from Mr A Kidd and Mr A Gray of the Veterinary Products Committee Medicines Unit CVL was published in the Veterinary Record. The letter read:</div>
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�The recent paper by Sreenan (VR.June25, page 624) prompts us to write regarding the use of pituitary derived follicle stimulating hormones of ovine or bovine origin�.</div>
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Apart from the legal position, we also wish to draw attention to the possible transmission of BSE or Bovine Spongiform Encephalopathy and to the potential hazard of using tissues of brain origin from cattle.</div>
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We are particularly concerned where bovine or ovine pituitary tissue is involved in the preparation of follicle stimulating hormones. The potential risk disseminating the scrapie agent by this means is well established and there is some evidence to suggest that a similar risk of spreading the agent of BSE may be associated with the use of bovine brain tissue.</div>
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If brain tissues are necessary at all in the production of any veterinary medicine, species other then sheep and cattle should be employed wherever possible�[307]</div>
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260. On 21 July 1988 the CMO wrote to Mr Derek Andrews about a proposed advisory group on BSE related research.[308]� After suggesting group members he commented� �With people of this quality, if and when the unfortunate time comes where a human health hazard becomes painfully evident, we will be able to justify what we have done in that we will have obtained advice at the very highest possible level.��</div>
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261. On 28 July 1988 the CSM held a meeting.[309]</div>
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262. On 11 August 1988 the CMO sent a copy of his letter of 21 July 1988 to Sir Richard Southwood.[310]</div>
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263. On 30 August 1988 Sir Richard replied agreeing with the CMO about the proposed advisory group[311]. He added that</div>
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�...the only outstanding practical matter that we need to address at the present time is the use of Serum in pharmacological work�Clearly, this is not a matter in which it would be easy for a British Government Department to issue regulations insisting of [sic] the use of foreign material, but I wondered if something could be done �through the usual channels� to check the policy of pharmaceutical companies concerned. I imagine your medicine section will know which companies use Bovine serum or other products in their preparations.�</div>
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Medicines Division Review</div>
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264. In September 1988, Dr Purves and Dr Rotblat prepared a paper for the CSM in which they recommended certain action.� Dr Rotblat commented on this in her Statement to the Inquiry:</div>
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�I believe that Dr Jefferys had asked us to prepare this paper.� However, I am unable to recall when he first asked us to prepare it.� I have some recollection that a decision was taken to prepare the paper so that it could be put before the November meeting of the Biologicals subcommittee and Dr Jefferys probably told Dr Purves and I to work towards completing it in time for that meeting.� I believe that when Dr Jefferys asked us to prepare it, he probably told us to prepare it as soon as we could given our existing workloads.� I do not believe that Dr Jefferys either told us to drop all our other work and concentrate exclusively on BSE or told us that the paper was a low priority.� I imagine that the paper was probably put together over 3-4 weeks.� It would appear that the paper was completed by 20th September (see minute dated 20th September from me to Dr Jefferys).�[312]</div>
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The paper was sent to Dr Jefferys on 20 September 1988 for internal distribution.[313]</div>
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265. Dr Jefferys has commented on the procedure involved in preparing such a paper:</div>
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�The practice and policy of Medicines Division was to put detailed, thorough and carefully prepared papers to the advisory committees; this was inevitably time-consuming. The Biologicals subcommittee would have expected the paper prepared for it on BSE to conform to this practice and the paper prepared by Dr Rotblat and Dr Purves did - it was a substantial piece of work containing a considerable amount of information on which the Committee could come to a considered judgement. The contents of such papers had to be capable of withstanding detailed scrutiny which could conceivably include legal action.</div>
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In addition to the time actually spent preparing the paper there was and remains about a 3 � 4 week �lead period� in that a paper has to be completed more than three weeks before a subcommittee meets so that it can be checked, photocopied, distributed to the members so that they have adequate time to read it and prepare for the meeting. It was the practice to issue papers two weeks before a meeting to committee members. This would have meant that if a paper was to be put to the September meeting of the subcommittees, it would have had to be available no later than the middle of August.�[314]</div>
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266. Dr Purves has said that:</div>
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�Before the matter was raised at the Biological Subcommittee meeting on 7 September 1988 and before Dr Rotblat forwarded our draft Paper on BSE to Dr Jefferys on 20 September 1988, there would have been a considerable amount of internal discussion about BSE.� We were generalists, we did not have specialist knowledge about slow viruses so we naturally would have sought the advice of others � including experts from outside the organisations.</div>
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�it was not within our normal course of business to prepare a paper on a general topic such as a new disease.�[315]</div>
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267. Dr Rotblat also said that although BSE was a new disease, there was, within Medicines Division, an existing framework to analyse the disease. The framework was based on previous methods of analysing analogous products. The two principles underlying this method were ensuring the safety of the raw ingredients and, by the use of sterilisation or inactivation procedures in the process of manufacture, minimising any remaining risk. These principles lay behind the paper that she and Dr Purves presented.[316]</div>
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268. The paper, submitted under a cover note, had two main parts.[317] The first part, entitled �Bovine Spongiform Encephalopathy�, was described as providing a background to the problem of BSE.� The second part, entitled �Bovine Spongiform Encephalopathy �Action by Medicines Division� contained recommendations for action on which the cover note asked the Committee for advice.� The paper also included a number of appendices. (See below.)</div>
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269. Dr Purves has stated:</div>
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�The purpose of the paper was to:</div>
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(1)�� summarise the current information on BSE;</div>
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(2)�� identify the issues that BSE raised for biological products - to consider the possible risk of transmission of the disease to humans through biological products containing or consisting� of bovine materials; and</div>
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(3) present draft recommendations for the Committee's consideration.</div>
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It was designed to be a discussion paper for the Committee.� As was our practice, we presented specific, but draft, recommendations to the Committee to assist in giving focus to the deliberations.�� Additional recommendations would be included as a result of discussion at committee.</div>
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We were very aware that the Southwood Working Group had been set up,� given its expert advice in this area and that before implementing industry wide measures, we would need further guidance from our group of experts.� However, in the interim we did not hesitate in examining the issue and formulating proposals for action.� These could be reviewed in the light of the subsequent recommendations that came from the Southwood Working Party including that Party's assessment of the possible risks associated with biological products.�[318]</div>
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270. The background part of the paper, �Bovine Spongiform Encephalopathy�, after describing the disease and some of its characteristics, went on to state:</div>
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�Before considering the implications of a BSE agent with respect to medicines, there is merit in reviewing briefly what is known about the agent. From the terms of reference of the working group, it is evident that little is known about the disease or the causal agent. The limited information available (APPENDIX 4- [see below]) would appear to indicate that BSE could be caused by a scrapie-like agent about which there are still many unknowns. As a result of this paucity of hard information on the agent and the disease, it is difficult to see what positive action can be taken by the Division, at least in the short term. In spite of this initial response, concentrating primarily on the relatively narrow aspects of agent and disease, it would be prudent to widen the considerations at least in a preliminary way to cover related aspects, namely,</div>
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2.1�� The animal species from which tissue may be sourced for use in the manufacture of medicinal products.</div>
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2.2�� The significance, if any, of the various types of tissue that may be used.</div>
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2.3�� The ability of the manufacturing and purification procedures to destroy or remove viral or virus-like agents.</div>
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2.4�� The products involved, the type of tissue they contain and the relative risk to the patient on administration of a contaminated product, parenterally, topically and orally.</div>
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Taking these issues seriatim, the first relates to the animal species from which the required tissue is sourced. The current problem relates to the bovine spongiform encephalopathy disease: however, should our concern be restricted to bovine material or should it be extended to other species in which a transmissible spongiform encephalopathy has been described eg goats, sheep? Regardless of the species involved, the next question might be to consider the merits of stepping up the physical and neurological examination of animals, to [sic] tissue of which is going to be used in the manufacture of medicines? The response to this might not be clear since, while there is merit in increasing the depth of examination of the animals health, the findings are severely limited because of the incubation period of the BSE agent. In an attempt to take action in the short term, it has been suggested that all ruminants, from which tissue will be used, should not be fed, at any time from birth, supplementary animal protein. This action has been proffered� following speculation that cattle may have contracted the disease through being fed contaminated feed supplement derived from sheep in which scrapie is endemic. The problem here is there are no facts to back up this speculation.</div>
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Were this speculation true then it might be helpful to take such action, although it would not overcome the problem of possible transmission by some other means.</div>
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The second issue relates to the significance of the various types of tissue that may be used in the manufacture of a medicinal product eg CNS, other nervous tissue, spleen, serum etc. The question here is if the source animal were to be infected with the BSE agent, would there be any relationship between the type of tissue used and the contamination of the product? With the lack of hard information available on the BSE agent, it is unlikely that a clear answer will be available to this question. Another question posed centred on the fact that since this disease appears to be confined to the UK �should we restrict our concerns to products manufactured (presumably from animals sourced) in the UK�? In response to this, it has already been stated that �with all the difficulties of diagnosis, negative evidence of its presence in cattle of other countries should be treated with due caution�. Thus, it would seem inadvisable to restrict our concerns to bovine materials sourced from UK cattle.</div>
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The third topic relates to the ability of the manufacturing process to destroy or remove viral or virus-like agents. For some time now, this information has been sought from companies with respect to viruses, the characteristics of which are known. One cannot be quite so pragmatic where the BSE agent is concerned because of the general paucity of information about its properties. As a consequence of this, it is impossible, at this juncture at least, to say that the agent, were it to contaminate a product, would be destroyed or removed by sterilisation or any other manufacturing or purification process. Indeed, if the agent is like scrapie, then it, too, might be extremely resistant to inactivation by heat, irradiation or by various chemicals.</div>
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The fourth and final topic relates to the medicinal product and covers three issues. It is clear there is a need to know which products contain bovine tissues, along with details of the type of tissue used in manufacture, so that a database is available for discussion later. In addition, consideration may need to be given to the risks associated with parenteral, topical and oral administration, should the product be contaminated by the BSE agent. Having given some consideration to the issue of the BSE agent and how it might impinge on the manufacture of medicinal products, these topics should be discussed so that some proposals may be presented for both short and medium term action. Some questions we may wish to ask are:</div>
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1.��� which products include bovine material and, therefore may contain the BSE agent;</div>
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2.��� what follow-up action is required especially in the absence of definitive information on the properties of the BSE agent;</div>
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3.��� what could be asked of companies in answer to concerns about BSE in addition to our current policy, where, in the last year or so, we have been asking for details of the quality of starting materials and the ability of the manufacturing and purification procedures to remove or inactivate hardy viruses;�</div>
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271. The second part of the paper, entitled �Bovine Spongiform Encephalopathy � Action by Medicines Division�� states:</div>
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�1.Product Licence Situation</div>
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The computer list shows 53 product licences extant for preparations of bovine origin and of these 42 are for insulin.</div>
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It is not clear how complete this list is, particularly on the review side where there may be grounds for concern, especially with regard to products for cellular therapy.</div>
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There is no computer list showing the use of products such as bovine albumin and foetal calf serum in the process of manufacture. The latter is fairly widely used in tissue culture work.</div>
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For the purpose of recommended actions products will be divided into those for oral and parenteral use and those derived from brain, tissue, and blood.</div>
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2. Products derived from brain</div>
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There are no licensed products derived from bovine brain.</div>
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3. Products from tissue</div>
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3.1 Parenteral use</div>
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There are three products in this category:</div>
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������ i.��������� Insulin</div>
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������ ii.�������� Bovine collagen implants</div>
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������ iii.�������� Bovine fibrin implants.</div>
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The latter two are used in surgery and are the province of the CDSM.</div>
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3.2 Oral use</div>
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There are two products in this category:</div>
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i.���� Bovine fibrin powder used as a haemostatic</div>
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ii.���� A sugar coated tablets which are alleged to contain ox bile. (I note the comment from MAFF suggesting that bile is safe from transmission of BSE).</div>
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4. Products derived from Bovine Blood</div>
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4.1 For parenteral use</div>
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There are two H products for parenteral use which contain bovine immunoglobulines, these are:</div>
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B, ampoules and [redacted]</div>
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single plant preparation injection. (PLRs)</div>
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4.2 Oral</div>
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B pilules and single plant preparation pills, H.</div>
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C Vitamin B12 absorption test kit which contains bovine albumin.</div>
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5. New products</div>
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CSM through the Biologicals Sub-Committee have been asking companies who put in applications for bovine products to show the ability of their manufacturing procedures to inactivate scrapie and similar agents. No new licences for these products have been granted for some time.</div>
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6. Summary</div>
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6.1 Oral products</div>
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No action should be taken with regard to these products in view of the widespread consumption of beef by the population at large.</div>
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6.2 Parenteral products</div>
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The major problem here appears to be with insulin. The use of bovine insulin is rapidly declining and maybe restricted to those patients who have antibodies to the human preparation, or who cannot tolerate it. In this case bovine insulin is life saving, and the risk to benefit would currently be in favour of retaining its use. In addition to this for parenteral products in general:</div>
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i.���� All cattle used for the preparation of these products should come from certified healthy herds, and not to have been given food supplements containing material of animal origin.</div>
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ii.���� No brain or lymphoid tissue should be used in parenteral products.</div>
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iii.��� Manufacturers of parenteral products should show that their manufacturing procedure is capable of inactivating scrapie-like agents.</div>
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iv.��� While the agent of BSE is not known it is not possible to advise specific inactivation processes.</div>
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7. Recommendations for action</div>
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i.���� No licensing action should be taken against oral products.</div>
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ii.���� All bovine products should come from cattle from healthy herds, which have not been given food supplements containing material of animal origin. No brain or lymphoid tissue should be used in parenteral products.</div>
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iii.��� Manufacturers of parenteral products should show that their manufacturing processes are capable of inactivating scrapie-like agents.</div>
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iv.��� All licences for new products from bovine material should comply with the above.�</div>
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v.��� The Review/CDSM Sections should carry out a search for preparations containing bovine material.</div>
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vi.��� There should be an article in MAIL requesting manufacturers to identify bovine preparations used in the manufacturing process. Bovine albumin and foetal calf serum should come from healthy herds.</div>
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vii.�� The ADR database should be searched for ADRs to bovine products.</div>
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viii.� The Committee is asked to consider whether to take any action against bovine insulin or whether the risk/benefit ratio is appropriate.�[319]</div>
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272. Appendix 1 to the paper is headed �BSE and Biological Products for Human Use� and is a report of the meeting held at NIBSC on 16 May 1988 (see paragraphs 191-193).</div>
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273. Appendix 2 was a magazine article from the New Scientist dated 11 August 1988 entitled �Mad Cows and Ministers Lose their Heads� with a sub-heading �Will a New �Mystery� Disease Inexorably Spread through British Cattle and Put Consumers at Risk or is the Panic Unnecessary?��</div>
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274. Appendix 3 is headed �BSE and Biological Products� and is the paper by G W Wood of CVL prepared on 6 July 1988 (see paragraphs 213-214 above).</div>
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275. Appendix 4 is headed �Options for the control of scrapie and its counterpart in cattle� by A G Dickinson and D N Taylor of Neuropathogenesis Unit, Edinburgh.� It explains some characteristics of the disease and implications for its control in animals.</div>
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276. Dr Purves comments on aspects of the paper in his statement to the Inquiry:</div>
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�The first part of the background paper set out general issues which needed to be discussed at the Committee, namely:</div>
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1.��� The animal species from which tissue may be sourced for use in the manufacture of medicinal products ;</div>
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[We wanted the Committee to consider whether we should be restricting our concern to only the geographic source of the bovine material i.e. avoiding material from the UK or including other species in which a transmissible spongiform encephalopathy had been found i.e. goats, sheep].</div>
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2.��� The significance if any of the various types of tissue that may be used in the manufacture of medicinal products.</div>
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[The essential question here was, if the source animal were to be infected with the BSE agent, would there be a relationship between the type of tissue used and the contamination of the product?]</div>
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3.��� The ability of the manufacturing and purification procedures to destroy or remove viral or virus-like agents;</div>
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[This was an inquiry we would always make of an application for a product, which may have contained a virus.� At the stage of writing the paper, it was impossible to say whether the BSE agent could be destroyed or removed by sterilisation or any other manufacturing or purification process.]</div>
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4.��� The evaluation of the products involved the assessment of the geographic source of the tissue, the type of tissue they contained and the relative risk to the patient of administration of a potentially contaminated product parenterally, topically and orally.�</div>
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[We identified here that there was a need to know which products contained bovine tissues along with details of the source and type of tissues used in manufacture and that a database should be set up.]�[320]</div>
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277. In relation to the computer database Dr Purves has commented that:</div>
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�It was clear that it did not identify all medicinal products that included bovine materials as excipients or ingredients used in the manufacture of the product.� The information it had given however was still useful as a basis for initial discussion.� It helped to identify what were some of the practical issues and that there was the need for further information from the industry.�[321]</div>
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278. Dr Jefferys has also said that by September 1988:</div>
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��I am sure everybody in the Division concerned with BSE had begun to realise the potential inadequacy of the divisional database for pursuing an enquiry of this nature. These problems were clearly identified in the Evans/Cunliffe Report which led to the development and installation of a completely new database in 1993�.[322]</div>
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279. Dr Rotblat and Dr Purves have commented on the recommendations contained in the paper in their statements to the Inquiry.� Dr Rotblat says:[323]</div>
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�i.��� No licensing action should be taken against oral products.</div>
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[The reasoning behind this was that it would have been inconsistent to take action against such products when no action was proposed against food containing bovine material.]</div>
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ii.���� All bovine products should come from cattle from healthy herds, which have not been given food supplements containing material of animal origin. No brain or lymphoid tissue should be used in parenteral products.</div>
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iii.��� Manufacturers of parenteral products should show that their manufacturing processes are capable of inactivating scrapie-like agents.</div>
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[These two recommendations were principally the work of Dr Purves assisted by Mr Sloggem. This was because they predominantly raised pharmaceutical rather than medical issues. The principles behind these two recommendations were those commonly adopted to preclude the transmission of agents by biological products. These principles were, first, to ensure the quality and safety of the ingredients and, secondly, to minimise, through sterilisation during the manufacturing process, any remaining risk. I presume that Dr Purves and Mr Sloggem framed the concept of �healthy herds� and specifically mentioned brain and lymphoid tissue following discussions between them and MAFF. I believe that the ban on the use of brain and lymphoid tissue in parenteral products was always intended to apply to their use in the manufacture of medicinal products in addition to their use as ingredients. It is clear from our paper that we were, at this time, aware of the widespread use of materials such as bovine serum in the manufacture of medicines.]</div>
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iv.��� All licences for new products from bovine material should comply with the above.</div>
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[I believe that recommendations ii and iii were always intended to apply to existing products. The purpose of this recommendation was to ensure that they were also applied to new products.]</div>
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v.��� The Review and CDSM (Committee on Dental and Surgical Materials) Sections should carry out a search for preparations containing bovine material.</div>
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vi.��� There should be an article in MAIL (the Medicines Act Information Leaflet) requesting manufacturers to identify bovine preparations used in the manufacturing process. Bovine albumin and foetal calf serum should come from healthy herds.</div>
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vii.�� The ADR (Adverse Drug Reactions) database should be searched for ADRs to bovine products.</div>
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[I consider that an analysis of recommendations (v) � (vii) makes it clear that the recommendations were intended to apply to existing products as well as to new products. The Review Section of Medicines Division served the CRM which did not consider anything other than existing medicinal products. The purpose of the proposed article in MAIL was to obtain information about the use of bovine preparations in the manufacture of existing products. The ADR database provided information about adverse reactions to existing products. The reason for searching it was to consider whether any adverse reactions had been recorded in respect of existing medicinal products connected with bovine material.]</div>
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viii.� The committee is asked to consider whether to take any action against bovine insulin or whether the risk/benefit ratio is appropriate.</div>
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[Bovine insulins were the only product derived from bovine tissue that fell within the remit of the CSM. Bovine collagen implants and bovine fibrin implants fell within the remit of CDSM.]�</div>
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280. Dr Purves has stated to the Inquiry:</div>
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�The draft recommendations would have been formulated by Dr Rotblat, and myself, as well as other members of the Biologicals Team.� I cannot specifically recall who was responsible for each, although I note Dr Rotblat states that recommendations (ii) and (iii) were mainly the work of myself and Mr Sloggem.� Because of the team approach to this BSE issue, I believe that each of the recommendations would have been discussed widely within the Biologicals Unit before they went to the Subcommittee.� I believe I also would have discussed them with Dr Minor of the NIBSC and most probably had them agreed by other senior officials within Medicines Division.�[324]</div>
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281. Dr Purves also comments: [325]</div>
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�I agree with Dr Rotblat�s comments on recommendations (i), (iv)-(viii) and have added my own comments to (ii), (iii) and (iv).</div>
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�</div>
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ii.���� All bovine products should come from cattle from healthy herds, which have not been given food supplements containing material of animal origin.� No brain or lymphoid tissue should be used in parenteral products.�</div>
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[The aim here was to focus on the source of the starting material.� If it was safe then infected material would not enter the manufacturing process.� Looking at the source of the starting materials was something we did in assessing all applications for Product Licences.� It was clear to me that before we could "refine" this recommendation, we would need input from specialists (probably from MAFF) about how to define "healthy herds".� That question was not within our remit.]�</div>
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iii.��� Manufacturers of parenteral products should show that their manufacturing processes are capable of inactivating scrapie-like agents.</div>
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[Again, this was a factor we would look at in assessing all applications for Product Licences.� It reflected the very cautious approach we took with applications for new drugs.� If the pharmaceutical companies could not prove that they could inactivate infective agents, their product licence applications would not be approved].</div>
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�</div>
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vi.��� There should be an article in MAIL (the Medicines Act Information Leaflet) requesting manufacturers to identify bovine preparations used in the manufacturing process.� Bovine albumin and foetal calf serum should come from healthy herds.</div>
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[We were aware that we had to go to the pharmaceutical industry directly to get comprehensive information about which bovine materials were used in the manufacture of their medicines.� We knew the computer list was incomplete.]�</div>
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282. On 6 September 1988 the VPC Biologicals Sub-Committee held a meeting and noted that� ��some replies had been received from companies using pituitary glands in their products. Copies of the BSE document had also been sent to DHSS and NIBSC.�[326]</div>
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283. On 6 September 1988 Sir Richard Southwood�s letter of 30 August was copied to Dr Harris (DCMO with responsibility for Medicines Division).[327]� The CMO asked him to provide the advice requested by Sir Richard. Dr Harris passed this to Dr Jones on 8 September 1988.[328]</div>
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284. On 7 September 1988 the CSM Biologicals Sub-Committee held a meeting.� The minutes record the following on BSE at point 7.3:</div>
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�Dr Purves informed the Sub-Committee that a paper was being prepared for internal discussions.� A paper would then be submitted to the Sub-Committee at a later date.�[329]</div>
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285. On 16 September 1988 Dr Jones replied to Dr Harris in relation to Sir Richard Southwood�s letter of 30 August saying that:</div>
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��The use of bovine serum in the manufacture of medicinal products is one of a number of questions being considered at the moment. Dr Pickles has already requested advice on a number of issues. If you agree I think we should give a considered reply to the Advisory Group on BSE with respect to all the issues.�[330]</div>
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286. A hand-written note at the top of this letter stated �I agree but you should write to Sir Richard stating that you will let him have the information as soon as it is to hand.� This appears to have been signed by Dr Harris.</div>
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287. On 22 September 1988 Dr Jones wrote to Sir Richard. He said:</div>
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�I am replying to your letter of 30 August addressed to our Chief Medical Officer. We are currently examining the potential problems of BSE with respect to medicinal products. This will involve consideration of a number of different issues including the difficult one of use of bovine serum or BSA in pharmaceutical manufacture. Also we will be discussing with our expert advisory committees. I will ensure that your advisory group has all the information relating to medicinal products as soon as it becomes available.�[331]</div>
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At the bottom of the page is written �silent copy Dr Jeffreys � please note our undertaking above (via Dr Pickles I presume)�.</div>
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288. On 22 and 23 September 1988 the CSM held a meeting.[332]</div>
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289. On 26 September 1988, Dr Pickles sent a minute[333] to Dr Jones in the following terms:</div>
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�I was pleased to see from your minute of 16 September to Dr Harris that you will be giving a considered reply to the advisory group on BSE. I have been asking for comment from Medicines Division for some months now and have made several suggestions as to pertinent questions that could be put before your expert committees. As yet, I understand that the topic has only been raised informally at Biologicals. You explained to me that it has lower priority than other work before you at the moment.</div>
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The next meeting of Southwood�s group is on the 10 November. Will I have something positive to report at that meeting from Medicines Division?�</div>
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290. In relation to this minute, Dr Rotblat says in her statement to the Inquiry:</div>
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�I should emphasise that I never regarded BSE as a low priority issue; nor, to the best of my knowledge, did any of my colleagues.�[334]</div>
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291. Dr Gerald Jones spoke of his perception at the time of the priority of BSE and medicines in his oral evidence to the BSE Inquiry.[335]</div>
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�MR THOMAS: Can I ask you on what basis -- who decided on the priority given to BSE?</div>
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DR JONES: Myself; but I am not here to speak on behalf of others who can speak for themselves, but that was a view of my own senior staff and the Chairman of the CSM.� At one point I did ask them what their views were about the concern.� We all knew that there was this appalling mess in cattle with horrendous consequences for the cattle and agriculture. On the food side we knew in June there was, whatever the words are, remote, theoretical risk to human health on the food side.</div>
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Our perception was the risk to human health from the medicinal products was, if anything, even lower; but that, nevertheless you had to check all the products inside and outside and take whatever was reasonable action.� But it was not regarded with the pressing concern of, for example, manufacturing defects with medicines, that could lead to the deaths of patients overnight; serious adverse reactions, which were collected by the Division at the rate of 15 to 20,000 a year.� These are adverse reactions in patients taking medicines; or publications, case control studies, showing that breast cancer is linked to the oral contraceptive.� When I say "linked", this has been recorded allegedly causally related to oral contraceptives.� These were the most pressing issues you would be facing in Medicines Division, then or now, in my opinion.�[336]</div>
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Dr Jones also said:</div>
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�DR JONES: </div>
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�I do not want to overplay this when I say no one believed that this was a pressing priority.� But I would like to stress that it was an exchange going on in July and the relevant staff in Medicines Division prepared papers in August and September and October and November.� It went through the Committee structure.</div>
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What I am not prepared to say is we should have recalled the Committee on Safety of Medicines in August, and the staff should drop everything to have looked at this in August.� That in my view would have been completely indefensible.� On the other hand, we did not put it away and forget about it for six months. People dealt with it over the summer period; and in October/November it went for its first crack at the committees.�[337]</div>
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292. On the perception of BSE risk in medicinal products compared to food, Dr Jones said the following[338]:</div>
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�SIR NICHOLAS PHILLIPS: I am interested in your perception of the BSE risk being even less than the perceived risk in relation to food because the Southwood Committee considered that the most serious risk would relate to medicinal products injected into people, as opposed to ingestion of food?</div>
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DR JONES: By injected, it depends which ones you are referring to.� There are a small number -- well, a small number, I am not sure of the exact number.� There would be a small number of products which contained bovine material.� The obvious example would be bovine insulin.��� There would be a larger number of parenterals which had been in contact with bovine material during manufacture.� There would have been a veritable army of oral products which would have had contact with bovine material.� I suppose the oral products would be dismissed.� With respect to the parenterals, I have seen some of the literature here and everybody seems to be concerned about vaccines.� That would have been my estimate then or now.</div>
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Vaccines are normally -- you only get two or three doses and maybe one booster.� There are other parenteral preparations which you would be taking more frequently. Obviously insulin will be taken daily or several times a day.� The view that we had was that if you take the parenterals, the biological products, foetal bovine serum or some foetal bovine material of other type would have been used at some point during the manufacture, perhaps at 5 per cent.� But the product then goes through extensive fractionation and separation stages. If any were to end up, it would have to be one of the most potent infective agents known to man.� We were doing things as a precaution in case we were wrong.�</div>
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But I do not think anybody seriously expected that you would get, in a final product of a vaccine produced in culture with cells with 5 per cent foetal bovine serum, that you would end up with infectious agent at the end that could pose a risk.� If it were a risk it would either be zero or so close to zero that it could never be detected.� That was the view.� As I say, I am giving it as my view now, but if I may, at that time Dr Pickles was concerned quite rightly because she wanted to get her work done.</div>
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I think it must have been in September or October I asked my three branch heads and the Chairman on the Committee on Safety of Medicines the same question, to ensure that it was not just me.� I said:� If you had, on a scale of zero to ten to estimate where you think is the greatest concern at the moment, ten being the most serious, where would you place breast cancer and the Pill, and where would you place BSE and medicinal products?� They all independently gave the same answer. Breast cancer was at eight or nine on this scale and bovine products and medicinal products was at about one.� I agreed with them.� My understanding of what was going on.</div>
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But nevertheless, having said that, steps were taken to clean up the British market.</div>
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SIR NICHOLAS PHILLIPS: If you asked the same question now or maybe were asking the same question now, would the answer be the same?</div>
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DR JONES: My view, I cannot answer for them now.� My view, yes.� I did not think then that medicinal products posed a risk with BSE and, sticking only to medicinal products; and that is my view today.� I do not think medicinal products up to, say, late 1988, early 1989 when nothing could be done, I did not think that they posed a risk then or now.�</div>
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293. Professor Collee also comments on the risks from parenteral products and vaccines in his statement to the Inquiry:</div>
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�We certainly regarded the greatest risk, if there was one, as being attached to parenteral and implantation products.� The point should be made, however, that all parenteral products are not the same and by the same token not all parenteral products involve the same degree of risk. That point is very important when one turns to consider the question of vaccines. By the January 1990 meeting of the BSE Working Party, the available knowledge at that time led us to the view that the risk from those products was not only remote, but very remote�.[339]</div>
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294. Dr Jones also gave his views on the relative safety of oral and topical medicines. He had been asked about the distinction between pharmaceutical products containing bovine material and those that come into contact with bovine material as part of the manufacturing process.� He highlighted the problem of identifying those products that had used bovine material in manufacture only.� In response to a question about whether the MD database would indicate if a product contained animal offals, he said:</div>
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�DR JONES: As an active ingredient, clearly, for all the excipients.� Well, on the oral side that could not be so.� I mean, things like magnesium stearate, I think they are in hundreds of medicines.� Magnesium stearate is the thing that is used to make powder slippery before tableting.� At some point it has been prepared from stearate acid, and that means it has come from fat, and some of the fats would have been from the cow.� I do not think anyone would suggest that could possibly be a risk to human health; but you would not know the source stearate acid and the fat that went in to make magnesium stearate.� It depends on what products you are talking about and how much detailed information you would require. There is not a general answer, it requires looking at individual files and maybe contacting the manufacturer for additional information not on your files.�[340]</div>
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Later in oral evidence Dr Jones also said:</div>
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�PROFESSOR FERGUSON-SMITH: Topical medicines are absorbed --</div>
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DR JONES: Absolutely.� This would not apply to the ordinary topical medicines, creams, ointments et cetera.� That clearly someone -- group of people had formed the view that the risk in that regard was like all orally excluded completely here, that topicals would be broadly excluded.</div>
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PROFESSOR FERGUSON-SMITH: Who would take that view?</div>
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DR JONES: It was a view formed in Medicines Division by advice from the Section 4 Committee, the dominant one.� Probably other sub-committees and the people on this combined group between BPC and CSM.�� This would be a collective exercise.� You recall earlier there was an exchange of correspondence between Southwood and Asscher, without being personal, not seeing quite eye to eye.� I think it was made quite clear then that large groups of products would be put aside and oral and topical clearly amongst those.</div>
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�</div>
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SIR NICHOLAS PHILLIPS: You mention Southwood and Asscher not being eye to eye as far as your own perceptions.� Do you think Southwood was making too much of a fuss in this area?</div>
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DR JONES: I think that is a harsh way to put it.� Southwood was looking at one specific issue, that is all he was asked to do for the Department.� Asscher and others on the medicine side, not just Asscher but the CSM, they were looking at hundreds of problems all the time and much more serious and pressing than this.� It is understandable that two people in different contexts would not have exactly the same point of view.� I must say I think in the end by the time this went out, at the same time as the Southwood Report, there was no difference of opinion between the two sides.�[341]</div>
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�</div>
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He also added:</div>
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�DR JONES: It is quite difficult to know the dose of a preparation given topically.� Of course it is not like the oral parenteral routes.� Again what we are talking about here in most cases would be creams, ointments et cetera which would have clearly fatty and oily materials in them, and at some point they may or may not have been derived from the source, from the cow.� I do not think anyone really would have been regarding that as a serious public health risk.� I really do not believe that.� This is an extra precautionary step over and above parenteral.� I really do not think that the Department would have been discussing something for the treatment of haemorrhoids or mouth ulcers.� The list goes on and on.� The line would be drawn somewhere to behave in a responsible yet reasonable way towards the industry.�[342]</div>
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295. On 29 September 1988 Dr Jones minuted the CMO with a copy to Dr Jefferys, Dr Adams and Dr Pickles.[343] He said:</div>
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�Further to our telephone conversation and my letter to Sir Richard Southwood I am providing the information on timing you requested. The internal review by divisional medical and pharmaceutical staff is complete and a draft paper with various recommendations has been prepared. This will be discussed by the Committee on Safety of Medicines and the Committees [sic] on Dental and Surgical Materials (CDSM) in November. The various sub-committees (Safety, Efficacy, Biologicals and Pharmaceutical) will have considered the subject before the meetings of the main Committees. A considered view on the whole issue will therefore be available in late November. It is unlikely that the Committee on Review of Medicines (CRM) will be able to contribute significantly because it meets early in November before the sub-committee meetings. (The Biologicals sub-committee, CRM and CDSM meet at 2 monthly intervals).�[344]</div>
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296. On 6 October 1988 the CMO wrote to Sir Richard Southwood about the progress on the review of biological products. The letter said:</div>
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�Further to your letter of 30 August, I am informed that a considered view on the whole issue of biologicals and bovine spongiform encephalopathy should be available in late November. You will appreciate that a number of our advisory committees including the Committee on Safety of Medicines and the Commttees (sic) on Dental and Surgical Materials, together with their sub-committees will have had to consider this important issue before we can reach the type of conclusion which is authoritative and which will be of most use to your Committee.�[345]</div>
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297. On 12 October 1988 Dr Pickles wrote to Dr Jefferys, with copies to Dr Purves and Dr Rotblat, thanking him for a copy of the paper prepared by Dr Rotblat and Dr Purves for the Biologicals Sub-Committee who were to meet on 2 November 1988. She said:�</div>
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�1.�� Thanks for sending me a copy of the paper for Biol. Please let me know when to expect it on the agenda and so when I should turn up.</div>
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2.��� I had hoped to have seen the paper in draft and regret not having had an opportunity to help those writing the paper. I think they might have found my comments useful and have saved discussion time at the meeting.</div>
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3.��� I have spoken to Dr Rotblat on the phone. If there is a chance to amend the paper before it goes to SEAR (I guess copies have already been made for Biol) then points you could look at are:</div>
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������ Page 1: total number of confirmed cases of BSE now over 1100</div>
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������ Page 4: there are plenty of facts to back up the hypothesis that food supplements prepared from sheep are linked with the emergency [sic]of BSE in cattle. Epidemiology is here being dismissed as �speculation�.</div>
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������ Page 5: there are good reasons for believing the problem could well be restricted to UK cows.</div>
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Product licence position</div>
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Under parenteral use, perhaps you need to look at [redacted � PL Licence No] which are bovine [redacted � PL Licence No] (but this may only be synthetic [redacted � PL Licence No] of bovine type). Also P is of bovine origin � but perhaps you are including this under collagen or fibrin implants.</div>
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Recommendations</div>
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I find some of the recommendations (eg iii) confusing as written since it is not clear whether they are to apply to all products, to all parenterals, to all parenterals of biological origin, or to all parenterals with bovine� ingredients, or to those parenterals of bovine origin from herds fed animal protein, or only to parenterals with bovine ingredients from British herds fed animal protein that might have been contaminated. (!)</div>
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4.��� In attempting to clarify what I think the authors intended I found I came up with some queries (as indicated below).</div>
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Redrafted recommendations</div>
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a. No action proposed against any non-parenteral products</div>
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b. New (? and renewed /reviewed) licences for parenteral products of bovine (?other animal) origin or using bovine ingredients:</div>
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������������� i��� actives/ingredients to be taken only from healthy herds not fed animal protein (?Britain only)</div>
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������������� ii�� manufacturing processes to be shown capable of inactivating scrapie agent (?even if b i. applies)</div>
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������������� iii�� brain and lymphoid tissue not to be used in any part of manufacture (?unless otherwise justified)</div>
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c. Current licences for parenteral �biological� products</div>
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������������� i��� licence holders to be asked to identify all bovine ingredients used (?and then asked to notify LA where they do not comply with bi-iii above)</div>
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������������� ii�� (compulsory?) variation to be considered for any parenteral products with bovine actives (eg bovine insulin) (?and bovine ingredients) which do not comply with b (?i-iii or only i and iii) above</div>
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d. Licence holders are to be advised of these recommendations by means of a MAIL article.</div>
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e. CDSM/CRM/ADR sections to be alerted to concern over (?parenteral only) products of bovine origin.</div>
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5.��� But there are also other recommendations on the MAFF list that could be looked at and easily incorporated into any recommendations of your own eg not using serum from cows killed by brain-penetrative stunning. Perhaps it would be wise to find out what has been happening in VPC before you put the problem to CSM and its sub committees (different recommendations about acceptability of non-British bovine sources could be embarrassing and would give legitimate grounds for appeal to the MC).</div>
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6.��� Dr Jones has promised to write to Sir Richard Southwood with the advice of the expert committees. I trust you feel there is sufficient information in this paper to enable Biol to give its decision at the November meeting. On the bovine insulins, for example, the range of options might need spelling out including, as it seems to me, doing nothing or merely adding a data sheet warning, to restricting the indications to those who cannot tolerate human insulin, or varying the source material to non-British or non-protein supplemented sources. In fact, the only option hinted at seems to be revocation which is clearly overkill. But perhaps these options come at a later stage.</div>
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7.��� I feel really bad about having to badger you about a �problem� that may not even exist but it is I that has to face Sir Richard and CMO and explain the lack of progress.</div>
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I hope you take these comments in the constructive spirit in which they are given.�[346]</div>
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298. Dr Rotblat said in her statement to the Inquiry:</div>
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�Dr Pickles said that she regretted not having had the opportunity to help in the writing of the paper. My only comment on that suggestion is that it would have been extremely unusual to involve an official from the Department of Health in the drafting of a Medicines Division paper.�[347]</div>
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299. Dr Purves notes:</div>
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�One comment Dr Pickles made about our draft recommendations was that we should have looked at, and incorporated into our recommendations, those made by MAFF on veterinary products with bovine materials.� We had most certainly considered the MAFF [sic] on recommendations and indeed had appended them as Appendix 3 to our own report.�[348]</div>
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300. On 14 October 1988 Dr Jefferys replied.[349] He said:</div>
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�1.�� I refer to your minute of the 12 October.</div>
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2.��� A copy of the BSE paper was sent to you as soon as it was available. You will appreciate with the present demands on our professional resources and the tight timescale that the paper could not have been sent to you earlier.</div>
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3.��� The paper has already been copied for circulation to the Biologicals Sub-Committee and to SEAR (which meets on the 4th November, two days after Biologicals). I note that you will be at the Biologicals Sub-Committee and therefore you will be able to give us an updated figure as to the number of confirmed cases of BSE. There will be plenty of virological advice at the Biologicals Sub-Committee.</div>
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4.��� The purpose of the paper is to provide a framework and basic recommendations. The second stage of the procedure will be to look at individual products if the Committees feel there is a problem and that action is necessary. This work will principally fall to CRM and CDSM.</div>
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5.��� The recommendations are a matter for the Committees. They will have the MAFF list before them. I think it is important that the recommendations are correct, rather than we seek conformity for the sake of conformity.</div>
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6.��� With regard to bovine insulin, we first need to decide whether there is a problem. If there is, then with Professor Harry Keen on Biologicals and Professor George Alberti on SEAR we have considerable diabutalogical expertise to frame any recommendations which might be necessary.�[350]</div>
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301. On 20 October 1988 the CSM held a meeting.[351]</div>
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302. On 1 November 1988 the CRM met and the minutes note that a paper on BSE �would be put to the Biologicals Sub-Committee for their expert consideration and that there would be an opportunity for the CRM to consider further.�[352]</div>
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303. On 2 November 1988 the CSM Biologicals Sub-Committee met to discuss the paper prepared by Dr Rotblat and Dr Purves (see paragraphs 264 - 281 above). Mr Ayling, Dr Adams and Dr Pickles also attended this meeting. The Sub-Committee recommended the following:</div>
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�7.1 Bovine Spongiform Encephalopathy</div>
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Following a full discussion the Sub-Committee made the following recommendations -</div>
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a.��� No immediate licensing action should be taken against oral products, in which bovine material has been used.</div>
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b.��� All bovine materials should come from cattle from appropriately certified healthy herds, which have not been given food supplements containing material of animal origin. No brain or lymphoid tissue should be used in parenteral products.</div>
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c.��� Manufacturers of parenteral products should show that their manufacturing processes are capable of eliminating scrapie-like agents.</div>
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d.��� All licences for new products from bovine materials should comply with the above.</div>
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e.��� There should be an article in MAIL requesting manufacturers to identify products in which bovine materials had been used. Bovine albumin and foetal calf serum should come from appropriately certified healthy herds.</div>
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f. The above should be drawn to the attention of the review/CDSM sections along with the need to search for preparations containing bovine material.</div>
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g. The above should be drawn to the attention of the ADR Section and SEAR along with the need to search the ADR database for reactions to bovine products.</div>
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7.2 The Sub-Committee also recommended that Licensing Authority�s attention should be drawn to the need to give ongoing consideration as to whether action was required on bovine insulin and heparin products.�[353]</div>
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304. In his Statement to the Inquiry Professor Collee commented on this meeting in the following terms:</div>
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�I recall reading the Purves/Rotblat paper with admiration . I thought that it was balanced and well researched. I recall that my preliminary feeling was that it seemed unlikely that the BSE agent would be transmissible to man, but that the possible consequences of transmission were potentially alarming.[354]</div>
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Everyone who attended the Biologicals Sub-Committee meeting on 2nd November was exercised by the issue of BSE. At the meeting, there was a very full discussion of the Purves/Rotblat paper, which was used as a baseline; we then had a wider, general discussion of the issues raised and I would have summarised these. We then went on carefully to discuss each of the recommendations which had been made. It appears that Dr Purves attended the meeting although Dr Rotblat did not. Dr Purves may well have introduced the paper; he certainly answered questions on it. Dr Pickles would almost certainly have contributed to the discussion.[355]</div>
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We faced considerable uncertainty at this time. I knew from my knowledge of other models of infectivity that parenteral delivery of similar agents was likely to be more effective than other potential routes of transmission, such as an oral challenge. I was also aware the infection could �home onto� particular organs or tissues; that brain was likely to be such an organ and that there might also be risks from the use of nervous tissue. The Purves/Rotblat paper had additionally drawn attention to possible risks from lymphoid tissue; I believe that I was unaware of the possibility of lymphoid tissue posing a particular risk before reading this paper. I was, however, alive to the concept of sub-clinical infection.[356]</div>
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On the other hand we were conscious that scrapie; which had existed in sheep for more than 200 years, had not been shown to have any implications for human health. It was not merely that people who had eaten lamb or mutton had not developed CJD. The evidence also suggested that those who had eaten high-risk tissues (eg sheep brain) had not developed CJD. In addition, those who worked in high-risk occupations had not developed CJD from contact with infected sheep, including those who had worked in situations where there might have been a risk of contamination of cuts or wounds.[357]</div>
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In order that the meeting is seen in the appropriate context, it should be remembered that at this time we had no idea that the disease would become as widespread as it did. The Purves/Rotblat paper spoke of approximately 500 cases of this new disease; even if the figure was closer to a thousand cases, we were still talking about relatively small numbers of cattle in any herd.�[358]</div>
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305. In his Statement to the Inquiry Professor Collee commented on each of the CSM Biologicals Sub-Committee recommendations:</div>
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�Recommendation (a): �</div>
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Our approach was based on the premise that the disease appeared to parallel scrapie, which had not been shown to be transmissible to man by the oral route. In the absence of further evidence we felt that it would be alarmist to take the view that BSE could be transmitted by the oral route, particularly in the case of orally administered medicinal products where the dose involved would be much smaller than in food. We added the word �immediate� to the recommendation to take account of the fact that the position might need to be changed if further relevant evidence came to light.</div>
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Recommendation (b): �</div>
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As to the first sentence of this recommendation, the words �appropriately certified� were added after discussion at the meeting. We knew that we would need further advice from MAFF on how to define this concept.</div>
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In due course, we learned that certification would not be workable and the phrase did not appear in the guidelines which ultimately went to manufacturers.</div>
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So far as the second sentence of this recommendation was concerned, I believe that we intended this recommendation to apply not only to the use of brain and lymphoid tissue in parenteral products, but also to the use of brain and lymphoid tissue in the manufacture of parenteral products.</div>
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I cannot specifically recall whether or not the question of topical products was discussed at this particular meeting, but I believe that topical products would have been thought of as very unlikely to pose a hazard to man and therefore did not warrant our immediate concern.</div>
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Recommendation (c): �</div>
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I cannot recall precisely why it was that we used the word elimination instead of inactivation. It may be that by use of the word elimination we had in mind the need for the wider manufacturing process (including sourcing) to eliminate the agent.</div>
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Recommendation (d): �</div>
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It was always our intention that the recommendations should apply to both existing and new products, rather than merely new products alone. The proposed article in the Medicines Act Information Leaflet (MAIL), for example, was to ask manufacturers to identify products in which bovine material had been used. Another recommendation was that the attention of the Review section (which only dealt with existing medicines) should be drawn to the recommendations. Thus, whilst I understand the fact that Sir Richard Southwood was concerned about the possibility of our only looking at new products, that was not our intention. The difficulty with existing products, however, was that they had to be identified first. That proved to be a very time-consuming task.</div>
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Recommendation (e): �</div>
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As I have stated, the intention was that the article in MAIL would be aimed at (and seen by) manufacturers of both new and existing products. I believe that the purpose of the article at this stage would have been to discover the extent of the use of bovine material, rather than to issue guidelines to industry.</div>
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I believe that the express reference to bovine albumin and foetal calf serum was made because we wanted to ensure that the use of these products, which we knew to be considerable, was not overlooked.</div>
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Recommendation (f): �</div>
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As I have explained, our intention was that the guidelines would apply to all products and it therefore made sense for the guidelines to be drawn to the attention of those committees.</div>
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Recommendation (g): �</div>
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This was included to ensure that the ADR section looked for any evidence of a link between existing medicinal products connected with bovine material and adverse reactions in humans.</div>
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The Sub-Committee also recommended that the Licensing Authority�s attention should be drawn to the need to give ongoing consideration as to whether action was required on bovine insulin and heparin products.</div>
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The Purves/Rotblat paper was able to identify these products as containing bovine material from the computer database. In particular, insulin had been identified in the paper as potentially the greatest problem (insulin is used virtually directly in the product; this is different from the indirect use of material in vaccines). In the event, it was discovered that no bovine insulins were manufactured from UK sourced material, save for one sample consignment in 1988 (see page 8 of Paper 1 submitted to the BSE Working Party in September 1989)�[359]</div>
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306. On topical products Professor Collee also said the following:</div>
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�As to topical products, one of the obvious reasons for our not being concerned about those products was the barrier provided by the skin.� I regard topical products, when applied to intact skin, as involving even less risk than products taken orally, though applications to broken skin would potentially involve a greater risk.� I believe we would also have discussed the possibility of infection being spread by the application of topical products to open wounds.� However, the lack of epidemiological evidence of CJD-like illness amongst those occupationally exposed to spongiform encephalopathies (e.g. butchers and farm hands) encouraged us to regard this issue as a very low risk.� In addition, the topical products involved appeared to contain low risk bovine material.�[360]</div>
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307. Dr Jefferys has commented:</div>
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�Once the Purves/Rotblat paper had been submitted to the expert advisory committees, consideration of the issues raised by BSE for the safety of medicines became a matter for the expert advisory committees who were supported and assisted in their task by officials from Medicines Division. It should be remembered that a number of such committees were involved. SEAR, the CRM and the CDSM were all involved in considering the recommendations of the Biologicals subcommittee and the CSM.�[361]</div>
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308. On 2 November 1988 Dr Pickles minuted Mr Lawrence, with a copy to Dr Jefferys, in the following terms:</div>
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�1.�� The Biological Sub committee of CSM today discussed BSE. The unconfirmed minutes of the meeting should be available in a day or two but the main conclusions as I recollect them are as in the attachment.</div>
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2.��� The problem has already been discussed in outline by the Committee of (sic) Dental and Surgical Materials (CDSM) who will now be taking action in the light of today�s decision. The safety, efficacy and adverse reactions (SEAR) sub committee of CSM will be discussing BSE on Friday and the main CSM later this month. Not until that stage would it be appropriate for any formal comment to go from the Licensing Authority back to Sir Richard�s Group. But I can give an interim progress report next week.</div>
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3.��� I hope we can persuade Sir Richard that the issue is now being looked at in depth by the appropriate experts who also have the executive power to do something about it. This means Sir Richard needs only a passing reference in his own report.</div>
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4.��� An area where I am still unclear is what, if anything, is happening with veterinary products. I have seen a draft paper from G W Wood (dated 6 July �88) but do not know if this was before or after consideration by the VPC. Please could you find out for me what progress there is there?�[362]</div>
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309. The attachment to Dr Pickles� letter was headed �Outline of Comments and Recommendations from Biological Sub-committees of CSM to November 1988�. It said:</div>
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�1.�� This potential problem needs to be taken seriously. The best working hypothesis is that BSE agent will have the same properties as scrapie agent. Medicinal products of concern could become contaminated in any of 3 ways:</div>
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a).�� bovine ingredients</div>
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b).�� bovine materials used in part of the manufacturing process eg BSA</div>
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c).�� bovine brain/heart infusion broth and similar products being used as culture medium. Whilst these media are autoclaved, the temperatures used may not be high enough.</div>
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The absence of disease in animals/herds must not be taken as absence of infection.</div>
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2.��� There is incomplete information on the licensed products potentially affected, as many products with licences of right (PLR�s) do not have even active ingredients correctly identified on the computer records. Non-active ingredients/materials of bovine origin may also be missed out. Some collagen implants of bovine origin as used by cosmetic clinics are not even licensed.</div>
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3.��� Questions could now be asked about many other products eg heparin, although it is believed all of this is now imported from overseas.</div>
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4.��� There is no need for action on any oral products.</div>
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5.��� Ideally, all bovine material in parenterals should come from healthy �approved� herds which have not been fed animal protein; processes should be such as to inactivate or eliminate scrapie or similar agents; alternatives to brain-penetrative stunning should be used for killing; brain and lymphoid tissue should not be used. But it is accepted evidence of elimination of scrapie-like agents may be unachievable in practice and some biological products may be physically damaged by processes adequate to destroy scrapie agent.</div>
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6.��� Whilst bovine insulins have only a very small place now in therapy, and safer alternatives are available for all but a handful of patients who do not take to human insulins, it would be premature to warn clinicians of the BSE-risk and this would run the risk of adverse publicity. Urgent review of bovine insulins, most if not all of which may be manufactured overseas� where BSE is not of concern, is what is needed next.</div>
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7.��� Were pigs to be susceptible to BSE/scrapie, then this would have very serious impact on supply of insulins.</div>
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8.��� The subcommittees recommendations could form the �framework� on which specific proposals for specific products could then be formulated by the secretariat and then brought back to the committee. Further information would be sought from MAFF and other experts on how disease-free herds, procedures and countries might be identified.</div>
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9.��� Biologicals also comment on the urgent need for further research in this area and were informed that the Southwood working party had reached the same conclusions.�[363]</div>
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310. On 4 November 1988 the CSM SEAR (Sub-Committee on Safety, Efficacy and Adverse Reactions) met to discuss BSE and endorsed the findings of the Biologicals Sub-Committee meeting two days earlier.[364]� The minutes also record that SEAR� ��commented that appropriate research should be encouraged in this area, because of the many unresolved issues which makes risk assessment difficult.�</div>
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311. On 8 November 1988 a meeting was held between NOAH and MAFF.[365] The minutes record that the following points were raised at the meeting on the BSE situation:</div>
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�4. BSE situation � progress discussion</div>
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i)���� �There is also possibility that BSE exists in the USA following tests carried out in Wisconsin.</div>
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As a result of these tests bovine material from the US can no longer be recommended for inclusion in biological products.�</div>
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312. Problems with supply of bovine material were identified together with the possibility of a change in production methods. The minute of the meeting records that:</div>
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��It was felt that the publication of the guidelines was required to protect the UK image and demonstrate to the Commission that we had a clear action policy. We remain the only MS to have admitted to recognising the disease so far�.[366]</div>
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Southwood Committee: second meeting</div>
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313. On 10 November 1988 the Southwood Committee met for the second time. The minutes recorded the following:</div>
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�Veterinary and biological products</div>
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2.(i)������� The outcome of preliminary discussions in the Veterinary Products Committee and Biologicals Sub-Committee of the Committee on Safety of Medicines (CSM) were reported. It was considered that a number of practical steps could be taken through advice to manufacturers on a voluntary basis. It was emphasised that advice should be given in relation to existing as well as new products. Sir Richard Southwood agreed to write to the Chairman of CSM on this issue. It was also agreed that the Report should contain a section on veterinary and medicinal products advising that the VPC and Biological Sub-Committee should have regard to the emergence of BSE in making recommendations and that they should take account of the products currently in use as well as new ones. Although possibly outside the Working Party�s terms of reference it was suggested that the use of sheep serum should be examined in human medicinal products.�[367]</div>
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The word �possibly� was a hand written addition.</div>
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314. On 14 November 1988 Sir Richard wrote to Professor Asscher, Chairman of the CSM,� in the following terms:</div>
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�I understand that the Committee on Safety on Medicines is shortly to consider whether bovine spongiform encephalopathy presents a hazard in those medicinal products for human use that have been manufactured from bovine sources. At a recent meeting of the expert working party which has been set up by MAFF and DH to consider the implications of this desase (sic), we were informed of the provisional conclusions of the Biologicals Subcommittee.</div>
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We were pleased to hear of the detailed consideration that was given to this issue. As you may know, we have already identified the pressing need for more research in this area. We understand that in due course you may be considering whether licensing action of some sort is appropriate in relation to any specific products. We trust that any steps that are thought necessary to safeguard new medicinal products will be applied also to existing products. There are various measures that manufacturers could take to reduce or eliminate the risk of contamination by BSE agent in pharmaceuticals and which could be introduced by agreement with relative ease and with no detriment to the product. Those steps include using material only from healthy herds not fed ruminant-derived protein; avoiding use of brain or lymphoid tissue directly or in culture media; and reducing nervous tissue contamination of serum by ensuring animals are not destroyed by brain-penetrative stunning. You may like to consider whether informal advice on these lines to the pharmaceutical industry might be helpful. Other steps, such as ensuring the manufacturing processes are such as to eliminate any scrapie or similar agent, seem likely to prove more problematic.</div>
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We look forward to hearing your considered view when you have completed your deliberations.�[368]</div>
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315. Professor Asscher has stated that �[t]his letter and Sir Richard�s other letters to me would have been circulated within the Medicines Division at the time.�[369]� He also said:</div>
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�I am glad that, in his letter, Sir Richard recognised that informal action was likely to be preferable to a formal licensing approach. As explained in paragraphs 64 - 66 of this statement, there would, at this time, have been no grounds for taking formal licensing action. Informal action is almost always preferable to formal licensing action. However, persuading the industry to accept informal recommendations was not necessarily going to be as easy a task as suggested in Sir Richard�s letter dated 14 November 1988�.[370]</div>
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316. Dr Pickles minuted Dr Jefferys on 15 November 1988 saying that Sir Richard Southwood �might be writing to CSM/MD to encourage the implementation of any action thought necessary to existing products as well as to any new ones.�[371]� She goes on to say that:</div>
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��the current intention is for the working party report to contain a paragraph or two about medicinal products but to leave the recommendation to something like �the attention of the LA, the CSM and the VPC are drawn to the potential of transfer of BSE between animals or species in medicinal products, and are asked to take any appropriate action�. OK?�</div>
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Dr Pickles� note also addressed concern about scrapie in products from sheep.</div>
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317. On 16 November 1988 the CDSM considered the paper discussed by the CSM Biologicals Sub-Committee at its meeting on 2 November 1988. The minutes record that the Committee noted the paper had been put to the Biologicals Sub-Committee and would now be seen by the CSM. The CDSM were to be kept informed of any developments. The Committee�s view was that at this stage synthetic materials should be used in surgery wherever possible and materials of bovine origin should be used only where essential.[372]</div>
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318. On 17 November 1988 a full meeting of the CSM was held, chaired by Professor Asscher[373]. The minutes record in relation to BSE:</div>
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�7.1 The Committee discussed the paper and endorsed the recommendations of the SEAR and Biologicals Sub-Committees.</div>
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7.2�� The committee also noted the letter from Sir Richard Southwood (Tabled Paper 4).� The Committee agreed that the Chairman should reply to Sir Richard Southwood detailing the view of the Committee and referring to preliminary consideration of this matter by CRM and CDSM.�</div>
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319. In his Statement to the Inquiry Professor Collee said[374]:</div>
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�On 17th November 1988, I attended a meeting of the CSM. I believe that I first saw the letter dated 14th November 1988 from Sir Richard Southwood to Professor Asscher at the meeting, when it was tabled. I am sure that there was a very full discussion of BSE at this meeting and that I played a large part in that discussion.</div>
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I am unable to recall our detailed discussions on Sir Richard�s letter. My recollection is that we saw it as a constructive letter rather than a critical letter. Sir Richard�s points were taken on board and guided the further detailed discussions which took place after the CSM meeting, leading up to the joint guidelines sent out in March 1989. The Inquiry will wish to know that it would have been most unusual for recommendations to be altered by the CSM without detailed working level discussion beforehand.�</div>
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320. Professor Asscher also commented on this meeting in his Statement to the Inquiry:</div>
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�My first involvement with BSE occurred in the course of preparing for the CSM meeting which took place on 17 November 1988.� The CSM was, however, aware of the issues involving CJD and human growth hormone at this time and of the occurrence of CJD following dura mater implants.� They had come to our attention in the course of considering product licences for dura mater.� These experiences made us particularly wary of parenteral, as compared to oral, medicinal products.� At the time, the fact that scrapie had not transmitted to man also gave us reassurance that BSE was unlikely to be acquired by the oral route.�[375]�</div>
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321. Professor Asscher also said in his Statement that copies of the Biological Sub-Committee�s recommendations were sent to the Chairman of the CRM (Professor David Lawson), the Chairman of the CDSM (Professor Colin Berry) and to MAFF. Professor Lawson had been present at the CSM meeting.[376]</div>
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322. On 18 November 1988, Dr Jefferys circulated Dr Pickles� minute of 15 November to Drs Jones, Rotblat, Purves, Adams and Wood, saying:</div>
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�I would have thought that we could take comfort in the fact that scrapie has been present in sheep for many years and we have no evidence of any human threat posed by infected sheep in relation to medicinal products.� However, it might be appropriate if we checked the computer database to see how many medicinal products may derive from ovine material.�[377]</div>
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323. On 24 November 1988 Professor Asscher replied to Sir Richard�s letter of 14 November. A draft reply had been prepared by Dr Jefferys and circulated for comments to Dr G Jones, Mr Wilson, Dr Adams, Dr Wood, Dr Purves, Mr Hagger, Miss Simpkins, Dr Rotblat and Mr Whitbread.[378] The letter stated[379]:</div>
<div style="font-family: arial; font-size: 13.3333px;">
�The CSM has now considered the issue of bovine spongiform encephalopathy at its recent November meeting. The Committee endorsed the views of the Biologicals and SEAR (Safety, Efficacy and Adverse Reactions) Sub Committees. I understand that you had already been sent the views of those Sub Committees. I can now attach the recommendations from the full CSM.</div>
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Preliminary discussions have also taken place within the Committee on the Review of Medicines and Committee on Dental and Surgical Materials to consider what action needs to be taken in relation to specific existing products.</div>
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I hope you will agree that we now have in progress the appropriate action to safeguard both new medicinal products and existing products.�</div>
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324. Professor Asscher said in his Statement to the Inquiry:</div>
<div style="font-family: arial; font-size: 13.3333px;">
�I wish to make it clear that the CSM always intended its recommendations to apply to existing as well as new products and the draft guidelines reflected this. The draft sixth recommendation would not have stated that the earlier recommendations should be drawn to the attention of the review (i.e. CRM) section of Medicines Division had the recommendations only been intended to apply to new products.�[380]</div>
<div style="font-family: arial; font-size: 13.3333px;">
�As to the second recommendation, Sir Richard Southwood appeared to be concerned that the proposed ban on the use of bovine brain and lymphoid tissue would not apply to the use of such tissues in the manufacture of parenteral products. However, the CSM was aware at this time of the use of bovine material in the manufacture of medicinal products (see paper prepared by Dr Rotblat and Dr Purves).The draft second recommendation was always intended to apply to the use of brain and lymphoid tissue in the manufacturing process as well as its use as an active ingredient.</div>
<div style="font-family: arial; font-size: 13.3333px;">
It should also be made clear that we were relying on MAFF and the Southwood Working Party to assist us to define the concept of a �healthy herd� and to advise which bovine tissues were likely to pose the greatest risk.�[381]</div>
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325. On 24 November 1988 there was a meeting between Mr MacGregor, Minister for Agriculture, Mr Meldrum, Mr Cruickshank, Mr Thompson, Sir Donald Acheson, Sir Richard Southwood and Dr Pickles.� This meeting was held to discuss the implementation of recommendations thus far and the progress of the Southwood Report. In relation to medicines it was recorded in a note prepared by the PS/Minister that:</div>
<div style="font-family: arial; font-size: 13.3333px;">
�8.�� Sir Richard thought it was also important with a view to containing the disease to ensure that veterinary products (eg. serum) were properly controlled. Mr Meldrum confirmed that a control system had been introduced on a voluntary basis. He undertook to let Sir Richard have full details of what had been done.�[382]</div>
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326. On 7 December 1988 Sir Richard replied to Professor Asscher�s letter of 24 November 1988. He stated:</div>
<div style="font-family: arial; font-size: 13.3333px;">
��I am glad that the CSM has now considered the problems posed by bovine spongiform encephalopathy. I will put your letter before my colleagues at our next meeting, and I know they will want to join me in thanking you for your response.</div>
<div style="font-family: arial; font-size: 13.3333px;">
Perhaps I might make two initial comments on the recommendations of the CSM. In the first place, I would strongly endorse and underline the importance of items 5-7 and also the �remark� below. As I wrote to you in my earlier letter, my colleagues and I are most anxious to ensure that existing products were identified and that manufacturers ensured that they conformed to the safety recommendations. The second point is that I believe in practice �the certification of healthy herds� is going to be more difficult, because as you know, this disease may be present for many years in an asymptomatic condition, thus certification would have to depend on evidence that food supplements containing material of animal origin have not been fed to the herds for as long as six or seven years or the lifetime of the animals concerned. I am not sure what arrangement the Ministry of Agriculture has in mind for certifying herds as healthy from this point of view, but as you will appreciate, the absence of a case of BSE would not be a sufficient condition.�[383]</div>
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327. Professor Asscher commented on this correspondence in his statement to the Inquiry:</div>
<div style="font-family: arial; font-size: 13.3333px;">
��the CSM had always intended to apply its recommendations to existing products and I had previously informed Sir Richard Southwood of the fact that the CRM, which only deals with existing products, would be considering the issue. When considering Sir Richard�s comments on the problems of certifying herds as healthy, it should be remembered that it was Sir Richard who had previously suggested �using material only from healthy herds not fed ruminant-derived protein� and described this as a measure �which could be introduced by agreement with relative ease� (see letter dated 14 November 1988 from Sir Richard Southwood to me) The experts� understanding of the BSE epidemic was constantly evolving at this time. In the circumstances, the CSM and the officials in Medicines Division had to rely upon MAFF and the Southwood Working Party for the latest information and interpretation of the facts relating to the extent of the development of the BSE epidemic and the infectivity of different bovine tissues We also had to rely on MAFF for guidance as to how best to define the concept of a BSE-free herd.�[384]</div>
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328. Dr Jefferys has commented that:</div>
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��a number of the recommendations needed to be considered with MAFF so as to ensure that they were practicable and scientifically justifiable. These usually involved areas of veterinary science in which MAFF could be expected to have a particular expertise. The concept of an �appropriately certified healthy herd� (recommendation (b)) and questions as to what manufacturing processes were capable of eliminating scrapie-like agents are obvious examples of such areas. MAFF themselves were at this time in the process of revising the draft guidelines which they had prepared in July 1988 and it was desirable that a consistent approach be adopted. It should be remembered that the same pharmaceutical companies produced both human and veterinary medicines.�[385]</div>
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329. In relation to Medicines Division contact with MAFF, Dr Adams has said:</div>
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�Towards the end of 1988 I had various informal conversations with MAFF colleagues about BSE as I was keen to know more about the disease and any possible implications it might have for human health. I also recall that I went to the CVL to see Mr Bradley in December 1988 for the same reason and spoke to colleagues within the Medicines Division.�[386]</div>
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330. On 8 December 1988 Dr Pickles wrote to Sir Richard. She said:</div>
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�I am not entirely happy with the reply from the chairman of the CSM. I do not see anything in their recommendations that gives me any confidence that they will be taking any necessary action on existing products, or indeed taking note of any of the points you raised in your letter (based, as I explained, on points raised in the biologicals sub Committee but which did not appear in their minutes). In case you would like to reply again I enclose at 4 a possible draft, but may be this is something you would like to discuss in more detail next week. For your information, I enclose at 5 the note I made following the biological subcommittee.�[387]</div>
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331. On 15 December 1988 the CSM held a meeting. The Committee noted the letter from Sir Richard Southwood.[388]</div>
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332. On 16 December 1988 Dr Jefferys minuted Dr Harris in the following terms:</div>
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�1.�� Dr Jones has asked me to detail the present position on BSE with regard to medicinal products.</div>
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2.��� A detailed paper considering the issues posed by BSE for medicinal products was considered by the three Sub Committees of the CSM during early November and by the CSM on the 17th November. Dr Hilary Pickles attended the meeting of the Biologicals Sub Committee and the draft recommendations of that Committee and of the Sub Committee on Safety, Efficacy and Adverse Reactions (SEAR) were sent to the Southwood committee which met on the 10th November. After the CSM meeting, Professor Asscher wrote to Sir Richard Southwood giving him and his committee the full recommendations of the CSM. These are attached as Annex A to this minute. The minute of the CSM meeting is set out in Annex B.</div>
<div style="font-family: arial; font-size: 13.3333px;">
3.��� Sir Richard Southwood replied to Professor Asscher on the 7th December. This letter is attached as Annex C. The CSM considered the letter as a tabled paper at its meeting yesterday and felt that a reply was not necessary.</div>
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4.��� The professional secretariat are now pursuing the recommendations made by the CSM. The CRM and CDSM will be involved as necessary.</div>
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5.��� The CPMP (the Committee on Proprietary Medicinal Products) was informed of the UK action at its recent December meeting.�[389]</div>
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Southwood Committee: third meeting</div>
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333. On 16 December 1988 the Southwood Working Party met for the third time. The minutes record the following:</div>
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�Matters arising</div>
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3.���������� The correspondence with Professor Asscher was discussed. It was felt that the response was somewhat complacent, particularly in relation to the problem of existing medicinal products. In the circumstances a further letter would be sent to Professor Asscher to suggest that practical advice could be given to the pharmaceutical industry. In addition the Chairman would write to Dr Little of the Veterinary Products Committee to establish what measures they were adopting in the light of this new disease problem.�[390]</div>
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334. On 20 December 1988 Sir Richard Southwood wrote to Dr Little about the potential risk from using biological products manufactured from bovine sources in the light of the emergence of BSE in cattle.[391]� He said �[w]e are pleased to hear of the detailed consideration which is being given to this issue.� As you may know we have already identified the pressing need for more research in this area.�� He went on to request information on what consideration the VPC had given to licence applications to new products. He said,� ��we trust that any steps that are thought necessary to safeguard new products will also be applied to existing products.�� Sir Richard suggested some steps that could be taken by manufacturers to reduce any possible risk of contamination by the BSE agent:</div>
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��Presumably one solution would be to purchase material from abroad. Other possibilities might be to avoid the use of brain or lymphoid tissue directly or in culture media and reducing nervous tissue contamination of serum by ensuring that animals are not destroyed by brain penetrative stunning.��</div>
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He concluded by indicating that he would appreciate Dr Little�s �views on whether some form of guidance to the industry might be useful.�</div>
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335. On 21 December 1988 Dr Pickles provided relevant papers on BSE and medicinal products to Dr Harris.[392]</div>
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336. On 23 December 1988 Sir Richard wrote to Professor Asscher.[393]� He said the following:</div>
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�I wrote to you on 7 December with my initial comments to your letter of 24 November, which enclosed the recommendations of the CSM in relation to bovine spongiform encephalopathy.</div>
<div style="font-family: arial; font-size: 13.3333px;">
I have now had the opportunity to obtain views from my colleagues on the working party and they have asked me to convey our continued concern. My letter of 14 November was written in the light of the draft recommendations we knew were to be put before the CSM and hoped the committee might have seen fit to amend their recommendations accordingly.</div>
<div style="font-family: arial; font-size: 13.3333px;">
We interpret your recommendations as drafted to mean that conditions that may be impossible in practice will be demanded of new products of bovine origin, and yet other than for the insulins we see no firm commitment to look at existing products.</div>
<div style="font-family: arial; font-size: 13.3333px;">
In my letter of 7 December I touched on one of the conditions that may prove very difficult in practice, the �certification of healthy herds� if this is to embrace those never fed ruminant protein. In the letter of 14 November I hinted at the problems there could be in another aspect, that of ensuring manufacturing processes are capable of eliminating scrapie agent. It is also not clear if the exclusion of brain and lymphoid tissue concerns only active ingredients or intermediates and culture media also, and whether this is an absolute condition. Some flexibility may be needed in interpretation of these guidelines.</div>
<div style="font-family: arial; font-size: 13.3333px;">
We understand that the CDSM and CRM will be informed of your recommendations and we trust they will take appropriate action. We note the recommendation to the Licensing Authority to consider bovine insulin and heparin, and would like reassurance that appropriate action would be taken against any other relevant parenteral products: this point is not clear from the CSM minutes.</div>
<div style="font-family: arial; font-size: 13.3333px;">
As my letter of 14 November mentioned, there are various steps that could be taken relatively easily to reduce or abolish the �risk� and we believe some manufacturers have already taken these measures. But there could be other manufacturers who are in ignorance of the potential problem and who might benefit from informal advice. Perhaps you intended that the MAIL article would cover these aspects as well as being a search for information on ingredients not available in the Licensing Authority records. Dr Hilary Pickles who is on the secretariat of my group would be happy to assist in drafting any article of this sort. We see that a reduction in �risk� could result more rapidly from informal action, much of which we believe could be taken without formal licence variation, rather than relying on a formal licensing approach.</div>
<div style="font-family: arial; font-size: 13.3333px;">
This new disease in cattle has caused us to question the possible risk to humans from zoonoses of all sort (sic), including perhaps some yet to be discovered. This is a general issue that the CSM may like to consider in relation to medicinal products of animal origin.</div>
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We are now finalising the report from my working party and will make reference to our concern about medicinal products and that we have drawn the attention of the Licensing Authority to that concern.�[394]</div>
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337. On 23 December 1988 a draft guidance document on BSE and biological products was prepared by the BP&S Department of the CVL. It was prepared to give guidance in order to reduce the risks of inadvertently contaminating biological products with the BSE agent.[395]</div>
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338. Sir Kenneth Calman told the BSE Inquiry that:[396]</div>
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�This was clearly a very important area at several different stages in the process. Right at the beginning in terms of the 1988/1989 issue, there was a very rapid review of all medicines, including vaccines which might or might not have contained products of a bovine nature. Because of that review all medicines were carefully considered and where there was a bovine product then this was changed rapidly to come from a bovine source outwith the United Kingdom.�</div>
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339. In his Statement to the Inquiry Professor Asscher stated that Sir Richard�s comments on existing products:</div>
<div style="font-family: arial; font-size: 13.3333px;">
��appear to be based on a continuing misunderstanding of CSM�s actions. As previously stated, the CSM had always intended that its recommendations should be applied to both existing and new products. It was for this reason that the CSM ensured that BSE was also considered by the CRM.�[397]</div>
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Professor Asscher also said:</div>
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�As Chairman of the CSM, my policy was always to attempt to use negotiation and recommendations rather than legal action. Formal regulation was only to be used in cases of extreme urgency or where the pharmaceutical industry had indicated an unwillingness to accept the CSM�s recommendations.</div>
<div style="font-family: arial; font-size: 13.3333px;">
Informal action is invariably both quicker and cheaper than regulatory action. The pharmaceutical industry is highly professional and is normally content to accept the recommendations of the CSM. It is not in the interests of pharmaceutical companies to promote products which are being questioned on safety grounds.</div>
<div style="font-family: arial; font-size: 13.3333px;">
I believe that in the case of BSE, the issuing of non-binding recommendations achieved a result that could not have been obtained through taking regulatory action. Licences cannot generally be revoked merely on the basis of a remote and theoretical risk. Such a revocation would very probably be overturned if legally challenged and we would never advise Ministers to take formal regulatory action in such circumstances. The risk posed by BSE was regarded as remote and theoretical and as such formal regulatory action could not have been scientifically justified. However, it was possible to achieve the same result through the issuing of recommendations because the industry wished to receive advice and was willing to accept it. As far as I am aware, no companies declined to follow the recommendations of the CSM on BSE and medicinal products.�[398]</div>
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340. On this issue Dr Rotblat has said:</div>
<div style="font-family: arial; font-size: 13.3333px;">
�I understand that the Inquiry may be interested in the reasons why non-binding guidelines were issued rather than formal regulatory action being taken. The issuing of non-binding informal recommendations is an integral part of the licensing process and the work of the MCA. Informal recommendations are used in the knowledge that regulatory action can be considered if it becomes necessary to do so. Pharmaceutical companies are very frequently told that if they comply with certain recommendations they will be granted a product licence. It is very unusual for a company to decline to follow the recommendations in such cases.</div>
<div style="font-family: arial; font-size: 13.3333px;">
The use of informal recommendations in the handling of BSE was entirely in keeping with the CSM�s general practice - the issuing of recommendations/guidelines was the method adopted on every matter of a similar nature. One advantage of this approach was that, in general, the use of recommendations was quicker than the process of revocations and appeals.</div>
<div style="font-family: arial; font-size: 13.3333px;">
The climate at the time was such that industry was very willing to comply with informal guidelines and to the best of my knowledge, no manufacturer refused to comply with the CSM/VPC guidelines on the use of bovine material. In the circumstances, there was never any need to take formal regulatory action with regard to BSE. Further, there was no need to impose formal deadlines on companies because, in my view, all companies changed sourcing as soon as they were able to do so.�[399]</div>
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1989</div>
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341. In January 1989 the Medicines Unit, MAFF, prepared a revised version of the guidelines for the VPC. The covering note said: �the document is presented to members essentially for information but it will be helpful to have comments on it, and suggestions from the Committee will whenever possible be incorporated�. The note also stated �it is important to progress the guideline as quickly as possible so that it can be distributed to appropriate organisations, and manufacturers using material of bovine origin in their products�. The guideline recommendations, which dealt with the �selection and treatment of material obtained from cattle in the UK and destined for use in the preparation of biological products�, provided:</div>
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�I)��� COLLECTION</div>
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1.��� No product from a BSE affected animal is acceptable for use.</div>
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2.��� Material should be obtained only from BSE-free herds.</div>
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3.��� Brain-penetrative stunning is unacceptable where tissues are collected post mortem.</div>
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4.��� Instruments used to collect samples and holding vessels should either be virgin�or be sterilised. After use reusable instruments should be sterilised after cleaning. Disposable materials should be incinerated.</div>
<div style="font-family: arial; font-size: 13.3333px;">
II)��� TISSUES UNSUITABLE FOR COLLECTION</div>
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1.��� Primary cell structures.</div>
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2.��� Endocrine glands including placenta.</div>
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3.��� Spleen and lymphoid tissue.</div>
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4.��� Neural tissue</div>
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III)� TISSUES AND OTHER MATERIALS SUITABLE FOR USE</div>
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It is recommended that wherever possible source animals are calves.</div>
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1.��� Serum. All cellular components must be removed.</div>
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2.���� Fetal calf serum provided great care is taken to avoid contamination by placenta and fetal fluids. All cellular components must be removed.</div>
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3.���� Milk, or products derived from milk collected aseptically from individual cows under 3 years old.</div>
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4.��� Faeces collected from the rectum.</div>
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5.��� Bile collected aseptically.</div>
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6.��� Cell lines not derived from� neural or lymphoid tissues or cells.</div>
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7.��� Sterilised tissues excluding those listed in II.�[400]</div>
<div style="font-family: arial; font-size: 13.3333px;">
Joint CSM/VPC Guidelines considered</div>
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342. On 3 January 1989 Drs Adams, Jefferys and Purves, of the Medicines Division DH, met Dr Little, Mr Kidd and Mr Bradley of MAFF.[401]� A note, taken by Dr Adams, recorded the following:</div>
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�Subject: BSE and Medicines Licensing</div>
<div style="font-family: arial; font-size: 13.3333px;">
1.��� MAFF stated that BSE had come before the veterinary Biologicals Sub-Committee in November 1987. With increased notifications of the disease, the implications for veterinary medicinal products were discussed with NOAH in July 1988 when draft guidelines were presented. A redraft of these guidelines, following discussions with MAFF and MD will be presented to VPC in January 1989.</div>
<div style="font-family: arial; font-size: 13.3333px;">
2. MAFF filled in background on trade implications, the Southwood Committee, inclusion of BSE on the Zoonosis Order and undertook to provide relevant documents for information.</div>
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3. MD described the progress of Committee considerations and unresolved questions such as</div>
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a). Is there a problem to man � what about scrapie in sheep which has not been associated with any human disease?</div>
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b). What is a �healthy herd�?</div>
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c). How may manufacturers be expected to show that scrapie is inactivated by specific processes?</div>
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d). How many products should be implicated?</div>
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MD stated concerns re bovine insulins, heparin; also re vaccines, monoclonal products and others that have used foetal calf serum/bovine albumin/bovine broth in manufacture.</div>
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4.��� MAFF considered that no herd could be guaranteed healthy, all have had some contact with animal (sheep) protein in feed-stuffs: the problem is not necessarily exclusive to UK, there is a risk of spread to to (sic) Europe especially as feed-stuffs are exported and export of calves, embryo and semen from UK is increasing. The US have had Transmissible Mink Encephalopathy from downer cow feed. Ireland have had 2 x confirmed BSE cases.</div>
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5.��� MAFF considered that the safest source of bovine material was from Australia/New Zealand where animal/tissue imports are strictly controlled and where scrapie is absent.</div>
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6.��� Collection of foetal calf serum (FSC) (sic) may be critical. In the diseased sheep, the placenta is heavily contaminated with scrapie; present collection of FCS is not be [sic]an aseptic procedure and great skill is needed to avoid the placenta.</div>
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7.��� No farm or abattoir can approach surgical cleanliness and many may be contaminated already with BSE.</div>
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8.��� Although high pressure/high temperature sterilisation is possible, MAFF understood that the industry was not equipped with high pressure vessels for processing.</div>
<div style="font-family: arial; font-size: 13.3333px;">
9.��� MD/MAFF agreed that it was essential to keep �in step� especially as MAFF concerns about animal vaccines would cause DH great difficulties of supply if current stock had to be lost.</div>
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10.�� MD/MAFF agreed to maintain official links regarding all developments. MAFF would put revised guidelines to VPC in January after which MD/MAFF would meet again with expert advisors (NIBSC & Biols) to produce joint guidelines for industry. These will be published in MAIL with a request for information on products.</div>
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11.�� A resume of the present position would be made to Dr Harris DCMO by MD. Dr Murrell (Zoonosis) would be kept informed.</div>
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Post meeting note: The MD/MAFF working group involving NIBSC & Biols (CSM) will meet at 2.30pm Wednesday, February 1.�[402]</div>
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343. In his Statement to the Inquiry, Dr Adams said[403] of the 3 January meeting:</div>
<div style="font-family: arial; font-size: 13.3333px;">
�At the end of the meeting, MAFF and MD agreed to maintain official links regarding all developments. The immediate plan was that MAFF would put revised guidelines to VPC in January after which time MD/MAFF were to meet again with expert advisors to produce joint guidelines for the pharmaceutical industry, so that there would be a consistent message to industry. We agreed that it was essential to keep �in step.��</div>
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344. On 4 January 1989 Mr Bradley minuted Dr Watson about the certification of BSE-free herds for sourcing material for biological products. He outlined a number of possible options for further discussion.[404]</div>
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345. On 4 January 1989 the Biologicals Sub Committee of the CSM met.[405]</div>
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346. On 5 January 1989 Dr Watson minuted Mr Meldrum, attaching a copy of Sir Richard Southwood�s letter of 20 December 1988 to Dr Little. Dr Watson stated that it had been agreed at the meeting on 3 January that �if possible both the veterinary and medical interests would be covered in a single note for the guidance of pharmaceutical companies.�[406]</div>
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347. On 9 January 1989 Dr Adams and Dr Jefferys jointly minuted Dr Harris to update him on the current situation.[407]� They said:</div>
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�1.�� CSM considered a paper produced by the Secretariat at its November meeting, following detailed discussion by the Sub-Committees when experts from NIBSC were present. CSM endorsed a set of 7 recommendations.</div>
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The recommendations were forwarded to Sir Richard Southwood. He had been sent a preliminary (and in the event identical) set of recommendations following the meeting of the Biologicals Sub Committee at the beginning of November.</div>
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However, CSM recognised that it needed more advice from officials in MAFF about the veterinary aspects of their proposals. The Committee also felt that their recommendations were in the form of initial proposals and that these might need to be amended in the light of increased knowledge about the disease.</div>
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CRM and CDSM have been kept informed.</div>
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2.��� Since the CSM meeting, the Secretariats have been looking at the recommendations and seeking to implement them. During this time the following issues have become apparent.</div>
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i)���� MAFF have produced draft guidelines regarding the use of bovine material in veterinary medicines which will be put to the VPC at its meeting on the 19thJanuary.</div>
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ii) �� It was originally assumed that BSE was exclusively a UK problem. Officials from MAFF now suggest that this may no longer be the case and this has implications for the sourcing of bovine materials.</div>
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iii)��� CSM considered the problem in the light of a list of 43 products from our computer in which �bovine� was included in the description of active ingredients.</div>
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����������� You will be aware that the computer record cannot provide a complete list of all products in which bovine material has been used as excipient, or as an intermediate in manufacture. Such products would include vaccines and monoclonal antibodies.</div>
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����������� This poses a much greater problem since bovine albumin, foetal calf serum and bovine nutrient broths are extensively used in the production of most biological and biotechnological products and are used for all vaccines and in the production of most monoclonal antibodies.</div>
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3.��� Extensive discussions have taken place with officials from MAFF and there have been meetings between the Secretariats. There is agreement that we must keep �in step� particularly as MAFF is concerned about the safely (sic) of vaccines for animals. These are prepared in the same way as for humans and involve the use of foetal calf serum.</div>
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It is known that for sheep infected with scrapie there is a high concentration of the scrapie-like agent in the placenta. This means that very strict control must be given to the collection of foetal calf serum if the scrapie model is of relevance to BSE.</div>
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4.��� New recommendations for the collection of bovine material are to be discussed by the VPC this month. These recommendations will then be considered by the CSM, CRM, CDSM and their Sub Committees alongside the original recommendations made by the CSM, and their views will be sought on the period of implementation.</div>
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An amalgamation of the two sets of recommendations will mean a slight change in emphasis since the MAFF proposals concentrate upon the collection of the bovine material, whereas the initial CSM proposals were concerned more with the production of the medicinal product.</div>
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This would allow clarification of the definition of healthy cattle, and would give clear advice about the collection of foetal calf serum and bovine albumin. At the same time, the CSM will be asked to reconsider its third recommendation since this may be very restrictive (this was commented upon by Sir Richard Southwood in his letter of the 14th November to Professor Asscher).</div>
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5.��� It is proposed that DH Medicines Division and Medicines Unit of MAFF should agree a common set of guidelines about procedures for collecting and using bovine material. These will be published jointly in MAIL (the Medicines Act Information Leaflet).</div>
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In view of the uncertain information as to which products contain bovine material, companies will also be requested to supply details to MD.</div>
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MD and MAFF officials have arranged a working group (involving NIBSC and Biologicals Sub-committee) to ensure that the proposals will be practicable and capable of implementation over as short a time period as possible, and also should not damage the supply of important products such as vaccines and monoclonal antibodies for human use.</div>
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6.��� A particular problem which needs to be considered is that of products (vaccines in particular) which have been produced and are awaiting distribution. It has to be recognised that for some vaccines there may be supplies of up to 5 years.</div>
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It is clearly important to ensure each recommendation can be sustained without raising public alarm that could impair vaccination programmes.</div>
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7.��� The CSM recommendations are set out as Appendix A. The correspondence between Sir Richard Southwood and Professor Asscher are attached as Annex B and a draft of the proposed MAFF recommendations are attached as Annex C.</div>
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9.��� So far, neither Medicines Division nor MAFF have been given a sight of the interim report from Sir Richard Southwood and it would be most helpful if this could be made available.�[408]</div>
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348. Dr Jones, Mr Wilson, Mr Stewart, Dr Pickles, Dr Wood, Dr Rotblat, Dr Purves, Dr Little, Mr Kidd and Mr Bradley were copied in on this minute.</div>
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349. Dr Jefferys has commented that:</div>
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�All of these issues needed to be debated and required considerable technical expertise. They were not questions which admitted of simple straightforward answers; indeed this was leading edge science. It was felt that the guidelines which were eventually to be approved had to be capable of withstanding scientific scrutiny and possible legal challenge. The guidelines would have to be seen to be proportionate. If the eventual guidelines were clearly justifiable and practical the chances of universal compliance would be greatly increased.�[409]</div>
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350. On 13 January 1989 Mr Scollen, of the MAFF Medicines Unit, sent a minute to Mr Cruickshank.[410]� It said:</div>
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�Dr Little, Mr Kidd, Mr Taylor and I have discussed the progress of the review being undertaken by DH and MAFF experts of the implications of BSE for the safe production of vaccines and other biological health products. You may also like to be brought up to date.</div>
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2. Given the nature of BSE and the lack of symptoms during its long incubation period, there is a problem in ensuring that foetal calf serum and other bovine material used in the preparation of biological products is free of contamination. While there may be safeguards which can be introduced for the future, there is a potential problem over existing stocks of vaccine, most of which will have been produced using some kind of bovine material. (The risk, or at least the perception of risk, could, of course, go much wider as Mr Meldrum points out in his minute of 10 January to PS/Minister.)</div>
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3. Medicines Unit and DH�s Medicines Division have prepared draft guidelines, respectively, on the selection and treatment of bovine material and production processes using it. The plan now is to combine the two so that the two Departments are seen by the industry to be speaking with one voice, particularly on a matter where they are so interdependent. There is also further work to be done in order to judge the need for more extensive action. For example, there are questions about the availability of BSE � free material even if overseas sources are included, the means of controlling production of the serum etc supplied to licensed vaccine manufacturers and the relationship, if any, between BSE and Creutzfeldt-Jacob Disease. Attention may be drawn to this last point by the inclusion of BSE in the Zoonosis Order and the restriction on the disposal of milk from suspect animals.</div>
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4. While there is potentially a need for radical � and expensive action, it is, of course, quite possible that in the course of a few years we will be able to demonstrate the effectiveness of the action already taken to eliminate BSE. Extravagant action now to deal with a contingent risk could then seem to be wholly disproportionate. Moreover, new collection methods would not deal with the problem of existing stocks of vaccine, noted above.</div>
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5. These are some of the issues to be pursued at a further meeting with DH on 1 February, which will be attended by Professor David Tyrrell among others. They will also be in the background to the reply which Dr Little will be preparing to the letter he has received from Professor Southwood. (I understand from Mr Lawrence, however, that Professor Southwood�s report may well be quite general in its recommendations for action in this area.) In my own view the issues involved centre on an assessment of the risks associated with maintaining or disrupting the supply of vaccines for human health purposes. The issue is therefore one to be addressed first and foremost in the human health context, with MAFF advising on the availability of animal material considered free of contamination. Judgements about what is needed and feasible on the animal medicines front can be more readily taken afterwards. In addition to the meeting on 1 February, I shall be taking up these points with Mr Wilson and his colleagues when they visit Tolworth on 23 January.�[411]</div>
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351. This letter was copied to Mr Meldrum, Mr Little, Mr Kidd, Mr Suich, Mr Lawrence and Mr Taylor.[412]</div>
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352. On 17 January 1989 Dr Pickles sent a letter to Sir Richard Southwood.� She commented that Medicines Division �appear to be taking the potential problem with medicinal products seriously at last� and that Sir Richard�s �latest letter to Professor Asscher should help.�[413]</div>
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353. On 19 January 1989 the VPC met and considered their draft guidelines on veterinary medicinal products.[414]</div>
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354. On 26 January 1989 Professor Asscher responded to Sir Richard Southwood�s letter of 23 December 1988 (see paragraph 336 above). He said:</div>
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�Thank you for your letter of the 23rd of December, which unfortunately did not reach Medicines Division until the 12th January.</div>
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The Secretariat of the CSM and also of the CRM and CDSM have been considering the initial recommendations which my Committee made and have been seeking to implement these.</div>
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We originally considered the problem of BSE in the light of the 43 products which our computer database showed to include bovine material as an active ingredient. We will now need to consider the possible hazard from the use of bovine material as an intermediate in the manufacture of products. This will include the use of bovine material in nutrient broths, foetal calf serum and the use of bovine serum albumin. You will be aware that these materials are used very extensively in the production of most vaccines, monoclonal antibodies and other biotechnologically derived products.</div>
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MAFF are also concerned about such products and they have now produced new draft guidelines regarding the use of bovine material in veterinary medicines: these are currently under consideration by the Veterinary Products Committee.</div>
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Following several meetings between Medicines Division officials and their counterparts at MAFF, it is hoped that a joint guideline for the manufacturers of both human and veterinary medicines can now be agreed and published. Therefore a further paper is being produced for consideration by the CSM and its Sub Committees. We will be reconsidering whether our recommendation that ��the manufacturing processes are capable of eliminating the scrapie agent� is too stringent. It will also be proposed that the CSM uses the definition of a BSE-free herd which has been proposed by MAFF (you will remember that my Committee deliberately chose the words �appropriately certified healthy herds� to allow us the freedom to obtain more expert advice from our veterinary colleagues).</div>
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We have to consider the impact on the supply of these important products whilst at the same time seeking to maintain public confidence in the vaccination programme. Many vaccines are stored for up to 5 years before being released and this will therefore have to be considered.</div>
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For all these products it will be important to ensure that our recommendations are practicable and can be scientifically justified.</div>
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Finally, I want to reassure you that CSM intends to take appropriate action in regard of products within its remit and that CRM and CDSM are being kept fully informed of our recommendations. I hope you will agree that the Secretariats and the Committees are giving considerable attention to this important issue.�[415]</div>
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355. Professor Collee commented on this correspondence in his statement to the Inquiry:</div>
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�In general terms, my feeling is that Sir Richard, perhaps understandably, believed that we were not going to take certain action, which in fact we had intended to take all along. In every other respect, I regarded his comments as constructive and took them on board. By the time the guidelines were finalised, I believe that all of the points made by him had been addressed.�[416]</div>
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356. Dr Jefferys saw or was copied in on the correspondence between Sir Richard Southwood and Professor Asscher on 14 November 1988, 24 November 1988, 7 December 1988, 23 December 1988 and 26 January 1989.[417]� Dr Adams saw the 14 November letter, a draft of the 24 November letter, and the 23 December and 26 January letters.� Dr Rotblat saw the letter from Professor Asscher to Sir Richard Southwood of 26 January 1989.[418]</div>
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357. On 26 January 1989 the CSM held a meeting.[419]</div>
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358. On 26 January 1989 Dr Little replied to Sir Richard Southwood�s letter of 20 December 1988.[420]� He said:</div>
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�The Veterinary Products Committee had a very full discussion on BSE at their last meeting on 19 January when they considered a set of draft guidelines which had been prepared by the Biologicals Committee in consultation with various experts at the Central Veterinary Laboratory and elsewhere.� The VPC have requested further information including a full list of products involved, including all the old medicines, to assess the likely effect of various control measures and their practicality.</div>
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The Biological Committee has discussed BSE on a number of occasions over the past year and we have met with the National Office of Animal Health (who represent the Veterinary pharmaceutical industry) in July, November and January and have warned them of the need to introduce control measures to avoid possible problems with material which could to (sic) be contaminated with BSE, and we have also met many of the individual product licence holders.</div>
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Given the difficulty of detecting the BSE agent our philosophy in drafting guidelines for consideration by the VPC has been to concentrate on the source and nature of the materials used in the manufacture of veterinary products.</div>
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The experience with Scrapie has led vaccine manufacturers to avoid sheep material.� One way forward with the current situation would be to substitute tissues from other species where either cattle or sheep material is used but this would cause widespread disruption of supplies.</div>
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Another way forward would be to use cattle material from a presumed BSE free source.� Manufacturers are already turning to overseas sources and particularly Ireland but the discovery recently of BSE in Ireland indicates the problem which may arise from this method of control.� Moreover, the presence of exotic diseases rules out tissues and sera from many other countries. It might be possible to certify some herds in the United Kingdom as free from BSE in the future but it will be a long time before the full range of products used in the manufacture of biologicals from foetal calf serum to milk casein, could be derived from such sources.</div>
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Another way forward is to look at the constituents of each product and assess the risk.� In some cases substitution may be possible � i.e. the use of synthetic media for Clostridial vaccines rather than cooked meat broths or pig bile instead of ox bile.� In other cases such as ox brain for pituitary hormones we have already stopped the use, as synthetic hormones are widely available.</div>
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Foetal calf serum poses a problem in that it will be difficult to find an adequate substitute.� Although the risk is likely to be very low, some manufactures (sic) are looking overseas for supplies.</div>
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We are also working very closely with colleagues in the Department of Health to ensure we issue consistent advice to manufacturers.</div>
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I will send you a copy of our guidelines when the VPC approves them.</div>
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This certainly is a very serious problem and we look forward to seeing your report and any other advice you may care to offer.�[421]</div>
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359. This letter was copied to the CVO, Mr Cruickshank, Dr Watson, Mr Kidd, Mr Taylor, Dr Thornton, Mr Lawrence, Mr Wilesmith, and Dr Adams of Department of Health.[422]</div>
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360. On 30 January 1989 Sir Richard wrote to acknowledge receipt of this letter and commented that veterinary medicines posed an �extremely difficult problem.�[423]</div>
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361. On 1 February 1989 a small working party of MAFF and DH officials and experts met.This group was known as the �Human and Veterinary Medicines BSE Briefing Group (HVMBG)�. Those present were Drs Jefferys, Adams, Purves and Rotblat of DH Medicines Division, Dr Little, Mr Kidd and Mr Bradley from MAFF, Professor Collee, Dr Schild and Dr Minor of the Biologicals Sub-Committee of the CSM, and Dr Pickles representing the Southwood Committee Secretariat.[424]</div>
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362. The meeting agreed the text of what were now to be joint VPC/CSM guidelines for product licence holders and manufacturers plus a timetable for clearance by various advisory committees to enable publication in MAIL (Medicines Act Information Leaflet) before Easter.[425]</div>
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363. Dr Purves has commented:</div>
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�At that time we were very much aware that the Southwood Working Party was shortly to report on its findings.� We would have wanted to await the report from the Southwood Working Party before approaching the industry.�[426]</div>
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364. Dr Jefferys has also said:</div>
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�I am sure that it was also felt that the questionnaire should be issued at the same time as the guidelines were sent to companies for a number of practical reasons. It was felt that neither guidelines nor a questionnaire were likely to be appropriate until the Southwood Working Party had provided an authoritative assessment of risk.�[427]</div>
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365. On 2 February 1989 Mr Scollen minuted Mr Cruickshank about BSE and Biological Medicinal Products. The minute reported on the main conclusions of the 1 February 1989 meeting of the HVMBG, which Mr Scollen had attended. The minute noted[428]:</div>
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�3.�� The Working Group (as it is now termed) agreed:</div>
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i).��� on the text of joint MAFF/DH guidance for manufacturers;</div>
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ii).�� a timetable for their clearance by advisory committees and publication in MAIL before Easter;</div>
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iii).�� that further action especially on current stocks of the affected products, should be determined once the scale of the problem has been more precisely identified with the help of manufacturers;</div>
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iv).� that any such action would need to be based on a human health risk/benefit assessment.</div>
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The revised guidelines will be put to the VPC on 16 February, following a previous full discussion in the Committee on 19 January</div>
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�</div>
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5.��� The Working Group was also shown an extract from the current draft of the Report. There was general dismay at the drafting, which tends to highlight the (theoretical) risk via medicines and to relegate the qualification that the risk is remote. The paragraphs concerned also imply (mistakenly) that numerous, licensed human medicinal products are affected; that some but not all manufacturers have taken necessary action; that various safeguards could readily be introduced into the production and processing of bovine material; and that the Licencing Authority and its advisory committees need to have their attention drawn to the problems.</div>
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6.��� The Working Group felt that much of this was, at best, misleading. For example, many manufacturers have been alerted to the problem but there is no reason to believe that they are in a position to take effective, unilateral action. Moreover, the start of MAFF/DH work on the issue comfortably pre-dates the Southwood Committee.</div>
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7.��� Even if the Report is modified in the light of these reactions, its appearance seems likely to trigger a need for a major public relations job which takes full account of the medicines angle. Consistency between MAFF and DH will be essential and should be achievable. The guidelines themselves could subsequently generate similar pressures since they clearly do not address the issue of current stocks and they could prompt questions � for example � on the standards applicable in the collection of animal material at slaughterhouses for biological medicinal purposes.</div>
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8.��� While I have no doubts about the Working Group�s staged approach and the balance being struck between risks and benefits to human health, this will not be the easiest position to present to a potentially critical public prone to see the influence of commercial interests.�</div>
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366. Mr Meldrum, Dr Little, Mr Suich, Mr Coe, Mr Kidd, Mr Bradley and Mr Taylor were copied this minute.</div>
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Southwood Committee: fourth meeting</div>
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367. On 2 February 1989 Dr Pickles wrote a letter to Sir Richard Southwood. She stated the following:</div>
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��I attended yesterday a meeting of experts from both the VPC and Biols CSM together with DH/MAFF officials. I can give a full report tomorrow. They expressed concern at the proposed wording in the report (which I informed them about at the meeting in confidence). As Professor Asscher attempted to explain in his letter of 26 January the problem is very involved. They have now realised that virtually none of the current essential human or animal vaccines could comply with the CSM guidelines as agreed by their November meeting, and there may be several years of some vaccines in stock to make matters more difficult. Public confidence in the vaccination programme must not be put in jeopardy and yet supplies of some vaccines are very limited. After a late start, it now seems that both human and veterinary sides of the medicines business are working together and putting together a package of measures that seem sensible and workable (and indeed now incorporate all the points you raised with Professor Asscher in your earlier letters, and which I had raised with them separately). The attached note from a colleague of mine to our Deputy Chief Medical Officer gives some of the details. I can give more tomorrow. You might also find it useful to give a ring to Professor Gerry Collee, in Edinburgh �. He is Chairman of the Biologicals subcommittee (and also on a vaccination subgroup) and was present at yesterday�s meeting.</div>
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If you are content that all is now in hand, a briefer version of 5.3.3 might be adequate. I attach my suggestions. This treats CSM/VPC like HSE: ie the problem has been referred to the body with the statutory responsibility in that area and it is then for them to take appropriate action. I also have suggestions for minor alterations to the summary sections to make it clear that the Licensing Authority has already started addressing the problem.�[429]</div>
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368. A handwritten note was written at the bottom of the page[430]:</div>
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�Since writing this we have discussed on the phone and it seems that the problem is resolved.�</div>
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369. On 3 February 1989 the fourth meeting of the Southwood Committee took place and was recorded in an informal note by Dr Pickles on 6 February 1989.[431] Correspondence between Professor Asscher, Dr Little, Mr Andrews and Sir Richard Southwood was considered. Amongst the other items mentioned were the following:</div>
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�6.��������� Draft Report</div>
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The report was considered page by page and numerous minor alterations and corrections were made. The most significant changes were:</div>
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�</div>
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(iv)� The section on medicinal products was shortened substantially to give no details of changes that might reduce risk, since the statutory responsibility in this area lay with the Licensing Authority [Dr Pickles was able to report on the very satisfactory response now being taken by both the human and veterinary sides of the Licensing Authority, but also explained the potentially grave problems to supply of essential vaccines if fetal calf serum were to be considered at risk of being infected]�</div>
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Prelude to publication of the Southwood Report</div>
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370. On 9 February 1989 the CMO minuted Dr Harris, the DCMO, in the following terms:</div>
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�My attention has been drawn to a sentence in Dr Pickles� draft of a submission to the Secretary of State on this matter. It reads: �At the present time we can�t give any complete guarantee of safety for human medicines that use bovine materials in manufacture such as most vaccines.� Having looked at the report I am not able to find any statement which supports this statement of concern. I have, however, therefore spoken to Dr Pickles on the telephone and she reports to me that for some considerable time she has had serious concern about the safety of bovine-based vaccines in the light of the fact it has been discovered that contamination with placental material (which is known to be heavily infected with the BSE particle) is a distinct possibility in the preparation of material for human vaccines derived from foetal serum. This matter as described to me by Dr Pickles gives me sufficient cause for concern to ask you to look into it urgently together with Medicines Divisions. I shall amend the submission to indicate that the question of the safety of vaccines derived from bovine material is a matter which has not been dealt with directly by Southwood�s group, but is one in which I am making urgent enquiries.�[432]</div>
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371. Commenting on this letter during his oral evidence to the BSE Inquiry, the CMO said that this intervention was� �[q]uite contrary to my normal practice� and that he was �trying to stir up more activity in the Medicines Division�. He did not think that the issue had been resolved despite past reassurances.[433]</div>
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372. The draft submission, referred to by the CMO in his minute of 9 February 1989, was written by Dr Pickles.[434] In relation to medicines it stated:</div>
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�Sir Richard Southwood is here presenting his report on bovine spongiform encephalopathy jointly to MAFF and DH ministers.� I can commend this report to you.</div>
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3. In Sir Richard�s view the risk to human health is minimal.� Nevertheless he has alerted the Licensing Authority and the Health and Safety Executive to potential problems in their areas of responsibility.� At the present time, we cannot give any complete guarantee of safety for human medicines that use bovine materials in manufacture, such as most vaccines.� However, appropriate action is being taken by Medicines Division following advice from Committee on Safety of Medicines, the Committee on the Review of Medicines and the Committee on Dental and Surgical Materials and defensive briefing is being prepared for when the report becomes public.</div>
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�</div>
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��������������������������������� E D ACHESON�</div>
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373. On 9 February 1989 the Southwood Report was presented to the Secretary of State for Health by the CMO.[435]� Sir Donald recommended the Report� �I regard it as a thorough study of the problem with sound and balanced conclusions. I recommend that it should be published as soon as possible.�[436]� On medicines he wrote,� �I am...putting work urgently in hand to satisfy myself that everything possible has been done to ensure (summary paragraph 10.5) that transfer of the BSE agent in human and veterinary medicinal products does not occur.�[437] The CMO said of the Southwood Report in his oral evidence to the BSE Inquiry:</div>
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�I thought it read extremely well. I thought it was a good report and I said so to Ministers. I also remember saying to Ministers that I had one thing I need further information on and that is biologicals.�[438]</div>
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374. On 10 February 1989, Dr Adams sent the draft BSE guidelines to some staff in his division, MB3B.[439]</div>
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375. On 13 February 1989, Dr Adams sought comments on the draft joint VPC/CSM guidelines from his staff and Miss Hepburn of MB5A.[440]</div>
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376. On 13 February 1989 an internal meeting was held in Medicines Division. Present were Dr Adams, Mr Hagger, Dr Purves, Dr Rotblat, Mr Sloggem, Mr Bewley, Mr Love and Mrs Alderman.[441] The minutes note that the meeting was held because of the CMO�s concern regarding the Southwood Report which had by then been submitted to Ministers. The Report posed the questions �are medicines safe� and �are there any guarantees�. At the meeting it was agreed that children�s vaccines would be identified and that Medicines Division would find out from the companies concerned: whether the products contained bovine material; the source of the bovine material; what bulk stocks of vaccines were available; and how long it would take to switch to another product. In addition, a working group was to be established.</div>
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377. Dr Rotblat said in her statement to the Inquiry:</div>
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�The action which I was asked to undertake was telephoning the pharmaceutical companies concerned and contacting Dr Tyrrell, whom it was hoped would become a member of the working group.�[442]</div>
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378. In his Statement to the Inquiry Dr Adams said the following about the same meeting:</div>
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�On 13th February 1989, a meeting was held in response to recent concern which the CMO had expressed in the light of the Southwood Report (minute 9th February 1989 to Dr Harris). I believe that as Dr Jefferys was away on 13th and 14th February, I took the lead on this occasion in his absence. It was agreed at the meeting that:</div>
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i.)��� Children�s vaccines and the companies manufacturing those vaccines would be identified;</div>
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ii)��� Information concerning the bovine material within those vaccines, the source of that material, the bulk stock of vaccines post 1980 and additionally the length of time it would take to switch to another product would be sought;</div>
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iii)��� That a working group would be established to consider the Southwood Report and the paper to CSM. The proposed membership of the group was Professor Collee, Dr Tyrrell, Dr Kimberlin, Dr Minor, Dr Schilds, Dr Martin, Dr Pickles and various MAFF representatives.�[443]</div>
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379. On 13 February 1989 Mr Lawrence distributed a minute to PS/Mr John MacGregor, Miss Phillips, Mr Gueterbock, Mr Smith, Professor Bell, Mr Cruickshank, Mr Meldrum, Mr Crawford, Mr Wentworth, Mrs Attridge, Drs Crossett, Watson and Little, Mr Myers, Mr Coe, Mr Suich, Mr McKinley, Mr Scollen, Mr Wilesmith, Mr Griffiths and Mr Alderton[444]. Attached was a brief for a meeting between the Minister and Sir Richard Southwood the following day, 14 February 1989. This note underlined the fact that the Working Party had concluded in paragraph 8.2 of their report that the risk of BSE transmission through the use of medicinal products was remote, but that various medical committees should be alerted.[445]</div>
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380. The brief stated the following:</div>
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�11. The Minister should note, however, that the [draft] guidelines [to be issued to all manufacturers of medicinal products] represent a counsel of perfection:</div>
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i).��� Guidance 1, on the use of defined, BSE-free sources, will be severely restrictive.� A number of farms in the UK will meet these criteria but they have not been identified; farms overseas ostensibly meet the criteria but we cannot be sure that non-detection of BSE in all cases equates with freedom from the disease.� Moreover, many countries are unsuitable sources of medicinal material because of other, endemic diseases.� New Zealand, and possibly Australia, appear the safest sources, but their supply is unlikely to match demand.</div>
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ii).�� Most pharmaceutical companies buy from specialist producers of primary and intermediate material, whose activities lie outside the powers of the Medicines Act.� Product licence holders, who are responsible for the quality of their products, would therefore need to secure assurances from their suppliers that the guidance is being respected.� This might pose problems in a minority of cases and if serious doubts were to be raised about the quality of any product we could withdraw its licence.</div>
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iii).�� Guideline 4, on collection techniques, conflicts with normal practice is (sic) abattoirs, where most material is obtained.� This is unlikely to matter if reliable BSE-free sources are used, although a risk of cross-contamination might remain.</div>
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iv).� The sterilisation treatment recommended in Guideline 5 is generally inappropriate to biological medicines � which it would destroy � but would be suitable for some tools and equipment.�[446]</div>
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381. On 14 February 1989 a meeting was held between the Minister for Agriculture, Fisheries and Food, and Sir Richard Southwood �to discuss the recommendations in the Working Party report, timing of publication, and handling.�[447] Also present were Mr Thompson, the Permanent Secretary, Mr Meldrum, Mr Cruickshank, Mr Lawrence, Dr Watson, Sir Donald Acheson (CMO), Dr Pickles and Mr Smith. Sir Donald said that there would be a special Working Party meeting on 22 February 1989, comprising people knowledgeable in biological and pharmaceutical areas to consider the implications for medicinal products. The CMO continued that it was hoped that this meeting would offer some reassurance on this area. He said it would be wise to delay publishing the Report until after this meeting. Sir Richard said �we were dealing with �probabilities� rather than certainties� in this area, and that made it difficult. In his opinion, care should be taken when sourcing medicinal material from any country with a significant sheep population and where sheep material might be fed to cattle. Mr Meldrum pointed out that this issue was extremely complex: some countries might be ostensibly BSE-free while having an underlying problem with the disease in a sub-clinical form in their animals. It was agreed to await the outcome of the 22 February meeting to be clear on this issue.</div>
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382. On 14 February 1989 Dr Adams attended a meeting with Drs Rotblat and Purves, Mr Hagger, Mr Sloggem, Mr Bewley and Mrs Alderman.[448] �The purpose of the meeting was to discuss the action agreed on vaccines at the internal Medicines Division meeting the previous day.</div>
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383. On 14 February 1989 Dr Adams minuted Dr Harris about the information received on human vaccines in response to telephone inquiries. It stated:</div>
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�Vaccines</div>
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We have contacted all the major vaccine product licence holders whose products are likely to be used in children.� Many manufacturers use bovine material.� As can be seen, this information is diverse and incomplete.� Each company stressed that they could not give an accurate assessment without detailed researches, given the complexity of sourcing/purchasing arrangements.</div>
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All the licences are detailed in appendix 1; the overview is as follows:</div>
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1.��� D have polio, measles, mumps, rubella, rotavirus vaccines.� All use bovine serum from a UK source and bovine commercial product from unknown source.� Some agent comes from the USA and New Zealand.</div>
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2.��� I gave most information (see Appendix 2).� All their vaccines apart from yellow fever, cholera and typhoid contain bovine material:</div>
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Oral polio; up to 1988, foetal calf serum was used from UK and New Zealand (pooled); since 1988 foetal calf serum only from New Zealand.� Large� stocks are held.</div>
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Rubella; bulk was made before 1979 from foetal calf serum from UK and New Zealand.� None has been made as there are some 15 years stock.</div>
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Diphtheria; UK bovine beef muscle and ox heart is used but since the end of 1988 this has been sourced from Eire.� There are 1,250 litres of stock.</div>
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Tetanus; this involves bovine material from UK mainlyScottish.� There are 21,000 litres of stock.</div>
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Pertussis; uses bovine material fromthe UK.� There are 63,000 litres of stock.</div>
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They consider that to switch to a non-UK source will take a minimum of 6-18 months and to switch to a non-bovine source will take a minimum of five years.</div>
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3.��� E have measles, mumps, MMR, rubella vaccines.� These are sourced from the USA and the company believes that US material only is used.</div>
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4.��� J have a measles vaccine using bovine serum from the UK.� There are 440,000 units of stock.</div>
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-����� They have also got MMR using bovine serum from the UK.</div>
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5.���� K have influenza, rubella, measles, MMR vaccines likely to be used in children.� Of those they think that only MMR contains bovine material which is probably a French origin.</div>
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6.��� L have diphtheria/tetanus and pertussis on clinical trial [redacted]; These use veal material, some of which has come from the UK and has been made by I (see above).</div>
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7.��� M have influenza vaccines which are made up in egg medium.</div>
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8.��� The Secretary of State has a number of licences.� We understand that the inactivated polio vaccine is no longer being used.� There is a stock of smallpox vaccine.� We have not been able to determine the source material.� (Made in sheep very unlikely to certain bovine ingredients).</div>
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9.��� N have acellular triple vaccine in which I material of UK bovine source has been used.</div>
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As far as I can see I are the sole supplier of pertussis vaccine which uses bovine casein digest.</div>
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You should also be aware that DH has made arrangements for meningococal vaccine to be available, on a named patient basis, from D and K.� Both companies use bovine media in production.�[449]</div>
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Dr Adams also set out details of forthcoming� expert group meetings (VPC, Human and Veterinary Medicines Working Group, and CSM).</div>
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384. On 15 February 1989 Mr Wilson minuted Mr Hagger,[450] and said:</div>
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�I spoke to Dr Harris today about our intention to send copies of the Southwood report to the members of the Collee group and to CSM for their respective meetings next week. We will be stressing the sensitive confidential nature of the report and associated papers. He is content that this action is necessary if the group and CSM are able to give us their best advice. You may accordingly assume that we have his authority for this action.�</div>
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385. On 15 February 1989 Mr Hagger minuted Mr Cunningham, Dr Salisbury, Mr Burton and Mr Dudley, with copies circulated within MD, to alert them to recent developments on BSE as they affected medicines and to invite representatives to the meeting on 22 February.[451]</div>
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386. On 15 and 16 February 1989 the VPC met. They considered revised joint CSM/VPC guidelines. Also attached for members� information were copies of correspondence between Dr Little and Sir Richard Southwood.� The minutes record the following:</div>
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�18.2 Members made the following comments on the guidelines at VPC(89)38:-</div>
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1).�� Members asked for clarification of paragraph 4a.� It was explained that under the BSE Order, the head had to remain intact.� Clarification was provided on the methods of slaughter that could be allowed</div>
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2).�� It was considered that subject to CSM advice, pancreas should be included at paragraph 3.� (�Tissues excluded�), and this paragraph could apply to material of other species not just bovine origin.</div>
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3).�� It was considered that paragraph 4c should be expanded to exclude animals fed ruminant derived protein.</div>
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4).�� With reference to paragraph 2, it was considered that in practice it could not be guaranteed that animals had not been fed rations containing ruminant derived protein.</div>
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5).�� It was considered that bovine serum albumin should also be included in paragraph 4e.</div>
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6).�� Members also asked for clarification about the recommendation to use calves under 6 months of age.</div>
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18.3 Officials noted members� comments and subject to the above comments the Committee agreed VPC(89)38.�[452]</div>
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387. On 17 February 1989 Mr Cruickshank minuted Mrs Stagg (PPS/Minister) with copies to Mr Guterbock, Mr Smith, Professor Bell, Mr Hadley, Mr Capstick, Mr Meldrum, Mr Wentworth, Mrs Attridge, Mr Myers, Mr Coe, Mr Suich, Mr Scollen and Mr Lawrence. The minute attached a draft paper for MISC 138, together with a draft announcement and Q&A brief.[453] Paragraph 8 of the draft paper said that the (Southwood) Report recommended that the attention of those involved in the licensing of medicines should be drawn to the emergence of BSE. Reference was made to the guidelines shortly to be issued to the pharmaceutical industry. Questions 5 � 10 of the Q&A brief attached to Mr Cruickshank�s minute addressed the issue of medicines.</div>
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388. Also on 17 February 1989 Mr Bewley circulated a list of questions on BSE and medicinal products within DH with the aim of providing a question and answer briefing to DH and MAFF ministers.[454]</div>
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389. On 19 February 1989 Professor Collee wrote to Dr Jefferys. He acknowledged the receipt of a copy of the Southwood Report on 10 February 1989[455].� He said� �I appreciate that the aim of Wednesday�s meeting of the Briefing Group is primarily to agree advice to CSM on 23.2.89�.� He also outlined a possible line of inquiry asking,� �Is there any evidence of an increased incidence of encephalopathic syndromes or CJD-like disease in patients who have been given bovine insulin from the early 1980�s?�� He went on to say,</div>
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�The object of such a model would be to seek justification for the reassuring public stance that many other considerations justify at this stage in our certain appreciation of the benefits of vaccines and other products , and our uncertain assessment of BSE as a real hazard to man.�</div>
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Professor Collee also stated:</div>
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�In relation to our consideration of particular product groups (item 3), there is some urgency to identify vaccines that have clear associations with bovine materials in their production. This especially applies to live vaccines that are processed gently.� It may not apply to heparin which is thermostable, but I suspect that bovine insulin also merits special consideration.�</div>
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390. Prior to the meeting of the HVMBG on 22 February 1989, Mr Sloggem prepared a briefing note for Professor Collee. The note covered the issues concerning BSE as they related to medicinal products, taking account of what was in the Southwood report.[456]</div>
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391. On 22 February 1989 the HVMBG met for the second time to consider medicines in the light of the Southwood Report and to give advice to the CSM which was due to meet next day.[457]� The minutes of the meeting record the following:</div>
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�Present:</div>
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Biologicals Sub Committee:��� Professor Collee (Chairman), Dr Minor, Dr Schild</div>
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Invited Experts: Professor Asscher, Professor Sir J Badenoch, Dr Kimberlin, Dr Martin, Professor Rawlins,</div>
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Department of Health Medicines Division: Dr Adams, Mrs Alderman (Secretary), Mr Bewley, Mr Hagger, Dr Jefferys, Mr Love, Dr Purves, Dr Rotblat, Mr Sloggem</div>
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Department of Health (Other): Dr Burton, Mr Colman, Mr L Wilson, Ms Nash, Dr Pickles, Dr Salisbury</div>
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MAFF:� Mr Bradley, Mr Kidd, Dr Little, Mr Scollen, Mr Wilesmith</div>
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Apologies for absence were received from Dr Tyrrell and Dr Sutton</div>
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1.���������� Information Exchange</div>
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1.1 It was thought that the Southwood Report would be published 24.2.89, when a press conference would be held, attended by CMO, CVetO, Sir Richard Southwood, and possibly representatives from MAFF.</div>
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1.2 The Southwood Committee considered that the most likely cause of BSE in cattle was feeding with protein derived from scrapie infected sheep. Although man has eaten scrapie infected sheep for many years, no incidence of BSE has been reported in humans. Because of the lengthy incubation period, no cases of BSE have been seen in humans arising from bovine sources and the Southwood Committee were of the opinion that cattle will prove to be �dead-end� hosts for the BSE causing agent, and it is unlikely that this (sic) will be any implications for human health.</div>
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1.3 Because of the above, clarification is needed on the acquisition of BSE by cattle via the oral route, which by analogy with scrapie is relatively inefficient. Although it is probably the primary route in cattle, there may be special factors involved, damage to the gut from roughage, causing an �injection� of BSE. It was felt that the oral route need not be of undue concern at this stage.</div>
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1.4 The slight theoretical risk of BSE being transferred to humans was considered to be more likely from products used parenterally by implantation than by the oral route. The implications of this for the vaccination programme (vaccines using bovine ingredients in manufacture) could be very serious and result in epidemics if public reaction turned against vaccination.</div>
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1.4�� The annual incidence of BSE in the UK at 31.12.88 was cited and represents 1 case per 1000 adult cattle (total population 4 million) but cases have not occurred uniformly throughout the UK.</div>
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1.5�� Despite the research and investigative studies already carried out on BSE, the cause of the relatively recent appearance of the disease in cattle has not been established and it may be the result of a mutant strain of scrapie being transmitted by the feedstuffs. There is a need for more research into BSE and a consultative research committee chaired by Dr Tyrrell has been set up to carry research initiatives forward.</div>
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2����������� CSM paper</div>
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2.1�� Joint proposed DH/MAFF draft guidelines</div>
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2.1.1 Draft guidelines covering all products licensed under the Medicines Act for human or veterinary use, for use parenterally in the eye or on open wounds and the source of bovine materials used in their manufacture had been drawn up.</div>
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2.1.2 Normally, in matters where there is as little knowledge as there is in the case of BSE, CSM would have been advised to take no action but to monitor the situation. Due to the publication of the� Southwood Report, this option is not open. It is not feasible to go to consultation with industry on the matter due to lack of time and the fact that this might be seen as our being led by industry. VPC had given broad approval to the draft guidelines.</div>
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2.1.3 The guidelines themselves were discussed. These are to be seen as a �gold standard�, and may be modified in the light of experience. It is intended that they should be parallel with those issued on the veterinary side, but not identical because they have more difficult problems to handle (BSE being a speculative hazard in man).</div>
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2.1.4 It was agreed that it would be better to try to eliminate BSE at source. The possibility of the identification of risk-free herds and their certification was discussed. Ideally, bovine materials obtained from calves should be taken from animals less than 6 months old, which have not been fed on ruminant-derived protein. The question of �BSE � free� countries was raised, but there are other pathogens which also need to be taken into consideration in selecting a source.</div>
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2.1.5 It was felt that to issue rules on oral products would challenge our concepts on foods, and cause problems with regard to gelatin capsules. The guidelines are a balance between flexibility and standards of ideal practice, and an attempt has been made to major on the question of source.</div>
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2.1.6 VPC had expressed anxiety about animal vaccines, and it was felt that in future we may need to ensure that bovine ingredients are not obtained as by-products of abattoirs. The possibility of herds being maintained specifically for this purpose was mentioned.</div>
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2.1.7 The question of excluded tissues was discussed. In the case of the intestine, this would eliminate heparin (although most of this is porcine sourced) and catgut. It was felt that the pancreas should not be excluded as this would eliminate bovine insulin.</div>
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2.1.8 The section headed �sterilisation� was clarified to refer to equipment used in production, and not to products themselves.</div>
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2.1.9 Anxiety was expressed over problems with availability of supply of vaccines if companies could not comply with the guidelines, as failures of supply could lead to epidemics. Drs Adams and Rotblat had, at the request of the CMO, contacted companies holding licences for vaccines, asking for information on the use of bovine ingredients. Most of the companies were aware of the problems of BSE and some have begun to take action. It was felt that most companies would welcome guidelines on this subject.</div>
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2.1.10 The question of unlicensed products involving bovine ingredients was raised. These are not subject to the Medicines Act and are controlled by Supplies Technology Division. Some preliminary screening of these products has taken place, and PD will follow the lead of CSM and issue similar guidelines.</div>
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2.2 Letter to licence holders</div>
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2.2.1����� The draft letter was discussed. MAFF and Department of Health are sending letters separately, those sent by MAFF being S.44 letters.</div>
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2.3 Questionnaires</div>
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2.3.1����� The background to the need for data was discussed, the problem at present being that we cannot identify products using bovine ingredients during the manufacture. The intention is to develop a full database of the use of bovine ingredients in human medicines, and companies will be asked to respond to the questionnaire by 1st May 1989. The questionnaire was seen to be adequate.</div>
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3.������������ Consideration of particular product groups</div>
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3.1��� Product groups likely to use bovine ingredients were listed and assessment of the theoretical risk involved in the use of vaccines and products in the other groups is required.</div>
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4.������������ Proposal for a Working Group on BSE</div>
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4.1��� It was agreed that a Working Group, associated with the Biologicals subcommittee should be set up, and a proposal of this was to be made to CSM. Suggestions for a core membership were made with other experts being brought in as needed.</div>
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5.������������ Form of statement and briefing for press</div>
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5.1��� The draft prepared by Medicines Division was discussed, and some amendments suggested.</div>
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6.������������ Other business</div>
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6.1��� Dr Burton asked to be kept informed as to CSM decisions, and also requested that a letter, guidelines and questionnaire be sent to him as holder of the Secretary of State licences.�[458]</div>
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Attached to the minute of this meeting was a template to be utilised in assessment of vaccines entitled �Medicinal Products Using Animal Matter�.[459]</div>
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392. Dr Purves notes in relation to point 2.1.3 that:</div>
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�I think that was an important point.� Although a considerable amount of work and thought had gone into the guidelines, as we had such a limited knowledge of BSE, it would necessarily follow that as the pool of knowledge became greater the guidelines may have to be amended.�[460]</div>
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393. Point 2.2 above refers to a draft letter.� A copy of a document headed �Draft Letter to Product Licence Holders.� Concern about BSE in Human Medicines� [thought by the Inquiry to be the draft referred to] reads as follows:</div>
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�Bovine Spongiform Encephalopathy (BSE) is a disease of cattle characterised by degenerative neurological changes culminating in the death of the animal.</div>
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Although there is no evidence to suggest that BSE may be transmitted to man, the Licensing Authority considers it prudent, having taken expert advice, including that of CSM and VPC, to advise that all manufacturers whose products contain bovine material should conform to a set of guidelines.� A copy of these is attached to this letter</div>
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BSE was made a notifiable disease in 1988 (under the Animal Health Act 1981).� It is therefore important that the Licensing Authority has completely up to date information on the use of animal tissues in the manufacture of medicinal products.</div>
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Accordingly I am writing to request information about all products which (sic) animal material has been used:��������� a).� as an active constituent�������������������������������������������������������� ������ b).� as an excipient�������������������������������������������������������������������������������� c).� during processing or manufacture</div>
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The information required is:</div>
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Company Name ������������������������������������������������������������������������������</div>
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������ PL/CTC/CTX Number and Product Name</div>
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������ Animal Ingredient (eg tissue, blood, etc)</div>
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Animal Species (eg bovine)</div>
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������ Purpose of inclusion (eg active, excipient, in-house use)</div>
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Country of origin of collected material</div>
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Does this product conform to the guidelines at present?</div>
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If not, over what timescale do you intend to apply the guidelines to this product?</div>
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What are your stocks of this product at present?</div>
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What is the anticipated utilisation of this product?</div>
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Information on each medicinal product must be submitted on a separate A4 form as attached.</div>
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This information should be addressed, for human medicines, to : The Information Room at Market Towers, by 1 May 1989.� Any professional enquiries should be made to Dr Rotblat (medical) Ext. �, and Dr Purves (pharmaceutical) Ext. �.�[461]�</div>
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The letter was to be signed by Mr Hagger</div>
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394. As a result of the meeting, and the CSM�s endorsement of its conclusions, the BSE Working Group, chaired by Professor Collee, was set up. Its terms of reference were� �To advise the section IV Committees on the implications of BSE to human medicinal products.�[462]</div>
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395. In a Statement to the Inquiry Dr Martin commented on the Statement of Sir Richard Southwood. About the second meeting of the HVMBG he said[463]:</div>
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�You may recall that I attended, on behalf of the Working Party, a meeting of the �Human & Veterinary Medicines Briefing Group Re. BSE� chaired by Professor Gerry Collee on 23.2.89. I was left with the impression that those on the human medicine side regarded BSE as an animal problem and that we, on your Working Party, were being excessively apprehensive. Your correspondence with Professor Asscher (Nov./Dec./Jan. 98/99) illustrates this. Because of our Report the health authorities found it necessary to take action.�</div>
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396. Dr Kimberlin also commented on this meeting in his Statement to the Inquiry:</div>
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�On 22 February 1989, just before the publication of the �Southwood Report�, I attended a meeting to advise on the Proposed Joint CSM/VPC Guidelines for Industry�with regard to medicinal products. Several meetings followed over the next few years.�[464]</div>
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397. On 22 February 1989 Miss Duncan minuted Dr Metters. Copies were sent to Drs Pickles, Sutton and Hoxey, Mr Luxton, Mr Allen and Mr Burton. This minute said, �As you will know from Dr Sutton we only became aware of the Southwood Report on Friday and it is clear that those compiling the report were unaware that there are a large range of unlicensed medical devices made from or containing material of bovine origin�, and that �from a public relations aspect the report does not draw attention to devices except for one reference to surgical implantation�. She went on to say that the majority of such products were manufactured in the USA, and continued:</div>
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�3.�� Irrespective of what public reaction, [sic] we may anticipate it is clear that the Department needs to take action to complement that which will be taken by Medicines Commission for licensed products.</div>
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4. As soon as we were aware of the possible implications we prepared a provisional list of devices which from our Manufacturer Registration data and from individual specialist knowledge we know to contain animal origin material. A copy of that list will be made available as soon as possible.</div>
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5. If you agree we would propose to follow whatever action CSM takes with a similar formal letter/questionnaire and consultative guidance (a) by facsimile to UK companies known to use bovine materials and (b) by post to all medical device companies making products which could conceivably include animal materials. The majority are in the USA.�[465]</div>
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398. On 23 February 1989 Dr Richardson minuted Miss Duncan about Medical Devices of �Animal� origin. He noted that �Distinct types of areas appeared, eg �heparin� coated disposables, heart valves etc and have therefore been divided into categories as indicated.� The issue of sterilisation was also mentioned.[466]</div>
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399. On 23 February 1989 Dr Metters replied to Miss Duncan�s minute of 22 February 1989, copies to all previous recipients. Dr Metters agreed that manufacturers of unlicensed medical devices with material of bovine origin should receive similar guidance and questionnaires to those the CSM were to give to manufacturers of licensed products. Dr Metters also noted the fact that sterilisation of products containing bovine material was one of the central uncertainties of BSE: nobody knew how infective it was, or of its potential to cross the species barrier. He advised that Dr Pickles should be kept closely informed on the subject of unlicensed medical devices.[467]</div>
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400. On 23 February 1989 the CSM met[468] and fully endorsed the proposals of the HVMBG. This meeting was summarised in a minute from Mr Hagger to Dr McInnes, Private Secretary to the CMO.[469] This said the following:</div>
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�1.�� The Committee on Safety of Medicines (CSM) considered the Southwood Report and its implications for human medicines at its meeting on 23 February, and agreed with the Southwood Working Party that the risk to man of infection via medicinal products is remote.</div>
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2. Before reaching this view the Chairman of the Committee on the Review of Medicines (CRM) and the Committee on Dental and Surgical Materials (CDSM) had been consulted. In addition, the CSM received a report of views expressed at a special meeting to discuss the subject held the previous day which was attended by representatives of CSM, other experts and officials from DH and MAFF (names at Annex A).</div>
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3. An agreed statement by CSM, for use if required, is at Annex B. It was agreed that no special action was required on any existing products although the CRM is due to consider very soon a number of �old� products using bovine materials. More information was needed from manufacturers and it was planned that the licensing authority would write, within the next 2 weeks, to all licence holders for relevant details. A copy of the draft letter and questionnaire in respect of human medicines is at Annex C. (As there are considerably fewer veterinary products, MAFF will be following a slightly different means of contacting their licence holders.)</div>
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4. The CSM and the Veterinary Products Committee have agreed on guidelines for good manufacturing practice which the licensing authority plan to send to licence holders at the same time as they write for information. The guidelines are intended to assist in strengthening the development of good manufacturing practice for the future, where animal materials are used (Annex D).</div>
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5. The CSM also decided to establish a special working party to advise it on this subject. Terms of reference and the names of the proposed core membership is at Annex E. Three members are also members of the Tyrrell Research Committee referred to in Southwood including Dr Tyrrell.</div>
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6. General agreement was expressed during the meeting on the urgent need for research in order to fill the current gap in information.</div>
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7. Professor Asscher is on standby in case press and other interest was such as to require comment by a CSM spokesman (although the Press Office would continue to be the first line of approach).</div>
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8. A short list of Qs and As are attached at Annex F. A fuller list will be ready tomorrow.�</div>
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401. Paragraph 8 of the minutes of the CSM meeting deal with BSE as follows:</div>
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�8.1 The Committee noted tabled paper VI.</div>
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The Chairman gave a brief history of the background of this issue.</div>
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Professor Collee reported in detail on a meeting held the previous day, which included representatives of DH, MAFF and invited experts to consider the implications of the Southwood Report to human medicines.� Issues considered, included transmission by parenteral and oral routes, and tissues to be excluded from human medicines.� The minutes of the meeting are at annex D.</div>
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The Committee then considered the following in detail �</div>
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a. the CSM position statement</div>
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b. letter to licence holders and questionnaire</div>
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c. guidelines to industry</div>
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d. formation of Working Party, its terms of reference and membership.</div>
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The Committees [sic] decisions are at Annex E.</div>
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The need for research into BSE in relation to medicines manufacture was recognised by the Committee.</div>
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The Committee also advised that in-house applications should be assessed using the new guidelines as seen [sic] appropriate.</div>
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Members were informed that all press enquiries on BSE should be referred to the Chairman of CSM who would take advice from the Secretariat.�[470]</div>
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402. The proposed membership of the CSM Working Party on BSE was Professor Asscher or Professor Rawlins, Professor Berry, Professor A Campbell, Professor Collee, Dr Kimberlin, Professor Lawson or Professor Kirby, Dr Schild or Dr Minor, Dr Taylor, Dr Tyrrell, a veterinary expert and Dr Will.[471]</div>
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403. The Question and Answer briefing document which formed Annex F� said the following:</div>
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�1.�� Can BSE be transmitted to patients by medicines?</div>
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The Southwood Report suggests that there may be a remote theoretical risk of BSE being transmitted to patients by the use of injectable medicines derived from bovine material. The CSM agreed that the risk is remote.</div>
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2.��� Which medicines are affected?</div>
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Bovine material is used as an active ingredient in some medicines, for example, the older bovine insulins. Bovine material is also used in small quantities in the production and manufacture of many biological and biotechnologically derived medicines including vaccines and monoclonal antibodies.</div>
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3.��� Are the risks greater with some medicines than with others?</div>
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Theoretically, injectable (parenteral) products might seem to pose a greater risk than oral medicinal products, but the CSM agreed that the risk from either is remote.</div>
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4.��� How are medicines affected?</div>
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Bovine material is used both as an active ingredient (for example in products such as bovine insulin) and in very small quantities in the production and manufacture of a wider range of medicines.</div>
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5.��� Are some of the products available over the counter from pharmacies or shops?</div>
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A range of products available over the counter may contain bovine material as an active ingredient or an excipient, including oral products and injectable insulin which is obtainable only from a pharmacy. But the CSM agrees that any risk of transmission of the agent by medicines is remote.</div>
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6.��� Are existing stocks safe?</div>
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The CSM agreed with the Southwood Working Party that the risk of transmission of BSE via medicinal products to man is remote and there is therefore no reason to question the safety of existing products.</div>
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7.��� Are there alternatives to the use of bovine material in medicinal products (including vaccines)?</div>
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Certain products such as insulin are now produced by using genetic engineering techniques. While it might be possible to replace bovine materials by using other ingredients or manufacturing methods in some other products, the Licensing Authority would need to be satisfied about the safety of such products before they could be made generally available. It would take some time to undertake the work needed to introduce such a change.</div>
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8.��� Which patients are at risk?</div>
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Although bovine material has been used in a wide range of medicinal products, it is not possible to say that any particular patients are at risk since we have no evidence of transmission of BSE to man.</div>
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9.��� What risks exist to those who have already used these medicines?</div>
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There is no evidence to suggest that people who have used medicines containing bovine material are at any risk from contracting BSE.</div>
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10.�� How long will it be before risks are quantified?</div>
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It is very difficult to answer this question since we are talking only about a theoretical risk. It is one of the issues which will be considered by the new Consultative Committee on Research which has been established by the Government. The Committee on Safety of Medicines are also establishing a working party to advise them on BSE and human medicines.</div>
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11.�� What action is the Licensing Authority taking to ensure proper scrutinising of source materials and manufacturing processes?</div>
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The Licensing Authority has sought the advice of the Committee on the Safety of Medicines, the Veterinary Products Committee and other outside experts. Guidelines on good manufacturing practice have been produced and are being sent to all manufacturers.</div>
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12.�� Will the guidelines be published?</div>
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They will be sent to all manufacturers of licensed products shortly.</div>
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13.�� What is being done to reassure parents and doctors about vaccines?</div>
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The benefits of immunisation are well founded and not affected by the remote theoretical risk from the use of bovine material in vaccines. We see no reason to take any special steps to reassure parents and doctors at present. We are also taking the advice of the Joint Committee on Vaccination and Immunisation (the expert Committee which advises the Health Department on immunisation). If it proves necessary, the message about the benefits of immunisation can be addressed generally in the publicity material and the professional advice on immunisation provided for parents and doctors.</div>
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14.�� What advice is the Government giving about its vaccination programme?</div>
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The immunisation programme for children and adults is vital to individuals and the public health. There are very considerable benefits in the prevention of serious or fatal disease. By any reckoning these outweigh the remote and theoretical risk for BSE.</div>
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15.�� Is the vaccination programme put at risk because of BSE?</div>
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No. The measures being taken about the use of bovine material in medicines are merely precautionary against a remote and theoretical risk.</div>
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16.�� Are there any risks from BSE to anyone who has already been vaccinated?</div>
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The Southwood report describes the possibility as remote (para 8.2) but has alerted the Licensing Authority to the potential concern. This has led to plans to issue guidance to the pharmaceutical industry as a precautionary measure.�[472]</div>
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404. The CSM Position Statement that was Annex B stated:</div>
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�The Committee on Safety of Medicines (CSM) has considered the safety of human medicines in the light of the report of the Working Party on Bovine Spongiform Encephalopathy (BSE) � the Southwood Report.� The CSM agrees with the Southwood Working Party that the risk to man of infection via medicinal products is remote.� As a precautionary measure, and for the sole aim of seeking to guard against what is no more than a theoretical risk to man, the CSM and the Veterinary Products Committee (VPC) have agreed joint guidelines on good manufacturing practice for the manufacturers of human and veterinary medicines who use bovine, or other animal, materials either as an ingredient or in the production process.� This guidance will be issued by the Licensing Authority to the manufacturers early in March.� Manufacturers will also be asked for further details about any animal materials used in their products and, where appropriate, to state how they propose to implement the guidelines in the future.� The need for further action will be considered by the Licensing Authority in the light of further information from the industry and expert advice.�[473]</div>
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405. Professor Asscher discussed this position statement in his Statement to the Inquiry. He said:�</div>
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�It appears that the wording of this position statement differed from the wording of that approved by the Human & Veterinary Medicines Working Group the previous day, in that the second paragraph of the previous day�s statement was not used in the final version of the position statement. As far as I can recall, this change was made because the CSM�s general policy on BSE and medicinal products was adequately set out in the first paragraph. There was no reason specifically to draw attention to vaccines. There was no advantage to be gained from doing so and there were potential disadvantages in that the vaccination programme might have been put at risk.�[474]�</div>
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Cabinet consideration</div>
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406. On 23 February 1989 the Southwood Report was discussed at a Cabinet meeting.[475] The minutes of this meeting show that John MacGregor, Minister of Agriculture and Food said ��in view of the intense current public interest in food safety and the risk of the working party�s findings being leaked, it was necessary to publish the report with as little delay as possible.�� With specific reference to vaccines the meeting minutes record that the proposed CSM/VPC Joint Guidelines that were about to be issued recommended� ��manufacturers of medicinal products to use non-bovine sources wherever possible�</div>
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407. On 23 February 1989, DH and MAFF Ministers met with officials to discuss baby food and vaccines, two items of concern arising out of the Southwood Report. The Minister of Agriculture, Mr John MacGregor, and Kenneth Clarke, the Secretary of State for Health were told that the VPC and CSM had concluded the risk of transmission of BSE through vaccines was remote. Despite this reassurance the two committees, ��so as to be doubly sure in future�intended to take the opportunity to improve standards throughout the field of biologically derived medicinal products and had prepared additional guidelines for users of bovine material.�[476]</div>
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408. On 24 February 1989 Mr Hagger minuted Mrs Goldhill, from the Secretary of State for Health�s Private Office, attaching a revised version of the Q & A brief he had sent earlier. This was copied to a number of DH officials.[477] Changes made since the earlier brief (see paragraph 403 above) were that Q7 now excluded the reference to vaccines and the new answer stated:</div>
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�In some cases alternatives have been introduced using genetic engineering techniques, for example certain insulins.�</div>
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409. A new Q8 had been included which asked</div>
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�8.�� Why can�t we eliminate the use of bovine materials in all medicines?</div>
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It might be possible to find alternative ingredients and methods but development of this kind takes time and requires careful testing.�[478]</div>
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410. The previous Q9 had been removed altogether:</div>
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�9.�� What risks exist to those who have already used these medicines?</div>
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There is no evidence to suggest that people who have used medicines containing bovine material are at any risk from contracting BSE.�[479]</div>
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The Southwood Report</div>
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411. On 27 February 1989 PS/Mr MacGregor sent a final revised announcement for the Southwood Report to the PS/Prime Minister. It noted that the announcement would be made that afternoon by written answer.[480] It stated in relation to medicines that:</div>
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�� the Committee on the Safety of Medicines and the Veterinary Products Committee have considered the comments of the Working Party on the implications of BSE for the manufacture of pharmaceutical products from bovine material; and agree that any risk of transmission of BSE through medicinal products to man appear remote; as a precautionary measure however they have advised that additional guidance should be issued to medicine manufacturers on good manufacturing practice;�[481]</div>
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412. On 27 February 1989 the Southwood Report was published.[482] Section 5.3.2 of the Report, under the heading �Possible Transmission to Man�, stated� �Information from several spongiform encephalopathies suggests that parenteral inoculation is much more efficient in transmitting disease than oral or topical exposure��� Section 5.3.3 continued:�</div>
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�The greatest risk in theory, would be from parenteral injection of material derived from bovine brain or lymphoid tissue.� Medicinal products for injection or surgical implantation which are prepared from bovine tissues might also be capable of transmitting infectious agents.� All medicinal products are licensed under the Medicines Act by the Licensing Authority following guidance, for example from the Committee on Safety on Medicine (CSM), the Committee on Dental and Surgical Materials (CDSM) and their sub-committees. The Licensing Authority have been alerted to potential concern about BSE in medicinal products and will ensure that scrutiny of source materials and manufacturing processes now takes account of BSE agent.�</div>
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413. Section 5.3.4 dealt with occupational risk and section 5.3.5 then stated �In these, as in other circumstances, the risk of transmission of BSE to humans appears remote.�</div>
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414. The recommendations with regard to medicinal products were contained in Section 8.2 where the Report stated:</div>
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�Although the risks appear remote the Working Party recommended that the attention of the Licensing Authority, the Committee on Safety of Medicines (CSM), the Committee on Dental and Surgical Materials and the Veterinary Products Committee (VPC) be drawn to the emergence of BSE so that they can take appropriate action. In this connection the Chairman of the Working Party has corresponded with the Chairman of the CSM and with the VPC.�</div>
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415. Professor Collee discussed the Southwood Report and medicines in his statement to the Inquiry. He said:</div>
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�I understand the Inquiry has expressed some interest in the wording of the Southwood Report, so far as the degree of risk from parenteral medicinal products is concerned.� My own reading of the report, even today, is that the view being expressed was that the risk from parenteral products, even though expressed to be the greatest risk, was still being categorised as remote.�[483]</div>
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416. In his Statement to the Inquiry Professor Asscher said that:</div>
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�Vaccines were the main group of existing products which came before the CSM for consideration. From my point of view, the risk-benefit analysis of existing stocks of vaccines was comparatively easy, principally for two reasons. The first was that the risk posed by BSE to human health was, during my time as Chairman of the CSM, always regarded as remote; that was certainly the view of the Southwood Working Party in its report. The second was that vaccines are very important to the protection of human health. The CSM�s judgement was that the risks associated with interruption of the UK vaccination programme were far greater than the potential risk of BSE being transmitted.�[484]</div>
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417. On 1 March 1989 Professor Collee wrote to Dr Kimberlin[485] in the following terms:</div>
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�This is a short note to thank you very much for your valued help at London last week.� As you can imagine, I was heavily dependent on your expertise and authority in a very difficult field.� I do hope that you will allow me to say that your performance was impressive and was certainly appreciated by many other colleagues.�</div>
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418. On 7 March 1989, the VPC Biologicals Sub-Committee met. The minutes record that �a joint set of guidelines had been agreed with the Department of Health. Separate questionnaires, prepared by MAFF and DH, had been sent out to all licence holders to be returned by May 1989.�[486]</div>
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419. The CRM also met on 7 March 1989.[487] Dr Adams introduced a paper on BSE.[488]</div>
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420. On 7 March 1989 David Mellor, the Minister of Health, announced the issue of the guidelines by way of reply to a Written Parliamentary Question. He said that the CSM agreed with the Southwood Working Party that any risk from injectable medicines including vaccines was both theoretical and remote, but as a purely precautionary measure, further guidance on good manufacturing practice in the area was about to be issued to manufacturers of all medicines including vaccines.[489]</div>
<div style="font-family: arial; font-size: 13.3333px;">
The Joint Guidelines</div>
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421. The Joint CSM/VPC Guidelines were as follows;[490]</div>
<div style="font-family: arial; font-size: 13.3333px;">
�The following guidelines are addressed to PL/CTC/CTX holders and applicants.</div>
<div style="font-family: arial; font-size: 13.3333px;">
1.��� Scope</div>
<div style="font-family: arial; font-size: 13.3333px;">
It is recommended that all products licensed under the Medicines Act 1968 for human or veterinary use, that are administered parenterally or to the eye or to open wounds, should in general conform to this guidance if they contain material from a bovine source, or if bovine material has been used in their manufacture.</div>
<div style="font-family: arial; font-size: 13.3333px;">
2.��� Tissues excluded</div>
<div style="font-family: arial; font-size: 13.3333px;">
No brain or neural tissue, spleen, thymus and other lymphoid tissue, placental tissue or cell cultures of bovine origin should be used in manufacture.</div>
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Cattle source for all other tissues</div>
<div style="font-family: arial; font-size: 13.3333px;">
Bovine material should come from animals, taken from a closed herd in the female line since 1980, in which no animal has been clinically suspected of having BSE, and which has not been fed rations containing ruminant derived protein during that period.</div>
<div style="font-family: arial; font-size: 13.3333px;">
3.��� Collection techniques</div>
<div style="font-family: arial; font-size: 13.3333px;">
All possible measures should be taken to avoid contamination of the bovine material with BSE agent, in particular:</div>
<div style="font-family: arial; font-size: 13.3333px;">
no tissue is to be used in relevant medicinal products when collected post-mortem from a bovine animal after brain penetrative stunning.</div>
<div style="font-family: arial; font-size: 13.3333px;">
all tissue collected from the bovine animal should be taken using sterile equipment. Needles, syringes, scalpel blades etc should be disposable items.</div>
<div style="font-family: arial; font-size: 13.3333px;">
it is recommended that whenever possible, source animals should be calves up to 6 months old.</div>
<div style="font-family: arial; font-size: 13.3333px;">
for serum: all cellular components must be removed.</div>
<div style="font-family: arial; font-size: 13.3333px;">
for foetal calf serum: great care should be taken to avoid contamination by placenta and foetal fluids. All cellular components must be removed.</div>
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4.��� Sterilisation of equipment</div>
<div style="font-family: arial; font-size: 13.3333px;">
When sterilisation procedures are used, they should be demonstrated to be capable of inactivating scrapie-like agents � at present thought to be autoclaving using a porous load cycle at 134�C-138�C for 18 minutes at 30 psi.</div>
<div style="font-family: arial; font-size: 13.3333px;">
5.��� Product</div>
<div style="font-family: arial; font-size: 13.3333px;">
Whenever possible, the product should be terminally sterilised by a validated method.</div>
<div style="font-family: arial; font-size: 13.3333px;">
Although these guidelines relate to BSE and materials of bovine origin, they should also be considered as generally applicable to material from sheep, goats, deer, and other animals susceptible to scrapie like agents. These guidelines may need to be updated in the light of further scientific knowledge.�</div>
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422. Professor Collee referred to the development of these guidelines in his statement to the Inquiry:</div>
<div style="font-family: arial; font-size: 13.3333px;">
�The first attempt at drawing up guidelines was made by Dr Purves and Dr Rotblat, who made various recommendations in their paper prepared for the Biologicals Sub-Committee meeting which took place in November 1988.� I saw that paper shortly before the meeting.� Those recommendations were subject to a process of continual refinement by various groups until they were sent out to manufacturers in February 1989 as joint CSM/VPC guidelines.� In general, I would say that comments made by Sir Richard Southwood on the guidelines during that period were regarded as helpful and constructive.� The two or three months over which correspondence took place and the guidelines were drafted was a period of intense activity with a steep learning curve during which new information and ideas were regularly coming to light.</div>
<div style="font-family: arial; font-size: 13.3333px;">
The guidelines were issued in February 1989 and intended to apply from then. However, we were aware that the complex way in which medicines are manufactured meant that manufacturers would often not be able to comply with the guidelines from the moment they received them. The questionnaire asked manufacturers to identify the time by which they believed they would be able to implement the guidelines.</div>
<div style="font-family: arial; font-size: 13.3333px;">
It is also correct to say that the guidelines were viewed as best practice and we knew that as we progressed, we would have to be flexible��[491]</div>
<div style="font-family: arial; font-size: 13.3333px;">
423. Professor Collee also said that the guidelines� ��applied not only to new products, but also the future production of existing products which were already licensed.�[492]</div>
<div style="font-family: arial; font-size: 13.3333px;">
424. Professor Asscher also comments on the guidelines in his statement to the Inquiry:</div>
<div style="font-family: arial; font-size: 13.3333px;">
�I believe that the guidelines addressed each of the points made by Sir Richard Southwood in his earlier correspondence with me. The first recommendation stated to which medicinal products the guidelines were intended to apply and clarified the CSM�s intention that they should apply both to the use of bovine material as an ingredient in medicines and to its use during the manufacture of medicines. It also made it clear that the guidelines were intended to apply to all medicinal products that fell within the remit of the CSM, including existing products. As previously stated, this had always been the CSM�s intention. Products which fell within the remit of the CDSM or the CRM were considered by those committees.�[493]</div>
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Issue of guidelines to holders of licences for human medicinal products</div>
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425. On 9-10 March 1989 Mr Hagger, of Medicines Division, DH sent the CSM/VPC Guidelines, questionnaire and covering letter to all licensed manufacturers and product licence holders. The letter was distributed on the basis of the MAIL address list.[494]</div>
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426. The letter read:</div>
<div style="font-family: arial; font-size: 13.3333px;">
�Dear Licence holder*</div>
<div style="font-family: arial; font-size: 13.3333px;">
Bovine Spongiform Encephalopathy: Guidance on good manufacturing practice and request for information</div>
<div style="font-family: arial; font-size: 13.3333px;">
The Secretary of State for Health and the Minister for Agriculture have received the Report of the Working Party on Bovine Spongiform Encaphalopathy (sic), chaired by Sir Richard Southwood (�the Southwood Report�). One of the recommendations concern (sic) medicinal products licensed under the Medicines Act 1968 and 1971, and the licensing authority has been asked to take account of the BSE agent and to take appropriate action.</div>
<div style="font-family: arial; font-size: 13.3333px;">
The Committee on Safety of Medicines (CSM) in consultation with the Chairman of CRM and CDSM has considered the Southwood Report and agrees that the risk to man of infected medicinal products is remote.</div>
<div style="font-family: arial; font-size: 13.3333px;">
As purely precautionary measure, CSM and the Veterinary Products Committee have agreed joint guidelines for the manufacturers of human and veterinary medicines who use bovine, or other animal, materials as an ingredient or in the production process. A copy of the guidelines is overleaf. It is felt that the guidance represent a standard that this is deemed �best practice� for the future, and steps should be taken to implement it. However, it is realised that the guidance may not be fully applicable in all circumstances.</div>
<div style="font-family: arial; font-size: 13.3333px;">
In order to update and complete our data on medicinal products, you are asked to fill in the attached form giving information about animal materials used in any of your medicinal products as specified in the guidelines (para 1). Information should be given on any �ingredient of animal origin as an active constituent, as an excipient, or used their manufacture (eg serum, enzymes, broth etc). In particular we are interested in the expected usage pattern of bulk and finished product where appropriate.�[495]</div>
<div style="font-family: arial; font-size: 13.3333px;">
Recipients were asked to return the completed questionnaires by 1 May 1989.</div>
<div style="font-family: arial; font-size: 13.3333px;">
427. In his Statement to the Inquiry Professor Asscher commented on the covering letter saying:</div>
<div style="font-family: arial; font-size: 13.3333px;">
�I understand the Inquiry is interested in why that letter described the recommendations as a �purely precautionary measure�.� The Southwood Report, which I read at the time, stated that the risk to human health from medicinal products was remote.� My understanding of the report was that the risk from all medicinal products was remote; I did not understand the report to say that the risk was only remote if action was taken in the form of the proposed guidelines being introduced.� The CSM was also of the view that the risk to human health from medicinal products was remote.� The fact that we thought the risk was remote per se explains why the guidelines were described as purely precautionary.�[496]</div>
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428. Professor Collee has also commented on the phrase �purely precautionary measure�:</div>
<div style="font-family: arial; font-size: 13.3333px;">
�I have to say that I saw the issuing of guidelines as being more than a precautionary measure; I did in fact regard action as a necessary measure. Nonetheless, I do not believe that the inclusion of that phrase would have made any difference in practice. The requirement to fill in the questionnaire was an obligation, not a request. The process was not completed until every single response had been received and analysed. Where necessary, when it was discovered that a product did not meet the guidelines, the matter was pursued until a satisfactory conclusion was reached. I believe that the pharmaceutical companies took the guidelines seriously.�[497]</div>
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429. The CMO commented in his oral evidence, in reply to a question from counsel about whether Ministers felt they were �fire-proof�:</div>
<div style="font-family: arial; font-size: 13.3333px;">
�I was concerned about biologicals from the beginning� and that is indicated in my minute to the Minister after my meeting on 17th March, it was specifically mentioned.� I also mentioned my concern about it later when I minuted him [Mr MacGregor] about the Southwood Report.� It is specifically noted in that.� So he knew that I was concerned, and it was really within the next few weeks that I personally got involved, in a way which is quite inappropriate in Civil Service terms�to tell them that they [the CSM and Biologicals Sub-Committee] must really focus down on biologicals and make sure; and that is I think one of the reasons why they wrote these 4,000 letters. I am not sure it is the only reason.�[498]</div>
<div style="font-family: arial; font-size: 13.3333px;">
Issue of guidelines to holders of licences for veterinary medicines</div>
<div style="font-family: arial; font-size: 13.3333px;">
430. On 15 March 1989 Mr Scollen, of MAFF wrote to all licence and certificate holders for veterinary medicinal products in the following terms:</div>
<div style="font-family: arial; font-size: 13.3333px;">
�Dear Licence Holder</div>
<div style="font-family: arial; font-size: 13.3333px;">
SPONGIFORM ENCEPHALOPATHIES OF BOVINE, OVINE AND CAPRINE ORIGIN: GUIDANCE ON GOOD MANUFACTURING PRACTICE AND REQUEST FOR INFORMATION</div>
<div style="font-family: arial; font-size: 13.3333px;">
The Minister of Agriculture, Fisheries and Food and the Secretary of State for Health have received the Report of the Working Party on Bovine Spongiform Encephalopathy (BSE), chaired by Sir Richard Southwood (�The Southwood Report�). One of these recommendations concerns medicinal products licensed under the Medicines Act 1968 and 1971, and the licensing authority has been asked to take account of the BSE agent and take appropriate action.</div>
<div style="font-family: arial; font-size: 13.3333px;">
On the 10th March 1989, 2398 farms have had at least one confirmed case of BSE, the total number of cases being 3395. This represents an annual incidence in cows of 1 per 1,000 of the population at risk. These figures demonstrate the serious nature of the problem.</div>
<div style="font-family: arial; font-size: 13.3333px;">
As a purely precautionary measure, the Veterinary Products Committee (the VPC) and the Committee on Safety of Medicines (CSM) have agreed joint guidelines for the manufacture of veterinary and human medicines which use material of bovine, ovine and caprine origin either as an ingredient or in the production process. A copy of the guidelines is attached. They represent a standard that is deemed to be �best practice� for the future, and steps should be taken to implement them. Where a company will find it impossible to meet the guidelines, or, where an alternative process is in use which is thought to give equivalent or better protection than the guidelines, details should be provided at (11) on the attached form.</div>
<div style="font-family: arial; font-size: 13.3333px;">
Since BSE has been made a notifiable disease it is important that the licensing authority is aware to what extent material of bovine, ovine and caprine origin are used in the manufacture of licensed veterinary products (including products subject to Animal Test Certificates and Animal Test Exemptions and Emergency Vaccines).</div>
<div style="font-family: arial; font-size: 13.3333px;">
In order to update and complete our data on veterinary medicinal products, you are asked to complete the attached form��[499]</div>
<div style="font-family: arial; font-size: 13.3333px;">
431. Recipients of this letter were asked to complete the enclosed questionnaire and return it to the Medicines Unit by 1 May 1989.</div>
<div style="font-family: arial; font-size: 13.3333px;">
Issue of guidelines regarding medical devices</div>
<div style="font-family: arial; font-size: 13.3333px;">
432. On 13 March 1989 Mr Burton, a Grade 7 in charge of the Pharmaceutical Supplies and Technology section, sent a draft letter, intended for regional pharmaceutical officers and the Chairmen of Quality Control and Production Sub-Committees, to Mr Hagger and Mr Ayling for their comment.[500]The draft was mainly intended to ��pre-empt criticism from the NHS that non-licensed pharmaceuticals had slipped through the net.� The letter noted:</div>
<div style="font-family: arial; font-size: 13.3333px;">
��the attached documents represent Medicines Division�s initial approach to the Pharmaceutical Industry and this package of documents is being copied to you for information. A similar exercise has been conducted to cover the medical device industry.�</div>
<div style="font-family: arial; font-size: 13.3333px;">
It must be stressed that the Committee on the Safety of Medicines has agreed, in line with the Southwood Report, that the risk to man of infection via medicinal products is remote.</div>
<div style="font-family: arial; font-size: 13.3333px;">
The Department does not consider it appropriate at the present time to extend this information gathering exercise to NHS manufactured �medicinal products� in general, but if any especially �at risk� products come to your attention I would be pleased to receive completed questionnaires which will then be considered at the same time as those from industry.�</div>
<div style="font-family: arial; font-size: 13.3333px;">
Mr Burton asked for an early response so that letters could be sent soon to achieve their objective.</div>
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433. On 16 March 1989 Mr Hagger minuted Mr Burton about �BSE and NHS manufactured medicinal products� in response to Mr Burton�s minute of 13 March 1989. The minute said:[501]</div>
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�2.�� We see no difficulties from an MD standpoint to the proposals in your minute and agree that it would seem appropriate for Miss Duncan to sign the letter.</div>
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3. �� I have a few small amendments to propose to your draft letter, as follows:-</div>
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a)��� Para 2, line 1, delete �initial� and inset [sic] �purely precautionary�.</div>
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�</div>
<div style="font-family: arial; font-size: 13.3333px;">
c)��� Para 3, line 4, delete �especially at risk�. Rest of that line to read: �products come to your attention which appear not to conform to the joint CSM/Veterinary Products Committee Guidelines I would be�.</div>
<div style="font-family: arial; font-size: 13.3333px;">
4.��� To amplify my comment at 3(c), I should say that it seems to me to be inappropriate to refer to products �especially �at risk�� when both Southwood and the CSM said that the risks to man were remote and theoretical. I have suggested � not conforming to the guidelines - as an alternative which should pick up the sort of cases we ought to know about while avoiding the need for a full scale questionnaire completing exercise in every case.�</div>
<div style="font-family: arial; font-size: 13.3333px;">
434. Some time after 16 March 1989 PD wrote in these terms to all the Regional Pharmaceutical Officers and the Chief Pharmacists of Scotland, Wales and Northern Ireland. �This letter was also sent to the Chairmen of the Pharmaceutical Production Sub-Committee and the Quality Control Sub-Committee.[502]</div>
<div style="font-family: arial; font-size: 13.3333px;">
435. On 17 March 1989 Miss Duncan issued guidelines to the manufacturers and suppliers of medical devices on the use of materials of animal origin.[503]The recipients of these were drawn from membership of the Manufacturers Registration Scheme (MRS) for sterile medical devices and surgical products. In all, 328 manufacturers were sent a copy of the guidelines and questionnaire.[504]</div>
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436. �The letter said:</div>
<div style="font-family: arial; font-size: 13.3333px;">
�Dear Manufacturer/Supplier</div>
<div style="font-family: arial; font-size: 13.3333px;">
BOVINE SPONGIFORM ENCEPHALOPATHY:</div>
<div style="font-family: arial; font-size: 13.3333px;">
GUIDANCE ON GOOD MANUFACTURING PRACTICE AND REQUEST FOR INFORMATION RELATING TO SURGICAL IMPLANTS AND BLOOD CONTACT MEDICAL DEVICES</div>
<div style="font-family: arial; font-size: 13.3333px;">
The British Government have recently received the Report of a Working Party on Bovine Spongiform Encephalopathy, chaired by Sir Richard Southwood�One of the recommendations of this report concerns medicinal products licensed under the UK Medicines Act 1968 and 1971, and the licensing authority has been asked to take account of the BSE agent and to take appropriate action. In parallel with this action the NHS Procurement Directorate, Supplies Technology Division, are considering the implications of the BSE agent for those surgical implants and blood contact medical devices which fall outside the scope of the Medicines Acts.</div>
<div style="font-family: arial; font-size: 13.3333px;">
Supplies Technology Division, in conjunction with the UK Committee of (sic) Safety of Medicines, has considered the Southwood Report and agrees that the risk to man of infection by BSE and other scrapie-like agents resulting from the use of such devices is remote. As a purely precautionary measure, we have developed the enclosed guidelines for manufacturers of medical devices who use bovine, or other animal materials, either as a component or in the production process. The guidance represents �best practice� for future manufacture and outlines the steps which should now be taken to implement it. It is realised that this guidance may not be fully applicable in all circumstances and it will be further developed in the light of experience.� [505]</div>
<div style="font-family: arial; font-size: 13.3333px;">
437. The letter went on to ask for the attached form, detailing information on the use of animal materials in medical devices, to be completed for each product and returned to PD by 1 May 1989.</div>
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438. The guidelines were headed �Supplies Technology Division Guidelines for the Medical Device Industry on the use of Materials of Animal Origin�[506]. They included the following:</div>
<div style="font-family: arial; font-size: 13.3333px;">
�1.�� Scope</div>
<div style="font-family: arial; font-size: 13.3333px;">
It is recommended that all products in the following categories, which are supplied to hospitals in the United Kingdom, and which do not fall under the remit of the Medicines Act, should in general conform to this guidance if they contain material from a bovine source, or if bovine material has been used during their manufacture.</div>
<div style="font-family: arial; font-size: 13.3333px;">
Categories:</div>
<div style="font-family: arial; font-size: 13.3333px;">
a).�� Biological heart valves.</div>
<div style="font-family: arial; font-size: 13.3333px;">
b)��� Other cardiovascular implants (eg vascular prostheses, cardiac patches etc)</div>
<div style="font-family: arial; font-size: 13.3333px;">
c).�� Orthopaedic implants such as tendons, bone grafts etc.</div>
<div style="font-family: arial; font-size: 13.3333px;">
d).�� Single use sterile devices that use such animal deviatives (sic) as heparin and gelatin in, for example, coatings.</div>
<div style="font-family: arial; font-size: 13.3333px;">
e).�� Any other implantable products or products which come into contact with blood or the lymphatic system and which utilise materials of bovine origin.�� ��</div>
<div style="font-family: arial; font-size: 13.3333px;">
439. The guidelines also covered: the tissues to be excluded; cattle sources for all other tissues; collection techniques; sterilisation of equipment; and sterilisation of product. It was noted that the guidelines might need to be updated in the light of further scientific knowledge.</div>
<div style="font-family: arial; font-size: 13.3333px;">
The Tyrrell Committee</div>
<div style="font-family: arial; font-size: 13.3333px;">
440. On 13 March 1989 the Tyrrell Committee met for the first time. The Committee was set up following a recommendation from the Southwood Working Party, to advise MAFF and DH on research into BSE and other transmissible spongiform encephalopathies. Dr Tyrrell headed the Committee and members included Dr Kimberlin (ex-Director of the Neuropathogenesis Unit, Edinburgh), Dr Watson (Director of the Central Veterinary Laboratory), Dr Will (Consultant Neurologist, Western General Hospital, Edinburgh). Dr Pickles from DH and Mr Maslin from MAFF acted as joint secretaries to the Committee.</div>
<div style="font-family: arial; font-size: 13.3333px;">
441. The Tyrrell Committee discussed the CSM/VPC Joint Guidelines, and the implications of using bovine material in plastic and other surgery were identified as matters to be considered.[507] �Dr Pickles was asked to produce a detailed paper and to circulate this before the next meeting.</div>
<div style="font-family: arial; font-size: 13.3333px;">
442. The CDSM met on 15 March 1989 and noted the guidelines, letter, questionnaire, position statement and membership of the Working Party.[508]</div>
<div style="font-family: arial; font-size: 13.3333px;">
443. On 15 March 1989 Mr Whitbread, Higher Executive Officer of the MCA responsible for the CSM and its Sub-Committees, minuted Dr Jefferys, Mr James, a solicitor, Dr Purves, Mr Hagger and Dr Adams in relation to the appointment of members to the BSE Working Party established by the CSM. He attached a draft letter of appointment together with a short background note.[509]�</div>
<div style="font-family: arial; font-size: 13.3333px;">
444. On 17 March 1989 Mr Hagger replied to Mr Whitbread�s minute of 15 March[510], stating that he would like the letters to make absolutely clear that:</div>
<div style="font-family: arial; font-size: 13.3333px;">
�the Working Party is subordinate to the Section IV Committees and has been set up to advise them � i.e. so as to avoid any temptation for the Working Party to be seen as an entirely separate entity answerable to all and sundry (including the press).�</div>
<div style="font-family: arial; font-size: 13.3333px;">
445. On 21 March 1989 the NOAH Biologicals Sub-committee met members of MAFF. The minutes of the meeting record:</div>
<div style="font-family: arial; font-size: 13.3333px;">
�9. BSE Guidelines</div>
<div style="font-family: arial; font-size: 13.3333px;">
Dr Little gave a brief outline of the position to date. Sir Richard Southwood�s Report had thus far turned out to be a damp squib. However it was stressed that care must be taken to ensure that certain elements of the press do not get hold of the wrong impression about the safety of vaccines � both human and veterinary � and cause major problems.</div>
<div style="font-family: arial; font-size: 13.3333px;">
The Guidelines had been issued by D of H on 10 March to all on the MAIL distribution list, which explained why veterinary product licence holders had received copies from D of H, and by MAFF veterinary product licence holders on 17 March. Dr Little pointed out that the guidelines took into account the fact that a high standard was being set, and also accepted that certain manufacturers may have other equivalent methods of attaining the required standard.�[511]</div>
<div style="font-family: arial; font-size: 13.3333px;">
It was agreed that the guidelines �would be discussed by a small group after the next meeting.�</div>
<div style="font-family: arial; font-size: 13.3333px;">
446. On 30 March 1989 the CSM held a meeting.[512]</div>
<div style="font-family: arial; font-size: 13.3333px;">
447. On 31 March 1989 Mr Hagger sent a minute to Dr Pickles attaching copies of the papers on BSE considered by the CSM and its Biologicals Sub Committee.� These were itemised as follows:</div>
<div style="font-family: arial; font-size: 13.3333px;">
�1.�� Paper appeared before the Biologicals and Safety, Efficacy and Adverse Reactions (SEAR) sub-committees in November 1988 (Pink sheets)</div>
<div style="font-family: arial; font-size: 13.3333px;">
2.��� Recommendation from Biologicals and SEAR (plus pink sheets)</div>
<div style="font-family: arial; font-size: 13.3333px;">
3.��� Extract from minutes of November CSM meeting.</div>
<div style="font-family: arial; font-size: 13.3333px;">
4.��� Letter from Sir Richard Southwood to Professor Asscher set before December CSM meeting.</div>
<div style="font-family: arial; font-size: 13.3333px;">
5.��� Paper set before February 1989 CSM (included 1,2,3 and 4 as annexes).</div>
<div style="font-family: arial; font-size: 13.3333px;">
5.1�� Further correspondence between Professor Asscher and Sir Richard Southwood was also included.</div>
<div style="font-family: arial; font-size: 13.3333px;">
6.��� Tabled paper set before February 1989 CSM, draft position statement and letter to product licence holders</div>
<div style="font-family: arial; font-size: 13.3333px;">
7.��� Extract from minutes of the February CSM meeting.</div>
<div style="font-family: arial; font-size: 13.3333px;">
7.1�� Minutes of the Human and Veterinary Medicines Briefing Group re. BSE.</div>
<div style="font-family: arial; font-size: 13.3333px;">
7.2�� Position statement on BSE as agreed at February CSM meeting.� Letter, questionnaire and guidelines for industry.� Proposed membership of, and terms of reference for, working party on BSE.�[513]</div>
<div style="font-family: arial; font-size: 13.3333px;">
448. On 5 April 1989 Dr Pickles minuted Mr J Barnes (RMD) on BSE research to update him prior to his meeting with the MRC. Enclosed were minutes of the first meeting of the Tyrrell group and a paper, being a first attempt at listing all the relevant research areas:</div>
<div style="font-family: arial; font-size: 13.3333px;">
�Those which might be thought of as falling in the DH/MRC field of interest are principally section 3; A3 to d, and B3, also C4 (although here the pharmaceutical industry or NIBSC might be expected to sponsor the work). However, much of the fundamental work planned by the NPU could be directly relevant to existing human disorders especially CJD. Their work and that of the CVL also could be important in determining whether humans have been or may be at risk from the bovine disorder, and also falls within our area of interest�� [514]</div>
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449. On 11 April 1989 a paper prepared by Dr Pickles on BSE and Medicinal Products[515] was considered by the Tyrrell Committee.[516]� The paper outlined the conclusions of the Southwood Working Party as well as outlining some research questions of immediate interest to the MCA. The Annex to the document included a position statement of the CSM, a note on medicinal products that used bovine ingredients, and the CSM/VPC guidelines and letter to licence holders. The minutes of the meeting record:</div>
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�4.� BSE and medicinal products [CCRSE6]</div>
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Dr Tyrrell explained that this paper was mainly for the information of the Committee but did raise questions relevant to research needs. It correctly stated that the risks from BSE were small but that there was a need to be careful and conduct research.</div>
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Dr Kimberlin said that bovine insulins were an important product in this area. Pharmaceutical companies were asking where they could find BSE-free herds to draw on. Dr Tyrrell concluded that no herds could be said to be BSE free in the British Isles but that a few farms that had not used compound rations might provide a possible source. It was not however for the Committee to advise on this.</div>
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Dr Will made the point that the paper did not cover dental products and yet these might be of concern since Kuru transmission could have involved gum abrasions.�[517]</div>
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Dr Pickles passed this concern to Mr Howard, Senior Dental Officer Dental Division, in a minute dated 17 April 1989.[518]</div>
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450. Dr Pickles� paper covered research questions of immediate interest to the MCA and the pharmaceutical industry.� These included:</div>
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�-���� can freedom from BSE-contamination be demonstrated in existing stocks of products at theoretical risk (many years supply of some vaccines, for example)</div>
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-����� for what processes/products are the risks sufficiently high to be worth subjecting to experimental test, eg with mouse inoculation</div>
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-����� how can BSE-free herds in the UK be demonstrated and material collected from these herds?</div>
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-����� what overseas sources of bovine material are acceptable?</div>
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-����� Are there any products for which the risk-benefit is now unacceptable (considered for the bovine insulins and heparin, but further action not thought appropriate at present)</div>
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-����� Should there be similar concern about other animal species used in pharmaceutical manufacture?�[519]</div>
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451. On 13 April 1989 Dr Pickles minuted Mr Barnes, from RMD, about the meeting of the Tyrrell Committee on 11 April 1989. She listed specific points that related to DH interests:</div>
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�*��� the need to continue and expand basic work on spongiform encephalopathies �</div>
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*���� the national and international importance of the monitoring study of CJD�but note that we would look to the MRC to supervise and administer this study��</div>
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*���� neuropathological examination of CJD material �</div>
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*���� the restrictions that may be placed on undertaking the high priority research identified by the Tyrrell group caused by limitations in people with appropriate expertise</div>
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*���� the very high cost and lengthy nature of much of the research work identified as high priority, and that this will involve many thousands of animals�[520]</div>
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Response to questionnaire</div>
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452. On 25 April 1989 PD met to consider the replies to the questionnaire from the manufacturers of medical devices. The minutes record that amongst those present were Miss Duncan, Dr Richardson, Mr Burton and Dr Hoxey. It was felt that to assess the accuracy of replies, letters should be sent to a random selection of the manufacturers asking for further information. Copies of all returned questionnaires were to be placed on the MRS files to allow their accuracy to be checked at the next MRS audit of the company. The validity of some of the replies so far received had been questioned at the meeting.[521]</div>
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453. Over 80 manufacturers out of more than 330 had failed to respond. It was decided that the British manufacturers amongst these should be telephoned and foreign manufacturers sent reminder letters.[522]</div>
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454. A paper entitled �Inactivation of scrapie-like agents�[523] was presented to the meeting by Mrs Dhell, a Higher Professional and Technology Officer for the PD, responsible for sterilisation and decontamination. It was suggested that this be forwarded to the trade association and to the Medicines Control Agency for comment.[524]</div>
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455. In May 1989 a follow-up letter was sent to those medical device manufacturers who had stated that one or more of their products conformed to the PD guidelines. This letter was designed to understand how these manufacturers had arrived at their affirmative answers.[525]</div>
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456. On 3 May 1989 the Biologicals Sub Committee of the CSM held a meeting.[526]</div>
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457. On 12 May 1989 Miss Duncan, of PD, minuted Mr Hagger, of Medicines Division, and said:[527]</div>
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�1.�� I attach minutes of a meeting held to discuss the preliminary results of the questionnaire and future action.</div>
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2.��� Our main concerns at present are the poor response � just over half; the lack of response from some known UK manufacturers; doubts about the positive responses to GMP compliance and, what to do now.</div>
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3.��� With regard to the last point we will obviously rely heavily on decisions made in the MCA and are anxious to be involved with the meetings you intend from the beginning.�</div>
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458. On 24 May 1989 Dr Pickles minuted Mr Hagger about the draft interim report of the Tyrrell committee. She attached a copy of the draft pharmaceutical section (C2), which included references to research on �bovine serum albumin and fetal calf serum and other common media that involve bovine materials�.[528] The draft report stated:</div>
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�2.� Pharmaceuticals</div>
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Part of the justification for using bovine rather than ovine material in pharmaceutical manufacture was because of uncertainty about the significance of scrapie in sheep.�Whilst there is no evidence of hazard in those biological medicinal products made using bovine ingredients or intermediates, the industry, drug regulators, the professions and the public naturally seek complete reassurance.</div>
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a.���� bovine serum albumin and fetal calf serum and other common media that involve bovine material: ic to mice.� Concern has been expressed about these materials not only by those involved in pharmaceutical manufacture but also by laboratory workers in immunology and microbiology, for example.� If procedures adequate to contain CJD agent had to be employed, much valuable experimental work would cease.� Artificial alternatives have been sought in recent years, mostly for economic reasons.� This trend will continue, although complete replacement of bovine material will not be possible and in pharmaceutical manufacture would have a lead-time of several years.� Titrations of the kind described in Cla are needed.� ***</div>
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b. similar attempts at transmission with various intermediates and perhaps also final products of pharmaceutical manufacture, chosen on theoretical grounds as plausibly contaminated with BSE including some when starting materials have been spiked or from known contaminated animals. An expert standing group of the CSM and VPC will be considering with the Medicines Control Agency, NIBSC and the Industry whether work in this area might be appropriate.�[529]</div>
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459. The Right Honourable John MacGregor, MAFF Minister, in oral evidence told the BSE Inquiry that he had a meeting around 26 May 1989 with the CMO�s representative and others about the possible ban on specified bovine offal in human food:[530]</div>
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�Then we had a meeting on whenever it was, 26th May or some time, and the Chief Medical Officer's representative there spoke against it, Dr Metters, on the grounds that (a) it was going beyond Southwood advice and Southwood had not recommended it, and (b) there was a problem with vaccines, that they would not be able to withdraw them until September. I still took the line I did and made clear what we were going to do. I think this obviously went back to the Department of Health. The Chief Medical Officer said there is a problem for me on sensitivity of handling vaccines as there was for us, but he quite understood why we wanted to get ahead and not wait for a few more months. That was really what it was. It obviously was not -- it just -- it went away, it was not a problem�</div>
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460. On 31 May 1989 Mr Cunningham minuted Dr Pickles and Dr Rubery about a meeting on 24 May 1989 with the CMO. The minute said:[531]</div>
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�Reference was made to the MCA and PD surveys of the use of bovine material in drugs, vaccines and unlicenced surgical implants. I subsequently spoke to Mr Hagger who told me that by no means all responses had been received by the deadline of 1st May and that it would take some time for the full response to be analysed. MCA was planning on a first meeting of their expert ad hoc group which would be advising the CSM and the JCVI in September. No decision had been made about whether the results of this survey should be made public and if so how.�</div>
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461. On 5 June 1989 Mr Hagger replied to Dr Pickles� minute of 24 May 1989. He attached a copy of �the proposed membership and terms of reference of the CSM Working Party on BSE�.[532]� He commented that:</div>
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�3.�� We believe that we have understood the gist of item C2 b (bold print) although we did not find it clear.� We would expect the working group to comment willingly on relevant research protocols and perhaps to make its own suggestions for fruitful topics in this field.� However we were not expecting the working group to be asked to undertake the task described at b.� In fact this is the sort of issue on which the CSM�s working group was expecting to look to the Tyrrell group for information� - it is of course very helpful that Dr Tyrrell is in both groups.�</div>
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Mr Hagger also passed on the comments that �the primary reason for the use of bovine rather than ovine material is that there is more of it per animal� and ��complete reassurance� is never possible, given or even demanded by scientists.�</div>
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462. In June 1989 the Interim Report of the Tyrrell Committee was completed (but not published). It listed research into possible transmission of BSE via pharmaceuticals as a high priority.[533] The report allocated stars to the various research options. Three stars indicated highest priority, two indicated medium priority for immediate work, and one star indicated low priority. Relevant sections of the report included sections A2 and C2:[534]</div>
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�A2. Human</div>
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Many extensive epidemiological studies around the world have contributed to the current consensus view that scrapie is not causally linked with CJD.� It is urgent that the same reassurance can be given about the lack of effect of BSE on human health. The best way of doing this is to monitor all UK cases of CJD over the next two decades. This UK cohort of CJD cases will be available for the testing of any future hypotheses.� The cost is low, the priority very high.� Prospective monitoring of putative �high risk� groups is more problematic: even a comprehensive nationwide survey of the relevant group might not provide any measurable gain over the usual surveillance for disease.</div>
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a. Surveillance of cases of CJD with particular reference to the overall incidence, the geographical distribution, the age and sex distribution, occupational history, association with medication; and any atypical clinical features.� There is a unique set of data of CJD gathered in England and Wales in the late 70�s and early 80�s.� Were BSE to prove a risk to humans, it must not be assumed that cases would present as typical CJD but perhaps, like with the iatrogenic cases associated with hGH, cases might have atypical features. A formal proposal for continuation and extension of the previous study has been received and we give it our full support.� We note the necessity for adequate facilities for the attendant neuropathology.� Alternative methods of monitoring disease, such as notifications to the CDSC [and CD (S) U] or from death certification, are considered inappropriate in a rare disease like CJD where the diagnosis can be difficult, even for the specialist.� Depending on the results of this surveillance, case control studies could then be mounted to test specific hypotheses, but in the view of the small numbers involved such methods would be technically difficult and might produce indeterminate results.� [Siv, Tiv][Southwood iv, Tyrrell iv]***</div>
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b. Prospective monitoring of groups with high exposure to bovine tissues, such as slaughtermen, veterinarians, and regular recipients of medicinal products of bovine origin.� Another classical technique in epidemiology is the prospective case-control study of those with presumed high exposure.� Such work in relation to �BSE risk� would need very careful design and might not prove realistic in practice.� The proposed surveillance of CJD (A2a) will, however, examine specifically for changes in occupational incidence. [Siv][Southwood iv]*�</div>
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463. Section C2 recommended certain transmission experiments relating to pharmaceuticals[535]:</div>
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�C2. Pharmaceuticals</div>
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Whilst there is no evidence of hazard in those biological medicinal products made using bovine ingredients or intermediates, the industry, drug regulators, the professions and the public naturally seek reassurance.</div>
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a. Bovine serum albumin and fetal calf serum and other common media that involve bovine material: ic to mice. Concern has been expressed here not only by those involved in pharmaceutical manufacture but also by laboratory workers in regular contact with these materials, in immunology and microbiology for example.� Artificial alternatives have been sought in recent years, mostly for economic reasons.� This trend will continue, although complete replacement of bovine material will not be possible and in pharmaceutical manufacture would have a lead-time of several years. Titrations of the kind described in C1a are needed.***</div>
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b. Additional transmission studies specifically relevant to pharmaceutical manufacture.� We recommend that the Medicines Control Agency, with expert advice, considers the need for work in this area.�</div>
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464. On 5 June 1989 Mr Hagger reported to Dr McInnes, Private Secretary to the Chief Medical Officer, on current progress of the human medicines questionnaire on the use of bovine by-products in human medicines. The 4,000 letters with questionnaires and guidelines sent out to all licence holders on 9-10 March 1989, had a deadline for return of the questionnaires of 1 May 1989. He reported that most licence holders had replied and that:</div>
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�The enquiry has produced a lot of material which will take time to study before papers can be prepared for a meeting on 6 September of the special working group set up by the CSM to advise it� At this stage, a preliminary scan of the data has not identified any information which would appear to warrant immediate special action.�The MCA is however taking account of the new guidelines in assessing applications for new licences and renewals.�[536].</div>
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465. Dr Rotblat commented,� ��we received a large number of telephone calls from recipients over the next few weeks.�it became obvious from the calls that the industry felt that the easiest way of complying with the guidelines on safe sourcing was to source from outside the UK with New Zealand the preferred option.�[537]</div>
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466. On 6 June 1989 a meeting took place between Z,[538] the producers of surgical catgut, and DH.� The minutes record the following:</div>
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�1.�� The meeting had been arranged following a request by the Company to discuss the application of the joint CSM/VPC Guidelines on BSE to 3 products.</div>
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2.��� The Company opened the meeting by stating that they saw no possibility of complying with the Guidelines, in particular for the major product , Surgical Catgut. DOH representatives suggested that a positive approach would be to consider the whole production process, starting with the source animal, with regard to potential points of intervention.</div>
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�</div>
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Clinical use of Catgut sutures</div>
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The company indicated that around 80% sutures used by UK surgeons were catgut, the rest synthetic.� Some specialists eg gynaecologists appeared to prefer catgut.</div>
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DOH asked about use in Neurosurgery, and the Company indicated that neurosurgeons tended to use synthetic absorbable sutures.</div>
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It was suggested that it would be useful to obtain a definitive picture of the spectrum of usage.</div>
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8.��� Forward Plan</div>
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8.1�� The Company was given an outline of likely DOH procedure, and that the first meeting of the Working Party on BSE would take place in September 1989.</div>
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8.2�� DOH informed the Company that the 2 renewal applications (Surgical Catgut and [redacted]) would be held pending the outcome of the Working Party on BSE.</div>
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8.3�� It was suggested that the Company should provide a dossier by mid-August containing further information on all the areas covered in the meeting, indicating</div>
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i.���� All current processes/procedures considered to limit the risk of BSE transmission by the product.</div>
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ii.���� Proposals for additional measures and when they can be implemented eg short-term � additional heat process medium to long-term � sourcing from Australasia.�[539]</div>
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467. On 7 June 1989 Dr Metters sent a submission to Ministers and other DH Officials. The purpose of the submission was stated as being to �alert Ministers to additional precautionary measures that MAFF propose to take� to reduce the risk to humans from cattle offal, namely that MAFF proposed �to ban bovine offal from food for human consumption.� He stated that this had resulted from a combination of two factors: anecdotal evidence that some cases of infected cattle were not identified before slaughter, and the fact that the exclusion of offal from baby foods had drawn attention to the potential risk from bovine offal in other human foods.� He noted that the scientific evidence for widening the ban on offal had not changed since the publication of the Southwood Report.� He further noted that this action might draw attention to continued use of bovine material in licensed pharmaceutical preparations.[540]�</div>
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468. In his Statement to the Inquiry Sir Donald Acheson said:[541]</div>
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�Although there was a conflict of view with my expert advisers, the new controls came entirely within MAFF's domain so I did not resist the ban and, with one 'caveat', supported it as an additional protection for human health without any apparent balancing disadvantage.</div>
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My �caveat� related to concern that an announcement of the SBO (sic) in advance of the anticipated reassurance concerning the safety of vaccines from the CSM might lead to a marked and unwarranted decline in the uptake of vaccines in children.� I had in mind a marked and extended previous reduction in the acceptance of whooping cough vaccine which had followed incorrect public allegations by a scientist that the administration of the vaccine carried a significant risk of encephalitis.� On the one hand I was aware that during the period 1980-1988, due to incomplete vaccination of our population of children, there had been 123 deaths from measles and 50 from whooping cough in England, together with a many times larger burden of illness and some long-term complications.� Against this I had to balance a remote risk of a fatal disease.� A warning was given to Ministers to this effect but in the event although the announcement was not delayed as I wished, it fortunately did not provoke an anti-vaccine scare.�</div>
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469. On 8 June 1989 Dr Metters minuted Dr McInnes with copies to Dr Harris, Miss Pease, Drs Pickles and Rubery, Mr Hagger and others, about �MAFF�s meeting with Sir Richard Southwood� the previous day. The meeting had been attended by Mr Cruickshank, Mrs Attridge, Mr Meldrum, Mr Coe, Sir Richard Southwood, Dr Metters and Dr Pickles.[542]� The minute noted the discussion at the meeting, which centred on possible removal of bovine offal from the human food chain. The minute went on to say:[543]</div>
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</div>
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�11. On timing Mr McGregor wants to make an announcement as soon as possible. MAFF officials expect this will be very early next week. MAFF�s first objective is to satisfy public pressure for a ban on offal. In their view it will not focus attention on bovine constituents of pharmaceuticals. But time will tell.�</div>
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470. On 8 June 1989 Dr Pickles sent Mr Hagger an amended version of the draft of section C2 of the interim Tyrrell report which now stated:[544]</div>
<div style="font-family: arial; font-size: 13.3333px;">
�b. additional transmission studies specifically relevant to pharmaceutical manufacture. The Medicines Control Agency, with expert advice, will be considering whether there is a need for work in this area.�[545]</div>
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471. On 9 June 1989 Dr Metters minuted the CMO, Sir Donald Acheson, with copies to Dr Pickles, Dr Rubery and Mr Hagger, about the �Action proposed by MAFF Ministers on bovine offal�. The minute referred to a meeting on 6 June 1989 between Dr Metters and Mr MacGregor, in preparation for a meeting between Mr MacGregor and Sir Richard Southwood on 7 June 1989, attended by Dr Metters. The minute said:[546]</div>
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�5.�� Preliminary Briefing Meeting</div>
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Mr McGregor wished to decide the detailed line he would take in discussion with Sir Richard the following day. This briefing was attended by a large number of MAFF officials, including their Permanent Secretary. All MAFF officials had copies of various papers, which had not been copied to DH.�</div>
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472. Paragraph 8 of the minute discussed �DH Points�:</div>
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�I told Mr McGregor of my conversation with Sir Richard Southwood earlier in the day, and I thought it unlikely Sir Richard would change his mind on the science. I mentioned Dr Tyrrell�s point about the inconsistency of banning bovine but not sheep offal. I also said that the CSM did not yet have the necessary data on which to consider pharmaceuticals with a bovine component and advise on any necessary action. A ban on bovine offal by MAFF could shift attention to the pharmaceutical problem.�</div>
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473. Dr Metters also comments at paragraph 14 of the minute under �DH Interests�:</div>
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�The possibility that MAFF�s action may refocus attention on bovine constituents of pharmaceuticals cannot be ruled out.� While I put this point more than once, it cut little ice with MAFF officials.�</div>
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474. On 9 June 1989 Mr Hagger also sent a minute to Mr Wilson[547], Grade 3 Administrative Head of Medicines Division, concerning the proposed offal ban. It was copied to, among others, Dr K Jones, Dr Adams, Dr Jefferys, Dr Rotblat, Dr Purves, Mr Love, Mr Sloggem, Mr Burton and Mr Scollen (MAFF). Mr Hagger attached a copy of Dr Metters� submission to the Secretary of State reporting on MAFF�s proposed offal ban. Mr Hagger noted:</div>
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�2.�� Another factor which might bring medicines back into the public debate of BSE is the likelihood that the Tyrrell report on BSE will be going to Ministers shortly and that it might then be published.</div>
<div style="font-family: arial; font-size: 13.3333px;">
4.��� My minute to Dr McInnes summarised the MCA position over the enquiry. To go into a little more detail, an in-house MCA meeting has been arranged for Monday morning 12 June in my room, to be attended by professionals and administrators, to take consideration of the company replies a step further and to produce a �project plan� leading to the CSM�s working group meeting on 6 September. We expect PD/STD to be represented on Monday�.�</div>
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475. In his Statement to the Inquiry Dr Jefferys said:</div>
<div style="font-family: arial; font-size: 13.3333px;">
�On 9th June 1989, I was copied a minute from Mr Hagger to Mr Wilson about the proposed offal ban. It stated that the proposed ban was in response to increasing public pressure rather than any new scientific evidence. It went on to state that another factor which might bring medicines back into the public debate was the likelihood that the Tyrrell report on research would be going to Ministers shortly and that it might then be published. Extracts from the draft report were enclosed with the minute; paragraph C2b of the report referred specifically to the MCA. It stated �Additional transmission studies specifically relevant to pharmaceutical manufacture. We recommend that the Medicines Control Agency, with expert advice, considers the need for work in this area.� The Tyrrell Report on research was submitted on 13th June 1989.�[548]</div>
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476. In relation to the draft report attached to Mr Hagger�s minute, Dr K Jones said in his Statement to the Inquiry:</div>
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�I did not disagree with the draft and therefore made no response.� Although the MCA is a regulatory body and as such does not carry out or fund research, I saw no reason why the CSM or its BSE Working Party should not make recommendations as to the type of studies which the experts considered would be helpful.� I would have expected the Tyrrell Report to be placed before the CSM and/or the BSE Working Party and for the CSM to respond as it thought appropriate.�[549]</div>
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477. On 12 June 1989 an internal meeting in Medicines Division was held, to undertake a preliminary review of the replies from licence holders to the human medicines questionnaire.[550] Approximately 50-60 per cent of the product licence holders who had been contacted had replied. Products were divided into 7 notional categories in descending order of risk.� These were set out in a note of the meeting as:</div>
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�2.2.1���������� Products with bovine brain/lymphoid tissue as ingredients and administered by injection.</div>
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2.2.2����������� Products with bovine ingredients (other than brain/lymphoid tissue) and administered by injection.</div>
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2.2.3����������� Tissue implants, open wound dressing, surgical materials, dental and ophthalmic products with bovine ingredients.</div>
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2.2.4����������� Products with bovine ingredients and administered topically.</div>
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2.2.5����������� Products with bovine ingredients and administered orally.</div>
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2.2.6����������� Products with other animal/insect/bird ingredients and administered.</div>
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a. by injection</div>
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b. topically</div>
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c. orally</div>
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2.2.7���������� Products/Ingredients of animal origin considered to be of no risk.�[551]</div>
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The first two categories were to be looked at by Dr Rotblat and Dr Purves, the third by Dr Adams and Dr Raine.[552]� No action was to be taken on the remaining products for the present.� It was also agreed that non-responders would be chased.[553]� The minutes note:</div>
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�Category 2.1���������� Products with bovine brain/lymphoid tissue as ingredients and administered by injection.</div>
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3 such products known at present, but could be more.� Action will need to be taken against these PLs in the light of MAFFs ban on bovine brain/lymphoid tissue in food.</div>
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Category 2.2 Products with bovine ingredients (other than brain/lymphoid tissue) and administered by injection.</div>
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This category includes those products containing foetal calf serum etc. and therefore covers injectable vaccines and other biologicals�</div>
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Category 2.3 Tissue implants, open wound dressing, surgical materials, dental and ophthalmic products with bovine ingredients</div>
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This MCA category matches those products of most concern to STD.</div>
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Sutures made from bovine material to be placed high on the agenda for the Working Party.</div>
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MCA have had discussions with Z who are producing a detailed submission on the subject.</div>
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Categories 2.4 to 2.6 Minimal emphasis and resource to be given to these categories at present�[554]</div>
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478. The minutes also record the following:</div>
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�Dr Jefferys reported that Mr MacGregor (MAFF Minister) was due to ban all use of bovine brain and lymph tissue in human food (note: already banned in baby food.)� It was understood that this would be announced tomorrow (13 June) and that a CMO meeting would follow.�[555]</div>
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And later:</div>
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�MAFF had diverged from MCA at the time the Guidelines were sent out and all matters relating to veterinary medicines were being handled directly by MAFF.� Concern was expressed that MAFF could be developing independent policies in the face of pressure from their food sections.� MCA to liase more directly with MAFF in future.�[556]</div>
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479. In her Statement to the Inquiry Dr Rotblat stated that non-responders were repeatedly written to by administrators until a satisfactory response was received.[557]</div>
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480. The note of the meeting concludes with action items:</div>
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�a.� MB1B to �follow up� as a matter of urgency those licence holders who had not returned a questionnaire.</div>
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b.� MB1B to notify MAFF of the meeting and developments within MCA.</div>
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c.� Specific companies to be contacted by MB1B on matters arising from their completed questionnaires�.</div>
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d.� MB1B to continue updating the BSE database with replies in the classes at 2.2.1 � 2.2.7 above and summaries of the replies to be circulated to those attending the meeting for review.</div>
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e.� Papers to be prepared for presentation to the Working Group based on the information provided by licence holders in response to the questionnaire.� Responsibility for the papers was assigned as follows:</div>
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������������������ Dr Rotblat/Dr Purves � 2.2.1, 2.2.2, 2.2.4, 2.2.6, and 2.2.7.</div>
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������������������ Dr Adams/Dr Raine � 2.2.3</div>
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With a deadline for completion by end July 1989.�[558]</div>
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481. In his Statement to the Inquiry, Dr Adams notes:</div>
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��By June 1989, we had received a number of responses from licence holders on the use of bovine materials in their products. A meeting was held within the Department of Health Medicines Division on 12th June 1989 in advance of the BSE Working Party meeting arranged for 6th September (minute dated 8th June from M.Love; agenda circulated 8th June). The responses had been broken down into categories (I do not recall by whom).� [559]</div>
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482. On 13 June 1989, following the Medicines Division internal meetings of 12 June 1989, Mr Armstrong circulated lists dividing up the information which had been received in response to the BSE questionnaire into the various categories.[560]</div>
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483. On 13 June 1989 Sir Donald Acheson minuted the Secretary of State about the Tyrrell Report on BSE research:</div>
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�2.�� �A large number of research areas are allocated high priority and this work will be laborious, time consuming and expensive. Almost all the recommended work is directly for MAFF (at the Central Veterinary Labs) or for the AFRC: the relatively small amount for DH/MRC (section A2a on page12) is being taken care of.�[561]</div>
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484. On 13 June 1989 Dr Pickles circulated the Tyrrell Report to a number of people including Medicines Division.[562]</div>
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485. On 27 June 1989 Mr Hagger minuted Dr Adams, Dr Jefferys, Dr Raine, Dr Rotblat, Dr Purves, Mr Sloggem, Mr Love and Mr Armstrong about keeping MAFF informed of MCA developments on BSE:</div>
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�Dr J M Rutter, the Director of the Veterinary Medicines Directorate, asked to be kept in touch with MCA developments on BSE.� He has seen my minute of 5 June to CM[O]�s office summarising progress to date and would like the Veterinary Medicines Directorate (VMD) to be involved in any meetings that we hold as well as being kept in touch with other significant developments.�[563]</div>
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486. In her Statement to the Inquiry Dr Rotblat[564] said:</div>
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�I, and other colleagues, received a minute dated 29th June 1989 from Mr Armstrong[565] [separate to the one sent on 13 June 1989] enclosing lists dividing up the information received from pharmaceutical companies along the lines of the categories referred to at the meeting on 12th June. In addition, a list of ingredients which did not give cause for concern had been drawn up. The reason for drawing up such a list was to eliminate many of the responses to the BSE questionnaire from further consideration. The list primarily consisted of non-bovine products or very highly processed tallow derivatives principally used in oral medicinal products.�</div>
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487. On 3 July 1989 Dr Pickles minuted Mr Maslin about cattle by-products and BSE. The minute said:[566]</div>
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�I was interested to see the list of by-products sent to the HSE. Those of particular concern included:</div>
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*small intestines: sutures ( I thought the source was ovine but you are checking this)</div>
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*spinal cord: pharmaceuticals</div>
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*thymus: pharmaceuticals</div>
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Are you able to give me more information on which UK manufacturers use these materials? Our proposed ban on bovine offal for human consumption would not affect these uses, I assume.�</div>
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488. A handwritten note on Dr Pickles� minute from Mr Mark Hawkins, Higher Executive Officer at MAFF, to �John� said:[567]</div>
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�1. � A few companies make sutures out of intestinal linings, worth around �300 k p.a; probably some sheep used as well, but minimal.</div>
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2.��� Virtually all spinal cord goes for rendering, with just a very small amount going for pharmaceutical use.</div>
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3.��� About 30 % of thymus production goes for pharmaceutical use (approx �132 K pa).</div>
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Incidentally, some spleen also goes for pharmaceutical uses (approx �170 K pa). The main company involved with pharmaceuticals is Y[568] (MLC is trying to find a contact). Is Hilary serious about her final sentence? I would have thought that a) the staining would make these materials unusable (this is also MLC�s view) and b) if they are unfit for consumption, they are certainly unfit for medication. Has she forgotten iatrogenic CJD?�</div>
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Risk to humans</div>
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489. On 4 July 1989 Dr Adams minuted Dr Raine about BSE. He said:</div>
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�Having seen Mr Armstrong�s print-out of the responses from the BSE questionnaire, the Z Catgut product seems to be the only UK source material and we would need a very strong justification to allow it to remain on the market�.Until now we had been of the view that many of the other catgut products were UK sourced as well. This is now shown not to be the case and I think Z and we have a problem!�[569]</div>
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490. On 5 July 1989 Sir Richard sent Dr Tyrrell his reaction to his interim report (�The Tyrrell Report�). He stated:�</div>
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�Thank you very much for sending me the interim report of your Consultative Committee on Research.� I read it with considerable interest and admiration.� I think it�s excellent and I just hoe that the Ministry and others will, notwithstanding the ridiculous attitude towards public expenditure, find the necessary funds to undertake the high priority research.� I was horrified to discover a little while ago that the formal controlled study of possible vertical transmission had not been put in place.� The danger is, of course, that some of the early animals will be lost.�</div>
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You are absolutely right to point out gently how we were forced to argue from analogy with scrapie and one waits with some anxiety for the experimental confirmation of that assumption!</div>
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If you were making a few drafting changes the only point I would ask you to consider would be on page 4, paragraph 2.2 where you say �the Southwood group was correct in their belief that this disease would not have implications for human health say through food��.� A more complete picture of our belief would be given if you add �provided various safeguards, that they recommended, were instituted�.� Personally I would have thought the possibility of human infection was moderately high if some medicinal products were made from tissues of infected animals and injected into humans.�[570]�</div>
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491. Kenneth Clarke, Secretary of State for Health, was shown this letter for the first time while giving oral evidence to the BSE Inquiry. He commented:�</div>
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��I am reacting in the way I suppose I would have reacted at the time when this is first put in front of me, when I got this out of a red box at some time: what on earth does Sir Richard mean by �moderately high�?� Then the next question is: What should we do about it?</div>
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�</div>
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If I had been shown this, I suppose I would have said how does this square with �risk is remote�?�[571]�</div>
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He was later asked what a Secretary of State would do confronted by a situation where there was a whole series of pharmaceutical products on the shelf derived from a bovine product which may be infected and have a moderately high risk of transmission if injected into humans. He replied� ��he would probably wind up ordering withdrawal of all the batches that might be affected�it could well mean that a significant number of patients may be infected by this.�[572]</div>
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492. Professor Collee said:</div>
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�I have very recently been shown a copy of a letter dated 5th July 1989 from Sir Richard Southwood to Dr Tyrrell�</div>
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Sir Richard�s comments should be seen against the methodology involved in manufacturing medicinal products such as vaccines. The use of foetal calf serum in the manufacture of vaccines could not fairly be related to the example given by Sir Richard Southwood. Had I seen Sir Richard�s letter in 1989, I would have asked him to clarify his remark. As it stands, the remark poses a hypothetical situation. I would also have described to Sir Richard the discussions we had on various medicinal products and our views on the hazards that might be posed by those products.�[573]</div>
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493. In his Statement to the Inquiry Professor Asscher stated the following with regard to this letter:</div>
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�I have been asked to comment on the letter dated 5 July 1989 from Sir Richard Southwood to Dr Tyrrell.� I should make it clear that I have not previously seen this letter.� I must confess that I am surprised by its contents.� The letter does not fit easily with the statement in the Southwood Report that the risk from medicinal products was remote.� Sir Richard�s comments are inconsistent with my understanding of his views; I believed that he considered the risk from all medicinal products to be remote.� I believe that if the CSM had seen this letter at the time we would have asked for clarification from Sir Richard.� We would have wanted to know his scientific basis for the comment that �Personally I would have thought the possibility of human infection was moderately high if some medicinal products were made from tissues of infected animals and injected into humans.�[574]������������������������������������������������������������� ��������������������������������������������������������������������������������������</div>
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494. On 10 July 1989 Dr Raine replied to Dr Adams� minute of 4 July 1989, by way of a hand written note, which stated that the company involved [Z] had been informed of the �need to review the situation� and that she had arranged a meeting with them for 20 July.[575]</div>
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495. On 14 July 1989 Dr John Purves minuted Dr Adams in the following terms.</div>
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�1.�� By copy of Dr June Raine�s minute about a meeting to be held with [Z] on Thursday 20 July, I note your observation that �we would need a very strong justification to allow it (catgut) to remain on the market�.</div>
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2.��� I was surprised to see that another meeting had been arranged with the Company without any prior multidisciplinary discussion.</div>
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3.��� You have identified some new information arising from the useful data provided by Murray Love�s group, in that it would appear only [Z] source raw material for this product from the UK.� The significance of this must be weighted against the fact that the presence of BSE in other countries cited has not been excluded.� In addition, when we are within six weeks of seeking the views of experts on how to deal with the whole problem of BSE in a range of pharmaceutical products, why have we picked out [Z] from all other companies?� You are no doubt aware of the minute of the meeting held at Market Towers with the Company on 6 June.� The Company�s keen awareness of the problem, scientific approach to solve it and responsible attitude � it was they who contacted the Agency for a meeting � all indicated to [sic] the pragmatic approach of letting them prepare a rounded paper on the topic, for submission to the expert Committee which is to meet at the beginning of September.� This they agreed to do.� They have been positive and helpful in their contacts with us.</div>
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4.��� Unless I am unaware of other information, it would seem premature to press this company on an issue about which the Agency is hoping to get expert advice in the near future.� Without good reasons, it seems iniquitous to isolate one Company for attention at this stage.</div>
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5.��� What is the objective of the meeting scheduled for next Thursday?</div>
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6.��� It would seem prudent � if the meeting with the Company is justified � to hold a briefing meeting to ensure a unified approach by Agency staff.�[576]</div>
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496. In relation to paragraph 2 of this letter, Dr Purves has explained:</div>
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�I did not think it was a [sic] necessary to set up another meeting with Company Z.� The reason was that we were within about 6 weeks of seeking the views of experts at the first meeting of the BSE Working Group on how to deal with the whole problem of BSE in a range of pharmaceutical products.� I referred to the meeting held with the company on 6 June.�� It had been agreed with the company that they would present us with a dossier, by mid August, reporting on the manufacturing procedures used to limit the risk of BSE transmission by the product and their proposals on how they could comply with the guidelines.� We had advised them at that meeting that the Company�s position would be reviewed at the BSE Working Group meeting in September.� Although the information provided by Murray Love's group in the list was helpful, we were already aware of the catgut suture issue and had taken steps.� I did not think a second meeting was necessary since Company Z had already shown itself to be willing and able to take steps to comply with the guidelines.�[577]</div>
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497. On 19 July 1989 Miss Green of the NOAH wrote to Mr Whitbread, a Higher Executive Officer of the MCA. The letter said:</div>
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498. ��I am writing regarding the guidance on good manufacturing practice for human and veterinary medicines which use material of bovine, ovine and caprine origin, issued by MAFF to all licence and certificate holders for veterinary medicinal products.� Many NOAH members are concerned over the relevance and practicality of certain aspects of the guidelines and have been advised by MAFF that comments would be useful and are best addressed to the Department of Health as it was you that fronted the exercise.�[578]</div>
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499. She also stated that �it is impossible to produce most types of bovine virus vaccines without the use of cell cultures of bovine origin�. She later stated that �according to the current approach adopted by the guidelines, virtually all cell cultures, of whatever origin could conceivably be prohibited by the guidelines from being used in vaccine manufacture�.� In relation to collection techniques, Miss Green noted that �it would be very difficult to obtain the quantities of sera (17, 000 litres per annum) required for all purposes from animals stunned using other techniques [other than brain penetration]�.</div>
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500. On 26 July 1989 Dr Adams minuted Dr Jefferys regarding the letter of 19 July from NOAH. He stated that the points raised by NOAH had been foreseen.[579] Mr Gutowski of the MCA replied to Miss Green on 24 August 1989 saying that Miss Green�s comments would be taken into account during the study of animal materials used in medicinal products.[580] This correspondence was drawn to the attention of the first meeting of the BSE Working Party on 6 September 1989.[581]</div>
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501. On 2 August 1989 Ms Margaret Williams, from X[582], wrote to Mr S Hutchins and said:[583]</div>
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�I have already spoken to our suppliers on the subject of BSE and the source of their raw material. The only information they have on the contamination and testing of the raw material is that the abattoirs used produce only food fit for human consumption. They did not think that any further control is at present possible on the raw intestine.�</div>
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502. On 2 August 1989, Mr Gummer (MAFF) wrote to Mr Kenneth Clarke (Secretary of State for Health) regarding the programme of research covered by Dr Tyrrell�s report.[584] Mr Gummer explained the contents of the annexed lists of research:</div>
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�The programme of research covered by Dr Tyrrell�s report is set out in Annex 1. �The research programme is divided into 3 categories of urgency and at the Committee�s suggestion I have concentrated on the two most urgent categories.� In these two categories I have costed in Table 1 those parts of the programme that would fall to me to finance and I have indicated in Table 2 where responsibility for other parts of the programme would appear to fall.� In view of the wide public concern about this disease, I see no option for the Government other than to ensure that all the projects in these two higher categories are initiated.� Not to do so would lay us open to the criticism that, while we were aware of the potential danger of BSE, we had failed to research into the public and animal health aspects adequately.� I consider that in order to keep the initiative, I need to announce urgently that the Government has accepted the findings of the Tyrrell report as regards the projects to which it attaches higher priority, and that we are making money available so that work can begin on the most pressing recommendations that were considered by Tyrrell to be of primary importance.�[585]</div>
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503. Next to the entry for C2a and C2b, in Table 2[586] annexed to Mr Gummer�s letter, is the comment:</div>
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�In these issues MAFF will have joint responsibility with DOH in support of the Medicines Act 1968.�</div>
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504. On 4 August 1989 Dr Lee, of MAFF, wrote to Mr Armstrong of the Information Section DH, to give an update on the replies to the veterinary medicines questionnaire sent out on 15 March 1989.[587] �She reported that of the 245 companies targeted, 186 had provided replies. These covered 3,239 products of which 303 contained bovine, ovine, or caprine products. Dr Lee said that MAFF would be undertaking an initial analysis of these 303 returns in the near future.</div>
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505. On 7 August 1989 Dr Metters sent a submission to the PS/Mr Kenneth Clarke advising the Minister�s agreement to the publication of the Tyrrell Report. He suggested that the announcement of the publication should include a reference to an early start being made on research falling to the Department of Health. He attached a draft letter to Mr Gummer which noted:</div>
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�The pharmacological studies in which our Departments have a joint interest will need to be considered again after we have the advice of an expert group convened under the Committee on Safety of Medicines. The advice from the group is not expected until September at the earliest.�[588]</div>
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506. On 9 August 1989 Mr Roger Freeman, Parliamentary Under Secretary of State for Health, wrote to John Gummer, the Minister of Agriculture in the terms of Dr Metters� draft letter.[589]</div>
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507. On 21 August 1989 Dr Adams minuted Mr Gutowski saying �information on the product � surgical cat gut � is concerning.�[590]</div>
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508. On 21 August 1989 PD held a meeting to review the responses to the medical devices questionnaire.[591] �The minutes of the meeting state:</div>
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�Despite letters and telephone calls to the companies who have not replied the final response was still only about 66%.� The committee was concerned about the number of UK companies who have not yet responded.� Concern was also shown about BSE products being transported around Europe.</div>
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The Committee decided that a definitive list was needed of the companies in the UK and Europe, who have not responded.� These companies would be sent a 2ndreminder.�</div>
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Of the responses received, 46 manufacturers used animal material, of whom 26 used bovine material. Two of these manufacturers used UK sourced pericardium tissue.[592]</div>
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509. The meeting also considered a paper entitled �Inactivation of Scrapie-Like Agents�,[593] which reviewed existing literature on inactivation studies and had been prepared to assist in discussion related to the validation of non-standard sterilization methods.</div>
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510. On 24 August 1989 Mr Gutowski, of the MCA, replied to NOAH�s letter of 19 July 1989, saying that the concerns raised would be taken into account and that the Licensing Authority was continuing its study in the light of questionnaire responses.[594]</div>
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511. On 30 August 1989 Mr Bradley minuted Dr Watson reporting on a meeting Mr Wilesmith, Mr Taylor, and he had with Z about suture material prepared from cattle. The minute stated that �[redacted] told us that [Z] had about 60% of the suture market in catgut; 90% being sourced from cattle and 10% sheep�. The minute also noted that �The quantity of gut required >100, 000 runner sets pa precluded any UK source such as a MAFF controlled BSE-free herd.�[595]</div>
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512. On 30 August 1989 Dr Lee prepared a note on the BSE questionnaire returns from licence holders for veterinary medicines:</div>
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��An initial analysis has now been undertaken of the 303 �positive� returns received so far. Approximately 45 different ingredients of bovine or ovine origin have been mentioned.</div>
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As expected, the most common listed ingredient of animal origin is bovine serum (86 products)�.</div>
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A country (or countries) of origin has been stated for a high proportion of the tissues mentioned. However, where more detail has been available it is clear that, for many, the country stated is that where the material has been purchased and this is not always the country of origin of the animal tissue.</div>
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Different companies have interpreted the questions posed in different ways and some of the apparently complete returns are, in fact, incomplete.</div>
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Much further work and time would therefore be needed to gain as complete a picture as possible of all the substances of animal origin in all veterinary medicinal products.</div>
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Effort will need to be concentrated, in the meantime, on those products which, from the returns and knowledge of the products, can be identified as having possible risk of BSE contamination. Follow up letters with specific questions will be required for the licence holders of these products.�[596]</div>
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513. On 5 September 1989 the CRM met and Dr Adams advised the Committee that the BSE working party would be discussing company responses to the questionnaire that accompanied the CSM/VPC guidelines on 6 September.[597]</div>
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The BSE Working Group (on human medicinal products): first meeting</div>
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514. The HVMBG as part of its deliberations on 22 February had recommended the setting up of a BSE Working Group to advise the section 4 committees on the implications of BSE for human medicinal products. The CSM had accepted this recommendation. The BSE Working Group met for the first time six months later on 6 September 1989. Professor JG Collee was its chairman. Other members included Professors Asscher, Campbell, Lawson, Berry and Rawlins, Drs Kimberlin, Kirby, Taylor, Tyrrell, Watson, Will and Watt. DH and MCA officials were in attendance as well as Dr A Lee for MAFF. The minutes of the meeting recorded:[598]</div>
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�3. Since the publication of the Southwood Report, no further evidence had come to light to change the original view that the risk of BSE being transferred to humans is considered to be remote and theoretical. Hence the likelihood of the BSE agent affecting humans via medicinal products by the use of bovine material in the production process is also thought to be remote. Nevertheless the Working Group would need to consider this risk and balance it against the obvious and known advantages to health afforded by the current availability of medicines and vaccines incorporating bovine material. To date available evidence has suggested that cattle are likely to be a dead-end host for the BSE agent, but the Chairman [Professor Collee] sounded a note of caution and stressed the need for further investigative research into the disease, of which little is really known and quoted from the Southwood Report: -</div>
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�From present evidence, it is�most unlikely that BSE will have any implications for human health. Nevertheless, if the assessments of these (sic) likelihood are incorrect, the implications would be extremely serious.��</div>
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515. It was reported that responses to the questionnaire were still being received; around 75% of licence holders had responded by this time. The Working Group emphasised the importance and desirability of achieving a total response. At that stage, the Working Group was told that BSE was confined to UK, the Channel Islands, Republic of Ireland, the Falkland Islands and Oman (the latter two probably in cattle imported from the UK).</div>
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516. Dr Rotblat presented a paper, prepared by her and Dr Purves, to the group based on the results so far received from the March questionnaire.[599] The valid responses were divided into the following categories in order of concern[600]:</div>
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�Products with bovine brain/lymphoid tissue as ingredients and administered by injection.���������������������������������������������������������������������������������������� 111</div>
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Products with bovine ingredients (other than brain/lymphoid tissue) and administered by injection.��������������������������������������������������������������������������� 135</div>
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Tissue implants, open wound dressings, surgical materials, dental and ophthalmic products with bovine ingredients.��������������������������������������������������������������� 27</div>
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Products with bovine ingredients and administered topically.����� 5</div>
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Products with bovine ingredients and administered orally.��������� 9</div>
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Products with other animal/insect/bird ingredients.���������������� 131</div>
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Products with materials produced from animal material by chemical processes eg. stearic acid, gelatin and lanolin.������������������������������������������������������������ 156�</div>
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517. The paper indicated that only two products were considered to give immediate concern[601],� ��although 176 products do not conform to the CSM/VPC guidelines.� These two were, first a range of� ��homoeopathic medicines [including 53 injectable ones] with material obtained from cattle and a number with material from the brain�, and secondly, a surgical catgut.</div>
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518. Dr Purves has explained that the reason that only 2 types of product gave concern was that:</div>
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��of the non conforming products, only two groups of medicinal products were likely to contain bovine brain or lymphoid tissue sourced in the UK as ingredients as opposed to merely using them during the manufacturing process.� The other non-conforming products were not disregarded (they most certainly were not - as is clear from the rest of this statement) - but we were focusing on those that were of most concern first.� Because of the prolific use of bovine materials in medicines we had to target the products with theoretically the highest risk first.� We could not apply a knee jerk reaction to all non-complying products.�[602]</div>
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519. The paper made the following recommendations[603]:</div>
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�1.�� That no licensing action is required at present in regard to products produced from bovine material other than brain, and sourced from outside the UK and Ireland.</div>
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2. No licensing action at present regarding use of prepared bovine brain in nutrient media.</div>
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3. The CRM should review the PLR for F[604] in view of the bovine brain used in manufacture.</div>
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4. The Joint CSM, VPC guidelines should apply to all UK and Eire sourced bovine material. Companies which at present cannot comply should be encouraged to do so as soon as possible. The time-scale should be agreed with the licensing authority for each individual product.</div>
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5. No licensing action is required at present in regard to products containing material from animals other than cattle.</div>
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6. The Licensing Authority should continue to review scientific progress in the field of BSE, so as to be in a position to take licensing action in the future should this be necessary.�</div>
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520. The paper also noted[605]:</div>
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�The above general and theoretical considerations must also take into account,</div>
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2.1 the findings of [the] Southwood Report in which it was stated that� �the risk to man of infection via medicinal products was remote�. It is important not to undermine this considered advice by demanding unnecessary assurances and information from manufacturers.</div>
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2.2 the paucity of hard scientific information on the nature of the BSE agent.</div>
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2.3 the type of bovine material used in the manufacture of products� (brain, lymphoid tissue sera etc.)</div>
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2.4 the type of product containing bovine material (injection, topical, oral etc).�</div>
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521. The Working Group considered that on the evidence available products with bovine ingredients administered topically or orally, products with other animal/insect/bird ingredients, and products with highly processed animal material (e.g. lanolin, gelatin and stearic acid) [ie. the fourth to seventh of the MD categories, see paragraph 516 above] were not a cause for concern at the present time.</div>
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522. The BSE Working Group made four general recommendations in relation to products falling within the first three categories:[606]</div>
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�1.�� That no licensing action is required at present in regard to products produced from bovine material or using prepared bovine brain in nutrient media and sourced from outside the United Kingdom, the Channel Isles and the Republic of Ireland provided that the country of origin is known to be free of BSE, has competent veterinary advisers and is known to practise good animal husbandry.</div>
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2. The Joint CSM/VPC guidelines should apply to all bovine material sourced from UK, Channel Islands and the Republic of Ireland and any other area known to have BSE. Companies which at present cannot comply should be encouraged to do so as soon as possible. The timescale should be agreed with the Licensing Authority for each individual product as appropriate.</div>
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3. No licensing action is required at present with respect to products containing material from animals other than cattle.</div>
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5.��� The Licensing Authority should continue to review scientific progress in the field of BSE, so as to be in a position to take licensing action in the future should this be necessary.�</div>
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523. In his Statement to the Inquiry Professor Collee stated[607] that although the guidelines excluded the use of all bovine material of a certain type, regardless of its source, it was reported to the BSE Working Group that BSE was confined to the British Isles, except some cases that had occurred as a result of export. (The meetings of September 1989 and July 1990 provide more detail on this point). Accordingly the BSE Working Group were able to recommend that no action be taken on certain products using the excluded material, if it was appropriately sourced.�</div>
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524. In her Statement to the Inquiry Dr Rotblat said[608] that she believed the reasoning behind identifying only two groups of products as giving cause for concern, was that only two groups were likely to contain bovine brain or lymphoid tissue as ingredients, as opposed merely to using them during the manufacturing process.�</div>
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525. In relation to the first group, the homoeopathic products identified by the Rotblat and Purves paper as being of concern, the BSE Working Group noted that further follow-up action would be needed, with the possible involvement of the CRM.</div>
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526. In relation to the second product (surgical catgut) identified by the Rotblat and Purves paper as giving cause for concern (which was the only such product in the third category) the BSE Working Group had before it a paper prepared by Dr Raine, based on information provided by the manufacturer Z. The paper said, inter alia:[609]</div>
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�1. Introduction</div>
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Surgical Catgut (PL� Z) represents the most immediate problem arising from the review of tissue implants, wound dressings, dental and surgical products containing material of bovine origin.� The reasons for concern are:</div>
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i.���� UK origin of the source material</div>
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ii.���� nature of the source material (serosal layer of bovine small intestine) and proximity to lymphoid tissue</div>
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iii.��� large scale production and use of product</div>
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�</div>
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2.��� Licensing Background</div>
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Surgical sutures which are capable of absorption by the body are licensed under the Surgical Materials Order 1971 (SI No 1267).� Z Surgical Catgut received a product licence of right in 1973, and a reviewed product licence was granted in April 1984.� An application for renewal was submitted in April 1989, and has not yet been determined pending the outcome of consideration by the Working Party on BSE.�</div>
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3.��� Surgical Catgut-BSE Questionnaire</div>
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Of the 9 product licences for surgical catgut, PL� , Z, is the only UK sourced product.</div>
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�</div>
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4.1 Scale of Production and use of Surgical Catgut</div>
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�One animal yields about 45 metres of intestine and the catgut manufacturing plant requires the input from 2,500 animals per day</div>
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4.2 Source Animal</div>
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4.2.1 Alternative Species</div>
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The utilisation of intestinal raw material from other species, for example porcine or caprine, on the scale required by Z is considered by the Company to be impracticable.</div>
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4.2.2 Country of Origin</div>
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The Company considers that the only safe material sources which could supply the quantities required are in Australia, and states that plans to change to Australian raw material are now well advanced.� This would entail procuring the equivalent of 10% of the annual cattle kill in Australia and 24% of the New Zealand kill, in a competitive raw material market.� The current projected date for commencing production from Australasian source material is 1991.</div>
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4.2.3 UK Cattle Source</div>
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The current raw material used cannot comply with the requirement that bovine material should come from animals taken from a closed herd in the female line since 1980, in which no animal has been clinically suspected of having BSE, and which has not been fed rations containing ruminant derived protein.</div>
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Z proposes to operate a limited selection procedure, confining raw material to �clean beef cattle� having an average age of 18 months to 2 years.� By January 1990, 18 month old cattle should not have been exposed to rations containing animal protein, since the Bovine Spongiform Encephalopathy Order 1988 prohibiting this came into force on 18 July 1988.</div>
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�</div>
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4.5 Catgut Manufacturing Process</div>
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A flow chart is provided at Appendix 3 of Company paper.� The catgut manufacturing process is basically a cleaning process involving a combination of physical and chemical operations.� The company contends that although no one step is known to be capable of inactivating BSE, there may be a cumulative effect against the BSE agent�</div>
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4.6 Clinical Usage</div>
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An alternative to the use of catgut, in the form of synthetic absorbable sutures, has been available since 1972, and conversion of the surgical profession to the use of synthetic materials would circumvent the BSE problem.</div>
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�</div>
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5. Z Proposals</div>
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The Company proposals are divided in to short-term and long-term objectives.</div>
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5.1�� Short Term������������������������������������������������������ Completed By</div>
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a.���� Source material � Feasibility studies</div>
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- operation of abattoir selection procedures����������������� End Aug 1989</div>
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- change over to Australasian raw material������������������ End Oct 1989</div>
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b.��� Manufacture � reintroduction of heat setting�������� End Dec 1989</div>
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c.���� Clinical � contraindicate in neurosurgery� ? </div>
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and paediatric surgery</div>
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5.2�� Long Term</div>
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a.���� Commence production from Australasian ����������� ? 1991</div>
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sourced raw material</div>
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b.��� Conversion of surgical profession to use of �������� ? date</div>
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synthetic absorbable sutures rather than catgut</div>
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6.��� Medical Comment and Recommendation</div>
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�</div>
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6.3�� The opinion of the Working Party is sought on the reassurance offered by the short term safety measures proposed.</div>
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i.���� Use of �clean beef cattle� ie 18 months to 2 years.</div>
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ii.���� Procedures specified by Company in current manufacturing process, as in para 4.5 (enzyme, alkali, tanning, alcohol packing, terminal sterilisation 25KGys).</div>
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iii.��� Reintroduction of heat-setting step (149�C for 1 hour)</div>
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iv.��� Contraindications in neurosurgery and paediatric surgery.</div>
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6.4�� In the light of 6.3 above, the advice of the Working Party is sought on the renewal of the Z surgical catgut product licence.</div>
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������������������������������������������������������������������������������ J M RAINE�</div>
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527. Dr Raine had also produced a paper entitled �Category 3: Tissue Implants, Open Wound Dressings, Surgical Materials, Dental and Ophthalmic Products with Bovine Ingredients � Review of Positive Responses to Questionnaire�.� This identified Z as failing to comply on one product.[610]</div>
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528. The BSE Working Group recommended that[611]:</div>
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��when material used to manufacture catgut is UK or Channel Island or Eire sourced, the company should -</div>
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8.6.1� Use �clean beef cattle� ie 18 months to 2 years of age</div>
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8.6.2� It was also noted by the Working Group that the Company uses specified procedures including enzyme, alkali, tanning, alcohol packing, terminal sterilisation by irradiation (25 kgs), and a dry heat treatment step at 149�C.�</div>
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529. The Working Group further considered that changeover to Australasian sourced raw material was the preferred option in the mid to long-term. It was noted that a minority of the BSE Working Group considered that �catgut should not be used in neurosurgery until or unless the materials are sourced from BSE free countries��[612]</div>
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530. Professor Collee has also said to the Inquiry:</div>
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�The question of bovine-derived catgut sutures was also carefully discussed at the meeting. On receiving the draft minutes of this meeting, I amended them and added a Chairman�s note (paragraph 9) to reflect our discussion. In light of the Working Party�s advisory function, I was anxious that the comments on the use of catgut sutures in neurosurgery should be recorded. I was personally concerned by this issue. Since the relevant sutures were manufactured from bovine intestine, this bovine intestine might be contaminated with bovine lymphoid tissue. Although at this time it was not proven that lymphoid tissue harboured the BSE agent, lymphoid tissue was regarded, on the basis of the scrapie analogy, as being potentially infective.�[613]</div>
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531. The BSE Working Group also heard a report from PD and agreed that ��there was no particular cause for concern here provided that the guidelines could be followed��</div>
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532. On 7 September 1989 Dr Pickles minuted Mr Woolley about Dr Metters� minute of 7 August 1989.[614] She stated:</div>
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�3. I have discussed with Dr Dastgir [DH] and Dr Levy at the MRC and the most urgent project for us to progress is that identified in A2a of the report ie the �surveillance� of CJD cases. �The most sensible way to progress this is for DH to arrange to fund the basic study, and for any later additions � such as molecular biology on neuropathological specimens, or detailed investigation of certain occupational groups � could be covered by MRC-grant aided work grafted on. In the long term � and this is a study we envisage lasting for at least a decade � we might ask the MRC to take over even the basic study�. But for the sake of speed now, we need to start with DH funds�</div>
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4. I hope there is no need for me or you to worry about the other items that could be linked with DH interests. Project A2b has only one star � principally because the group doubted that such a study could be mounted to provide any more information than would arise from other routes. However, if preliminary findings from Dr Will�s work suggests it would be worthwhile, we could investigate this further in the coming years. In the meantime, I am approaching the OPCS, who are already looking at occupational groupings for all CJD deaths notified to them, in case they have any specific proposals. Item A2c is already taken care of by Professor Preece�s study [,] and the Medicines Control Agency, together with the pharmaceutical industry, will be taking care of C2a and b. I think it� unlikely they will be calling on RM�s funds, but that is up to them.</div>
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5. BSE is a new disease, and who knows what we may want to investigate in the future. For now it looks as if we will not be draining the RM�s coffers too much.�[615]</div>
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533. On 7 September 1989, Dr Pickles minuted Mr Hagger.[616] She commented:</div>
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�1. As you will no doubt hear, we had a very useful meeting about BSE and medicinal products this afternoon.</div>
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2. One matter not discussed was research�� As I think we agreed earlier, we will look to the MCA to provide any necessary defensive briefing over the response to those items affecting them [see C2a and b on p18].</div>
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3. The general line is likely to be that we will try to get going all work starred +++ or ++, and if it is necessary and appropriate by direct funding.� As a result of today�s meeting, you may want to argue that the pharmaceutical problem is being circumvented by ensuring no potentially contaminated material will ever start into pharmaceutical processing � the line is up to you of course.� But if you are going to argue that these experiments are not now necessary, we must make sure Dr Tyrrell at least is willing to back you up.� From my preliminary chat with him this afternoon, I think you will find him very supportive of whatever line you want to take.</div>
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4. It is of course open to individual companies to demonstrate by transmission experiments that stockpiles of material they hold or B.S.A that went into them are not capable of transmitting agent to mice. They may find that they need this information to satisfy other regulatory agencies, even if the MCA is relatively relaxed in the short term.�[617]</div>
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534. On 7 September 1989 Dr Pickles also minuted Mr Maslin, of MAFF, about the risk of BSE contamination of bovine gut. She said:</div>
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�1.�� We spoke�about yesterday�s meeting at the Medicines Control Agency which was also attended by Dr Watson.</div>
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2.��� I was concerned by some statements made by a commercial company with product licences for material made from UK-sourced bovine intestine. They claim that there is no way of physically separating the serosal layer from lymphatic tissue and they claim discussions with the CVL have backed up this view. In spite of the chemical treatments to which their product is exposed, the company proposes that the only long-term solution is to source their material in Australasia.</div>
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3.��� These statements seem inconsistent with what has been said in justification for the exclusion of sausage casings from the proposed offal ban. The statements made by the licence holder are of course confidential under the Medicines Act, but inevitably there is a risk that the advice they have received might become public�.�[618]</div>
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535. On 13 September 1989 Dr Winship sent a letter to H,[619] the manufacturers of the homoeopathic products identified at the meeting of the BSE Working Group on 6 September as giving cause for concern. The letter said that the Licensing Authority required H to provide details about the country of origin of the cattle used for the bovine material in each of the listed products.[620]� In October Dr Winship prepared a paper for the CRM noting that the bovine materials used in these products were all sourced from West Germany.� In light of the information received, Dr Winship�s suggestion was that no further action was required in relation to the products concerned.[621]</div>
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536. On 18 September 1989 a meeting was held between MAFF and DH Officials and a number of invited experts, to discuss BSE. Those present included Sir Richard Southwood and Drs Tyrrell and Kimberlin. Drs Metters and Pickles represented DH and the CVO and Mr Lawrence represented MAFF. According to the notes of the meeting they agreed that foetal calf serum was ��a low risk provided that care was taken when it was collected� and they noted that the issue of sutures was being looked at by the CSM.[622]</div>
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537. On 19 September 1989 Dr Metters minuted Mr Hagger about the meeting. He said:[623]</div>
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�I attended a meeting at MAFF on 18 September called by the Chief Veterinary Officer Mr Meldrum to discuss various details of the proposed ban on bovine offal from food intended for human consumption�</div>
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The purpose was to discuss possible exceptions to the ban�[A] range of�matters were clearly in MAFF�s domain.</div>
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However, during the discussion two subjects were raised that are primarily for DH and MCA. These were:-</div>
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a: the potential risk of �catgut� derived from bovine intestinal origin. When bovine offal is to be excluded from human consumption on grounds of BSE risks, is it consistent to continue to allow the use of bovine derived catgut?</div>
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b: fetal calf serum. Here the problem identified was BSE risk through medicinal products containing fetal calf serum, or whose manufacture involves its use.</div>
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I indicated these subjects were primarily for DH MCA and that my understanding was MCA, having consulted the industry, would be holding a special meeting shortly to consider the various implications for BSE and licensed products that have a bovine constituents (sic) or in which bovine material is used during the manufacturing process.</div>
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MAFF officials are content to leave these issues to MCA. However, could you confirm that both are on the list of subjects to be discussed at the forthcoming meeting.�</div>
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538. On 19 September 1989 Dr Raine minuted Dr Adams about surgical catgut.[624]� She noted that Z had proposed to change to the use of clean beef.� This proposal had been endorsed by the Working Party, but the company�s proposed action had met with opposition from abattoirs.</div>
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539. On 20 September 1989 the CDSM met.� At this meeting the surgical catgut suture licence was renewed subject to conditions.[625]</div>
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540. Mr Love sent a minute about catgut to Drs Jefferys, Rotblat, Adams, Raine and Purves, with a copy to Mr Hagger, on 21 September 1989.� He attached a copy of the minute from Dr Metters to Mr Hagger of 19 September.[626]</div>
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541. On 21 September 1989 PD held a further meeting. A list had been drawn up of medical device manufacturers who had still not responded to the questionnaire and it was decided to send a second reminder to those manufacturers both in the UK and Europe.[627] Mr Burton reported on the first meeting of the BSE Working Group. The Working Group discussion on sutures was discussed in detail �as they offered a close parallel to PD products.�</div>
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542. The meeting also heard a report on the follow-up letters sent to the ten randomly selected manufacturers who had indicated compliance with the guidelines in May 1989. Of the 8 replies received, 4 had changed their response, and the others stated that their animal materials were not susceptible to BSE.</div>
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543. The meeting considered again[628] the paper on �Inactivation of Scrapie-like Agents� and agreed that it was suitable for distribution to manufacturers using bovine or porcine materials in their products. Finally, the meeting decided that the guidelines on tissue collection needed to be finalised and issued, the MCA was to be contacted on their plans for doing so.</div>
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544. On 28 September 1989 the CSM met.[629] Professor Collee delivered an oral report on the BSE Working Group meeting of 6 September 1989.[630]� The CSM endorsed the findings of the Working Group.</div>
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545. On 3 October 1989 Mr Lawrence�s submission to Ministers stated that it had been concluded that:</div>
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�(a)� the proposed exemption from staining and sterilisation for materials used in making pharmaceuticals (principally sutures produced from small and large intestines) should remain, on the basis that it would be for any controls to be applied under the Medicines Act, in the light of the views of the Committee on Safety of Dental and Surgical Materials.�[631]</div>
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546. On 3 October 1989 Dr Pickles minuted Miss Duncan of the PD in relation to the proposed offal ban. She noted that she was aware that there were several unlicensed products made from cattle, and that she had �argued� not to ban collection of offal intended for pharmaceutical and related use, since more rigorous control would be applied later.� Dr Pickles also noted that the MAFF rules might only apply to products licensed under the Medicines Act and sought Miss Duncan�s comments as soon as possible.[632]</div>
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547. On 4 October 1989 Dr Metters minuted Dr Pickles, copied to Dr K Jones, Director of the MCA.� The minute said:[633]</div>
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�6. At the MAFF meeting on 18 September Dr Kimberlin was content for calf spinal cord to remain in the carcass up to the age of 6 months as the evidence suggests that BSE entry to the CNS takes place later. Dr Kimberlin was much more concerned about the evidence that BSE appears much earlier in the reticulo-endotheial elements of bovine intestine.</div>
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7. Is there an inconsistency between the six month limit MAFF have in mind for the inclusion of bovine spinal cord in calf carcasses for human consumption and the 18 months � 2 years limit on bovine raw material from �clean beef cattle� used for the manufacture of surgical catgut?�</div>
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548. On 5 October 1989 Dr Pickles provided Sir Donald Acheson with a brief for his meeting with Mr Gummer on 16 October. The brief stated that �Mr Gummer has already had several briefing sessions on BSE with MAFF officials, but may want to hear CMO confirm that the risk to humans is considered remote.� She noted that the MCA and the HSE were taking appropriate action on parenteral medicinal products of bovine origin and occupational inoculation. The brief also stated that the MCA were considering whether action on specific products was appropriate.[634]</div>
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549. On 6 October 1989 Mr Burton replied on behalf of Miss Duncan to Dr Pickles� minute of 3 October 1989. The minute said:[635]</div>
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�3. We are pleased to note that, as a result of your intervention, the removal of specified bovine offal from the place of slaughter to a pharmaceutical manufacturer would remain permissible�</div>
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4. On the medical device front we are only currently aware of two British manufacturers using UK derived bovine material. Both make heart valves using pericardium and this tissue is not included in the definition of �specified bovine offal�. Consequently the proposed regulations should not affect these products. However if 8.1 of the proposals could be amended to read ��.pharmaceutical and other medical product manufacturers�� it would not then act as a barrier to any further developments. Products made from such offal would still come under the scope of the PD/STD Guidelines. We would be grateful if you would pass this view on to MAFF.</div>
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5. There may be some unlicensed medicinal products, used on a named patient basis, which would be assisted by proposal 8.1. This causes us some concern since rigorous licensing controls would be bypassed in these cases. I have been passing details of any such products to Mr Love as we become aware of them.</div>
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6. We also find it strange that research is not included alongside �instructional or diagnostic purposes� in 8.1 of the proposals.�</div>
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550. On 9 October 1989 Dr Pickles minuted Dr Metters, in reply to his minute of 4 October. She said that �the advice to the MCA is now rather more practicable and realistic (and incidentally closer to what Sir Richard Southwood argued for a year back in correspondence with Professor Asscher), accepting more flexibility for material sourced overseas. But for injectables sourced in the UK their advice is unchanged.� Z were shifting their operation overseas but in the interim had volunteered to reduce the risk by using beef rather than milk cows, and use animals under 2 years.� She said that �The expert working party accepted this interim compromise, knowing neither being beef cattle nor being under 2 years was any real guarantee, but realising there was no alternative.� [636]</div>
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551. On 10 October 1989 Mr Love minuted Dr Jefferys and said:[637]</div>
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�1. Following the meeting of the CSM at the end of September and its acceptance of the recommendations of the BSE Working Party, it would now seem appropriate for the LA to consider what action is required to take the exercise forward in line with the recommendations.</div>
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2. I have set out below some possible points which may or not be completely relevant and are certainly not exhaustive and I would be grateful for your opinion and those of the copy recipients of this minute [Drs Adams, Purves, Raine and Rotblat, Mr Hagger and Mrs Shersby] on the following</div>
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a. do the guidelines need updating as a result of the Working Party meeting?</div>
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b. what further action, if any, should be taken re notifying industry of the recommendations of the Working Party? (by means of a possible article in MAIL?)</div>
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c. should active encouragement now be given to those companies which do not meet the guidelines and source material from areas where BSE is known, to change within appropriate timescales to BSE free sources? This would be for all applicable products in the first three categories as set out in the Working Party minutes and not merely catgut.</div>
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d. a need to consider further products which may be stock-piled and not meet the guidelines.</div>
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e. a need to alert the CRM about the [homoeopathic] products and determine if any special action should be instigated.</div>
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3. Some or all of the above points may be unnecessary or are already being taken forward but I believe that the necessity for a coordinated LA role in the BSE exercise should now be considered along with �what needs to be done and by whom� being developed.�</div>
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552. On 12 October 1989 Dr Metters replied to Dr Pickles� minute of 9 October 1989, with copies to Dr K Jones and Dr Jefferys. The minute said:[638]�</div>
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�Thank you for your minute of 9 October. I can see the practical reasons that led the Working Party to agree the interim arrangements proposed by Z while they are making arrangements to source their material from overseas.</div>
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2.��� As you say, the agreement with the Company is �confidential� so that there will be no direct comparisons between the �six month limit� that MAFF have in mind for offal with the �18 months to 2 years� for suture material from clean beef cattle.</div>
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3.��� The crucial question is, can we defend this difference between the age limits if the disparity becomes public knowledge? Can the difference be defended and justified on scientific grounds?�</div>
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553. Dr Pickles replied to Dr Metters� minute by way of an undated hand-written annotation, copied to Dr K Jones and Dr Jefferys, stating, �We discussed. The ready defence is that these decisions were taken on expert advice.�[639]</div>
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554. On 13 October 1989 Dr Jefferys minuted Mr Love in reply to his minute of 10 October. He said that he did not think that the CSM/VPC guidelines needed updating and there was no need to notify the industry further. He stated that he had discussed the matter with Dr Adams, Dr Purves and Mr Hagger and that they agreed that the Working Party needed to meet in January.� On companies not complying with the guidelines Dr Jefferys wrote that an in-house procedure would need to be considered for approaching those companies which did not comply with the guidelines and for establishing an acceptable timetable for them to do so.[640] Dr Jefferys said in his Statement to the Inquiry that Mr Hagger�s division was responsible for contacting manufacturers who did not respond to the questionnaire.� He also said that approaching those companies that did not comply with the guidelines and establishing an acceptable timetable for them to do so was the responsibility of the MCA and the Inspectorate rather than the CSM.[641]</div>
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555. On 16 October 1989 Mr Love sent a handwritten minute to Mr Burton[642] and said:</div>
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�I have written to Dr. Jefferys suggesting a number of avenues that we in the MCA should possibly be considering following as next steps in the BSE exercise.</div>
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Aspects such as:</div>
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a) possible updating of guidelines and what steps do we need to take���� to ensure compliance</div>
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b) how do we propose to ensure that companies stop using material from areas where BSE is known</div>
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c) consideration of products which are stock-piled and do not meet the guidelines</div>
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d) further notification to industry � what form should it take</div>
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As soon as the MCA stance on these and other points is finalised I shall let you know.�</div>
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556. On 31 October 1989, 129 human medicinal product licence holders had not responded to the BSE questionnaire despite a reminder being sent.[643]</div>
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557. In November 1989 the paper �Inactivation of Scrapie-like Agents� was reviewed again by PD in relation to medical devices (see paragraphs 454, 509, 543 above for other considerations). The aim was to consider the knowledge and application of the inactivation methods suggested by various professional organisations.[644]� Following this review PD sent a letter to manufacturers in the industry requesting information they had about inactivation of agents akin to the causative agent for BSE.[645]�</div>
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558. On 7 November 1989 the CRM considered the issue of the homoeopathic products.� It had before it the paper prepared by Dr Winship.� It considered that no further action was required.[646]</div>
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559. �On 8 November 1989 a MAFF press release announced the implementation of the SBO ban, which was described as a �further� addition to the very tough measures which Sir Richard Southwood�s expert committee recommended earlier this year.� A copy of this document found on DH files has been annotated by hand �cc Adams, Purves, Baker and Sloggem.�[647]</div>
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560. At some point between 8 and 18 November Dr Lee, of the Veterinary Medicines Directorate (VMD) MAFF, gave a speech on the subject of veterinary medicines.[648]� She stated� �BSE has few implications for production of veterinary medicines. Indeed, there would be no implications at all if the Veterinary Medicines Directorate and manufacturers did not take what is really a belt, braces and pieces of string approach to all aspects of safety and quality of veterinary medicines.�� She talked about re-assessing licence applications which became necessary after the emergence of BSE and came to the conclusion that� ��the implications of the emergence of BSE on the production of these products has been extremely limited and no evidence of problems have been identified.�</div>
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561. On 9 November 1989 Mr Burton replied to Mr Love�s minute of 16 October 1989. He said:[649]</div>
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������ �2. Our next internal STD meeting on BSE is scheduled for 24 November 1989 and I would be particularly grateful for any update you can provide�Point a) [�Possible updating of guidelines and what steps MCA needs to take to ensure compliance�] is of special interest to us.�</div>
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562. On 10 November 1989 Dr Metters minuted Mr Meldrum about the SBO ban. He also said that he was �glad to see that you had on reflection recommended that bovine intestines should be included from the offal ban�. He also said:[650]</div>
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�The questions of suture material of bovine origin is, as you know, being considered by the Committee on Safety of Medicines. The Committee will, interalia (sic), need to consider the implications, if any, of the offal ban.�</div>
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563. On 13 November 1989 the Bovine Offal (Prohibition) Regulations 1989 came into effect.[651]</div>
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564. On 15 November 1989 the Manager of Technical and Regulatory Affairs at Z wrote to Dr Raine. He said:[652]</div>
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�1.)� Z issued instructions effective from 14th September, 1989 that the company was ceasing to procure bovine serosal threads from all suppliers who could not comply with our requirement to supply clean beef material.</div>
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An initial fact finding visit to Australasia regarding the sourcing of our total raw material requirements for bovine serosal threads has just been completed. A 5 year contract has been signed with our supplier and it is expected that raw material supplies will come fully on stream in early 1990, although I can tell you that we have already begun to receive shipments. More specific time scales cannot be stated at this time but I can tell you that an equipment installation and personnel training programme is progressing well.�</div>
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The letter also noted that the company had around two months� stock of finished goods.</div>
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565. On 15 November 1989 the Committee on Dental and Surgical Materials considered the matter of catgut sutures. They agreed with the recommendations of the BSE Working Group that the risk of taking action against the licences outweighed the theoretical risk from BSE and on that basis did not advise any action against the catgut licences under consideration.[653]� In a minute about sutures and BSE, Dr Adams noted that:</div>
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�CDSM are content to maintain their view, based on the BSE Working Party advice, that the risk of taking action against the licences far outweighs the theoretical risk from BSE.� Thus CDSM do not advise any action against the catgut licences.� [654]</div>
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566. On 24 November 1989 PD held a meeting on BSE. It was reported that all the manufacturers sent the medical devices questionnaire had now replied and the information had been placed on a database. The minutes record that �[t]he committee felt that in future, companies that are inspected should be checked for usage of animal or human material in their product. New information could then be passed on to be placed on the database.�[655]� The survey revealed that 76 products from manufacturers worldwide were sourced from all kinds of animals. 34 of these products contained bovine materials of which 13 were sourced from the UK or Europe. Of these 13, bovine material constituted a major component in only three cases.[656]���</div>
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567. On 27 November 1989 Mrs Shersby sent a minute to Dr Jefferys, Mr Hagger, Dr Adams, Dr Rotblat, Dr Raine, Dr Purves, Mr Love and Mr Sloggem about the forthcoming meeting of the MCA secretariat of the BSE Working Group.� She set out the proposed agenda for the BSE Working Group meeting, which included at item 3 whether the Working Group should re-examine and review the current guidelines and at item 6 the effect of the �Proposed Bovine Offal ban� on the human medicines situation. [657]</div>
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568. The MCA Secretariat of the BSE Working Group met on 7 December 1989 to discuss the agenda for the BSE Working Group meeting, circulated by Mrs Shersby.[658]</div>
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569. In December 1989 PD wrote to the Manufacturers Registration Scheme (MRS) Audit Team Leaders informing them that a database had been created on the manufacturers of sterile medical devices and surgical products using animal materials in their products. This was to be kept up to date and PD requested that information on animal materials be kept in the �Company Information� section of the audit reports.[659]</div>
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570. On 8 December 1989 officials from PD met separately with the two medical device manufacturers whose products were of concern.[660] �The minute records that:</div>
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�The main purpose of the meeting was to discuss the companies [sic] current manufacturing procedures, future plans and their compliance with the BSE guidelines.� Their views were also sought as to the practical feasibility of the guidelines with respect to the manufacturing process, and any improvements that could be suggested.�</div>
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571. On 13 December 1989 Mrs Shersby sent a minute to Dr Jefferys, copied to Dr Adams, Dr Rotblat, Dr Raine, Dr Winship, Dr Purves and Mr Love, attaching the draft agenda for the BSE Working Group meeting.� She asked Dr Raine to send her the papers (i.e. the press release and �draft regulations�) for Annex 1 as at item 9 (�MAFF - Proposed Bovine Offal Ban� � the affect on the human medicines situation).� She also asked Dr Raine to contribute paper 5 (comment from the secretariat on the proposed bovine offal ban - effect on human medicine situation).[661]</div>
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572. On 19 December 1989 the agenda for the BSE Working Group meeting on 10 January 1990 was circulated by Mrs Shersby to Professor Collee and members of the BSE Working Group and Secretariat.� The agenda included at item 7,� �The Guidelines � Does the working group wish to re-examine and review the current guidelines?� Oral discussion� and at item 9,� �MAFF � Proposed Bovine Offal Ban � effect on human medicine situation.� MAFF press release and draft regulations attached at Annex 1.� Comment from the Secretariat � Paper 5�.[662]��</div>
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573. Dr Pickles sent a minute to Mrs Shersby on 21 December 1989, attaching a copy of the Bovine Offal (Prohibition) Regulations 1989, and informing Mrs Shersby that these had come into effect in November.[663]</div>
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574. On 28 December 1989 Dr Lee gave a further update on replies to the animal medicines questionnaire.[664]� Since August only four more replies had been received bringing the total to 190 companies. There were now 348 products identified as having substances of animal origin with 302 having materials of bovine, ovine or caprine origin as ingredients.</div>
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1990</div>
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575. On 2 January 1990 the manufacturers of a number of allergen products provided updated information on their �current position�. An MCA summary document of this response notes that advice is sought from the BSE Working Party.� It also states:[665]</div>
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�2.2 BEEF RAW MATERIAL</div>
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The Company have not yet found a satisfactory source of supply, and are investigating European sources, or the use of a closed herd.</div>
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Decontamination procedures are also under consideration (phenol or autoclaving)</div>
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2.3 ANIMAL HAIR � COW, GOAT & SHEEP</div>
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The Company state that the animals from which the hair is collected are certified as being free from the symptoms of BSE at the time of slaughter.</div>
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It is not clear whether these animals are certified as fit for human consumption as fresh meat under the EEC directives and slaughtered in EEC approved abattoirs. This would mean that pre and post-mortem veterinary examination was required.</div>
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Autoclaving has been found unacceptable. Exposure to phenol or gamma-irradiation are being considered.</div>
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2.4 CULTURE MEDIA</div>
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2.4.1 MOULDS</div>
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The culture media for mould contain [a compound] which presumably is bovine in origin, but that is not specifically stated. A European source material is being investigated. Validation studies are required by the Company to show its acceptability. Data may be available by June 1990.</div>
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No information on the method of manufacture is given. The medium is said to be Tyndallised.</div>
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2.4.2 MITES</div>
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A liver digest sourced from Ireland is used. Alternative sourcing is being investigated.</div>
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The material is heated to 60� for 1 hour before use, and for 2 hours after the mites have been cultivated.� It is not clear if this is in the wet or dry state.</div>
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Autoclaving was found unacceptable.� Gamma-irradiation would be investigated, if the BSE working party think it is appropriate.</div>
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2.4.3 BACTERIA</div>
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Brain Heart Infusion Broth, from [a company] is used. The source of the calf brain is not known to [the Company], or it seems to [the supplier company] (page 3 of the letter). The final medium is said to be autoclaved at 121o for 15 minutes.</div>
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Alternative sources and autoclaving, using the recommended cycle are being investigated.�</div>
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576. On 3 January 1990 Mrs Shersby minuted Professor Collee and the members and secretariat of the BSE Working Group on the meeting scheduled for 10 January 1990.� She referred to the agenda for that meeting.� Point 3 stated �Item 9 on the Agenda refers to the proposed Bovine Offal Ban.� This came into force on 13 November 1989 and SI No 2061 is attached to Annex 1.� Paper 5 has been deleted from the Agenda.�[666]</div>
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577. On 9 January 1990 the interim report of the Tyrrell Committee was published.[667]</div>
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578. Also on 9 January 1990 the CRM met.[668]</div>
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BSE Working Group: second meeting</div>
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579. On 10 January 1990 the second meeting of the BSE Working Group was held.[669] Four papers were considered at the meeting. Paper 1 was from MAFF and discussed BSE in cattle in Britain. Paper 2 was a summary of responses to the questionnaire[670]. Paper 3 considered products other than catgut, using UK sourced beef and not meeting the guidelines[671]. Paper 4 concerned the manufacturer of surgical catgut sutures.[672]</div>
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580. The minutes of the meeting note that it was reported that 94% of licence holders had responded to the questionnaire, their replies had been evaluated and appropriate action taken. The Working Group recommended that the MCA look at the licences of the non-responding licence holders.</div>
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581. In relation to Paper 3, the minutes record that, with one exception (the range of allergen products referred to in paragraph 575 above) there were no products sourced from high-risk material (i.e. brain and lymphoid tissue) which did not meet the guidelines. The majority of products considered in Paper 3 used bovine serum albumin or foetal calf serum from UK sources. Most of these were vaccines. The paper identified four such products: (i) a measles vaccine; (ii) a tuberculin PPD product; (iii) an MMR vaccine; and (iv) a DTP vaccine.� The paper included information on the existing stocks of these vaccines, and asked for advice about the use of these stocks.[673]</div>
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582. �The minutes note:</div>
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�6.3 [Two companies] have given assurances that they are converting to New Zealand sources for their products; however it is clear that there are stocks of vaccines made using BSA or FCS from UK herds.�[674]</div>
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583. The Working Group considered the four vaccines identified as using UK sourced material.� They concluded that the benefits accruing from continuance of the vaccine programme� ��outweighed the very remote risk to the population from the use of bovine material in these products.�� The Working Group ��considered after some discussion that negotiations should take place to ensure that sources are changed as soon as possible and to replace existing stocks with new material whenever feasible.�[675]</div>
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584. The Working Group considered the range of allergen products made by one company, which used bovine calf brain in culture media. The Working Group� ��decided that alternative sterilisation programmes suggested by the Company would not be effective and that effective programmes would destroy the nature of the materials being used.�� They agreed:</div>
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�6.4 �it was not reasonable to use calf brain from the UK if other sources, such as Australia and New Zealand are available, and a changeover to Australasian material within a reasonable timescale should be insisted upon by the Licensing Authority. The MCA will reply to the request for advice, taking into account the views expressed by the Working Group.�[676]</div>
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585. The Working Group also considered the steps taken in relation to Z Surgical Catgut Sutures. This was dealt with in Paper 4, prepared by Mr Sloggem and Dr Raine[677]. The minutes of the meeting stated[678]:</div>
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�The Working Group approved the following changes in the Company�s working practices, some of which have already been introduced.</div>
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6.5.1 Changeover to material sourced from �clean beef cattle� of UK origin on 14 September 1989</div>
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6.5.2 Cessation of sourcing material from UK cattle on 20 November 1989.</div>
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6.5.3 Changeover to bovine material sourced from Australia from 5 February 1990.�[679]</div>
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586. The Working Group recommended decontamination procedures be followed prior to the change to Australian sourcing.� It also asked for assurances that Z would replace stocks held in their own store as soon as they had assured stocks available.� Consideration was also given to a press briefing being available in the event of media approaches arising from the closure of the factory for the decontamination and cleansing operation.</div>
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587. In his Statement to the BSE Inquiry, Professor Collee said of this meeting: �The minutes state that the Working Party regarded the risk from vaccines as very remote. The bovine materials involved were very low risk and, as a result, the risk from vaccines could generally be described as very remote rather than merely remote.�[680]</div>
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588. Professor Collee also said[681] that he believes he had sought the advice of Dr David Taylor and others in advance of the meeting, on the likelihood of the BSE agent being present in foetal calf serum and bovine serum albumin, and that he had asked about the risk of maternal transmission in cattle and the risk of contamination of the material in the course of its collection.� Professor Collee also stated[682] that once new stocks of vaccines were manufactured, they expected existing stocks to be replaced. Dr Jefferys has commented that at the meeting:</div>
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��the working party discussed the hazard-to-benefit ratio for the vaccines and decided that the benefits accruing from continuance of the vaccine programme outweighed the very remote risk to the population from the use of bovine material in these products.�[683]</div>
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589. A summary of the reports of the chairmen of Section 4 Committees was recorded in the meeting minutes. The Chairman of the CSM, Professor Asscher, stated that no further action was required on products in his domain.[684]� This view was echoed by the Chairman of the Committee for the Review of Medicines (CRM).� The Chairman of the CDSM also reported to the meeting.</div>
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590. The minutes of the meeting also record, �It was considered that the guidelines had served their purpose well and that there was no need to amend them at this stage.�� Under the heading for paragraph 9, �MAFF - The Bovine Offal (Prohibition) Regulations 1989 SI No 2061� the minutes simply state, �A copy of these is attached as Annex 5.�</div>
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591. In his Statement to the Inquiry Dr Adams said following about the meeting:</div>
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��the Chairman of the CRM explained that the committee had examined the products referred to it and that no further action was required: the licence of one of the products had lapsed and the other used bovine material from outside the UK.� The Chairman of the CDSM reported that the Committee had agreed with the recommendations of the Working Group and was content with the measures being taken on surgical catgut. The minutes record that he commented on the reservations which had been expressed by the members of the Working Group and said that he wished to make it clear that the selection of materials other than those established by clinical experience exposed patients to potential hazards greater than those posed by catgut.�[685]�</div>
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592. On 12 January 1990 Dr Adams sent a minute to colleagues (including Dr Metters, Dr Jones, Dr Jefferys, Mr Hagger, Dr Raine, Dr Purves, Mr Sloggem)to say that the company which manufactured catgut sutures (Z) had brought forward the date of changing the source of its catgut from UK to Australasian bovine intestine. Production was intended to begin in February 1990 with the finished product being available from May 1990.[686]</div>
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593. On 17 January 1990 the CDSM met and considered a paper on catgut sutures.[687]</div>
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594. On 26 January 1990 PD met to discuss two medical device manufacturers using bovine material as a major ingredient.[688]� One manufacturer was now using material from calves under the age of six months and material from older animals was sourced from overseas. The other manufacturer was unable to comply with the guidelines and had added that it would not be able to do so in the near future. It was agreed to organise a further meeting with this company.</div>
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595. The meeting also concluded that the paper �Chemical Methods for the Sterilisation of Animal Tissue Used in Medical Devices� should be amended to include tissue harvesting and presented to the next BSE Working Party meeting on 4 July 1990.</div>
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596. On 20 February 1990 a meeting was held between PD and the one medical device manufacturer whose products did not meet the Medical Devices Guidelines[689] (see paragraph 594 above).� The company reiterated that it could not source its material from calves under six months and it was investigating the possibility of sourcing material from West Germany. The company was also investigating suitable sterilisation procedures which would not damage its product.</div>
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597. On 22 February 1990 the CSM heard an oral report from Professor Collee and noted the minutes of the Working Group meeting.[690]</div>
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598. On 14 March 1990 Dr Jefferys received a letter from the British Diabetic Association asking whether the CSM had discussed BSE with regard to the use of bovine insulins and if so whether a statement had resulted.� The letter said the issue was to be discussed at a meeting of their Professional Advisory Committee at the beginning of June.[691]</div>
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599. On 26 March 1990 Dr Metters sent a minute to Mr Bewley, a Grade 7 with the MCA, responsible for the Committee on Safety of Medicines.� The minute was in relation to the European Commission decision to ban the export of certain bovine tissues and organs.� Dr Metters expressed concern about the possible effect of the decision on UK pharmaceuticals and asked about the number of products using bovine material sourced from the UK.[692]</div>
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600. On 9 April 1990 Mr Barnes minuted Dr Pickles about DH research objectives:</div>
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�2. Our objectives are on two levels �</div>
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i)���� directly commissioned DH research</div>
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ii)��� area of DH interest without financial sponsorship.</div>
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3. Following the Southwood and Tyrrell Reports, the DH research effort so far has been concentrated on setting up a research surveillance system, to monitor the incidence of CJD. The two �Will� projects, one already contracted and the other � consisting of neuropathological support for the first � currently being refereed, were considered sufficient to satisfy our immediate policy objectives.</div>
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4. Another high priority area identified in the Tyrrell report which falls within DH�s responsibility concerns certain bovine materials used in pharmaceuticals. Dr K Jones [Dr Keith Jones (DH)], to whom this minute is copied, is asked to up-date us on the current position on whether this research is going ahead, and if so with what sponsorship�.</div>
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5. We agreed that DH should not, at least for the time being, be directly involved in, or seek to sponsor, any research into the direct transmission of CJD�.�[693]</div>
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Other routes of transmission (SEAC: first meeting)</div>
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601. On 17 April 1990 Dr Jefferys sent a minute, on behalf of Dr K Jones to Dr Barnes on research. He said that the MCA was unaware of any research which had been commissioned or was being undertaken concerning bovine material used in pharmaceuticals. He added that the MCA would not be funding any research and it appeared that the industry had accepted the guidelines and had made arrangements to switch sourcing so as to comply with the guidelines.[694]</div>
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602. On 26 April 1990 the CSM held a meeting.[695]� Mr Hagger says in his statement to the Inquiry that:</div>
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�� a letter from the British Diabetic Association concerning the safety of bovine insulin was considered and a response approved confirming there was no insulin sourced from cattle in the UK or Ireland and that the situation in other countries was being monitored.�[696]</div>
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603. On 27 April 1990 Mr Bewley responded to Dr Metters minute of 26 March 1990. He set out the current situation with regard to the few licensed medicinal products which used bovine material sourced from the UK.[697]</div>
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604. On 27 April 1990 Ms Campbell minuted Miss Duncan, Drs Richardson and Hoxey, Mrs Dhell, Mr Burton and Ms Turner, about a meeting with a medical device manufacturer that day. The minute said:[698]</div>
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�2. [the company] have made the decision that as from Monday April 30 manufacture of their [specifically named] heart valve will cease. Valves remaining on the shelves will be retrieved, but not on a recall basis.</div>
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�</div>
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4�No information regarding this decision will be sent by post in order to avoid stimulating widespread interest.</div>
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5. Please find attached a copy of the press report which [the company] plan to release. They have deliberately avoided mention of BSE in the hope of preventing the generation of wider media interest, with its associated implications. They also hope to keep [the parent company] out of press coverage.�</div>
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605. On 30 April 1990 Dr Jefferys, on behalf of the CSM, replied to the British Diabetic Association.[699]� He �was able to inform the BDA that there were no bovine insulins sourced from cattle in the UK or Ireland.�[700]</div>
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606. On 1 May 1990 Dr Metters sent Mr Bewley a minute about BSE and Commission Decision VI/7096/89.[701] He said:</div>
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�4.�� Paragraph 5 is the key to the safety of continued use of these vaccine stocks.� Here I note that the Working Group have considered the safety issue and agreed that continued use of existing stocks within the vaccine programme far outweigh the remote risk of BSE occurring through innoculation (sic).</div>
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5.��� While this risk may be remote, it would be desirable to pursue the policy of sourcing replacement vaccine stocks as soon as possible with New Zealand sourced products.</div>
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6.��� I am sure you will keep me informed with action taken to reduce whatever small risk there may be of BSE being transmitted through pharmaceutical products.�</div>
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607. On 3 May 1990 Dr Pickles sent a minute to Mr Burton, a Grade 7 in charge of the Pharmaceutical Supplies and Technology section, requesting help in identifying UK suppliers of foetal calf serum and bovine serum albumin.[702]� She was concerned about the safety of laboratory reagents and wanted to make �discrete [sic] enquiries� based on the identities of these suppliers. She stressed that� �We must be careful in making these enquiries to be sure that we are not suggesting these materials in their original form are somehow dangerous (since of course we are not saying this for meat or other parts of the animal).� The enquiries confirmed that none of these suppliers were still using UK sources.[703]</div>
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608. Some time after 16 May 1990, Dr Raine prepared a paper for the Committee on Dental, and Surgical Materials updating them on the status of Z Surgical Catgut Sutures. Under �Secretariat comment� she said:</div>
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�The Company has implemented as rapidly as possible the changeover from UK sourced raw material.� 100% finished product supplied is now derived from material sourced from Australia and New Zealand.</div>
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The advice of the Working Party is sought on the Secretariat view that no further action is [a handwritten annotation adds the word �currently�[704]] necessary on the part of the Licensing Authority.�[705]</div>
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609. On 23 May 1990 PD met again.[706] Dr Richardson agreed to contact Professor Taylor at the Heart Valve registry to request a check of all death certificates of heart valve users who had died of any BSE/CJD related diseases and a full check from the start of the Registry in January 1986 of any reported deaths of any patients using the heart valves produced by these two companies. The meeting also noted that the company had ceased production of the bovine heart valve. An update was also given on the one remaining manufacturer�s attempt to comply with the guidelines relating to sourcing. Areas of research raised by the Tyrrell Report were discussed although it was decided to liaise with MAFF on projects of relevance if MAFF was prepared to co-operate.[707]</div>
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</div>
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Agriculture Select Committee</div>
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610. On 7 June 1990 Mr Love, of Medicines Division DH, sent Drs Jefferys, Adams, Rotblat, Purves, Raine and Mr Robertson a copy of DH�s draft memorandum on BSE for the Agriculture Select Committee.[708] Dr Rotblat minuted Mr Love the following day to say that she was �not happy with the section on medicinal products�. She said:</div>
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�1.�� �I feel that the sentence� �where risk is thought to be present, the MCA has powers to require products to be modified but this has not proved necessary so far in relation to worries about BSE� should be deleted. It appears to be totally contradictory to the following statement that companies appear to be changing sources for their bovine material.�[709]</div>
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611. On 8 June 1990 Mr Love sent a minute to Dr Pickles about the draft memorandum for the Agriculture Select Committee on BSE.[710]� The draft memorandum made the point that the Medicines Control Agency (MCA) had recommended that all bovine material should be sourced from BSE free countries.</div>
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612. On 11 June 1990 Mr Love minuted Drs Jefferys, Purves, Raine, Rotblat and Mr Hagger with a final submission on the medical section of the memorandum.[711]</div>
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613. In the final memorandum produced by the DH for the Agriculture Select Committee the section on medicines stated:</div>
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�4. Medicinal Products and Medical Devices</div>
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The Medicines Control Agency (MCA) agreed in February 1989 and issued in March 1989 joint Committee on Safety of Medicines� (CSM)/Veterinary Products Committee (VPC) guidelines to the holders of all licensed medicinal products advising on the use of bovine material as an ingredient or in the production of parenteral medicinal products.</div>
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As a purely precautionary measure the MCA recommend that all bovine material should be sourced from BSE free countries with competent veterinary services. This has been accepted and implemented by manufacturers supplying the UK market.</div>
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The CSM through its high level BSE Working Party continues to monitor developments.��</div>
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Supplies Technology Division (STD) of the NHS Procurement Directorate have responsibility for medical devices and have issued similar guidance to manufacturers of surgical implants and blood contact devices. STD are liaising closely with the CSM Working Party on BSE.� [712]</div>
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614. Mr Love also sent Question and Answer briefing material to the CMO on 20 June 1990, prior to the Agriculture Select Committee.� This material was copied to a number of people in MCA.[713]</div>
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615. Sir Donald Acheson gave evidence to the Agriculture Select Committee on 20 June 1990. In answer to a question on BSE free herds in other countries, Sir Donald Acheson stated:</div>
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�That is really a veterinary question, but if behind it is the question of the safety of medicinal products perhaps I could say this: this is a crucial subject which was raised with me during 1988 about the time it was decided to set up the Southwood Committee, and of course I am sure the Committee knows that the safety and quality of medicines is a specialist subject in which ministers are the licensing authority and under the Medicines Act they are advised by the Committee on the Safety of Medicines and sister committees, which deal with other things like veterinary products and so on, but I have to satisfy myself on the public health aspects. Before we had the benefit of Sir Richard�s report the relevant committees and the Committee on Safety of Medicines were asked to consider the implications of BSE in medicines, and later a special expert group was set up which had cross-representation with the Tyrrell Committee to make sure the expertise was covered. In February 1989 the Committee on Safety of Medicines made a public statement at the same time as the publication of the Southwood Report, which agreed with Sir Richard Southwood, that the risk to man from medicinal products of bovine origin, which includes injectables, was remote on theoretical grounds. Now this reassured me that the stocks of medicine in this country, which of course might have been produced from material during the 1980s which to some degree had been contaminated with BSE, were nevertheless safe. That was a public statement made by the experts in that matter. The second issue, of course, is, well, if that is the case is there anything else that in prudence we should do now knowing there is this condition? The CSM decided that in future we should remove from medicinal products any bovine material that might have come from infected animals. Guidelines were issued in March 1989 to all manufacturers of medicinal and veterinary products in respect of any product wherever manufactured in the world which is licensed in this country� So we have belt and braces.� First of all, we have the pronouncement that we are talking about a theoretical risk; secondly, in order to be doubly sure, these recommendations have gone out with a code of practice which will seek to ensure that in future no bovine material that might have come from infected animals is used for medicinal products.� [714]</div>
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616. On 15 June 1990 company I[715] sent a copy of their statement on BSE to Mr Love at MCA.[716] This statement had originally been sent to the BBC.� It said that none of their vaccines utilised tissues such as brain, spinal cord and spleen and that, in consultation with external experts, they had transferred their sourcing to outside the UK.� The statement finished by saying that I had been producing vaccines in compliance with UK Government Guidelines issued in 1989.</div>
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617. On 29 June 1990 Mr Coleman, a Higher Executive Officer in STD responsible for the central purchase and supply of certain vaccines and sera, minuted Mr Burton, a Grade 7 in STD responsible for the Pharmaceutical Supplies and Technology section, about letters which had been received from vaccine manufacturers[717]. The minute commented on details in the letters about the current stocks of vaccines prepared using UK sourced bovine material. Dr Rotblat saw a copy of this minute. [718]</div>
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BSE Working Group: third meeting</div>
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618. On 4 July 1990 the third meeting of the BSE Working Group took place. The Working Group considered again the range of allergen products:[719]</div>
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�Para 6.4: Discussions and correspondence are ongoing with [a company] on their range of allergen products�which use bovine sourced material not meeting the guidelines. These are diagnostic and therapeutic products containing a range of specific allergens. Calf-brain and an ox-liver digest were constituents of certain special culture media used in the production of some of the allergens. Animal hides and hairs were used to produce others. They are marketed for use in the management of allergies.</div>
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The Working Group considered that where bovine material was used it was essential that the licence holder should comply with the guidelines unless the material being used was derived from milk or casein. [The company] has been concerned about infringement of the Anthrax Regulations when importing hides or hairs.</div>
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�The licence holder will be contacted again; the discussions will be continued and the outcome reported to the next Working Group meeting. In the case of other animal components used in the manufacture of this range of allergens, such as sheep hair or cat hair a more relaxed approach was considered appropriate.�</div>
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619. Paper 1 at the meeting was from MAFF and was an �[u]pdate on epidemiological aspects of BSE)[720]. The minutes record concern raised about the sources of bovine material from Australia and New Zealand being finite. The minutes said Australasian bovine material was being �taken up so that there is no spare supply capacity�.[721] The Working Group also considered the availability of bovine products from calves under the age of 6 months. Not subject to any ban, it was felt that these calves� ��could be incubating the disease, even though the prion or causative organism was not detectable�.</div>
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620. The Working Group also had before it a paper prepared by Dr Rotblat which provided them with the latest factual information from two individual companies about their vaccine stocks.[722]</div>
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621. The Working Group considered again the four vaccines previously identified. In relation to the MMR vaccine, this was not yet licensed, and it was recommended that a licence should only be granted if the bovine components complied with the guidelines.� The applicant was understood to have changed to a New Zealand source.� Other companies had licences and were producing sufficient quantities to meet demand. �The Working Group also recommended that existing trial batches prepared with UK bovine material should not be marketed.</div>
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622. In relation to the tuberculin PPD, this was the only source of the product available, and there were stocks until September 1991.� The manufacturer used glycerol beef broth derived from bovine muscle.� It was changing to peptone broth as quickly as possible, and stocks would be replaced as appropriate.� The Working Group noted that replacement should be encouraged as quickly as practicable, but that since the use of glycerol beef broth was low on the list for potential infectivity and since there were no alternative sources, the hazard from having no available stocks outweighed the potential risks from use.</div>
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623. In relation to the measles vaccine, the manufacturer was changing to a New Zealand source.� There were no stocks of single vaccine currently available and other stocks would be depleted by September 1990.�</div>
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624. In relation to the DTP vaccine the Working Group recommended that a meeting should be held with the manufacturer to bring forward the time for compliance.</div>
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625. Topical products were also discussed. It remained the position that they were not considered cause for concern.� In any event, the use of bovine material in topical products had been considered, and appeared to be confined to products by two manufacturers, the source of the material being Germany.�The Working Group considered that no further action was required by the MCA.</div>
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626. The Working Group discussed reports of the diagnosis of three cases of Feline Spongiform Encephalopathy in cats. It was confirmed that there actually were two medicinal products using feline material. The minutes said:[723]</div>
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�The Working Group considered that because only three affected cats had been positively diagnosed to date and the aetiology of the spongiform encephalopathy was not fully understood, any action against products using feline material, even though UK sourced would be precipitate. These types of encephalopathy may have existed before current awareness of the condition.�</div>
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627. The list of non-respondents to the questionnaire was reported to have been reduced to only four.[724]</div>
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628. In her Statement to the Inquiry Dr Rotblat made the following comments on vaccines:</div>
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�Vaccines were the most important group of such products and the one with which I had most involvement.� Many vaccine manufacturers used foetal calf serum (FCS) in their production processes.� While the companies rapidly decided to source from New Zealand because that country had no history of scrapie, it was clear that this could not be done overnight because of the long time scale for manufacture of new batches of the vaccines.[725]</div>
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We held meetings with the companies and there were many discussions in the CSM and the BSE working group about this issue.� It was agreed that the benefits of the vaccination programme outweighed the theoretical risk of transmission and that the current vaccines could be used until new batches became available.� The theoretical risk of transmission of BSE had to be set against the disease which would occur if the vaccination programme was interrupted.� The vaccines in question had proven efficacy in protecting the public against serious diseases.� The fact that low risk bovine material had been used in the manufacturing process in no way outweighed the benefit derived from these vaccines.[726]</div>
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Such an approach would not have been possible had formal regulatory action such as revocation been taken, rather than non-binding recommendations being issued, because revocation of a product licence prevents the use of existing stocks of that product.[727]</div>
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I believe that pharmaceutical companies could not have produced new stocks of vaccines manufactured using non-UK sourced bovine material any quicker than they did.� The last to be replaced was a rarely used adult DTP vaccine which had a longer shelf life.� This was replaced in 1990/91 with a new batch made with New Zealand sourced bovine material.� I believe that this was the last vaccine to be replaced in this way.[728]</div>
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�</div>
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By the time of the final meeting of the BSE Working Group in July 1992 all vaccines available in the UK fully complied with the Joint CSM/VPC Guidelines and did not use UK sourced bovine material.[729]</div>
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Dr Rotblat also noted that the DTP vaccine was rarely used and it was used on adults rather than infants. [730]</div>
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629. Dr Jefferys also comments on vaccines in his statement to the Inquiry:</div>
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�In all the deliberations the proven benefits of the medicine had to be set against the theoretical risk. I observed that the CSM paid very particular attention to vaccines. Here there was a very real concern to avoid any damage to the vaccine programme and the inevitable consequences that this would have. Even in 1989, most vaccines used material sourced from outside the UK.�[731]</div>
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630. Professor Collee has also commented:</div>
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�In any consideration of vaccines we had also to take into account the obvious risk if stocks of vaccines were withdrawn. I should add, however, that once new stocks were manufactured, we expected existing stocks to be replaced.�[732]</div>
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631. In his Statement to the Inquiry, Sir William Asscher said:</div>
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�When considering the question of vaccines, it is important to be aware that manufacturing vaccines is an art � it is not easy to manufacture large supplies of effective vaccines. Manufacturers tended to keep large stocks of existing vaccines which, in some cases, were likely not to be exhausted for as much as 5 years.�[733]</div>
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632. On 26 July 1990, at a meeting of the CSM, Professor Collee reported on the meeting of the BSE Working Group on 4 July 1990.[734] The minutes of the CSM meeting said �[t]he Committee noted�the minutes of Working Party�s meeting of 4 July 1990�and endorsed the recommendations of the Working Party.�[735]</div>
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Spongiform Encephalopathy in a pig</div>
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633. On 11 September 1990 Mr Meldrum minuted Mr Lowson, copied to Mrs Attridge, Mr Bradley, Mr Lawrence and Dr Pickles, about transmission of BSE to a pig.� He also commented in the minute that he had been concerned for some time about the comments that raw materials for medicines should be sourced from countries where BSE in cattle was believed not to have occurred.� He stated that this was a very weak argument to deploy since detection of disease depended on the surveillance programme and notification procedures.� He would prefer to source such material in countries where neither BSE nor scrapie was present, and which had not imported significant quantities of British cattle or meat and bone meal.[736]</div>
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634. On 12 September 1990 Dr Metters minuted Dr Jones about SE in pigs.[737] Dr Jones minuted Dr Jefferys on the point the same day.[738] �Dr Jones said that he wished to consider the question of BSE and porcine derived therapeutic agents within a small group in order to determine the line that the MCA should take. He said that the working party would also need to take a view, following which he would advise Dr Metters on any necessary action. Dr Pickles minuted Dr Jefferys on the subject on 13 September 1990.[739]</div>
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635. In his Statement to the Inquiry Professor Asscher said[740] that he had not seen the minute from Mr Meldrum to Mr Lowson.� He stated, however, that Mr Meldrum�s comments fail to appreciate that the February 1989 guidelines were not the only advice being given to manufacturers, and that in practice manufacturers had decided that they would be best advised to source from New Zealand or Australia.� After the BSE Working Group was established, it encouraged such an approach.� He considered that the extent of liaison between manufacturers, the CSM and BSE Working Group, the manufacturers� knowledge of the current position and their willingness to accept the advice of the CSM and BSE Working Group made it unnecessary formally to amend the recommendation on safe sourcing.� Professor Collee also stated[741] that he had not seen that minute, nor did he believe that the views expressed had been brought to the attention of the BSE Working Group or the CSM.� Dr Jefferys stated[742] that he had not seen the minute at the time.� He also noted that Dr Watson from the CVL attended the meetings of the BSE Working Group.</div>
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636. Mr Sloggem said in his statement to the Inquiry:</div>
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��an issue had arisen concerning the possibility of porcine encephalopathy.� This was because one pig had developed "BSE" after being injected with a large dose of infected material directly into the brain.� In the light of the unnatural route of this infection, the members of the working party [on 31.10.90] did not consider it had significance in the use of porcine materials, as a possible porcine BSE hazard.�[743]</div>
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637. In a minute to Dr Metters on 21 September 1990, Mr Hagger suggested the following line to take:</div>
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�There are no medicinal products licensed for use on the UK market which make use of UK derived porcine tissues with which any hypothetical �high risk� might be associated.� The results of the recent experimental work at the CVL will be carefully examined by the CSM�s working group on spongiform encephalopathy at its next meeting [in October].�[744]</div>
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638. Dr Pickles comments in her statement to the Inquiry:</div>
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�A preliminary meeting of SEAC then took place on 7.9.90 which I attended.� Mr Pepper attended this meeting as a new member.� Papers were submitted by myself on behalf of DH and by MAFF and notes from CVL describing the transmission experiment.� The Committee accepted CVL�s conclusion that the experiment provided incontrovertible evidence that BSE could be transmitted to a pig.� The meeting stressed the importance of improving surveillance to ascertain whether SEs were occurring naturally in pigs in the UK although� it was felt that it was not likely to have gone unrecognised.� It was decided that it would be prudent to exclude specified bovine offal from the diet of all animals, including pigs and that non-UK sources be used for pharmaceutical products involving injectable or implantable porcine material.</div>
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The Inquiry has asked what action was taken subsequently about human medicines using porcine material.� I alerted Dr Metters immediately following the meeting and he passed this on to Dr Jones of the MCA.� I also provided further information direct to the MCA.� Later I was present at a meeting of the CSM BSE Working Party at a meeting on 31.10.90 at which the issue was discussed, informed by a listing of pharmaceuticals using porcine materials sourced in the UK.�� The Minutes record that a decision was taken that no action with regard to human medicines or medical devices was warranted at that time.�[745]</div>
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639. At the CPMP meeting held on 11 October 1990, it was decided that a CPMP BSE working party would be set up to monitor the implications of BSE for the circulation of human medicinal products within the EC.[746]</div>
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BSE Working Group: fourth meeting</div>
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640. On 31 October 1990 the 4th meeting of the BSE Working Group was held.[747] In relation to the range of allergen products that did not meet the joint Guidelines the minutes record:</div>
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�3.1 Para. 3: Progress to date in discussions with [a company] on their range of allergen products, using animal sourced materials was reported and the advice of the Working Group sought in relation to further action with regard to this group of products, for which there appears to be a continuing clinical requirement.</div>
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�</div>
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Cow-hair - The preferred source would be Australia or New Zealand or a closed herd in the UK. It is understood that [the company] has a closed herd in the UK, used to obtain sera for the production of their vaccines, and the company should be encouraged to use this source, since they were concerned that decontamination procedures necessary for overseas sources and required by the anthrax regulations could denature the material and alter its antigenicity.</div>
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Beef-veal � from Holland. The licence holder should be advised to specify that beef-veal from Holland was from milk fed animals.</div>
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Mycological media � containing ox-liver sourced from Italy as a component are acceptable as the source is not UK, provided that the usual assurances are given concerning good animal husbandry and adequate veterinary service</div>
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Bacteriological Media -� A peptone based medium now replaces the brain heart medium used previously. Since this is highly refined and autoclaved at 132 �C for 80 minutes, the Working Group considered the use of this material acceptable.�[748]</div>
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641. Further consideration was given to the possible infection of foetal calf serum and it was suggested that the guidelines might need extending to cover methods of collection, should further investigations reveal cleanliness deficiencies in this area.</div>
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642. Under item 9 �Porcine Material in Human Medicines and Devices� the Working Group:</div>
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��considered the extent to which porcine material is used in medicines and devices intended for human use and whether action to avoid or limit the use of any such material, originating in the United Kingdom is warranted at the present time.</div>
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�</div>
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The unanimous view of the Working Group was that since transmission of spongiform encephalopathy has only been seen under experimental conditions and in a single animal, no action with regard to human medicines or medical devices is warranted at present.�[749]</div>
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643. Under item 10 �Dural implants � Requests for Advice� the advice of the Working Party was sought in relation to grant of a licence for a product derived from bovine pericardium and renewal of product licences for implants derived from human dura mater�and porcine dermis.[750]</div>
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644. Under item 11 �Response to Questionnaire from Industry� it was reported that the four outstanding replies had now been received. One company had confirmed that bovine material was not used, and the other three confirmed that non-UK sourced material was used.</div>
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645. Under item 14 �Vaccine Stock� it was reported that in regard to the vaccine stocks of one company:</div>
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�The Working Group considered that the Secretariat should explore with the Company the possibility that the unadsorbed vaccines which had limited usage should be replaced with batches using bovine materials which complied with the guidelines, especially where the stock out date extended beyond 1991. There may be some commercial loss to the licence holder but it is unlikely to be very large.[751]</div>
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This was the one outstanding vaccine identified at the previous Working Group meeting (see paragraph 624 above).</div>
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646. In her Statement to the Inquiry Dr Rotblat said that the Working Group was updated on the position of the one outstanding vaccine: the DTP vaccine.[752]</div>
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647. In November 1990 the VMD put together a report which detailed �response to questionnaires and compliance with guidelines� in relation to BSE. It was noted:</div>
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��Most of the companies have now made satisfactory arrangements. The VMD has recently written again to the smaller number of companies where further information and reassurance on satisfactory progress is required. The replies received to some of these may need to be considered by the committee in the future. In the meantime, the following are being brought to the attention of the Committee.</div>
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�1.�� A number of products for external use contain lanolin from UK sheep. A number of oral products contain gelatin from UK cattle. Such products were defined as outside the scope of the guidelines and it is proposed that no action is taken with regard to these.</div>
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2. Lungworm vaccines are produced by harvesting larvae from the faeces of UK production calves. These calves are less then 6 months of age. Since faecal material is classed as a very low risk tissue for scrapie infectivity then the vaccines are given orally, it is proposed that no action is taken.</div>
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3. Three products are manufactured in bovine origin brain heart infusion broth�The bovine material used for one of these has never been of UK origin and the other manufacturer has indicated that he has now changed to a non-UK source�It is considered that the use of any bovine brain material is to be discouraged. The two fish vaccine manufacturers have been trying to find an alternative growth medium. It is proposed that pressure is maintained on these two manufacturers to finalise this work.</div>
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�</div>
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5. �� Some of the questions on the BSE questionnaire were interpreted differently by different companies. As a result it is thought that we are likely to have incomplete data of when all stocks of batches of products made before changes to comply with the guidelines will be used up�.�[753]</div>
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648. On 22 November 1990 the CSM met.[754] The minutes record that �[t]he Committee endorsed the recommendations of the Working Party relevant to the CSM and noted the advice given to the CDSM concerning their products and the action taken by the CDSM.�</div>
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649. At the CSM meeting Professor Collee reported on the meeting of the BSE Working Group on 31 October 1990. In relation to vaccines he said:</div>
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�We are still worried about this matter, and it is right that we should continue to send signals to CSM�that present evidence allows us to give no absolute assurance but some relative assurance. Meanwhile, it seems unreasonable to allow vaccines that have some association with UK-sourced bovine products to be used when they could be replaced with batches that have been processed in compliance with the guidelines. Accordingly�our line of advice to CSM is hardening I would like you to count me amongst the hawks on this.�</div>
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650. On 18 December 1990 MDD BSE Working Group met and discussed the 4th meeting of the BSE Working Group.[755] For bovine materials it was reported that the BSE Working Group considered that providing the Guidelines were adhered to and the material was sourced from outside the UK, then the bovine material would be acceptable. Sterilisation procedures were insisted upon. This point was taken up in the MDD Working Group discussion in relation to bovine heart valves. The meeting noted that bovine heart valves had 15 per cent of the total implant market. Concerns were expressed about sterilisation procedures that might alter the valve�s performance. It was suggested further research on sterilants was required. It was also reported the BSE Working Group had commented on the MDD paper �Guidance on Chemical Methods for the Sterilisation of Animal Tissues used in Medical Devices�. These comments would be incorporated before the paper was sent out to registered manufacturers of sterile medical devices.</div>
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1991</div>
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651. On 8 January 1991 Dr Hoxey of the MDD wrote to Dr David Taylor of the Neuropathogenesis Unit (NPU). He asked to be kept informed of the NPU�s proposed research into the inactivation of the BSE agent, as the MDD had an interest in methods of sterilisation and disinfection.[756]</div>
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652. On 6 May 1991 the proposed meeting of the BSE Working Party, scheduled for 2 July 1990, was cancelled. After discussions involving Professor Collee, Dr Keith Jones, Professor Asscher and Dr Jefferys it was decided that no new issues had arisen and thus there were no items to put on the agenda.[757]</div>
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653. On 9 May 1991 Dr Jefferys wrote to Ms Murphy of the PHLS regarding a copy of a PHLS booklet on infections and communicable diseases in England and Wales � 1990.� He stated that:</div>
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�The view of the [MCA] is that it would be inappropriate to make any reference to medicinal products in relation to BSE.� The statements contained in the present report do not reflect the action which has been taken by the MCA and the BSE Working Party set up under the Committee on the Safety of Medicines.�[758]</div>
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654. On 14 May 1991 Dr Pickles wrote to Dr David Taylor saying:</div>
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�One of the reasons the Medicines Control Agency took no action against natural bovine insulins was the belief that the pancreas would not be affected in BSE. If there is new evidence to challenge that view, I think they would like to know. What more information can you give us, or could you indicate who else we should approach?�[759]</div>
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655. On 21 May 1991 Dr Jefferys replied to this letter from Dr Pickles, which he had been copied by Mrs Shersby. He said:</div>
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�As you state in our letter of the 14th May there were several reasons why the CSM Working Party decided that no action should be taken against bovine insulins. Foremost amongst these were that BSE remains a remote theoretical risk, bovine insulins are sourced from outside the UK (principally Argentina), the good manufacturing guidelines have been put in place and that the use of bovine insulin was small and restricted to diabetics who were intolerant of both the human insulins and porcine insulin.</div>
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Nevertheless, the BSE Working Party was set up to continue to review developments and if there is any new data we can always return to this question.�[760]</div>
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656. On 23 July 1991 the BSE Working Group meeting scheduled for 29 October 1991 was cancelled. Again, the reason given was that no new issues had arisen and therefore there were no items to put on the agenda.[761]</div>
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657. On 31 July 1991 the MDD BSE Working Group met and reviewed the information collected by Dr Hoxey and Mrs Dhell, a Higher Professional and Technology Officer responsible for sterilisation and decontamination, during a visit to the NPU.[762] Mrs Dhell had looked for information about the treatment of bovine heart valve materials with sodium hydroxide, but had found none. Reference had been found to the use of sodium metaperiodate, but it had been shown that this was not a good agent to be used for heart valve material; particular chemicals were shown not to be good inactivating agents. Also at this meeting, progress on the document �Guidance on Chemical Methods for the Sterilisation of Animal Tissues used in Medical Devices� was discussed.</div>
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658. On 15 August 1991 Mr Bradley minuted Dr Little, Dr Shreeve and Mr Dawson about a meeting he had had that day with Dr Hoxey and Mrs Dhell. He said:[763]</div>
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�The same guidelines issued to pharmaceutical/biological manufacturers have been issued to MD manufacturers. No sourcing now occurs from UK cattle and the point was taken re sourcing from Europe, in regard to BSE cases, France and Switzerland and export of cattle to Portugal and MBM to Europe as well as the exposure of pigs and poultry. They were well versed in the BSE control regulations. Prompt action at the start of the epidemic reduced risk factors so low that they did not pursue transmission studies. Things are different now.</div>
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We exchanged information on source materials used in MD. I knew some things they did not and they refined my information. They had not thought all aspects through but generally had a sound approach.</div>
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RESEARCH</div>
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MDD had a research budget but now re-distributed. They are considering the need for R&D on infectivity of sourced tissues from cattle, pigs and perhaps poultry and are clear they would have to find this alone or in collaboration with industry. There is no rush and they may approach us say next year to conduct such experiments. This area did not seem to be fundable from AHVG except if there were food or animal health connotations.�</div>
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659. On 8 November 1991 the MDD BSE Working Group met,[764] and reviewed a meeting between Dr Hoxey and Mr Bradley, of the Central Veterinary Laboratory. The MDD meeting concluded that more information was needed on the availability of data on CJD patients and/or implanted biological medical devices. The decision on whether to fund the testing of tissue was to be made following receipt of this information.</div>
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660. On 12-14 November 1991 The World Health Organisation met in Geneva to discuss Transmissible Spongiform Encephalopathies and came to the conclusion that the careful selection of source material was the best way of securing safety from the theoretical/remote risk posed by bovine materials in medicinal products and medical devices. This meeting confirmed that the measures being taken in the UK were sufficient at that time to minimise the risk to all species including humans.[765]</div>
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661. On 28 November 1991 SEAC�s attention was drawn at its 11th meeting to deactivation experiments conducted by Dr Taylor of NPU.[766]�� The Committee felt that the results, in themselves, were not sufficient to merit a change in existing DH guidance on decontamination of the CJD agent.</div>
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1992</div>
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662. In 1992, the Spongiform Encephalopathy Advisory Committee interim report on research stated:[767]</div>
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��The [CSM/VPC] guidelines recommended that all products licensed under the Medicines Act 1968 for human or veterinary use that are administered parenterally or to the eye or to open wounds should in general conform to the guidance if they contained material from a bovine source or if bovine material was used during their manufacture. In the event the pharmaceutical industry decided to source bovine ingredients or bovine materials used during manufacture from BSE-free animals in BSE-free herds in BSE-free countries�In the light of this development the relevance of studies on the safety of pharmaceuticals manufactured from tissues from British cattle is now questionable.�</div>
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663. On 8 April 1992 the Institute of Animal Health�s Neuropathogenesis Unit (NPU) and MAFF�s Central Veterinary Laboratory (CVL) held a further meeting in a series discussing BSE R&D.[768] One of the matters arising from the previous meeting was the inactivation experiments conducted by Dr Taylor of the NPU. The minutes record that the results of these experiments had been drawn to the attention of SEAC which had recommended that proposals for further work be drawn up. These had been passed over to MAFF and DH for consideration. DH felt that an immediate change to their advice on inactivation procedures would be an over-reaction.</div>
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664. In May 1992 the European guidelines issued by the Committee on Proprietary Medicinal Products (CPMP) and titled �Minimising the Risk of Transmitting Agents causing Spongiform Encephalopathy via Medicinal Products� came into force.[769] The draft guidelines �were derived from and almost identical to the UK guidelines.�[770]</div>
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BSE Working Group: fifth meeting</div>
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665. On 8 July 1992 the 5th meeting of the BSE Working Group took place[771]. Under item 3 �Minutes of the Previous Meeting� it was noted that in relation to the vaccine stocks of one company (the DTP vaccine): �This matter had now been resolved by the company producing a new batch with New Zealand FCS [foetal calf serum] of assured quality.�</div>
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666. Under item 4.2 �Scientific Update� it was reported that:</div>
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�The statement that autoclaving at 134�C does not give complete destruction of the BSE agent indicated a potential problem. It was explained that the statement came from work on BSE or scrapie exposed in a porous load autoclave at 134�C for 18 minutes which was found not to be effective�More studies were required to determine whether or not 136�C would be effective in destroying the BSE agent within the standard time. A grant application to study the effectiveness of exposure to 136�C had been made but the studies had not yet started�.[772]</div>
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</div>
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667. Professor Asscher said[773] that he believed that manufacturers changed their sourcing as soon as possible regardless of the financial cost to them.� Dr Rotblat stated[774] that she believed pharmaceutical companies could not have produced new stocks of vaccines any quicker than they did, and that the last to be replaced was the rarely used adult DTP vaccine, which was replaced in 1990/1991 with a new batch made with New Zealand sourced bovine material.</div>
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668. On 21 July 1992 Dr Minor, Head of Virology at NIBSC, wrote to Professor Collee:[775]�</div>
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�At a recent meeting in Heidelberg a gentleman from a gelatin manufacturing concern presented an account of the process which was very worrying. As you know, the assumption has been that gelatin is produced under such vigorous conditions that it gives no cause for concern, but the process he described was, to me, shockingly mild. Moreover he claimed that any old cow bone went into the production vat, including spine and skull�A number of other BSE working party members were present at the meeting, including John Purves, Richard Kimberlin and David Taylor, so it is possible that the matter was raised [at the BSE Working Group meeting of 8 July 1992]�</div>
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669. On 30 July 1992 Dr Taylor of NPU in a letter to Professor Collee, commented on this subject. He said,[776]</div>
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�Like Philip [Minor], I was not impressed by the reassuring noises made � at the Heidelberg meeting. However, I am not really familiar with gelatin manufacturing processes in the UK�I would certainly be concerned if it is produced by a similar procedure to the German process described at the meeting.�</div>
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670. On 31 July 1992 Dr Kimberlin wrote to Professor Collee about Dr Minor�s observations.[777] In summarising he said:</div>
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�a).� The general assumption that gelatin is of very low risk with regard to BSE contamination is still tenable.</div>
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b).�� Any uncertainty would be if the source material included significant amounts of brain and spinal cord from countries which either had reported BSE or were at risk of getting BSE cases, and which do not have a specified offals ban.</div>
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c).�� In these circumstances it might be reasonable to require either that these potential risk tissues were excluded from the source material, or that validation studies were carried out which were capable of demonstrating a clearance factor appropriate to the potential contamination.�</div>
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671. On 5 August 1992 Dr Tyrrell wrote to Professor Collee saying that he had seen Dr Minor�s letter of 21 July and he thought it was �necessary to get more details��[778]</div>
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672. On 18 August 1992 Professor Collee produced a written opinion on gelatin and BSE.[779]� He said:</div>
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�It is possible that gelatin is of low risk with regard to BSE contamination, but there are justifiable anxieties when the source material includes brain and spinal cord of cattle (or sheep) from countries with known cases of BSE or at risk of having BSE cases.</div>
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Validation studies to demonstrate the safety of processing and extraction procedures in this context would be commendable, but there are very significant practical difficulties and such an exercise would take some years.</div>
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It is reasonable to press for assurances with regard to quality and sourcing, analogous to those sought with respect to catgut sutures, in relation to gelatin manufactured for use in the pharmaceutical industry�Full compliance with the BSE guidelines should be required for the starting material.</div>
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ACKNOWLEDGEMENT</div>
<div style="font-family: arial; font-size: 13.3333px;">
The writer acknowledges with thanks the help of his colleagues.� He is especially indebted to Dr Philip Minor who raised the matter, and to Dr Richard Kimberlin who contributed most of the facts on which this opinion is based.�</div>
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673. On 28 August 1992 Dr Minor wrote to Professor Collee.[780] He said there</div>
<div style="font-family: arial; font-size: 13.3333px;">
��may be a slight difficulty raised by the sentence in your summary requiring full compliance with the BSE guidelines. In the European version of the document�gelatin is specifically singled out as a product which given assurances of adequate collection and processing is unlikely to present any risk of contamination. The implication to me is that the source animal probably does not matter��</div>
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674. On 11 September 1992 the CVO wrote a minute to Mr Lowson about BSE and gelatin.[781]� He said,� �I am a little concerned at the comment that the raw materials should be sourced from a BSE-free country. I have no difficulty with the definition applying to Australia and New Zealand, but not to other countries where they do not have an active surveillance system.�� He went on� �I am worried at the possibility that we may be clobbering the UK even though we have got excellent controls in place, but still be ignoring the unknown and unquantifiable risks from overseas.�</div>
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675. On 18 September 1992 Mr Maslin minuted Mr K C Taylor, Mr R Bradley, Mr A J C Taylor and Mr S Hutchins about BSE and gelatin. He said that he had suggested to Diane Whyte, from DH, that as DH were the sponsoring department of the CSM, they should take the lead on the paper for the Tyrrell Committee.[782]��</div>
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676. The CSM met on 23 and 24 September 1992. The minutes of the meeting state:[783]</div>
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�11. BSE Working Group � Chairman�s summary statement to CSM of 8th July 1992 Meeting</div>
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The Committee noted the report and Dr Rotblat confirmed that there was no cause for concern regarding the use of foetal calf serum.�</div>
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677. At this meeting the issue of BSE and gelatin was deferred to another meeting.[784]</div>
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678. In her Statement to the Inquiry Dr Rotblat said[785] that she recalled around:</div>
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�� 1992, a new EC Directive came into force, the effect of which was to require vaccines, blood products or immunologicals to be reviewed. Such products had previously continued to enjoy a product licence of right without being subject to the Review procedure. By then the CRM was no longer in existence and the review work was carried out by the Biologicals subcommittee and the CSM. Within the MCA, this work was carried forward by Dr [Mary] Duncan and Mrs Dow. BSE issues would have been taken into account by the pharmacist in this review.�</div>
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1993</div>
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1994</div>
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679. On 7 June 1994 the MDD Spongiform Encephalopathy Working Party for Sterile Medical Devices met[786] and noted the publication of the �Guidance on Chemical Methods of Sterilisation for Animal Tissues in Medical Devices�. The meeting also noted that the Research Division had been funding some work by David Taylor on spongiform encephalopathies and their survival after autoclaving at 134�C-138�C.</div>
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680. On 29 June 1994 the CMO, Sir Kenneth Calman, and the CVO, Mr Meldrum announced in a joint statement� �We have concluded that it would be consistent with the Government�s policy of extreme caution on BSE, and would be appropriate in the light of the latest information, to extend the definition of specified bovine offal to include the intestines and thymus of calves under 6 months of age.� An ongoing study had for the first time detected BSE infectivity outside the brain and spinal cord of cattle, namely at the end of the small intestine. This development gave rise to the possibility that the BSE agent could be present in offal from calves under the age of 6 months.[787]</div>
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681. Mr Sloggem prepared a �BSE Position Paper� for the July meeting of the Biologicals Sub-Committee Meeting in which he concluded:</div>
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�Ensuring that bovine materials are only sourced from cattle which have not been fed ruminant feed is the biggest safeguard against BSE contamination of medicinal products.� A WHO meeting [sic] May 1993 indicated that appropriate measures were in place to control BSE�</div>
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Current research on the inactivation of TSE infectivity may require the revision of the CPMP TSE Guideline section on methods thought to inactivate TSE.�[788]</div>
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682. On 27 September 1994 the MDD became the Medical Devices Agency (MDA).</div>
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1995</div>
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1996</div>
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683. In March and April 1996 the MCA undertook an audit of UK medicines manufacturers. The MCA said in its letter of 1 April 1996 that the purpose of the audit was to� ��reassure itself that proper procedures are being followed.� [789] They also asked in this letter for written confirmation that the 1992 CPMP Guidelines were being complied with. The audit itself was carried out from 10 to 18 April 1996 and focussed on all those manufacturers of medicines that might contain material of bovine origin. Inspectors visited 166 sites in all. [790]</div>
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684. On 28 March 1996 the CSM met to review the safety of medicines derived from bovine materials.[791] Dr Jefferys notes in his statement to the Inquiry:</div>
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�The Committee confirmed that all parenteral products manufactured using materials of bovine origin conformed to the CPMP guidelines and that patients could continue to take their recommended medications with full confidence. The Committee also satisfied itself of the safety of gelatine used in capsules containing medicines. A position statement to this effect was issued by the CSM confirming that all bovine material used in the manufacture of parenteral medicinal products was sourced from herds from outside the UK which had not been fed material of ruminant origin.�[792]</div>
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685. On 4 April 1996 Mrs Oliver head of Licensing Administration wrote to authorisation holders individually requesting urgent information about �all ingredients of bovine origin in veterinary medicines authorised or manufactured in the UK� following the EC�s decision to ban UK exports which might contain BSE transmissible material. The letter said:</div>
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�I should be grateful if you would confirm that each of the products listed on the attached sheet, where appropriate, conformed to the Committee for veterinary medicinal products guidelines which were finally approved in January 1993. I should also be grateful for confirmation of the source of all ingredients (eg gelatin, sera etc) contained in the products, which are or might be of bovine origin if you either do or intend to export the product�.[793]</div>
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686. A report of the audit was issued in a summary document on 26 April 1996.[794] It stated:</div>
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�The results of the audit:</div>
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re-confirmed that no bovine material of UK origin is used in the manufacture of vaccines or other injectable medicines in the UK since 1989. The audit confirms that all injectable products are therefore free from any risk associated with UK bovine materials;</div>
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re-confirmed certification of compliance with the 1992 CPMP guidelines;</div>
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established that since mid-April 1996 no pharmaceutical product for human use manufactured in the UK uses gelatin derived from materials of UK bovine origin;</div>
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established that there are three UK manufacturers of gelatin who supply gelatin certified for pharmaceutical use, and that they do not supply gelatin derived from materials of UK bovine origin to manufacturers of pharmaceutical products for human use in the UK;</div>
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established that in respect of tallow derivatives, as a result of a commercial decision virtually all UK manufacturers have moved away from using tallow derivatives which have been refined from tallow of UK bovine origin. However it should be noted that the UK produced a detailed paper on tallow derivatives, which was considered by the special meeting of the CPMP on 15 April 1996. The EMEA opinion of that meeting emphasised that the processes used to produce tallow derivatives which are used in pharmaceutical products are more than sufficient to render them safe.�</div>
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687. The Report also notes that: �The audit has confirmed full compliance [with the 1992 CPMP Guidelines].� [795]</div>
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</div>
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</div>
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<br /></div>
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[1] L12</div>
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[2] L12 pA139-140</div>
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[3] sic presumably �inducing�</div>
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[4] L12 pA140</div>
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[5] DH01 Tab12 para 3</div>
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[6] L12 pA139-140</div>
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[7] DH01 Tab12 para 17</div>
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[8] DH01 Tab 13 para 1</div>
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[9] L14 Tab J p 1-32</div>
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[10] DH01 Tab 11</div>
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[11] (SI 1994 No 3017), L14 pJ33</div>
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[12] L12 Tab 12 p A145.</div>
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[13] L16 Tab 1 p 65</div>
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[14] L16 Tab 1 p 65 - article 3.</div>
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[15] L16 Tab 1 p 65 - article 5.</div>
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[16] L16 Tab 1 p 65 - article 11.</div>
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[17] L16 Tab 1 p 65 - article 21.</div>
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[18] See original article 2.</div>
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[19] L16 Tab 1 p 65 - article 1.</div>
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[20] L 16 p 191</div>
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[21] L16 Tab 1 p 66a</div>
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[22]L13 Tab D p 12</div>
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[23] L15 Tab U p 1- see in particular regulations 1(2) and 9(2).</div>
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[24] L15 Tab U p 4 -6</div>
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[25] L16 Tab 1 p 67</div>
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[26] L16 Tab 1 p 95</div>
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[27] L16 Tab 1 p 97 - article 8</div>
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[28] L16 Tab 1 p 70</div>
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[29] L16 p 3</div>
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[30] L12</div>
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[31] DHO1 Tab 14 para 9</div>
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[32] L12� p A27</div>
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[33] L13 Tab I p 1</div>
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[34] Section 5(2)</div>
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[35] Section 4(5)</div>
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[36] Sections 3(2) and� 4(1).</div>
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[37] Section 5(3).</div>
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[38] L13 Tab F p 2</div>
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[39] L13 Tab F p 7</div>
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[40] S Asscher para 8</div>
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[41] S Asscher para 5</div>
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[42] S Asscher para 13</div>
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[43] S Asscher para 9</div>
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[44] S Hagger para 16</div>
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[45] S Collee para 30</div>
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[46] S Collee para 24</div>
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[47] S Hagger para 18</div>
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[48] L13 Tab F p 9 [The Medicines (Committee on Dental and Surgical Materials) Order 1975 SI 1975/1473 article 2, as amended in 1980]�</div>
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[49] L13 Tab F p24 [By the Medicines (Committee on Dental and Surgical Materials)(Revocation) Order 1994 SI 1994/3120, because in connection with the implementation of Council Directive 93/42/EEC (OJ L169, 12.7.93, p.1) concerning medical devices, most of the substances and articles referred to were no longer covered by the Act; in the case of those remaining, the statutory functions of the CDSM fall to another s 4 committee or to the Medicines Commission.]</div>
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[50] M67 Tab 1</div>
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[51] T71 p16</div>
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[52]DM01 Tab 14</div>
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[53] L13 Tab F p22</div>
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[54] DH01 Tab6 p 2</div>
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[55] S Lawson para 8</div>
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[56] L13 Tab F p22 [By the Medicines (Committee on the Review of Medicines)(Revocation) Order 1992 SI 1992/606.]</div>
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[57] L13 Tab F p 6 [The Medicines (British Pharmacopoeia Commission)� Order 1970 SI 1970/1256, explanatory note.]</div>
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[58] L15 Tab U p8 [SI 1994 3144, s 9(2)]</div>
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[59] L12� pA46 [Medicines Act 1968 s 35]</div>
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[60] L12 pA19 [Medicines Act 1968 s 9]</div>
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[61] L12� pA16 [Medicines Act 1968 s 7(2A)]</div>
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[62] L12 Tab A p 139-140 [Medicines Act 1968 s 130]</div>
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[63] Section 130 (2)</div>
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[64] Presumably �inducing�</div>
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[65] Section 130 (5)</div>
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[66] Section 130 (5A)</div>
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[67] L12� pA115</div>
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[68] L15 Tab R p 1 [The Medicines (Surgical Materials) Order 1971 SI 1971 1267]</div>
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[69] L15 Tab R p 7 [The Medicines (Specified Articles and Substances) Order 1976 SI 1976/968]</div>
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[70] L15 Tab R p 17 [The Medicines (Control of Substances for Manufacture) Order 1971 SI 1971/1200 article 3 and schedule 1; since 11.4.94, this has applied only to ingredients for animal medicinal products, whereas previously human medicines had been included.]</div>
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[71] L15 Tab R p 20 [The Medicines (Control of Substances for Manufacture) Order 1971 SI 1971/1200 article 3 and schedule 1.]</div>
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[72] L13 Tab D p 27 [The Medical Devices (Consequential Amendments � Medicines) Regulations 1994]</div>
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[73] L12 pA22 [Medicines Act 1968 s 12]</div>
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[74] L13 Tab G p 26 [The Medicines (Exemption from Licenses) (Foods and Cosmetics) Order 1971 SI 1971/1410 article 2(1).]</div>
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[75] The Medicines (Exemption from Licenses) (Foods and Cosmetics) Order 1971 SI 1971/1410 article 1(2)</div>
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[76] Ibid, article 2(2)(a).</div>
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[77] Ibid, article 2(2)(b) and Schedule.</div>
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[78] Ibid, article 2(2)(c).</div>
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[79] Ibid, article 2(2)(d).</div>
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[80] Ibid, article 2(3).</div>
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[81] DHO1 Tab 13 para 6</div>
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[82] L 13 Tab H p1</div>
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[83] L13 Tab H p40A</div>
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[84] Section 19(1)(a)</div>
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[85] Section 20(1)</div>
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[86] Section 20(3)</div>
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[87] L12� pA13, 143 [Medicines Act 1968 s 4(6) and 132(1)]</div>
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[88] Section 24(1)</div>
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[89] Section 24(2)</div>
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[90] Section 24(4)</div>
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[91] L12 pA38</div>
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[92] L12 pA39,A151 [Medicines Act 1968 s 29(1) and� Schedule 2]</div>
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[93] L12� pA28, A151 [Medicines Act 1968 s 21 and Schedule 2]</div>
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[94] L15 Tab U p 1 - SI 1994/3144 - see in particular regulations 1(2) and 9(2).</div>
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[95] DH01 Tab 13 para 1</div>
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[96] DH01 Tab 13para 8-9</div>
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[97] L14 Tab J p 1 [The Active Implantable Medical Devices Regulations 1992 SI 1992/3146, amended by the Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995 SI 1995/1671]</div>
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[98] DH01 Tab 11</div>
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[99]L14 Tab J p3</div>
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[100] L14 Tab J� p33 [The Medical Devices Regulations 1994 SI 1994/ 3017]</div>
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[101] L14 Tab J p35 [The Medical Devices Regulations 1994 article 2(1)]</div>
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[102] L14 Tab J p37 [Regulation 3(2)(b)]</div>
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[103] L14 Tab J p38 [Regulation 3(2)(g)]</div>
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[104] DH01 Tab 11</div>
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[105] DH01 Tab 11 p1-2</div>
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[106] DH01 Tab 13 para 10</div>
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[107] DH01 Tab 13 para 11</div>
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[108] DH01 Tab 11 p2</div>
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[109]DH01 Tab11</div>
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[110] Penguin Medical Encyclopedia (4th Edition 1996; Editors Peter Wingate and Richard Wingate).</div>
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[111] L 13 Tab H p1 [The Medicines (Applications for Product Licences and Clinical Trial and Animal Test Certificates) Regulations 1971 SI 1917/973 refer to applications for licences for homoeopathic products.]</div>
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[112] T71 p46</div>
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[113] T71 p 45</div>
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[114] L15 Tab T p1</div>
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[115] L16 Tab 1 p159</div>
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[116] L15 Tab T p1 [The Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 SI 1994/105 regulation 3]</div>
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[117] L13 Tab F p27 [Medicines (Advisory Board on the Registration of Homoeopathic Products) Order 1995 article 1.]</div>
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[118] L16 p 158</div>
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[119] L13 Tab F p27 [Established pursuant to sections 4 and 129(4) of the Medicines Act 1968 by the Medicines (Advisory Board on the Registration of Homoeopathic Products) Order 1995 SI 1995/309.]</div>
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[120] The Board considers those products which satisfy either the conditions set out in Article 7 of Council Directive 92/74/EEC (OJ No. L297, 13.10.92, p.12) or the conditions set out in paragraph (2) of Article 2 of the Medicines (Advisory Board on the Registration of Homoeopathic Products) Order 1995, namely that the product is one to which Article 2(1) of Council Directive 92/73/EEC OJ No. L297 13.10.92, p.8 applies; that it is for oral administration; that no specific therapeutic indication appears on the labelling or any associated information; and that an application for a certificate of registration (i.e. a certificate for the purposes of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 SI 1994/105: see Article 1(2) of the Medicines (Advisory Board on the Registration of Homoeopathic Products) Order 1995 SI 1995/309) or for renewal of such a certificate has been made, or the licensing authority proposes to suspend or revoke the certificate of registration.</div>
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[121] DH01 Tab 22</div>
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[122] DH01 Tab 22</div>
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[123] DH01 Tab 22</div>
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[124] DH01 Tab 22</div>
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[125] DH01 Tab 22</div>
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[126] DH01 Tab 6 p 1, S G Jones para 6</div>
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[127] S Jefferys para 8</div>
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[128] S G Jones para 3</div>
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[129] S G Jones para 3</div>
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[130] S G Jones para 3, M16 Tab 7</div>
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[131] S Jefferys para 8</div>
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[132] S G Jones para 8</div>
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[133] S Jefferys para 8-9, M16 Tab 22</div>
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[134] S Jefferys para 10</div>
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[135] S Jefferys 3 (WS 419B) para 18</div>
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[136] S Wills para 4</div>
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[137] S Rotblat para 8-9</div>
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[138] DH01 Tab 21</div>
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[139] M16 and S Rotblat para 8-9</div>
<div style="font-family: arial; font-size: 13.3333px;">
[140] S Purves para 30</div>
<div style="font-family: arial; font-size: 13.3333px;">
[141] S Jefferys para 11</div>
<div style="font-family: arial; font-size: 13.3333px;">
[142] S Jefferys para 38</div>
<div style="font-family: arial; font-size: 13.3333px;">
[143] M39 Tab 12</div>
<div style="font-family: arial; font-size: 13.3333px;">
[144] M39 Tab 12 p7</div>
<div style="font-family: arial; font-size: 13.3333px;">
[145] M39 Tab 12 p24</div>
<div style="font-family: arial; font-size: 13.3333px;">
[146] M39 Tab 12 p24</div>
<div style="font-family: arial; font-size: 13.3333px;">
[147] M39 Tab 12 p2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[148] T71 p23-24</div>
<div style="font-family: arial; font-size: 13.3333px;">
[149] S Jefferys 3 (419B) para 6-7</div>
<div style="font-family: arial; font-size: 13.3333px;">
[150] S Jefferys 3 (419B) para 9-10</div>
<div style="font-family: arial; font-size: 13.3333px;">
[151] S Jefferys 3 (419B) para 13</div>
<div style="font-family: arial; font-size: 13.3333px;">
[152] T79 p117-118</div>
<div style="font-family: arial; font-size: 13.3333px;">
[153] M39 Tab 21 pp2, 4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[154] S K Jones para 8</div>
<div style="font-family: arial; font-size: 13.3333px;">
[155] S Rotblat para 10</div>
<div style="font-family: arial; font-size: 13.3333px;">
[156] DH01 Tab 21, S Jefferys para 12</div>
<div style="font-family: arial; font-size: 13.3333px;">
[157] M16A Tab 7</div>
<div style="font-family: arial; font-size: 13.3333px;">
[158] M39 Tab 21 p7</div>
<div style="font-family: arial; font-size: 13.3333px;">
[159] S K Jones para 11</div>
<div style="font-family: arial; font-size: 13.3333px;">
[160] S K Jones para 13</div>
<div style="font-family: arial; font-size: 13.3333px;">
[161] S Jefferys para 12</div>
<div style="font-family: arial; font-size: 13.3333px;">
[162] S Rotblat para 12-13</div>
<div style="font-family: arial; font-size: 13.3333px;">
[163] S Jefferys p13</div>
<div style="font-family: arial; font-size: 13.3333px;">
[164] M16A Tab 27</div>
<div style="font-family: arial; font-size: 13.3333px;">
[165] S Wilson para 3.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[166] S Jefferys 3 (WS419B) para 12</div>
<div style="font-family: arial; font-size: 13.3333px;">
[167] S Jefferys para 53</div>
<div style="font-family: arial; font-size: 13.3333px;">
[168] S Jefferys para 23</div>
<div style="font-family: arial; font-size: 13.3333px;">
[169] S Jefferys para 24-27</div>
<div style="font-family: arial; font-size: 13.3333px;">
[170] S Jefferys 3 (WS 419B) para 11</div>
<div style="font-family: arial; font-size: 13.3333px;">
[171] S Jefferys para 29</div>
<div style="font-family: arial; font-size: 13.3333px;">
[172] S Jefferys para 28</div>
<div style="font-family: arial; font-size: 13.3333px;">
[173] S Hagger para 9</div>
<div style="font-family: arial; font-size: 13.3333px;">
[174] T71 p25-26</div>
<div style="font-family: arial; font-size: 13.3333px;">
[175] S Jefferys para 30</div>
<div style="font-family: arial; font-size: 13.3333px;">
[176] S Jefferys para 33</div>
<div style="font-family: arial; font-size: 13.3333px;">
[177] S Asscher para 15 - 16</div>
<div style="font-family: arial; font-size: 13.3333px;">
[178] S Asscher para 19</div>
<div style="font-family: arial; font-size: 13.3333px;">
[179] T84 p45-47</div>
<div style="font-family: arial; font-size: 13.3333px;">
[180] T93 p13-14</div>
<div style="font-family: arial; font-size: 13.3333px;">
[181] T88 p89-90</div>
<div style="font-family: arial; font-size: 13.3333px;">
[182] S Hine para8</div>
<div style="font-family: arial; font-size: 13.3333px;">
[183] S Acheson para 12</div>
<div style="font-family: arial; font-size: 13.3333px;">
[184] S Acheson para18</div>
<div style="font-family: arial; font-size: 13.3333px;">
[185] DH01 Tab21</div>
<div style="font-family: arial; font-size: 13.3333px;">
[186] T79 p45-46</div>
<div style="font-family: arial; font-size: 13.3333px;">
[187] DH01 Tab 21</div>
<div style="font-family: arial; font-size: 13.3333px;">
[188] S Jefferys para 34</div>
<div style="font-family: arial; font-size: 13.3333px;">
[189]M39 Tab22</div>
<div style="font-family: arial; font-size: 13.3333px;">
[190]DH01 Tab11</div>
<div style="font-family: arial; font-size: 13.3333px;">
[191] DH01 Tab11</div>
<div style="font-family: arial; font-size: 13.3333px;">
[192] M16 Tab 12</div>
<div style="font-family: arial; font-size: 13.3333px;">
[193] DH01 Tab 19</div>
<div style="font-family: arial; font-size: 13.3333px;">
[194] DH01 Tab 21, Dh01 Tab 19, M16A Tab 7</div>
<div style="font-family: arial; font-size: 13.3333px;">
[195] M16A Tab 12</div>
<div style="font-family: arial; font-size: 13.3333px;">
[196] DH01 Tab 19</div>
<div style="font-family: arial; font-size: 13.3333px;">
[197] M39 Tab 22 p3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[198] M16A Tab22</div>
<div style="font-family: arial; font-size: 13.3333px;">
[199] M39 Tab 22 p7</div>
<div style="font-family: arial; font-size: 13.3333px;">
[200] DM01 Tab 14, M16A, and S Little para5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[201] DM01 Tab 15</div>
<div style="font-family: arial; font-size: 13.3333px;">
[202] S Rutter para 21</div>
<div style="font-family: arial; font-size: 13.3333px;">
[203] S Little para 4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[204] S Armour para 5 i</div>
<div style="font-family: arial; font-size: 13.3333px;">
[205] M16 Tab 26, S Cruickshank para 1.4, E6845, E7890</div>
<div style="font-family: arial; font-size: 13.3333px;">
[206]DM01 Tab 15</div>
<div style="font-family: arial; font-size: 13.3333px;">
[207] DM01 Tab 14 Annex 2 p4, DM01 Tab15</div>
<div style="font-family: arial; font-size: 13.3333px;">
[208] DM01 Tab 15 Annex 2 p5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[209] DM01 TB 14 Annex 2 p6</div>
<div style="font-family: arial; font-size: 13.3333px;">
[210] DM01 Tab 15</div>
<div style="font-family: arial; font-size: 13.3333px;">
[211] DM01 Tab 15</div>
<div style="font-family: arial; font-size: 13.3333px;">
[212] DM01 Tab 15</div>
<div style="font-family: arial; font-size: 13.3333px;">
[213] YB 83/6.00/1.1-1.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[214] J/L/1985II/837</div>
<div style="font-family: arial; font-size: 13.3333px;">
[215] S Sloggem para 25-27</div>
<div style="font-family: arial; font-size: 13.3333px;">
[216] S Sloggem para 26</div>
<div style="font-family: arial; font-size: 13.3333px;">
[217] S Sloggem para 28-30</div>
<div style="font-family: arial; font-size: 13.3333px;">
[218] YB87/8.24/2.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[219] S Sloggem para 31</div>
<div style="font-family: arial; font-size: 13.3333px;">
[220] YB 87/9.09/1.1-1.12</div>
<div style="font-family: arial; font-size: 13.3333px;">
[221] S Little para 13-15</div>
<div style="font-family: arial; font-size: 13.3333px;">
[222] T99 p51</div>
<div style="font-family: arial; font-size: 13.3333px;">
[223] YB 87/9.09/1.1-1.12</div>
<div style="font-family: arial; font-size: 13.3333px;">
[224] S Adams para 26, S Purves para 43 and S Rotblat para 42</div>
<div style="font-family: arial; font-size: 13.3333px;">
[225] S Collee para 55</div>
<div style="font-family: arial; font-size: 13.3333px;">
[226] S Jefferys para 57</div>
<div style="font-family: arial; font-size: 13.3333px;">
[227] T99 p 52-53</div>
<div style="font-family: arial; font-size: 13.3333px;">
[228] T99 p 55</div>
<div style="font-family: arial; font-size: 13.3333px;">
[229] S Little 3 (331B) para 19</div>
<div style="font-family: arial; font-size: 13.3333px;">
[230] S Sloggem 2 (WS 454A) para 4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[231] S Sloggem 2 (WS 454A) para 4-7, 10-12</div>
<div style="font-family: arial; font-size: 13.3333px;">
[232] YB 87/9.10/1.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[233] S Little 2 (331A) para 14</div>
<div style="font-family: arial; font-size: 13.3333px;">
[234] YB 87/9.14/1.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[235] YB 87/10.1/1.1-1.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[236] YB87/12.00/1.1-1.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[237] YB87/12.00/1.1-1.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[238] S Rotblat para 44 and YB 87/8.24/2.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[239] YB 88/1.06/2.12.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[240] This company will be referred to as G throughout the DFA.� For reasons of confidentiality, product and company names cannot be used. We have adopted an alphabetical key for products and companies that are mentioned. This allows the story to be traced while protecting confidentiality.�</div>
<div style="font-family: arial; font-size: 13.3333px;">
[241] YB 88/2.25/1.1-1.6 & 2.1-2.5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[242] S Collee para 56-59</div>
<div style="font-family: arial; font-size: 13.3333px;">
[243] S Jefferys 3 (WS419B) para 27</div>
<div style="font-family: arial; font-size: 13.3333px;">
[244] YB88/01.06/1.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[245]YB 88/2.03/1.1-1.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[246] YB 88/3.02/6.1-6.8</div>
<div style="font-family: arial; font-size: 13.3333px;">
[247] YB 88/3.3/4.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[248] S Acheson para 42</div>
<div style="font-family: arial; font-size: 13.3333px;">
[249] YB 88/3.17/8.1-8.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[250] YB 88/3.17/5.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[251] YB 88/3.17/8.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[252] YB 88/3.17/5.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[253] YB88/03.21/1.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[254] T79 p72-73</div>
<div style="font-family: arial; font-size: 13.3333px;">
[255] T79 p91-92</div>
<div style="font-family: arial; font-size: 13.3333px;">
[256] YB 88/3.21/1.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[257] YB 88/3.24/3.1-3.7</div>
<div style="font-family: arial; font-size: 13.3333px;">
[258] S Jefferys para 58</div>
<div style="font-family: arial; font-size: 13.3333px;">
[259] S Jefferys 3 (WS419B) para 29</div>
<div style="font-family: arial; font-size: 13.3333px;">
[260] YB 88/4.13/5.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[261] YB88/4.13/5.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[262] S Jefferys para 36</div>
<div style="font-family: arial; font-size: 13.3333px;">
[263] S Jefferys 2 para 3-4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[264]YB 88/4.13/5.1,</div>
<div style="font-family: arial; font-size: 13.3333px;">
[265] S Jefferys 2 (WS 419A) para 2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[266] S Jefferys para 61</div>
<div style="font-family: arial; font-size: 13.3333px;">
[267] S Jefferys 3 (WS 419B) para 33</div>
<div style="font-family: arial; font-size: 13.3333px;">
[268] YB 88/4.28/5.1-5.6</div>
<div style="font-family: arial; font-size: 13.3333px;">
[269] YB 88/5.04/6.1-6.9</div>
<div style="font-family: arial; font-size: 13.3333px;">
[270] YB 88/5.16/2.12.12</div>
<div style="font-family: arial; font-size: 13.3333px;">
[271] S Little 2 (331A) para 12</div>
<div style="font-family: arial; font-size: 13.3333px;">
[272] YB 88/5.16/2.10-2.11</div>
<div style="font-family: arial; font-size: 13.3333px;">
[273] YB 88/5.16/2.12</div>
<div style="font-family: arial; font-size: 13.3333px;">
[274] YB 88/5.23/4.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[275] YB 88/5.20/12.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[276] YB 88/5.20/4.1-4.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[277] YB 88/5.23/9.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[278] YB 88/5.24/3.1-3.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[279] S Jefferys para 64</div>
<div style="font-family: arial; font-size: 13.3333px;">
[280] YB 88/5.26/6.1-6.5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[281] YB 88/6.2/15.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[282] YB 88/6.3/12.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[283] YB 88/6.6/3.1-3.19</div>
<div style="font-family: arial; font-size: 13.3333px;">
[284]YB 88/6.07/10.6</div>
<div style="font-family: arial; font-size: 13.3333px;">
[285] YB 88/6.08/11.1-11.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[286] YB 88/6.10/1.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[287] YB 88/6.13/8.1, S Wilkes para13</div>
<div style="font-family: arial; font-size: 13.3333px;">
[288] YB 88/6.14/6.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[289] YB 88/6.20/2.1-2.5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[290] YB 88/6.20/7.1-7.25</div>
<div style="font-family: arial; font-size: 13.3333px;">
[291] YB 88/6.20/7.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[292] YB 88/6.21/4.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[293] S. Jones para 11</div>
<div style="font-family: arial; font-size: 13.3333px;">
[294] S Jefferys para 66</div>
<div style="font-family: arial; font-size: 13.3333px;">
[295] S Jefferys 3 (WS 419B) para 36</div>
<div style="font-family: arial; font-size: 13.3333px;">
[296] S Rotblat para 47</div>
<div style="font-family: arial; font-size: 13.3333px;">
[297] YB 88/6.30/7.1-7.6</div>
<div style="font-family: arial; font-size: 13.3333px;">
[298] YB 88/7.3/1.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[299] YB 88/7.05/6.1-6.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[300] YB 88/7.06/8.1-8.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[301] YB 88/7.06/10.1-10.11</div>
<div style="font-family: arial; font-size: 13.3333px;">
[302] YB88/7.11/12.1-12.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[303] YB 88/7.11/8.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[304] YB88/7.11/13.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[305] YB 88/7.14/11.1-11.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[306] YB 88/7.14/11.1-11.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[307] J/VR/123/87</div>
<div style="font-family: arial; font-size: 13.3333px;">
[308] YB 88/7.21/1.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[309] YB 88/7.28/9.1-9.6</div>
<div style="font-family: arial; font-size: 13.3333px;">
[310] YB 88/8.11/2.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[311] YB 88/8.30/3.1 and S Acheson para 56</div>
<div style="font-family: arial; font-size: 13.3333px;">
[312] S Rotblat para 51</div>
<div style="font-family: arial; font-size: 13.3333px;">
[313] YB 88/9.20/3.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[314] S Jefferys 3 (WS 419B) para 38-39</div>
<div style="font-family: arial; font-size: 13.3333px;">
[315] S Purves para 50-51</div>
<div style="font-family: arial; font-size: 13.3333px;">
[316] S Rotblat para 29</div>
<div style="font-family: arial; font-size: 13.3333px;">
[317] YB 88/9.00/3.2-3.37</div>
<div style="font-family: arial; font-size: 13.3333px;">
[318] S Purves para 56-58</div>
<div style="font-family: arial; font-size: 13.3333px;">
[319] YB 88/09.00/3.7-3.9</div>
<div style="font-family: arial; font-size: 13.3333px;">
[320] S Purves para 59</div>
<div style="font-family: arial; font-size: 13.3333px;">
[321] S Purves para 63</div>
<div style="font-family: arial; font-size: 13.3333px;">
[322] S Jefferys 3 (WS 419B) para 43</div>
<div style="font-family: arial; font-size: 13.3333px;">
[323] S Rotblat para 56</div>
<div style="font-family: arial; font-size: 13.3333px;">
[324] S Purves para 66</div>
<div style="font-family: arial; font-size: 13.3333px;">
[325] S Purves para 67</div>
<div style="font-family: arial; font-size: 13.3333px;">
[326] YB 88/9.06/5.1-5.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[327] YB 88/9.6/2.1, S G Jones para 2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[328] YB 88/9.16/2.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[329] YB 88/9.07/2.1-2.22</div>
<div style="font-family: arial; font-size: 13.3333px;">
[330] YB 88/9.16/2.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[331] YB 88/9.22/1.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[332] YB 88/9.22/6.1-6.7</div>
<div style="font-family: arial; font-size: 13.3333px;">
[333] YB 88/9.26/4.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[334] S Rotblat para 49</div>
<div style="font-family: arial; font-size: 13.3333px;">
[335] T71 p 37</div>
<div style="font-family: arial; font-size: 13.3333px;">
[336] T71 pp 37-38</div>
<div style="font-family: arial; font-size: 13.3333px;">
[337] T71 pp 47-48</div>
<div style="font-family: arial; font-size: 13.3333px;">
[338] T 71 p39-41</div>
<div style="font-family: arial; font-size: 13.3333px;">
[339] S Collee para 44</div>
<div style="font-family: arial; font-size: 13.3333px;">
[340] T71 p44</div>
<div style="font-family: arial; font-size: 13.3333px;">
[341] T71 p94-95</div>
<div style="font-family: arial; font-size: 13.3333px;">
[342] T71 p96</div>
<div style="font-family: arial; font-size: 13.3333px;">
[343] YB 88/9.29/4.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[344] YB 88/9.29/4.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[345] YB 88/10.06/1.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[346] YB88/10.12/2.1-2.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[347] S Rotblat para 57</div>
<div style="font-family: arial; font-size: 13.3333px;">
[348] S Purves para 69</div>
<div style="font-family: arial; font-size: 13.3333px;">
[349] YB 88/10.14/6.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[350] YB 88/10.14/6.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[351] YB 88/10.20/3.1-3.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[352] YB 88/11.1/12.6</div>
<div style="font-family: arial; font-size: 13.3333px;">
[353] S Jeffreys para 72 and YB 88/11.02/4.1-4.10</div>
<div style="font-family: arial; font-size: 13.3333px;">
[354] S Collee para 66</div>
<div style="font-family: arial; font-size: 13.3333px;">
[355] S Collee para 67</div>
<div style="font-family: arial; font-size: 13.3333px;">
[356] S Collee para 68</div>
<div style="font-family: arial; font-size: 13.3333px;">
[357] S Collee para 69</div>
<div style="font-family: arial; font-size: 13.3333px;">
[358] S Collee para 70</div>
<div style="font-family: arial; font-size: 13.3333px;">
[359] S Collee para 72-83</div>
<div style="font-family: arial; font-size: 13.3333px;">
[360] S Collee para 108</div>
<div style="font-family: arial; font-size: 13.3333px;">
[361] S Jefferys 3 (WS 419B) para 48</div>
<div style="font-family: arial; font-size: 13.3333px;">
[362] YB 88/11.2/3.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[363] YB 88/11.2/3.2-3.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[364] YB 88/11.04/7.1-7.19</div>
<div style="font-family: arial; font-size: 13.3333px;">
[365] YB 88/11.08/5.1-5.6</div>
<div style="font-family: arial; font-size: 13.3333px;">
[366] YB88/11.08/5.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[367] YB 88/11.10/2.1-2.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[368] YB 88/11.14/6.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[369] S Asscher para 36</div>
<div style="font-family: arial; font-size: 13.3333px;">
[370] S Asscher para 50</div>
<div style="font-family: arial; font-size: 13.3333px;">
[371] YB 88/11.18/2.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[372]YB 88/11.16/6.1-6.7</div>
<div style="font-family: arial; font-size: 13.3333px;">
[373] YB 88/11.17/9.1-9.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[374] S Collee para 84- 85</div>
<div style="font-family: arial; font-size: 13.3333px;">
[375] S Asscher para 35</div>
<div style="font-family: arial; font-size: 13.3333px;">
[376] S Asscher para 38</div>
<div style="font-family: arial; font-size: 13.3333px;">
[377] YB 88/11.18/2.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[378] YB 88/11.18/3.1, S Jefferys para 79</div>
<div style="font-family: arial; font-size: 13.3333px;">
[379] YB 88/11.24/1.1-1.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[380] S Asscher para 40</div>
<div style="font-family: arial; font-size: 13.3333px;">
[381] S Asscher para 41-42</div>
<div style="font-family: arial; font-size: 13.3333px;">
[382] YB88/11.25/2.3,� S Meldrum para 57</div>
<div style="font-family: arial; font-size: 13.3333px;">
[383] YB 88/12.7/1.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[384] S Asscher para 44</div>
<div style="font-family: arial; font-size: 13.3333px;">
[385] S Jefferys 3 (WS419 B) para 49</div>
<div style="font-family: arial; font-size: 13.3333px;">
[386] S Adams para 42</div>
<div style="font-family: arial; font-size: 13.3333px;">
[387] YB 88/12.8/1.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[388] YB 88/12.15/9.1-9.5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[389] YB 88/12.16/3.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[390] YB 88/12.16/1.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[391] YB 88/12.20/2.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[392] YB 88/12.21/4.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[393] YB 88/12.23/1.1-1.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[394] YB 88/12.23/1.1-1.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[395] YB 88/12.23/2.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[396] T66 p77</div>
<div style="font-family: arial; font-size: 13.3333px;">
[397] S Asscher para 48</div>
<div style="font-family: arial; font-size: 13.3333px;">
[398] S Asscher para 64-66</div>
<div style="font-family: arial; font-size: 13.3333px;">
[399] S Rotblat para 32-34</div>
<div style="font-family: arial; font-size: 13.3333px;">
[400] YB89/1.00/2.1-2.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[401] YB 89/1.03/2.1-2.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[402] YB 89/01.03/2.1-2.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[403] S Adams para 44</div>
<div style="font-family: arial; font-size: 13.3333px;">
[404] YB 89/1.4/1.1-1.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[405] YB 89/1.04/5.1-5.16</div>
<div style="font-family: arial; font-size: 13.3333px;">
[406] YB 88/1.5/1.1 ( Note: although doc dated 5/1/88 it is apparent the minute was sent 5/1/89 see YB89/9.1/1.2)</div>
<div style="font-family: arial; font-size: 13.3333px;">
[407] YB 89/01.09/2.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[408] YB 89/01.09/2.1-2.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[409] S Jefferys 3 (WS 419B) para 51</div>
<div style="font-family: arial; font-size: 13.3333px;">
[410] YB 89/1.13/1.1-1.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[411] YB 89/1.13/1.1-1.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[412] YB 89/1.13/1.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[413] YB 89/1.17/1.1-1.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[414] YB 89/1.19/6.1, S Rotblat para 64</div>
<div style="font-family: arial; font-size: 13.3333px;">
[415] YB 89/1.26/1.1-1.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[416] S Collee para 88</div>
<div style="font-family: arial; font-size: 13.3333px;">
[417] S Adams para 36,40,41,48,� S Jefferys para 77,83,84,85,92</div>
<div style="font-family: arial; font-size: 13.3333px;">
[418] S Rotblat para 66</div>
<div style="font-family: arial; font-size: 13.3333px;">
[419] YB 89/1.26/7.1-7.8</div>
<div style="font-family: arial; font-size: 13.3333px;">
[420] YB 89/1.26/2.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[421] YB 89/01.26/2.1-2.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[422] YB 89/1.26/2.1-2.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[423] YB 89/1.30/1.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[424] YB 89/2.1/4.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[425] S Little para 8</div>
<div style="font-family: arial; font-size: 13.3333px;">
[426] S Purves para 87</div>
<div style="font-family: arial; font-size: 13.3333px;">
[427] S Jefferys 3 (WS 419B) para 55</div>
<div style="font-family: arial; font-size: 13.3333px;">
[428] YB 89/2.2/4.1-4.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[429] YB 89/02.02/1.1-1.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[430] YB 89/2.02/1.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[431] YB 89/2.03/2.1-2.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[432] YB 89/2.09/7.1, S Acheson para63</div>
<div style="font-family: arial; font-size: 13.3333px;">
[433] T79 p99-101</div>
<div style="font-family: arial; font-size: 13.3333px;">
[434] YB 89/2.00/8.1-8.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[435]YB 89/2.9/5.1-5.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[436] YB 89/2.9/5.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[437] YB 89/2.9/5.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[438] T79� p89</div>
<div style="font-family: arial; font-size: 13.3333px;">
[439] YB 89/2.10/3.1, S Adams para 52</div>
<div style="font-family: arial; font-size: 13.3333px;">
[440] YB 89/2.13/10.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[441] YB 89/2.14/7.1-7.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[442] S Rotblat para 68</div>
<div style="font-family: arial; font-size: 13.3333px;">
[443] S Adams para 53</div>
<div style="font-family: arial; font-size: 13.3333px;">
[444] YB 89/2.13/2.1-2.18</div>
<div style="font-family: arial; font-size: 13.3333px;">
[445] YB 89/2.13/2.6</div>
<div style="font-family: arial; font-size: 13.3333px;">
[446] YB 89/2.13/2.7-2.8</div>
<div style="font-family: arial; font-size: 13.3333px;">
[447] YB 89/2.14/5.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[448] YB 89/2.15/8.1-8.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[449] YB 89/2.14/2.1-2.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[450] YB 89/2.15/9.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[451] YB 89/2.15/3.1-3.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[452] YB89/2.15/6.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[453] YB 89/2.17/1.1-1.16</div>
<div style="font-family: arial; font-size: 13.3333px;">
[454] YB 89/2.17/10.1-10.5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[455] YB89/02.19/1.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[456] S Sloggem para 52</div>
<div style="font-family: arial; font-size: 13.3333px;">
[457] YB 89/2.22/11.1-11.5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[458] YB 89/2.22/11.1-11.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[459] YB89/2.22/11.5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[460] S Purves para 93</div>
<div style="font-family: arial; font-size: 13.3333px;">
[461] YB 89/02.00/5.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[462] YB/89/2.22/11.6</div>
<div style="font-family: arial; font-size: 13.3333px;">
[463] S Martin para 16</div>
<div style="font-family: arial; font-size: 13.3333px;">
[464] S Kimberlin para 6.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[465] YB 89/2.22/10.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[466]YB 89/2.23/10.1-10.11</div>
<div style="font-family: arial; font-size: 13.3333px;">
[467] YB89/2.23/5.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[468] YB 89/2.23/13.1-13.5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[469]� YB 89/2.23/6.1-6.2, S Adams para 60, S Jones para 17</div>
<div style="font-family: arial; font-size: 13.3333px;">
[470] YB 89/2.23/13.5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[471] YB 89/2.23/6.8</div>
<div style="font-family: arial; font-size: 13.3333px;">
[472] YB 89/2.23/6.9-6.11</div>
<div style="font-family: arial; font-size: 13.3333px;">
[473] YB 89/2.23/6.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[474] S Asscher para 58</div>
<div style="font-family: arial; font-size: 13.3333px;">
[475] YB 89/02.23/9.1-9.5, S Clarke para24</div>
<div style="font-family: arial; font-size: 13.3333px;">
[476] YB 89/2.23/3.1-3.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[477] YB 89/02.24/12.1-12.5, S Asscher para 67</div>
<div style="font-family: arial; font-size: 13.3333px;">
[478] YB 89/02.24/12.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[479] YB 89/2.23/6.9-6.11</div>
<div style="font-family: arial; font-size: 13.3333px;">
[480] YB 89/2.27/1.1-1.8</div>
<div style="font-family: arial; font-size: 13.3333px;">
[481] YB 89/2.27/1.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[482] IBD 1 Tab 2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[483] S Collee para 43</div>
<div style="font-family: arial; font-size: 13.3333px;">
[484] S Asscher para 32</div>
<div style="font-family: arial; font-size: 13.3333px;">
[485] YB 89/3.01/4.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[486] YB89/3.7/2.1-2.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[487] YB 89/3.7/6.1-6.6</div>
<div style="font-family: arial; font-size: 13.3333px;">
[488] S Adams para 63, YB 89/3.6/6.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[489] YB 89/3.07/4.1, S Asscher 69, S Jefferys 107</div>
<div style="font-family: arial; font-size: 13.3333px;">
[490] YB 89/3.00/1.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[491] S Collee para 39-41</div>
<div style="font-family: arial; font-size: 13.3333px;">
[492] S Collee para 37</div>
<div style="font-family: arial; font-size: 13.3333px;">
[493] S Asscher para 61</div>
<div style="font-family: arial; font-size: 13.3333px;">
[494] S Hagger para 34</div>
<div style="font-family: arial; font-size: 13.3333px;">
[495] YB 89/3.00/1.1-1.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[496] S Asscher� para 60</div>
<div style="font-family: arial; font-size: 13.3333px;">
[497] S Collee para 100</div>
<div style="font-family: arial; font-size: 13.3333px;">
[498] T79 p92</div>
<div style="font-family: arial; font-size: 13.3333px;">
[499] YB 89/3.15/4.1-4.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[500] YB 89/3.13/10.1-10.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[501] YB 89/3.16/7.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[502]YB 89/3.00/3.1-3.8</div>
<div style="font-family: arial; font-size: 13.3333px;">
[503] YB 89/3.17/10.1-10.5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[504]DH01 Tab11 p4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[505] YB 89/3.17/10.1-10.5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[506] YB 89/3.00/3.4-3.6</div>
<div style="font-family: arial; font-size: 13.3333px;">
[507] YB 89/03.22/1.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[508] YB 89/5.17/5.1, S Adams para 66</div>
<div style="font-family: arial; font-size: 13.3333px;">
[509] YB 89/3.15/6.1-6.5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[510] YB 89/3.17/8.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[511] YB 89/3.21/13.1-13.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[512] YB 89/3.30/4.1-4.10</div>
<div style="font-family: arial; font-size: 13.3333px;">
[513] YB 89/3.31/3.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[514] YB89/4.5/4.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[515] YB 89/4.00/1.1-1.7</div>
<div style="font-family: arial; font-size: 13.3333px;">
[516] YB 89/4.11/2.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[517] YB 89/4.11/2.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[518] YB 89/4.17/5.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[519] YB 89/4.00/1.1-1.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[520] YB 89/4.13/6.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[521] YB 89/5.12/10.1-10.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[522] YB 89/5.12/10.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[523] YB 89/8.21/10.4-10.17</div>
<div style="font-family: arial; font-size: 13.3333px;">
[524] YB 89/5.12/10.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[525]DH01 Tab11 p5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[526] YB 89/5.3/6.1-6.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[527] YB 89/5.12/5.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[528] YB 89/5.24/6.1-6.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[529] YB 89/5.24/6.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[530] T90 p139</div>
<div style="font-family: arial; font-size: 13.3333px;">
[531] YB89/5.31/4.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[532] YB 89/6.5/4.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[533] YB 89/4.27/1.18, IBD 1 Tab 4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[534] IBD1 Tab 4� p10-15</div>
<div style="font-family: arial; font-size: 13.3333px;">
[535] IBD 1 Tab 4 p15</div>
<div style="font-family: arial; font-size: 13.3333px;">
[536] YB 89/6.5/3.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[537] S Rotblat para 75</div>
<div style="font-family: arial; font-size: 13.3333px;">
[538] this company will be referred to as Z throughout this DFA</div>
<div style="font-family: arial; font-size: 13.3333px;">
[539] YB 89/6.06/10.1-10.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[540] YB 89/6.7/6.1-6.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[541] S Acheson para 70</div>
<div style="font-family: arial; font-size: 13.3333px;">
[542] YB 89/6.7/1.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[543] YB 89/6.8/7.1-7.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[544] YB89/6.8/10.1-10.5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[545] YB 89/6.8/10.5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[546] YB89/6.9/5.1-5.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[547] YB 89/6.9/14.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[548] S Jefferys para 113</div>
<div style="font-family: arial; font-size: 13.3333px;">
[549] S K Jones para 26</div>
<div style="font-family: arial; font-size: 13.3333px;">
[550] YB 89/6.12/14.1-14.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[551] YB 89/6.12/15.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[552] S Adams para 74</div>
<div style="font-family: arial; font-size: 13.3333px;">
[553] YB 89/6.12/14.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[554] YB 89/6.12/14.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[555] YB 89/06.12/14.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[556] YB 89/06.12/14.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[557] S Rotblat para 78</div>
<div style="font-family: arial; font-size: 13.3333px;">
[558] YB 89/6.12/15.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[559] S Adams para 74</div>
<div style="font-family: arial; font-size: 13.3333px;">
[560] YB 89/6.13/16.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[561] YB 89/6.13/10.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[562] YB 89/6.13/18.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[563] YB 89/6.27/7.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[564] S Rotblat para 82</div>
<div style="font-family: arial; font-size: 13.3333px;">
[565] YB 89/6.29/4.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[566] YB89/7.3/4.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[567] YB 89/7.03/8.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[568] this company will be referred to as Y throughout this DFA</div>
<div style="font-family: arial; font-size: 13.3333px;">
[569] YB89/07.04/3.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[570] YB 89/7.05/11.1 & 19.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[571] T87 p131</div>
<div style="font-family: arial; font-size: 13.3333px;">
[572] T87 p133</div>
<div style="font-family: arial; font-size: 13.3333px;">
[573] S Collee para 50-51</div>
<div style="font-family: arial; font-size: 13.3333px;">
[574] S Asscher para 72</div>
<div style="font-family: arial; font-size: 13.3333px;">
[575] YB89/07.04/3.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[576] YB89/07.14/10.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[577] S Purves para 115</div>
<div style="font-family: arial; font-size: 13.3333px;">
[578] YB 89/7.19/11.1-11.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[579] YB89/07.26/12.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[580] YB 89/8.24/9.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[581] YB 89/9.6/10.6</div>
<div style="font-family: arial; font-size: 13.3333px;">
[582] this company will be referred to X throughout this DFA</div>
<div style="font-family: arial; font-size: 13.3333px;">
[583] YB 89/8.2/6.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[584] YB 89/8.2/2.1-2.9</div>
<div style="font-family: arial; font-size: 13.3333px;">
[585] YB 89/8.2/2.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[586] YB 89/8.2/2.7</div>
<div style="font-family: arial; font-size: 13.3333px;">
[587] YB 89/8.04/9.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[588] YB89/8.7/4.1-4.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[589] YB 89/8.09/4.1-4.3, S Jefferys para 118</div>
<div style="font-family: arial; font-size: 13.3333px;">
[590] YB 89/8.21/11.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[591] YB 89/8.21/10.1-10.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[592] DH01 Tab11 p5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[593]YB 89/8.21/10.4-10.17</div>
<div style="font-family: arial; font-size: 13.3333px;">
[594] YB 89/8.24/9.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[595] YB 89/8.30/1.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[596] YB 89/8.30/6.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[597] YB 89/9.5/5.2, S Adams para 80</div>
<div style="font-family: arial; font-size: 13.3333px;">
[598] YB 89/9.6/10.1-10.12</div>
<div style="font-family: arial; font-size: 13.3333px;">
[599] YB 89/9.06/10.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[600] YB 89/9.06/11.2-11.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[601] YB 89/9.06/11.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[602] S Purves para 126</div>
<div style="font-family: arial; font-size: 13.3333px;">
[603] YB 89/9.06/11.12</div>
<div style="font-family: arial; font-size: 13.3333px;">
[604] this product will be referred to as F throughout this DFA</div>
<div style="font-family: arial; font-size: 13.3333px;">
[605] YB 89/9.06/11.5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[606] YB89/9.6/10.7</div>
<div style="font-family: arial; font-size: 13.3333px;">
[607] S Collee para 41</div>
<div style="font-family: arial; font-size: 13.3333px;">
[608] S Rotblat para 80</div>
<div style="font-family: arial; font-size: 13.3333px;">
[609] YB 89/9.06/13.1-13.6</div>
<div style="font-family: arial; font-size: 13.3333px;">
[610] YB 89/9.06/14.1-14.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[611] YB 89/9.06/10.5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[612] YB 89/9.6/10.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[613] S Collee para 109</div>
<div style="font-family: arial; font-size: 13.3333px;">
[614] YB 89/9.7/3.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[615] YB 89/9.7/3.1-3.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[616] YB 89/9.7/5.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[617] YB 89/9.7/5.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[618]YB 89/9.7/2.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[619] This company will be referred to as H throughout the DFA.</div>
<div style="font-family: arial; font-size: 13.3333px;">
[620] YB 89/9.13/7.1-7.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[621] YB 89/10.00/5.1-5.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[622] YB 89/9.20/3.1-3.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[623] YB 89/9.19/10.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[624] YB 89/9.19/11.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[625] YB 89/11.15/17.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[626] YB 89/9.21/13.1-13.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[627]YB 89/9.21/12.1-12.7</div>
<div style="font-family: arial; font-size: 13.3333px;">
[628]DH01 Tab11 p6</div>
<div style="font-family: arial; font-size: 13.3333px;">
[629] YB 89/9.28/10.1-10.8</div>
<div style="font-family: arial; font-size: 13.3333px;">
[630] YB89/9.28/10.3, S Collee para 112</div>
<div style="font-family: arial; font-size: 13.3333px;">
[631] YB89/10.3/3.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[632] YB89/10.3/7.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[633] YB 89/10.4/2.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[634] YB 89/10.5/3.1-3.5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[635] YB 89/10.06/5.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[636] YB 89/10.9/2.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[637] YB 89/10.10/7.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[638] YB 89/10.12/8.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[639] YB 89/10.12/8.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[640] YB 89/10.13/6.1, S Adams para 85</div>
<div style="font-family: arial; font-size: 13.3333px;">
[641] S Jefferys para 123 and 126</div>
<div style="font-family: arial; font-size: 13.3333px;">
[642] YB 89/10.16/4.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[643] YB 89/10.31/9.1, S Rotblat para 86</div>
<div style="font-family: arial; font-size: 13.3333px;">
[644]DH01 Tab11 p6</div>
<div style="font-family: arial; font-size: 13.3333px;">
[645]DH01 Tab11 p7</div>
<div style="font-family: arial; font-size: 13.3333px;">
[646] YB 89/11.7/10.3, S Adams para 88</div>
<div style="font-family: arial; font-size: 13.3333px;">
[647] YB 89/11.8/1.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[648] YB 89/11.00/11.1-11.6</div>
<div style="font-family: arial; font-size: 13.3333px;">
[649] YB 89/11.09/22.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[650] YB 89/11.10/3.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[651] L2� Tab 3B</div>
<div style="font-family: arial; font-size: 13.3333px;">
[652] YB 89/11.15/18.1-18.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[653] YB 89/11.15/17.1-17.3, YB 89/11.15/16.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[654] YB 89/11.15/16.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[655] YB 89/11.27/4.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[656]DH01 Tab11 p7</div>
<div style="font-family: arial; font-size: 13.3333px;">
[657] YB 89/11.27/3.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[658] S Adams para 91</div>
<div style="font-family: arial; font-size: 13.3333px;">
[659] DH01 Tab 11 p 8</div>
<div style="font-family: arial; font-size: 13.3333px;">
[660]YB 89/12.12/8.1-8.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[661] YB 89/12.13/12.1-2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[662] YB 89/12.19/9.1-9.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[663] YB 89/12.21/6.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[664]YB 89/12.28/1.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[665] YB 90/1.02/3.1-3.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[666] YB 90/1.03/2.1-2.9</div>
<div style="font-family: arial; font-size: 13.3333px;">
[667] YB 90/1.20/1.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[668] YB 90/1.9/11.1-11.6</div>
<div style="font-family: arial; font-size: 13.3333px;">
[669] YB 90/1.10/1.1-1.24</div>
<div style="font-family: arial; font-size: 13.3333px;">
[670] YB 90/1.10/10.1-10.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[671] YB 90/1.10/9.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[672] YB 90/1.10/8.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[673] YB 90/1.10/1.4-1.5, YB 90/1.10/9.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[674] YB 90/1.10/1.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[675] YB 90/1.10/1.5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[676] YB 90/1.10/1.5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[677] YB 90/1.10/8.1-8.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[678] YB 90/1.10/7.5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[679] YB 90/1.10/1.5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[680] S Collee para 116</div>
<div style="font-family: arial; font-size: 13.3333px;">
[681] S Collee para 116</div>
<div style="font-family: arial; font-size: 13.3333px;">
[682] S Collee para 49</div>
<div style="font-family: arial; font-size: 13.3333px;">
[683] S Jefferys para 132, YB 90/1.10/7.5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[684] YB 90/1.10/1.6</div>
<div style="font-family: arial; font-size: 13.3333px;">
[685] S Adams para 96</div>
<div style="font-family: arial; font-size: 13.3333px;">
[686] YB/90/01.12/10.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[687] YB 90/1.17/12.1-12.5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[688]YB 90/1.26/16.1-16.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[689] DH01 Tab 11 p9</div>
<div style="font-family: arial; font-size: 13.3333px;">
[690] YB 90/2.22/12.1-12..2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[691] YB 90/3.14/10.1, S Jefferys para 136</div>
<div style="font-family: arial; font-size: 13.3333px;">
[692] YB 90/3.26/6.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[693] YB 90/4.09/4.1-4.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[694] YB 90/4.17/6.1, S Jefferys para 140</div>
<div style="font-family: arial; font-size: 13.3333px;">
[695] YB 90/4.26/9.1-9.5</div>
<div style="font-family: arial; font-size: 13.3333px;">
[696] S Hagger para 44</div>
<div style="font-family: arial; font-size: 13.3333px;">
[697] YB 90/4.27/5.1, S Jefferys para 138</div>
<div style="font-family: arial; font-size: 13.3333px;">
[698] YB 90/4.27/6.1-6.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[699] YB 90/4.30/5.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[700] S Jefferys para 141</div>
<div style="font-family: arial; font-size: 13.3333px;">
[701] YB 90/5.01/8.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[702] YB 90/5.3/5.1, S Pickles para59.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[703] YB 90/7.16/5.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[704] There is no indication of who wrote this annotation or when.</div>
<div style="font-family: arial; font-size: 13.3333px;">
[705] YB 90/5.00/11.1-11.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[706]YB 90/5.23/13.1-13.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[707]DH01 Tab11 p10</div>
<div style="font-family: arial; font-size: 13.3333px;">
[708] YB 90/6.7/19.1, YB90/06.04/14.1-14.6</div>
<div style="font-family: arial; font-size: 13.3333px;">
[709] YB90/06.08/20.1, S Rotblat para 94-95</div>
<div style="font-family: arial; font-size: 13.3333px;">
[710]YB 90/6.08/16.1-16.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[711] YB90/06.11/23.1, S Rotblat para 83 & 84</div>
<div style="font-family: arial; font-size: 13.3333px;">
[712] IBD 1 Tab7 p159</div>
<div style="font-family: arial; font-size: 13.3333px;">
[713] YB 89/6.20/19.1-19.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[714] IBD 1 Tab 7 p126</div>
<div style="font-family: arial; font-size: 13.3333px;">
[715] This company will be referred to as I throughout the DFA.</div>
<div style="font-family: arial; font-size: 13.3333px;">
[716] YB 90/6.15/22.1-22.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[717] YB 90/6.29/8.1-8.2</div>
<div style="font-family: arial; font-size: 13.3333px;">
[718] S Rotblat para 97</div>
<div style="font-family: arial; font-size: 13.3333px;">
[719] YB90/7.4/1.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[720] YB90/7.4/1.3</div>
<div style="font-family: arial; font-size: 13.3333px;">
[721] YB90/7.4/1.4</div>
<div style="font-family: arial; font-size: 13.3333px;">
[722] S Rotblat para 98</div>
<div style="font-family: arial; font-size: 13.3333px;">
[723] YB90/7.4/1.7</div>
<div style="font-family: arial; font-size: 13.3333px;">
[724] S Jefferys para 145</div>
<div style="font-family: arial; font-size: 13.3333px;">
[725] S Rotblat para 36</div>
<div style="font-family: arial; font-size: 13.3333px;">
[726] S Rotblat para 37</div>
<div style="font-family: arial; font-size: 13.3333px;">
[727] S Rotblat para 38</div>
<div style="font-family: arial; font-size: 13.3333px;">
[728] S Rotblat para 39</div>
<div style="font-family: arial; font-size: 13.3333px;">
[729] S Rotblat para 41</div>
<div style="font-family: arial; font-size: 13.3333px;">
[730] S Rotblat para 87</div>
<div style="font-family: arial; font-size: 13.3333px;">
[731] S Jefferys para 55</div>
<div style="font-family: arial; font-size: 13.3333px;">
[732] S Collee para 49</div>
<div style="font-family: arial; font-size: 13.3333px;">
[733] S Asscher para 77</div>
<div style="font-family: arial; font-size: 13.3333px;">
[734] YB90/07.26/15.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[735] YB 90/7.25/12.1-12.16</div>
<div style="font-family: arial; font-size: 13.3333px;">
[736] YB 90/9.11/5.1</div>
<div style="font-family: arial; font-size: 13.3333px;">
[737] YB 90/9.12/2.1</div>
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[738] YB 90/09.12/6.1</div>
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[739] YB 90/9.13/4.1</div>
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[740] S Asscher para 88</div>
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[741] S Collee para 131</div>
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[742] S Jefferys para 146</div>
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[743] S Sloggem para 80</div>
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[744] YB 90/9.21/9.1</div>
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[745] S Pickles para 62.1-62.2</div>
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[746] YB 90/10.12/5.1</div>
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[747] YB 90/10.31/3.1-3.18</div>
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[748] YB 90/10.31/3.2</div>
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[749] YB 90/10.31/3.4</div>
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[750] YB 90/10.31/3.4-3.5</div>
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[751] YB 90/10.31/3.7</div>
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[752] S Rotblat para 112</div>
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[753] YB90/11.00/5.1-5.2</div>
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[754] YB 90/11.22/14.1-14.9</div>
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[755] DH01 Tab 11 p11</div>
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[756]DH01 Tab11 p11</div>
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[757] S Jefferys para 152</div>
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[758] YB 91/5.9/6.1</div>
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[759] YB 91/5.14/3.1</div>
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[760] YB 91/5.21/8.1</div>
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[761] S Jefferys para 156</div>
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[762]YB 91/7.31/8.1-8.6</div>
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[763] YB 91/8.15/9.1-9.2</div>
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[764]YB 91/11.08/4.1-4.4</div>
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[765] YB 91/11.12/2.1-2.19, DH01 Tab11 p9</div>
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[766] YB 91/11.28/2.1-2.4</div>
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[767] IBD 2 Tab 13 p11 para 4.15</div>
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[768] YB 92/4.8/6.1-6.2</div>
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[769] DH01 Tab6 p 13</div>
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[770] S Jefferys para 155</div>
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[771] YB 92/7.8/15.1-15.7</div>
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[772] YB 92/7.8/1.2</div>
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[773] S Asscher para 31</div>
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[774] S Rotblat para 39</div>
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[775] YB92/07.21/2.1</div>
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[776] YB92/07.30/3.1</div>
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[777] YB92/07.31/1.1-1.3</div>
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[778] YB 92/8.5/3.1-3.2</div>
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[779] YB92/08.18/4.1-4.2</div>
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[780] YB92/08.28/1.1</div>
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[781]YB 92/9.11/1.1</div>
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[782]YB 92/9.18/4.1</div>
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[783] YB 92/9.23/4.6</div>
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[784] YB 92/9.23/3.1-3.2</div>
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[785] S Rotblat para 121</div>
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[786]DH01 Tab11 p14-15, M39 Tab19</div>
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[787] YB 94/6.29/5.4-5.7</div>
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[788] YB 94/6.07/5.7</div>
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[789] YB 96/4.01/2.1</div>
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[790] DH01 Tab12 para 29-30</div>
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[791] YB 96/3.28/9.1-9.2</div>
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[792] S Jefferys para 176</div>
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[793] YB 96/4.04/5.1</div>
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[794] DH01 Tab 12 Annex D</div>
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[795] M39 Tab18</div>
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BSE INQUIRY<br />
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“Unprecedented” row delays second phase of BSE inquiry</div>
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BMJ 1999; 318 doi: https://doi.org/10.1136/bmj.318.7183.558 (Published 27 February 1999) Cite this as: BMJ 1999;318:558 Article Related content Metrics Responses This article has a correction. </div>
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Correction - March 06, 1999 Witnesses at the inquiry into bovine spongiform encephalopathy claim procedures are unfair. Will the Bristol inquiry adopt the same methods, and will witnesses again cry foul? Clare Dyer, legal correspondent, reports Sparks have been flying behind the scenes at the inquiry into bovine spongiform encephalo-pathy (BSE). The bland press release issued last week by the inquiry announcing that it will not be able to report, as planned, in June 1999 and adding that it needs more time, contains little hint of the backstage drama, beyond a statement by the chairman, Lord Phillips, that “preparing for phase two is proving a more exacting process than we had anticipated, and we are anxious that it should be done fully and fairly.”</div>
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The word “unprecedented” has been used to describe the row that has blown up between the inquiry and lawyers representing civil servants from the Ministry of Agriculture, Fisheries, and Food and the Department of Health. Strongly worded letters have been exchanged between the lawyers and the inquiry, and judicial review has been threatened.</div>
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Phase one of the inquiry, the fact finding exercise, has ended after evidence from more than 300 witnesses was presented over 95 days. Civil servants have objected to the “draft factual accounts” produced on the various issues, and have posted them on the internet with an invitation for corrections to be made. Witnesses claim that these accounts, far from being factual, are “value laden” and prosecutorial, …</div>
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<a href="http://www.bmj.com/content/318/7183/558" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://www.bmj.com/content/318/7183/558</a></div>
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<span style="font-family: "arial";"><span style="font-size: 13.3333px;">Subject: History of Inquiry report delays Date: Fri, 22 Sep 2000 08:04:19 -0800 From: tom Reply-To: Bovine Spongiform Encephalopathy To: BSE-L@uni-karlsruhe.de</span></span><br />
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<span style="font-family: "arial";"><span style="font-size: 13.3333px;">######### Bovine Spongiform Encephalopathy #########</span></span><br />
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<span style="font-family: "arial";"><span style="font-size: 13.3333px;">Inquiring into inquiries Richard Smith BMJ 2000 321(7263): p. 715-716 http://bmj.com/cgi/content/full/321/7263/715</span></span><br />
<span style="font-family: "arial";"><span style="font-size: 13.3333px;"><br /></span></span>
<span style="font-family: "arial";"><span style="font-size: 13.3333px;">"...This inquiry is not alone in being criticised. The inquiry into the circumstances that resulted in bovine spongiform encephalopathy being passed to humans was supposed to report in June 1999 but has now had to enter a second stage to deal with "potential criticism, clarification, and conflicts of evidence." [7] The inquiry heard from over 300 witnesses, and many objected to the "draft factual accounts" published on the internet. These accounts were accused of being far from factual, "value laden" and wrong."</span></span><br />
<span style="font-family: "arial";"><span style="font-size: 13.3333px;"><br /></span></span>
<span style="font-family: "arial";"><span style="font-size: 13.3333px;">[Actually, no one has criticized the BSE Inquiry as far as I know, other than the 7 million pounds of MAFF lawyers. Everyone testifying had the opportunity to submit lengthy accounts of their own and most did. These claims about unfairness were never buttressed with any supporting specifics, but here is a journal reporter repeating them as if handed down on clay tablets.</span></span><br />
<span style="font-family: "arial";"><span style="font-size: 13.3333px;"><br /></span></span>
<span style="font-family: "arial";"><span style="font-size: 13.3333px;">Indeed, how can a reprinted memo be wrong or far from factual? It is their own words. The documents that Terry has been supplying are the very ones that were suppressed from the internet -- and the object of all the whining from the lawyers.</span></span><br />
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<span style="font-family: "arial";"><span style="font-size: 13.3333px;">tom] </span></span><br />
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<span style="font-family: "arial";"><span style="font-size: 13.3333px;">Dyer C. "Unprecedented" row delays second phase of BSE inquiry. BMJ 1999; 318: 558 http://www.bmj.com/cgi/content/full/318/7183/558?ijkey=OAKJJor7RmxXA</span></span><br />
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<span style="font-family: "arial";"><span style="font-size: 13.3333px;">BMJ;318:558 ( 27 February 1999) "Unprecedented" row delays second phase of BSE inquiry</span></span><br />
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<span style="font-family: "arial";"><span style="font-size: 13.3333px;">Witnesses at the inquiry into bovine spongiform encephalopathy claim procedures are unfair. Will the Bristol inquiry adopt the same methods, and will witnesses again cry foul? Clare Dyer, legal correspondent, reports</span></span><br />
<span style="font-family: "arial";"><span style="font-size: 13.3333px;"><br /></span></span>
<span style="font-family: "arial";"><span style="font-size: 13.3333px;">Sparks have been flying behind the scenes at the inquiry into bovine spongiform encephalo-pathy (BSE). The bland press release issued last week by the inquiry announcing that it will not be able to report, as planned, in June 1999 and adding that it needs more time, contains little hint of the backstage drama, beyond a statement by the chairman, Lord Phillips, that "preparing for phase two is proving a more exacting process than we had anticipated, and we are anxious that it should be done fully and fairly."</span></span><br />
<span style="font-family: "arial";"><span style="font-size: 13.3333px;"><br /></span></span>
<span style="font-family: "arial";"><span style="font-size: 13.3333px;">The word "unprecedented" has been used to describe the row that has blown up between the inquiry and lawyers representing civil servants from the Ministry of Agriculture, Fisheries, and Food and the Department of Health. Strongly worded letters have been exchanged between the lawyers and the inquiry, and judicial review has been threatened.</span></span><br />
<span style="font-family: "arial";"><span style="font-size: 13.3333px;"><br /></span></span>
<span style="font-family: "arial";"><span style="font-size: 13.3333px;">Phase one of the inquiry, the fact finding exercise, has ended after evidence from more than 300 witnesses was presented over 95 days. Civil servants have objected to the "draft factual accounts" produced on the various issues, and have posted them on the internet with an invitation for corrections to be made. Witnesses claim that these accounts, far from being factual, are "value laden" and prosecutorial, contain errors of fact, and selective, and even inaccurate, quotes from documents and, thanks to technology, they have now been broadcast to the world.</span></span><br />
<span style="font-family: "arial";"><span style="font-size: 13.3333px;"><br /></span></span>
<span style="font-family: "arial";"><span style="font-size: 13.3333px;">The row is delaying the start of phase two, which is set to deal with "potential criticisms, clarification, and conflicts of evidence." The inquiry had planned to put "Salmon letters" the letters that witnesses receive before they appear before the inquiry detailing the criticisms they are likely to face on the internet, together with the witness"s response, on the day the witness gave evidence.</span></span><br />
<span style="font-family: "arial";"><span style="font-size: 13.3333px;"><br /></span></span>
<span style="font-family: "arial";"><span style="font-size: 13.3333px;">This is now being reconsidered. Those whose conduct comes under scrutiny at official inquiries inevitably feel vulnerable, and questions about fairness come with the territory. Britons are used to the adversarial process of court cases and disciplinary hearings by regulatory bodies like the General Medical Council (GMC). Unlike inquiries, however, these have a body of formal precedent laying down strict procedural rules. Court cases and GMC hearings take place in public but few documents are publicly available, and there are tight controls over what evidence can be admitted.</span></span><br />
<span style="font-family: "arial";"><span style="font-size: 13.3333px;"><br /></span></span>
<span style="font-family: "arial";"><span style="font-size: 13.3333px;">The inquisitorial process of the inquiries often comes as a shock to witnesses, and it is not accompanied by the strict procedural rules that operate in the court system. Though all the inquiry chairmen emphasise that they are not presiding over a court of law, that no one is accused, and that they are merely trying to get at the truth, to the witness whose professional reputation is on the line it can feel like a court of law but without the safeguards.</span></span><br />
<span style="font-family: "arial";"><span style="font-size: 13.3333px;"><br /></span></span>
<span style="font-family: "arial";"><span style="font-size: 13.3333px;">The internet has also introduced a new element into the equation. Everything is instantly available to the tabloid reporter or to fellow professionals halfway around the globe. The BSE inquiry has posted transcripts of evidence and witness statements on the internet. It also has a library of all its documents which the public can consult. Even documents such as civil service memos, thought when written to be protected by public interest immunity even from scrutiny by a court, are freely available to the public. Extracts have been read out in public, ensuring that they get on the internet.</span></span><br />
<span style="font-family: "arial";"><span style="font-size: 13.3333px;"><br /></span></span>
<span style="font-family: "arial";"><span style="font-size: 13.3333px;">If the inquiry is being delayed because of the anger and sense of injustice felt by witnesses, can the Bristol inquiry into paediatric heart surgery at Bristol Royal Infirmary, learn anything from the experience of the BSE team?</span></span><br />
<span style="font-family: "arial";"><span style="font-size: 13.3333px;"><br /></span></span>
<span style="font-family: "arial";"><span style="font-size: 13.3333px;">The Bristol inquiry, which starts on 16 March and is chaired by Ian Kennedy, professor of health law, ethics, and policy at University College London, is going to adopt some of the same procedures as used in the BSE inquiry. There are plans, for example, to put transcripts of evidence and witness statements on the internet.</span></span><br />
<span style="font-family: "arial";"><span style="font-size: 13.3333px;"><br /></span></span>
<span style="font-family: "arial";"><span style="font-size: 13.3333px;">The Bristol inquiry"s terms of reference go far beyond those of the General Medical Council"s investigation of the case, which itself prompted allegations of unfairness from the doctors" lawyers. The GMC considered only whether two surgeons at Bristol Royal Infirmary and the chief executive of United Bristol Healthcare Trust were guilty of serious professional misconduct, and looked at only 53 paediatric heart operations of two types, in which 29 babies died.</span></span><br />
<span style="font-family: "arial";"><span style="font-size: 13.3333px;"><br /></span></span>
<span style="font-family: "arial";"><span style="font-size: 13.3333px;">The inquiry will want to identify factors in the running of the hospital and the department which allowed the tragedy to happen. Illuminating evidence may come from three Bristol consultants two cardiologists and an anaesthetist who refused on legal advice to give evidence to the GMC. They will not have that choice at this inquiry because it is a statutory one; it will be convened under section 84 of the National Health Service Act 1977, which gives it the power to compel witnesses to attend, to call for documents, and to imprison anyone who refuses to comply. The inquiry into the personality disorder unit at Ashworth Hospital, chaired by Peter Fallon QC, a retired circuit judge, which reported in January, was also a section 84 inquiry. The BSE inquiry, by contrast, is a non-statutory inquiry, with no powers of compulsion.</span></span><br />
<span style="font-family: "arial";"><span style="font-size: 13.3333px;"><br /></span></span>
<span style="font-family: "arial";"><span style="font-size: 13.3333px;">In both types of inquiry, most of the decisions about how to proceed are taken by the inquiry panel, and particularly the chairman. The Bristol inquiry, for example, has still not finalised its thinking on Salmon letters. It has not yet decided which witnesses should receive them and how they should be framed, both being issues fraught with difficulty.</span></span><br />
<span style="font-family: "arial";"><span style="font-size: 13.3333px;"><br /></span></span>
<span style="font-family: "arial";"><span style="font-size: 13.3333px;">A recent comment from a spokesman for the Bristol inquiry suggests that its members are aware of the delicate nature of its work and the tightrope that it is going to have to walk. The spokesman said: "Lord Justice Scott [chairman of the inquiry investigating the sale of arms to Iraq] criticised Salmon letters as excessively adversarial. Ours is an inquisitorial process. At the same time there has to be a commitment to fairness."</span></span><br />
<span style="font-family: "arial";"><span style="font-size: 13.3333px;"><br /></span></span>
<span style="font-family: "arial";"><span style="font-size: 13.3333px;">Whether the present furore over the BSE inquiry will provide lessons for the Bristol inquiry team remains to be seen.</span></span><br />
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<span style="font-family: "arial";"><span style="font-size: 13.3333px;">"Ours is an inquisitorial process. At the same time there has to be a commitment to fairness"</span></span><br />
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Research Project: TRANSMISSION, DIFFERENTIATION, AND PATHOBIOLOGY OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES</div>
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Location: Virus and Prion Research</div>
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Title: Disease-associated prion protein detected in lymphoid tissues from pigs challenged with the agent of chronic wasting disease</div>
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Author item Moore, Sarah item Kunkle, Robert item Kondru, Naveen item Manne, Sireesha item Smith, Jodi item Kanthasamy, Anumantha item West Greenlee, M item Greenlee, Justin</div>
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Submitted to: Prion Publication Type: Abstract Only Publication Acceptance Date: 3/15/2017 Publication Date: N/A Citation: N/A Interpretive Summary:</div>
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Technical Abstract: Aims: Chronic wasting disease (CWD) is a naturally-occurring, fatal neurodegenerative disease of cervids. We previously demonstrated that disease-associated prion protein (PrPSc) can be detected in the brain and retina from pigs challenged intracranially or orally with the CWD agent. In that study, neurological signs consistent with prion disease were observed only in one pig: an intracranially challenged pig that was euthanized at 64 months post-challenge. The purpose of this study was to use an antigen-capture immunoassay (EIA) and real-time quaking-induced conversion (QuIC) to determine whether PrPSc is present in lymphoid tissues from pigs challenged with the CWD agent.</div>
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Methods: At two months of age, crossbred pigs were challenged by the intracranial route (n=20), oral route (n=19), or were left unchallenged (n=9). At approximately 6 months of age, the time at which commercial pigs reach market weight, half of the pigs in each group were culled (<6 challenge="" groups="" month="" pigs="" remaining="" the="">6 month challenge groups) were allowed to incubate for up to 73 months post challenge (mpc). The retropharyngeal lymph node (RPLN) was screened for the presence of PrPSc by EIA and immunohistochemistry (IHC). The RPLN, palatine tonsil, and mesenteric lymph node (MLN) from 6-7 pigs per challenge group were also tested using EIA and QuIC.</6></div>
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Results: PrPSc was not detected by EIA and IHC in any RPLNs. All tonsils and MLNs were negative by IHC, though the MLN from one pig in the oral <6 5="" 6="" at="" by="" detected="" eia.="" examined="" group="" in="" intracranial="" least="" lymphoid="" month="" months="" of="" one="" pigs="" positive="" prpsc="" quic="" the="" tissues="" was="">6 months group, 5/6 pigs in the oral <6 4="" and="" group="" months="" oral="">6 months group. Overall, the MLN was positive in 14/19 (74%) of samples examined, the RPLN in 8/18 (44%), and the tonsil in 10/25 (40%). Conclusions:</6></6></div>
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This study demonstrates that PrPSc accumulates in lymphoid tissues from pigs challenged intracranially or orally with the CWD agent, and can be detected as early as 4 months after challenge.</div>
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CWD-infected pigs rarely develop clinical disease and if they do, they do so after a long incubation period. This raises the possibility that CWD-infected pigs could shed prions into their environment long before they develop clinical disease.</div>
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Furthermore, lymphoid tissues from CWD-infected pigs could present a potential source of CWD infectivity in the animal and human food chains.</div>
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<a href="https://www.ars.usda.gov/research/publications/publication/?seqNo115=337105" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">https://www.ars.usda.gov/research/publications/publication/?seqNo115=337105</a></div>
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CONFIDENTIAL</div>
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EXPERIMENTAL PORCINE SPONGIFORM ENCEPHALOPATHY</div>
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While this clearly is a cause for concern we should not jump to the conclusion that this means that pigs will necessarily be infected by bone and meat meal fed by the oral route as is the case with cattle. ...</div>
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<a href="http://web.archive.org/web/20031026000118/www.bseinquiry.gov.uk/files/yb/1990/08/23004001.pdf" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://web.archive.org/web/20031026000118/www.bseinquiry.gov.uk/files/yb/1990/08/23004001.pdf</a></div>
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we cannot rule out the possibility that unrecognised subclinical spongiform encephalopathy could be present in British pigs though there is no evidence for this: only with parenteral/implantable pharmaceuticals/devices is the theoretical risk to humans of sufficient concern to consider any action.</div>
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<a href="http://web.archive.org/web/20030822031154/www.bseinquiry.gov.uk/files/yb/1990/09/10007001.pdf" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://web.archive.org/web/20030822031154/www.bseinquiry.gov.uk/files/yb/1990/09/10007001.pdf</a></div>
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Our records show that while some use is made of porcine materials in medicinal products, the only products which would appear to be in a hypothetically ''higher risk'' area are the adrenocorticotrophic hormone for which the source material comes from outside the United Kingdom, namely America China Sweden France and Germany. The products are manufactured by Ferring and Armour. A further product, ''Zenoderm Corium implant'' manufactured by Ethicon, makes use of porcine skin - which is not considered to be a ''high risk'' tissue, but one of its uses is described in the data sheet as ''in dural replacement''. This product is sourced from the United Kingdom.....</div>
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<a href="http://web.archive.org/web/20030822054419/www.bseinquiry.gov.uk/files/yb/1990/09/21009001.pdf" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://web.archive.org/web/20030822054419/www.bseinquiry.gov.uk/files/yb/1990/09/21009001.pdf</a></div>
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snip...see much more here ;</div>
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WEDNESDAY, APRIL 05, 2017</div>
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Disease-associated prion protein detected in lymphoid tissues from pigs challenged with the agent of chronic wasting disease</div>
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<a href="http://chronic-wasting-disease.blogspot.com/2017/04/disease-associated-prion-protein.html" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://chronic-wasting-disease.blogspot.com/2017/04/disease-associated-prion-protein.html</a></div>
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<span style="font-size: 10pt; line-height: 1.22em;">*** U.S.A. 50 STATE BSE MAD COW CONFERENCE CALL </span></div>
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Jan. 9, 2001 </div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;">[host Richard Barns] and now a question from Terry S. Singeltary of CJD Watch.</span></div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;">[TSS] yes, thank you, U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?</span></div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;">[no answer, you could hear in the back ground, mumbling and 'we can't. have him ask the question again.]</span></div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;">[host Richard] could you repeat the question?</span></div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;">[TSS] U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?</span></div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;">[not sure whom ask this] what group are you with?</span></div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;">[TSS] CJD Watch, my Mom died from hvCJD and we are tracking CJD world-wide.</span></div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;">[not sure who is speaking] could you please disconnect Mr. Singeltary</span></div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;">[TSS] you are not going to answer my question?</span></div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;">[not sure whom speaking] NO </span></div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;">SNIP...read full transcript and history here;</span></div>
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<a href="http://tseac.blogspot.com/2011/02/usa-50-state-bse-mad-cow-conference.html" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://tseac.blogspot.com/2011/02/usa-50-state-bse-mad-cow-conference.html</a></div>
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TUESDAY, JULY 18, 2017 </div>
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USDA announces Alabama case of Bovine Spongiform Encephalopathy Alabama</div>
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<a href="http://bovineprp.blogspot.com/2017/07/usda-announces-alabama-case-of-bovine.html" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://bovineprp.blogspot.com/2017/07/usda-announces-alabama-case-of-bovine.html</a></div>
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THURSDAY, JULY 20, 2017 </div>
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USDA OIE Alabama Atypical L-type BASE Bovine Spongiform Encephalopathy BSE animal feeds for ruminants rule, 21 CFR 589.200</div>
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<a href="http://bovineprp.blogspot.com/2017/07/usda-oie-alabama-atypical-l-type-base.html" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://bovineprp.blogspot.com/2017/07/usda-oie-alabama-atypical-l-type-base.html</a></div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;">SUNDAY, JULY 30, 2017 </span></div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;">Do we need to explain the occurrence of atypical scrapie?</span></div>
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<span style="font-family: "arial" , "helvetica"; line-height: 1.22em;"><a href="http://nor-98.blogspot.com/2017/07/do-we-need-to-explain-occurrence-of.html" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://nor-98.blogspot.com/2017/07/do-we-need-to-explain-occurrence-of.html</a></span></div>
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TUESDAY, JULY 18, 2017 </div>
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MINK FARMING USA TRANSMISSIBLE MINK ENCEPHALOPATHY TSE PRION DISEASE SURVEILLANCE AND TESTING</div>
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<a href="http://transmissible-mink-encephalopathy.blogspot.com/2017/07/mink-farming-usa-transmissible-mink.html" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://transmissible-mink-encephalopathy.blogspot.com/2017/07/mink-farming-usa-transmissible-mink.html</a></div>
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<a href="http://transmissible-mink-encephalopathy.blogspot.com/" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://transmissible-mink-encephalopathy.blogspot.com/</a></div>
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WEDNESDAY, APRIL 05, 2017 </div>
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Disease-associated prion protein detected in lymphoid tissues from pigs challenged with the agent of chronic wasting disease </div>
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<a href="http://chronic-wasting-disease.blogspot.com/2017/04/disease-associated-prion-protein.html" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://chronic-wasting-disease.blogspot.com/2017/04/disease-associated-prion-protein.html </a></div>
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TUESDAY, APRIL 18, 2017 </div>
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*** EXTREME USA FDA PART 589 TSE PRION FEED LOOP HOLE STILL EXIST, AND PRICE OF POKER GOES UP *** </div>
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<a href="http://usdameatexport.blogspot.com/2017/04/extreme-usa-fda-part-589-tse-prion-feed.html" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://usdameatexport.blogspot.com/2017/04/extreme-usa-fda-part-589-tse-prion-feed.html </a></div>
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WEDNESDAY, JULY 26, 2017 </div>
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APHIS USDA Emerging Animal Disease Preparedness and Response Plan July 2017</div>
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<a href="http://animalhealthreportpriontse.blogspot.com/2017/07/aphis-usda-emerging-animal-disease.html" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://animalhealthreportpriontse.blogspot.com/2017/07/aphis-usda-emerging-animal-disease.html</a></div>
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<a href="http://equinespongiformencephalopathy.blogspot.com/2010/05/horse-prion-protein-nmr-structure-and.html" rel="noopener noreferrer" style="color: blue; cursor: pointer; font-size: 10pt; line-height: 1.22em;" target="_blank">http://equinespongiformencephalopathy.blogspot.com/</a></div>
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<a href="http://caninespongiformencephalopathy.blogspot.com/" rel="noopener noreferrer" style="color: blue; cursor: pointer; line-height: 1.22em;" target="_blank">http://caninespongiformencephalopathy.blogspot.com/</a></div>
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<span style="font-size: 13px; line-height: 1.22em;">Induction of IAPP amyloid deposition and associated diabetic abnormalities by a prion-like mechanism</span></div>
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View ORCID ProfileAbhisek Mukherjee, Diego Morales-Scheihing, Natalia Salvadores, Ines Moreno-Gonzalez, Cesar Gonzalez, View ORCID ProfileKathleen Taylor-Presse, View ORCID ProfileNicolas Mendez, Mohammad Shahnawaz, View ORCID ProfileA. Osama Gaber, View ORCID ProfileOmaima M. Sabek, View ORCID ProfileDaniel W. Fraga, View ORCID ProfileClaudio Soto DOI: 10.1084/jem.20161134 | Published August 1, 2017</div>
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ArticleFigures & DataInfoMetrics Preview PDF Abstract</div>
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Although a large proportion of patients with type 2 diabetes (T2D) accumulate misfolded aggregates composed of the islet amyloid polypeptide (IAPP), its role in the disease is unknown. Here, we show that pancreatic IAPP aggregates can promote the misfolding and aggregation of endogenous IAPP in islet cultures obtained from transgenic mouse or healthy human pancreas. Islet homogenates immunodepleted with anti-IAPP–specific antibodies were not able to induce IAPP aggregation. Importantly, intraperitoneal inoculation of pancreatic homogenates containing IAPP aggregates into transgenic mice expressing human IAPP dramatically accelerates IAPP amyloid deposition, which was accompanied by clinical abnormalities typical of T2D, including hyperglycemia, impaired glucose tolerance, and a substantial reduction on β cell number and mass. Finally, induction of IAPP deposition and diabetic abnormalities were also induced in vivo by administration of IAPP aggregates prepared in vitro using pure, synthetic IAPP. Our findings suggest that some of the pathologic and clinical alterations of T2D might be transmissible through a similar mechanism by which prions propagate in prion diseases.</div>
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<span style="background-color: white; font-family: "georgia"; font-size: x-small;">Terry S. Singeltary Sr.</span></div>
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Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-4687453285836897153.post-39024427640887750212012-04-19T12:52:00.001-05:002012-04-19T12:57:03.425-05:00Wendy Grant, who has died aged 89, was a neuropathologist who became one of the first scientists to warn the public that BSE, also known as Mad Cow Disease<span style="font-family: Times New Roman;">Wendy Grant</span><br />
<div class="storyHead"><div></div><h2><span style="font-family: Times New Roman;">Wendy Grant, who has died aged 89, was a neuropathologist who became one of the first scientists to warn the public that BSE, also known as Mad Cow Disease, could be incubating in the human population.</span></h2><div></div><div></div></div><br />
<div class="oneHalf gutter"><div class="story"><div id="storyEmbSlide"><div class="slideshow ssMain"><div class="nextPrevLayer"><div class="ssImg" style="display: block;"><img alt="Wendy Grant" height="287" src="http://i.telegraph.co.uk/multimedia/archive/02194/grant2_2194000c.jpg" width="460" /> <br />
<div class="artImageExtras"><div class="imgLoadingText hide"></div><div class="tools imgindex"><span style="font-family: Times New Roman;"></span> </div><div class="tools imgindex"><span style="font-family: Times New Roman;"></span> </div><div class="tools imgindex"><span style="font-family: Times New Roman;">Image <span class="index">1</span> of <span class="total">2</span></span></div><div class="tools imgindex"><span style="font-family: Times New Roman;"><span class="total"></span></span> </div><div class="tools imgindex"><span style="font-family: Times New Roman;"><span class="total"></span></span> </div><div class="ingCaptionCredit"><span style="font-family: Times New Roman;"><span class="caption">May 1990: In one of the most celebrated images of the BSE crisis, Agriculture minister John Selwyn Gummer and his 4 year old daughter Cordelia tuck into beefburgers on a visit to the East Coast Boat Show. </span><span class="credit">Photo: PA</span></span></div><div class="ingCaptionCredit"><span style="font-family: Times New Roman;"><span class="credit"></span></span> </div><div class="ingCaptionCredit"><span style="font-family: Times New Roman;"><span class="credit"></span></span> </div><div class="ingCaptionCredit"><span style="font-family: Times New Roman;"><span class="credit"></span></span> </div></div></div><div class="ssImg" style="display: none;"><img alt="Wendy Grant" height="287" src="http://i.telegraph.co.uk/multimedia/archive/02193/grant_2193999c.jpg" width="460" /> <br />
<div class="artImageExtras"><div class="imgLoadingText hide"></div><div class="tools imgindex"><span style="font-family: Times New Roman;">Image <span class="index">1</span> of <span class="total">2</span></span></div><div class="tools imgindex"><span style="font-family: Times New Roman;"><span class="total"></span></span> </div><div class="tools imgindex"><span style="font-family: Times New Roman;"><span class="total"></span></span> </div><div class="ingCaptionCredit"></div></div></div><div class="tools"><div class="imgGallImg"><a class="allOver" href="http://www.blogger.com/" style="filter: alpha(opacity = 0); opacity: 0;"></a></div><div class="prev"><a class="prevArrowImg" href="http://www.blogger.com/" style="filter: alpha(opacity = 0.5); opacity: 0.7;"></a></div><div class="next"><a class="nextArrowImg" href="http://www.blogger.com/" style="filter: alpha(opacity = 0.5); opacity: 0.7;"></a></div><div class="cl"><img alt="Wendy Grant" height="287" src="http://i.telegraph.co.uk/multimedia/archive/02193/grant_2193999c.jpg" width="460" /></div><div class="cl"></div><div class="cl"></div></div><div class="cl"></div><div class="cl">2 OF 2 Wendy Grant</div><div class="cl"></div></div></div></div><div class="cl"></div><div class="byline"><div></div><div class="publishedDate"><span style="font-family: Times New Roman;">7:50PM BST 15 Apr 2012</span></div><div class="publishedDate"><span style="font-family: Times New Roman;"></span> </div><div class="cl"></div></div><div id="mainBodyArea"><div class="firstPar"><span style="font-family: Times New Roman;">The disease was first identified in cows in 1985</span><span style="font-family: Times New Roman;">. Two years later government scientists suggested the most likely source was cattle feed made from the remains of dead sheep with scrapie, a similar brain disease. In 1988 John MacGregor, then agriculture minister, imposed a ban on cattle feed derived from dead animals.</span><br />
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</div><div class="secondPar"><span style="font-family: Times New Roman;">A month before the ban came into force, however, a junior doctor, Tim Holt, became the first to suggest, in an article in the British Medical Journal, that BSE might pose a significant threat to human health, after he and a colleague discovered that some butchers were selling cow brains for human consumption. He suggested that the use of brains in British food should be banned. </span><br />
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</div><div class="thirdPar"><span style="font-family: Times New Roman;">Wendy Grant, a retired consultant neuropathologist and an expert in slow viruses (associated with diseases with long incubation periods of months to years) was alarmed by Holt’s piece, particularly when she discovered, through slaughterhouse workers, that cattle brains were being added to meat products such as pies, pâtés and stock cubes. As one of the few people to have read the literature on scrapie and the human equivalent, Creutzfeldt-Jakob disease (CJD), she realised that government assurances about BSE, “namely 'we have lived with scrapie for two and a half centuries and it has not done us any harm’,” were based on the false premise that cattle brains and sheep brains were dealt with in the same way at abattoirs, “which they obviously were not”. Humans, she argued, had not been seriously exposed over the centuries to the scrapie agent as sheep brains are seldom removed to be eaten. But when she wrote to the government pressing the need for an inquiry into the dangers of contamination, she was ignored. </span><br />
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</div><div class="fourthPar"><span style="font-family: Times New Roman;">In February 1989 a report by a committee chaired by Sir Richard Southwood highlighted “unnatural feeding practices” in modern intensive farming but concluded that it was “most unlikely” that BSE might be transmitted to humans, though the risk could not be entirely ruled out. The day the report was published Wendy Grant appeared on the BBC warning that infected tissues of cattle were still going into human food. The risks of humans contracting the disease were being underplayed, she maintained, pointing out that experimental work on scrapie-infected brains had revealed that it is very easy to infect almost any mammal, including apes, “and we are just another ape”. “Who knows?” she added, “some of us may be incubating it already.” </span><br />
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</div><div class="fifthPar"><span style="font-family: Times New Roman;">The government’s immediate response to growing public concern was to impose a ban on the use of offal in baby foods, but in an article Wendy Grant accused it of using baby foods “to divert the public from thinking about other foods and thus to imply they are safe, which they are not”. The official inquiry into the BSE scandal later identified her article as one of the influences that drove the government towards the decision in November 1989 to ban the use of cows’ brain and spinal cord for human consumption. </span><br />
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</div><div class="body"><span style="font-family: Times New Roman;">As ministers and the food industry battled to reassure consumers that British beef was “perfectly safe” and that eating it carried “no conceivable risk”, Wendy Grant, like other scientists involved, found herself the victim of a smear campaign, treated with hostility by Ministry of Agriculture officials and accused of being “out of date”. </span><br />
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<span style="font-family: Times New Roman;">But she refused to go away. When, in 1990, she discovered that, under pressure from the meat lobby, ministers had agreed that brains could be removed from cattle by splitting open the skulls, she pointed out that this frequently resulted in bits of brain being splattered on to meat destined for human consumption. Slaughtered cattle, she said, should be decapitated and the intact heads incinerated. </span><br />
<span style="font-family: Times New Roman;">In 1994 she described it as “incomprehensible” that the brains of calves under six months old were still being allowed into the human food chain and called for an immediate ban: “We should not be eating the offal even from calves, because we do not yet know whether the disease is passed from mother to calf,” she said. Two years later government scientists confirmed that cows could indeed pass on BSE to their calves.</span><br />
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<span style="font-family: Times New Roman;">The turning point came after the first recorded death from what was later described as new variant Creutzfeldt-Jakob Disease (vCJD), on May 21 1995. Within a year 10 cases had been identified and on March 20 1996, the Health Secretary Stephen Dorrell made the announcement that these cases were most probably linked to the consumption of BSE-infected beef or beef products. In June, in the face of a worldwide ban on exports of British beef imposed by the EU, the government agreed to implement a more thoroughgoing slaughter programme and more effective removal of potentially infective materials from carcases.</span><br />
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<span style="font-family: Times New Roman;">The announcement of a public inquiry into the affair under the senior judge Lord Phillips in 1997 was welcomed by campaigners and when it was published in 2000, it vindicated Wendy Grant and other scientists who had persisted in voicing their concerns. The report concluded that the government had misled the public about the dangers of British beef and the chances of mad cow disease being spread to humans for years. It also said that bureaucratic delays had hampered the response to the crisis.</span><br />
<span style="font-family: Times New Roman;">But Wendy Grant only felt able to give the report a qualified welcome: If action had been taken to ban cattle brains from the human food chain in 1989 when she had first warned of the possibility of transmission, there would have been fewer vCJD victims: “They should have listened to me,” she said. Since vCJD was first reported in 1996, a total of 217 patients from 11 countries have been identified. Altogether, since the disease became notifiable in 1996, 176 people in Britain have died from the disease, but uncertainties relating to the potential length of the incubation period complicate predictions of the future number of cases.</span><br />
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<span style="font-family: Times New Roman;">Helen Grant, always known as Wendy, was born in Ealing, west London on May 11 1922. Her parents were involved in relief work with refugees and her father had spent some time in prison in the First World War, as a conscientious objector.</span><br />
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<span style="font-family: Times New Roman;">Wendy was educated at schools in France, Austria, New Zealand and finally at Bedales, where she became head girl. After taking a degree in Medicine at Cambridge, she did her clinical training at University College London. She decided to specialise in neuropathology and in 1970 joined the Middlesex Hospital as a consultant. In 1985 she moved to Charing Cross Hospital as a senior lecturer and honorary consultant in neuropathology. </span><br />
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<span style="font-family: Times New Roman;">A life-long opponent of boxing, Wendy Grant was able to demonstrate that the part of the brain most affected by punching corresponds with the areas attacked by other neurological conditions such as Parkinsons. When Cassius Clay, alias Muhammad Ali, degenerated into an incoherent wreck within 10 years of retiring and the sport’s defenders claimed he was not punch drunk but was suffering from Parkinson’s, she observed that if he was indeed suffering from Parkinsons, it was a convenient coincidence. “Boxing is bad for the brain full stop,” she said.</span><br />
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<span style="font-family: Times New Roman;">Wendy Grant married, in 1945, Alick Elithorn, but the marriage was later dissolved. She is survived by a son. A daughter predeceased her.</span><br />
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<span style="font-family: Times New Roman;">Wendy Grant, born May 11 1922, died March 14 2012</span><br />
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<a href="http://www.telegraph.co.uk/news/obituaries/medicine-obituaries/9205842/Wendy-Grant.html" title="http://www.telegraph.co.uk/news/obituaries/medicine-obituaries/9205842/Wendy-Grant.html">http://www.telegraph.co.uk/news/obituaries/medicine-obituaries/9205842/Wendy-Grant.html</a><br />
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THANKS WENDY ! R.I.P. ...TSS</div></div></div></div><br />
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<div><br />
</div>The BSE Inquiry / Statement No 410<br />
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Dr Helen Grant<br />
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Issued 13/05/1999 (not scheduled to give oral evidence)<br />
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BSE INQUIRY<br />
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STATEMENT OF DR HELEN GRANT MD FRCP<br />
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1. My credentials in the matters of BSE and CJD are:<br />
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a. 1970-1982 Consultant Neuropathologist at the Middlesex Hospital.<br />
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b. 1985-1989 Consultant Neuropathologist at the Charing Cross Hospital.<br />
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c. I have carried out six autopsies on CJD victims and reported on a similar number of cerebral biopsies from CJD patients.<br />
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1. Through my interest in slow viruses (particularly with reference to multiple sclerosis) I was one of only a few people to be aware of both Scrapie and CJD in 1988.<br />
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2. I have never had any formal links with the farming community, renderers, pet food manufacturers, etc. However, slaughterhouse workers began telephoning me as early as February 1989 after they learned through the media of my concern and knowledge about TSEs. Several of them rang me because they had had no instructions from the Health and Safety Executive about precautions to be taken to avoid infection from BSE carcases. (I have kept some of the correspondence with these workers together with my list of precautions to be taken in abattoirs).<br />
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3. I asked the slaughterhouses workers in detail to explain the routine slaughtering practices and was astonished to learn that sheep’s brains were generally left inside the skull whereas cattle brains were routinely removed to be added to our "meat products" – meat pies, pates, tinned items and stock cubes. I therefore feared that this almost indestructible infective agent was being swallowed by all beef eaters in the UK in large doses which would inevitably infect genetically susceptible people.<br />
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4. I was horrified because I suddenly realised why Government assurances about BSE – namely "we have lived with scrapie for two-and-a-half centuries and it has not done us any harm so we won’t have any trouble with BSE" – were based on a false premise which was that cattle brains and sheep’s brains were dealt with in the same way in the abattoirs which they obviously were not. Since sheep’s brains were seldom removed from the skulls (which is why cattle caught scrapie in the first place) we humans have never been seriously exposed over the centuries to the scrapie agent. Simple economics is the reason: sheep’s brains are too small to make the intricate process of their removal worthwhile.<br />
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5. I appeared on the BBC nine o’clock television news on February 27, 1989 (the day the Southwood Report was published) in my capacity as consultant neuropathologist at Charing Cross hospital. I was asked among other things to comment on the possible human hazard of BSE and I warned that I thought there was a risk because cattle brains were going into our food chain. I added: "Who knows? Some of us may be incubating it already." Some of us were.<br />
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6. I was called to give evidence to the House of Commons Agriculture Select Committee on 13 June 1990 (IBD 1 Tab 7 p 42). On re-reading it, I see no reason to change anything in my evidence except the numbers of animals mentioned. The Government of the day was hardly disposed to ask my advice about BSE on a regular basis given my critical attitude since early 1989. But the then Labour Opposition, understandably anxious for information, turned to me frequently. Opposition Members included David Clark MP, Ron Davies MP and Ian McCartney MP. It was my technical information which helped Ron Davies MP to make his effective speech about BSE in the House of Commons on 17 May 1989 (M 7 Tab 7). Shortly afterwards, the Minister for Agriculture, John MacGregor, announced that legislation would be brought in to ban all cattle brains from human food (YB 89/6.13/5.1-5.2). The long summer recess delayed this legislation and the "specified offals" ban was finally enacted on 9 November 1989 (L2 Tab 4) (9 February 1990 in Scotland) (L10 Tab 9). Of course this was more than a year (15 months) after cattle had been protected in the same way.<br />
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7. Apart from my involvement with CJD I have of course been interested in that worldwide scourge, multiple sclerosis (MS). This led me to ponder the question of "slow virus infection – now labelled "prion infection" (an inaccurate title. In my opinion prion is a short title for an organism which causes Transmissible Spongiform Encephalopathy (TSE) such as scrapie, CJD, BSE, Kuru and others. Prion diseases has therefore become widely used instead of the cumbersome alternative (YB 94/4.25/10.1)) – which is one of the aetiological factors involved in MS. Scrapie, the ovine TSE, was then and still is by far the most extensively researched slow virus infection. I therefore read up all the papers on the subject as they appeared during the 1950s, ‘60s and ‘70s and was therefore immediately aware of the human hazard posed by the BSE catastrophe. Vets generally did not know about CJD (why should they?) and neuropathologists were mostly ignorant of scrapie. I happened to know about both in those early days due to my interest in "slow viruses".<br />
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8. I was in receipt of no extra funds beyond those provided by the NHS and the University of London to run my laboratories and pay my salary as a senior lecturer/honorary Consultant and I suffered no constraints over my publications, lectures to my students, or statements to the media. However, I became increasingly aware after 1988 that questioning official dogma about BSE brought difficulties to one’s career. I was myself about to retire from the Charing Cross Hospital, where I worked as a Consultant Neuropathologist, but I observed with horror that the good reputations of dissenting scientists in the field, not least Dr Stephen Dealler and especially Dr Harash Narang were systematically undermined.<br />
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9. My primary function has been to teach medical under-graduates and post-graduates about diseases of the brain and nervous system and, of course, to fulfil my clinical functions as a consultant neuropathologist at two London teaching hospitals. This, of course, meant that I conducted both biopsies and autopsies including those on patients with CJD: it was not primarily to publish scientific articles. My scientific publications include only one case which I think in retrospect may be CJD before that was known to be an infection with this agent. ("Post Traumatic Dementia": Helen C Grant, Behrman et al. Archiv für Psyciatre und Zeitschrift für die ges. Neurologie. 1965; 207: 128) More importantly I have carried out several biopsies and autopsies on CJD patients. My duties also included the initiation and supervision of research projects. When my trainees and PhD students published their resulting scientific papers I took the view that the work was theirs, they should get the credit (not I) and therefore I made it a matter of principle not to add my name as co-author.<br />
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10. I corresponded frequently from February 1989 onwards with Government ministers including John MacGregor, Donald Thomson, Gillian Shepherd and Angela Browning. But I received only short and reassuring replies containing what I believed to be inaccurate information. Because official bodies treated my early warnings with hostility, I soon learned that the only way to convey my concerns was to contribute relevant letters to the broadsheet newspapers and to speak to responsible members of the press, the broadcasting services and informed members of Opposition parties.<br />
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11. Since February 1989 I have answered innumerable letters from members of the public understandably anxious – if not panicky – about the effect on their diets of the outbreak. They came/come from a cross-section of the community: parents ("is the milk safe?"), restaurateurs, doctors, butchers, journalists, Education Committees. Since I retired finally in March 1989 I have had the time to answer them all eventually.<br />
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12. The BSE/CJD problem is quite incomprehensible without knowledge of the facts set out in Annex 1. The infective agent has unique and sinister properties. <br />
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Issued on behalf of the witness by:<br />
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The BSE Inquiry Press Office 6th Floor Hercules House Hercules Road London SE1 7DU Fax: 0171 803 0893 Website: <a href="http://www.bse.org.uk/">http://www.bse.org.uk</a> Email: <a href="mailto:inquiry@bse.org.uk">inquiry@bse.org.uk</a> <br />
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<a href="http://web.archive.org/web/20071014074839/http://www.bseinquiry.gov.uk/files/ws/s410.pdf">http://web.archive.org/web/20071014074839/http://www.bseinquiry.gov.uk/files/ws/s410.pdf</a> <br />
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annex 1 (wiped clean from internet) <br />
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<a href="http://web.archive.org/web/20050117205909/http://www.bseinquiry.gov.uk/files/ws">http://web.archive.org/web/20050117205909/http://www.bseinquiry.gov.uk/files/ws</a> <br />
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however, my files have this ; <br />
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ANNEX 1 to witness statement 410 of Dr. Helen Grant<br />
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Annex 1<br />
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Unique Properties of the scrapie/BSE/CJD Agent, the so-called "prion"<br />
A. The transmissible organism which causes all the transmissible spongiform encephalopathies (TSEs) -- scrapie, BSE, CJD and Kuru -- is almost indestructible, unlike any other virus, bacterium, protozoon, fungus or parasite. For example, it still transmits scrapie after being 'fixed' in formaldehyde for ten years. Heating it to a very high temperature, exposing it to enormous doses of ultraviolet light, or to ionising radiation, do not affect it. Incineration is the only way of destroying it and even then the temperature must be very high indeed.<br />
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B. It proliferates only in the brain, eyes, spinal cord, pituitary and, in some mammals, the placenta. The transmission of these diseases is dose-related and although the virus usually enters the bloodstream from the stomach, and then visits all tissues for a few hours, it lingers and proliferates only in the brain etc. The red meat (muscle) of BSE-infected cattle has never transmitted the disease in the laboratory and we have not had any trouble from eating scrapie-infected muscle over the centuries.<br />
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C. It lurks for years in an outwardly completely healthy individual.<br />
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D. During this long 'incubation period' the brain etc. is infective which is why it was necessary to ban the brains etc. of all cattle from human foods.<br />
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E. It raises no antibodies -- which might then be tested for -- in the infected host.<br />
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F. There is officially no live test to reveal infected individuals. "Officially" because a live (urine) test has recently been devised and has been used successfully in 15 out of 15 humans who were subsequently shown to have suffered CJD. MAFF's vets refuse to make use of this live test and denigrate it whenever they are asked about it. It could also be used to screen blood donors.<br />
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G. Individuals' susceptibility to this organism is genetically determined. Not all types of sheep develop scrapie; not all types of cattle develop BSE and only some humans -- those of an unusual genotype -- will, if infected, develop CJD.<br />
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H. Scrapie, the orginal disease in sheep, has been easily transmitted by mouth to many experimental mammals including primates.<br />
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Humans are primates.<br />
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Items b (placenta), c, d and f establish that the Government's present 'culling' policy, which is not based on science, cannot possibly eradicate BSE. <br />
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snip...end...tss <br />
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Subject: ANNEX 1 to Witness statement 410 of Dr. Helen Grant <br />
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Date: Wed, 19 Jan 2000 15:58:39 -0600 <br />
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From: "Terry S. Singeltary Sr." <<a href="mailto:flounder@wt.net">flounder@wt.net</a>> <br />
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Reply-To: Bovine Spongiform Encephalopathy <<a href="mailto:BSE-L@uni-karlsruhe.de">BSE-L@uni-karlsruhe.de</a>> <br />
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To: <a href="mailto:BSE-L@uni-karlsruhe.de">BSE-L@uni-karlsruhe.de</a><br />
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<br />
######### Bovine Spongiform Encephalopathy <<a href="mailto:BSE-L@UNI-KARLSRUHE.DE">BSE-L@UNI-KARLSRUHE.DE</a>> #########<br />
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Greetings List Members,<br />
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I have often wondered about scrapie and it's possible relationship to sporadic CJD. A few things I thought interesting in this statement from Dr. Helen Grant, I would like to share with you.....snip...end...tss <br />
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556 In the first place there was the public reaction to the Report. This started with a broadcast on the day the Report was published from Dr Helen Grant, a consultant neuropathologist at Charing Cross Hospital in London, who commented on the risk posed by cattle brains that were going into the human food chain. In an article in The Guardian on 2 March 1989, she suggested that the Government was concentrating on baby food ‘to divert the public from thinking about other foods and thus to imply that they are safe, which they are not’. <br />
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The press contrasted MAFF’s statement with views expressed by Dr Helen Grant, Consultant Neuropathologist:<br />
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My gut feeling is that some genetically susceptible people may have become infected with material by eating meat products. <br />
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<span style="font-family: Times New Roman;"><div><span style="font-family: Calibri;"></span><br />
Sunday, May 18, 2008</div><br />
<div><br />
BSE Inquiry DRAFT FACTUAL ACCOUNT DFA</div><br />
<div><br />
BSE Inquiry DRAFT FACTUAL ACCOUNTS DFA's</div></span> <br />
<div><a href="http://bseinquiry.blogspot.com/2008/05/bse-inquiry-draft-factual-account-dfa.html"><span style="font-family: Times New Roman;">http://bseinquiry.blogspot.com/2008/05/bse-inquiry-draft-factual-account-dfa.html</span></a><br />
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Sunday, May 18, 2008</div><br />
<div><br />
BSE, CJD, and Baby foods (the great debate 1999 to 2005)</div></span> <br />
<div><a href="http://bseinquiry.blogspot.com/2008/05/bse-cjd-and-baby-foods-great-debate.html"><span style="font-family: Times New Roman;">http://bseinquiry.blogspot.com/2008/05/bse-cjd-and-baby-foods-great-debate.html</span></a></div><div></div><br />
<div><span style="font-family: Times New Roman;"></span> </div><br />
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<div><span style="font-family: Times New Roman;">Sunday, May 18, 2008</span></div><br />
<div><span style="font-family: Times New Roman;"><br />
MAD COW DISEASE BSE CJD CHILDREN VACCINES<br />
</span><a href="http://bseinquiry.blogspot.com/2008/05/mad-cow-disease-bse-cjd-children.html"><span style="font-family: Times New Roman;">http://bseinquiry.blogspot.com/2008/05/mad-cow-disease-bse-cjd-children.html</span></a><span style="font-family: Times New Roman;"><br />
</span></div><br />
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<span style="font-family: Times New Roman;">BSE INQUIRY DFA </span></div><br />
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<div><a href="http://bseinquiry.blogspot.com/"><span style="font-family: Times New Roman;">http://bseinquiry.blogspot.com/</span></a><br />
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<div>R.I.P. DR. GRANT !!!</div><br />
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<div>1: J Infect Dis 1980 Aug;142(2):205-8 </div><br />
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<div>Oral transmission of kuru, Creutzfeldt-Jakob disease, and scrapie to nonhuman primates. </div><br />
<div></div><br />
<div>Gibbs CJ Jr, Amyx HL, Bacote A, Masters CL, Gajdusek DC. </div><br />
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<div>Kuru and Creutzfeldt-Jakob disease of humans and scrapie disease of sheep and goats were transmitted to squirrel monkeys (Saimiri sciureus) that were exposed to the infectious agents only by their nonforced consumption of known infectious tissues. The asymptomatic incubation period in the one monkey exposed to the virus of kuru was 36 months; that in the two monkeys exposed to the virus of Creutzfeldt-Jakob disease was 23 and 27 months, respectively; and that in the two monkeys exposed to the virus of scrapie was 25 and 32 months, respectively. Careful physical examination of the buccal cavities of all of the monkeys failed to reveal signs or oral lesions. One additional monkey similarly exposed to kuru has remained asymptomatic during the 39 months that it has been under observation. </div><br />
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<div>snip... </div><br />
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<div>The successful transmission of kuru, Creutzfeldt-Jakob disease, and scrapie by natural feeding to squirrel monkeys that we have reported provides further grounds for concern that scrapie-infected meat may occasionally give rise in humans to Creutzfeldt-Jakob disease.</div><br />
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<div>PMID: 6997404 </div><br />
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<div><a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=6997404&dopt=Abstract">http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=6997404&dopt=Abstract</a> </div><br />
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<div>12/10/76</div><br />
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<div>AGRICULTURAL RESEARCH COUNCIL REPORT OF THE ADVISORY COMMITTE ON SCRAPIE</div><br />
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<div>Office Note CHAIRMAN: PROFESSOR PETER WILDY</div><br />
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<div>snip...</div><br />
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<div>A The Present Position with respect to Scrapie A] The Problem Scrapie is a natural disease of sheep and goats. It is a slow and inexorably progressive degenerative disorder of the nervous system and it ia fatal. It is enzootic in the United Kingdom but not in all countries. The field problem has been reviewed by a MAFF working group (ARC 35/77). It is difficult to assess the incidence in Britain for a variety of reasons but the disease causes serious financial loss; it is estimated that it cost Swaledale breeders alone $l.7 M during the five years 1971-1975. A further inestimable loss arises from the closure of certain export markets, in particular those of the United States, to British sheep. It is clear that scrapie in sheep is important commercially and for that reason alone effective measures to control it should be devised as quickly as possible. Recently the question has again been brought up as to whether scrapie is transmissible to man. This has followed reports that the disease has been transmitted to primates. </div><br />
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<div>One particularly lurid speculation (Gajdusek 1977) conjectures that the agents of scrapie, kuru, Creutzfeldt-Jakob disease and transmissible encephalopathy of mink are varieties of a single "virus". The U.S. Department of Agriculture concluded that it could "no longer justify or permit scrapie-blood line and scrapie-exposed sheep and goats to be processed for human or animal food at slaughter or rendering plants" (ARC 84/77)" The problem is emphasised by the finding that some strains of scrapie produce lesions identical to the once which characterise the human dementias" Whether true or not. the hypothesis that these agents might be transmissible to man raises two considerations. First, the safety of laboratory personnel requires prompt attention. Second, action such as the "scorched meat" policy of USDA makes the solution of the acrapie problem urgent if the sheep industry is not to suffer grievously. </div><br />
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<div>snip... </div><br />
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<div>76/10.12/4.6 </div><br />
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<div><a href="http://web.archive.org/web/20010305223125/www.bseinquiry.gov.uk/files/yb/1976/10/12004001.pdf">http://web.archive.org/web/20010305223125/www.bseinquiry.gov.uk/files/yb/1976/10/12004001.pdf</a> </div><br />
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<div>Nature. 1972 Mar 10;236(5341):73-4. </div><br />
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<div>Transmission of scrapie to the cynomolgus monkey (Macaca fascicularis). </div><br />
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<div>Gibbs CJ Jr, Gajdusek DC. Nature 236, 73 - 74 (10 March 1972); doi:10.1038/236073a0 </div><br />
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<div>Transmission of Scrapie to the Cynomolgus Monkey (Macaca fascicularis) </div><br />
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<div>C. J. GIBBS jun. & D. C. GAJDUSEK National Institute of Neurological Diseases and Stroke, National Institutes of Health, Bethesda, Maryland </div><br />
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<div>SCRAPIE has been transmitted to the cynomolgus, or crab-eating, monkey (Macaca fascicularis) with an incubation period of more than 5 yr from the time of intracerebral inoculation of scrapie-infected mouse brain. The animal developed a chronic central nervous system degeneration, with ataxia, tremor and myoclonus with associated severe scrapie-like pathology of intensive astroglial hypertrophy and proliferation, neuronal vacuolation and status spongiosus of grey matter. The strain of scrapie virus used was the eighth passage in Swiss mice (NIH) of a Compton strain of scrapie obtained as ninth intracerebral passage of the agent in goat brain, from Dr R. L. Chandler (ARC, Compton, Berkshire). </div><br />
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<div><a href="http://www.nature.com/nature/journal/v236/n5341/abs/236073a0.html">http://www.nature.com/nature/journal/v236/n5341/abs/236073a0.html</a> </div><br />
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<div>Nature. 1972 Mar 10;236(5341):73-4. </div><br />
<div></div><br />
<div>Transmission of scrapie to the cynomolgus monkey (Macaca fascicularis). </div><br />
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<div>Gibbs CJ Jr, Gajdusek DC. Nature 236, 73 - 74 (10 March 1972); doi:10.1038/236073a0 </div><br />
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<div>Transmission of Scrapie to the Cynomolgus Monkey (Macaca fascicularis) </div><br />
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<div>C. J. GIBBS jun. & D. C. GAJDUSEK National Institute of Neurological Diseases and Stroke, National Institutes of Health, Bethesda, Maryland </div><br />
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<div>SCRAPIE has been transmitted to the cynomolgus, or crab-eating, monkey (Macaca fascicularis) with an incubation period of more than 5 yr from the time of intracerebral inoculation of scrapie-infected mouse brain. The animal developed a chronic central nervous system degeneration, with ataxia, tremor and myoclonus with associated severe scrapie-like pathology of intensive astroglial hypertrophy and proliferation, neuronal vacuolation and status spongiosus of grey matter. The strain of scrapie virus used was the eighth passage in Swiss mice (NIH) of a Compton strain of scrapie obtained as ninth intracerebral passage of the agent in goat brain, from Dr R. L. Chandler (ARC, Compton, Berkshire). </div><br />
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<div><a href="http://www.nature.com/nature/journal/v236/n5341/abs/236073a0.html">http://www.nature.com/nature/journal/v236/n5341/abs/236073a0.html</a> </div><br />
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<div>Wednesday, February 16, 2011</div><br />
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<div>IN CONFIDENCE</div><br />
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<div>SCRAPIE TRANSMISSION TO CHIMPANZEES</div><br />
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<div>IN CONFIDENCE</div><br />
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<div><a href="http://scrapie-usa.blogspot.com/2011/02/in-confidence-scrapie-transmission-to.html">http://scrapie-usa.blogspot.com/2011/02/in-confidence-scrapie-transmission-to.html</a> </div><br />
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<div>why do we not want to do TSE transmission studies on chimpanzees $ </div><br />
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<div>snip... </div><br />
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<div>5. A positive result from a chimpanzee challenged severly would likely create alarm in some circles even if the result could not be interpreted for man. I have a view that all these agents could be transmitted provided a large enough dose by appropriate routes was given and the animals kept long enough. Until the mechanisms of the species barrier are more clearly understood it might be best to retain that hypothesis. </div><br />
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<div>snip... </div><br />
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<div>R. BRADLEY </div><br />
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<div><a href="http://collections.europarchive.org/tna/20080102222950/http://www.bseinquiry.gov.uk/files/yb/1990/09/23001001.pdf">http://collections.europarchive.org/tna/20080102222950/http://www.bseinquiry.gov.uk/files/yb/1990/09/23001001.pdf</a> </div><br />
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<div></div><br />
<div>BSE: TIME TO TAKE H.B. PARRY SERIOUSLY</div><br />
<div></div><br />
<div>If the scrapie agent is generated from ovine DNA and thence causes disease in other species, then perhaps, bearing in mind the possible role of scrapie in CJD of humans (Davinpour et al, 1985), scrapie and not BSE should be the notifiable disease. ... </div><br />
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<div><a href="http://collections.europarchive.org/tna/20090505194948/http://bseinquiry.gov.uk/files/yb/1988/06/08004001.pdf">http://collections.europarchive.org/tna/20090505194948/http://bseinquiry.gov.uk/files/yb/1988/06/08004001.pdf</a> </div><br />
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<div>Thursday, November 18, 2010 </div><br />
<div></div><br />
<div>Increased susceptibility of human-PrP transgenic mice to bovine spongiform encephalopathy following passage in sheep </div><br />
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<div><a href="http://bse-atypical.blogspot.com/2010/11/increased-susceptibility-of-human-prp.html">http://bse-atypical.blogspot.com/2010/11/increased-susceptibility-of-human-prp.html</a> </div><br />
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<div>Wednesday, January 19, 2011</div><br />
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<div>EFSA and ECDC review scientific evidence on possible links between TSEs in animals and humans Webnachricht 19 Januar 2011 </div><br />
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<div><a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/efsa-and-ecdc-review-scientific.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/efsa-and-ecdc-review-scientific.html</a> </div><br />
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<div>Monday, June 27, 2011</div><br />
<div></div><br />
<div>Comparison of Sheep Nor98 with Human Variably Protease-Sensitive Prionopathy and Gerstmann-Sträussler-Scheinker Disease</div><br />
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<div><a href="http://prionopathy.blogspot.com/2011/06/comparison-of-sheep-nor98-with-human.html">http://prionopathy.blogspot.com/2011/06/comparison-of-sheep-nor98-with-human.html</a></div><br />
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<div></div><br />
<div>RESEARCH</div><br />
<div></div><br />
<div>Emerging Infectious Diseases • www.cdc.gov/eid • Vol. 17, No. 5, May 2011</div><br />
<div></div><br />
<div>Experimental Oral Transmission of Atypical Scrapie to Sheep </div><br />
<div></div><br />
<div>Marion M. Simmons, S. Jo Moore,1 Timm Konold, Lisa Thurston, Linda A. Terry, Leigh Thorne, Richard Lockey, Chris Vickery, Stephen A.C. Hawkins, Melanie J. Chaplin, and John Spiropoulos</div><br />
<div></div><br />
<div>To investigate the possibility of oral transmission of atypical scrapie in sheep and determine the distribution of infectivity in the animals’ peripheral tissues, we challenged neonatal lambs orally with atypical scrapie; they were then killed at 12 or 24 months. Screening test results were negative for disease-specifi c prion protein in all but 2 recipients; they had positive results for examination of brain, but negative for peripheral tissues. Infectivity of brain, distal ileum, and spleen from all animals was assessed in mouse bioassays; positive results were obtained from tissues that had negative results on screening. These fi ndings demonstrate that atypical scrapie can be transmitted orally and indicate that it has the potential for natural transmission and iatrogenic spread through animal feed. Detection of infectivity in tissues negative by current surveillance methods indicates that diagnostic sensitivity is suboptimal for atypical scrapie, and potentially infectious material may be able to pass into the human food chain.</div><br />
<div></div><br />
<div>SNIP...</div><br />
<div></div><br />
<div>Although we do not have epidemiologic evidence that supports the effi cient spread of disease in the fi eld, these data imply that disease is potentially transmissible under fi eld situations and that spread through animal feed may be possible if the current feed restrictions were to be relaxed. Additionally, almost no data are available on the potential for atypical scrapie to transmit to other food animal species, certainly by the oral route. However, work with transgenic mice has demonstrated the potential susceptibility of pigs, with the disturbing fi nding that the biochemical properties of the resulting PrPSc have changed on transmission (40). The implications of this observation for subsequent transmission and host target range are currently unknown.</div><br />
<div></div><br />
<div>How reassuring is this absence of detectable PrPSc from a public health perspective? The bioassays performed in this study are not titrations, so the infectious load of the positive gut tissues cannot be quantifi ed, although infectivity has been shown unequivocally. No experimental data are currently available on the zoonotic potential of atypical scrapie, either through experimental challenge of humanized mice or any meaningful epidemiologic correlation with human forms of TSE. However, the detection of infectivity in the distal ileum of animals as young as 12 months, in which all the tissues tested were negative for PrPSc by the currently available screening and confi rmatory diagnostic tests, indicates that the diagnostic sensitivity of current surveillance methods is suboptimal for detecting atypical scrapie and that potentially infectious material may be able to pass into the human food chain undetected.</div><br />
<div></div><br />
<div>Emerging Infectious Diseases • www.cdc.gov/eid • Vol. 17, No. 5, May 2011</div><br />
<div></div><br />
<div></div><br />
<div><a href="http://wwwnc.cdc.gov/eid/article/17/5/pdfs/10-1654.pdf">http://wwwnc.cdc.gov/eid/article/17/5/pdfs/10-1654.pdf</a></div><br />
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<div></div><br />
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<span style="font-family: Times New Roman;">Thursday, March 29, 2012<br />
<br />
atypical Nor-98 Scrapie has spread from coast to coast in the USA 2012 <br />
<br />
NIAA Annual Conference April 11-14, 2011San Antonio, Texas<br />
</span><a href="http://nor-98.blogspot.com/2012/03/atypical-nor-98-scrapie-has-spread-from.html"><span style="font-family: Times New Roman;">http://nor-98.blogspot.com/2012/03/atypical-nor-98-scrapie-has-spread-from.html</span></a><br />
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<h2 class="date-header" style="letter-spacing: 1px; margin: 0px; text-transform: uppercase; word-wrap: break-word;"><span style="letter-spacing: 1px;"><span style="font-family: Georgia;"><span style="color: #29303b;"><span style="font-size: 10.8pt;"><span style="font-weight: normal;">Monday, April 16, 2012</span></span></span></span></span></h2><br />
<h2 class="date-header" style="letter-spacing: 1px; margin: 0px; text-transform: uppercase; word-wrap: break-word;"><span style="letter-spacing: 1px;"></span> </h2><br />
<h2 class="date-header" style="letter-spacing: 1px; margin: 0px; text-transform: uppercase; word-wrap: break-word;"><span style="letter-spacing: 1px;"><span style="color: #29303b; font-family: Georgia;"></span></span></h2><br />
<div class="date-posts" style="word-wrap: break-word;"><div class="post-outer"><div class="post hentry uncustomized-post-template" itemscope="itemscope" itemtype="http://schema.org/BlogPosting" style="margin: 8px 0px 24px;"><a href="http://www.blogger.com/" name="6855008206195563217"></a> <br />
<h3 class="post-title entry-title" itemprop="name" style="margin: 0px;"><span style="font-family: Georgia;"><span style="color: #1b0431;"><span style="font-size: 16.8pt;"><span style="font-weight: normal;">Continuing Enhanced National Surveillance for Prion Diseases in the United States </span></span></span></span></h3><div class="post-title entry-title" itemprop="name" style="margin: 0px;"></div><div class="post-title entry-title" itemprop="name" style="margin: 0px;"></div><div class="post-title entry-title" itemprop="name" style="margin: 0px;"></div><div class="post-title entry-title" itemprop="name" style="margin: 0px;"></div><div class="post-title entry-title" itemprop="name" style="margin: 0px;"><a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/04/continuing-enhanced-national.html" title="http://transmissiblespongiformencephalopathy.blogspot.com/2012/04/continuing-enhanced-national.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/04/continuing-enhanced-national.html</a></div><div class="post-title entry-title" itemprop="name" style="margin: 0px;"></div><div class="post-title entry-title" itemprop="name" style="margin: 0px;"></div><div class="post-title entry-title" itemprop="name" style="margin: 0px;"></div></div></div></div><br />
<div>Subject: Bovine Spongiform Encephalopathy; Importation of Bovines and Bovine Products APHIS-2008-0010-0008 RIN:0579-AC68</div><br />
<div></div><br />
<div>Comment from Terry Singeltary</div><br />
<div>Document ID: APHIS-2008-0010-0008 Document Type: Public Submission </div><br />
<div>This is comment on Proposed Rule: Bovine Spongiform Encephalopathy; Importation of Bovines and Bovine Products</div><br />
<div>Docket ID: APHIS-2008-0010 RIN:0579-AC68 </div><br />
<div></div><br />
<div>Topics: No Topics associated with this document</div><br />
<div>View Document:</div><br />
<div>More </div><br />
<div></div><br />
<div>Document Subtype: Public Comment </div><br />
<div>Status: Posted </div><br />
<div>Received Date: March 22 2012, at 12:00 AM Eastern Daylight Time </div><br />
<div>Date Posted: March 22 2012, at 12:00 AM Eastern Daylight Time </div><br />
<div>Comment Start Date: March 16 2012, at 12:00 AM Eastern Daylight Time </div><br />
<div>Comment Due Date: May 15 2012, at 11:59 PM Eastern Daylight Time </div><br />
<div>Tracking Number: 80fdd617 </div><br />
<div>First Name: Terry </div><br />
<div>Middle Name: S. </div><br />
<div>Last Name: Singeltary </div><br />
<div>City: Bacliff </div><br />
<div>Country: United States </div><br />
<div>State or Province: TX </div><br />
<div>Organization Name: CJD TSE PRION </div><br />
<div>Submitter's Representative: CONSUMERS </div><br />
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<div>Comment:</div><br />
<div>comment submission Document ID APHIS-2008-0010-0001 Greetings USDA, OIE et al, what a difference it makes with science, from one day to the next. i.e. that mad cow gold card the USA once held. up until that fateful day in December of 2003, the science of BSE was NO IMPORTS TO USA FROM BSE COUNTRY. what a difference a day makes$ now that the shoe is on the other foot, the USDA via the OIE, wants to change science again, just for trade $ I implore the OIE decision and policy makers, for the sake of the world, to refuse any status quo of the USA BSE risk assessment. if at al, the USA BSE GBR should be raise to BSE GBR IV, for the following reasons. North America is awash with many different TSE Prion strains, in many different species, and they are mutating and spreading. IF the OIE, and whatever policy makers, do anything but raise the risk factor for BSE in North America, they I would regard that to be highly suspicious. IN fact, it would be criminal in my opinion, because the OIE knows this, and to knowingly expose the rest of the world to this dangerous pathogen, would be ‘knowingly’ and ‘willfully’, just for the almighty dollar, once again. I warned the OIE about all this, including the risk factors for CWD, and the fact that the zoonosis potential was great, way back in 2002. THE OIE in collaboration with the USDA, made the legal trading of the atypical Nor-98 Scrapie a legal global commodity. yes, thanks to the OIE and the USDA et al, it’s now legal to trade the atypical Nor-98 Scrapie strain all around the globe. IF you let them, they will do the same thing with atypical BSE and CWD (both strains to date). This with science showing that indeed these TSE prion strains are transmissible. I strenuously urge the OIE et al to refuse any weakening to the USA trade protocols for the BSE TSE prion disease (all strains), and urge them to reclassify the USA with BSE GBR IV risk factor. SEE REFERENCE SOURCES IN ATTACHMENTS</div><br />
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<div>SEE Terry S. Singeltary Sr. Attachment WORD FILE ;</div><br />
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<div><a href="http://www.regulations.gov/#!documentDetail;D=APHIS-2008-0010-0008">http://www.regulations.gov/#!documentDetail;D=APHIS-2008-0010-0008</a></div><br />
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<div><a href="http://www.regulations.gov/#!docketDetail;D=APHIS-2008-0010">http://www.regulations.gov/#!docketDetail;D=APHIS-2008-0010</a></div><br />
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<div>Sunday, March 11, 2012</div><br />
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<div>APHIS Proposes New Bovine Spongiform Encephalopathy Import Regulations in Line with International Animal Health Standards Proposal Aims to Ensure Health of the U.S. Beef Herd, Assist in Negotiations </div><br />
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<div><a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/03/aphis-proposes-new-bovine-spongiform.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/03/aphis-proposes-new-bovine-spongiform.html</a></div><br />
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<h2 class="date-header" style="letter-spacing: 1px; margin: 0px; text-transform: uppercase; word-wrap: break-word;"><span style="letter-spacing: 1px;"><span style="font-family: Georgia;"><span style="color: #29303b;"><span style="font-size: 10.8pt;"><span style="font-weight: normal;">Wednesday, April 4, 2012</span></span></span></span></span></h2><br />
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<div class="date-posts" style="word-wrap: break-word;"><div class="post-outer"><div class="post hentry uncustomized-post-template" itemscope="itemscope" itemtype="http://schema.org/BlogPosting" style="margin: 8px 0px 24px;"><a href="http://www.blogger.com/" name="7136181172666998874"></a> <br />
<h3 class="post-title entry-title" itemprop="name" style="margin: 0px;"><span style="font-family: Georgia;"><span style="color: #1b0431;"><span style="font-size: 16.8pt;"><span style="font-weight: normal;">Bovine Spongiform Encephalopathy; Importation of Bovines and Bovine Products APHIS-2008-0010-0008 RIN:0579-AC68 </span></span></span></span></h3></div></div></div><br />
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<div><a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/04/bovine-spongiform-encephalopathy.html" title="http://transmissiblespongiformencephalopathy.blogspot.com/2012/04/bovine-spongiform-encephalopathy.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/04/bovine-spongiform-encephalopathy.html</a></div><br />
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<div>pink slime and a ship of fools, with Governor Rick Perry at the helm.</div><br />
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<div>john gummer of England, force fed his daughter mad cow beef. a few years later, a young friend of theirs (23) died from mad cow disease. NOW, Governor Rick Perry, shows he is as big a fool as John Gummer.</div><br />
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<div><a href="http://media.kansascity.com/smedia/2012/03/29/21/01/MiPpi.SlMa.81.jpg">http://media.kansascity.com/smedia/2012/03/29/21/01/MiPpi.SlMa.81.jpg</a></div><br />
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<div>see more on this sad sad saga here ;</div><br />
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<div>Wednesday, March 14, 2012</div><br />
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<div>PINK SLIME, MRM’s, BSE AKA MAD COW DISEASE, AND THE USDA NSLP</div><br />
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<div><a href="http://madcowusda.blogspot.com/2012/03/pink-slime-mrms-bse-aka-mad-cow-disease.html">http://madcowusda.blogspot.com/2012/03/pink-slime-mrms-bse-aka-mad-cow-disease.html</a></div><br />
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<div>Sunday, August 28, 2011</div><br />
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<div>Rick Perry, Texas, BSE aka mad cow disease, CJD, and 12 years of lies there from </div><br />
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<div><a href="http://sciencebushwhacked.blogspot.com/2011/08/rick-perry-texas-bse-aka-mad-cow.html">http://sciencebushwhacked.blogspot.com/2011/08/rick-perry-texas-bse-aka-mad-cow.html</a></div><br />
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<div>BY the way, ammonia treated beef DOES NOT KILL MAD COW DISEASE !!!</div><br />
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<div>> > > Ackerman says downed cattle are 50 times more likely to have mad cow disease (also known as Bovine Spongiform Encephalopathy, or BSE) than ambulatory cattle that are suspected of having BSE. Of the 20 confirmed cases of mad cow disease in North America since 1993, at least 16 have involved downer cattle, he said. < < < </div><br />
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<div>don’t forget the children... </div><br />
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<div>PLEASE be aware, for 4 years, the USDA fed our children all across the Nation (including TEXAS) dead stock downer cows, the most high risk cattle for BSE aka mad cow disease and other dangerous pathogens. </div><br />
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<div>who will watch our children for CJD for the next 5+ decades ??? </div><br />
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<div>WAS your child exposed to mad cow disease via the NSLP ??? </div><br />
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<div>SCHOOL LUNCH PROGRAM FROM DOWNER CATTLE UPDATE </div><br />
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<div><a href="http://downercattle.blogspot.com/2009/05/who-will-watch-children.html">http://downercattle.blogspot.com/2009/05/who-will-watch-children.html</a> </div><br />
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<div><a href="http://downercattle.blogspot.com/">http://downercattle.blogspot.com/</a> </div><br />
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<div>DID YOUR CHILD CONSUME SOME OF THESE DEAD STOCK DOWNER COWS, THE MOST HIGH RISK FOR MAD COW DISEASE ??? </div><br />
<div>you can check and see here ; </div><br />
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<div><a href="http://www.fns.usda.gov/fns/safety/pdf/Hallmark-Westland_byState.pdf">http://www.fns.usda.gov/fns/safety/pdf/Hallmark-Westland_byState.pdf</a> </div><br />
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<div>Saturday, March 5, 2011 </div><br />
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<div>MAD COW ATYPICAL CJD PRION TSE CASES WITH CLASSIFICATIONS PENDING ON THE RISE IN NORTH AMERICA </div><br />
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<div><a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/mad-cow-atypical-cjd-prion-tse-cases.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/mad-cow-atypical-cjd-prion-tse-cases.html</a> </div><br />
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<div>Sunday, February 12, 2012 </div><br />
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<div>National Prion Disease Pathology Surveillance Center Cases Examined1 (August 19, 2011) including Texas </div><br />
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<div><a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/02/national-prion-disease-pathology.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/02/national-prion-disease-pathology.html</a> </div><br />
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<div>Monday, April 16, 2012</div><br />
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<div>Continuing Enhanced National Surveillance for Prion Diseases in the United States </div><br />
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<div><a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/04/continuing-enhanced-national.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/04/continuing-enhanced-national.html</a></div><br />
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<div>TSS</div>Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-4687453285836897153.post-73634021696762584602010-07-22T14:56:00.000-05:002010-07-22T15:02:48.744-05:00BSE INQUIRY DFA 18 COSMETICSFrom: TSS<br /><br />Subject: Use of Materials Derived From Cattle in Human Food and Cosmetics [Docket No. 2004N-0081] RIN 0910-AF47<br /><br />Date: April 17, 2008 at 2:41 pm PST<br /><br /><br /><a href="http://www.fda.gov/OHRMS/dockets/98fr/05-17693.htm">http://www.fda.gov/OHRMS/dockets/98fr/05-17693.htm</a><br /><br /><br /><br /><a href="http://www.fda.gov/ohrms/DOCKETS/dockets/04n0081/04N-0081_emc1148-02.pdf">http://www.fda.gov/ohrms/DOCKETS/dockets/04n0081/04N-0081_emc1148-02.pdf</a><br /><br /><br /><br /><a href="http://www.fas.usda.gov/info/fr/2004/071404BSEFDA1.htm">http://www.fas.usda.gov/info/fr/2004/071404BSEFDA1.htm</a><br /><br /><br /><br /><a href="http://edocket.access.gpo.gov/2005/pdf/05-17693.pdf">http://edocket.access.gpo.gov/2005/pdf/05-17693.pdf</a><br /><br /><br /><br />In experimentally infected cattle, brain and spinal cord were again been confirmed to be infectious, but in addition the distal ileum (lower small intestine) also contained significant amounts of infectivity(31, 32). Two key ganglia, which are key intermediate points linking the central and peripheral nervous systems, namely TAFS 3 the trigeminal and dorsal root ganglia (DRG), were also clearly infectious(32, 33). This is not surprising given their close association with central nervous tissue. Peripheral nerves have also been demonstrated to become positive after the brain and spinal cord(1, 19). Completion of bioassay studies has also enabled a better understanding of the sequence of events, and rate of accumulation of infectivity, especially in relation to ileum, brain and spinal cord(1,2), and have confirmed the basic assumptions upon risk management policy were based.<br /><br />PAGE 3<br /><br /><br /><a href="http://www.tseandfoodsafety.org/position_papers/TAFS_POSITION_PAPER_SPECIFIED%20RISK%20MATERIALS_2009_feb.pdf">http://www.tseandfoodsafety.org/position_papers/TAFS_POSITION_PAPER_SPECIFIED%20RISK%20MATERIALS_2009_feb.pdf</a><br /><br /><br /><br /><br />Thursday, April 17, 2008<br /><br />Use of Materials Derived From Cattle in Human Food and Cosmetics [Docket No. 2004N-0081] RIN 0910-AF47 [Federal Register: April 17, 2008 (Volume 73, Number 75)] [Rules and Regulations] [Page 20785-20794] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr17ap08-7]<br /><br /><br /><a href="http://cjdmadcowbaseoct2007.blogspot.com/2008/04/use-of-materials-derived-from-cattle-in.html">http://cjdmadcowbaseoct2007.blogspot.com/2008/04/use-of-materials-derived-from-cattle-in.html</a><br /><br /><br /><br /><br />Monday, February 01, 2010<br /><br />Import Alert 17-04 BSE CJD HIGH RISK TISSUES, Nutritional Supplements and Cosmetics<br /><br /><a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/02/import-alert-17-04-bse-cjd-high-risk.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/02/import-alert-17-04-bse-cjd-high-risk.html</a><br /><br /><br /><br /><br />SEE HISTORY OF COSMETICS AND MAD COW TYPE DISEASE<br /><br /><br />-------- Original Message --------<br /><br /><br />Subject: Docket No. 2004N-0081 and or RIN number RIN-0910-AF47 Use of Materials Derived From Cattle in Human Food and Cosmetics [comment submission]<br /><br />Date: Tue, 13 Jul 2004 16:08:38 -0500<br /><br />From: "Terry S. Singeltary Sr." T<br /><br />o: fdadockets@oc.fda.gov<br /><br />CC: burt.pritchett@fda.gov, Agriculture@mail.house.gov<br /><br />COMMENT SUBMISSION [Docket No. 2004N-O081] RIN-0910--AF47 Use of Materials Derived From Cattle in Human Food and Cosmetics<br /><br /><a href="http://www.fda.gov/OHRMS/DOCKETS/98fr/04n-0081-nir0001.pdf">http://www.fda.gov/OHRMS/DOCKETS/98fr/04n-0081-nir0001.pdf</a><br /><br /><br />Greetings FDA,<br /><br />I would kindly like to comment on the potential for TSE transmission from cosmetics to humans and why I think that ALL animal by-products should be excluded from cosmetics. IF we look at the TSE 'KURU'. Kuru is a transmissible spongiform encephalopathy that was identified in Papua New Guinea in the late 1950s. Several thousand cases of the disease occurred during a period of several decades. Epidemiologic investigations implicated ritual endocannibalistic funeral feasts as the likely route through which the infectious agent was spread. The incubation period in females was estimated to be shorter than that in males. The shortest incubation periods were estimated in adult women, who may have been exposed to the largest doses of infectious material. MY question is, was the woman exposed to larger doses, are was it the route of the agent that may have been the factor of shorter incubation in woman, or both?<br /><br />What is Kuru? Kuru is a rare and fatal brain disorder that occurred at epidemic levels during the 1950s-60s among the Fore people in the highlands of New Guinea. The disease was the result of the practice of ritualistic cannibalism among the Fore, in which relatives prepared and consumed the tissues (including brain) of deceased family members. Brain tissue from individuals with kuru was highly infectious, and the disease was transmitted either through eating or by contact with open sores or wounds. Government discouragement of the practice of cannibalism led to a continuing decline in the disease, which has now mostly disappeared.<br /><br />snip...<br /><br />PLEASE NOTE the later ''or by contact with open sores or wounds.''<br /><br />and the disease was transmitted either through eating or by contact with open sores or wounds.<br /><br /><a href="http://www.ninds.nih.gov/health_and_medical/disorders/kuru.htm">http://www.ninds.nih.gov/health_and_medical/disorders/kuru.htm</a><br /><br /><br />the Fore women would scoop the brains of their dead relatives out of their skulls by hand before cooking. They then wiped the residual liquid and cadaver tissue over their paint-daubed bodies, leaving it caked in their hair and on their bodies for weeks after a mortuary feast.<br /><br />Jennifer Cooke: kuru deaths continue in 1999<br /><br />Sydney Morning Herald, Saturday, August 28, 1999<br /><br />TSE INFECTION does takes place when the skin surface has been broken by scarification (Taylor et al, 1996).<br /><br />The transmission of KURU into animals supported the belief that the disease had been transmitted through ceremonial cannibalistic rituals in New Guinea with a possible route of spread involving handling fresh tissue and inoculation through mucous membranes and wounds including skin abrasions (Gajdusek, 1977)<br /><br />Masters, C.J., Gajdusek, D.C. and Gibbs, C.J., (1980). The spongiform encephalopathies: the natural history of CJD and its relationship to kuru and scrapie.<br /><br />* Gajdusek D.C. (1996). Kuru: From the New Guinea field journals 1957-1962. Grand Street, 15:6-33<br /><br />* Gajdusek D.C. (1973). Kuru in the New Guinea Highlands. In Spillane JD (ed): Tropical Neurology. New York, Oxford University Press.<br /><br />* Gajdusek D.C., Gibbs C.J., and M. Alpers (1966). Experimental transmission of a kuru-like syndrome to chimpanzees. Nature, 209:794.<br /><br />* Lindenbaum S. (1979). Kuru Sorcery. Mountain View, Ca, Mayfield Publishing Company.<br /><br />SCCNFP/0724/03, final THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS OPINION CONCERNING USE OF SPECIFIED RISK MATERIAL IN COSMETICS CLARIFICATION FOR TALLOW DERIVATIVES adopted by the SCCNFP on 30 July 2003 by means of the written procedure SCCNFP/0724/03, final Opinion on the Use of specified risk material in cosmetics - Clarification for tallow derivatives<br /><br />____________________________________________________________________________ _________________<br /><br /><br />2 1. Background<br /><br />snip...<br /><br /><a href="http://europa.eu.int/comm/health/ph_risk/committees/sccp/documents/out229_en.pdf">http://europa.eu.int/comm/health/ph_risk/committees/sccp/documents/out229_en.pdf</a><br /><br /><br /><br />4. For GBR-C III and IV countries, tallow derivatives are safe if, in addition to the above (3), the specific risk materials have been removed and are not used for the production of tallow/tallow derivatives.<br /><br />PLEASE NOTE, under the old BSE GBR, the USA would be re-classified as at least a GBR III risk assessment, if not a GBR IV in my opinion due to the misgivings from USDA/APHIS et al, some documented below in my references from Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission).<br /><br />Report on the Assessment of the Geographical BSE - Risk of USA (July 2000) (220kb)<br /><br /><a href="http://europa.eu.int/comm/food/fs/sc/ssc/out137_en.pdf">http://europa.eu.int/comm/food/fs/sc/ssc/out137_en.pdf</a><br /><br /><br /><br />snip...end<br /><br /><br />Subject: DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A., a prime market for Jersey cattle]<br /><br />From: "Terry S. Singeltary Sr." <flounder@wt.net><br /><br />Reply-To: Bovine Spongiform Encephalopathy <bse-l@uni-karlsruhe.de><br /><br />Date: Mon, 1 Nov 1999 09:28:04 -0600<br /><br />Content-Type: text/plain<br /><br />Parts/Attachments: text/plain (66 lines)<br /><br />Reply<br /><br />Terry S. Singeltary Sr., Bacliff, Texas USA --<br /><br />Greetings,<br /><br />I have been reading over the latest DFA 18, about cosmetics, and the possible route of BSE, through this source. Several interesting comments I find, that have brought several questions in mind, ones in which I have asked before, and still no answer. The CDC refuses to answer any of my questions through their site, and no one else seems to know the answer. Is the U.S.A. considered to be B.S.E. free, by other Countries? I asked this question to Dr. Detwiler, her reply was; "To the best of my knowledge there are no countries in the world which restrict any animals or animal products from the United States due to a risk from BSE. I am not sure if all such countries are using the term BSE free"...<br /><br />The reason in bringing this up, I find several statements in this draft, that pertains to this, statements that I find quite interesting; <http:><br /><br />Page 24, DFA 18, -- "the line taken on cosmetics including sourcing from overseas was based on that given for licensed medicinal products by a group that included Drs. Kimberlin, Watson and Will, as well as other MAFF officials. There is no question that the UK is an "infected area": the only question is whether other countries should be included too. The Licensing Authority, quite reasonably in my view, feels they can only insist on sourcing in Countries where there is no evidence of BSE and the veterinary service and reporting system is adequate to detect it were it is present. Most manufacturers of mainline pharmaceuticals are not risking having to change sources yet again and so are looking to Australasia. If the CVO thinks he has enough evidence, _say concerning the USA_, to persuade the CSM, CDSM etc to advise more strongly against sourcing there too, he should present that evidence in a convincing form and in writing. I do not see this as a matter for our group, since there are statutory responsibilities under the Medicines Act. What we should do is ensure consistent advice is given for those borderline products (like these "cosmetics" with medicinal claims) that currently fall outside that Act."<br /><br />Page 60, DFA 18, cosmetics -- 4. If it is possible for humans to contract "mad cow" disease from cosmetics, the risk is greater from "exotica" products because, unlike soap ingredients, the ingredients are not subject to repeated boiling and some are just merely chilled. MAFF have advised the CTPA that the only safe source is Australasia. Along with other European countries, France and Germany have imported from the UK infected feedstuff and live cattle. There have been reports of BSE outbreaks in Germany and France and _even in the USA_, a prime market for Jersey cattle. The Germans claim that they have "cured" their infected cattle by bathing them in a special dip they have developed but MAFF say there is no magic German cure. The French are masters at suppressing bad news. However, their higher scientific committee has issued "approved BSE guidelines" for French industry to follow. These guidelines cover, amongst other things, cosmetic products and are based on guidelines issued by MAFF. The French have not credited MAFF at all and are touting their guidelines around the Commission.<br /><br />I suppose my question would still be, does the EU, and or all the rest of the European Countries, consider the U.S.A. to be B.S.E. Free?<br /><br />------------------ http://www.uni-karlsruhe.de/~listserv/ -------------------<br /><br /><br /><a href="https://lists.aegee.org/cgi-bin/wa?A2=ind9911&L=BSE-L&P=R270&1=BSE-L&9=A&I=-3&J=on&X=2D25604264697D83A3&Y=flounder9%40verizon.net&d=No+Match%3BMatch%3BMatches&z=4">https://lists.aegee.org/cgi-bin/wa?A2=ind9911&L=BSE-L&P=R270&1=BSE-L&9=A&I=-3&J=on&X=2D25604264697D83A3&Y=flounder9%40verizon.net&d=No+Match%3BMatch%3BMatches&z=4</a><br /><br /><br /><br />Subject: COSMETICS, TOILETRY AND THE PERFUME INDUSTRY & B.S.E.<br /><br />From: "Terry S. Singeltary Sr." <flounder@wt.net><br /><br />Reply-To: Bovine Spongiform Encephalopathy <bse-l@uni-karlsruhe.de><br /><br />Date: Sun, 3 Sep 2000 10:55:19 -0700<br /><br />Content-Type: text/plain<br /><br />Parts/Attachments: text/plain (305 lines)<br /><br />Reply<br /><br />######### Bovine Spongiform Encephalopathy <bse-l@uni-karlsruhe.de>#########<br /><br />Greetings List Members,<br /><br />Human transmission: There are some in the media and even the medical profession who are trying to make connections between BSE and the human disorder CJD. There is _no_ evidence of any association nor would we expect any cases by now even were BSE to be transmissible to humans. Dr Wills' study (see 2i above) will monitor the situation for the next decade or two.<br /><br />I thought i would break off the vaccines & BSE related issues just briefly, to show you another fine example of the, hmmmmmmmm, i will not use _cover-ups_, because people cannot accept that, even if that is where the truth lies. So i will call them, the _purposely miss judgements_, or _happen-stances of mega-ignorance_.<br /><br />kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA<br /><br />=======================================================================<br /><br />dti<br /><br />Miss Marion Kelly Cosmetic, Toiletry and Perfumery Association 35 Dover Street London W1X3RA<br /><br />Department of Trade and Industry<br /><br />10-18 Victoria Street London SW1H ONN<br /><br />Enquiries 01-215 5000<br /><br />Telex 8811074 DTHQ G<br /><br />01 215 3324<br /><br />1 February 1990<br /><br />Dear Marion<br /><br />As you know there is no record of bovine spongiform encepalopathy crossing to humans, but we need to take precautions to avoid any risk.<br /><br />There a number of cosmetric products on sale in the United Kingdom such as anti-ageing creams that contain extracts of bovine offal, primarily from spleen and Thymus.<br /><br />The purpose of this letter is to ask you to ask your members to eliminate any risk by reformulating such products to eliminate these extracts, or alternatively to use material derived from cattle reared outside the UK, Eire or the Channel Islands.<br /><br />Please let me know if you have any trouble persuading your members to do so.<br /><br />Yours sincerely<br /><br />R J ROSCOE<br /><br />CONSUMER SAFETY UNIT<br /><br />ROOM 407<br /><br />90/02.01/14.1<br /><br />==============<br /><br />BSE110/1 0080<br /><br />DEPARTMENT OF HEALTH AND SOCIAL SECURITY HANNIBAL HOUSE Room No ELEPHANT AND CASTLE LONDON SE1 6TE<br /><br />1 February 1990<br /><br />Mr R Roscoe Consumer Affairs Department of Trade and Industry 10-18 Victoria Street London SW1<br /><br />Dear Richard<br /><br />USE OF BOVINE OFFAL IN COSMETICS<br /><br />I am replying to your request for advice on the safety of the use of extracts of bovine offal in certain cosmetics, such as skin products claimed to have 'anti-ageing' properties with respect to bovine spongiform encephalopathy (BSE). As you are aware there are a number of cosmetic products on sale in the UK that contain small amounts of such extracts, primarily from spleen and thymus.<br /><br />we accept that the risk of transmission is likely to be remote, but believe that it would be prudent to eliminate any risk by reformulating such products. Alternatively if the incorporation of bovine extracts is retained, material derived from cattle reared outside the UK, Eire or the Channel Islands should be used.<br /><br />We would be grateful if you would transmit these recommendations to industry via the Trade Association CTPA.<br /><br />I attach background briefing prepared by medical colleagues from those sections most involved with consideration of BSE in DH, together with a copy of the Southwood report.<br /><br />Please let me know if you need any further information.<br /><br />Yours sincerely<br /><br />DR R J FIELDER<br /><br />Enclosure<br /><br />90/2.1/7.1<br /><br />===========<br /><br />BSE110/1 0081<br /><br />BACKGROUND BRIEFING<br /><br />presence of Bovine Offals in Cosmetics and Bovine Spongiform Encephalopathy<br /><br />(1) Extracts of bovine spleen and thymus are present at between ca 0.1 and 5% in certain cosmetic preparations, for example certain products claimed to delay the signs of ageing of skin. The concern about the increasing incidence of BSE in cattle in the UK has made it necessary to reconsider the safety of such products.<br /><br />The disease<br /><br />BSE is a progressive neurological disorder in cattle, which results from infection with an "unconventional viral' agent. The first case was described in cows in 1986. By 19 January 1990 there had been 9436 confirmed cases in the UK on 5474 farms. There are no confirmed cases outside the British Isles, apart from a case in a cow recently exported from England. BSE is one of a family of spongiform encephalopathies which also include scrapie in sheep and kuru and Creutzfeldt Jakob disease (CJD) in man. The infection which leads to BBE appears to have been introduced into cattle from the contaminated feeding stuff, meat and bone meal, made partly from sheep offal: scrapie is endemic in sheep in the UK.<br /><br />The causative agents of these diseases are thought to be unconventional transmissible agents (referred to variously as prions, virinos, filamentous viruses or slow viruses). They are extremely resistant to most denaturing processes eg heat, UV, high salt concentration, formalin and alkylating agents. The current DH guideline for treating items used on CJD patients is a temperature of 134-138 C (at 2 atmospheres) held for 18 minutes. They are also not removed by normal microbiological filters. It is thus unlikely that the mild processing techniques used to obtain the extracts used in cosmetics would remove the causative agents.<br /><br />(2) Government action to date includes:<br /><br />a. An expert working party was set up under Sir Richard Southwood and reported in February 1989. All their recommendations have been acted upon.<br /><br />b. The disease has been made notifiable in cattle.<br /><br />c. All suspect animals are slaughtered and carcases destroyed (50% compensation policy but 100% if diagnosis not confirmed); milk from such animals is also destroyed.<br /><br />d. Sale or supply of animal protein from ruminants for feeding to ruminants prohibited - hopefully to prevent any new infections in cattle. This has had a major effect on the rendering industry.<br /><br />e. Another committee was set up under Dr David Tyrrell to report on research needs. An interim report was published in January 1990 together with an announcement about additional funding. Much research work into the disease is currently in progress and additional studies are being planned.<br /><br />Regulations in November 1989 introduced a ban on various<br /><br />90/2.1/7.2<br /><br />===========<br /><br />BSEllO/1 0082<br /><br />bovine offal for human consumption, going wider than the Southwood recommendations which were for such a ban to affect baby food only.<br /><br />The Medicines Control Agency have gathered information from pharmaceutical companies about use of bovine ingredients in parenteral pharmaceuticals and issued interim guidelines. Many biological products and vaccines use such ingredients. The MCA are considering whether action on specific products is appropriate.<br /><br />h. The Health and Safety Executive (HSE) is reviewing its guidance to those who come into direct contact with bovine 'risk' tissues. A press release for those who handle BSE carcases has been issued and one for abattoir workers is in preparation. The HSE ara also discussing risks from BSE exposure with the veterinary profession.<br /><br />i. All UK cases of CJD will be monitored in a study to be conducted by Dr R G Will in Edinburgh, funded by the Department of Health: this should allow detection of any spread of infection to hummans, although this possibility is considered remote.<br /><br />(3) Current live issues<br /><br />Research: Dr Tyrell's interim report identified a large research programme classed as high priority. Almost all of this research falls to MAFF {Central Veterinary Labs} or the AFRC, although the MRC also has an interest. Substantial money has been made available for this work but research will be laborious and results will come slowly.<br /><br />Food: There has been constant pressure on MAFF about the supposed risk to humans from eating beef and beef products. Infected animals who are incubating the disease but do not show any abnormalities cannot be detected at present and will be entering the human food chain. The offal ban removes the highest 'risk' tissues. Some critics may not be satisfied by this. However, others may argue the action to date is over the top, not demanded by the experts, and illogical since scrapie-infected sheep can still be eaten and doing so for the last 200 years has not caused harm to humans. We expect BSE agent to be resistant to irradiation as applied to food, as well as relatively resistant to cooking.<br /><br />Other animals: There is no evidence that animals other than cattle (and domesticated, deer) have been or could be affected by BSE, other than experimentally, but there are pressures to extend the ruminant protein ban: at present pigs and poultry receive this sort of feed. Such action, as well as being hard to justify scientifically, would increase costs for the industry and cause perhaps insurmountable problems for abattoirs, who would find renderers no longer willing to accept offal. Many 1000's of tons of offal need to be disposed of daily.<br /><br />Compensation: This has been set at 50% for BSE, although for some other diseases it is higher. Some critics believe this encourages evasion, with cows affected minimally being sent for human consumption. Even the current level of compensation is proving expensive for MAFF.<br /><br />Exports: Some foreign countries have banned British exports of seman, embryos and livestock. The EC now no longer accepts live cattle over 6 months of age. The Germans are creating difficulties over beef exports too. The EC are also considering making BSE<br /><br />90/2.1/7.3<br /><br />=============<br /><br />BSE110/1 0083<br /><br />notifiable and banning ruminant protein feeding to rminants, as we have done here. At present, British meat and bone meat can still be exported and might spread infection overseas (MAFF claim importers have been warned that it is not regarded suitable for feeding to ruminants).<br /><br />Human transmission: There are some in the media and even the medical profession who are trying to make connections between BSE and the human disorder CJD. There is _no_ evidence of any association nor would we expect any cases by now even were BSE to be transmissible to humans. Dr Wills' study (see 2i above) will monitor the situation for the next decade or two.<br /><br />90/2.1/7.4<br /><br />=========== [like i have said, they really did miss the boat on this whole ordeal. from day one, to date, and they still continue to deny the inevitable.] TSS<br /><br />=========== [also, found this in this pile, so will just add...tss] ===========<br /><br />BOVINE SPONGIFORM ENCEPHALOPATHY<br /><br />I have been asked to provide a draft reply to the attached letter from Sir Richard Southwood to the Minister. The Minister has indicated that we must meet Sir Richard's points (a} on the need for him to be fully briefed as to developments and (b) on the urgency of making progress with the transmission study.<br /><br />On (a), I would suggest that the draft reply should indicate that you will be in touch with Sir Richard regularly to keep him in the picture. On (b), I hope we can now tell Sir Richard that the arrangements for the purchase and relocation of the animals are under way.<br /><br />A R Cruickshank<br /><br />20 June 1989<br /><br />Mr A J Lawrence<br /><br />AH<br /><br />cc Mr K C Meldrum Dr W A Watson Mr R C Lowson<br /><br />89/6.20/8.1<br /><br />============<br /><br />############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############<br /><br /><br /><a href="https://lists.aegee.org/cgi-bin/wa?A2=ind0009&L=BSE-L&P=R2540&1=BSE-L&9=A&I=-3&J=on&X=57C86A263C194B4411&Y=flounder9%40verizon.net&d=No+Match%3BMatch%3BMatches&z=4">https://lists.aegee.org/cgi-bin/wa?A2=ind0009&L=BSE-L&P=R2540&1=BSE-L&9=A&I=-3&J=on&X=57C86A263C194B4411&Y=flounder9%40verizon.net&d=No+Match%3BMatch%3BMatches&z=4</a><br /><br /><br /><br />From: TSS (216-119-138-155.ipset18.wt.net)<br /><br />Subject: FAT LIPS/SHINY HAIR/Creams (Cosmetics) PRETTY WOMEN $ MOVIE STARS $ MAD COW DISEASE ...<br /><br />Date: June 10, 2001 at 8:24 am PST<br /><br />Greetings ALL,<br /><br />was reading a 'smut' magazine about the 'babes' and came across this article about the different movie stars 'fat lips' (collagen injections). something in the article caught my eye. ONE was Collagen and the other was HASK PLACENTA No-Rinse Treatment. (if containing animal tissues, and then running down into the eye's, seems like a potential transmission route, if you consider kuru and the fact transmission of that TSE agent via topical applications {rubbing of organs etc on skin, cuts etc...TSS}).<br /><br />""Attention, Goldie Hawn: You might want to forget about more collagen infections for that full-lipped look. Collagen for the procedure usually comes from cows -- as in "mad cow disease". So what's a girl to do? Some docs are using an acid found in roosters' combs instead of collagen. Others use collagen from 'ELITE' herds that don't mix with common bovines. And one scientist is awaiting approval for a human collagen from the foreskin of infant boys -- further proof that beauty is only skin deep""-- 'The National Enquirer' 5/6/01<br /><br /><br />are these babes in far a 'rude' awakening. firstly, these so called 'ELITE' herds they speak of, are what they call, 'tissue donor herds', that are suppose to be fed 'only' certain products that _do not_ include ruminant feed of any sort. AND from the exact question i asked at the infamous '50 STATE EMERGENCY CONFERENCE CALL' of Jan, 9, 2001, sadly we find, there is absolutley, NO SUCH THING. It was all a joke. The 'partial' ruminant to ruminant feed ban of August 4, 1997, never was enforced, and most knew nothing about it, and/or chose to ignore it.<br /><br /><br /><a href="http://bseusa.blogspot.com/2010/04/upcoming-bse-webinar-on-thursday-april.html">http://bseusa.blogspot.com/2010/04/upcoming-bse-webinar-on-thursday-april.html</a><br /><br /><br />Hask Placenta® No-Rinse Hair Repair Treatment<br /><br />Nature's protein treatment. Excellent for hair that is abused by relaxing, tinting, bleaching and exposure to the sun.<br /><br />Price: US$4.95 Package: 5 fl oz (150 ml) Item No.: P8225 **discontinued** - replaced by Perm-Aid® No-Rinse Conditioning Treatment<br /><br />Placenta, the most powerful natural protein for the hair instantly restores life and luster to day brittle hair.<br /><br />Directions:<br /><br />Shake well. Apply after shampooing. Use pump and spray until hair is saturated. Massage thoroughly. Do not rinse. Wait 3 minutes: proceed as usual with setting or styling.<br /><br />Ingredients:<br /><br />Water, SD Alcohol 40, Placental Protein, Cetrimonium Bromide, Lactic Acid, Fragrance, Stearamide MEA, Polysorbate 80, Phenoxyethanol, Methylparaben, Butylparaben, Propylparaben, Stearyl Imidazoline, Cetearyl Alcohol, Dimethicone, FD&C Yellow #5.<br /><br /><a href="http://www.folica.com/shampoos/haskplacenta.htm">http://www.folica.com/shampoos/haskplacenta.htm</a><br /><br /><br />Hask Perm-Aid® Revitalizing Treatment<br /><br />Special care for permed hair, also for chemically damaged and extremely abused hair.<br /><br />Price: US$3.95 Package: 2.5 oz (70.94 grams) Item No.: P8216 Availability: **discontinued** recommend Perm-Aid No Rinse Conditioning Treatment<br /><br />This product had been discontinued by the manufacturer, we recommend Perm-Aid® No Rinse Conditioning Treatment, which is more potent!<br /><br /><a href="http://www.folica.com/shampoos/haskpermaid_revtre.htm">http://www.folica.com/shampoos/haskpermaid_revtre.htm</a><br /><br /><br />Part No : 1227 Description : Hask Placenta Treat.Vial 24/unit<br /><br />This product is in stock, and will ships in one to two business day. If the order is received before 1:00 pm Pacific Time, usually ships on same business day.<br /><br /><a href="http://www.beautycentury.com/mall/stockIS.asp?sku=1227">http://www.beautycentury.com/mall/stockIS.asp?sku=1227</a><br /><br /><br />HASK PLACENTA products are leaders in the Deep Conditioner segment of Hair Care. Henna-n-Placenta Pacs are #13 in Unit Sales of ALL conditioners and #1 of all DEEP conditioners in the Drug Class*. Hask Placenta Instant Hair Repair, with No-Rinse treatment, is a top-10 unit seller*. National Media Support drives the brand and Hask’s strong professional heritage has consumer recognition.<br /><br /><a href="http://www.ecrm-epps.com/Expose/V4_7/Table_Profiles/Alleghany.html">http://www.ecrm-epps.com/Expose/V4_7/Table_Profiles/Alleghany.html</a><br /><br /><br />BSE INQUIRY<br /><br />Use of Bovine offal in Cosmetics;<br /><br /><br /><a href="http://collections.europarchive.org/tna/20081105233036/http://www.bseinquiry.gov.uk/files/yb/1990/02/01004001.pdf">http://collections.europarchive.org/tna/20081105233036/http://www.bseinquiry.gov.uk/files/yb/1990/02/01004001.pdf</a><br /><br /><br /><a href="http://web.archive.org/web/20040625033734/www.bseinquiry.gov.uk/files/yb/1990/02/01007001.pdf">http://web.archive.org/web/20040625033734/www.bseinquiry.gov.uk/files/yb/1990/02/01007001.pdf</a><br /><br /><br />6. Information on the transfer of spongiform encephalopathies indicates that the risks from parenternal exposure are greater than orally; though the transfer through intact skin is probably unlikely, the effect of a cut or abrasion to the skin is unknown. ...<br /><br /><br /><a href="http://web.archive.org/web/20030516061153/http://www.bseinquiry.gov.uk/files/yb/1990/01/26018001.pdf">http://web.archive.org/web/20030516061153/http://www.bseinquiry.gov.uk/files/yb/1990/01/26018001.pdf</a><br /><br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102164040/http://www.bseinquiry.gov.uk/files/yb/1990/01/29001001.pdf">http://collections.europarchive.org/tna/20080102164040/http://www.bseinquiry.gov.uk/files/yb/1990/01/29001001.pdf</a><br /><br /><br /><br /><a href="http://web.archive.org/web/20030526094945/http://www.bseinquiry.gov.uk/files/yb/1990/01/29015001.pdf">http://web.archive.org/web/20030526094945/http://www.bseinquiry.gov.uk/files/yb/1990/01/29015001.pdf</a><br /><br /><br /><br /><a href="http://web.archive.org/web/20030515204421/http://www.bseinquiry.gov.uk/files/yb/1990/01/31014001.pdf">http://web.archive.org/web/20030515204421/http://www.bseinquiry.gov.uk/files/yb/1990/01/31014001.pdf</a><br /><br /><br /><br />*** (Third paragraph: The wording of this paragraph will raise NEW concerns which cannot be scientifically answered. We would ask that the third paragraph be OMITTED.)<br /><br /><br /><a href="http://collections.europarchive.org/tna/20081105233038/http://www.bseinquiry.gov.uk/files/yb/1990/01/31014001.pdf">http://collections.europarchive.org/tna/20081105233038/http://www.bseinquiry.gov.uk/files/yb/1990/01/31014001.pdf</a><br /><br /><br /><br />NOT FOR PUBLICATION<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102164021/http://www.bseinquiry.gov.uk/files/yb/1991/06/00005001.pdf">http://collections.europarchive.org/tna/20080102164021/http://www.bseinquiry.gov.uk/files/yb/1991/06/00005001.pdf</a><br /><br /><br /><br />(there may still be some strange products administered by injection that are trying to _evade_ the Medicines Act by calling themselves cosmetics. If _any_ of those involve bovine ingredients, they need to _comply_ with the CSM guidelines)...<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102164014/http://www.bseinquiry.gov.uk/files/yb/1991/07/25003001.pdf">http://collections.europarchive.org/tna/20080102164014/http://www.bseinquiry.gov.uk/files/yb/1991/07/25003001.pdf</a><br /><br /><br /><br /><a href="http://collections.europarchive.org/tna/20081105233044/http://www.bseinquiry.gov.uk/files/yb/1991/06/26003001.pdf">http://collections.europarchive.org/tna/20081105233044/http://www.bseinquiry.gov.uk/files/yb/1991/06/26003001.pdf</a><br /><br /><br /><a href="http://web.archive.org/web/20030529120226/http://www.bseinquiry.gov.uk/files/yb/1991/06/30001001.pdf">http://web.archive.org/web/20030529120226/http://www.bseinquiry.gov.uk/files/yb/1991/06/30001001.pdf</a><br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102164053/http://www.bseinquiry.gov.uk/files/yb/1991/10/15002001.pdf">http://collections.europarchive.org/tna/20080102164053/http://www.bseinquiry.gov.uk/files/yb/1991/10/15002001.pdf</a><br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102164025/http://www.bseinquiry.gov.uk/files/yb/1991/10/31009001.pdf">http://collections.europarchive.org/tna/20080102164025/http://www.bseinquiry.gov.uk/files/yb/1991/10/31009001.pdf</a><br /><br /><br />BSE110/1 0180<br /><br />RUMINANT-DERIVED MATERIAL IN COSMETICS<br /><br />The Department of Health wishes to reinforce the advice given to the Cosmetics Industry in February 1990 (ref.)<br /><br />It is possible that some ruminant-derived materials are being incorporated into cosmetics or beauty treatments which are then marketed as 'natural products.<br /><br />The particular materials that should not under _ANY_ circumstances be used in the manufacturer of cosmetics or beauty treatments are:<br /><br />1. bovine (cattle)-derived offals, or proteins derived from these offals. These offals are: brain, spinal cord, spleen, thymus, tonsils, intestines of Bovine offal (prohibition) regulations<br /><br />2. ovine (sheep)-derived offals and ovine placenta.<br /><br />In view of the current uncertainty about the incidence of infection with spongiform encephalopathy agents it is probably advisable that these recommendations apply to the above ruminant-derived materials of ANY COUNTRY OF ORIGIN...<br /><br />31 October 1991<br /><br />91/10.31/9.1<br /><br />It also emerged from the 16- volume report of Lord Phillips, released on Thursday, that people who bought anti-aging cream may have exposed themselves to BSE unwittingly.<br /><br />The report describes their use as “a potential pathway to infection” because some creams may have included cattle brain placenta.<br /><br /><a href="http://www.sesahs.nsw.gov.au/albionstcentre/infection_control/newsletter6.htm">http://www.sesahs.nsw.gov.au/albionstcentre/infection_control/newsletter6.htm</a><br /><br /><br />A CONSIDERATION OF THE POSSIBLE HAZARD OF GELATIN TO MAN IN RELATION TO THE TRANSMISSION OF BSE<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102120826/http://www.bseinquiry.gov.uk/files/sc/seac13/tab07.pdf">http://collections.europarchive.org/tna/20080102120826/http://www.bseinquiry.gov.uk/files/sc/seac13/tab07.pdf</a><br /><br /><br /><br />Subject: BSE aka MAD COW DISEASE AND TOPICAL APPLICATIONS COSMETICS (cuts/abrasions etc.)<br /><br />From: "Terry S. Singeltary Sr." <flounder@wt.net><br /><br />Reply-To: Bovine Spongiform Encephalopathy <bse-l@uni-karlsruhe.de><br /><br />Date: Wed, 12 Sep 2001 16:51:36 -0700<br /><br />Content-Type: text/plain<br /><br />Parts/Attachments: text/plain (257 lines)<br /><br />Reply<br /><br />######## Bovine Spongiform Encephalopathy <bse-l@uni-karlsruhe.de>#########<br /><br />Greetings everyone,<br /><br />since the debate on this ended abruptly, i thought some might be interested in the following;<br /><br />TOSS =====<br /><br />DOA 18<br /><br />Cosmetics<br /><br />snip...<br /><br />73. On 29 January 1990 Dr Pickles sent a minute to Dr Singh, copied to Mr Love and Mr Maslin. Dr Pickles referred to a conversation about Dr Singh’s draft letter to Mr Roscoe, and stated:[73]<br /><br />snip...<br /><br />But I think application to broken skin is getting rather close to parenteral administration. Together with problems of policing the 6 month limit, and the fact that the ‘benefit’ from such material is so dubious, I would prefer to see a complete ban.’<br /><br />snip...<br /><br />75. On 29 January 1990 Mr Sloggem replied to Mrs Shersby’s minute of the same date. He said:[75]<br /><br />“1. The advice from Dr Fielder seems fine to me. There could be a problem with abraded skin providing a route of entry. Spleen and placenta could well have high titres, assuming the analogy with scrapie holds good. Sourcing abroad would seem the sensible thing to do. Some tissues may have higher titres earlier than brain tissue eg gut, hence these are best avoided from British sources.<br /><br />snip...<br /><br />“… the line taken on cosmetics including sourcing from overseas was based on that given for licensed medicinal products by a group that included Drs Kimberlin, Watson and Will, as well as other MAFF officials. There is no question that the UK is an “infected area”: the only question is whether other countries should be included too. The Licensing Authority, quite reasonably in my view, feels they can only insist on sourcing in countries where there is no evidence of BSE and the veterinary service and reporting system is adequate to detect it were it present. Most manufacturers of mainline pharmaceuticals are not risking having to change sources yet again and so are looking to Australasia. If the CVO thinks he has enough evidence, say concerning the USA, to persuade the CSM, CDSM etc to advise more strongly against sourcing there too, he should present that evidence in a convincing form and in writing. I do not see this as a matter for our group, since there are statutory responsibilities under the Medicines Act. What we should do is ensure consistent advice is given for those borderline products (like these “cosmetics” with medicinal claims) that currently fall outside that Act.”<br /><br /><br />http://www.bse.org.uk/dfa/dfa18.htm<br /><br />snip...<br /><br /><br />136. On 25 July 1991, Dr Pickles replied to Mr Murray’s request. She agreed that the geographical aspects needed updating. She said ‘[the] background briefing is not really appropriate in that form (it was not something I had intended should have gone to DTI in any case).’ She also suggested that it could be pointed out that there were potential concerns:[142]<br /><br />‘* for workers in the cosmetic industry who may be exposed frequently to these materials, especially if inoculation injuries might occur and<br /><br />* those who by repeated application particularly to thinned, scarified or diseased skin might absorb material including infective agent that way, also<br /><br />* there may still be some strange products administered by injection that are trying to evade the Medicines Act by calling themselves cosmetics. If any of those involve bovine ingredients, they need to comply with the CSM guidelines.’<br /><br />snip...<br /><br />‘I have the feeling we are far too remote from the industry to make meaningful comments. Contacts via DOH/DTI do not inspire me with confidence. I would advise we need to know what bovine materials are really used in cosmetics and for what purposes. We either need to send someone into the industry (as I did for tripe, casings and rennet) or have a closer contact via the trade association. I am not satisfied yet that the industry is ‘in the clear’ and it is us that may shoulder some blame if it is later found ladies are rubbing cow brain or placenta on to their faces. It may not be our job but if we have any responsibility we need to get at the facts.’<br /><br />snip...<br /><br />‘Cosmetics<br /><br />3. In February 1990 the Department of Health wrote to the Department of Trade and Industry, following a request for advice on the safety of using extracts of bovine offal in certain cosmetics. Placenta is used for its supposed anti-ageing properties. Gangliosides, spleen and thymus may also be used, although there is no firm knowledge on this.<br /><br />4. DTI issued advice to the industry, via the Trade Association, to the effect that even though the risks were remote it would be prudent to reformulate these products or source from countries free from BSE. In this context it was agreed at the Tyrrell committee meeting on 28 June that DTI would be reminded that since BSE had been found in other countries their guidance to cosmetic manufacturers needed to be updated.<br /><br />snip...<br /><br />‘MK and JS said that the cosmetics of concern can be divided into two – 10% expensive ‘exotica’ which could contain the particular tissues of concern to DH such as cerebrocides, placenta (either human or other animal) and 90% are the routine products, many of which are based on collagen, elastin and gelatin. …<br /><br />MK explained that the French cosmetics industry was soon to hold discussions with their Department of Health and it was likely that the use of placental material, particularly human, would be discontinued in any cosmetics. The main producers of ‘exotica’ were French and American, the products very expensive and therefore the companies would have the resources to ensure the safety of their products by safe sourcing eg from Australasia where there is no scrapie and no BSE. Small UK manufacturers would not be producing products containing animal materials but would rely on vegetable materials. They were not thought to be likely to be incorporating materials of concern, and this was also true for those producers of ‘natural’ products who would not necessarily be members of the CTPA.’<br /><br />snip...<br /><br />The delegation thought that cosmetic products applied to the mucous membranes or around the eyes were the most dangerous.<br /><br />http://www.bse.org.uk/dfa/dfa18.htm<br /><br /><a href="https://lists.aegee.org/cgi-bin/wa?A2=ind0109&L=BSE-L&P=R4117&1=BSE-L&9=A&I=-3&J=on&X=57C86A263C194B4411&Y=flounder9%40verizon.net&d=No+Match%3BMatch%3BMatches&z=4">https://lists.aegee.org/cgi-bin/wa?A2=ind0109&L=BSE-L&P=R4117&1=BSE-L&9=A&I=-3&J=on&X=57C86A263C194B4411&Y=flounder9%40verizon.net&d=No+Match%3BMatch%3BMatches&z=4</a><br /><br /><br />Subject: Use of Materials Derived From Cattle in Human Food and Cosmetics [Docket No. 2004N-0081] RIN 0910-AF47<br /><br />From: "Terry S. Singeltary Sr." <flounder9@verizon.net><br /><br />Reply-To: Bovine Spongiform Encephalopathy <bse-l@lists.aegee.org><br /><br />Date: Thu, 17 Apr 2008 12:46:56 -0500<br /><br />Content-Type: text/plain<br /><br /><a href="https://lists.aegee.org/cgi-bin/wa?A2=ind0804&L=BSE-L&P=R7115&1=BSE-L&9=A&I=-3&J=on&X=4C5F74434D94442225&Y=flounder9%40verizon.net&d=No+Match%3BMatch%3BMatches&z=4">https://lists.aegee.org/cgi-bin/wa?A2=ind0804&L=BSE-L&P=R7115&1=BSE-L&9=A&I=-3&J=on&X=4C5F74434D94442225&Y=flounder9%40verizon.net&d=No+Match%3BMatch%3BMatches&z=4</a><br /><br /><br />Subject: CHINA TO START IMPORTING COSMETICS FROM COUNTRIES WITH BSE<br /><br />From: "Terry S. Singeltary Sr." <flounder9@verizon.net><br /><br />Reply-To: Bovine Spongiform Encephalopathy <bse-l@lists.aegee.org><br /><br />Date: Sun, 1 Apr 2007 13:05:42 -0500<br /><br />Volume 7 Medicines and Cosmetics 8. Cosmetics and toiletries Introduction Exotica Standard topical products Collagen implants How the issue was handled<br /><br />8.1 In this chapter we consider the Government's response to the risks posed by the use of bovine material in cosmetics. Cosmetics, as defined by the Cosmetics Products (Safety) Regulations 1996, include:<br /><br />any substance or preparation intended to be placed in contact with any part of the external surfaces of the human body (that is to say, the epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours except where such cleaning, perfuming, protecting, changing, keeping or correcting is wholly for the purpose of treating or preventing disease. 1<br /><br />8.2 Cosmetics using bovine materials fell into three categories: (i) products using lightly treated high-risk bovine offals: 'exotica'; (ii) standard topically applied products using heavily processed bovine by-products; and (iii) implants using bovine collagen.<br /><br />Exotica<br /><br />8.3 Concern about a risk of possible BSE contamination focused mainly on those cosmetic products commonly described as 'exotica'. These included 'premium priced facial skin care products' such as certain anti-ageing and anti-wrinkle creams. There was no ban on the use in them of animal material such as 'cellular extracts' that was deemed an unacceptable risk in food and medicines, and accordingly proscribed under the food safety and medicines safety legislation. Such material might be only lightly processed or simply chilled. Possible ingredients identified relatively early on were gangliocides extracted from the brain; and placental material, spleen and thymus. 2<br /><br />Standard topical products<br /><br />8.4 Although never considered a serious risk, questions were also raised about how to ensure the safety of more standard cosmetic products. These included the full range of topically applied cosmetics, ie, creams and toiletries applied to the skin, lips and eyelids, and included soaps, skin creams, shaving sticks and stick deodorants. Many of these used heavily processed bovine by-products such as collagen, elastin, gelatine and tallow derivatives. 3<br /><br />Collagen implants<br /><br />8.5 Concern was also expressed about bovine collagen used in implants. Although not mentioned in the highly condensed minutes of the CSM/BSC meeting of 2 November 1988, Dr Pickles's own note at the time records that this came up at the meeting as an area of concern: 'Some collagen implants of bovine origin as used by cosmetic clinics are not even licensed.' 4 Collagen products intended for correction of contour deficiencies of the skin were considered licensable under the Surgical Materials Order SI 1971 No. 1276. DH has told us that although collagen implants might have been used for 'cosmetic' reasons, this would have been under medical supervision as they were 'prescription only' medicines. 5<br /><br />How the issue was handled<br /><br />8.6 Although specifically identified in the Tyrrell Report in June 1989 as a small-scale user that might not be covered by the regulations and guidelines then in place, 6 the cosmetics industry was not itself the subject of advice or guidance until February 1990.<br /><br />8.7 In January of that year Mr Richard Roscoe of the Department of Trade and Industry (DTI), the Department with policy responsibility for the safety of cosmetics, had on his own initiative asked DH for advice about the risk from BSE associated with the use of bovine offal in certain cosmetics. 7 DH's advice was that although the risk of transmission of BSE was remote, it would be prudent to reformulate, or source bovine material from cattle reared outside the British Isles. 8 DTI passed this advice on to the cosmetics industry trade association, the Cosmetics, Toiletries and Perfumery Association (CTPA), which in turn informed its members. 9<br /><br />8.8 SEAC considered the use of bovine material in non-food products generally in June 1991. 10 By that time, BSE had been identified in countries other than the UK, and it was suggested that the advice issued to the cosmetics industry in February 1990 should be updated to take this into account. Updated advice was not sent to the CTPA until April 1992. 11<br /><br />8.9 One approach that was considered within DH was the introduction of a voluntary ban on bovine materials from countries in which cases of BSE had been reported. Such a ban, if it were to be introduced, would have to be implemented at EU level, so as not to fall foul of European law. The question of BSE and cosmetics was therefore taken forward in the EC Working Party on Cosmetics (ECWPC). Progress at EC/EU level was slow; by the end of October 1994 the Scientific Committee on Cosmetology (SCC) had produced only an interim statement suggesting that material from animals with the potential to transmit infectious agents should not be used in the manufacture of cosmetics. 12 In February 1995 the ECWPC decided that the existing Cosmetics Directive did not need alteration. 13 This decision was based in part on assurance by COLIPA, the European cosmetics trade association, that its members were following certain approved basic precautions on a voluntary basis. 14<br /><br />8.10 When, in March 1996, the EU ban on the export from the UK of bovine products destined for use in cosmetic, medicinal and pharmaceutical products was introduced, 15 the CTPA conducted a survey of its members and reported that almost all had been using non-UK-sourced bovine material for some time. 16<br /><br />8.11 In the sections that follow we look first at the regulatory framework on cosmetics safety, which was markedly different from that on either food or medicinal products safety. The sponsoring Department for the industry, which was also responsible for its regulation, was DTI. As we shall see, there was some confusion at various points in the sequence of events about the respective responsibilities of DTI and DH for minimising risks to human health from the production and use of cosmetic products.<br /><br />8.12 In the final section of the chapter we review some lessons that emerge from the way BSE was handled.<br /><br /><a href="http://web.archive.org/web/20010218202403/http://www.bseinquiry.gov.uk/report/volume7/chapter8.htm#416223">http://web.archive.org/web/20010218202403/http://www.bseinquiry.gov.uk/report/volume7/chapter8.htm#416223</a><br /><br /><br />Volume 7 Medicines and Cosmetics 8. Cosmetics and toiletries Regulatory framework Enforcement DTI handling of cosmetics DH's role in cosmetics safety<br /><br />8.13 The regulation of cosmetics is based on the EU Cosmetics Directive (1976), which was implemented in the UK by regulations made under the Consumer Protection Act 1987. Under this system, cosmetic products must meet various safety requirements, but, unlike medicinal products, they do not require a licence.<br /><br />8.14 The Cosmetics Directive seeks to ensure the safety of cosmetics and their unhindered trade throughout the EU. In relation to safety, Article 2 provides:<br /><br />Cosmetic products put on the market within the Community must not be liable to cause damage to human health when applied under normal conditions of use. 1<br /><br />8.15 Dr Robin Fielder of DH told us that the Cosmetics Directive places the onus on manufacturers and suppliers to ensure that the product is safe for the use intended. 2<br /><br />8.16 Member States have a duty to 'take all necessary measures to ensure that only cosmetic products which conform to [the Directive] may be put on the market'. 3 The Annexes to the Cosmetics Directive list substances that must not be used in cosmetics and substances whose use is regulated. They also contain lists of substances ('the prescribed lists') permitted for certain uses (preservatives, colourants, sun screens) and only these substances may be used for those purposes in cosmetic products. 4 The prescribed lists may be amended following consideration by the European Commission's Cosmetic Products Working Party, which consists of representatives from the Member States and the industry. DTI led for the UK on this with DH also having a role. The final decision is taken by the Committee on the Adaptation to Technical Progress, which is chaired by the Commission and consists of representatives from Member States. Both the Working Party and the Commission have access to the opinions of the Scientific Committee on Cosmetology (SCC), an independent multidisciplinary body of scientists appointed by the Commission to assess the safety of cosmetics ingredients, as well as to advice from their own national scientific advisers. 5<br /><br />8.17 The Cosmetics Directive limits the action individual Member States can take to regulate cosmetics. 6 If a product complies with the relevant Annex, the UK Government cannot prohibit its use unless, on the basis of a 'substantiated justification', it represents a hazard to health. 7<br /><br />8.18 Regulations made, in part, under section 11 of the Consumer Protection Act 1987 give effect to the Cosmetics Directive in UK law. The Cosmetic Products (Safety) Regulations 1984 (made under a predecessor of the Act) were replaced on 1 January 1990 by the Cosmetic Products (Safety) Regulations 1989 ('the 1989 Regulations').<br /><br />8.19 The main provisions of the 1989 Regulations are as follows: 8<br /><br />1.A cosmetic product shall not be liable to cause damage to human health when it is applied under normal conditions of use (reg. 3(1)). 2.No cosmetic product may contain any substance listed in column 2 of Schedule 1, unless it is only a trace that could not reasonably have been removed during or after manufacture (reg. 4(2)). 3.A cosmetic product must not contain any substance listed in column 2 of Schedule 2 unless specified requirements in that schedule are satisfied (reg. 4(3)). 4.The Secretary of State may authorise the use in a cosmetic product of any substance not listed in either schedule 1 or 2 (reg. 5(1)). In giving authorisation the Secretary of State may impose conditions relating to the use of the substance (reg. 5(2)). 5.There are various conditions and standards for labelling and packaging (reg. 6).<br /><br />8.20 The Consumer Protection Act imposes a general safety requirement on all consumer goods. Section 10 of the Act makes it an offence to supply consumer goods that fail to comply with the general safety requirement. For this purpose, consumer goods fail to comply with the safety requirement if they are not reasonably safe having regard to all the circumstances. 'Safe' means that there is no risk (apart from one reduced to a minimum) that the goods will (whether immediately or later) cause death or personal injury to any person. 9<br /><br />8.21 The Cosmetics Directive and the 1989 Regulations left only limited scope for the application of section 10 of the Act. Since the introduction of the General Product Safety Regulations 1994 10 there has been virtually no scope for its application.<br /><br />8.22 In practice informal contact and voluntary cooperation played an important part in the regulation of the cosmetics industry.<br /><br />Enforcement<br /><br />8.23 DTI had policy responsibility for the safety of cosmetics in the UK. Day-to-day enforcement of safety regulations such as the 1989 Regulations fell to the trading standards departments of local authorities. 11<br /><br />8.24 Supplying consumer goods that failed to comply with the general safety requirement or with certain requirements of safety regulations was an offence and punishable in the courts. 12<br /><br />8.25 In addition, enforcement authorities (which for these purposes meant DTI and the trading standards departments of local authorities) had power to serve a suspension notice prohibiting the person on whom it was served from supplying goods for up to six months; power to apply to the court for a forfeiture order; 13 and power for an authorised officer of the enforcement authority to enter any premises, inspect any goods, or examine any procedure, or in appropriate circumstances to seize and detain goods. 14<br /><br />8.26 The Secretary of State also had the power to serve a notice on a person prohibiting the person from selling consumer goods if the Secretary of State considered them to be unsafe (a prohibition notice), or requiring the person to publish a warning about such goods (a notice to warn). 15 However, these powers applied only to the person on whom the notice was served or against whom the order was sought, rather than to a general category of goods, and no power existed to recall products under these provisions. 16<br /><br />8.27 DTI told us that it was unaware of any instance in which these powers had been used in respect of a BSE risk in cosmetics. 17<br /><br />DTI handling of cosmetics<br /><br />8.28 Within DTI overall responsibility for the safety of cosmetics lay with the Consumer Safety Unit (CSU). Within the CSU, the Chemical Hazards Section (CHS) had day-to-day responsibility for cosmetics. 18<br /><br />8.29 Mr David Jones, a Grade 5 official, was Head of the CSU until 1995. Mr Roscoe, a Grade 7 official, was Head of the CHS from 1983 to 1992, with specific responsibility for ensuring the safety of cosmetics sold in the UK. 19 He was succeeded by Mr John Walker. Mrs M L Payne, a Higher Executive Officer in the CSU from 1990, was responsible for developing policy on regulation covering chemicals, including ingredients used in cosmetics. 20<br /><br />8.30 The CTPA was the peak representative body for the UK cosmetics industry and the channel through which DTI distributed cautionary guidance on BSE to cosmetics manufacturers.<br /><br />DH's role in cosmetics safety<br /><br />8.31 Although DTI had overall regulatory responsibility for cosmetics, DH also played a role as DTI's adviser on toxicity. 21 The relevant Division in DH was MED TEP (Medical Toxicology Environmental Protection), 22 later evolving into the HEF M (Health Aspects of Environment and Food Medical), 23 which would give advice when necessary.<br /><br />8.32 Mr Roscoe told us that whenever the CHS was alerted to the presence of a potentially 'risky' ingredient in a particular cosmetic product it would refer the matter to DH. 24 Upon receipt of advice from DH, the CHS would then decide on a course of action. According to Mr Roscoe, DTI would always act on this advice 'unless there were very strong reasons for not doing so'. 25<br /><br />8.33 Mr Roscoe also told the Inquiry that he believed that when DH encountered a new risk it was its responsibility to pass on the information to DTI. 26<br /><br />8.34 The DH adviser on toxicology over the period of concern was Dr Fielder, who was assisted by Dr Dewhurst (1988-90), Dr Gott (1991-93) and Ms Mulholland (1993-97). 27<br /><br /><a href="http://web.archive.org/web/20010218200336/http://www.bseinquiry.gov.uk/report/volume7/chapteg2.htm">http://web.archive.org/web/20010218200336/http://www.bseinquiry.gov.uk/report/volume7/chapteg2.htm</a><br /><br /><br />COSMETICS-further reading from the inquiry on this subject;<br /><br /><br /><a href="http://web.archive.org/web/20010218201247/http://www.bseinquiry.gov.uk/report/volume7/chapteg3.htm">http://web.archive.org/web/20010218201247/http://www.bseinquiry.gov.uk/report/volume7/chapteg3.htm</a><br /><br /><br /><a href="http://web.archive.org/web/20010218201548/http://www.bseinquiry.gov.uk/report/volume7/chaptef4.htm">http://web.archive.org/web/20010218201548/http://www.bseinquiry.gov.uk/report/volume7/chaptef4.htm</a><br /><br /><br /><br /><a href="http://web.archive.org/web/20010624184106/http://www.bseinquiry.gov.uk/report/volume7/chapted5.htm">http://web.archive.org/web/20010624184106/http://www.bseinquiry.gov.uk/report/volume7/chapted5.htm</a><br /><br /><br /><a href="http://web.archive.org/web/20020328132354/http://www.bseinquiry.gov.uk/report/volume7/chapteb6.htm">http://web.archive.org/web/20020328132354/http://www.bseinquiry.gov.uk/report/volume7/chapteb6.htm</a><br /><br /><br /><br /><a href="http://web.archive.org/web/20010624172330/http://www.bseinquiry.gov.uk/report/volume7/chapteb7.htm">http://web.archive.org/web/20010624172330/http://www.bseinquiry.gov.uk/report/volume7/chapteb7.htm</a><br /><br /><br /><br /><a href="http://web.archive.org/web/20010624184940/http://www.bseinquiry.gov.uk/report/volume7/chaptea8.htm">http://web.archive.org/web/20010624184940/http://www.bseinquiry.gov.uk/report/volume7/chaptea8.htm</a><br /><br /><br /><br />Volume 7: Medicines and Cosmetics 8. Cosmetics and toiletries 1997/98<br /><br />8.145 Although outside the period covered by the Inquiry, it is of interest to note the Cosmetics Directive was subsequently amended by Commission Directive 97/1/EC on 10 January 1997 to prohibit the use in cosmetics of:<br /><br />Bovine, ovine and caprine tissues and fluids from the encephalon, the spinal cord and the eyes, and ingredients derived therefrom. 1 8.146 The Cosmetics Directive was further amended by Commission Directive 98/16/EC on 5 March 1998 to prohibit the use in cosmetics of: 2<br /><br />(a) the skull, including the brain and eyes, tonsils and spinal cord of: - bovine animals aged 12 months, - ovine and caprine animals which are aged over 12 months or have a permanent incisor tooth erupted through the gum; (b) the spleens of ovine and caprine animals and ingredients derived therefrom. However, tallow derivatives may be used provided that the following methods have been used and strictly certified by the producer: - Transesterification or Hydrolysis at at least: 200ºC, 40 bars (40,000 hPa) for 20 minutes (glycerol and fatty acids and esters); - Saponification with NaOH 12 M (glycerol and soap); - Batch process: at 95ºC for three hours, or - Continuous process: at 140ºC, two bars (2000 hPa) for eight minutes or equivalent conditions.<br /><br /><br /><a href="http://web.archive.org/web/20010218200025/http://www.bseinquiry.gov.uk/report/volume7/chapteri.htm">http://web.archive.org/web/20010218200025/http://www.bseinquiry.gov.uk/report/volume7/chapteri.htm</a><br /><br /><br /><a href="http://web.archive.org/web/20020328151016/http://www.bseinquiry.gov.uk/report/volume7/chapte10.htm">http://web.archive.org/web/20020328151016/http://www.bseinquiry.gov.uk/report/volume7/chapte10.htm</a><br /><br /><br />8.227 These matters stretch well beyond our remit. However, it appears to us, as it did to the Tyrrell Committee, that cosmetics were indeed a potential pathway for pathogens, and that not enough was known about this. Future occasions could arise when, as with BSE, there needs to be a means of turning off the tap at source, rather than catching droplets downstream. Consideration might usefully be given to what powers and processes would assist this.<br /><br /><br /><a href="http://web.archive.org/web/20030702111440/http://www.bseinquiry.gov.uk/report/volume7/chapter9.htm">http://web.archive.org/web/20030702111440/http://www.bseinquiry.gov.uk/report/volume7/chapter9.htm</a><br /><br /><br /><br /><a href="http://web.archive.org/web/20020328140201/http://www.bseinquiry.gov.uk/report/volume7/chapteh2.htm">http://web.archive.org/web/20020328140201/http://www.bseinquiry.gov.uk/report/volume7/chapteh2.htm</a><br /><br /><br /><a href="http://web.archive.org/web/20010218201146/http://www.bseinquiry.gov.uk/report/volume7/chapteh3.htm">http://web.archive.org/web/20010218201146/http://www.bseinquiry.gov.uk/report/volume7/chapteh3.htm</a><br /><br /><br /><br />9.63 Mr Bradley replied by letter dated 17 June 1990 to Dr Pickles's letter of 11 June. He stated in relation to A1d:<br /><br />I have not got far with this. Where do fetal calves, placenta and uteri go and are any uses made of lymph nodes? Cosmetics, ointments, oils, indeed anything that is used on the skin (it could have a lesion) could presen an increased hazard. I have some concern over mesenteric lymph nodes though they are not eaten, though DOH/MAFF agreed earlier there was no need to include them in the offal ban. This is one to discuss in Committee. 34<br /><br />I understand that there is concern on the Tyrrell Committee recommendation A1d on pharmaceuticals and cosmetics. This has never been considered a primary responsibility of MAFF although collaboration with the principals (DOH and industry) was anticipated.<br /><br />I suspect the VMD approach will be to avoid or selectively reduce use of bovine tissues in medicinal products for animals. Presumably the authorities responsible for human medicinal products and cosmetics have taken similar action. 35<br /><br /><br /><a href="http://web.archive.org/web/20010624174011/http://www.bseinquiry.gov.uk/report/volume7/chapteg4.htm">http://web.archive.org/web/20010624174011/http://www.bseinquiry.gov.uk/report/volume7/chapteg4.htm</a><br /><br /><br /><br />(iii) Non-food uses of bovine material. The Committee asked for a note on the use of bovine material for cosmetics in particular, although it might make sense to cover all the non-food uses that we can think of (harp strings, tennis rackets etc). I think that all that is required is a factual note about the range of uses, and quantities, together with an assessment of possible risk factors. It looks to me like a job for Dr Pickles. 1<br /><br /><br /><a href="http://web.archive.org/web/20010624170118/http://www.bseinquiry.gov.uk/report/volume7/chaptee5.htm">http://web.archive.org/web/20010624170118/http://www.bseinquiry.gov.uk/report/volume7/chaptee5.htm</a><br /><br /><br /><a href="http://web.archive.org/web/20010218184950/http://www.bseinquiry.gov.uk/report/volume7/chaptec6.htm">http://web.archive.org/web/20010218184950/http://www.bseinquiry.gov.uk/report/volume7/chaptec6.htm</a><br /><br /><br /><br /><a href="http://web.archive.org/web/20010624181038/http://www.bseinquiry.gov.uk/report/volume7/chaptec7.htm">http://web.archive.org/web/20010624181038/http://www.bseinquiry.gov.uk/report/volume7/chaptec7.htm</a><br /><br /><br /><br /><a href="http://web.archive.org/web/20010624173202/http://www.bseinquiry.gov.uk/report/volume7/chapteb8.htm">http://web.archive.org/web/20010624173202/http://www.bseinquiry.gov.uk/report/volume7/chapteb8.htm</a><br /><br /><br /><br /><a href="http://web.archive.org/web/20030506095053/http://www.bseinquiry.gov.uk/report/volume7/chaptea9.htm">http://web.archive.org/web/20030506095053/http://www.bseinquiry.gov.uk/report/volume7/chaptea9.htm</a><br /><br /><br /><br />Annex 2 to Chapter 9: Uses made of the cattle carcass<br /><br />Item Products derived Additional comments<br /><br />HEAD<br /><br />Brain Human food Laboratory reagents Veterinary medicines Pharmaceuticals Cosmetics<br /><br /><br /><br /><a href="http://web.archive.org/web/20010218201535/http://www.bseinquiry.gov.uk/report/volume7/glossary.htm">http://web.archive.org/web/20010218201535/http://www.bseinquiry.gov.uk/report/volume7/glossary.htm</a><br /><br /><br /><br /><a href="http://web.archive.org/web/20020328150145/http://www.bseinquiry.gov.uk/report/volume7/whoswho.htm">http://web.archive.org/web/20020328150145/http://www.bseinquiry.gov.uk/report/volume7/whoswho.htm</a><br /><br /><br /><br /><a href="http://web.archive.org/web/20010624175300/http://www.bseinquiry.gov.uk/report/volume7/index.htm">http://web.archive.org/web/20010624175300/http://www.bseinquiry.gov.uk/report/volume7/index.htm</a><br /><br /><br /><br /><a href="http://web.archive.org/web/20010221160942/http://www.bseinquiry.gov.uk/report/volume7/volume72.htm">http://web.archive.org/web/20010221160942/http://www.bseinquiry.gov.uk/report/volume7/volume72.htm</a><br /><br /><br /><br /><a href="http://web.archive.org/web/20010221160108/http://www.bseinquiry.gov.uk/report/volume7/volume73.htm">http://web.archive.org/web/20010221160108/http://www.bseinquiry.gov.uk/report/volume7/volume73.htm</a><br /><br /><br /><br /><a href="http://web.archive.org/web/20030907100258/www.bseinquiry.gov.uk/report/volume7/volume74.htm">http://web.archive.org/web/20030907100258/www.bseinquiry.gov.uk/report/volume7/volume74.htm</a><br /><br /><br /><br /><a href="http://web.archive.org/web/20010221160018/http://www.bseinquiry.gov.uk/report/volume7/volume75.htm">http://web.archive.org/web/20010221160018/http://www.bseinquiry.gov.uk/report/volume7/volume75.htm</a><br /><br /><br /><br />4.4 On 10.1.90 I attended the second meeting of the CSM BSE Working Party. The discussions which took place and the conclusions reached can be found in the Minutes of the meeting [YB 90/1.10/1.1-1.24]. I provided comments to Dr Singh in Med TEH on his draft letter to DTI which responded to a request for advice on the safety of the use of bovine offal (in particular, spleen and thymus) in cosmetics [YB 90/1.29/1.1-1.2]. My briefing notes were used to accompany the reply to DTI [YB 90/2.1/4.1]. I indicated I was not happy about the use of bovine offal from calves under 6 months in cosmetics (in contrast to foods) because on damaged skin such use could be close to parenteral administration so the nearest parallel might be injectable medicines. Besides there were no compensating benefits.<br /><br />57. April 1990<br /><br />57.1 The formation of SEAC was announced by Mr Gummer on 3.4.90 [YB 90/5.24/4.1-4.2]. As requested, I supplied comments on the draft Agenda prepared by Mr Lowson for SEAC's first meeting [YB 90/4.6/4.1-4.3] and I supplied a list of documents to accompany the formal papers for background information. I offered to put together a discussion paper on bovine eyeballs and the use of bovine material in cosmetics. This draft paper entitled Routes of Possible Transmission into Man was later sent to Mr Lowson for comment [YB 90/4.12/1.1-1.4]. It met with the approval of Mr Lowson but it was not submitted to SEAC at that time as CVO indicated he thought a more detailed paper was needed [YB 90/4.24/3.1-3.2 and see YB 90/4.23/1.1].<br /><br />http://www.bse.org.uk/witness/htm/stat115.htm<br /><br /><a href="http://www.telegraph.co.uk/et?ac=003789727059657&rtmo=weoeinKb&atmo=rrrrrrrq&pg=/et/96/9/7/wbse07.html">http://www.telegraph.co.uk:80/et?ac=003789727059657&rtmo=weoeinKb&atmo=rrrrrrrq&pg=/et/96/9/7/wbse07.html</a><br /><br /><br /><a href="http://www.telegraph.co.uk/et?ac=003789727059657&rtmo=weoeinKb&atmo=rrrrrrrq&pg=/et/99/11/2/nbse02.html">http://www.telegraph.co.uk:80/et?ac=003789727059657&rtmo=weoeinKb&atmo=rrrrrrrq&pg=/et/99/11/2/nbse02.html</a><br /><br /><br /><a href="http://www.telegraph.co.uk/et?ac=003789727059657&rtmo=weoeinKb&atmo=rrrrrrrq&pg=/et/00/10/29/nbse129.html">http://www.telegraph.co.uk:80/et?ac=003789727059657&rtmo=weoeinKb&atmo=rrrrrrrq&pg=/et/00/10/29/nbse129.html</a><br /><br /><br />Content-Type: text/plain<br /><br /><a href="https://lists.aegee.org/cgi-bin/wa?A2=ind0704&L=BSE-L&P=R2765&1=BSE-L&9=A&I=-3&J=on&X=57C86A263C194B4411&Y=flounder9%40verizon.net&d=No+Match%3BMatch%3BMatches&z=4">https://lists.aegee.org/cgi-bin/wa?A2=ind0704&L=BSE-L&P=R2765&1=BSE-L&9=A&I=-3&J=on&X=57C86A263C194B4411&Y=flounder9%40verizon.net&d=No+Match%3BMatch%3BMatches&z=4</a><br /><br /><br />BSE Inquiry report criticises ex-Tory ministers<br /><br />Sat, Sep 2, 2000 PA News<br /><br />Conservative former ministers and Whitehall officials face strong criticism in the official report into the BSE crisis, it was reported tonight. The inquiry chairman Lord Phillips is believed to have notified several former health and agriculture ministers that they are facing criticism in the 13-volume report he is to publish in a few weeks.<br /><br />Reports in several Sunday newspapers suggested the former ministers would be taken to task for being "too adamant" in their assurances that British beef was safe, and for failing to react swiftly enough to scientists' findings that the disease could spread to humans. Scientists first suspected that there was a risk to humans eating BSE-infected offal in the mid-80s, but it was not until March 1996 that Tory ministers admitted that there was a danger to the public.<br /><br />But the ex-ministers could come off lightly compared with senior civil servants who ran the two departments as the decade-long saga unfolded.<br /><br />Lord Phillips' two-year inquiry is said to have concluded that too much importance was attached to the interests of the livestock industry, and not enough to those of consumers. The BSE affair led to a worldwide ban on British beef exports which is estimated to have cost the taxpayer 4.6 billion.<br /><br />Comment (webmaster): It is unclear why the judge released the findings prior to publication. What purpose is served anyway with polite criticism (1, 2) of long-departed political figures and retired civil servants? Keith Meldrin, who masterminded the coverup within MAFF for 10 years, also receives a wrist-slap for a leading role in 82 human deaths. His successor at MAFF who continued these abominable policies was forced into retirement this year but given a handsome 400,000 pound retirement package. MAFF itself has spent 7 million pounds of public money on lawyers even and successfully fought the Inquiry practise of publishing fulltext of government memos on the Internet.<br /><br />However, these documents can still be obtained in print form. Terry S. Singeltary Sr. of Bacliff, Texas, has obtained many of the documents alluded to in the Inquiry but never released. These have been optically character read into electronic form and distributed to the German BSE listserve archive as well as to this web site:<br /><br />BSE offals used in cosmetics, toiletry and perfume industry<br /><br />Sun, 3 Sep 2000. Unpublished Inquiry documents obtained by CJD activist Terry S. Singeltary Sr. of Bacliff, Texas<br /><br />Miss Marion Kelly Cosmetic, Toiletry and Perfumery Association 35 Dover Street London W1X3RA<br /><br />Department of Trade and Industry 10-18 Victoria Street London SW1H ONN Enquiries 01-215 5000 Telex 8811074 DTHQ G 01 215 3324 1 February 1990<br /><br />Dear Marion<br /><br />As you know there is no record of bovine spongiform encepalopathy crossing to humans, but we need to take precautions to avoid any risk.<br /><br />There a number of cosmetric products on sale in the United Kingdom such as anti-ageing creams that contain extracts of bovine offal, primarily from spleen and thymus. [Two of the highest risk tissues. Note the epidemic has been raging for 4 years by the time of the non-binding voluntary suggestions here. -- webmaster]<br /><br />The purpose of this letter is to ask you to ask your members to eliminate any risk by reformulating such products to eliminate these extracts, or alternatively to use material derived from cattle reared outside the UK, Eire or the Channel Islands. [Eire, Channel Islands, and many other countries were thoroughly infected by then -- webmaster]<br /><br />Please let me know if you have any trouble persuading your members to do so.<br /><br />Yours sincerely<br /><br />R J ROSCOE CONSUMER SAFETY UNIT ROOM 407<br /><br />90/02.01/14.1 ==============<br /><br />BSE110/1 0080<br /><br />DEPARTMENT OF HEALTH AND SOCIAL SECURITY HANNIBAL HOUSE Room No ELEPHANT AND CASTLE LONDON SE1 6TE<br /><br />1 February 1990<br /><br />Mr R Roscoe Consumer Affairs Department of Trade and Industry 10-18 Victoria Street London SW1<br /><br />Dear Richard<br /><br />USE OF BOVINE OFFAL IN COSMETICS<br /><br />I am replying to your request for advice on the safety of the use of extracts of bovine offal in certain cosmetics, such as skin products claimed to have 'anti-ageing' properties with respect to bovine spongiform encephalopathy (BSE). As you are aware there are a number of cosmetic products on sale in the UK that contain small amounts of such extracts, primarily from spleen and thymus.<br /><br />We accept that the risk of transmission is likely to be remote, but believe that it would be prudent to eliminate any risk by reformulating such products. Alternatively if the incorporation of bovine extracts is retained, material derived from cattle reared outside the UK, Eire or the Channel Islands should be used.<br /><br />We would be grateful if you would transmit these recommendations to industry via the Trade Association CTPA.<br /><br />I attach background briefing prepared by medical colleagues from those sections most involved with consideration of BSE in DH, together with a copy of the Southwood report.<br /><br />Please let me know if you need any further information.<br /><br />Yours sincerely DR R J FIELDER Enclosure 90/2.1/7.1 ===========<br /><br />BSE110/1 0081<br /><br />BACKGROUND BRIEFING<br /><br />Presence of Bovine Offals in Cosmetics and Bovine Spongiform Encephalopathy<br /><br />(1) Extracts of bovine spleen and thymus are present at between ca 0.1 and 5% in certain cosmetic preparations, for example certain products claimed to delay the signs of ageing of skin. The concern about the increasing incidence of BSE in cattle in the UK has made it necessary to reconsider the safety of such products.<br /><br />BSE is a progressive neurological disorder in cattle, which results from infection with an "unconventional viral' agent. The first case was described in cows in 1986. By 19 January 1990 there had been 9436 confirmed cases in the UK on 5474 farms. There are no confirmed cases outside the British Isles, apart from a case in a cow recently exported from England. BSE is one of a family of spongiform encephalopathies which also include scrapie in sheep and kuru and Creutzfeldt Jakob disease (CJD) in man. The infection which leads to BBE appears to have been introduced into cattle from the contaminated feeding stuff, meat and bone meal, made partly from sheep offal: scrapie is endemic in sheep in the UK.<br /><br />The causative agents of these diseases are thought to be unconventional transmissible agents (referred to variously as prions, virinos, filamentous viruses or slow viruses). They are extremely resistant to most denaturing processes eg heat, UV, high salt concentration, formalin and alkylating agents. The current DH guideline for treating items used on CJD patients is a temperature of 134-138 C (at 2 atmospheres) held for 18 minutes. They are also not removed by normal microbiological filters. It is thus unlikely that the mild processing techniques used to obtain the extracts used in cosmetics would remove the causative agents.<br /><br />(2) Government action to date includes:<br /><br />a. An expert working party was set up under Sir Richard Southwood and reported in February 1989. All their recommendations have been acted upon.<br /><br />b. The disease has been made notifiable in cattle.<br /><br />c. All suspect animals are slaughtered and carcases destroyed (50% compensation policy but 100% if diagnosis not confirmed); milk from such animals is also destroyed.<br /><br />d. Sale or supply of animal protein from ruminants for feeding to ruminants prohibited - hopefully to prevent any new infections in cattle. This has had a major effect on the rendering industry.<br /><br />e. Another committee was set up under Dr David Tyrrell to report on research needs. An interim report was published in January 1990 together with an announcement about additional funding. Much research work into the disease is currently in progress and additional studies are being planned.<br /><br />Regulations in November 1989 introduced a ban on various bovine offal for human consumption, going wider than the Southwood recommendations which were for such a ban to affect baby food only.<br /><br />The Medicines Control Agency have gathered information from pharmaceutical companies about use of bovine ingredients in parenteral pharmaceuticals and issued interim guidelines. Many biological products and vaccines use such ingredients. The MCA are considering whether action on specific products is appropriate.<br /><br />h. The Health and Safety Executive (HSE) is reviewing its guidance to those who come into direct contact with bovine 'risk' tissues. A press release for those who handle BSE carcases has been issued and one for abattoir workers is in preparation. The HSE ara also discussing risks from BSE exposure with the veterinary profession.<br /><br />i. All UK cases of CJD will be monitored in a study to be conducted by Dr R G Will in Edinburgh, funded by the Department of Health: this should allow detection of any spread of infection to hummans, although this possibility is considered remote.<br /><br />(3) Current live issues<br /><br />Research: Dr Tyrell's interim report identified a large research programme classed as high priority. Almost all of this research falls to MAFF {Central Veterinary Labs} or the AFRC, although the MRC also has an interest. Substantial money has been made available for this work but research will be laborious and results will come slowly.<br /><br />Food: There has been constant pressure on MAFF about the supposed risk to humans from eating beef and beef products. Infected animals who are incubating the disease but do not show any abnormalities cannot be detected at present and will be entering the human food chain. The offal ban removes the highest 'risk' tissues. Some critics may not be satisfied by this. However, others may argue the action to date is over the top, not demanded by the experts, and illogical since scrapie-infected sheep can still be eaten and doing so for the last 200 years has not caused harm to humans. We expect BSE agent to be resistant to irradiation as applied to food, as well as relatively resistant to cooking.<br /><br />Other animals: There is no evidence that animals other than cattle (and domesticated, deer) have been or could be affected by BSE, other than experimentally, but there are pressures to extend the ruminant protein ban: at present pigs and poultry receive this sort of feed. Such action, as well as being hard to justify scientifically, would increase costs for the industry and cause perhaps insurmountable problems for abattoirs, who would find renderers no longer willing to accept offal. Many 1000's of tons of offal need to be disposed of daily.<br /><br />Compensation: This has been set at 50% for BSE, although for some other diseases it is higher. Some critics believe this encourages evasion, with cows affected minimally being sent for human consumption. Even the current level of compensation is proving expensive for MAFF.<br /><br />Exports: Some foreign countries have banned British exports of seman, embryos and livestock. The EC now no longer accepts live cattle over 6 months of age. The Germans are creating difficulties over beef exports too. The EC are also considering making BSE notifiable and banning ruminant protein feeding to rminants, as we have done here. At present, British meat and bone meat can still be exported and might spread infection overseas (MAFF claim importers have been warned that it is not regarded suitable for feeding to ruminants).<br /><br />Human transmission: There are some in the media and even the medical profession who are trying to make connections between BSE and the human disorder CJD. There is _no_ evidence of any association nor would we expect any cases by now even were BSE to be transmissible to humans. Dr Wills' study (see 2i above) will monitor the situation for the next decade or two.<br /><br />I have been asked to provide a draft reply to the attached letter from Sir Richard Southwood to the Minister. The Minister has indicated that we must meet Sir Richard's points (a} on the need for him to be fully briefed as to developments and (b) on the urgency of making progress with the transmission study.<br /><br />On (a), I would suggest that the draft reply should indicate that you will be in touch with Sir Richard regularly to keep him in the picture. On (b), I hope we can now tell Sir Richard that the arrangements for the purchase and relocation of the animals are under way.<br /><br />A R Cruickshank 20 June 1989 Mr A J Lawrence AH cc Mr K C Meldrum Dr W A Watson Mr R C Lowson 89/6.20/8.1<br /><br /><a href="http://www.mad-cow.org/00/sep00_news.html#aaa">http://www.mad-cow.org/00/sep00_news.html#aaa</a><br /><br /><br />update<br /><br /><a href="http://europa.eu.int/comm/food/fs/sc/ssc/out109_en.html">http://europa.eu.int/comm/food/fs/sc/ssc/out109_en.html</a><br /><br /><br /><a href="http://europa.eu.int/comm/food/fs/sc/ssc/out80_en.pdf">http://europa.eu.int/comm/food/fs/sc/ssc/out80_en.pdf</a><br /><br /><br /><br />P.S. -- one must consider 'accumulation' of agent over time. ...<br /><br /><br /><br />2009<br /><br /><br />To date the OIE/WAHO assumes that the human and animal health standards set out in the BSE chapter for classical BSE (C-Type) applies to all forms of BSE which include the H-type and L-type atypical forms. This assumption is scientifically not completely justified and accumulating evidence suggests that this may in fact not be the case. Molecular characterization and the spatial distribution pattern of histopathologic lesions and immunohistochemistry (IHC) signals are used to identify and characterize atypical BSE. Both the L-type and H-type atypical cases display significant differences in the conformation and spatial accumulation of the disease associated prion protein (PrPSc) in brains of afflicted cattle. Transmission studies in bovine transgenic and wild type mouse models support that the atypical BSE types might be unique strains because they have different incubation times and lesion profiles when compared to C-type BSE. When L-type BSE was inoculated into ovine transgenic mice and Syrian hamster the resulting molecular fingerprint had changed, either in the first or a subsequent passage, from L-type into C-type BSE. In addition, non-human primates are specifically susceptible for atypical BSE as demonstrated by an approximately 50% shortened incubation time for L-type BSE as compared to C-type. Considering the current scientific information available, it cannot be assumed that these different BSE types pose the same human health risks as C-type BSE or that these risks are mitigated by the same protective measures.<br /><br /><a href="http://www.prionetcanada.ca/detail.aspx?menu=5&dt=293380&app=93&cat1=387&tp=20&lk=no&cat2">http://www.prionetcanada.ca/detail.aspx?menu=5&dt=293380&app=93&cat1=387&tp=20&lk=no&cat2</a><br /><br /><br /><br />I ask Professor Kong ;<br /><br />Thursday, December 04, 2008 3:37 PM Subject: RE: re--Chronic Wating Disease (CWD) and Bovine Spongiform Encephalopathies (BSE): Public Health Risk Assessment<br /><br />''IS the h-BSE more virulent than typical BSE as well, or the same as cBSE, or less virulent than cBSE? just curious.....''<br /><br />Professor Kong reply ;<br /><br />.....snip<br /><br />''As to the H-BSE, we do not have sufficient data to say one way or another, but we have found that H-BSE can infect humans. I hope we could publish these data once the study is complete.<br /><br />Thanks for your interest.''<br /><br />Best regards,<br /><br />Qingzhong Kong, PhD Associate Professor Department of Pathology Case Western Reserve University Cleveland, OH 44106 USA<br /><br />END...TSS<br /><br />P02.35<br /><br />Molecular Features of the Protease-resistant Prion Protein (PrPres) in H-type BSE<br /><br />Biacabe, A-G1; Jacobs, JG2; Gavier-Widén, D3; Vulin, J1; Langeveld, JPM2; Baron, TGM1 1AFSSA, France; 2CIDC-Lelystad, Netherlands; 3SVA, Sweden<br /><br />Western blot analyses of PrPres accumulating in the brain of BSE-infected cattle have demonstrated 3 different molecular phenotypes regarding to the apparent molecular masses and glycoform ratios of PrPres bands. We initially described isolates (H-type BSE) essentially characterized by higher PrPres molecular mass and decreased levels of the diglycosylated PrPres band, in contrast to the classical type of BSE. This type is also distinct from another BSE phenotype named L-type BSE, or also BASE (for Bovine Amyloid Spongiform Encephalopathy), mainly characterized by a low representation of the diglycosylated PrPres band as well as a lower PrPres molecular mass. Retrospective molecular studies in France of all available BSE cases older than 8 years old and of part of the other cases identified since the beginning of the exhaustive surveillance of the disease in 20001 allowed to identify 7 H-type BSE cases, among 594 BSE cases that could be classified as classical, L- or H-type BSE. By Western blot analysis of H-type PrPres, we described a remarkable specific feature with antibodies raised against the C-terminal region of PrP that demonstrated the existence of a more C-terminal cleaved form of PrPres (named PrPres#2 ), in addition to the usual PrPres form (PrPres #1). In the unglycosylated form, PrPres #2 migrates at about 14 kDa, compared to 20 kDa for PrPres #1. The proportion of the PrPres#2 in cattle seems to by higher compared to the PrPres#1. Furthermore another PK–resistant fragment at about 7 kDa was detected by some more N-terminal antibodies and presumed to be the result of cleavages of both N- and C-terminal parts of PrP. These singular features were maintained after transmission of the disease to C57Bl/6 mice. The identification of these two additional PrPres fragments (PrPres #2 and 7kDa band) reminds features reported respectively in sporadic Creutzfeldt-Jakob disease and in Gerstmann-Sträussler-Scheinker (GSS) syndrome in humans.<br /><br /><a href="http://www.neuroprion.com/pdf_docs/conferences/prion2007/abstract_book.pdf">http://www.neuroprion.com/pdf_docs/conferences/prion2007/abstract_book.pdf</a><br /><br /><br /><br />Monday, October 19, 2009<br /><br />Atypical BSE, BSE, and other human and animal TSE in North America Update October 19, 2009<br /><br /><a href="http://bse-atypical.blogspot.com/2009/10/atypical-bse-bse-and-other-human-and.html">http://bse-atypical.blogspot.com/2009/10/atypical-bse-bse-and-other-human-and.html</a><br /><br /><br /><br />14th International Congress on Infectious Diseases H-type and L-type Atypical BSE January 2010 (special pre-congress edition)<br /><br />18.173 page 189<br /><br />Experimental Challenge of Cattle with H-type and L-type Atypical BSE<br /><br />A. Buschmann1, U. Ziegler1, M. Keller1, R. Rogers2, B. Hills3, M.H. Groschup1. 1Friedrich-Loeffler-Institut, Greifswald-Insel Riems, Germany, 2Health Canada, Bureau of Microbial Hazards, Health Products & Food Branch, Ottawa, Canada, 3Health Canada, Transmissible Spongiform Encephalopathy Secretariat, Ottawa, Canada<br /><br />Background: After the detection of two novel BSE forms designated H-type and L-type atypical BSE the question of the pathogenesis and the agent distribution of these two types in cattle was fully open. From initial studies of the brain pathology, it was already known that the anatomical distribution of L-type BSE differs from that of the classical type where the obex region in the brainstem always displays the highest PrPSc concentrations. In contrast in L-type BSE cases, the thalamus and frontal cortex regions showed the highest levels of the pathological prion protein, while the obex region was only weakly involved.<br /><br />Methods:We performed intracranial inoculations of cattle (five and six per group) using 10%brainstemhomogenates of the two German H- and L-type atypical BSE isolates. The animals were inoculated under narcosis and then kept in a free-ranging stable under appropriate biosafety conditions.At least one animal per group was killed and sectioned in the preclinical stage and the remaining animals were kept until they developed clinical symptoms. The animals were examined for behavioural changes every four weeks throughout the experiment following a protocol that had been established during earlier BSE pathogenesis studies with classical BSE.<br /><br />Results and Discussion: All animals of both groups developed clinical symptoms and had to be euthanized within 16 months. The clinical picture differed from that of classical BSE, as the earliest signs of illness were loss of body weight and depression. However, the animals later developed hind limb ataxia and hyperesthesia predominantly and the head. Analysis of brain samples from these animals confirmed the BSE infection and the atypical Western blot profile was maintained in all animals. Samples from these animals are now being examined in order to be able to describe the pathogenesis and agent distribution for these novel BSE types. Conclusions: A pilot study using a commercially avaialble BSE rapid test ELISA revealed an essential restriction of PrPSc to the central nervous system for both atypical BSE forms. A much more detailed analysis for PrPSc and infectivity is still ongoing.<br /><br /><a href="http://www.isid.org/14th_icid/">http://www.isid.org/14th_icid/</a><br /><br /><br /><a href="http://ww2.isid.org/Downloads/IMED2009_AbstrAuth.pdf">http://ww2.isid.org/Downloads/IMED2009_AbstrAuth.pdf</a><br /><br /><br /><a href="http://www.isid.org/publications/ICID_Archive.shtml">http://www.isid.org/publications/ICID_Archive.shtml</a><br /><br /><br /><br />14th ICID International Scientific Exchange Brochure -<br /><br />Final Abstract Number: ISE.114<br /><br />Session: International Scientific Exchange<br /><br />Transmissible Spongiform encephalopathy (TSE) animal and human TSE in North America<br /><br />update October 2009<br /><br />T. Singeltary<br /><br />Bacliff, TX, USA<br /><br />Background:<br /><br />An update on atypical BSE and other TSE in North America. Please remember, the typical U.K. c-BSE, the atypical l-BSE (BASE), and h-BSE have all been documented in North America, along with the typical scrapie's, and atypical Nor-98 Scrapie, and to date, 2 different strains of CWD, and also TME. All these TSE in different species have been rendered and fed to food producing animals for humans and animals in North America (TSE in cats and dogs ?), and that the trading of these TSEs via animals and products via the USA and Canada has been immense over the years, decades.<br /><br />Methods:<br /><br />12 years independent research of available data<br /><br />Results:<br /><br />I propose that the current diagnostic criteria for human TSEs only enhances and helps the spreading of human TSE from the continued belief of the UKBSEnvCJD only theory in 2009. With all the science to date refuting it, to continue to validate this old myth, will only spread this TSE agent through a multitude of potential routes and sources i.e. consumption, medical i.e., surgical, blood, dental, endoscopy, optical, nutritional supplements, cosmetics etc.<br /><br />Conclusion:<br /><br />I would like to submit a review of past CJD surveillance in the USA, and the urgent need to make all human TSE in the USA a reportable disease, in every state, of every age group, and to make this mandatory immediately without further delay. The ramifications of not doing so will only allow this agent to spread further in the medical, dental, surgical arena's. Restricting the reporting of CJD and or any human TSE is NOT scientific. Iatrogenic CJD knows NO age group, TSE knows no boundaries. I propose as with Aguzzi, Asante, Collinge, Caughey, Deslys, Dormont, Gibbs, Gajdusek, Ironside, Manuelidis, Marsh, et al and many more, that the world of TSE Transmissible Spongiform Encephalopathy is far from an exact science, but there is enough proven science to date that this myth should be put to rest once and for all, and that we move forward with a new classification for human and animal TSE that would properly identify the infected species, the source species, and then the route.<br /><br /><br /><a href="http://ww2.isid.org/Downloads/14th_ICID_ISE_Abstracts.pdf">http://ww2.isid.org/Downloads/14th_ICID_ISE_Abstracts.pdf</a><br /><br /><br /><br />Wednesday, March 31, 2010<br /><br />Atypical BSE in Cattle<br /><br /><a href="http://bse-atypical.blogspot.com/2010/03/atypical-bse-in-cattle-position-post.html">http://bse-atypical.blogspot.com/2010/03/atypical-bse-in-cattle-position-post.html</a><br /><br /><br /><br />Tuesday, March 16, 2010<br /><br />COMMONWEALTH OF AUSTRALIA Hansard Import restrictions on beef FRIDAY, 5 FEBRUARY 2010 AUSTRALIA<br /><br />COMMONWEALTH OF AUSTRALIA<br /><br />Proof Committee Hansard<br /><br />RRA&T 2 Senate Friday, 5 February 2010<br /><br />RURAL AND REGIONAL AFFAIRS AND TRANSPORT<br /><br />[9.03 am]<br /><br />BELLINGER, Mr Brad, Chairman, Australian Beef Association<br /><br />CARTER, Mr John Edward, Director, Australian Beef Association<br /><br />CHAIR—Welcome. Would you like to make an opening statement?<br /><br />Mr Bellinger—Thank you. The ABA stands by its submission, which we made on 14 December last year, that the decision made by the government to allow the importation of beef from BSE affected countries is politically based, not science based. During this hearing we will bring forward compelling new evidence to back up this statement. When I returned to my property after the December hearing I received a note from an American citizen. I will read a small excerpt from the mail he sent me in order to reinforce the dangers of allowing the importation of beef from BSE affected countries. I have done a number of press releases on this topic, and this fellow has obviously picked my details up from the internet. His name is Terry Singeltary and he is from Bacliff, Texas. He states, and rightfully so:<br /><br />You should be worried. Please let me explain. I’ve kept up with the mad cow saga for 12 years today, on December 14th 1997, some four months post voluntary and partial mad cow feed ban in the USA, I lost my mother to the Heinemann variant Creutzfeldt-Jakob disease (CJD). I know this is just another phenotype of the infamous sporadic CJDs. Here in the USA, when USA sheep scrapie was transmitted to USA bovine, the agent was not UK BSE—it was a different strain. So why then would human TSE from USA cattle look like UK CJD from UK BSE? It would not. So this accentuates that the science is inconclusive still on this devastating disease. He goes on to state:<br /><br />The OIE— the International Organisation of Epizootics, the arm of the WTO— is a failed global agent that in my opinion is bought off via bogus regulations for global trade and industry reps. I have done this all these years for nothing but the truth. I am a consumer, I eat meat, but I do not have to sit idly by and see the ignorance and greed of it all while countless numbers of humans and animals are being exposed to the TSE agents. All the USA is interested in is trade, nothing else matters.<br /><br />Even Dr Stanley Prusiner, who incidentally won the Nobel Health Prize in 1997 for his work on the prion—he invented the word ‘prion’, or it came from him—states:<br /><br />The BSC policy was set up for one purpose only, trade—the illegal trading of all strains of TSE globally throughout North America, which is home to CBSC, IBSC and HBSC, many scrapie strains and two strains of CJD to date. (please note typo error, those should have read cBSE, lBSE, and hBSE...tss)<br /><br />I would also like, while I have the opportunity, to explain the beef-off-the-shelves myth. At the first Senate hearing on 14 December, it was explained that the reason why they allowed BSC beef into Australia was the beef-off-the-shelves policy, whereby if we found a case of BSC in Australia they would have to recall all—<br /><br />Friday, 5 February 2010 Senate RRA&T 3<br /><br />RURAL AND REGIONAL AFFAIRS AND TRANSPORT<br /><br />Senator HEFFERNAN—Which of course is total BS.<br /><br />Mr Bellinger—Correct. This is written in the FSANZ document—Food Standards Australia New Zealand. Why isn’t this same policy in New Zealand? It is not—it is only in Australia. We are the only country in the world to have this idiotic policy. So we again call for the tabling of the WTO obligations paperwork. We do not believe that exists.<br /><br />snip...see full text 110 pages ;<br /><br /><a href="http://www.aph.gov.au/hansard/senate/commttee/S12742.pdf">http://www.aph.gov.au/hansard/senate/commttee/S12742.pdf</a><br /><br /><br /><br />for those interested, please see much more here ;<br /><br />http://docket-aphis-2006-0041.blogspot.com/2010/03/commonwealth-of-australia-hansard.html<br /><br /><a href="http://transmissiblespongiformencephalopathy.blogspot.com/">http://transmissiblespongiformencephalopathy.blogspot.com/</a><br /><br /><br /><br />Thursday, July 08, 2010<br /><br />Nosocomial transmission of sporadic Creutzfeldt-Jakob disease: results from a risk-based assessment of surgical interventions Public release date: 8-Jul-2010<br /><br /><a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/07/nosocomial-transmission-of-sporadic.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/07/nosocomial-transmission-of-sporadic.html</a><br /><br /><br /><br />Thursday, July 08, 2010<br /><br />GLOBAL CLUSTERS OF CREUTZFELDT JAKOB DISEASE - A REVIEW 2010<br /><br /><a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/07/global-clusters-of-creutzfeldt-jakob.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/07/global-clusters-of-creutzfeldt-jakob.html</a><br /><br /><br /><br />TSSTerry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-4687453285836897153.post-19941077742952799892008-05-19T11:03:00.000-05:002022-08-19T14:59:25.398-05:00SPORADIC CJD IN FARMERS, FARMERS WIVES, FROM FARMS WITH BSE HERD AND ABATTOIRS<h2 class="date-header" style="background-color: #fff3db; color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 11.7px; font-weight: normal; letter-spacing: 0.1em; margin: 0px; padding: 0px; text-transform: uppercase;">MONDAY, MAY 19, 2008</h2><div class="date-posts" style="background-color: #fff3db;"><div class="post-outer"><div class="post hentry uncustomized-post-template" itemprop="blogPost" itemscope="itemscope" itemtype="http://schema.org/BlogPosting" style="margin: 8px 0px 24px;"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><a name="1994107774295279989" style="color: #0096ef; cursor: pointer;"></a></span></span><h3 class="post-title entry-title" itemprop="name" style="color: #1b0431; font-family: Georgia, "Times New Roman", sans-serif; font-size: 18.2px; font-weight: normal; margin: 0px; padding: 0px;">SPORADIC CJD IN FARMERS, FARMERS WIVES, FROM FARMS WITH BSE HERD AND ABATTOIRS</h3><div style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-header" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><div class="post-header-line-1"></div></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">SPORADIC CJD IN FARMERS, FARMERS WIVES, FROM FARMS WITH BSE HERD AND ABATTOIRS<br /><br />‘The first farmer’ – August 1992<br /><br />5.7 At the beginning of August 1992, Dr Will confidentially informed Dr Ailsa Wight (DH, senior medical officer with responsibility for TSEs), that a probable case of CJD had occurred in a 60-year-old farmer whose farm, in the Manchester area, had a history of BSE. Dr Wight passed on this information to Sir Kenneth Calman (CMO) on 13 August 1992, stating that the CJD patient was alive and had been visited by the CJDSU.188 Although unconfirmed, the diagnosis was considered likely to be CJD on clinical grounds. Dr Wight advised that: There is no direct evidence that the two events (BSE and CJD) are linked and Dr Will feels they are probably a coincidence. Despite the rarity of CJD, it was perhaps only a matter of time before this situation arose, given the large numbers of people employed in the agricultural and related industries, and the fact that BSE cases now total over 65,000.189<br /><br />5.8 This ‘first case’ of CJD in a cattle farmer was discussed by SEAC190 at their 13th meeting on 15 October 1992.191 Dr Will informed the meeting that one of the farmer’s cows had confirmed BSE in 1989 and that the farmer had developed CJD two years later.192<br /><br />5.9 Dr Will informed SEAC that he intended to publish a report of his study of this case in a scientific journal ‘which would probably draw the conclusion that there was no evidence that this was not a chance occurrence of normal disease’. Dr Will also reported that his studies at the CJDSU had failed to reveal a correlation between occupational backgrounds and CJD to date.193<br /><br />5.10 On 22 October 1992, a minute from Mr Thomas Murray (SEAC DH Secretariat) informed the Secretary of State about the SEAC meeting and the fact that the farmer had now died.194 He noted that the diagnosis of CJD had been confirmed by pathology and that the CJDSU had also ruled out iatrogenic or familial CJD, as well as exposure to cattle brain. He commented that the SEAC meeting had come ‘to the view that all indications suggested that it was a typical sporadic case of CJD. However in view of the history it is hoped to carry out further laboratory studies to try to confirm this.’ 185<br /><br />YB89/10.26/3.1 186 YB89/10.26/3.2 187 YB89/11.20/11.1 188 YB92/8.13/2.1–2.2 189 YB92/8.13/2.1–2.2 190<br /><br />SEAC – Spongiform Encephalopathy Advisory Committee. This Committee was set up after advice from the Tyrrell Committee. Dr Will was a member of SEAC from its outset 191<br /><br />YB92/10.15/2.1–2.8 192 YB92/10.15/2.4 193 YB92/10.15/2.4 194 YB/92/10.22/1.1–1.2<br /><br />EMERGENCE OF VARIANT CJD 35 5.11<br /><br />Dr Will published his report of the case, ‘Creutzfeldt-Jakob Disease in an Individual Occupationally Exposed to BSE’, as a letter in The Lancet on 6 March 1993.195 The letter concluded that ‘CJD in our case is most likely to have been a chance finding and a causal link with BSE is at most conjectural’. The letter noted that the only possible direct route of cross-contamination was that the farmer had drunk pooled milk from his herd which included that from the affected cow, but that epidemiological evidence had largely precluded milk as a route of transmission in spongiform encephalopathies.<br /><br />5.12 This letter created much media interest over the following few days, and its contents were reported in The Times,196 Today,197 Daily Express,198 Daily Mail,199 and Daily Telegraph which also reported Mr Kevin Taylor (Assistant Chief Veterinary Officer, MAFF) stating ‘I don’t think that a link between this case and BSE is even conjectural’ and rejecting fears that the farmer might have contracted the illness from milk.200<br /><br />5.13 On 10 March 1993, Mr Jimmy Young of BBC Radio 2, interviewed microbiologist Professor Richard Lacey, who commented that: The good news is that this farmer, I think, got it too soon. If BSE produces this disease in people it will take, perhaps, another 5 or 10 years. So I think this is a one-off coincidence and I don’t think this farmer got his disease, CJD, from BSE. But nevertheless the underlying worries remain and I think it’s reasonable that this issue should be discussed. 201<br /><br />5.14 The Second Annual Report of the CJDSU, published in July 1993, concluded that: 202 This is most likely to have been a chance occurrence rather than indicating any causal link with BSE.<br /><br />5.15 It further noted that: A farmer’s wife who was diagnosed in 1992 had worked on a small holding for over 20 years but there had not been a case of BSE in the herd (Wilesmith, Personal Communication).203<br /><br />snip...<br /><br />‘The second farmer’ – July 1993<br /><br />5.16 In early July 1993, Dr Will informed DH of a ‘second’ case of CJD in a farmer with BSE in his herd. The diagnosis had been confirmed by brain biopsy.204<br /><br />5.17 Dr Wight described the case in a minute sent on 12 July 1993 to the private secretaries to Baroness Cumberlege and Sir Kenneth Calman. The minute was copied to others in DH and to Mr Howard of MAFF. The 64-year-old dairy farmer from the West Country was thought to have had at least two BSE cases in his herd, which were diagnosed in 1992. He was also thought to have assisted in calving and to have drunk the milk from his herd. His clinical symptoms had begun in May 1993. She commented that the history did not suggest anything other than a sporadic case of CJD but that DH was taking expert advice on the case.205<br /><br />5.18 On 19 July 1993, Mr Kevin Taylor (MAFF) minuted the private secretary to Mrs Gillian Shephard, the MAFF Minister, in a response to a request for more detailed briefing.206 He noted that neither Dr Will nor the CJDSU intended to publicise the case at that time unless it attracted media attention, as they intended to include the information in their Third Annual Report due in approximately one year, ie, July 1994.<br /><br />5.19 The minute attached a briefing note for the Minister. This specifically mentioned the consideration of occupational exposure to BSE as discussed in the CJDSU’s Second Annual Report which concluded that: . . . current information does not suggest that occupation is linked to an increased risk of developing CJD and it includes occupations which might involve an increased exposure to the agent of BSE.207<br /><br />5.20 On 20 July 1993, SEAC held a meeting to consider this ‘second case’.208 They decided that a connection between occupation and CJD was unlikely and no conclusions could be drawn from the available statistical information. A paper by Professor Smith was presented which concluded that ‘the observation of two cases in workers in dairy farms with BSE-infected herds is disquieting, but the evidence is insufficient at this stage to draw any definite conclusions’.209<br /><br />5.21 On 12 August 1993, the Daily Mail and Today publicised the story of the ‘second case’ of CJD in a dairy farmer.210 Both named the farmer and reported a DH spokesman saying that the Government’s experts had considered the case and ‘agreed that there are no features that give cause for undue concern’. The spokesman had also commented that it was most unlikely that there was any direct link between BSE and CJD in the patient.<br /><br />5.22 In September 1993, the case study of this ‘second farmer’ was published in The Lancet. This letter gave the farmer’s age as 54.211 204<br /><br />YB93/7.12/1.1 205 YB93/7.12/1.1 206 YB93/7.19/1.1 207 IBD2 tab 6 p. 6 208 YB93/7.20/1.1 209 YB93/7.20/1.5 210 YB93/8.12/1.3–1.4 211 Davies, P.T., Jahfar, S., Ferguson, I.T. and Windl, O. (1993) Creutzfeldt-Jakob Disease in an Individual Occupationally Exposed to BSE, The Lancet, 342, 680<br /><br />snip...<br /><br />Her note had a separate heading for ‘Comparison with young onset cases in world literature’. Here she noted that Creutzfeldt’s first patient was 23 years old (reported in 1920), and that there were other cases of CJD in young people which predated the emergence of BSE. These were a 20-year-old female and a 16-year-old female in the US and a 19-year-old female in France.219<br /><br />snip...<br /><br />‘The third farmer’ – December 1994<br /><br />5.33 A ‘third case’ associated with farming where cattle in the herd had contracted BSE concerned a farm worker from Cornwall who had died in early December 1994, aged 54. There had been two confirmed cases of BSE on the farm, in August 1991 and October 1992. Additionally, a cow sold off the farm in December 1987 had been diagnosed with BSE in September 1988.224<br /><br />5.34 On 1 December 1994, the case was reported in the local newspaper, The Cornishman, while the patient was still in hospital.225<br /><br />5.35 On 19 December 1994, Mr Charles Lister, DH, minuted the private secretary to Baroness Cumberlege with information about this possible ‘third case in farmers/ farm workers who have had BSE cases in their herds’.226 This minute enclosed the article from The Cornishman and was copied to DH officials and to Mr Eddy at 219<br /><br />YB94/1.14/1.2 220 YB94/1.26/3.1 221 YB94/1.26/2.3; YB94/1.14/1.2 222 YB94/1.26/2.2 223<br /><br />The report formed Annex 2 to the CJDSU’s Third Annual Report (IBD2 tab 8) 224<br /><br />YB94/12.19/3.1 225 YB94/12.19/3.4 226 YB94/12.19/5.1<br /><br />EMERGENCE OF VARIANT CJD 39 MAFF. He noted that diagnosis would not be confirmed until post mortem, but the Surveillance Unit thought it highly likely to be CJD.<br /><br />5.36 On the same day, Mr Thomas Eddy, MAFF secretary to SEAC, passed the newspaper article and basic information about the case on to MAFF Ministers and officials.227<br /><br />5.37 On 13 January 1995, SEAC held a special meeting to discuss the significance of this third case of CJD in a farmer in the first four years of surveillance.228 Dr Sheila Gore, an epidemiologist from the MRC Biostatistic Unit, was invited as an independent expert.<br /><br />5.38 Detailed consideration was given to the case itself and the epidemiological implications. Dr Will commented that the post-mortem results were not yet available, but it was highly likely that the diagnosis of CJD would be confirmed. He stated that the man had no significant medical history and that he had worked as a farm labourer on the same dairy farm since 1955: The man was known to have assisted with calving but never with any operative procedure; he rarely drank unpasteurised milk and never from BSE-affected animals. It was not known if he had ever eaten cattle feed.229<br /><br />5.39 As to the epidemiological significance of the case, the members recalled the advice given by Professor Smith after SEAC had considered the second case of CJD in a farmer: Professor Smith had advised that if four cases arose in the first 5 years of the surveillance scheme the possibility of an association which was not due to chance had to be given very serious consideration.230<br /><br />5.40 Dr Gore commented that: If the adult incidence of sporadic CJD in the UK was taken as one case per million (the figure used by Professor Smith) and if the same incidence applied to workers on dairy farms with BSE-affected herds, then the probability of observing three or more definite CJD cases in such workers in England and Wales in 5 years was low: 4 in 1,000. The probability was higher if the calculation was made using the total number of dairy farm workers in England and Wales. However, this was considered to be less relevant as the only reported cases of CJD in dairy farm workers since 1990 had been in lifetime dairy workers all with BSE-affected herds.<br /><br />snip...<br /><br />5.63 On 29 September 1995, various newspapers reported the third case of CJD in a dairy farmer.255 Reference was made to a letter published in The Lancet (dated 30 September 1995) by Dr (now Professor) Smith (LSHTM).<br /><br />5.64 The letter reported: The occurrence of CJD in another dairy farmer with a potential occupational exposure to BSE is clearly a matter of concern. Statistical analysis indicates that the probability of discovering three or more dairy farmers with CJD by chance since 1990 in England and Wales ranges from 0.09 to 0.0002, depending on the occupational denominator (individuals who work on farms to full-time workers on BSE-affected dairy farms).256<br /><br />5.65 Statistics for CJD in European farmers were also reported in the 30 September 1995 edition of The Lancet.257 The paper concluded that ‘there is no differential increase in the risk of CJD to farmers in the UK through potential occupational contact with cases of BSE’. On the continent there was also a slightly higher proportion of cases of CJD arising in farmers.258 This indicated that in the UK, CJD in farmers had probably not arisen from transmission of BSE.259<br /><br />The fourth farmer – September 1995<br /><br />5.66 On 28 September 1995, Dr Wright minuted the private secretary to the CMO about a probable fourth case of CJD in a farmer. The 59-year-old beef farmer lived in North Wales and was alive when the case was reported to the CMO. The farm, which had a 70-strong suckler herd, had a confirmed case of BSE about four years previously in a 4½ to 5-year-old cow.260<br /><br />5.67 The minute recorded the urgency of dealing with the issue as the case was in the public domain and BBC Wales were making a programme referring to the case.261 An urgent meeting of SEAC was called for the following week.<br /><br />5.68 On 4 October 1995, SEAC held a special meeting to discuss this further suspected case of CJD in a cattle farmer.262 Professor Smith (LSHTM) and Dr Cousens (LSHTM) were in attendance to provide the Committee with expert epidemiological advice.263 5.69 Dr Will advised that although the Unit had initially clarified the case as probable CJD, he felt that it was more appropriate to look at it as a suspect case. Consideration was given by SEAC to European data that showed 12 cases of BSE in France, along with a progressive neurological disease in a farmer associated with 255<br /><br />YB95/9.29/12.1; YB95/9.29/10.1; YB95/9.29/14.1 256<br /><br />Smith, P.E., Zeidler, M., Ironside, J.W., Estibeiro, P. and Moss, T.H. (1995) Creutzfeldt-Jakob Disease in a Dairy Farmer, The Lancet, 346, 898 257 Delasnerie-Laupretre, N., Poser, S., Pocchiari, M., Wientjens, D.P. and Will, R. (1995) Creutzfeldt-Jakob Disease in Europe, The Lancet, 346, 898 258 T71 p. 115 259 T24 p. 95 260 YB95/9.28/3.1 261 YB95/9.28/3.1 262 YB95/10.4/1.1–1.8 263 YB95/10.04/1.1<br /><br />EMERGENCE OF VARIANT CJD 45 one of those cases. (In the eventuality, this farmer was not diagnosed with CJD. At the beginning of January 2000, there had been no reported cases of CJD in farmers in France where BSE had been found in that farmer’s herd.)<br /><br />5.70 Mr Wilesmith gave SEAC information about the farm associated with the possible UK fourth case of CJD under discussion. The farm had not been visited by MAFF. It had one case of BSE in a purchased animal which died in September 1991. From available information, the animals had not been fed on concentrates (although this had not been double-checked). It was thought, however, that the farm did have a big poultry battery unit, which may have meant that ruminant-derived feed was available on the farm.<br /><br />5.71 Dr Cousens made a presentation of the epidemiology.264 He had calculated age specific mortality rates for sporadic CJD from 1990 to 1994 and applied these to data on farmers to calculate the expected number of sporadic CJD cases in farmers. The following conclusions were reached: i. there had been an alarming number of cases in farmers who had had contact with cattle with BSE. However, other occupational groups, expected to carry greater risk (eg, abattoir workers, veterinary surgeons), did not appear to be affected; ii. it was now difficult to explain the cases as a chance phenomenon. Yet the absolute risk still remained extremely low; iii. it was unclear whether the possible risk factor might be associated with cattle with BSE or the food given to them; and iv. as there was a problem with establishing a causal link, transmission studies would be extremely important.<br /><br />5.72 At this meeting, Dr Wight invited members of SEAC to make a fairly clear statement on how they viewed the significance of a fourth case and to consider whether they were satisfied that nothing else needed to be done in terms of practical measures.265 In evidence to the Inquiry, Dr Wight said that trying to get a clear statement as to what would be a significant number of cases in farmers was bound to be difficult. She said, ‘I do not think that SEAC any more than anybody else had any idea how to make sense of this at this stage.’266 At the meeting, Dr Tyrrell’s response was that although numbers were higher than expected, they were still extremely small. It would be irrational to take specific measures at the moment. Members of SEAC agreed to draw up a statement which the Department of Health could issue in response to media inquiries.267 The text of the statement included the following:268 The Committee concluded that it was difficult to explain this simply as a chance phenomenon. There is a statistical excess in cattle farmers compared with the general population but the absolute risk, even for farmers, is extremely low at about 2 cases per million per year. There may be other explanations for such an association besides infection with BSE, and the Committee noted that there are no recorded cases in other occupational 264<br /><br />YB95/10.4/1.2–1.4 265 YB95/10.4/4.5 266 T71 pp. 135–6 267 YB95/10.4/4.5 268 YB95/10.4/4.9<br /><br /><br />VARIANT CJD<br /><br />46 groups such as veterinarians who might be expected to be similarly exposed. They also noted that the surveillance of CJD elsewhere in Europe has shown a similar incidence of CJD in farmers, including dairy farmers, in countries with no or very few cases of BSE. They therefore felt that it was important to undertake further epidemiological studies to detect any particular risk factors which might be involved, and reiterated their advice that the UK cases of CJD in cattle farmers and the strain of agent recovered from them should be studied in detail. The Committee have asked for further work to be done, but have not altered their advice to Government on the precautions necessary to protect either the public health, including farmers, and animal health.<br /><br />5.73 Mr Eddy minuted the MAFF Minister and Parliamentary Secretaries advising them of the outcome of the SEAC meeting.269 He commented that SEAC had concluded that it would be worrying if the fourth case of CJD in a farmer from a BSE farm was confirmed. The chances of four CJD cases occurring randomly in farmers with BSE in their herds was . . . [since 1990] around 3/10,000. The Committee therefore concluded that it was difficult to explain the incidence as a chance phenomenon. This is a change to the Committee’s position; it had said that the most likely explanation of the three previous cases of CJD in dairy farm workers was that they were chance phenomena.270<br /><br />5.74 Mr Eddy also stated that the SEAC did not recommend changes to any of the measures currently in place to protect human and animal health, including those of farmers and others handling cattle and BSE suspects.<br /><br />5.75 On the same day, Mr Eddy prepared a second minute which was sent to Dr Matthews and Mr Keith Meldrum (CVO) amongst others about discussions during the SEAC meeting.271 Mr Eddy included a list of four ways in which the farmers might have been exposed to BSE that might have then led to their infection with CJD: i. cattle were excreting the agent in some form – no evidence for this; ii. meat and bone meal (MBM) in cattle feed – if so this would affect pig and poultry farmers equally (these feeds also contained MBM); iii. normal food – unclear why this discriminated in favour of farmers, although farmers could have been exposed to foods that other people might not have been routinely exposed to, such as unpasteurised milk; and iv. contact with animals – possibly animals killed on the farm.<br /><br />snip..<br /><br />5.93 Dr Will updated SEAC on CJD surveillance results at their 23rd meeting on 5 January 1996.292 He ‘reaffirmed that the incidence of CJD in dairy farmers in Europe showed an excess over the incidence for the population as a whole’. He confirmed that a 52-year-old abattoir worker from York was suspected of having CJD. The patient had worked mainly as a stockman in a mixed abattoir for 18 months in the late 1980s, and had occasionally pithed animals but had much less exposure than other abattoir workers. Dr Will believed that the patient was no more than a suspect at that stage.<br /><br />5.94 The minutes of the meeting record that Professor Smith commented on this case: He [Professor Smith] felt that it was not possible to come to any conclusions on the basis of this case alone even if CJD is confirmed. Nevertheless, taking into consideration the affected farmers as well, and even though the abattoir worker was in an apparently relatively low risk category, the ‘box’ of ‘at 289 S61D Will para. 4 290 T138 p. 34 291 S61D Will para. 18 292<br /><br />YB96/1.5/1.6–1.8; S61D Will paras 19–22<br /><br />EMERGENCE OF VARIANT CJD 51 risk’ occupations was getting full compared to expectation on pure chance and could not be dismissed.293<br /><br />snip...<br /><br />Update on cases of CJD in farmers<br /><br />5.152 During the period 1986–96, much attention and publicity was focussed on four cases of CJD in farmers (see above). Although those four cases were regarded as likely to be more than might be expected for the known population frequency of the disease, analysis of CJD in Europe showed the incidence of disease in farmers was similar to that in the UK.373 In addition, the clinical and pathological features of these cases were no different to those found in classical sporadic CJD.<br /><br />5.153 It is understood that since 20 March 1996, at least two further cases of sporadic CJD in a relevant occupational group have been reported to the CJDSU, one in a farmer and another in an abattoir worker.374 Recent transmission studies in mice indicate that the causal agent in these cases has transmission characteristics (incubation period and neuropathology) which are distinct from both vCJD and BSE, and that the protein deposited in the brain in all of these cases has a glycosylation pattern distinct from the type 4 pattern observed in vCJD and BSE.<br /><br />snip...<br /><br />Is occupation a risk factor in vCJD?<br /><br />5.192 One of the original proposals in the CJD surveillance project was to monitor occupational groups exposed to BSE-affected cattle and their products. Such groups include farmers, veterinarians, slaughtermen and butchers. This part of the project was given a low priority by the Tyrrell Committee and was not implemented. It was felt that rather than set up longitudinal study of a fixed number of individuals in each group, together with matched controls, it would be adequate to take an occupational history of each CJD case at the time of referral.<br /><br />5.193 From 1990 to 1996, the CJDSU had referred to it four farmers affected with CJD who were known to have had cases of BSE on their farms. Assuming a total of 155,000 dairy farmers in the UK,384 the number of observed CJD cases is significantly higher than expected from population estimates. Counting only those farmers with affected cattle, the probability of observing four or more confirmed cases of CJD is estimated at less than one in 10,000.385 In addition, two farmers’ wives were known to have CJD from farms in which clinical BSE had not been reported (although preclinical cases of BSE on these farms might have been expected). 384 Gore, S. (1995) More than Happenstance: Creutzfeldt-Jakob Disease in Farmers and Young Adults, British Medical Journal, 311, 1416–8 385 Ibid.<br /><br />EMERGENCE OF VARIANT CJD 79<br /><br />5.194 The affected farmers were aged between 54 and 64 and had signs and symptoms typical of sporadic CJD. Two had EEG changes typical of the sporadic disease and all four had type 2 glycosylation patterns. Three farmers were homozygous for methionine at codon 129 and the fourth was a valine homozygote. None conformed to the phenotype characteristic of vCJD. The findings remained unexplained, although a European collaborative study showed a similar increased incidence in deaths due to CJD in farmers in several member states. It was noted that unexpected numbers of affected individuals occurred in other occupational groups, such as the clergy, but numbers in each occupation remained small.<br /><br />5.195 Among occupational groups exposed to BSE, farmers remain unusual in having such an excess over the incidence of CJD for the population as a whole. No cases of CJD have been reported amount veterinarians exposed to BSE. Four people in the meat industry (butchers, abattoirs, rendering plants, etc) have been reported to have vCJD.386 The present evidence has been accepted by some as reassuring in that such occupations may not pose as serious a risk as might have been expected.<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102111737/http://www.bseinquiry.gov.uk/pdf/volume8/chapter5.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080102111737/http://www.bseinquiry.gov.uk/pdf/volume8/chapter5.pdf</a></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">NEW URL LINK 2022</div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090505200142/http://www.bseinquiry.gov.uk/pdf/volume8/Chapter5.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090505200142/http://www.bseinquiry.gov.uk/pdf/volume8/Chapter5.pdf</a><br /><br /><br />This was not simply another farmer but the third farmer......<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102141416/http://www.bseinquiry.gov.uk/files/yb/1995/06/21002001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080102141416/http://www.bseinquiry.gov.uk/files/yb/1995/06/21002001.pdf</a></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">NEW URL LINK 2022</div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090505233408/http://www.bseinquiry.gov.uk/files/yb/1995/06/21002001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090505233408/http://www.bseinquiry.gov.uk/files/yb/1995/06/21002001.pdf</a><br /><br /><br />suspect case of CJD in a farmer who has had a case of BSE in his beef suckler herd.<br /><br /><br /><a href="http://web.archive.org/web/20030331213802/http://www.bseinquiry.gov.uk/files/yb/1995/10/23006001.pdf" style="color: #473624; cursor: pointer;">http://web.archive.org/web/20030331213802/http://www.bseinquiry.gov.uk/files/yb/1995/10/23006001.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090506063655/http://www.bseinquiry.gov.uk/files/yb/1995/10/23006001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506063655/http://www.bseinquiry.gov.uk/files/yb/1995/10/23006001.pdf</a><br /><br /><br />cover-up of 4th farm worker ???<br /><br /><br /><a href="http://web.archive.org/web/20030516083454/http://www.bseinquiry.gov.uk/files/yb/1995/10/23006001.pdf" style="color: #473624; cursor: pointer;">http://web.archive.org/web/20030516083454/http://www.bseinquiry.gov.uk/files/yb/1995/10/23006001.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><a href="http://web.archive.org/web/20090506063655/http://www.bseinquiry.gov.uk/files/yb/1995/10/23006001.pdf" style="color: #29303b; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px; text-decoration-line: none;">http://web.archive.org/web/20090506063655/http://www.bseinquiry.gov.uk/files/yb/1995/10/23006001.pdf</a><br /><br /><br /><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">CJD4/3 0453</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">BHW194241.10</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Richmond House 79 Whitehall London SWIA 2NS Telephone 071 210 3000</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">From the Partiameatary Under Secretary of State</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">POH(3}4184/241</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Michael Ancram Esq MP</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">20 OCT 1995</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">- Che oe</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Thank you for your letters of 8 September and 13 October to Gerald Malone on behalf of your</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">coastituents . , . about Creutzfeldt Jakob </span></span><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Disease (CID). I am sorry you have not received an earlier reply.</span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">We share your concern that the monitoring of CJD in the UK should be as effective as possible.</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">That is why we set up the National CJD Surveillance Unit in 1990. The monitoring system used</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">by the Unit is kept under constant review by the Department and we are satisfied that the level of</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">ascertainment of CJD is very high.</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">The Surveillance Unit maintains excellent relations with all neurologists in the UK and, especially</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">now that clinicians are well aware of the disease, it will be rare to find a case of CJD going</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">unreported. In fact a substantial number of cases reported to the Unit turn out not to be CJD. The</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Unit also receives copies of death certificates from the Office of Population, Censuses and Surveys</span><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">from which one or two cases a year are identified.</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">I enclose a copy of the fourth annual report of the CJD Surveillance Unit, published earlier this</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">month, which you may find helpful. I assume this is the research you referred to in your letter of</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">13 October.</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">The question of a public inquiry into the death of xxx was first raised by </span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">the Today newspaper in articles published on 14 and 15 August. Copies are enclosed for your</span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">information. The Department’s refusal of a public inquiry was in response to questions from the</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">newspaper. We felt such an inquiry to be unnecessary because we have already established the</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">independent Spongiform Encephalopathy (SE) Advisory Committee (SEAC) with a remit to advise</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Government on all matters concerning SEs, including CJD.</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">CJD in young people, although extremely rare, is by no means unique. For example, a 20 year</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">old died from CJD in the USA in 1980 and a 16 year old in 1981. A 19 year old died from the</span><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">disease in France in 1985. Creutzfeldt’s first patient in 1920 was aged 23. There is no evidence</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">IMPROVING THE HEALTH OF THE NATION if</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">95/10.20/6.</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">; 39 20/6.1</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"> CJD4/3 0454</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">of an iatrogenic cause for those cases nor, of course, was BSE a factor. It does, therefore, seem</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">that there are rare cases where CJD is found in younger age groups than would normally be</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">expected.</span><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">The role of the SEAC in research is to advise the Ministry of Agriculture, Fisheries and Food</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">(MAFF) and the Department of Health on all aspects of research into SEs, including research</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">priorities, new work required, and advice on work in progress. MAFF and the Department of</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Health have responsibility for the co-ordination of that research.</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">ao:</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">o~—</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">TOM SACKVILLE</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Ve</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">40 95/10.20/6.2</span></span></div><br /><br /><a href="http://web.archive.org/web/20030330175323/http://www.bseinquiry.gov.uk/files/yb/1995/10/20006001.pdf" style="color: #473624; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">http://web.archive.org/web/20030330175323/http://www.bseinquiry.gov.uk/files/yb/1995/10/20006001.pdf</a><br /><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">NEW URL LINK 2022</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090506063610/http://www.bseinquiry.gov.uk/files/yb/1995/10/20006001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506063610/http://www.bseinquiry.gov.uk/files/yb/1995/10/20006001.pdf</a></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">SEE ;</div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><div style="color: #1d2129; font-family: inherit; font-size: 14px; letter-spacing: 0px; line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;">''The association between venison eating and risk of CJD shows similar pattern, with regular venison eating associated with a 9 FOLD INCREASE IN RISK OF CJD (p = 0.04).''<br clear="none" /></div><div style="color: #1d2129; font-family: inherit; font-size: 14px; letter-spacing: 0px; line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><br clear="none" /></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;">CREUTZFELDT JAKOB DISEASE SURVEILLANCE IN THE UNITED KINGDOM THIRD ANNUAL REPORT AUGUST 1994</span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;"><br clear="none" /></span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;">Consumption of venison and veal was much less widespread among both cases and controls. For both of these meats there was evidence of a trend with increasing frequency of consumption being associated with increasing risk of CJD. (not nvCJD, but sporadic CJD...tss) These associations were largely unchanged when attention was restricted to pairs with data obtained from relatives. ...</span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;"><br clear="none" /></span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;">Table 9 presents the results of an analysis of these data.</span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;"><br clear="none" /></span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;">There is STRONG evidence of an association between ‘’regular’’ veal eating and risk of CJD (p = .0.01).</span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;"><br clear="none" /></span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;">Individuals reported to eat veal on average at least once a year appear to be at 13 TIMES THE RISK of individuals who have never eaten veal.</span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;"><br clear="none" /></span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;">There is, however, a very wide confidence interval around this estimate. There is no strong evidence that eating veal less than once per year is associated with increased risk of CJD (p = 0.51).</span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;"><br clear="none" /></span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;">The association between venison eating and risk of CJD shows similar pattern, with regular venison eating associated with a 9 FOLD INCREASE IN RISK OF CJD (p = 0.04).</span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;"><br clear="none" /></span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;">There is some evidence that risk of CJD INCREASES WITH INCREASING FREQUENCY OF LAMB EATING (p = 0.02).</span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;"><br clear="none" /></span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;">The evidence for such an association between beef eating and CJD is weaker (p = 0.14). When only controls for whom a relative was interviewed are included, this evidence becomes a little STRONGER (p = 0.08).</span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;"><br clear="none" /></span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;">snip...</span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;"><br clear="none" /></span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;">It was found that when veal was included in the model with another exposure, the association between veal and CJD remained statistically significant (p = < 0.05 for all exposures), while the other exposures ceased to be statistically significant (p = > 0.05).</span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;"><br clear="none" /></span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;">snip...</span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;"><br clear="none" /></span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;">In conclusion, an analysis of dietary histories revealed statistical associations between various meats/animal products and INCREASED RISK OF CJD. When some account was taken of possible confounding, the association between VEAL EATING AND RISK OF CJD EMERGED AS THE STRONGEST OF THESE ASSOCIATIONS STATISTICALLY. ...</span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;"><br clear="none" /></span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;">snip...</span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;"><br clear="none" /></span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;">In the study in the USA, a range of foodstuffs were associated with an increased risk of CJD, including liver consumption which was associated with an apparent SIX-FOLD INCREASE IN THE RISK OF CJD. By comparing the data from 3 studies in relation to this particular dietary factor, the risk of liver consumption became non-significant with an odds ratio of 1.2 (PERSONAL COMMUNICATION, PROFESSOR A. HOFMAN. ERASMUS UNIVERSITY, ROTTERDAM). (???...TSS)</span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;"><br clear="none" /></span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;">snip...see full report ;</span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;"><br clear="none" /></span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><a href="http://web.archive.org/web/20090506050043/http://www.bseinquiry.gov.uk/files/yb/1994/08/00004001.pdf" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; cursor: pointer; font-size: 14px;" target="_blank">http://web.archive.org/web/20090506050043/http://www.bseinquiry.gov.uk/files/yb/1994/08/00004001.pdf</a><br clear="none" /></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;"><br clear="none" /></span></div><div style="line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><span style="color: #1d2129; font-size: 14px;"> </span><a href="http://web.archive.org/web/20090506050007/http://www.bseinquiry.gov.uk/files/yb/1994/10/00003001.pdf" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; cursor: pointer; font-family: inherit; font-size: 14px; letter-spacing: 0px;" target="_blank">http://web.archive.org/web/20090506050007/http://www.bseinquiry.gov.uk/files/yb/1994/10/00003001.pdf</a></div></div><div style="color: #1d2129; font-family: inherit; font-size: 14px; letter-spacing: 0px; line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><br clear="none" /></div><div style="color: #1d2129; font-family: inherit; font-size: 14px; letter-spacing: 0px; line-height: 1.22em; margin-bottom: 6px; margin-top: 6px;"><a href="http://web.archive.org/web/20090506050244/http://www.bseinquiry.gov.uk/files/yb/1994/07/00001001.pdf" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; cursor: pointer;" target="_blank">http://web.archive.org/web/20090506050244/http://www.bseinquiry.gov.uk/files/yb/1994/07/00001001.pdf</a></div></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /><br />CONFIRMATION OF CJD IN FOURTH FARMER<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102203608/http://www.bseinquiry.gov.uk/files/yb/1995/11/03008001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080102203608/http://www.bseinquiry.gov.uk/files/yb/1995/11/03008001.pdf</a><br /><br /><br />SEE NEW URL LINKS 2022</div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090506065141/http://www.bseinquiry.gov.uk/files/yb/1995/11/03008001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506065141/http://www.bseinquiry.gov.uk/files/yb/1995/11/03008001.pdf</a></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br />now story changes from;<br /><br /><br />SEAC concluded that, if the fourth case were confirmed, it would be worrying, especially as all four farmers with CJD would have had BSE cases on their farms.<br /><br /><br />to;<br /><br /><br />This is not unexpected...<br /><br />was another farmer expected?<br /><br /><br /><a href="http://web.archive.org/web/20030728074919/http://www.bseinquiry.gov.uk/files/yb/1995/11/13010001.pdf" style="color: #473624; cursor: pointer;">http://web.archive.org/web/20030728074919/http://www.bseinquiry.gov.uk/files/yb/1995/11/13010001.pdf</a><br /><br /><br />SEE NEW URL LINKS</div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090506065045/http://www.bseinquiry.gov.uk/files/yb/1995/11/13010001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506065045/http://www.bseinquiry.gov.uk/files/yb/1995/11/13010001.pdf</a><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br />4th farmer, and 1st teenager<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102235004/http://www.bseinquiry.gov.uk/files/yb/1996/02/27003001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080102235004/http://www.bseinquiry.gov.uk/files/yb/1996/02/27003001.pdf</a><br /><br /><br />SEE NEW URL LINK</div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090506053239/http://www.bseinquiry.gov.uk/files/yb/1996/02/27003001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506053239/http://www.bseinquiry.gov.uk/files/yb/1996/02/27003001.pdf</a><br /><br /><br />2. snip...<br /><br />Over a 5 year period, which is the time period on which the advice from Professor Smith and Dr. Gore was based, and assuming a population of 120,000 dairy farm workers, and an annual incidence of 1 per million cases of CJD in the general population, a DAIRY FARM WORKER IS 5 TIMES MORE LIKELY THAN an individual in the general population to develop CJD. Using the actual current annual incidence of CJD in the UK of 0.7 per million, this figure becomes 7.5 TIMES.<br /><br />3. You will recall that the advice provided by Professor Smith in 1993 and by Dr. Gore this month used the sub-population of dairy farm workers who had had a case of BSE on their farms - 63,000, which is approximately half the number of dairy farm workers - as a denominator. If the above sums are repeated using this denominator population, taking an annual incidence in the general population of 1 per million the observed rate in this sub-population is 10 TIMES, and taking an annual incidence of 0.7 per million, IT IS 15 TIMES (THE ''WORST CASE'' SCENARIO) than that in the general population...<br /><br /><br /><a href="http://web.archive.org/web/20030516181226/http://www.bseinquiry.gov.uk/files/yb/1995/01/31004001.pdf" style="color: #473624; cursor: pointer;">http://web.archive.org/web/20030516181226/http://www.bseinquiry.gov.uk/files/yb/1995/01/31004001.pdf</a><br /><br /><br />SEE NEW URL LINK 2022</div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090506015122/http://www.bseinquiry.gov.uk/files/yb/1995/01/31004001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506015122/http://www.bseinquiry.gov.uk/files/yb/1995/01/31004001.pdf</a></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /><br />CJD FARMERS WIFE 1989<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103005651/http://www.bseinquiry.gov.uk/files/yb/1989/10/13007001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080103005651/http://www.bseinquiry.gov.uk/files/yb/1989/10/13007001.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090506055019/http://www.bseinquiry.gov.uk/files/yb/1989/10/13007001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506055019/http://www.bseinquiry.gov.uk/files/yb/1989/10/13007001.pdf</a></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">BSE11/1 0006</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"> </span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">DEPARTMENT OF HEALTH Eilecn House Room 80-94 Newington Causeway</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">¥ London SE! 6GEF</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">‘our reference</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Our reference -Wi11135 Telephone No 01-972-2000 (Switchboard)</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">01972 (Direct Line)</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Fax 01-972 2844 Telex 883669</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">IN CONFIDENCE</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Dr RG Will</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Consultant Neurologist</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Western General Hospital</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Crewe Road</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">EDINBURGH</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">EH4 2XU 13 OctOber 1989</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Dear Bob</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">An otherwise enjoyable dinner last night as quest of the Association of Clinical Pathology was marred by a ca with a neuropathologist who was just about to write to details of a case of CJD he had just seen. When first mentioning the case, he claimed she was only 36, but after a few more glasses of wine he became less certain of that and thought she could have </span></span><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">been older. Locally, they made quite an association with BSE, since she was a farmers wife on a farm that, atypically for that area of S Yorkshire, had several BSE cases. I was told the</span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">clinical and pathological pictures were typical of CJD. The brain is now preserved in Sheffield, but fresh material was sent to Newcastle for animal inoculation. I suggested the NPU might be interested in molecular biology studies at some time so asked them to retain any other material they may still have in the freezer.</span><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">When I hear more, I will pass on the details to you, but you may hear from your own grapevine contacts in any case. Lets hope Dr Timperley got the age wrong by several decades. And lets also hope the media do not hype it up before we have a chance: to investigate in adequate detail.</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">I presume all is going well with your plans for the monitoring study and that my lack of news on that at this end only means that you and Dr Dastgir are still sorting it out between you. Still no news of when the "Tyrrell" report will be published. With best wishes.</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Yours sincerely</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Dr Hilary Pickles Principal Medical Officer</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">vd: leer ty Qe Tenspeeny</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">89/10.13/3.1 </span></span></div><br /><a href="http://collections.europarchive.org/tna/20080102155149/http://www.bseinquiry.gov.uk/files/yb/1989/10/13003001.pdf" style="color: #473624; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">http://collections.europarchive.org/tna/20080102155149/http://www.bseinquiry.gov.uk/files/yb/1989/10/13003001.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><a href="http://web.archive.org/web/20090505233430/http://www.bseinquiry.gov.uk/files/yb/1989/10/13003001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090505233430/http://www.bseinquiry.gov.uk/files/yb/1989/10/13003001.pdf</a></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">20 year old died from sCJD in USA in 1980 and a 16 year old in 1981. A 19 year old died from sCJD in France in 1985. There is no evidence of an iatrogenic cause for those cases....</span></span><br /><br /><br /><a href="http://web.archive.org/web/20030330212925/http://www.bseinquiry.gov.uk/files/yb/1995/10/04004001.pdf" style="color: #473624; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">http://web.archive.org/web/20030330212925/http://www.bseinquiry.gov.uk/files/yb/1995/10/04004001.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><a href="http://web.archive.org/web/20090505233353/http://www.bseinquiry.gov.uk/files/yb/1995/10/04004001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090505233353/http://www.bseinquiry.gov.uk/files/yb/1995/10/04004001.pdf</a></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">USA 2008</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Prion surveillance in cattle has been reduced by 90% (from about 470,000 to 40,000 in the U.S. in 2007 out of about 35 million cattle slaughtered). Termination of human prion surveillance would therefore remove the second line of surveillance, thereby eliminating prion surveillance in the U.S. entirely. This development would be extremely worrisome in view of recent reports that precautions to limit the spread of the prion infectious agent may not have been followed in some slaughter houses in the U.S. Cattle affected with bovine spongiform encephalopathy (BSE) continue to be discovered in Canada, which has more rigorous BSE surveillance than the U.S. At the same time, Canada imposes few limitations in the trade of potentially prion-infectious cattle with the U.S.</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">snip...</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Atypical forms of BSE have emerged which, although rare, appear to be more virulent than the classical BSE that causes vCJD.</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">please see full text with additional comments and links @ ;</span></span><br /><br /><br /><a fg_scanned="1" href="http://prionunitusaupdate2008.blogspot.com/" style="color: #473624; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">http://prionunitusaupdate2008.blogspot.com/</a><br /><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM 1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype of 'UNKNOWN' strain growing. ...</span></span><br /><br /><br /><a fg_scanned="1" href="http://www.cjdsurveillance.com/resources-casereport.html" style="color: #473624; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">http://www.cjdsurveillance.com/resources-casereport.html</a><br /><br /><br />NEW URL LINK 2022</div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><a fg_scanned="1" href="https://case.edu/medicine/pathology/divisions/national-prion-disease-pathology-surveillance-center/resources-professionals/tables-cases-examined" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://case.edu/medicine/pathology/divisions/national-prion-disease-pathology-surveillance-center/resources-professionals/tables-cases-examined</a></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">There is a growing number of human CJD cases, and they were presented last week in San Francisco by Luigi Gambatti(?) from his CJD surveillance collection.</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">He estimates that it may be up to 14 or 15 persons which display selectively SPRPSC and practically no detected RPRPSC proteins.</span></span><br /><br /><br /><a fg_scanned="1" href="http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm" style="color: #473624; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm</a></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody">NEW URL LINK 2022</div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><a fg_scanned="1" href="http://web.archive.org/web/20080126131329/http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20080126131329/http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm</a><br /><br /><br /><span style="font-size: 13.3333px;">Meeting of: TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE September 18, 2006 </span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><br /><br /><a href="http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf" style="color: #473624; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><a href="http://web.archive.org/web/20100309064113/http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20100309064113/http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf</a><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">PLEASE NOTE IN USA CJD UPDATE AS AT JUNE 2007, please note steady increase in ''TYPE UNKNOWN''. ...TSS</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">1 Acquired in the United Kingdom; 2 Acquired in Saudi Arabia; 3 Includes 17 inconclusive and 9 pending (1 from 2006, 8 from 2007); 4 Includes 17 non-vCJD type unknown (2 from 1996, 2 from 1997, 1 from 2001, 1 from 2003, 4 from 2004, 3 from 2005, 4 from 2006) and 36 type pending (2 from 2005, 8 from 2006,</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">*** 26 from 2007)</span></span><br /><br /><br /><a href="http://www.cjdsurveillance.com/pdf/case-table.pdf" style="color: #473624; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">http://www.cjdsurveillance.com/pdf/case-table.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><a fg_scanned="1" href="https://case.edu/medicine/pathology/divisions/national-prion-disease-pathology-surveillance-center/resources-professionals/tables-cases-examined" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://case.edu/medicine/pathology/divisions/national-prion-disease-pathology-surveillance-center/resources-professionals/tables-cases-examined</a></div><div><br /></div></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Diagnosis and Reporting of Creutzfeldt-Jakob Disease</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Singeltary, Sr et al. JAMA.2001; 285: 733-734.</span></span><br /><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><a fg_scanned="1" href="https://jamanetwork.com/journals/jama/article-abstract/1031186" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://jamanetwork.com/journals/jama/article-abstract/1031186</a></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">JOURNAL OF NEUROLOGY</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">MARCH 26, 2003</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">disease in the United States</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Email Terry S. Singeltary:</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">flounder@wt.net</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">comment on the CDC's attempts to monitor the occurrence of emerging</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">forms of CJD. Asante, Collinge et al [1] have reported that BSE</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">transmission to the 129-methionine genotype can lead to an alternate</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">phenotype that is indistinguishable from type 2 PrPSc, the commonest</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">sporadic CJD. However, CJD and all human TSEs are not reportable</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">nationally. CJD and all human TSEs must be made reportable in every</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">state and internationally. I hope that the CDC does not continue to</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">expect us to still believe that the 85%+ of all CJD cases which are</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">sporadic are all spontaneous, without route/source. We have many TSEs in</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">the USA in both animal and man. CWD in deer/elk is spreading rapidly and</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">CWD does transmit to mink, ferret, cattle, and squirrel monkey by</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">intracerebral inoculation. With the known incubation periods in other</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">TSEs, oral transmission studies of CWD may take much longer. Every</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">victim/family of CJD/TSEs should be asked about route and source of this</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">agent. To prolong this will only spread the agent and needlessly expose</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">others. In light of the findings of Asante and Collinge et al, there</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">should be drastic measures to safeguard the medical and surgical arena</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">from sporadic CJDs and all human TSEs. I only ponder how many sporadic</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">CJDs in the USA are type 2 PrPSc?</span></span><br /><br /><br /><a fg_scanned="1" href="https://n.neurology.org/content/re-monitoring-occurrence-emerging-forms-creutzfeldt-jakob-disease-united-states" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://n.neurology.org/content/re-monitoring-occurrence-emerging-forms-creutzfeldt-jakob-disease-united-states</a></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><br /></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">THE PATHOLOGICAL PROTEIN</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Hardcover, 304 pages plus photos and illustrations. ISBN 0-387-95508-9</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">June 2003</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">BY Philip Yam</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">CHAPTER 14 LAYING ODDS</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Answering critics like Terry Singeltary, who feels that the U.S. under- counts CJD, Schonberger conceded that the current surveillance system has errors but stated that most of the errors will be confined to the older population.</span></span><br /><br /><br /><a fg_scanned="1" href="http://www.thepathologicalprotein.com/" style="color: #473624; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">http://www.thepathologicalprotein.com/</a><br /><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">USA 2007-2008 sporadic CJD statistics revised to 1 in 9,000 in ages 55 and older !</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">The statistical incidence of CJD cases in the United States has been revised to reflect that there is one case per 9000 in adults age 55 and older. Eighty-five percent of the cases are sporadic, meaning there is no known cause at present.</span></span><br /><br /><br /><a fg_scanned="1" href="http://www.cjdfoundation.org/fact.html" style="color: #473624; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">http://www.cjdfoundation.org/fact.html</a><br /><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Sunday, March 16, 2008</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">MAD COW DISEASE terminology UK c-BSE (typical), atypical BSE H or L, and or Italian L-BASE</span></span><br /><br /><a fg_scanned="1" href="http://bse-atypical.blogspot.com/2008/03/mad-cow-disease-terminology-uk-c-bse.html" style="color: #473624; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">http://bse-atypical.blogspot.com/2008/03/mad-cow-disease-terminology-uk-c-bse.html</a><br /><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Subject: HUMAN and ANIMAL TSE Classifications i.e. mad cow disease and the UKBSEnvCJD only theory Date: January 29, 2006 at 9:03 am PST</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">HUMAN and ANIMAL TSE Classifications i.e. mad cow disease and the UKBSEnvCJD only theory</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">TSEs have been rampant in the USA for decades in many species, and they all have been rendered and fed back to animals for human/animal consumption. propose that the current diagnostic criteria for human TSEs only enhances and helps the spreading of human TSE from the continued belief of the UKBSEnvCJD only theory in 2007. With all the science to date refuting it, to continue to validate this myth, will only spread this TSE agent through a multitude of potential routes and sources i.e. consumption, surgical, blood, medical, cosmetics etc. I propose as with Aguzzi, Asante, Collinge, Caughey, Deslys, Dormont, Gibbs, Ironside, Manuelidis, Marsh, et al and many more, that the world of TSE Transmissible Spongiform Encephalopathy is far from an exact science, but there is enough proven science to date that this myth should be put to rest once and for all, and that we move forward with a new classification for human and animal TSE that would properly identify the infected species, the source species, and then the route.</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">This would further have to be broken down to strain of species and then the route of transmission would further have to be broken down. Accumulation and Transmission are key to the threshold from sub-clinical to clinical disease, and key to all this, is to stop the amplification and transmission of this agent, the spreading of, no matter what strain. In my opinion, to continue with this myth that the U.K. strain of BSE (one strain TSE in cows), and the nv/v CJD (one strain TSE humans) and that all the rest of human TSE are just one single strain i.e. sporadic CJD (when to date there are 6 different phenotypes of sCJD, and growing per Gambetti et al), and that no other animal TSE transmits to humans, to continue with this masquerade will only continue to spread, expose, and kill, who knows how many more in the years and decades to come. ONE was enough for me, My Mom, hvCJD i.e. Heidenhain Variant CJD, DOD 12/14/97 confirmed, which is nothing more than another mans name added to CJD, like CJD itself, Jakob and Creutzfeldt, or Gerstmann-Straussler-Scheinker syndrome, just another CJD or human TSE, named after another human.</span></span><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">WE are only kidding ourselves with the current diagnostic criteria for human and animal TSE, especially differentiating between the nvCJD vs the sporadic CJD strains and then the GSS strains and also the FFI fatal familial insomnia strains or the ones that mimics one or the other of those TSE? Tissue infectivity and strain typing of the many variants of the human and animal TSEs are paramount in all variants of all TSE. There must be a proper classification that will differentiate between all these human TSE in order to do this. With the CDI and other more sensitive testing coming about, I only hope that my proposal will some day be taken seriously. ...</span></span><br /><br /><br /><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Terry S. Singeltary Sr. P.O. Box Bacliff, Texas USA 77518 flounder9@verizon.net</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">2022 UPDATE</span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-1994107774295279989" itemprop="description articleBody"><div style="background-color: white; text-align: justify;"><span style="color: #29303b;">THURSDAY, JUNE 23, 2022 </span></div><div style="background-color: white; text-align: justify;"><span style="color: #29303b;"><br /></span></div><div style="background-color: white; text-align: justify;"><span style="color: #29303b;">UK Research and analysis Creutzfeldt-Jakob disease (CJD) update (data to end of December 2021) Updated 21 June 2022</span><br /></div><div style="background-color: white; text-align: justify;"><span style="color: #29303b;"><br /></span></div><div style="background-color: white; text-align: justify;"><span style="color: #29303b;"><a fg_scanned="1" href="https://creutzfeldt-jakob-disease.blogspot.com/2022/06/uk-research-and-analysis-creutzfeldt.html" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://creutzfeldt-jakob-disease.blogspot.com/2022/06/uk-research-and-analysis-creutzfeldt.html</a></span></div><div><br /></div><div><div style="background-color: white;"><div dir="ltr" style="font-family: Arial, Helvetica, sans-serif; font-size: 12px;">TUESDAY, MAY 10, 2022 <br /></div><div dir="ltr" style="font-family: Arial, Helvetica, sans-serif; font-size: 12px;"><br /></div><div dir="ltr" style="font-family: Arial, Helvetica, sans-serif; font-size: 12px;">Concordance of CSF RT-QuIC across the European Creutzfeldt-Jakob Disease surveillance network<br /></div><div dir="ltr" style="font-family: Arial, Helvetica, sans-serif; font-size: 12px;"><br /></div><div dir="ltr" style="font-family: Arial, Helvetica, sans-serif; font-size: 12px;"><a fg_scanned="1" href="https://creutzfeldt-jakob-disease.blogspot.com/2022/05/concordance-of-csf-rt-quic-across.html" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://creutzfeldt-jakob-disease.blogspot.com/2022/05/concordance-of-csf-rt-quic-across.html</a></div></div><div dir="ltr" style="background-color: white; font-family: Arial, Helvetica, sans-serif; font-size: 12px;"><br /></div><div dir="ltr" style="background-color: white; font-family: Arial, Helvetica, sans-serif; font-size: 12px;"><div><div style="line-height: 1.22em;"><div style="font-family: arial, helvetica;"><div style="font-family: BerninaSansWeb, Arial, sans-serif; font-size: 18px; margin-bottom: 12px;"><span style="font-family: arial; font-size: 13.3333px;">MONDAY, JANUARY 31, 2022 </span></div><div style="font-family: arial; font-size: 10pt;">Validation of Revised International Creutzfeldt-Jakob Disease Surveillance Network Diagnostic Criteria for Sporadic Creutzfeldt-Jakob Disease Singeltary Comment Submission</div><div style="font-family: arial; font-size: 10pt;"><br /></div><div style="font-family: arial; font-size: 10pt;"><a fg_scanned="1" href="https://creutzfeldt-jakob-disease.blogspot.com/2022/01/validation-of-revised-international.html" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://creutzfeldt-jakob-disease.blogspot.com/2022/01/validation-of-revised-international.html</a><br /></div><div style="font-family: BerninaSansWeb, Arial, sans-serif; font-size: 18px;"><br /></div><div style="font-family: arial; font-size: 10pt;">Friday, March 11, 2022 </div><div style="font-family: arial; font-size: 10pt;"><br /></div><div style="font-family: arial; font-size: 10pt;">Prevalence of Surgical Procedures at Symptomatic Onset of Prion Disease<br /></div><div style="font-family: arial; font-size: 10pt;"><br /></div><div style="font-family: arial; font-size: 10pt;"><a fg_scanned="1" href="https://itseprion.blogspot.com/2022/03/prevalence-of-surgical-procedures-at.html" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://itseprion.blogspot.com/2022/03/prevalence-of-surgical-procedures-at.html</a></div><div style="font-family: BerninaSansWeb, Arial, sans-serif; font-size: 18px;"><br /></div><div style="font-family: arial;"><div class="yiv5849607341aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;"><div style="line-height: 1.22em;"><div class="yiv5849607341aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;"><div style="font-stretch: normal; line-height: normal; margin: 0px;"><div style="background-color: #f0f2f5; margin-bottom: 2em; margin-top: 0.5em;"><div dir="ltr"><div style="background-color: white;"><div class="yiv5849607341aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;"><div style="font-size: 10pt;"><div style="color: #222222;"><div dir="ltr" style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: 12px;"><div style="font-family: arial; font-size: 13.3333px;"><div style="font-size: 10pt; letter-spacing: 0px;">WEDNESDAY, FEBRUARY 02, 2022 <br /></div><div><br /></div><div>Understanding the nature of PrP found in Appendix tissues in the UK population <br /></div><div><br /></div><div><a fg_scanned="1" href="https://vcjd.blogspot.com/2022/02/understanding-nature-of-prp-found-in.html" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://vcjd.blogspot.com/2022/02/understanding-nature-of-prp-found-in.html</a></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div><div style="font-size: 10pt;"><div dir="ltr" style="font-size: 12px;"><div style="font-family: arial; font-size: 13.3333px;"><div style="color: #222222; font-family: Roboto, sans-serif; font-size: 10pt; letter-spacing: 0px;"><div style="color: black; font-family: arial;">FRIDAY, DECEMBER 24, 2021 </div><div style="color: black; font-family: arial;"><br /></div><div style="color: black; font-family: arial;">***> Creutzfeldt Jakob Disease CJD TSE Prion Update December 25, 2021 <***<br /></div><div style="color: black; font-family: arial;"><br /></div><div style="color: black; font-family: arial;"><a fg_scanned="1" href="https://creutzfeldt-jakob-disease.blogspot.com/2021/12/creutzfeldt-jakob-disease-cjd-tse-prion.html" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://creutzfeldt-jakob-disease.blogspot.com/2021/12/creutzfeldt-jakob-disease-cjd-tse-prion.html</a></div><div style="color: black; font-family: arial;"><br /></div><div style="color: black; font-family: arial;">TUESDAY, OCTOBER 26, 2021 <div><br /></div><div>Sporadic Creutzfeldt-Jakob Disease in a Very Young Person Singeltary Reply 2021</div><div><br /></div><div><a fg_scanned="1" href="https://creutzfeldt-jakob-disease.blogspot.com/2021/10/sporadic-creutzfeldt-jakob-disease-in.html" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://creutzfeldt-jakob-disease.blogspot.com/2021/10/sporadic-creutzfeldt-jakob-disease-in.html</a></div></div></div></div></div></div><div><div class="yiv5849607341aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;"><div style="line-height: 1.22em;"><div class="yiv5849607341aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;"><div style="font-stretch: normal; line-height: normal; margin: 0px;"><div style="background-color: #f0f2f5; margin-bottom: 2em; margin-top: 0.5em;"><div dir="ltr"><div style="background-color: white;"><div class="yiv5849607341aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_aolmail_MsoNormal" style="line-height: 1.22em; margin: 0in 0in 0.0001pt;"><div style="font-size: 10pt;"><div style="color: #222222;"><div dir="ltr" style="color: black; font-size: 12px;"><div style="font-family: arial; font-size: 13.3333px;"><br /></div></div><div dir="ltr" style="color: black; font-size: 12px;">Saturday, December 18, 2021 <br /></div><div dir="ltr" style="color: black; font-size: 12px;"><br /></div><div dir="ltr" style="color: black; font-size: 12px;">Direct neural transmission of vCJD/BSE in macaque after finger incision <br /></div><div dir="ltr" style="color: black; font-size: 12px;"><br /></div><div dir="ltr" style="color: black; font-size: 12px;"><a fg_scanned="1" href="https://itseprion.blogspot.com/2021/12/direct-neural-transmission-of-vcjdbse.html" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://itseprion.blogspot.com/2021/12/direct-neural-transmission-of-vcjdbse.html</a></div><div dir="ltr" style="color: black; font-size: 12px;"><br /></div><div dir="ltr" style="color: black; font-size: 12px;"><div class="yiv5849607341MsoNormal" style="color: #222222; font-family: arial; font-size: 13.3333px; line-height: 14.65pt; margin: 0cm 0cm 0.0001pt;">Tuesday, November 30, 2021 </div><div class="yiv5849607341MsoNormal" style="color: #222222; font-family: arial; font-size: 13.3333px; line-height: 14.65pt; margin: 0cm 0cm 0.0001pt;"><br /></div><div class="yiv5849607341MsoNormal" style="color: #222222; font-family: arial; font-size: 13.3333px; line-height: 14.65pt; margin: 0cm 0cm 0.0001pt;">Second death in France in a laboratory working on prions</div><div class="yiv5849607341MsoNormal" style="color: #222222; font-family: arial; font-size: 13.3333px; line-height: 14.65pt; margin: 0cm 0cm 0.0001pt;"><br /></div><div class="yiv5849607341MsoNormal" style="color: #222222; font-family: arial; font-size: 13.3333px; line-height: 14.65pt; margin: 0cm 0cm 0.0001pt;"><a fg_scanned="1" href="https://itseprion.blogspot.com/2021/11/second-death-in-france-in-laboratory.html" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://itseprion.blogspot.com/2021/11/second-death-in-france-in-laboratory.html</a></div></div><div dir="ltr" style="color: black; font-size: 12px;"><br /></div><div dir="ltr" style="color: black; font-size: 12px;"><div style="color: #222222; font-family: arial; font-size: 13.3333px;"><div><div>Second lab worker with deadly prion disease prompts research pause in France</div><div><br /></div><div>A lab worker died of prion disease in 2019, nine years after a lab accident.</div><div><br /></div><div>BETH MOLE - 7/29/2021, 5:16 PM</div></div><div><br /></div><div></div><a fg_scanned="1" href="https://arstechnica.com/science/2021/07/second-lab-worker-with-deadly-prion-disease-prompts-research-pause-in-france/" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://arstechnica.com/science/2021/07/second-lab-worker-with-deadly-prion-disease-prompts-research-pause-in-france/</a></div><div style="color: #222222; font-family: arial; font-size: 13.3333px;"><br /></div><div style="color: #222222; font-family: arial; font-size: 13.3333px;"><div>A 2020 paper published in the New England Journal of Medicine left little doubt that Jaumain had been infected on the job. She had variant CJD, but since Europe’s ‘mad cow’ outbreak ended after 2000 and the disease virtually disappeared, the paper said it was virtually impossible for someone her age in France to contract food-borne vCJD.</div><div><br /></div><div>Science also said two independent reports – one by government inspectors – had found no safety violations at the lab where Jaumain worked. The press release also noted that the inspectors concluded there was “the presence of a risk control culture within the research teams”. The Jaumain family’s lawyer called the neutrality of the reports into question, however.</div><div><br /></div><div>At the same time, the government inspectors’ report also revealed that there had been at least 17 accidents among the 100 or so scientists and technicians in France working with prions in the previous decade, raising concerns about how effective this risk control culture is. Five of these occurred when workers “stabbed or cut themselves with contaminated syringes or blades”.</div><div><br /></div><div><a fg_scanned="1" href="https://science.thewire.in/the-sciences/second-case-of-fatal-disease-prompts-french-moratorium-on-prion-research/" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://science.thewire.in/the-sciences/second-case-of-fatal-disease-prompts-french-moratorium-on-prion-research/</a><br /></div></div><div style="color: #222222; font-family: arial; font-size: 13.3333px;"><br /></div><div style="color: #222222; font-family: arial; font-size: 13.3333px;"><div dir="ltr" style="font-family: Helvetica, Arial, sans-serif; font-size: 10pt;">Wednesday, July 28, 2021 <br clear="none" /></div><div dir="ltr" style="font-family: Helvetica, Arial, sans-serif; font-size: 10pt;"><br clear="none" /></div><div dir="ltr" style="font-family: Helvetica, Arial, sans-serif; font-size: 10pt;">France issues moratorium on prion research after fatal brain disease strikes two lab workers<br clear="none" /></div><div dir="ltr" style="font-family: Helvetica, Arial, sans-serif; font-size: 10pt;"><br clear="none" /></div><div dir="ltr" style="font-family: Helvetica, Arial, sans-serif; font-size: 10pt;"><a fg_scanned="1" href="https://itseprion.blogspot.com/2021/07/france-issues-moratorium-on-prion.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; cursor: pointer;" target="_blank">https://itseprion.blogspot.com/2021/07/france-issues-moratorium-on-prion.html</a></div></div></div></div><div style="color: #222222;"><br clear="none" /></div><div style="color: #222222;"><div dir="ltr" style="color: black; font-family: Helvetica, Arial, sans-serif;">Wednesday, July 28, 2021 <br clear="none" /></div><div dir="ltr" style="color: black; font-family: Helvetica, Arial, sans-serif;"><br clear="none" /></div><div dir="ltr" style="color: black; font-family: Helvetica, Arial, sans-serif;">France issues moratorium on prion research after fatal brain disease strikes two lab workers<br clear="none" /></div><div dir="ltr" style="color: black; font-family: Helvetica, Arial, sans-serif;"><br clear="none" /></div><div dir="ltr" style="color: black; font-family: Helvetica, Arial, sans-serif;"><a fg_scanned="1" href="https://itseprion.blogspot.com/2021/07/france-issues-moratorium-on-prion.html" rel="nofollow noopener noreferrer" shape="rect" style="color: blue; cursor: pointer;" target="_blank">https://itseprion.blogspot.com/2021/07/france-issues-moratorium-on-prion.html</a></div></div></div><div style="font-size: 10pt;"><br /></div><div><div style="font-size: 13.2px;">Friendly fire, pass it forward, they call it iatrogenic cjd, or what i call 'tse prion poker', are you all in $$$</div><div style="font-size: 13.2px;"><br /></div><div style="font-size: 13.2px;">all iatrogenic cjd is, is sporadic cjd, before the iatrogenic event is discovered, traced back, proven, documented, put into the academic domain, and then finally the public domain, this very seldom happens, thus problem solved, it's all sporadic cjd...</div><div style="font-size: 13.2px;"><br /></div><div style="font-size: 13.2px;">SATURDAY, AUGUST 01, 2020</div><div style="font-size: 13.2px;"><br /></div><div style="font-size: 13.2px;">Sporadic Creutzfeldt-Jakob Disease among Physicians, Germany, 1993–2018 high proportion of physicians with sCJD were surgeons</div><div style="font-size: 13.2px;"><br /></div><div style="font-size: 13.2px;"><a fg_scanned="1" href="https://creutzfeldt-jakob-disease.blogspot.com/2020/08/" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://creutzfeldt-jakob-disease.blogspot.com/2020/08/</a><br /></div><div style="font-size: 13.2px;"><br /></div><div style="font-size: 10pt;"><div><span style="font-size: 13.2px;">SUNDAY, JULY 19, 2020 </span></div><div><span style="font-size: 13.2px;"><br /></span></div><div><span style="font-size: 13.2px;">Joseph J. Zubak Orthopaedic surgeon passed away Monday, July 6, 2020, Creutzfeldt-Jakob Disease (CJD)</span></div><div><span style="font-size: 13.2px;"><br /></span></div><div><a fg_scanned="1" href="https://creutzfeldt-jakob-disease.blogspot.com/2020/07/joseph-j-zubak-orthopaedic-surgeon.html" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://creutzfeldt-jakob-disease.blogspot.com/2020/07/joseph-j-zubak-orthopaedic-surgeon.html</a><br /></div><div><br /></div><div><span style="font-size: 13.2px;">Variant Creutzfeldt–Jakob Disease Diagnosed 7.5 Years after Occupational Exposure</span></div><div><span style="font-size: 13.2px;"><br /></span></div><div><span style="font-size: 13.2px;">Variant Creutzfeldt–Jakob disease was identified in a technician who had cut her thumb while handling brain sections of mice infected with adapted BSE 7.5 years earlier. The long incubation period was similar to that of the transfusion-transmitted form of the disease.</span></div><div><span style="font-size: 13.2px;"><br /></span></div><div><a fg_scanned="1" href="https://www.nejm.org/doi/full/10.1056/NEJMc2000687" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://www.nejm.org/doi/full/10.1056/NEJMc2000687</a><br /></div><div><br /></div><div><a href="https://www.nejm.org/doi/suppl/10.1056/NEJMc2000687/suppl_file/nejmc2000687_appendix.pdf" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://www.nejm.org/doi/suppl/10.1056/NEJMc2000687/suppl_file/nejmc2000687_appendix.pdf</a><br /></div><div><br /></div><div><span style="font-size: 13.2px;">THURSDAY, JULY 02, 2020 </span></div><div><span style="font-size: 13.2px;"><br /></span></div><div><span style="font-size: 13.2px;">Variant Creutzfeldt–Jakob Disease Diagnosed 7.5 Years after Occupational Exposure</span></div><div><span style="font-size: 13.2px;"><br /></span></div><div><a fg_scanned="1" href="https://vcjd.blogspot.com/2020/07/variant-creutzfeldtjakob-disease.html" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://vcjd.blogspot.com/2020/07/variant-creutzfeldtjakob-disease.html</a></div><div><br /></div><div><div dir="ltr" style="font-size: 12px;">TUESDAY, MAY 24, 2022 </div><div dir="ltr" style="font-size: 12px;"><br /></div><div dir="ltr" style="font-size: 12px;">Texas Creutzfeldt Jakob Disease CJD TSE Prion Update Singeltary FOIA Request Received May 23, 2022</div><div dir="ltr" style="font-size: 12px;"><br /></div><div dir="ltr" style="font-size: 12px;"><a fg_scanned="1" href="https://cjdtexas.blogspot.com/2022/05/texas-creutzfeldt-jakob-disease-cjd-tse.html" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://cjdtexas.blogspot.com/2022/05/texas-creutzfeldt-jakob-disease-cjd-tse.html</a></div></div><div><br /></div><div><div class="yiv5849607341AOLWebSuite yiv5849607341AOLWebSuiteM1" style="font-size: 12px;"><div id="yiv5849607341"><div style="font-family: arial; font-size: 10pt; font-stretch: normal; line-height: normal;"><div><div style="text-align: justify;">MONDAY, JUNE 14, 2021 </div><div style="text-align: justify;"><br /></div><div style="text-align: justify;">Texas Health and Human Services The Department of State Health Services Creutzfeldt Jakob Disease TSE Prion Report 2021?<br /></div><div style="text-align: justify;"><br /></div><div style="text-align: justify;"><a fg_scanned="1" href="http://cjdtexas.blogspot.com/2021/06/texas-health-and-human-services.html" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">http://cjdtexas.blogspot.com/2021/06/texas-health-and-human-services.html</a></div></div><div><br /></div><div><div style="text-align: justify;"><span style="color: #29303b;">SUNDAY, MAY 08, 2022 </span></div><div style="text-align: justify;"><span style="color: #29303b;"><br /></span></div><div style="text-align: justify;"><span style="color: #29303b;">USA National Prion Disease Pathology Surveillance Center Surveillance Update April 11th, 2022</span><br /></div><div style="text-align: justify;"><span style="color: #29303b;"><br /></span></div><div style="text-align: justify;"><span style="color: #29303b;"><a fg_scanned="1" href="https://creutzfeldt-jakob-disease.blogspot.com/2022/05/usa-national-prion-disease-pathology.html" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://creutzfeldt-jakob-disease.blogspot.com/2022/05/usa-national-prion-disease-pathology.html</a></span></div></div><div style="text-align: justify;"><br /></div><div style="text-align: justify;">TUESDAY, APRIL 05, 2022 </div><div style="text-align: justify;"><br /></div><div style="text-align: justify;">Incidence of Creutzfeldt-Jakob Disease in the United States 1993-2014<br /></div><div style="text-align: justify;"><br /></div><div style="text-align: justify;"><a fg_scanned="1" href="https://creutzfeldt-jakob-disease.blogspot.com/2022/04/incidence-of-creutzfeldt-jakob-disease_5.html" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://creutzfeldt-jakob-disease.blogspot.com/2022/04/incidence-of-creutzfeldt-jakob-disease_5.html</a></div></div></div></div></div></div><div style="font-size: 10pt;"><br /></div><div style="font-size: 10pt;"><div><span style="font-family: arial, helvetica;">TUESDAY, MARCH 29, 2022 </span></div><div><span style="font-family: arial, helvetica;"><br /></span></div><div><span style="font-family: arial, helvetica;">OIE Agent causing chronic wasting disease (CWD) TSE Prion of Cervid</span><br /></div><div><span style="font-family: arial, helvetica;"><br /></span></div><div><span style="font-family: arial, helvetica;"><a fg_scanned="1" href="https://animalhealthreportpriontse.blogspot.com/2022/03/oie-agent-causing-chronic-wasting.html" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://animalhealthreportpriontse.blogspot.com/2022/03/oie-agent-causing-chronic-wasting.html</a></span></div></div><div style="font-size: 10pt;"><br /></div><div><span style="font-family: arial; font-size: 10pt; text-align: justify;">THURSDAY, MARCH 31, 2022 </span><span style="font-family: arial; font-size: 13.3333px; text-align: justify;"></span><div style="font-family: arial; font-size: 10pt; text-align: justify;"><br /></div><div style="font-family: arial; font-size: 10pt; text-align: justify;">EFSA ONE Conference 2022 Chronic Wasting Disease CWD TSE PrP of Cervid and Zoonosis Zoonotic Transmission Singeltary Submission</div><div style="font-family: arial; font-size: 10pt; text-align: justify;"><br /></div><div style="font-family: arial; font-size: 10pt; text-align: justify;"><a fg_scanned="1" href="https://efsaopinionbseanimalprotein.blogspot.com/2022/03/efsa-one-conference-2022-chronic.html" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">https://efsaopinionbseanimalprotein.blogspot.com/2022/03/efsa-one-conference-2022-chronic.html</a></div></div></div></div></div></div></div></div></div></div></div></div></div><div style="background-color: white;"><div style="color: #29303b; font-size: 10pt; text-align: justify;">Terry S. Singeltary Sr., Bacliff, Tx. 77518 <a href="mailto:flounder9@verizon.net" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank" ymailto="mailto:flounder9@verizon.net">flounder9@verizon.net</a> Galveston Bay...on the bottom.</div></div></div><div><br style="font-family: arial; font-size: 13.3333px;" /></div></div></div></div></div>Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-4687453285836897153.post-32537775298112332162008-05-18T20:02:00.000-05:002022-08-17T11:25:24.939-05:00MAD COW DISEASE BSE CJD CHILDREN VACCINES<div style="background-color: white; font-family: arial; font-size: 13.3333px;"><h2 class="yiv1590953550ydpdffa49e3date-header" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 11.7px; font-weight: normal; letter-spacing: 0.1em; margin: 0px; padding: 0px; text-transform: uppercase;">SUNDAY, MAY 18, 2008</h2><div class="yiv1590953550ydpdffa49e3date-posts"><div class="yiv1590953550ydpdffa49e3post-outer"><div class="yiv1590953550ydpdffa49e3post yiv1590953550ydpdffa49e3hentry yiv1590953550ydpdffa49e3uncustomized-post-template" style="margin: 8px 0px 24px;"><span style="font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a name="3253777529811233216" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer; text-decoration-line: underline;"></a></span><h3 class="yiv1590953550ydpdffa49e3post-title yiv1590953550ydpdffa49e3entry-title" itemprop="name" style="color: #1b0431; font-family: Georgia, "Times New Roman", sans-serif; font-size: 18.2px; font-weight: normal; margin: 0px; padding: 0px;">MAD COW DISEASE BSE CJD CHILDREN VACCINES</h3><div style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-header" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><div class="yiv1590953550ydpdffa49e3post-header-line-1"></div></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Sunday, May 18, 2008<br /><br />MAD COW DISEASE BSE CJD CHILDREN VACCINES<br /><br />TIP740203/l 0424 CONFIDENTIAL<br /><br /><br /><a fg_scanned="1" href="http://www.mad-cow.org/00/may00_news.html#aaa" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer;" target="_blank">http://www.mad-cow.org/00/may00_news.html#aaa</a><br /><br /><br /><br />TWA LITTLE minute<br /><br />2. We have identified one problem over where we are unable to act and this is the use of gonadotrophins in embryo transfer work. Some veterinary surgeons are quite legally using this exemption from the Medicines Act contained in Section 9(2) to prepare gonadotrophins from pituitary glands from various species, including cattle. These hormones are used to stimulate superovulation in donor cows.<br /><br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102164806/http://www.bseinquiry.gov.uk/files/yb/1988/06/10001001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer;" target="_blank">http://collections.europarchive.org/tna/20080102164806/http://www.bseinquiry.gov.uk/files/yb/1988/06/10001001.pdf</a><br /><br /><br />NEW LINK URL 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090718143101/http://www.bseinquiry.gov.uk/files/yb/1988/06/10001001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090718143101/http://www.bseinquiry.gov.uk/files/yb/1988/06/10001001.pdf</a><br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102164811/http://www.bseinquiry.gov.uk/files/yb/1988/06/13010001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer;" target="_blank">http://collections.europarchive.org/tna/20080102164811/http://www.bseinquiry.gov.uk/files/yb/1988/06/13010001.pdf</a></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /><br />NEW LINK URL 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090718143112/http://www.bseinquiry.gov.uk/files/yb/1988/06/13010001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090718143112/http://www.bseinquiry.gov.uk/files/yb/1988/06/13010001.pdf</a><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /><br /><a href="http://collections.europarchive.org/tna/20080103031215/http://www.bseinquiry.gov.uk/files/yb/1988/06/14006001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer;" target="_blank">http://collections.europarchive.org/tna/20080103031215/http://www.bseinquiry.gov.uk/files/yb/1988/06/14006001.pdf</a><br /><br /><br />NEW LINK URL 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /><a href="http://web.archive.org/web/20090718143117/http://www.bseinquiry.gov.uk/files/yb/1988/06/14006001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090718143117/http://www.bseinquiry.gov.uk/files/yb/1988/06/14006001.pdf</a></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /><br />COMMERCIAL IN CONFIDENCE<br /><br />3.2 Minute 5.3 - 5.4 Bovine Spongiform Encephalopathy<br /><br />It was reported that some replies had been received from Companies using pituitary glands in their products. Copies of the BSE document had also been sent to DHSS and NIBSC.<br /><br />and then another 3 + pages of blank space. ...TSS<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102164813/http://www.bseinquiry.gov.uk/files/yb/1988/09/06005001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer;" target="_blank">http://collections.europarchive.org/tna/20080102164813/http://www.bseinquiry.gov.uk/files/yb/1988/09/06005001.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090718143134/http://www.bseinquiry.gov.uk/files/yb/1988/09/06005001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090718143134/http://www.bseinquiry.gov.uk/files/yb/1988/09/06005001.pdf</a><br /><br /><br />COMMERCIAL IN CONFIDENCE<br /><br /><br />BSE - CURRENT POSITION WITH VETERINARY LICENCED PRODUCTS (MA.1968)<br /><br />There are three areas of particular concern, vaccines (including emergency vaccines), pharmaceuticals which are covered by MA licences and unlicenses hormonal products produced under exemptions claimed under (Section 9(2) Medicines Act).<br /><br />1) Vaccines<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103033809/http://www.bseinquiry.gov.uk/files/yb/1988/10/06005001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer;" target="_blank">http://collections.europarchive.org/tna/20080103033809/http://www.bseinquiry.gov.uk/files/yb/1988/10/06005001.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090718143144/http://www.bseinquiry.gov.uk/files/yb/1988/10/06005001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090718143144/http://www.bseinquiry.gov.uk/files/yb/1988/10/06005001.pdf</a><br /><br /><br />NOT FOR PUBLICATION<br /><br />another 6 pages of blank space. ...TSS<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103032658/http://www.bseinquiry.gov.uk/files/yb/1988/11/01012001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer;" target="_blank">http://collections.europarchive.org/tna/20080103032658/http://www.bseinquiry.gov.uk/files/yb/1988/11/01012001.pdf</a></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /><br />NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; 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font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090506070206/http://www.bseinquiry.gov.uk/files/yb/1988/11/04003001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506070206/http://www.bseinquiry.gov.uk/files/yb/1988/11/04003001.pdf</a><br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103033926/http://www.bseinquiry.gov.uk/files/yb/1988/04/00007001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer;" target="_blank">http://collections.europarchive.org/tna/20080103033926/http://www.bseinquiry.gov.uk/files/yb/1988/04/00007001.pdf</a></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">NEW LINK URL 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090718143048/http://www.bseinquiry.gov.uk/files/yb/1988/04/00007001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090718143048/http://www.bseinquiry.gov.uk/files/yb/1988/04/00007001.pdf</a><br /><br /><br />COMMERCIAL IN CONFIDENCE<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103034137/http://www.bseinquiry.gov.uk/files/yb/1988/07/00007001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer;" target="_blank">http://collections.europarchive.org/tna/20080103034137/http://www.bseinquiry.gov.uk/files/yb/1988/07/00007001.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090718143123/http://www.bseinquiry.gov.uk/files/yb/1988/07/00007001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090718143123/http://www.bseinquiry.gov.uk/files/yb/1988/07/00007001.pdf</a><br /><br /><br />COMMERCIAL IN CONFIDENCE</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /><br />Medicines Act - Veterinary Products Committee<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103034140/http://www.bseinquiry.gov.uk/files/yb/1988/09/00004001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer;" target="_blank">http://collections.europarchive.org/tna/20080103034140/http://www.bseinquiry.gov.uk/files/yb/1988/09/00004001.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090718143129/http://www.bseinquiry.gov.uk/files/yb/1988/09/00004001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090718143129/http://www.bseinquiry.gov.uk/files/yb/1988/09/00004001.pdf</a></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /><br />COMMERCIAL IN CONFIDENCE<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102164744/http://www.bseinquiry.gov.uk/files/yb/1988/10/00003001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer;" target="_blank">http://collections.europarchive.org/tna/20080102164744/http://www.bseinquiry.gov.uk/files/yb/1988/10/00003001.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090718143137/http://www.bseinquiry.gov.uk/files/yb/1988/10/00003001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090718143137/http://www.bseinquiry.gov.uk/files/yb/1988/10/00003001.pdf</a><br /><br /><br />MANAGEMENT IN CONFIDENCE</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /><br />CERTIFIED BSE-FREE HERDS FOR SOURCE OF MATERIAL FOR BIOLOGICAL PRODUCTS<br /><br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102184729/http://www.bseinquiry.gov.uk/files/yb/1989/01/04001001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer;" target="_blank">http://collections.europarchive.org/tna/20080102184729/http://www.bseinquiry.gov.uk/files/yb/1989/01/04001001.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090718143157/http://www.bseinquiry.gov.uk/files/yb/1989/01/04001001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090718143157/http://www.bseinquiry.gov.uk/files/yb/1989/01/04001001.pdf</a><br /><br /><br />COMMERCIAL IN CONFIDENCE</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /><br />NOT FOR PUBLICATION<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102185137/http://www.bseinquiry.gov.uk/files/yb/1989/01/26007001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer;" target="_blank">http://collections.europarchive.org/tna/20080102185137/http://www.bseinquiry.gov.uk/files/yb/1989/01/26007001.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090718143205/http://www.bseinquiry.gov.uk/files/yb/1989/01/26007001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090718143205/http://www.bseinquiry.gov.uk/files/yb/1989/01/26007001.pdf</a></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /><br /><a href="http://web.archive.org/web/20030515185220/http://www.bseinquiry.gov.uk/files/yb/1989/01/30001001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer;" target="_blank">http://web.archive.org/web/20030515185220/http://www.bseinquiry.gov.uk/files/yb/1989/01/30001001.pdf</a><br /><br /><br />NEW LINK URL 2022<br /><br /><br /><a href="http://web.archive.org/web/20090718143213/http://www.bseinquiry.gov.uk/files/yb/1989/01/30001001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090718143213/http://www.bseinquiry.gov.uk/files/yb/1989/01/30001001.pdf</a></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /><br />COMMERCIAL IN CONFIDENCE</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /><br />NOT FOR PUBLICATION<br /><br /><br /><a href="http://web.archive.org/web/20030704202503/http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer;" target="_blank">http://web.archive.org/web/20030704202503/http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf</a><br /><br /><br />NON-LICENSED HUMAN TISSUE DEVICES WERE NOT COMMERCIALLY AVAILABLE<br /><br />snip...<br /><br />I was quite prepared to believe in unofficial pituitary hormones, also in the 1970's, whether as described by Dr. Little, or in other circumstances, for animal use.<br /><br />snip...<br /><br />The fact that there were jars of pituitaries (or extract) around on shelves is attested by the still potent 1943 pituitaries, described in Stockell Hartree et al. (J/RF/17/291) which had come from the lab. at Mill Hill. Having taken the trouble to collect them, they were not lightly thrown out...<br /><br /><br /><a href="http://collections.europarchive.org/tna/20090114045856/http://www.bseinquiry.gov.uk/files/ws/s467bx.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer;" target="_blank">http://collections.europarchive.org/tna/20090114045856/http://www.bseinquiry.gov.uk/files/ws/s467bx.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090718143039/http://www.bseinquiry.gov.uk/files/ws/s467bx.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090718143039/http://www.bseinquiry.gov.uk/files/ws/s467bx.pdf</a><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /><br />more on the 1968 medicine act, they forgot to follow i.e. no Scrapie-like disease. ...TSS<br /><br /><br /><a href="http://web.archive.org/web/20030526124448/http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer;" target="_blank">http://web.archive.org/web/20030526124448/http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090718143216/http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090718143216/http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf</a><br /><br /><br />Draft cover letter to product licence holders (considered by Human and Vet Medicines including deer)<br /><br /><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">CONCERN ABOUT BSE IN HUMAN MEDICINE</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /><br />Although these materials relate to materials of bovine origin, they should also be considered as applicable to material from SHEEP, GOATS, DEER, AND SOME OTHER ANIMALS SUSCEPTIBLE TO SCRAPIE LIKE AGENTS.<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103002832/http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer;" target="_blank">http://collections.europarchive.org/tna/20080103002832/http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090718143224/http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090718143224/http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf</a></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /><br /><a href="http://collections.europarchive.org/tna/20081105201818/http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer;" target="_blank">http://collections.europarchive.org/tna/20081105201818/http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf</a></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /><br />(It was noted with concern that hormone extracts could be manufactured by a veterinary surgeon for administration to animals under his care without any Medicines Act Control.)<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102164725/http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer;" target="_blank">http://collections.europarchive.org/tna/20080102164725/http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090718143059/http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090718143059/http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf</a></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /><br /><a href="http://collections.europarchive.org/tna/20090505223756/http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer;" target="_blank">http://collections.europarchive.org/tna/20090505223756/http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090718143059/http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090718143059/http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf</a><br /><br /><br />COMMERCIAL IN CONFIDENCE<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102164736/http://www.bseinquiry.gov.uk/files/yb/1988/06/07010001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer;" target="_blank">http://collections.europarchive.org/tna/20080102164736/http://www.bseinquiry.gov.uk/files/yb/1988/06/07010001.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090718143053/http://www.bseinquiry.gov.uk/files/yb/1988/06/07010001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090718143053/http://www.bseinquiry.gov.uk/files/yb/1988/06/07010001.pdf</a><br /><br /><br />TWA LITTLE STATEMENT 331<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102163939/http://www.bseinquiry.gov.uk/files/ws/s331.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer;" target="_blank">http://collections.europarchive.org/tna/20080102163939/http://www.bseinquiry.gov.uk/files/ws/s331.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090718143038/http://www.bseinquiry.gov.uk/files/ws/s331.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090718143038/http://www.bseinquiry.gov.uk/files/ws/s331.pdf</a><br /><br /><br />snip...<br /><br /><br />Singeltary concerns submitted to FDA;</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><span style="color: black; font-family: "Times New Roman"; font-size: medium;">PDF]Freas, William TSS SUBMISSION</span><br style="color: black; font-family: "Times New Roman"; font-size: medium;" /><br style="color: black; font-family: "Times New Roman"; font-size: medium;" /><span style="color: black; font-family: "Times New Roman"; font-size: medium;">File Format: PDF/Adobe Acrobat -</span><br style="color: black; font-family: "Times New Roman"; font-size: medium;" /><br style="color: black; font-family: "Times New Roman"; font-size: medium;" /><span style="color: black; font-family: "Times New Roman"; font-size: medium;">Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary</span><br style="color: black; font-family: "Times New Roman"; font-size: medium;" /><br style="color: black; font-family: "Times New Roman"; font-size: medium;" /><span style="color: black; font-family: "Times New Roman"; font-size: medium;">Sr. [</span><a class="moz-txt-link-abbreviated" href="mailto:flounder@wt.net" style="color: #0096ef; cursor: pointer; font-family: "Times New Roman"; font-size: medium; text-decoration-line: none;">flounder@wt.net</a><span style="color: black; font-family: "Times New Roman"; font-size: medium;">] Monday, January 08,200l 3:03 PM freas ...</span><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><span style="color: black; font-family: "Times New Roman"; font-size: medium;"><br /></span></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20170301223601/http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20170301223601/http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf</a><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">2003<br /><br /><a fg_scanned="1" href="http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer;" target="_blank">http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm</a></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a fg_scanned="1" href="http://web.archive.org/web/20110828071905/http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20110828071905/http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm</a><br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103032631/http://www.bseinquiry.gov.uk/files/yb/1988/11/04003001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer;" target="_blank">http://collections.europarchive.org/tna/20080103032631/http://www.bseinquiry.gov.uk/files/yb/1988/11/04003001.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><a href="http://web.archive.org/web/20090506070206/http://www.bseinquiry.gov.uk/files/yb/1988/11/04003001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506070206/http://www.bseinquiry.gov.uk/files/yb/1988/11/04003001.pdf</a><br /><br /><br />8. The Secretary of State has a number of licences. We understand that the inactivated polio vaccine is no longer being used. There is a stock of smallpox vaccine. We have not been able to determine the source material. (Made in sheep very unlikely to contain bovine ingredients).<br /><br /><br /><br />CONFIDENTIAL<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102164642/http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer;" target="_blank">http://collections.europarchive.org/tna/20080102164642/http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><a href="http://web.archive.org/web/20090505223918/http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf" style="color: #29303b; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px; text-decoration-line: none;">http://web.archive.org/web/20090505223918/http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf</a><br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">From: TSS Subject: How many NHS patients as having received blood from a donor who later developed vCJD were people with haemophilia Date: December 21, 2006 at 9:13 am PST</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Health: vCJD Lord Morris of Manchester asked Her Majesty's Government:</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">How many NHS patients identified by the National Blood Service as having received blood from a donor who later developed vCJD were people with haemophilia. [HL750]</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">19 Dec 2006 : Column WA291</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">The Minister of State, Department of Health (Lord Warner): No patient with haemophilia or other bleeding disorders have been identified as having received blood from a blood donor who subsequently developed vCJD, nor have there been any reported cases of vCJD associated with receipt of plasma products.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">However, all haemophilia patients who received plasma products between 1980 and 2001 sourced from UK donor plasma have been designated as "at risk of vCJD for public purposes". All plasma products are now sourced from non-UK plasma. The United Kingdom Haemophilia Centre Doctors' Organisation is collecting data that will provide an estimate of the number of haemophilia patients who have been exposed to plasma products which may be implicated with vCJD.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Lord Morris of Manchester asked Her Majesty's Government:</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">What is their response to the findings of Professor John Collinge in the December 2006 edition of the Lancet on the transmission by infected blood of variant CJD; and what action they are planning to take. [HL751]</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Lord Warner: The Lancet article refers to the third known case of vCJD transmission via blood transfusion from a vCJD-infected donor. This case was originally notified to the department in January 2006 and announced by the Health Protection Agency in a press release on 9 February 2006, a copy of which has been placed in the Library.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">There are 24 living patients in a group of people who had received blood components from donors subsequently known to have developed vCJD. They were all notified in 2005 or earlier, through their GPs, of their risk status and have been provided with information and support. The Health Protection Agency contacted the GPs earlier in the year to notify them of this third case and the agency has ensured that the GPs are fully informed and briefed about the subsequent Lancet publication.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">The department has implemented a series of measures to reduce the risk of vCJD being transmitted through the blood supply. Shortly after vCJD was first identified in 1996, the possibility of human-to-human transmission through blood was considered, and the department implemented precautionary measures to reduce what was, at that time, a theoretical risk. These measures have been strengthened since evidence of transmission via blood began to emerge from animal studies, and following the first case of transfusion-associated transmission in humans, reported in December 2003. An important additional step, introduced in March 2004, was to exclude from blood donation those people who had themselves received a blood transfusion since January 1980. Other precautionary measures include:</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">from December 1997, blood components, plasma products or tissues obtained from any individual who later develops vCJD, were withdrawn/recalled;</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">19 Dec 2006 : Column WA292</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">in July 1998, it was announced that plasma for the manufacture of blood products, such as clotting factors, would be obtained from non-UK sources;from November 1999, white blood cells, which may carry a significant risk of transmitting vCJD, were removed from all blood used for transfusion;in August 2002, it was announced that fresh frozen plasma for treating babies and young children born on or after 1 January 1996 would be obtained from the USA; in July 2004, the exclusion criteria for blood donation were extended to include previously transfused platelet donors, and donors who were unsure if they had previously had a blood transfusion;in September 2004, the department announced further precautionary measures for patients who had received certain batches of plasma products;in July 2005, the use of USA-sourced fresh frozen plasma was extended to all children up to the age of 16;in July 2005, the department announced further precautionary measures for those patients who donated blood to three people who later developed vCJD. The department continues to keep all the evidence in relation to transmission of vCJD by blood under close review.</span><br /><br /><br /><a fg_scanned="1" href="http://www.publications.parliament.uk/pa/ld200607/ldhansrd/text/61219w0004.htm#06121940000034" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://www.publications.parliament.uk/pa/ld200607/ldhansrd/text/61219w0004.htm#06121940000034</a><br /><br /><br /><br /><a fg_scanned="1" href="http://www.whale.to/v/singeltary7.html" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://www.whale.to/v/singeltary7.html</a><br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Subject: Re: VACCINES/CHILDREN/TSE'S -- 'CONFIDENTIAL' </span></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Date: Wed, 6 Sep 2000 18:20:09 -0800 </span></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">From: tom </span></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Reply-To: Bovine Spongiform Encephalopathy To: </span><a href="mailto:BSE-L@uni-karlsruhe.de" rel="noopener noreferrer" style="color: blue; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">BSE-L@uni-karlsruhe.de</a><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"> </span></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">References: 1</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">######### Bovine Spongiform Encephalopathy #########</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Just when I was thinking the Internet had reached a terminal condition of shallow pages and broken links, some young people come along and invent a really effective Internet search engine: </span><a href="http://www.google.com/" rel="noopener noreferrer" style="color: blue; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://www.google.com/</a><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"> This works quite well to search the entire </span><a fg_scanned="1" href="http://www.mad-cow.org/" rel="noopener noreferrer" style="color: blue; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://www.mad-cow.org</a><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"> site (or find 393 web sites such as GenBank that link to it, or 936 sites that cite it in text) back to 1996 as well as the BSE Inquiry </span><a fg_scanned="1" href="http://www.bse.org.uk/" rel="noopener noreferrer" style="color: blue; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://www.bse.org.uk/</a><br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Thus for louping ill (unnecessary cites suppressed):</span></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></span></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Paragraph 94 of Dr Maddocks supplementary statement (WS 467A)</span></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></span></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">(a)A sheep is another sheep’s worst enemy. I agree.</span></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></span></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">(b)Louping ill vaccine in sheep is associated with scrapie and growth hormone in humans. Someone at CVL would be very qualified to answer questions on the trial of louping ill vaccine which were carried out many years ago. Sheep tissue was used in the preparation. Unfortunately scrapie type symptoms and lesions appeared in the recipients of this vaccine. I am sure our medical colleagues could give more details of the human derived growth hormone, which was reported to have caused CJD symptoms in recipients of treatment with that product.</span></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></span></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Vaccines and hormones are species specific prepared. This was not the case in this country. No cow pituitaries were used in the preparation of FSH products compared with the case of louping ill vaccine for scrapie. </span></div></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></span><br /><a fg_scanned="1" href="http://www.bse.org.uk/witness/htm/stat537.htm" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://www.bse.org.uk/witness/htm/stat537.htm</a></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /><br />NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><a fg_scanned="1" href="http://web.archive.org/web/20001009101158/http://www.bse.org.uk/witness/htm/stat537.htm" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20001009101158/http://www.bse.org.uk/witness/htm/stat537.htm</a></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Witness Statements 537 - Coulthard</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">29.Pituitary FSH from pigs has been used in the USA prior to its use in the UK and much more extensively there and Canada.... 30.Thousands of embryos were exported from this country to the USA prior to the ban being imposed... 42. No cow pituitaries were used in the preparation of FSH [follicular stimulating hormone] products compared with the case of louping ill vaccine for scrapie.</span><br /><br /><a fg_scanned="1" href="http://www.mad-cow.org/~tom/fda_late.html#ill" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://www.mad-cow.org/~tom/fda_late.html#ill</a></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216">NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><a fg_scanned="1" href="https://webarchive.nationalarchives.gov.uk/ukgwa/20060525120000/http://www.bseinquiry.gov.uk/evidence/ws/ws10.htm" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://webarchive.nationalarchives.gov.uk/ukgwa/20060525120000/http://www.bseinquiry.gov.uk/evidence/ws/ws10.htm</a></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216">WOW, WE NOW KNOW CWD AND SCRAPIE TRANSMITS TO PIGS BY ORAL ROUTE...terry<br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">In the 1930's: 18,000 UK sheep were inoculated against louping ill, a brain inflammatory illness spread by ticks. Despite formalin-treatment of the inoculated agent, the procedure gave rise to 1,500 cases of scrapie. Louping is a Scottish word for fleeing or leaping, related to loping. In humans, louping ill is called Russian spring-summer encephalitis, a meningo-encephalitis with muscular tremors and spasms followed by varying degrees of paralysis.... [John Lanchester 2 Dec 96 New Yorker]</span><br /><br /><a fg_scanned="1" href="http://www.foodsafety.org/consumer/ht/ht294.htm" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://www.foodsafety.org/consumer/ht/ht294.htm</a><br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">In what the story calls a grand historical irony, this landmark series of experiments was being confirmed at the same time in England as a result of an outbreak of scrapie in several hundred sheep that had been immunized against louping ill with a vaccine prepared from tissue from the brain, spinal cord, and spleen of sheep that were belatedly discovered to have been exposed to natural scrapie infection.[6.Gordon WS. Advances in veterinary research. Vet Rec 1946; 58: 516-520] The transmissible nature of the scrapie agent was thus established beyond any doubt. [P Brown, 1755 and All That: A Historical Primer of TSE.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">We need to look at the full text of the article and its cites to see how they actually made the vaccine, whether they exported vaccine-infected sheep to Canada and the US, and what became of the vaccinated flocks. Perhaps there is still sample available, Moredun Institute is still around.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Gordon WS. Advances in veterinary research. Vet Rec 1946; 58: 516-520 (not covered by Medline) Gordon, Bronlee and Wilson 1939 [full cite is available only in a letter we don't have)</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Terry was reading Draft Factual Account 17</span><br /><br /><a fg_scanned="1" href="http://www.bse.org.uk/dfa/dfa17.htm" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://www.bse.org.uk/dfa/dfa17.htm</a></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /><br />NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><a fg_scanned="1" href="http://web.archive.org/web/20001219215500/http://www.bse.org.uk/dfa/dfa17.htm" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20001219215500/http://www.bse.org.uk/dfa/dfa17.htm</a><br /><br /><br /><a fg_scanned="1" href="http://bseinquiry.blogspot.com/2008/05/bse-inquiry-draft-factual-account-dfa.html" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://bseinquiry.blogspot.com/2008/05/bse-inquiry-draft-factual-account-dfa.html</a><br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">236. Mrs Alderman replied on 3 June 1988, listing products containing bovine insulin and noting there were two rabies vaccines listed but the species used in manufacture was not shown.[282] 237. On 6 June 1988 Mr Lawrence wrote to Sir Richard Southwood and enclosed some brief answers to the questions that had been tabled at the meeting on 19 May.[283] In relation to Q6, which asked OWhat is meat and other material from scrapie infected sheep used for - does it include pet food and material for biological products?¹ Part of the answer stated: ...</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">There has been one instance of inadvertant [sic] transmission of the scrapie agent to sheep through louping ill vaccine (Gordon, Bronlee and Wilson 1939). One of the three batches of vaccine made in 1935 at the Moredun Institute contained the scrapie agent resulting in 7% of the recipients of the 18, 000 doses in the batch developing scrapie. This vaccine was made from formalin-inactivated sheep brain, and brought to the attention of research workers that formalin, at a concentration of 0.35% for at least 3 months, which inactivated conventional viruses, did not totally inactivate the scrapie agent.</span><br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">----------------------------</span><br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">4. Questions we might want to have answered are: the highest risk would be from parenterals prepared from brain (eg rabies vaccine). Any species in which transmissible spongiform encephalopathies have been described would be suspect ("natural" infections in sheep, goats, cattle, deer, mink, but can be transmitted to hamster, mouse, guinea-pig etc). Are sterilisation processes adequate for the most resistant strain of scrapie agent or for CJD agent? Should companies be asked to include investigation for inclusion of scrapie agent (eg mouse innoculation [sic]) in at least some batches? If BSE behaves like scrapie, then we might expect other nervous tissue, spleen, lymph nodes and placenta to be contaminated. Infection has been described in other tissues too, eg gut wall, and we can not [sic] be sure blood is free. Do we know what bovine materials are used in which products, both as the active ingredient and in production? Bovine active ingredients in human products include insulin, vasopressin, bone, immune globulins, fibrin, dermal collagen, albumin. Bovine serum albumin and fetal calf serum must be used in preparation of very many products. For each of these products would any "BSE agent" be destroyed or eliminated in processing? If not, and the product is administered parenterally or topically into an open wound, might there be a risk? [For oral products, there would only be a trivially increased load on top of that taken in food in omnivores/carnivores including man. But for some herbivores, this might allow the agent to be introduced into yet another species].</span><br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">--------------------------</span><br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Medicines and medical devises;</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Subject: 2 known incidents of iatrogenic scrapie Date: Thu, 7 Sep 2000 09:51:14 -0800 From: tom Reply-To: Bovine Spongiform Encephalopathy To: </span><a href="mailto:BSE-L@uni-karlsruhe.de" rel="noopener noreferrer" style="color: blue; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">BSE-L@uni-karlsruhe.de</a><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"> References: 1</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">######### Bovine Spongiform Encephalopathy #########</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">One really has to wonder what went on in veterinary products produced during the peak BSE years. At this point, there are only 2 known incidents, both involving sheep brain vaccines.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">I found a better source for needed references for iatrogenic scrapie in a nice review by Ray Bradley at </span><a fg_rewritten="1" fg_scanned="1" href="http://www.iica.org.ar/Bse/6-%20Bradley.html" rel="noopener noreferrer" style="background-color: rgb(200, 26, 0) !important; color: blue; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px; padding-bottom: 3px; padding-left: 3px; padding-right: 3px;" target="_blank">http://www.iica.org.ar/Bse/6-%20Bradley.html</a><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">. Disclosure has been meagre on the 1998 vaccine incident in Italy. Note 3 of the 5 references are totally off Medline and the other 2 fail to have abstracts or links, due to journal ineptness, burial in conference proceedings, and age of article.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">If anyone has the first 3, I would appreciate a fax </span><a rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px; text-decoration-line: underline;">542-484-0669</a><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"> US.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">tom</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">GORDON , W.S., 1959. Scrapie panel. In: Proceedings of 63rd Annual Meeting of the US Livestock Sanitary Association, 63, 286-294. [no medline record]</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">GORDON, W.S., 1946. Advances in Veterinary Research: Louping ill, tick-borne fever and scrapie. Veterinary Record, 58, 516-525. [no medline record]</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">GORDON , W.S., BROWNLEE, A.& WILSON, D.R., 1939. Studies in louping-ill, tick-borne fever and scrapie. 3rd International Congress for microbiology, 362-363. [no medline record]</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">-=-=--=</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">CAPUCCHIO, M.T., GUARDA,F., ISAIA,M.C., CARACAPPÀ, S. & DiMARCO,V., 1998. Natural occurrence of scrapie in goats in Italy. Veterinary Record, 143, 452-453. [title only]</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">AGRIMI, U., GLUSOPPE, R.U., CARDONE, F., POCCHIARI, M. & CARAMELLI, M., 1999. Epidemic transmissible spongiform encephalopathy in sheep and goats in Italy. Lancet, 353, 560-561. [title only]</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">IATROGENIC DISEASE IN ANIMALS</span><br /><br /><br /><a fg_rewritten="1" fg_scanned="1" href="http://www.iica.org.ar/Bse/6-%20Bradley.html" rel="nofollow noopener noreferrer" style="background-color: rgb(200, 26, 0) !important; color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px; padding-bottom: 3px; padding-left: 3px; padding-right: 3px;" target="_blank">http://www.iica.org.ar/Bse/6-%20Bradley.html</a><br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Ray Bradley Private BSE Consultant Veterinary Laboratories Agency, United Kingdom</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">There have been two reported incidents of iatrogenic disease in animals, both involving scrapie. One was in Great Britain (Gordon, Brownlee and Wilson, 1939, Gordon 1946, 1959) the other in Italy (Capucchio et al, 1998, Agrimi et al, 1999). Both resulted from infection being introduced into vaccines, louping ill vaccine in Great Britain, Mycoplasma agalactiae vaccine in Italy. Each of these vaccines was prepared from tissues that included sheep brain. In both episodes it seems most likely that natural scrapie infection was present unknowingly in some brains used for the purpose. Once prepared and having passed all the conventional vaccine tests large numbers of sheep in Great Britain, and goats and some sheep in Italy were inoculated. After the necessary incubation period large numbers (> 1,000 in each case) of inoculated animals came down with scrapie. In the meantime some inoculated clinically healthy goats and sheep may have entered food and feed chains or have been used for other purposes. In the British outbreak there appears to have been no consequence for humans who may have consumed infected sheep. It is too early to say what may be the consequences in Italy but measures have been taken to reduce any risk there may have been. .........end</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Louping-ill vaccine documents from November 23rd, 1946 FULL TEXT</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">THE VETERINARY RECORD 516 No 47. Vol. 58 November 23rd, 1946</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">NATIONAL VETERINARY MEDICAL ASSOCIATION OF GREAT BRITAIN AND IRELAND</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">ANNUAL CONGRESS, 1946</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">The annual Congress, 1946, was held at the Royal Veterinary College, Royal College Street, London, N.W.I. from September 22nd to September 27th.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Opening Meeting</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">[skip to scrapie vaccine issue...tss]</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Papers Presented to Congress</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">SNIP...FULL TEXT ;</span><br /><br /><a fg_scanned="1" href="http://whale.to/v/singeltary.html" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://whale.to/v/singeltary.html</a><br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">although 176 products do _not_ conform to the CSM/VPC guidelines.</span><br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">COMMERCIAL IN CONFIDENCE</span></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></span><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">NOT FOR PUBLICATION</span><br /><br /><br /><a href="http://web.archive.org/web/20030704202503/http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://web.archive.org/web/20030704202503/http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf</a><br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">8. The Secretary of State has a number of licences. We understand that the inactivated polio vaccine is no longer being used. There is a stock of smallpox vaccine. We have not been able to determine the source material. (Made in sheep very unlikely to contain bovine ingredients).</span><br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">CONFIDENTIAL</span><br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102164642/http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://collections.europarchive.org/tna/20080102164642/http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><a href="http://web.archive.org/web/20090505223918/http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090505223918/http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf</a><br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">CONFIDENTIAL</span><br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103002544/http://www.bseinquiry.gov.uk/files/yb/1989/02/14011001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://collections.europarchive.org/tna/20080103002544/http://www.bseinquiry.gov.uk/files/yb/1989/02/14011001.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><a href="http://web.archive.org/web/20090506060303/http://www.bseinquiry.gov.uk/files/yb/1989/02/14011001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506060303/http://www.bseinquiry.gov.uk/files/yb/1989/02/14011001.pdf</a><br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">more on the 1968 medicine act, they forgot to follow</span><br /><br /><br /><a href="http://web.archive.org/web/20030526124448/http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://web.archive.org/web/20030526124448/http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><a href="http://web.archive.org/web/20090718143216/http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090718143216/http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf</a></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Draft cover letter to product licence holders (considered by Human and Vet Medicines including deer)</span><br /><br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103002832/http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://collections.europarchive.org/tna/20080103002832/http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf</a></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216">NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><a href="http://web.archive.org/web/20090718143224/http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090718143224/http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf</a><br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102155758/http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://collections.europarchive.org/tna/20080102155758/http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><a href="http://web.archive.org/web/20090718143228/http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090718143228/http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf</a><br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">2.3.Iatrogenic exposure</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Iatrogenic exposure of scrapie has probably occurred twice. The first report determined that the vehicle was a louping ill vaccine prepared from sheep tissues and this infected a large number of sheep sheep (Gordon, 1946, Greig, 1950). The second was more recent and in this case a vaccine against Mycoplasma agalactiae prepared from sheep tissues was incriminated (Agrimi et al 1999, Capucchio, 1998) but not all outbreaks could be linked to the use of the vaccine. In this episode goats were predominantly affected10.</span><br /><br /><br /><a href="http://ec.europa.eu/food/fs/sc/ssc/out170_en.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://ec.europa.eu/food/fs/sc/ssc/out170_en.pdf</a><br /><br /><br /><br /><a href="http://ec.europa.eu/food/fs/sc/ssc/out247_en.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://ec.europa.eu/food/fs/sc/ssc/out247_en.pdf</a><br /><br /><br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">5.3.3 The greatest risk, in theory, would be from parenteral injection of material derived from bovine brain or lymphoid tissue. Medicinal products for injection or surgical implantation which are prepared from bovine tissues, or which utilise bovine serum albumin or similar agents in their manufacture, might also be capable of transmitting infectious agents. All medicinal products are licensed under the Medicines Act by the Licensing Authority following guidance, for example from the Committee on Safety of Medicines (CSM), the Committee on Dental and Surgical Materials (CDSM) and their subcommittees. The Licensing Authority have been alerted to potential concern about BSE in medicinal products and will ensure that scrutiny of source materials and manufacturing processes now takes account of BSE agent.</span><br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102132706/http://www.bseinquiry.gov.uk/files/ib/ibd1/tab02.pdf" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://collections.europarchive.org/tna/20080102132706/http://www.bseinquiry.gov.uk/files/ib/ibd1/tab02.pdf</a><br /><br /><br />NEW URL LINK 2022</div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><a href="http://web.archive.org/web/20090530225750/http://www.bseinquiry.gov.uk/files/ib/ibd1/tab02.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090530225750/http://www.bseinquiry.gov.uk/files/ib/ibd1/tab02.pdf</a><br /></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">BEFORE the BSE Inquiry went online, i was requesting the daily hearings and submissions, and they were sending them to me via air mail. then, when the BSE Inquiry finally went online, i was then able to go back and match up some of what i had with the YB numbers (above), with the official documents. ...TSS</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">BSE offals used in cosmetics, toiletry and perfume industry Sun, 3 Sep 2000. Unpublished Inquiry documents obtained by CJD activist Terry S. Singeltary Sr. of Bacliff, Texas Miss Marion Kelly Cosmetic, Toiletry and Perfumery Association 35 Dover Street London W1X3RA</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Department of Trade and Industry 10-18 Victoria Street London SW1H ONN Enquiries </span><a rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px; text-decoration-line: underline;">01-215 5000</a><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"> Telex 8811074 DTHQ G </span><a rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px; text-decoration-line: underline;">01 215 3324 1</a><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">February 1990</span><br /><br /><br /><a fg_scanned="1" href="http://www.mad-cow.org/00/sep00_news.html#bbb" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://www.mad-cow.org/00/sep00_news.html#bbb</a><br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">40,000 human heart valves a year from BSE herds Sun, 3 Sep 2000. Unpublished Inquiry documents obtained by CJD activist Terry S. Singeltary Sr. of Bacliff, Texas</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Opinion (webmaster): Below are some shocking documents. Here is a British company preparing 40,000 heart valves a year from bovine pericardium, primarily for export, and they are not required to source this material from BSE-free herds even in peak epidemic years. It is amazing to watch health "authorities" grovelling on their bellies to wring petty concessions from middle management at obscure little companies. The main worry is not the practise of using 800 potentially infected cows a week for human heart transplant material but that the press or recipients will get wind of it, hurting business.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">BSE wasn't the problem, it was awkward queries from importing countries like the US. The cows are stunned using brain penetration -- can't do anything about the chunks of bovine brain blasted into the circulatory system, it's the norm. Can't use younger lower-risk animals either, patch would not be big enough. It is fascinating to see the British government worrying about, but doing nothing, with pigs with BSE 10 years ago.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">While scrapie was long used as an excuse for continuing with human use of BSE-tainted material, little sheep material was used medically. Bovine transplants, vaccines, insulin doeses, etc. are far more dangerous than dietary material as injections, and are done on a very wide scale. So scrapie was never a valid analogy to BSE, as MAFF knew full well.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">The British government deferred to the manufacturer's rep for an opinion on how contaminated pericardium might be, just as this appeared showing that this tissue is extremely dangerous:</span><br /><br /><a fg_scanned="1" href="http://www.mad-cow.org/00/sep00_news.html#hhh" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://www.mad-cow.org/00/sep00_news.html#hhh</a><br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">England worried briefly about infecting other countries 27 Aug 00 confidential correspondence obtained by Terry S. Singeltary Sr.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">BSE11/2 020;</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">SC1337p</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">DEPARTMENT OF HEALTH AND SOCIAL SECURITY Richmond House, 79 Whitehall, London SWIA 2NS Telephone </span><a rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px; text-decoration-line: underline;">01-210 3000</a><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"> From the Chief Medical Officer Sir Donald Achson KBE DM DSc FRCP FFCM FFOM</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Mr K C Meldrum Chief Veterinary Officer Ministry of Agriculture, Fisheries and Food Government Buildings Hook Rise South Tolworth Surbiton Surrey KT6 7NG 3 January 1990</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Dear Mr Meldrum</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">BOVINE SPONGIFORM ENCEPHALOPATHY</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">You will recall that we have previously discussed the potential risks of BSE occurring in other countries as a result of the continuing export from the UK of meat and bone that may be contaminated by scrapie or possibly BSE.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">I remain concerned that we are not being consistent in our attempts to contain the risks of BSE. Having banned the feeding of meat and bone meal to ruminamts in 1988, we should take steps to prevent these UK products being fed to ruminants in other countries. This could be achieved either through a ban on the export of meat and bone meal, or at least by the proper labelling of these products to make it absolutely clear they should not be fed to ruminants [or zoo animals, including rare and endangered primates -- webmaster]. Unless some such action is taken the difficult problems we have faced with BSE may well occur in other countries who import UK meat and bone meal. Surely it is short sighted for us to risk being seen in future as having been responsible for the introduction of BSE to the food chain in other countries.</span><br /><br /><a fg_scanned="1" href="http://www.mad-cow.org/00/aug00_last_news.html#fff" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://www.mad-cow.org/00/aug00_last_news.html#fff</a><br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">The documents below were provided by Terry S. Singeltary Sr on 8 May 2000. They are optically character read (scanned into computer) and so may contain typos and unreadable parts.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">TIP740203/l 0424 CONFIDENTIAL</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Mr Cunningham CMP3 From: D O Hagger MBI Dr Salisbury MED/IMCD3 Mr Burton PD/STB/PG1B B/17/2 Date: 15.02.1989 Mr Dudley PD/AD4</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">BOVINE SPONGIFORM ENCEPHALOPATHY</span><br /><br /><br /><a fg_scanned="1" href="http://www.mad-cow.org/00/may00_news.html#aaa" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://www.mad-cow.org/00/may00_news.html#aaa</a><br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Other US BSE risks: the imported products picture 24 Jul 00 Trade Statistics: UK to US Compiled by Terry S. Singeltary Sr of Bacliff, Texas</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">[Opinion (webmaster): The US has focused for years on tracing, containing, and eradicating live animal imports from the UK or other countries with acknowledged BSE like Belgium, including some 499 cattle and the Vermont sheep. This strategy does not acknowledge imports of rendered bovine products from England during the BSE period nor secondary products such as surgical catgut, which is to say surgical cowgut, or dairy cattle embryos, vaccines for veterinarian and human medicines. What has become of these?</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Mr. Singeltary, who lost his mother to CJD of unexplained origin a few years back and went on to became a well-known TSE activist, has tracked down voluminous pertinent import data through correspondence with UK officials and searches of government web sites. Imports of such products are frequently cited by Europeans in rating BSE risks in the US and in shutting out US exports.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Many people's eyes glaze over when reviewing reams of sometimes older trade statistics. There is no proof that any of the imported products was contaminated with BSE nor if so, any evidence that any BSE product lead to infection in US livestock, surgical patients, or what not. Nonetheless, the data obtained by Mr. Singeltary establish that an appalling variety and tonnage of products that were imported by the US from the UK and othr BSE-affected countries during the peak of the BSE epidemic years.]</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">10 January 1990 COMMERCIAL IN CONFIDENCE</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">NOT FOR PUBLICATION</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">COMMITTEE ON SAFETY OF MEDICINES WORKING PARTY ON BOVINE SPONGIFORM ENCEPHALOPATHY</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">SURGICAL CATGUT SUTURES 2.1 At the first meeting of the Working Party on Bovine Spongiform Encephalopathy on 6 September 1989, detailed consideration was given to XXXXX Surgical Catgut. This arose from the Company's response to the Letter to Licence Holders, indicating that the bovine small intestine source material was derived from UK cattle, unlike 8 other licenced catgut sutures. In contrast XXXXX Surgical Catgut was stated to hold over 90% share of the market for catgut sutures, and to constitute approximately 83% of all sutures used in U.K. IMPORTS OF SUTURES FROM THE KNOWN BSE COUNTRY;</span><br /><br /><br /><a fg_scanned="1" href="http://www.mad-cow.org/00/jul00_dont_eat_sheep.html#hhh" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://www.mad-cow.org/00/jul00_dont_eat_sheep.html#hhh</a><br /><br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">The documents below were provided by Terry S. Singeltary Sr on 8 May 2000. They are optically character read (scanned into computer) and so may contain typos and unreadable parts.</span><br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">TIP740203/l 0424 CONFIDENTIAL</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Mr Cunningham CMP3 From: D O Hagger MBI Dr Salisbury MED/IMCD3 Mr Burton PD/STB/PG1B B/17/2 Date: 15.02.1989 Mr Dudley PD/AD4</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">BOVINE SPONGIFORM ENCEPHALOPATHY</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">1. The purpose of this minute is to alert you to recent developments on BSE as they affect medicines and to invite representatives to a meeting in Market Towers on 22 February 1989.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">2. The report of the Working Party on Bovine Spongiform Encephalopathy (BSE) was submitted by the CMO to the Secretary of State for Health and Minister for Agriculturer on 9 February.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">3. The summary at the end of the report records, inter alia: 'we have drawn the attention of the Licensing Authority to the potential of transfer of BSE agent in human and veterinary medicinal products. In paragraph 7 of his submission (Annex A), the CMO notes:</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">"I am also putting work urgently in hand to satisfy myself that everything possible has been done to ensure .... that transfer of the BBE agent in human and veterinary medicinal products does not occur."</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">4. The Veterinary products Committee meets on 16 February and The committee on Safety of Medicines on 23 February when each will be considering a draft of some joint guidelines for manufacturers of medicinal products which use bovine material as an ingredient or an intermediate in the manufacturing process (Annex B).....</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">6. Although a wide range of medicines may be implicated - and the present proposal is to write to companies for more information - an "instant" telephone survey of manufacturer of vaccines used for children has already been undertaken in response to a request from Dr Harris. The results are in Dr Adams' minute of 14 February (Annex C) - the proviso in his second paragraph, last sentence should be noted. 89/02.15/11.1</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">89/02.15/11.2 MF580439/1 0584 SOUTHWOOD REPORT: BSE AND MEDICINAL PRODUCTS</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">1. I attach a list of questions on BSE and medicines compiled with the aim of providing question and answer briefing to DH and MAFF Ministers upon publication of the Southwood Report. I have suggested names of those who may be able to provide answers. All recipients are invited to consider which if any important areas have been missed. Also attached is copy QA briefing being proposed by MAFF. I understand MAFF have produced General QA briefing on the reports as a whole. ..</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">MF580439/1 0585 Question</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">1. Which medicines are affected? (person to provide reply) Dr. Jefferys</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">2. Are the risks greater with some medicines than others? Dr. Jefferys</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">3. Why are medicines affected? Dr. Jefferys</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">4. Are some affected products available over the counter from pharmacies or shops? Dr. Purves</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">5. Are only UK products at risk? Dr. Jefferys</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">6. Are existing stocks safe? Dr. Jefferys</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">7. Are pre 1980 stocks available? Mr. Burton</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">8. Are these alternatives to the use of bovine material? Dr. Purves</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">9. Why can't we throw away suspect stock and import or manufacture safe medicines? Dr. Jefferys</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">10. Which patients are at risk? Dr. Jefferys</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">11. Are some patients particularly vulnerable? Dr Jefferys</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">12. What risks exist to those who have already used these medicines? Dr. Jefferys</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">13. HOW might patients be affected? Dr. Jefferys</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">14. Can BSE be transmitted to patients by medicines? Dr. Jefferys</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">15. How long will it be before risks are quantified? Dr. Jefferys</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">100 89/02.17/10.2 MF580439/1 0586</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">16. What research is going on to find out if medicines can transmit this disease and if any patients have been affected? Dr Jefferys</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">17. Could recent cases of Creuuzfeld Jacob Disease have been caused by transmission of BSE through medicines? Dr. Jefferys</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">18. What action is the Licensing Authority taking to ensure proper scrutinising of source materials and manufacturing processes? Dr. Jefferys/Dr. Purves</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">19. Are the guidelines practical? Dr. Jefferys/Dr. Purves</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">20. Will the guidelines remove the risk? Dr. Jefferys</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">21. How will the guidelines be enforced? Dr. Jefferys/Dr. Purves</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">22. How soon will they come into force? Dr. Jefferys</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">23. Will the guidelines be published? Mr. Hagger</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">24. What is being done to reassure patients, parents etc? Mr. Hagger/Dr. Salisbury</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">25. What advice is being given to doctors, pharmacists etc? Mr. Hagger</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">26. What advice is the Government giving about its vaccination programme? Dr. Salisbury</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">27. Is the vaccination programme put at risk because of BSE? Dr. Salisbury</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">89/02.17/10.3</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Q. Will government act on this?</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">A. Yes - thymus is not used in preparation of baby foods but it is contacting all manufacturers to seek their urgent views on use of kidneys and liver from ruminants. Will consider any necessary measures in the light of their response.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">VETERINARY MEDICINES</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Q. Can medicines spread BSE to other cattle/animals?</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">A. The report describes any risks as remote.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Q. How can risks be avoided?</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">A. In liaison with the DOH the Veterinary Products Committee is examining guidelines for the veterinary pharmaceutical industry which will be issued shortly.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Q. What will Guidelines say?</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">A. In essence they call for non-bovine sources to be used if possible, including synthetic material of biotechnological origin. Where this is not possible the industry should look for sources which are free of BSE and which are collected in a manner which avoids risk of contamination by the BSE agent.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">89/02.17/10.4 MF580439/1 0588</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">A. Bovine source material is used in [garbled, cannot read...TSS] and some other medicines.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Q. How many medicines are involved?</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">A. Computer records show that about 300 of the 3,050 veterinary medicines licensed in the U.K. are manufactured directly from bovine source material. However, other medicines may be produced from bovine sources and a letter is going to all license holders so that a comprehensive list can be drawn up.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">89/06.19/8.1 BSE3/1 0191 Hr J Maslin (MAFF) Ref: Maslin3g</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">From: Dr H Pickles Med SEB/B Date: 3 July 1989</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">CATTLE BY-PRODUCTS AND BSE</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">I was interested to see the list of by-products sent to the HSE. Those of particular concern included:</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">* small intestines: sutures (I thought the source was ovine but you are checking this)</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">* spinal cord: pharmaceuticals</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">* thymus: pharmaceuticals</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Are you able to give me more information on which UK manufacturers use these materials? Our proposed ban on bovine offal for human consumption would not affect these uses, I assume.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Id No. 1934/RD/1 89/08.10/6.1 117A</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">BOVINE SPONGIFORM ENCEPHALAPATHY MEETING HELD ON 21 AUGUST 1989 AT 2;15 IN ROOM 720 Miss M Duncan (Chairman) Mr W Burton Dr E Hoxey Mrs J Dhell Ms K Turner Dr S Whittle Mr N Weatherhead ... 5. The MCA had sent 2700 questionnaires out, 1,124 had made valid returns; of these 122 use animal material of some kind and there are 582 products involved. ... 6. The MCA/BSE working group will meet on 6th September. Their aim is to review responses from professional officers in MCA who have suggested seven categories of importance (with 1 being the most important} for medical products:</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">ID 2267/NRE/1 89/08.21/10.1</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">1. Products with Bovine brain/lymph tissue administered by injection.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">2. Products with bovine tissue other than brain/lymph administered by inection.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">3. Tissue implants/open wound dressing/surgical materials/dental and ophthlamic products with bovine ingredients.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">4. Products with bovine ingredients administered topically.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">5. Products with bovine ingredients administered orally.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">6. Products with other animal/fish/insect/bird ingredients administered by injection/topically/oral routes.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">7. Products with ingredients derived from animal material by chemical processing (eg stearic acid, gelatine, lanolin ext.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">The BSE working group will decide which of these are important, and should be examined more closely, and which categories can be eliminated.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">The responses by the companies were presented by Ms Turner and were categorised by MCA standards, the products that were discussed were all low volume usage products eg sutures, heart valves.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">8. As the responses included some materials of human origin it was decided that more information should be sought about CJD. There had been 2 recent deaths reported associated with human growth hormone. These were being investigated.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">9. Re-editing of the Paper on "Incubation of Scrapie-like Agents"</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">It was suggested that the document could be sent out to companies with the non-standard sterilization Document. The document could have severe implications on the companies whose products have a high risk factor as decided by the MCA working group....</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">11. The Need for a list of High Priority Implantables The commitee decided that no list is necessary as all implantables, including ones from a human source are of high priority. Concern was shown over Killingbeck who use human material but had not yet responded. The company will be chased for a response. Concern was shown over the fact that there may be other scrapie-like organisms in other animals and further enquiries should be made.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">2334q/RD/4 89/08.21/10.7</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">BOVINE MATERIAL USED IN THE MANUFACTURE OF SURGICAL IMPLANTS AND BLOOD CONTACT MEDICAL DEVICES</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Glutaraldehyde, formaldehyde, and ethylene oxide are used in the sterilization of these devices.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">However, glutaraldehyde 4,10,12,19 formaldehyde 5,10,11,13,19 and ethylene oxide 19,23 are all reported to be ineffective methods for sterilization of material infected with the agents of CJD or scrapie.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Previous advice and research using the agents of CJD and scrapie, has concentrated on the decontamination of equipment; protection of health care workers from contaminated human material; human growth hormone; and dura mater. The methods developed may not be directly applicable or transferable to material of bovine origin for use in human implantation.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">2334q/RD/7 89/08.21/10.10 BSE11/2 020 SC1337</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">DEPARTMENT OF HEALTH AND SOCIAL SECURITY Richmood House 79 Whitehall, London SW1A 2NS Telephone </span><a rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px; text-decoration-line: underline;">01-210-3000</a><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"> From the Chief Medical Officer Sir Donald Acheson KBE DM DSc FRCP FFCM FFOM</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Mr K C Meldrum Chief Veterinary Officer Ministry of Agriculture, Fisheries and Food Government Buildings Hook Rise South Tolworth Surbiton Surrey KT6 7NG</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">3 January 1990</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Dear Mr. Meldrum,</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">BOVINE SPONGIFORM ENCEPHALOPATHY</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">You will recall that we have previously discussed the potential risks of BSE occurring in other Countries as a result of the continuing export from the UK of meat and bone that may be contaminated by scrapie or possibly BSE.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">I remain concerned that we are not being consistent in our attempts to contain the risks of BSE. Having banned the feeding of meat and bone meal to ruminants in 1988, we should take steps to prevent these UK products being fed to ruminants in other countries. This could be achieved either through a ban on the export of meat and bone meal, or at least by the proper labelling of these products to make it absolutely clear they should not be fed to ruminants. Unless some such action is taken the difficult problems we have faced with BSE may well occur in other countries who import UK meat and bone meal. Surely it is short sighted for us to risk being seen in future as having been responsible for the introduction of BSE to the food chain in other countries.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">I would be very interested to hear how you feel this gap in the present prcautionary measures to eliminate BSE should be closed. We should be aiming at the global elimination of this new bovine disease. The export of our meat and bone meal is a continuing risk to other countries.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Signed Sincerely Donald Acheson</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Did the US import fetal calf serum and vaccines from BSE-affected countries? 3002.10.0040: FETAL BOVINE SERUM (FBS) U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date (Customs Value, in Thousands of Dollars) (Units of Quantity: Kilograms)</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><--- Dec 1998 ---> <--- 1998 YTD ---> Country Quantity Value Quantity Value</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">================================================================= WORLD</span><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">TOTAL . . . . . . . 2,</span><a rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px; text-decoration-line: underline;">727 233 131,486</a><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"> 8,502 Australia . . . . . . . . --- --- 19,637 2,623 Austria . . . . . . . . . --- --- 2,400 191 Belgium . . . . . . . . . --- --- 17 32 Canada . . . . . . . . . </span><a rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px; text-decoration-line: underline;">900 110 30,983</a><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"> 3,220 Costa Rica . . . . . . . 500 20 4,677 169 Federal Rep. of Germany --- --- 105 21 Finland . . . . . . . . . 1 8 9 83 France . . . . . . . . . --- --- 73 7 Guatemala . . . . . . . . --- --- 719 42 Honduras . . . . . . . . --- --- 1,108 88 Israel . . . . . . . . . --- --- 24 165 Netherlands . . . . . . . --- --- 1 5 New Zealand . . . . . . . 26 5 65,953 913 Panama . . . . . . . . . --- --- 1,195 64 Switzerland . . . . . . . 971 8 1,078 23 United Kingdom . . . . . </span><a rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px; text-decoration-line: underline;">329 82 743 756</a><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"> Uruguay . . . . . . . . . --- --- 2,764 98 ------------------------------------------------------------------ 3002.20.0000: VACCINES FOR HUMAN MEDICINE U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date (Customs Value, in Thousands of Dollars) (Units of Quantity: Kilograms)</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><--- Dec 1998 ---> <--- 1998 YTD ---> Country Quantity Value Quantity Value ================================================================= WORLD TOTAL . . . . . . . 25,702 26,150 550,258 378,735 Austria . . . . . . . . . --- --- 45 225 Belgium . . . . . . . . . 14,311 12,029 248,041 199,036 Canada . . . . . . . . . 1,109 1,527 15,798 16,305 Denmark . . . . . . . . . </span><a rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px; text-decoration-line: underline;">80 234 246 682</a><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"> Federal Rep. of Germany 1,064 4,073 12,001 6,329 France . . . . . . . . . 3,902 4,859 87,879 92,845 Ireland . . . . . . . . . --- --- 120 478 Italy . . . . . . . . . . --- --- 2,359 81 Japan . . . . . . . . . . 445 1,903 11,350 11,298 Netherlands . . . . . . . --- --- 94 6 Republic Of South Africa --- --- 2 1 Spain . . . . . . . . . . --- --- 60 30 Switzerland . . . . . . . 716 353 9,303 4,271 United Kingdom . . . . . 4,075 1,172 162,960 47,148 ------------------------------------------------------------------ 3002.30.0000: VACCINES FOR VETRINARY MEDICINE U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date (Customs Value, in Thousands of Dollars) (Units of Quantity: Kilograms)</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><--- Dec 1998 ---> <--- 1998 YTD ---> Country Quantity Value Quantity Value ================================================================= WORLD TOTAL . . . . . . . 6,</span><a rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px; text-decoration-line: underline;">528 237 87,149</a><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"> 2,715 Canada . . . . . . . . . --- --- 2,637 305 Federal Rep. of Germany --- --- 104 5 Netherlands . . . . . . . </span><a rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px; text-decoration-line: underline;">138 64 472 192</a><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"> New Zealand . . . . . . . 6,</span><a rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px; text-decoration-line: underline;">390 173 83,882</a><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"> 1,895 United Kingdom . . . . . --- --- 54 318</span><br /><br /><br /><br /><a fg_scanned="1" href="http://www.mad-cow.org/00/may00_news.html" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://www.mad-cow.org/00/may00_news.html</a><br /><br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Procedures Manual</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Bovine Spongiform Encephalopathy (BSE)</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Ongoing Surveillance Plan</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Ongoing Surveillance Plan Implementation July 20, 2006</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">snip...</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Personal Safety</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">If BSE is transmissible to humans in the occupational setting, the most likely routes would be through contact with infective tissues through wounds or open lesions on the skin, contact with mucous membranes (eyes and mouth), or exceptionally, by swallowing. .....snip...end</span><br /><br /><a fg_scanned="1" href="http://www.aphis.usda.gov/vs/nvsl/PDFs/BSE%20Ongoing%20Surveillance%20SOP%207-20-06.doc" rel="nofollow noopener noreferrer" style="color: #956839; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://www.aphis.usda.gov/vs/nvsl/PDFs/BSE%20Ongoing%20Surveillance%20SOP%207-20-06.doc</a><br /><br /><a fg_scanned="1" href="http://creutzfeldt-jakob-disease.blogspot.com/2013/09/nordion-us-inc-and-bioaxone-biosciences.html" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://creutzfeldt-jakob-disease.blogspot.com/2013/09/nordion-us-inc-and-bioaxone-biosciences.html</a><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">SO, looks like to me the most likely route of transmission of BSE to humans would be through inoculation i.e.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">the most likely routes would be through contact with infective tissues through wounds or open lesions on the skin,</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">IF you look at all the successful transmission studies in the lab with TSE, inoculations was the most successful route.</span><br /><br /><a href="mailto:BSE-L@LISTS.AEGEE.ORG" rel="noopener noreferrer" style="color: blue; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">BSE-L@LISTS.AEGEE.ORG</a><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Bovine Spongiform Encephalopathy</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">BSE-L is a discussion forum for scientists who are interested in Bovine Spongiform Encephalopathy (BSE). BSE-L has been created on 20th July, 1994 by Siegfried Schmitt. Impressum: </span><a fg_scanned="1" href="http://www.kaliv.de/impressum.html" rel="noopener noreferrer" style="color: blue; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">http://www.kaliv.de/impressum.html</a><br /><br /><a fg_scanned="1" href="http://lists.aegee.org/" rel="noopener noreferrer" style="color: blue; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;" target="_blank">LISTS.AEGEE.ORG</a><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"> ( BSE-L: 484 matches (only the first 50 will be shown).. )</span><br /><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">From: TSS (</span><a fg_rewritten="1" fg_scanned="1" href="http://216-119-138-163.ipset18.wt.net/" rel="noopener noreferrer" style="background-color: rgb(200, 26, 0) !important; color: blue; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px; padding-bottom: 3px; padding-left: 3px; padding-right: 3px;" target="_blank">216-119-138-163.ipset18.wt.net</a><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">) </span></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Subject: Louping-ill vaccine documents from November 23rd, 1946 </span></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Date: September 10, 2000 at 8:57 am PST</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Subject: Louping-ill vaccine documents from November 23rd, 1946 Date: Sat, 9 Sep 2000 17:44:57 -0700 From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To: </span><a href="mailto:BSE-L@uni-karlsruhe.de" rel="noopener noreferrer" style="color: blue; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">BSE-L@uni-karlsruhe.de</a><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">######### Bovine Spongiform Encephalopathy #########</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">THE VETERINARY RECORD 516 No 47. Vol. 58 November 23rd, 1946</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">NATIONAL VETERINARY MEDICAL ASSOCIATION OF GREAT BRITAIN AND IRELAND</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">ANNUAL CONGRESS, 1946</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">The annual Congress, 1946, was held at the Royal Veterinary College, Royal College Street, London, N.W.I. from September 22nd to September 27th.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Opening Meeting</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">[skip to scrapie vaccine issue...tss]</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Papers Presented to Congress</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">The papers presented to this year's Congress had as their general theme the progressive work of the profession during the war years. Their appeal was clearly demonstrated by the large and remarkably uniform attendance in the Grand Hall of the Royal Veterinary College throughout the series; between 200 and 250 members were present and they showed a keen interest in every paper, which was reflected in the expression of some disappointment that the time available for discussion did not permit of the participation of more than a small proportion of would-be contributors.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">In this issue we publish (below) the first to be read and discussed, that by Dr. W. S. Gordon, M.R.C.V.S., F.R.S.E., "Advances in Veterinary Research." Next week's issue will contain the paper on "Some Recent Advances in Veterinary Medicine and Surgery in Large-Animal Practice" by Mr. T. Norman Gold, M.R.C.V.S. In succeeding numbers of the Record will be reproduced, also with reports of discussions, that by Mr. W. L. Weipers, M.R.C.V.S., D.V.S.M., on the same subject as relating to small-animal practice, and the papers by Mr. J. N. Ritchie, </span><a fg_rewritten="1" fg_scanned="1" href="http://b.sc/" rel="noopener noreferrer" style="background-color: rgb(200, 26, 0) !important; color: blue; cursor: pointer; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px; padding-bottom: 3px; padding-left: 3px; padding-right: 3px;" target="_blank">B.SC</a><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">., M.R.C.V.S., D.V.S.M., and Mr. H.W. Steele-Bodger, M.R.C.V.S., on "War-time Achievements of the British Home Veterinary Services."</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">The first scientific paper of Congress was read by Dr. W. S. Gordon, M.R.C.V.S., F.R.S.E. on Monday, September 23rd, 1946, when Professor J. Basil Buxton, M.A., F.R.C.V.S, D.V.H., Prinicipal of the Royal Veterinary College, presided.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Advances in Veterinary Research</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">by</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">W.S. GORDON, PH.D., M.R.C.V.S., F.R.S.E.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Agriculteral Research Council, Field Station, Compton, Berks.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Louping-ill, Tick-borne Fever and Scrapie</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">In 1930 Pool, Browniee & Wilson recorded that louping-ill was a transmissible disease. Greig et al, (1931) showed that the infective agent was a filter-passing virus with neurotropic characters and Browniee & Wilson (1932) that the essential pathology was that of an encephalomyelitis. Gordon, Browniee, Wilson & MacLeod (1932) and MacLeod & Gordon (1932) confirmed and extended this work. It was shown that on louping-ill farms the virus was present in the blood of many sheep which did not show clinical symptoms indicating involvement of the central nervous system and that for the perpetuation and spread of the disease these subclinical cases were probably of greater importance that the frank clinical cases because, in Nature, the disease was spread by the tick, lxodes ricinus L. More recently Wilson (1945, 1946) has described the cultivation of the virus in a chick embryo medium, the pathogenic properties of this culture virus and the preparation of louping-ill antiserum.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Between 1931 and 1934 I carried out experiments which resulted in the development of an effective vaccine for the prevention of louping-ill.* This vaccine has been in general use since 1935 and in his annual report to the Animal Diseases Research Association this year, Dr. Greig stated that about 227,000 doses of vaccine had been issued from Moredun alone.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Dr. Gordon illustrated this portion of his paper by means of graphs and diagrams projected by the epidiascope.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">This investigation, however, did not begin and end with the study of louping-ill; it had, by good fortune, a more romantic turn and less fortunately a final dramatic twist which led almost to catastrophe. After it had been established that a solid immunity to louping-ill could be induced in sheep, a group of immunized and a group of susceptible animals were placed together on the tick-infected pasture of a louping-ill farm. Each day all the animals were gathered and their temperatures were recorded. It was anticipated that febrile reactions with some fatalities would develop in the controls while the louping-ill immunes would remain normal. Contrary to expectation, however, every sheep, both immune and control, developed a febrile reaction. This unexpected result made necessary further investigation which showed that the febrile reaction in the louping-ill immunes was due to a hitherto undescribed infective agent, a Rickettsia-like organism which could be observed in the cytoplasm of the granular leucocytes, especially the neutrophil polymorphs (MacLeod (1932), Gordon, Browniee, Wilson & MacLeod. MacLeod & Gordon (1933). MacLeod (1936). MacLeod collected ticks over many widely separated parts of Scotland and all were found to harbour the infective agent of tick-borne fever, and it is probable that all sheep on tick-infested farms develop this disease, at least on the first occasion that they become infested with ticks. When the infection is passed in series through susceptible adult sheep it causes a sever, febrile reaction, dullness and loss of bodily condition but it rarely, if ever, proves fatal. It is clear, however, that it aggravates the harmful effects of a louping-ill infection and it is a serious additional complication to such infections as pyaemia and the anacrobic infections which beset lambs on the hill farms of Northern Britain.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Studying the epidemiology of louping-ill on hill farms it became obvious that the pyaemic condition of lambs described by M'Fadyean (1894) was very prevalent on tick infested farms Pyaemia is a crippling condition of lambs associated with tick-bite and is often confused with louping-ill. It is caused by infection with Staphylococcus aureus and affected animals may show abscess formation on the skin, in the joints, viscera, meninges and elsewhere in the body. It was thought that tick-borne fever might have been a predisposing factor in this disease and unsuccessful attempts were made by Taylor, Holman & Gordon (1941) to reproduce the condition by infecting lambs subcutaneously with the staphylococcus and concurrently producing infections with tickborne fever and louping-ill in the same lambs. Work on pyaemia was then continued by McDiarmid (1946a, 1946b, 1946c), who succeeded in reproducing a pyaemic disease in mice, guinea-pigs and lambs similar to the naturally occurring condition by intravenous inoculation of Staphylococcus aureus. He also found a bacteraemic form of the disease in which no gross pyaemic lesions were observed. The prevention or treatment of this condition presents a formidable problem. It is unlikely that staphylococcal ???oid will provide an effective immunity and even if penicillin proved to be a successful treatment, the difficulty of applying it in adequate and sustained dosage to young lambs on hill farms would be almost insurmountable.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">From 1931 to 1934 field trials to test the immunizing value and harmlessness of the loup-ill vaccine were carried out on a gradually increasing scale. Many thousands of sheep were vaccinated and similar numbers, living under identical conditions were left as controls. The end result showed that an average mortability of about 9 percent in the controls was reduced to less than 1 percent in the vaccinated animals. While the efficiency of the vaccine was obvious after the second year of work, previous bitter experience had shown the wisdom of withholding a biological product from widespread use until it had been successfully produced in bulk, as opposed to small-scale experimental production and until it had been thoroughly tested for immunizing efficiency and freedom from harmful effects. It was thought that after four years testing this stage had been reached in 1935, and in the spring of that year the vaccine was issued for general use. It comprised a 10 percent saline suspension of brain, spinal cord and spleen tissues taken from sheep five days after infection with louping-ill virus by intracerebral inoculation. To this suspension 0-35 percent of formalin was added to inactivate the virus and its safety for use as a vaccine was checked by intracerbral inoculation of mice and sheep and by the inoculation of culture medium. Its protective power was proved by vaccination sheep and later subjecting them, along with controls, to a test dose of living virus.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Vaccine for issue had to be free from detectable, living virus and capable of protecting sheep against a test dose of virus applied subcutaneously. The 1935 vaccine conformed to these standards and was issued for inoculation in March as three separate batches labelled 1, 2, and 3. The tissues of 140 sheep were employed to make batch 1 of which 22,270 doses were used; 114 to make batch 2 of which 18,000 doses were used and 44 to make batch 3 of which 4,360 doses were used. All the sheep tissues incorporated in the vaccine were obtained from yearling sheep. During 1935 and 1936 the vaccine proved highly efficient in the prevention of loup-ill and no user observed an ill-effect in the inoculated animals. In September, 1937, two and a half years after vaccinating the sheep, two owners complained that scrapie, a disease which had not before been observed in the Blackface breed, was appearing in their stock of Blackface sheep and further that it was confined to animals vaccinated with louping-ill vaccine in 1935. At that stage it was difficult to conceive that the occurrence could be associated with the injection of the vaccine but in view of the implications, I visited most of the farms on which sheep had been vaccinated in 1935. It was at this point that the investigation reached its dramatic phase; I shall not forget the profound effect on my emotions when I visited these farms and was warmly welcomed because of the great benefits resulting from the application of louping-ill vaccine, wheras the chief purpose of my visit was to determine if scrapie was appearing in the inoculated sheep. The enquiry made the position clear. Scrapie was developing in the sheep vaccinated in 1935 and it was only in a few instances that the owner was associating the occurrence with louping-ill vaccination. The disease was affecting all breeds and it was confined to the animals vaccinated with batch 2. This was clearly demonstrated on a number of farms on which batch 1 had been used to inoculate the hoggs in 1935 and batch 2 to inoculate the ewes. None of the hoggs, which at this time were three- year-old ewes. At this time it was difficult to forecast whether all of the 18,000 sheep which had received batch 2 vaccine would develop scrapie. It was fortunate, however, that the majority of the sheep vaccinated with batch 2 were ewes and therfore all that were four years old and upwards at the time of vaccination had already been disposed of and there only remained the ewes which had been two to three years old at the time of vaccination, consequently no accurate assessment of the incidence of scrapie could be made. On a few farms, however, where vaccination was confined to hoggs, the incidence ranged from 1 percent, to 35 percent, with an average of about 5 percent. Since batch 2 vaccine had been incriminated as a probable source of scrapie infection, an attempt was made to trace the origin of the 112 sheep whose tissues had been included in the vaccine. It was found that they had been supplied by three owners and that all were of the Blackface or Greyface breed with the exception of eight which were Cheviot lambs born in 1935 from ewes which had been in contact with scrapie infection. Some of these contact ewes developed scrapie in 1936-37 and three surviving fellow lambs to the eight included in the batch 2 vaccine of 1935 developed scrapie, one in September, 1936, one in February, 1937, and one in November, 1937. There was, therefore, strong presumptive evidence that the eight Cheviot lambs included in the vaccine although apparently healthy were, in fact, in the incubative stage of a scrapie infection and that in their tissues there was an infective agent which had contaminated the batch 2 vaccine, rendering it liable to set up scrapie. If that assumption was correct then the evidence indicated that:-</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">(1) the infective agent of scrapie was present in the brain, spinal cord and or spleen of infected sheep: (2) it could withstand a concentration of formalin of 0-35 percent, which inactivated the virus of louping-ill: (3) it could be transmitted by subcutaneous inoculation; (4) it had an incubative period of two years and longer.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Two Frenchmen, Cuille & Chelle (1939) as the result of experiments commenced in 1932, reported the successful infection of sheep by inoculation of emulsions of spinal cord or brain material by the intracerebral, epidural, intraocular and subcutaneous routes The incubation period varied according to the route employed, being one year intracerebrally, 15 months intraocularly and 20 months subcutaneously. They failed to infect rabbits but succeeded in infecting goats. Another important part of their work showed that the infective agent could pass through a chamberland 1.3 filter, thus demonstrating that the infective agent was a filtrable virus. It was a curious coincidence that while they were doing their transmission experiments their work was being confirmed by the unforeseeable infectivity of a formalinized tissue vaccine.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">As a result of this experience a large-scale transmission experiment involving the ue of 788 sheep was commenced in 1938 on a farm specially taken for the purpose by the Animal Diseases Research Association with funds provided by the Agricultural Research Council. The experiment was designed to determine the nature of the infective agent and the pathogenesis of the disease. It is only possible here to give a summary of the result which showed that (1) saline suspensions of brain and spinal cord tissue of sheep affected with scrapie were infective to normal sheep when inoculated intracerebrally or subcutaneously; (2) the incubation period after intracerebral inoculation was seven months and upwards and only 60 percent of the inoculated sheep developed scrapie during a period of four and a half years; (3) the incubation period after subcutaneous inoculation was 15 months and upwards and only about 30 percent of the inoculated sheep developed the disease during the four and a half years: (4) the infective agent was of small size and probably a filtrable virus.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">The prolonged incubative period of the disease and the remarkable resistance of the causal agent to formalin are features of distinct interest. It still remains to determine if a biological test can be devised to detect infected animals so that they can be killed for food before they develop clinical symptoms and to explore the possibilities of producing an immunity to the disease.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">==================================================================</span></div><div class="yiv1590953550ydpdffa49e3post-body yiv1590953550ydpdffa49e3entry-content" id="yiv1590953550ydpdffa49e3post-body-3253777529811233216"><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></span><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Greetings List Members,</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">pretty disturbing document. now, what would stop this from happening with the vaccineCJD in children???</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">kind regards,</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Terry S. Singeltary Sr.</span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">P.O. Box </span><br /><br /><span style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;">Bacliff, Texas USA 77518</span></div></div></div></div></div><div style="background-color: white; font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 16px;"><br /></div><div style="background-color: white; font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 16px;"><a fg_scanned="1" href="http://bseinquiry.blogspot.com/2008/05/mad-cow-disease-bse-cjd-children.html" rel="nofollow noopener noreferrer" style="color: blue; cursor: pointer;" target="_blank">http://bseinquiry.blogspot.com/2008/05/mad-cow-disease-bse-cjd-children.html</a></div>Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-4687453285836897153.post-72712547134926468462008-05-18T19:21:00.000-05:002022-08-17T16:31:50.293-05:00BSE, CJD, and Baby foods (the great debate 1999 to 2005)<h2 class="date-header" style="background-color: #fff3db; color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 11.7px; font-weight: normal; letter-spacing: 0.1em; margin: 0px; padding: 0px; text-transform: uppercase;">SUNDAY, MAY 18, 2008</h2><div class="date-posts" style="background-color: #fff3db; color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><div class="post-outer"><div class="post hentry uncustomized-post-template" itemprop="blogPost" itemscope="itemscope" itemtype="http://schema.org/BlogPosting" style="margin: 8px 0px 24px;"><a name="7271254713492646846" style="color: #0096ef; cursor: pointer;"></a><h3 class="post-title entry-title" itemprop="name" style="color: #1b0431; font-size: 18.2px; font-weight: normal; margin: 0px; padding: 0px;">BSE, CJD, and Baby foods (the great debate 1999 to 2005)</h3><div><br /></div><div class="post-header"><div class="post-header-line-1"></div></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody">BSE, CJD, and Baby foods (the great debate 1999 to 2005)<br /><br />Bovine Spongiform Encephalopathy<br /><br />BSE-L is a discussion forum for scientists who are interested in Bovine Spongiform Encephalopathy (BSE). BSE-L has been created on 20th July, 1994 by Siegfried Schmitt. Impressum: http://www.kaliv.de/impressum.html<br /><br />LISTS.AEGEE.ORG ( BSE-L: 61 matches baby foods (only the first 50 will be shown).. )<br /><br /><a fg_scanned="1" href="https://lists.aegee.org/cgi-bin/wa?S2=BSE-L&X=1D1B9A2D19721D3331&Y=flounder9@verizon.net&q=baby+foods&s=&f=&a=&b" style="color: #473624; cursor: pointer;">https://lists.aegee.org/cgi-bin/wa?S2=BSE-L&X=1D1B9A2D19721D3331&Y=flounder9@verizon.net&q=baby+foods&s=&f=&a=&b</a>=<br /><br /><br />CJD and Baby foods (the great debate 1999)<br /><br />Subject: Re: Girl, 13, shows CJD symptoms.<br /><br />From: "Terry S. Singeltary Sr."<br /><br />Reply-To: Bovine Spongiform Encephalopathy<br /><br />Date: Wed, 24 Nov 1999 11:35:44 -0600 Content-Type: text/plain Parts/Attachments: text/plain (67 lines)<br /><br />######### Bovine Spongiform Encephalopathy <bse-l uni-karlsruhe.de="">#########<br /><br />Heather Paine should be educated on the products she over-sees. These children's health are at risk, and if she does not know what has and has not been going into baby-foods, she does not need to hold that position. The Inquiry was very concerned about baby foods, and at one point said something about; they were no different than the SBO's, in some cases, depending on the ingredients, of that particular kind of baby food. I forget the exact quote and by whom it was said??? I have it somewhere, but my filing system has a lot, _not_ to be desired for..............<br /><br />Debora MacKenzie wrote:<br /><br />######### Bovine Spongiform Encephalopathy <bse-l uni-karlsruhe.de="">#########<br /><br />GIRL, 13, SHOWS CJD SYMPTOMS November 23, 1999 PA News John von Radowitz, Medical Correspondent, PA News<br /><br />A 13-year-old girl may, according to this story, be the youngest victim of the human form of mad cow disease. The girl, whose identity and whereabouts are being kept secret, is, the story adds, thought to be displaying symptoms of new variant Creutzfeldt Jakob Disease. The story says that if the case is confirmed it has major implications. It raises the question of whether the girl was infected by baby food, and may shed light on the disease's incubation period. The girl was less than a year old in 1986 when BSE, the cattle disease thought to manifest itself in humans as the new variant form of CJD, was formally identified. Three years later the Government banned parts of the cow most likely to be infected, such as the brain and spinal cord, from human food products. So far the youngest of the 48 people to have died from nvCJD has been 16. David Churchill, chairman of the support group the Human BSE Foundation, was cited as saying he was aware of the case, adding, "I can confirm that the story is true - the girl is showing symptoms of the disease. This case raises a whole new spectre. There's no way anyone can say this child picked up nvCJD prior to knowledge about BSE. Back in 1986 BSE was not only identified but becoming prevalent. It can only have been picked up after the emergence of BSE, and the likelihood is that it was through baby food. ...<br /><br />The ability to diagnose this illness from its symptoms is improving with each case, and there are some fairly clear diagnostic guidelines now. The chances of a misdiagnosis, or missed diagnosis, are less likely than they used to be." Although the disease could only be confirmed for certain after death, the girl was showing signs and behaviour known to be linked with nvCJD. Heather Paine, spokeswoman for the Infant and Dietetic Foods Association, was cited as saying that as far as she knew no high-risk beef material, such as mechanically recovered meat stripped off the spine, had ever been used in baby products, adding, "To my knowledge no MRM from cattle has ever been put in baby food. Manufacturers are very aware of what mothers want to feed their babies." At one-year-old the girl would probably have been weaned off commercial baby food and eating home-prepared meals which may have included mince and beef cuts, said Ms Paine.<br /><br />Debora MacKenzie, Europe correspondent, New Scientist. tel: +32-2-245-0412 fax: +32-2-245-0552 email: d.mackenzie@chello.be<br /><br />############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############<br /><br /><br />############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############<br /><br /><br /><a fg_scanned="1" href="https://lists.aegee.org/cgi-bin/wa?A2=ind9911&L=BSE-L&P=R13460&X=1D1B9A2D19721D3331&Y=flounder9%40verizon.net" style="color: #473624; cursor: pointer;">https://lists.aegee.org/cgi-bin/wa?A2=ind9911&L=BSE-L&P=R13460&X=1D1B9A2D19721D3331&Y=flounder9%40verizon.net</a><br /><br /><br />Subject: Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><br />From: "Terry S. Singeltary Sr."<br /><br />Reply-To: Bovine Spongiform Encephalopathy<br /><br />Date: Thu, 25 Nov 1999 11:21:52 -0600 Content-Type: text/plain Parts/Attachments: text/plain (66 lines)<br /><br />######### Bovine Spongiform Encephalopathy <bse-l uni-karlsruhe.de="">#########<br /><br />Hello Robert and All,<br /><br />I would like to point out in DFA 9<http:><br /><br />99. Mr. Lawrence wrote a letter to Sir Richard on 6 January 1989 (110) explaining that there were _no_ special regulations with regard to the composition of baby food except in relation to additives, and that there was therefore _nothing_ in the rules that would exclude certain parts of animal being incorporated into baby foods as long as they were fit for human consumption.<br /><br />152. There is _no_ evidence of written assurances from the manufacturers supplied to either MAFF or the Department of Health asserting that Baby Food did not contain bovine brain, spinal cord, spleen, intestines or thymus.<br /><br />155. The reply also outlined the following actions already taken or to be taken by the Government in response to the Working Party's recommendations. 1) As a precautionary measure the Government would enact secondary legislation to ensure it was illegal to sell Baby Food containing brain, spinal cord, spleen and intestines.<br /><br />165. On 23 May 1989 Mr. Cockbill prepared draft regulations prohibiting the use of certain _specified offals_ in Baby Foods...<br /><br />Kind Regards, Terry S. Singeltary Sr., Bacliff, Texas USA<br /><br /><br /><a fg_scanned="1" href="https://lists.aegee.org/cgi-bin/wa?A2=ind9911&L=BSE-L&P=R13607&X=1D1B9A2D19721D3331&Y=flounder9%40verizon.net" style="color: #473624; cursor: pointer;">https://lists.aegee.org/cgi-bin/wa?A2=ind9911&L=BSE-L&P=R13607&X=1D1B9A2D19721D3331&Y=flounder9%40verizon.net</a><br /><br /><br />Subject: Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><br />From: J Ralph Blanchfield<br /><br />Reply-To: Bovine Spongiform Encephalopathy<br /><br />Date: Thu, 25 Nov 1999 22:30:36 +0000 Content-Type: text/plain Parts/Attachments: text/plain (168 lines)<br /><br />######### Bovine Spongiform Encephalopathy <bse-l uni-karlsruhe.de="">#########<br /><br />Hello Robert, Terry and Everyone,<br /><br />On Thu, 25 Nov 1999 13:17:45 -0500, Robert LaBudde wrote:<br /><br />######### Bovine Spongiform Encephalopathy <bse-l uni-karlsruhe.de="">#########<br /><br />At 11:21 AM 11/25/99 -0600, Terry wrote: I would like to point out in DFA 9<http:><br /><br />99. Mr. Lawrence wrote a letter to Sir Richard on 6 January 1989 (110) explaining that there were _no_ special regulations with regard to the composition of baby food except in relation to additives, and that there was therefore _nothing_ in the rules that would exclude certain parts of animal being incorporated into baby foods as long as they were fit for human consumption.<br /><br />152. There is _no_ evidence of written assurances from the manufacturers supplied to either MAFF or the Department of Health asserting that Baby Food did not contain bovine brain, spinal cord, spleen, intestines or thymus.<br /><br />155. The reply also outlined the following actions already taken or to be taken by the Government in response to the Working Party's recommendations. 1) As a precautionary measure the Government would enact secondary legislation to ensure it was illegal to sell Baby Food containing brain, spinal cord, spleen and intestines.<br /><br />165. On 23 May 1989 Mr. Cockbill prepared draft regulations prohibiting the use of certain _specified offals_ in Baby Foods...<br /><br />Thanks for the relevant information, Terry.<br /><br />I over-generalized based on US experience. There's a thick wad of FDA regulations concerning baby food in this country, and I made the mistake of presuming that this was a similar occurrence in Europe.<br /><br />If the UK was really this cavalier about baby food, the regulations on 'normal' food must be very weak. It's still hard to believe this is really true.<br /><br />Perhaps JRalph could help us out with an authoritative comment on this issue.<br /><br />I'll do my best. You really are keeping me hard at work today here and elsewhere, aren't you, Robert?<br /><br />_Specific_ Regulations relating to baby foods prohibit added colours, artificial sweeteners and some additives, limit pesticide residues and vitamin A content. There are no "recipe" Regulations affecting them.<br /><br />Baby foods, and all other foods, are subject to the general provisions that are in the Food Safety Act 1990 and were in its predecessors all the way back to 1872.. Section 7 of the 1990 Act states:<br /><br />7. Rendering food injurious to health<br /><br />~~~~~~~~~~~~~~~~~~~~~~~~~~~~~<br /><br /><br />(1) Any person who renders any food injurious to health by means of any of the following operations, namely- (a) adding any article or substance to the food; (b) using any article or substance as an ingredient in the preparation of the food; (c) abstracting any constituent from the food; and (d) subjecting the food to any other process or treatment; with intent that it shall be sold for human consumption, shall be guilty of an offence. (2) In determining for the purposes of this section and section 8(2) below whether any food is injurious to health, regard shall be had- (a) not only to the probable effect of that food on the health of a person consuming it; but (b) also to the probable cumulative effect of food of substantially the same composition on the health of a person consuming it in ordinary quantities. (3) In this Part ‘injury’, in relation to health, includes any impairment, whether permanent or temporary, and ‘injurious to health’ shall be construed accordingly.<br /><br />Section 8 contains two provisions -- 8(2)(b) and 8(2)(c) -- not in the predecessors of the 1990 Act:<br /><br />8 Selling food not complying with food safety requirements<br /><br />~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~<br /><br />(1) Any person who-<br /><br />(a) sells for human consumption, or offers, exposes or advertises for sale for such consumption, or has in his possession for the purpose of such sale or of preparation for such sale; or<br /><br />(b) deposits with, or consigns to, any other person for the purpose of such sale or of preparation for such sale, any food which fails to comply with food safety requirements shall be guilty of an offence.<br /><br />(2) For the purposes of this Part food fails to comply with food safety requirements if-<br /><br />(a) it has been rendered injurious to health by means of any of the operations mentioned in section 7(1) above;<br /><br />(b) it is unfit for human consumption; or<br /><br />(c) it is so contaminated (whether by extraneous matter or otherwise) that it would not be reasonable to expect it to be used for human consumption in that state, and references to such requirements or to food complying with such requirements shall be construed accordingly.<br /><br />(3) Where any food which fails to comply with food safety requirements is part of a batch, lot or consignment of food of the same class or description, it shall be presumed for the purposes of this section and section 9 below, until the contrary is proved, that all of the food in that batch, lot or consignment fails to comply with those requirements.<br /><br />(4) For the purposes of this Part, any part of, or product derived wholly or partly from, an animal-<br /><br />(a) which has been slaughtered in a knacker’s yard, or of which the carcase has been brought into a knacker’s yard; or<br /><br />(b) in Scotland, which has been slaughtered otherwise than in a slaughterhouse, shall be deemed to be unfit for human consumption.<br /><br />(5) In subsection<br /><br />(4) above, in its application to Scotland, ‘animal’ means any description of cattle, sheep, goat, swine, horse, ass or mule; and paragraph (b) of that subsection shall not apply where accident, illness or emergency affecting the animal in question required it to be slaughtered as mentioned in that paragraph.<br /><br />Baby foods, like all foods, are of course also subject to the extensive provisions of the Food Safety (General Food Hygiene) Regulations 1995 (and parallel Hygiene Regulations covering specific food sectors).<br /><br />It is easy with the 20/20 vision of hindsight to say now that certain animal derivatives should not have been used in baby foods (and indeed we do not know that they were, and Heather Paine is quoted as saying that to her knowledge they were not). Until the investigations of the Southwood Committee, there was anyway no reason to suppose that these materials, from apparently healthy cows, were other than wholesome or had any connection with BSE or indeed vCJD (the existence of which was at that point unknown). As it happens, the food manufacturer for which I worked in the early 1950s, among its many canned, bottled, frozen and dehydrated products, manufactured a range of baby foods including a beef broth, which was made from Argentinian frozen beef -- no offals of any kind.<br /><br />But each manufacturer decided for itself what ingredients to use, and they were/are in no way controlled or "overseen" by a trade association, which is what the Infant and Dietetic Foods Association was/is. So Terry, your attack on Heather Paine was unwarranted and badly misconceived, and I think you owe her an apology.<br /><br />I happen to know Heather well in an entirely different connection, and a more honest and conscientious person it would be hard to find.<br /><br />Finally, if it is vCJD, there is no more reason to suppose that the girl in question acquired the infection from baby food than from infected mince after weaning or from the infected vaccines that we now know were in use.<br /><br />Regards Ralph<br /><br /><br />******************************************************************<br /><br />J Ralph Blanchfield MBE Food Science, Food Technology & Food Law Consultant Chair, IFST External Affairs Web Editor, Institute of Food Science & Technology IFST Web address <www .ifst.org="">e-mail: <jralphb easynet.co.uk="">ICQ# 6254687. ICQ Web page<br /><br />******************************************************************<br /><br />############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############<br /><br /><br /><a fg_scanned="1" href="https://lists.aegee.org/cgi-bin/wa?A2=ind9911&L=BSE-L&P=R13781&X=1D1B9A2D19721D3331&Y=flounder9%40verizon.net" style="color: #473624; cursor: pointer;">https://lists.aegee.org/cgi-bin/wa?A2=ind9911&L=BSE-L&P=R13781&X=1D1B9A2D19721D3331&Y=flounder9%40verizon.net</a><br /><br /><br />Subject: Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><br />From: "Terry S. Singeltary Sr."<br /><br />Reply-To: Bovine Spongiform Encephalopathy<br /><br />Date: Fri, 26 Nov 1999 10:36:34 -0600 Content-Type: text/plain Parts/Attachments: text/plain (210 lines)<br /><br /><br />######### Bovine Spongiform Encephalopathy <bse-l uni-karlsruhe.de="">#########<br /><br /><br />Hello Ralph and All, I think you are correct Ralph, after reading back over my comments, I was a bit hasty, and in a friends eyes, may have even seemed rude. For that I would like to apologize to Heather and You. It still does not change my position on the matter. It would have been better directed, if I would have directed my haste, to the _whole_ industry involved, as opposed to Heather and the Baby Food industry. For obvious reasons, if the DFA's are accurate, and the statements within from the Working Party and the Gov. and the statement from the manufacturers of Baby Foods, where they are stating in DFA 9; "152. There is no evidence of written assurances from the manufacturers supplied to either Maff or the Department of Health asserting that Baby Food did not contain bovine brain, spinal cord, spleen, intestines or thymus". Then from past experiences from big industry, I would bet that the ingredients in question were used.<br /><br /><br />Not to change the subject, but if the people that oversee adult products for consumption, allows manufactures of pills in (nutritional supplements) in 1999, to put "brain, eyeballs, pituitary, and scrotum" in these pills, then pass them off as miracle cures from heaven that will cure everything from aids to the common cold. Then allow them to label it as "100% herbal". And then top it all off, instead of classifying them as pharmaceuticals, they classify them as _food_. If the people that oversees this, has anything to do with what goes in baby foods, after the manufactures comments, I just find it hard to believe, that this did not take place, and to some extent, still is. All this, going into the year 2000, and we are still debating if brain and or other sbo's should be going into the human food chain (and they still are), after knowing for many years about the highly infectivity of the brain, eye and other organs and or tissues. This I do not understand, and this is why I most hastily replied to Heather's comments. Hope this smoothes' things over Ralph.........<br /><br /><br />Kind Regards, Terry<br /><br /><br /><a fg_scanned="1" href="https://lists.aegee.org/cgi-bin/wa?A2=ind9911&L=BSE-L&P=R14285&X=1D1B9A2D19721D3331&Y=flounder9%40verizon.net" style="color: #473624; cursor: pointer;">https://lists.aegee.org/cgi-bin/wa?A2=ind9911&L=BSE-L&P=R14285&X=1D1B9A2D19721D3331&Y=flounder9%40verizon.net</a><br /><br /><br />Subject: Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><br />From: "Terry S. Singeltary Sr."<br /><br />Reply-To: Bovine Spongiform Encephalopathy<br /><br />Date: Sat, 27 Nov 1999 18:54:39 -0600 Content-Type: text/plain Parts/Attachments: text/plain (397 lines)<br /><br /><br />######### Bovine Spongiform Encephalopathy <bse-l uni-karlsruhe.de="">#########<br /><br /><br />Thanks Ralph,<br /><br />re-Heather<><br /><br />I have learned from the past, about TSE's and information. Being passive, or suttle, and or subdued, and simply saying o.k. to an answer, does not get it. You don't find out much that way. Although since being on this list, I have learned a great deal about being diplomatic, "I thought". Although I guess you could say sometimes, that I am ranting. It is for a good cause, and I probably have a lot more to learn. Speaking through these machines, across oceans, it's easy to do sometimes. I don't believe I have been the only one on this list to rant.<br /><br />guilt by association, and U.K. laws about nutritional supplements<>the manufactures".<br />< a2="ind9911&L=" p="R15856&X=" y="flounder9%40verizon.net">Reply-To: Bovine Spongiform Encephalopathy <bse-l uni-karlsruhe.de="">Date: Sun, 28 Nov 1999 11:46:07 +0000 Content-Type: text/plain Parts/Attachments: text/plain (119 lines)<br /><br /><br />######### Bovine Spongiform Encephalopathy <bse-l uni-karlsruhe.de="">#########<br /><br /><br />Hello Terry and Everyone,<br /><br />On Sat, 27 Nov 1999 18:54:39 -0600, Terry wrote:<br /><br />######### Bovine Spongiform Encephalopathy <bse-l uni-karlsruhe.de="">#########<br /><br />I have one question for you Ralph; from the statement made by the manufactures to the Gov. "152. There is no evidence of written assurances from the manufacturers supplied to either Maff or the Department of Health asserting that Baby Food did not contain bovine brain, spinal cord, spleen, intestines or thymus". If in fact, the manufactures could not supply this information to the Gov., confirming that baby food did not or has not contained bovine brain, spinal cord, spleen intestines and thymus;<br /><br />What would you understand this to mean?<br /><br />Firstly, the DFA paragraph 152 does _not_ say "the manufactures could not supply this information to the Gov". It says that there is no written evidence that they did -- not the same thing at all.<br /><br />I do _not_ understand the DFA paragraph 152 to mean "the statement made by the manufacturers to the Gov." and nor should you. Paragraph 152 refers to the _absence_ of written evidence of a statement by the baby food manufacturers. You should not find it difficult to perceive the difference between what paragraph 152 actually says and what you say it says.<br /><br />I have no first-hand knowledge of what was contained in babyfoods on sale in the UK at that time, and neither do you; but from my much earlier first-hand experience of babyfood manufacture, and Rachel's first-hand experience too, I regard it prima facie as most unlikely that SBOs were ever used in babyfoods.<br /><br />Nor do I personally (or you) have any knowledge of _why_ there was "no evidence of written assurances from the manufacturers supplied to either Maff or the Department of Health asserting that Baby Food did not contain bovine brain, spinal cord, spleen, intestines or thymus".<br /><br />Fortunately, in answer to my requests for her comments on your previous posts, I have now received two e-mail messages from Heather Paine which give clear answers on these matters, and which I regard as setting the record straight,.<br /><br />Dear Ralph<br /><br />Further to our telephone conversation yesterday here is a brief summary of my discussion with the journalist John Radowitz re BSE and babyfoods.<br /><br />The journalist was mainly interested in MRM and asked me if the baby food industry used MRM to 'bulk out' baby foods!<br /><br />I said no and that to my knowledge the UK baby food industry had never used MRM. I also told him that when the SBO offal ban came into being this had no effect on baby food industry practice because we didn't use these materials either.<br /><br />Commercial baby food manufacturers work to very strict specifications and only use ingredients that meet their tough specifications. Mothers expect baby food manufacturers to use the best cuts of meat and so the meat used is similar to that used in preparing baby foods at home. Baby food manufacturers, therefore, do not use MRM from the carcases of cattle, sheep (lamb) or pig.<br /><br />I also questioned his assumption that at one year old the child would have been fed only commercial baby foods. At that age it was just as likely that the child would be eating home made foods/family meals.<br /><br />Hope this helps<br /><br />Heather<br /><br />Dear Ralph<br /><br />Just read your latest e-mail. Nice to see the apology which I accept, but I do not accept his accusations that we are still guilty.<br /><br />Just because MAFF have no written assurance about SBOs not being used in baby foods doesn't mean that we used these materials. In fact, MAFF were fully aware in 1989 that the baby food industry did not use SBOs. The trouble was that there is no written record.<br /><br />When the Southwood Report was being put together, MAFF contacted IDFA at quite a late stage (and it was me in those days) to ask whether the baby food industry used these materials. We said 'no' (both IDFA and individual companies were contacted) but it was all by telephone, (MAFF wanted a quick response so they could advise the Southwood Committee) - so unfortunately there is nothing on record (at least IDFA records)! - Except, after the Southwood Report was published IDFA complained to the then Minister about their handling of the issue which implied a change in baby food industry practice.<br /><br />Of course when the consultation on the Regulations took place IDFA did not comment as we did not use SBOs and so we had no objections. Again no written record! But the fact is UK baby food manufacturers did not use these materials in their products.<br /><br />The moral of the story is of course always place your comments on record - even when you have 'no objections'. Hindsight is a wonderful thing!<br /><br />All the best<br /><br />Heather<br /><br />Regards Ralph<br /><br />******************************************************************<br /><br />J Ralph Blanchfield MBE Food Science, Food Technology & Food Law Consultant Chair, IFST External Affairs Web Editor, Institute of Food Science & Technology IFST Web address <www .ifst.org="">e-mail: <jralphb easynet.co.uk="">ICQ# 6254687. ICQ Web page<br /><br />******************************************************************<br /><br /><br />############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############<br /><br /><br /><a fg_scanned="1" href="https://lists.aegee.org/cgi-bin/wa?A2=ind9911&L=BSE-L&P=R16495&X=1D1B9A2D19721D3331&Y=flounder9%40verizon.net" style="color: #473624; cursor: pointer;">https://lists.aegee.org/cgi-bin/wa?A2=ind9911&L=BSE-L&P=R16495&X=1D1B9A2D19721D3331&Y=flounder9%40verizon.net</a><br /><br /><br />Subject: Baby Food * June 23, 1999 BSE Inquiry<br /><br />From: "Terry S. Singeltary Sr." <flounder wt.net="">Reply-To: Bovine Spongiform Encephalopathy<br /><br />Date: Tue, 30 Nov 1999 11:16:54 -0600 Content-Type: text/plain Parts/Attachments: text/plain (125 lines)<br /><br /><br />######### Bovine Spongiform Encephalopathy <bse-l uni-karlsruhe.de="">#########<br /><br />Terry S. Singeltary Sr., Bacliff, Texas USA<br /><br />> Greetings everyone, I thought these comments were interesting. Thought<br />> some of you might find some interest in them...<br />><br />> 2 MR LAWRENCE: Yes.<br />> 3 MR WALKER: I think you thank Mr Cockbill later for help on<br />> 4 the idiosyncracies of the meat products regulations. Is<br />> 5 that what he helped on?<br />> 6 MR LAWRENCE: I think that is right. But I think in<br />> 7 conjunction with what I was being asked to do, I think<br />> 8 Charles Cockbill was considering, am I right, the<br />> 9 possible regulations in relation to baby food?<br />> 10 MR WALKER: Yes.<br />> 11 MR LAWRENCE: So he was also making an assessment of those<br />> 12 tissues which might contain infective agent for that<br />> 13 piece of legislation.<br />> 14 MR WALKER: Yes. He was head of Food Standards Division,<br />> 15 reporting to Mrs Attridge.<br />> 16 MR LAWRENCE: Yes.<br />> 17 MR WALKER: And I think we have seen documents which<br />> 18 suggest he was in correspondence with Dr Pickles at the<br />> 19 Department of Health in relation to the baby food<br />> 20 regulations.<br />> 21 MR LAWRENCE: I think I have seen some of those, yes.<br />> 22 MR WALKER: Can you recall whether he was helping you on<br />> 23 the tissues, then, that might be infective?<br />> 24 MR LAWRENCE: It may well be. I cannot quite recall.<br />> 25 I mean there were a lot of documents at the time. But<br />> 1 obviously I gleaned information from various different<br />> 2 sources because, you know, I did produce a draft,<br />> 3 I think of 27th April. So whether I took on board some<br />> 4 of the information that I had seen from Charles or not,<br />> 5 I do not know. It may well have been, yes.<br />> _______________________________________________________<br />><br />> 15 Could you just help us on the manuscript that we<br />> 16 see here? Is this from Mr Meldrum to you dated 14th<br />> 17 May?<br />> 18 MR LAWRENCE: Yes, I think that is.<br />> 19 MR WALKER: And he said:<br />> 20 "Thank you for a chance to comment. I think there<br />> 21 is some danger of Don fusing the proposed legislation on<br />> 22 baby foods and a wider ban on brains, spinal cord et<br />> 23 cetera. I am a little uneasy about some of the<br />> 24 assumptions made because I am advised that some bovine<br />> 25 brains are used for human consumption."<br />><br />> 1 Have I deciphered that correctly?<br />> 2 MR LAWRENCE: Yes, I think that is right.<br />> 3 MR WALKER: We see on the left, against that reference to<br />> 4 some bovine brains being used for human consumption:<br />> 5 "But not in meat products".<br />> 6 MR LAWRENCE: I think that is my writing.<br />><br />> 4 MR WALKER: That is very helpful. Thank you very much.<br />> 5 That comment, is that something that, from your point of<br />> 6 view, you simply took at face value?<br />> 7 MR LAWRENCE: Well, yes. I mean, as a non-scientist I was<br />> 8 really relying on their expertise to advise me, you<br />> 9 know, in what I should be putting up to the Minister in<br />> 10 the way of advice, yes.<br />> 11 MR WALKER: Did you see it as your role to seek to identify<br />> 12 what the level was in animals suffering from the disease<br />> 13 and how much lower the level was in these sub-clinically<br />> 14 infected animals?<br />> 15 MR LAWRENCE: No.<br />> 16 MR WALKER: From your point of view, that was a matter for<br />> 17 the expert advisers?<br />> 18 MR LAWRENCE: Yes. I mean, I think I have said in perhaps<br />> 19 a rather simplistic way I simply wanted to know from<br />> 20 these blokes which tissues they felt should be banned<br />> 21 from human consumption. And it did not concern me, you<br />> 22 know, about titre levels or anything else. It was<br />> 23 really yes or no.<br />> 24 MR WALKER: Yes, thank you.<br />> _____________________________________________________<br />><br />> 1 MR WALKER: Why was it you were saying to UKASTA that the<br />> 2 SBO ban was simply to maintain public confidence?<br />> 3 MR LAWRENCE: Well, can I again read out what I intend to<br />> 4 say in...<br />> 5 MR WALKER: Yes.<br />> 6 MR LAWRENCE: I am saying in response to what you are<br />> 7 asking me I think the answer to that is that it was. As<br />> 8 I have already stated, the risks from BSE were regarded<br />> 9 as remote so the SBO ban was a measure of additional<br />> 10 reassurance against that remote risk. The determination<br />> 11 of which tissues to proscribe was a scientific<br />> 12 assessment based on the scrapie analogy of those offals<br />> 13 which might contain the agent in cattle with<br />> 14 pre-clinical disease.<br />> 15 My minute, again, may be a bit of shorthand<br />> 16 because I wanted to refer, and I will do when I send the<br />> 17 supplementary note, to another document I sent out on<br />> 18 that very same day; and that was the consultation letter<br />> 19 in relation to the proposed SBO ban, which is reference<br />> 20 YB 89/7.26/1.1.<br />> 21 In that what I am saying, in the letter, amongst<br />> 22 other things, is that scientific advice, including that<br />> 23 reflected in Southwood Report, is that in clinically<br />> 24 diseased animals and those which may be incubating the<br />> 25 disease, the BSE agent might be present in the brain,<br />> lawrence<br />><br />> 1 spinal cord, spleen, thymus, tonsils and intestines.<br />> 2 The Southwood Working Party suggested, merely as a<br />> 3 precautionary measure, that manufacturers of baby food<br />> 4 should refrain from using certain offals in their<br />> 5 products.<br />> 6 In all the circumstances, Ministers have decided<br />> 7 that the most effective way of ensuring the protection<br />> 8 of public health would be to make regulations under the<br />> 9 Food Act 1984, those regulations being the SBO ban.<br />> 10 So, yes, you know, my minute in the way it is<br />> 11 worded -- sorry, the minute you are referring to, yes,<br />> 12 does look as if it was simply maintaining public<br />> 13 confidence. But I think in the letter I sent the same<br />> 14 day, the consultation letter, I am explaining it in more<br />> 15 detail, you know, the reasoning behind it that there was<br />> 16 a scientific reason for going a bit further..................<br /><br /><br />############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############<br /><br /><br /><a fg_scanned="1" href="https://lists.aegee.org/cgi-bin/wa?A2=ind9911&L=BSE-L&P=R18499&X=1D1B9A2D19721D3331&Y=flounder9%40verizon.net" style="color: #473624; cursor: pointer;">https://lists.aegee.org/cgi-bin/wa?A2=ind9911&L=BSE-L&P=R18499&X=1D1B9A2D19721D3331&Y=flounder9%40verizon.net</a><br /><br /><br />Subject: Southwood Working Party advice on baby food. >witness statement 184e - Meldrum issued 10/14/99<br /><br />From: "Terry S. Singeltary Sr."<br /><br />Reply-To: Bovine Spongiform Encephalopathy<br /><br />Date: Tue, 30 Nov 1999 12:32:34 -0600 Content-Type: text/plain Parts/Attachments: text/plain (872 lines)<br /><br /><br />######### Bovine Spongiform Encephalopathy <bse-l uni-karlsruhe.de="">#########<br /><br /><br />Terry S. Singeltary SR., Bacliff, Texas USA<br /><br /><http:>For those of you interested, the following report, helps us look at the big picture, about baby foods. Although you should remember, they were still implying<br /><br />(or hoping), that BSE could not be transmitted to humans. Unfortunately, they found out different...<br /><br /><br />___________________________________________________________<br /><br /><br /><br />Southwood Working Party advice on baby food<br /><br />5.In my oral evidence (T69, Vol. T7, Tab 9, page 74 to 75) I stated that it was normal practice when an expert working party reported for the recommendations to be accepted as they stood. As regards the Southwood Report, I went on to say that it was not until later when I and my colleagues came to think through the advice on baby food that it became clear that it appeared to lack some logic, "that if particular tissues should be removed from baby food, why should not those same tissues be removed from the food of adolescents or pregnant mothers or adult people? Where do you draw the line? So it was a gradual thinking process in part accelerated by the request from Sir Donald Thompson that he put in about the same time when he asked us to consider the possibility of removing from the human food chain adult cows and adult ewes at the end of their life….".<br /><br />6.At first sight the advice that baby food manufacturers should avoid the use of ruminant offal and thymus did make sense; (a) the Southwood Working Party had concluded that the risk of transmission of BSE to humans was remote, (b) it was accepted at the time that the young were more susceptible to the TSEs, (c) nevertheless steps had already been taken to ensure that clinically affected cattle should not enter the human food chain, (d) but if the BSE agent were to be present in an animal it was most likely to be in the spleen and lymphatic tissues in the early stages of infection, and in brain and neural tissue as the disease progressed, (e) accordingly consideration had been given to the risks from products containing tissues from sub-clinically infected cattle, and (f) it was believed that the risks as perceived at that time did not justify action beyond that advised for baby food manufacturers. When further pressed on the matter in oral evidence, I reiterated that at the time the Southwood Report was submitted and considered by Ministers, I was quite content with the recommendations as they stood. It was not until shortly thereafter, and arising from discussions with colleagues and representatives from outside organisations, that there appeared to be a certain element of illogicality in the advice (T69, Vol. T7, Tab 9, page 76 to 77), i.e. how do you define a baby, do you draw the line at toddlers and what about adolescents. My view that consideration of the advice for baby food manufacturers was a gradual process is supported by Sir Derek Andrews' oral evidence (T81, Vol. T9, Tab 1, page 117, line 21 to page 118, line 23).<br /><br />7.It follows that since it was a gradual thinking process, so too the advice to Ministers developed gradually. This advice might not have been formulated to expressly state that the recommendation "made no sense", but rather that certain aspects of it required clarification before steps could be taken to implement it. Also, whilst such advice may have been gradual, Ministers nevertheless did receive advice on (i) the definition of offals as used in the Southwood Report advice on baby food, (ii) whether the definition included liver and kidney, and (iii) why one should distinguish between babies and older humans. Even if it was not me personally who put forward the advice, it was put forward by other MAFF officials and I was aware that the issues were being discussed and Ministers kept informed by virtue of the fact that I was a copy recipient of numerous minutes. If I had felt that I needed to put forward additional separate advice to express my view as CVO I would have done so, as indeed I did later in relation to the draft regulations on baby food (see the section below on "Development of the SBO ban"). Ministers themselves took a very keen interest in BSE and the Southwood Report, asked many questions and put forward their views themselves on the options open to MAFF. They were therefore intimately involved with discussions on the development of the Government’s policy on the disease.<br /><br />8.Turning to point (i) in paragraph 7 above, the Southwood Report did identify the offals in question, albeit indirectly, and also explained why such offals and thymus caused concern. Paragraph 5.3.5 of the Southwood Report referred to the generic term "offal" and cross-referred by a footnote to those regulations from which the definition of that term had been taken. When asked subsequently (see sub-paragraph 9(a) below), Sir Richard Southwood confirmed that the intention was that the reference was to mean offal as described in the regulations identified within that paragraph of the Southwood Report. As regards the reasons why such offals and thymus should cause concern, this follows from the statement earlier in paragraph 5.3.5 of the Southwood Report (IBD 2, Vol. IBD 1, Tab 2) that if the BSE agent were to be present in an animal it would most likely be in the spleen, lymphatic tissues, brain and neural tissue. Whether or not it was realised at that stage what the specific definition of offals was intended to be, it would be clear that if those were the tissues where the BSE agent might be found, then "offal" (even if defined as just brain and spleen) could be a concern. Similarly, if lymphatic tissue might harbour the agent, then thymus, which is part of the lympho-reticular system, could be a concern.<br /><br />9.In any event, the definition of offals used in the Southwood Report was clarified in the course of consideration of the advice to baby food manufacturers. As the events set out below show, Ministers were aware of and were advised on this process of clarification, and particularly whether liver and kidney were included in the Southwood Report definition. Some of the key events are as follows: a.13th February, 1989. In Mr Lawrence's minute and brief for Ministers and the Permanent Secretary (copied to me) it was stated in relation to the advice on baby food that thymus was not used in baby foods but on the other hand kidneys and liver, but no other offals were. Manufacturers' agreement would be sought to using non-ruminant liver and kidney as a replacement in baby foods (YB89/2.13/4.1-4.15).<br /><br />b.15th February, 1989. In a minute to Mr Cruickshank (copied to me), Mrs Attridge pointed out that liver and kidney were the major element of offal likely to be found in baby foods and constituted an important part of a baby's diet. Mrs Attridge said there could be a risk of malnutrition if the rather vague recommendation in the Southwood Report led to the removal of cow and sheep liver from baby food. She suggested referring the matter to the CMO so that further investigations could be made on the risks involved (YB89/2.15/2.1-2.2).<br /><br />c.20th February, 1989. In a minute to Mr Cruickshank (copied to me), Mrs Attridge raised concerns over parts of the submission and question and answer brief for the Southwood Report that related to baby food. She said that definitive answers were needed so that MAFF would not be accused of spreading uncertainty over products which actually had very considerable nutritional advantages for all sectors of the population (YB89/2.20/1.1).<br /><br />As well as being copied to me, Mrs Attridge's minute dated 15th ebruary, 1989 (YB89/2.15/2.1-2.2) was copied to the Minister (Mr MacGregor) and the minute dated 20th February, 1989 (YB89/2.20/1.1) was copied to Private Offices (i.e. Ministers and the Permanent Secretary). As such, Ministers received information and advice on the need to clarify the definition of offals used in the outhwood Report.<br /><br />d.21st February, 1989. In a minute to Mrs Stagg (PS/Minister) (copied to me), Mr Cruickshank stated that the reference to the baby food advice in the paper for MISC138 had been amended to reflect Mrs Attridge's suggestion. The paper stated that the Southwood Working Party had not examined all the scientific evidence relating to offal, particularly liver and kidney in baby food, and the CMO would therefore consider this further and advise on any action required (YB89/2.21/2.1-2.19).<br /><br />It should be noted that the wording in the paper reflected that suggested by Mrs Attridge as a way of enabling MAFF to assess the risks of any ban on liver and kidney without causing too many presentational difficulties. This minute was copied to Private Offices.<br /><br />e.23rd February, 1989. A minute from Mr Garnett to Mrs Stagg (PS/Minister) (further copied to me by the original copy recipient Mr Cruickshank) recorded the CMO's clarification with Sir Richard Southwood of what was meant by the reference to "ruminant offal and thymus" in the Southwood Report. Mr Garnett explained that it was intended that the reference would be to offal as described in the Meat Products and Spreadable Fish Products Regulations 1984 (L11 Tab 6). This meant that liver, kidney and heart which might otherwise be regarded as "offal" would not be restricted by the Southwood Working Party's advice. The CMO's advice, cleared with Sir Richard Southwood, would be that they need not be concerned at the inclusion in infant diets of kidney, liver and heart (YB89/2.23/7.1-7.2).<br /><br />The CMO had passed this information on to the Minister Mr MacGregor) at a meeting on 23rd February, 1989 which was also attended by the Secretary of State for Health. I did not attend this meeting but did receive a copy of the note of the meeting (YB89/2.23/3.1-3.3). As such I was aware of Mr MacGregor's iscussions with the Department of Health on this issue. The note of the meeting records that after the CMO explained the confirmation received from Sir Richard Southwood as to the definition of offals, it was felt appropriate for the Government to take legislative steps to implement the advice on baby foods. If the Minister had felt that he was not clear on the Southwood Working Party's advice or had not received sufficient advice on the issue, I am of the view that he would not have come to the judgement to proceed with legislation.<br /><br />10.Turning to point (ii) in paragraph 7 above, Mr Garnett's minute of 23rd February, 1989 (YB89/2.23/7.1) indicates that the Southwood Working Party had never intended the reference to offal to include liver and kidney, but rather it had been part of their deliberations prior to submitting the Southwood Report to Ministers that the offals they were concerned about were those described in the Meat Products and Spreadable Fish Products Regulations 1984 (L11 Tab 6) (see also the oral evidence of the Southwood Working Party; T 106, Vol. T11, Tab 6, pages 101 and 102). The question as to whether this was a correct conclusion for the Southwood Working Party to make is, more properly, an issue on which the members of the Southwood Working Party might care to comment rather than me. In addition, the question of the risks to babies from liver and kidney was quite properly identified as a matter for the CMO to follow up with Sir Richard Southwood. I was aware from the minutes and meeting notes (YB89/2.23/3.1-3.3) that were copied to him that this was how it was being pursued, with the full knowledge of the Minister (Mr MacGregor).<br /><br />11.Finally, turning to point (iii) in paragraph 7 above, whilst it is correct to say that the Southwood Report did not appear to give any explanation why a distinction could be drawn between babies and other groups of people, the contemporaneous documents demonstrate that the reasons for this were known and explained to Ministers. In addition I was aware at the time of the thinking on the susceptibility of the young to which I have already referred in paragraph 6 above (see point (b)). For example:<br /><br />(a) 24th February, 1989. The Q&A brief circulated to the Prime Minister's office, the Cabinet Secretary and members of MISC 138 included a question n why there should be concern about offal in baby food and not food for adults. The answer was that young animals were more susceptible than adults to orally acquired SEs (YB89/2.24/10.1-10.13).<br /><br />The version of the Q&A brief circulated to the Minister and Private Offices on 21st February, 1989 (see paragraph 9(d) above) also included this nformation.<br /><br />(b) 3rd April, 1989. At a meeting between the Parliamentary Secretary and Compassion in World Farming, Mr Lowson referred to the possibility that oung 'animals' might be more susceptible than older ones (YB89/4.05/1.1-1.3).<br /><br />This view was also expressed by Dr Pickles in a letter to Mr Cockbill (YB89/4.13/2.1-2.3), although I was not involved in Mr Cockbill's discussions with the Department of Health relating to the drafting of the baby food regulations.<br /><br />Development of the SBO ban<br /><br />12.As I explained in my oral evidence and as referred to in the sections above on "Assessment of the Southwood Report" and "Southwood Working Party advice on baby food", it was a "gradual thinking process" that led to the decision being made by Mr MacGregor in June 1989 that wider action was needed on offals to meet concerns about some tissues from sub-clinically infected animals and the possibility that cattle affected with BSE were "getting through the net to the market" (YB89/6.7/7.1-7.2). Events preceding the meeting with Mr MacGregor on 6th June, 1989 should be seen as development of the thinking by a number of people on the need to take wider action than that advised by the Southwood Working Party on baby food and earlier agreed by Ministers.<br /><br />13.Mr Thompson requested advice on 21st March, 1989 as to whether MAFF should consider requiring that cull cows be excluded from human consumption as a precautionary measure as such animals could be culled before they started to display clinical symptoms of BSE (YB89/3.21/5.1). This was one of the factors contributing to the "gradual thinking process". In oral evidence, I referred to this as having in part "accelerated" that process (T69, Vol. T7, Tab 9, page 75). Mr MacGregor's thinking appears in his manuscript note dated 26th February, 1989 querying, amongst other things, whether MAFF should be taking further action on offal in new product preparations and that given that animals are slaughtered the moment they show signs of BSE, whether there were any risks from animals just before that stage (YB89/02.24/14.1). It is not clear whether that note was passed to any particular MAFF official or whether it was for Mr MacGregor's use only. I cannot recall seeing this note. However, my minute of 5th April, 1989 to Mr Lawrence (YB89/04.05/2.1) indicates that he was aware that both Mr MacGregor and Mr Thompson were concerned about the human health implications of consumption of high risk material derived from both cattle and sheep. In that minute I noted that Mr Thompson had asked about the disposal of cull ruminants and the Permanent Secretary (Mr Andrews) was speaking to Mr MacGregor about the use of brain and spinal cord in meat preparations and that a meeting might be called if Mr MacGregor so wished. There was no suggestion by this minute that either Mr Thompson or Mr MacGregor had made a specific proposal for action on sub-clinical cases. At that stage, these were concerns in respect of which advice was requested and provided.<br /><br />14.In any event, my previous minute to Mr Lawrence dated 30th March, 1989 (YB89/3.30/2.1) appears to indicate that Mr Andrews' concerns stemmed from the adverse publicity being received on the use of brains, etc. in human food generally rather than specifically in relation to risks to human health from BSE, or more particularly from sub-clinically infected cattle (YB89/3.30/2.1). When Mr Thompson told me that the concerns he had expressed about cull cows actually related to the remote risk associated with the consumption of brain and spinal cord derived from cows, bulls, ewes and rams at the end of their working life, this served to clarify the detailed issue on which he required advice (YB89/4.10/2.1). Following consultation with the CVL, advice was put forward by Mr Lawrence on 22nd May, 1989 (YB89/5.22/1.1-1.4). So far as I can recall, prior to May 1989 no other events took place that could amount to a proposal from either Mr Thompson or Mr MacGregor, or indeed any other source, for "action on sub-clinical cases".<br /><br />15.My minute of 26th May, 1989 (YB89/5.26/5.1-5.2) was put forward to Mr MacGregor after discussion with Mr Andrews, so that I could express my own views in a note to go to Mr MacGregor in parallel with the submission which Mr Andrews would be putting forward. That submission had been prepared by Mr Cockbill (YB89/5.26/4.1-4.12) to seek Ministers' approval for proceeding to public consultation on the draft regulations prohibiting the use of certain specified offals in baby food. As the note had to go from me in parallel with Mr Andrews' submission which was going forward on 26th May, 1989 (YB89/5.26/5.1-5.2), the minute (YB89/5.26/5.1-5.2) was prepared hurriedly and I recognise that the wording of that minute is not as clear as I feel it could have been if I had had more time to draft it. However, any imperfections would have been ironed out at the later meetings with Ministers.<br /><br />16.As noted in Mr Cockbill's minute to Mr Ryder on the draft regulations, and in paragraph 4 of the submission itself, the list of prohibited offal in the draft regulations had been made wider than the limited list in the Southwood Report for "ease of enforcement and for the sake of consistency with other regulations made under the Food Act" (YB89/5.23/4.6). The draft regulations thus included offal from all mammalian species and covered a number of tissues which, although not likely to be significant in BSE terms, were equally not used in baby foods. This is the context in which the sentence in my minute of 26th May, 1989 (YB89/5.26/5.1-5.2) which reads, "I am becoming increasingly concerned that Ministers are being forced to consider a ban on the use for human consumption of certain offals, such as brain, spinal cord and spleens, derived from both cattle and sheep, even though there is no scientific evidence to support such action", should be read. It should also be noted that the reference to evidence in this part of the minute refers to cattle and sheep and not to one species alone; this is important in the context of later comments in the minute where reference is made to the scientific findings of Professor Hadlow and others. Mr Cockbill's minute to Mr Ryder (YB89/5.5/9.1-9.2) (copied to Mr MacGregor and Mr Andrews) had also noted that the proposals for the regulations as to baby food might stimulate suggestions that the ban should be extended to all meat products. My concerns expressed in his minute related to a large extent to the possibility that the proposals in Mr Cockbill's submission (YB89/5.26/4.1-4.12) might lead to pressure on MAFF to take action on sheep offals when scrapie had been in the UK and other countries for around 250 years without any scientific evidence of it being a human hazard. In addition, the control of scrapie in sheep and goats would have been a virtually impossible task at that time. This point had been made by me in a minute dated 30th March, 1989 to Mr Lawrence (YB89/3.30/2.1). Paragraph 5 of my minute dated 26th May, 1989 (YB89/5.26/5.1) further clarifies where my concerns lay and what action I did support; "it could be argued that the brain, spinal cord and spleen of adult cattle should be removed from the human food chain for the reasons expressed above but to go further and extend this to sheep would reopen the whole of the scrapie issue and would signal that we were concerned about the human health aspects of that disease".<br /><br />17.My minute of 26th May, 1989 (YB89/5.26/5.1-5.2) went on to note that the argument for prohibiting the use of offals such as brain, spinal cord and spleens derived from adult cattle was more persuasive as we were dealing with a new condition in cattle and could not be certain that the agent could not jump yet another species barrier and affect man. This is clearly an indication of my support for a policy of destruction of potentially infective tissues in the event that Ministers felt that such action was necessary. In my minute, I specifically pointed out that on occasions the BSE agent would be present in the brain of apparently healthy cattle that were in the incubative stage and the BSE agent was also likely to be present on occasion in other materials such as spleen, lymph glands and nerves. This is information that I discussed at the meeting with Dr Kimberlin on 16th May, 1989 (YB89/5.18/5.1; YB89/5.16/1.1-1.3; paragraph 7 of section F of WS 184A).<br /><br />18.Having received the information I did as a result of the meeting with Dr Kimberlin and Pedigree Petfoods, it is difficult to see how I either could or would oppose or fail to support a policy of destruction of potentially infective material in the event that Ministers decided to pursue such a policy. Once the decision to go further than the Southwood Working Party had advised had been taken, Dr Kimberlin's knowledge was applied to determine what tissues could sensibly be included in any ban. I knew from Dr Kimberlin that it was possible to extrapolate from Professor Hadlow's work in sheep. This was not new scientific evidence, but Dr Kimberlin’s assessment of the risk was new so far as I was concerned. It should also be noted that this was not scientific evidence on the BSE agent, rather it was a scientific comparison based on published data on the distribution of the scrapie agent in clinically affected sheep. In my oral evidence (T69, Vol. T7, Tab 9, pages 87 to 88), I explained that it was clear to me that Dr Kimberlin thought it was a "good idea" to keep those offals with the highest infectivity load out of the human food chain. It is important to note that I used the words "good idea" and that I did not say that such action on offals was either necessary or warranted at that time. A different distinction was made at a later date in the light of further assessments and knowledge.<br /><br />19.In any event, the issue was discussed in detail with Ministers. In my minute of 26th May (YB89/5.26/5.1-5.2), I advised that Ministers should consult with Sir Richard Southwood, and asked for a meeting with Ministers himself to discuss the issues. The meeting between Mr MacGregor, MAFF officials and Dr Metters took place on 6th June, 1989 (YB89/6.7/7.1-7.2) and the meeting with Sir Richard Southwood took place on 7th June, 1989 (YB89/6.8/4.1-4.2).<br /><br />20.Finally, I wish to comment on my recollection of the meeting on 16th May, 1989 with Dr Kimberlin. I described this in my previous statement (WS 184A, section F, paragraph 7). At the time I was preparing my previous statement (WS 184A) the only documents which I had available to me were my own handwritten notes of the meeting. Since then a number of additional documents have been found by the MAFF Liaison Unit which are relevant to the meeting. Whilst confirming that the meeting with Dr Kimberlin was on a confidential basis, these documents indicate that it was also attended by Mrs Owen, Mr Garnett and Dr Woolfe. I believe that there were two meetings. The first was attended by MAFF officials, Pedigree Petfoods and Dr Kimberlin (YB89/5.18/5.1) and the second was a more open meeting between Dr Kimberlin and myself. It was at that later meeting that Dr Kimberlin gave me a copy of the Pedigree Petfoods papers, in confidence. As regards the point of clarification over the number of documents which I received from Dr Kimberlin at the meeting, I can confirm that I received the five documents dated 2nd September, 1988 (M49 Tab 6)), January 1989 (M49 Tab 6A), February 1989 (two documents(M69 Tab 6B and 6C) and March 1989 (M69 Tab 6D). I did not recognise the earlier reference to five documents since my set of five documents are bound together as two separate documents.<br /><br />Approach taken to the Southwood Working Party advice<br /><br />21.I have been asked to consider whether the approach to be taken to advice from the Southwood Working Party should have been as follows:<br /><br />"(1) where the Working Party had expressed their view on a scientific question (e.g. whether there was a risk that tissues from sub-clinically infected animals could be infective to humans if eaten or accidentally inoculated, and the best estimate of the extent of that risk in scientific terms) Ministers should not depart from this unless they had scientific advice to cast doubt about it;<br /><br />(2) where such a body had made a value judgement as to whether any articular risk merited the taking of any particular steps it was for government to assess the costs and benefits of those steps in the light of scientific advice.<br /><br />22.It is very difficult to draw such a clear cut distinction as between an advisory committee's view on a scientific question and a value judgment as to the merit of taking any particular steps, such a value judgment having been made as a result of a view taken on a scientific issue. To a certain extent it is agreed that an advisory committee's view on a scientific question could and should not be challenged except with further scientific data (see paragraphs 1 to 6 on the section above on "Relationship with the Southwood Working Party" which set out views on the Southwood Working Party and the approach to advisory committees in general; see also paragraph 18 of the section above on "Assessment of the Southwood Report".)<br /><br />23.Taking, as an example, the Southwood Working Party's view on the scientific question as to the risks to human health from tissues from sub-clinically infected cattle, and their value judgment as to whether those risks as perceived at that time merited particular steps, be it labelling or advice to baby food manufacturers, I did not advise Ministers that they should not depart from or go further than the Southwood Working Party's advice that baby food manufacturers should avoid using ruminant offals and thymus. As explained in the section above on "Development of the SBO ban", my minute of 26th May, 1989 (YB89/5.26/5.1-5.2) did not amount to advice that Ministers should not go further than the Southwood Working Party's value judgment that the risks as perceived did not justify requiring the labelling of food products containing brain and spleen. If I had advised Ministers not to depart from this value judgment, then there may never have been an SBO ban. It was the assessment of the steps suggested by the Southwood Working Party that led to the development of the thinking behind the SBO ban.<br /><br />24.In the context of this section, I have also been asked to consider the following matters: a.Southwood Report "unnatural practices" recommendation.<br /><br />I was questioned on the issue of the Southwood Working Party's proposed "unnatural practices" recommendation in my oral evidence. I was asked whether it was my own view that, as stated by Mr Suich in a minute of 10th January, 1989 (YB89/1.10/2.1-2.2) to the Permanent Secretary, "such a controversial recommendation went wider than the Southwood Committee's remit". My answer was: "It would have been the general view at the time, whilst on the other hand accepting that if Government and Ministers decide to appoint an expert working party, it is most unhelpful to then fetter them in the ecommendations that they can make. Therefore this was simply and solely an issue of reporting that this consideration was taking place and to make sure that the Permanent Secretary … was in fact alerted to it" (T69, Vol. T7, Tab 9, page 72). In this respect, I would also comment that there were spurious suggestions in the press at the time that MAFF had influenced and altered the Southwood Report and that the final wording had been cleared with MAFF. As the contemporaneous documents show, this was not the case. Indeed, as far as I can recall, I was never formally consulted on the draft Southwood Report in the way that it appears to have been suggested that I would be (YB89/1.17/9.1). I believe it was quite proper that I should not be invited to comment in this way. When the Permanent Secretary (Mr Andrews) suggested to Sir Richard Southwood that I should attend the final meeting of the Southwood Working Party to discuss rendering practices, this was turned down by Sir Richard Southwood, who made it clear that my input was not equired (YB89/1.31/1.1-1.8; YB89/2.2/2.1). In any event, at the time it was recognised that the Southwood Working Party seemed intent on including the recommendation on "unnatural practices" in its final report. However, it was felt that a paper rom MAFF making the Southwood Working Party aware of what the rendering industry did and its scale of activity, would at least leave room for the Government to examine a number of options apart from a prohibition on the use of recycled animal waste in animal feed (YB89/1.10/2.1-2.2).<br /><br />b.Southwood Report advice for baby food manufacturers.<br /><br />It was accepted that the wording of the advice for baby food manufacturers was less than precise and some clarification was subsequently required, but the drafting of the Southwood Report was a matter for the Southwood Working Party and them alone. This has been discussed in more detail in the section above on "Southwood Working Party advice on baby food"<br /><br /><br />############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############<br /><br /><br /><a fg_scanned="1" href="https://lists.aegee.org/cgi-bin/wa?A2=ind9911&L=BSE-L&P=R18647&X=1D1B9A2D19721D3331&Y=flounder9%40verizon.net" style="color: #473624; cursor: pointer;">https://lists.aegee.org/cgi-bin/wa?A2=ind9911&L=BSE-L&P=R18647&X=1D1B9A2D19721D3331&Y=flounder9%40verizon.net</a><br /><br /><br />*** BABY FOODS 2001<br /><br />Subject: FSA ADMITS ERROR OVER BABY FOOD - BABY FOODS AND MAD COW DISEASE back on table...<br /><br />From: "Terry S. Singeltary Sr."<br /><br />Reply-To: Bovine Spongiform Encephalopathy<br /><br />Date: Sat, 20 Oct 2001 10:19:30 -0700 Content-Type: text/plain Parts/Attachments: text/plain (203 lines)<br /><br /><br />######## Bovine Spongiform Encephalopathy <bse-l uni-karlsruhe.de="">#########<br /><br /><br />Saturday, 20 October, 2001, 02:24 GMT 03:24 UK<br /><br />FSA admits error over baby food<br /><br />Many parents remain concerned over baby food ingredients The Food Standards Agency has admitted its chairman wrongly asserted that British sheep were not used in baby food production.<br /><br />Sir John Krebs said lamb from the UK was not being used in baby food.<br /><br />He suggested there was a voluntary agreement by the food industry to use lamb only from countries like New Zealand.<br /><br />Sir John hoped the assertion would be reassuring for those who feared sheep might harbour BSE.<br /><br />But a spokesman for the baby food industry, Heather Payne, told the BBC manufacturers are still using British lamb.<br /><br />"The lamb that baby food manufacturers use comes from a number of different sources. But it includes the UK, New Zealand, France and Germany.<br /><br />"We had a meeting earlier this year with the Food Standards Agency and we explained all our procedures and all our operations to them.<br /><br />"They advised us there was no need to change our source of lamb."<br /><br />Lethal illness<br /><br />There have been fears that BSE could be present in the national flock, sparking fears of a mass slaughter.<br /><br />BSE-infected meat is widely believed to be the source of the lethal vCJD illness in humans<br /><br />The FSA said in August that there was a "theoretical risk" BSE was in sheep, but stressed it was not asking people to stop eating lambs.<br /><br />There have previously been concerns, fiercely denied by the baby food industry, that mechanically-recovered meat from heavily infected areas of cattle could have been used in the 1980s.<br /><br />The FSA has joined in the chorus of criticism after it was revealed on Friday that scientists investigating whether BSE was in sheep had actually been examining the brains of cattle.<br /><br /><br /><a fg_scanned="1" href="http://news.bbc.co.uk/hi/english/health/newsid_1609000/1609832.stm" style="color: #473624; cursor: pointer;">http://news.bbc.co.uk/hi/english/health/newsid_1609000/1609832.stm</a><br /><br /><br />Greetings list members,<br /><br />we debated this issue in great length on Nov. 25, 1999. i even got a spanken from Ralph for being a bit rude for attacking Heather. But thought since the issue is back in the media and Heather is making comments again, some might be interested in the debate of 1999 on baby foods and BSE. no attack intended on Heather...<br /><br />with kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA<br /><br />Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><br />Date: Thu, 25 Nov 1999 22:30:36 +0000<br /><br />J Ralph Blanchfield<jralphb easynet.co.uk=""><br /><br />snip...<br /><br />It is easy with the 20/20 vision of hindsight to say now that certain animal derivatives should not have been used in baby foods (and indeed we do not know that they were, and Heather Paine is quoted as saying that to her knowledge they were not). Until the investigations of the Southwood Committee, there was anyway no reason to suppose that these materials, from apparently healthy cows, were other than wholesome or had any connection with BSE or indeed vCJD (the existence of which was at that point unknown). As it happens, the food manufacturer for which I worked in the early 1950s, among its many canned, bottled, frozen and dehydrated products, manufactured a range of baby foods including a beef broth, which was made from Argentinian frozen beef -- no offals of any kind.<br /><br />But each manufacturer decided for itself what ingredients to use, and they were/are in no way controlled or "overseen" by a trade association, which is what the Infant and Dietetic Foods Association was/is. So Terry, your attack on Heather Paine was unwarranted and badly misconceived, and I think you owe her an apology.<br /><br />I happen to know Heather well in an entirely different connection, and a more honest and conscientious person it would be hard to find.<br /><br />snip...<br /><br />===================================<br /><br />At 11:35 AM 11/24/99 -0600, Terry wrote:<br /><br />Heather Paine should be educated on the products she over-sees. These children's health are at risk, and if she does not know what has and has not been going into baby-foods, she does not need to hold that position. The Inquiry was very concerned about baby foods, and at one point said something about;<br /><br />It is very unlikely that baby food would contain SBO's, since baby food is the most highly regulated and safest of all commercial foods.<br /><br />So, if baby food is suspected as a vehicle for BSE->ukCJD, then it would be base on its containing normal cuts of meat. Baby foods contain more liver than the general population eats, so perhaps there could be a correlation there.<br /><br />Babies of all species have more porous intestinal membranes, so uptake of prions would be expected to be more efficient.<br /><br />snip...<br /><br />========================================<br /><br />99. Mr. Lawrence wrote a letter to Sir Richard on 6 January 1989 (110) explaining that there were _no_ special regulations with regard to the composition of baby food except in relation to additives, and that there was therefore _nothing_ in the rules that would exclude certain parts of animal being incorporated into baby foods as long as they were fit for human consumption.<br /><br />152. There is _no_ evidence of written assurances from the manufacturers supplied to either MAFF or the Department of Health asserting that Baby Food did not contain bovine brain, spinal cord, spleen, intestines or thymus.<br /><br />155. The reply also outlined the following actions already taken or to be taken by the Government in response to the Working Party's recommendations. 1) As a precautionary measure the Government would enact secondary legislation to ensure it was illegal to sell Baby Food containing brain, spinal cord, spleen and intestines.<br /><br />165. On 23 May 1989 Mr. Cockbill prepared draft regulations prohibiting the use of certain _specified offals_ in Baby Foods...<br /><br />snip...<br /><http:><br /><br />========================================<br /><br />for anyone interested and wanting to search data of this thread, search BSE-L archive NOVEMBER 1999. towards the bottom, #35.<br /><br />kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA<br /><br />########### http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############<br /><br /><br /><a fg_scanned="1" href="https://lists.aegee.org/cgi-bin/wa?A2=ind0110&L=BSE-L&P=R10662&X=4F0C9B3D9F1736BD9D&Y=flounder9%40verizon.net" style="color: #473624; cursor: pointer;">https://lists.aegee.org/cgi-bin/wa?A2=ind0110&L=BSE-L&P=R10662&X=4F0C9B3D9F1736BD9D&Y=flounder9%40verizon.net</a><br /><br /><br />Subject: Re: FSA ADMITS ERROR OVER BABY FOOD - BABY FOODS AND MAD COW DISEASE back on table...<br /><br />From: J Ralph Blanchfield<br /><br />Reply-To: Bovine Spongiform Encephalopathy<br /><br />Date: Sat, 20 Oct 2001 19:15:48 +0100 Content-Type: text/plain Parts/Attachments: text/plain (249 lines)<br /><br />######## Bovine Spongiform Encephalopathy <bse-l uni-karlsruhe.de="">#########<br /><br />Hello Terry and Everyone,<br /><br />The question of the sources of lamb used is of course a totally different issue from that of the past allegations about the use of MRM,, as Terry is very well aware, and he deserves another (and severe) spanking for intentionally misrepresenting the two issues as the same issue ("since the issue is back in the media").<br /><br />Sir John had obviously been badly briefed when in an interview he said that no UK lamb was used in babyfood, when in fact FSA actually knew that it was one of the sources. Moreover, on advice published by FSA there was no reason why it should not have been one of the sources (actually UK lamb "of scrapie-free lineage").<br /><br />As regards the "lamb brains" paste from the early 1990s that turned out to be cow brains paste, Terry has assumed his usual "conspiracy theory" explanation. Generally speaking, in real life sensible people examine the likelihood of cock-up before jumping to the conclusion of conspiracy I certainly think there was no excuse for the curious timing and obscure method of disclosure (the Jo Moore syndrome?), but as to the wrong material being tested for four years, I think that this was the major cock-up of all time. Fortunately, a separate investigation, at the Weybridge veterinary laboratories has been proceeding in parallel, on 163 scrapie-affected present-day sheep and so far no BSE has been found. And before Terry produces his usual condescending lecture and mantra about "absence of evidence is not evidence of absence", all of those with any sort of scientific background on this list were trained to understand that as a basic principle long before he entered this list and picked up the phrase.<br /><br />Best wishes Ralph<br /><br />******************************************************<br /><br />Prof J Ralph Blanchfield, MBE Food Science, Food Technology and Food Law Consultant Chair, External Affairs, Institute of Food Science and Technology Webmaster / Editor, Institute of Food Science and Technology Vice President, European Food Law Association of the UK Chair, IFT Committee for Global Interests Past Chair, IFT British Section Adjunct Professor, Michigan State University IFST Web address <www .ifst.org="">Personal Web address<www .jralphb.co.uk=""><br /><br /><br />*****************************************************<br /><br /><a fg_scanned="1" href="https://lists.aegee.org/cgi-bin/wa?A2=ind0110&L=BSE-L&P=R10888&X=4F0C9B3D9F1736BD9D&Y=flounder9%40verizon.net" style="color: #473624; cursor: pointer;">https://lists.aegee.org/cgi-bin/wa?A2=ind0110&L=BSE-L&P=R10888&X=4F0C9B3D9F1736BD9D&Y=flounder9%40verizon.net</a><br /><br /><br />Subject: Re: FSA ADMITS ERROR OVER BABY FOOD - BABY FOODS AND MAD COW DISEASE back on table...<br /><br />From: Brian MATTHEWS<br /><br />Reply-To: Bovine Spongiform Encephalopathy<br /><br />Date: Mon, 22 Oct 2001 15:33:42 +0100 Content-Type: text/plain Parts/Attachments: text/plain (270 lines)<br /><br /><br />######## Bovine Spongiform Encephalopathy <bse-l uni-karlsruhe.de="">#########<br /><br /><br />Ralph,<br /><br />Regarding the second part of the posting (sheep), would this be the same or a different study to that reported in the last week or so where the wrong animals' brains were examined.<br /><br />Given the latest display of ineptitude on the part of UK scientists, what faith can be placed in the data?<br /><br />Regards,<br /><br />Brian Matthews lt09@dial.pipex.com<br /><br /><br /><a fg_scanned="1" href="https://lists.aegee.org/cgi-bin/wa?A2=ind0110&L=BSE-L&P=R11463&X=4F0C9B3D9F1736BD9D&Y=flounder9%40verizon.net" style="color: #473624; cursor: pointer;">https://lists.aegee.org/cgi-bin/wa?A2=ind0110&L=BSE-L&P=R11463&X=4F0C9B3D9F1736BD9D&Y=flounder9%40verizon.net</a><br /><br /><br />Subject: Re: FSA ADMITS ERROR OVER BABY FOOD - BABY FOODS AND MAD COW DISEASE back on table...<br /><br />From: J Ralph Blanchfield<br /><br />Reply-To: Bovine Spongiform Encephalopathy<br /><br />Date: Mon, 22 Oct 2001 19:00:08 +0100 Content-Type: text/plain Parts/Attachments: text/plain (311 lines)<br /><br /><br />######## Bovine Spongiform Encephalopathy <bse-l uni-karlsruhe.de="">#########<br /><br /><br />Hello Brian and Everyone,<br /><br />I only have access to the same information that you do. I thought it was crystal-clear, and I think I reflected that in the second part of my posting, that there were two separate experiments, namely<br /><br />1) the experiment at the Institute of Animal Health (the so-called Bostock experiment) supposedly on a paste of scrapie-infected sheep collected in 1990 for a different purpose along with brains from BSE-infected cattle. Because of fears of cross-contamination, DEFRA referred a sample of the sheep-brain paste for testing to the Laboratory of the Government Chemist which has now determined by DNA that the supposed ovine material was in fact wholly bovine. This is the experiment that I described as "the major cock-up of all time". But whose cock-up? Before rushing to blame the IAH scientists, I would want to know exactly what was the provenance of the material provided to them to test.<br /><br />2) A totally separate experiment on a number (too-small, 163) of present-day scrapie infected sheep brains, carried out by Veterinary Laboratory Agency in Weybridge, which so far has produced no evidence of BSE.<br /><br />Best wishes Ralph<br /><br />******************************************************<br /><br />Prof J Ralph Blanchfield, MBE Food Science, Food Technology and Food Law Consultant Chair, External Affairs, Institute of Food Science and Technology Webmaster / Editor, Institute of Food Science and Technology Vice President, European Food Law Association of the UK Adjunct Professor, Michigan State University IFST Web address <www .ifst.org="">Personal Web address<www .jralphb.co.uk=""><br /><br />******************************************************<br /><br /><a fg_scanned="1" href="https://lists.aegee.org/cgi-bin/wa?A2=ind0110&L=BSE-L&P=R11852&X=4F0C9B3D9F1736BD9D&Y=flounder9%40verizon.net" style="color: #473624; cursor: pointer;">https://lists.aegee.org/cgi-bin/wa?A2=ind0110&L=BSE-L&P=R11852&X=4F0C9B3D9F1736BD9D&Y=flounder9%40verizon.net</a><br /><br /><br />Subject: Re: FSA ADMITS ERROR OVER BABY FOOD - BABY FOODS AND MAD COW DISEASE back on table...<br /><br />From: Brian MATTHEWS<lt09 dial.pipex.com=""><br /><br />Reply-To: Bovine Spongiform Encephalopathy<bse-l uni-karlsruhe.de=""><br /><br />Date: Mon, 22 Oct 2001 19:22:09 +0100 Content-Type: text/plain Parts/Attachments: text/plain (334 lines)<br /><br /><br />######## Bovine Spongiform Encephalopathy <bse-l uni-karlsruhe.de="">#########<br /><br /><br />Dear Ralph,<br /><br />I seems at least possible that the mix up of brain material involved the former MAFF laboratories. This is currently under investigation, of course. Perhaps this information will also be published in a government press release at 22.30!<br /><br />If the MAFF scientists were involved in the first cock-up, why should their information be seen to be any more reliable for the second experiment unless it is first vetted by independent scientists? After all, the same people did not all come out with glowing testimonials in the BSE Inquiry report.<br /><br />Another aspect of the cock-up that concerns me is that the work was being undertaken in a laboratory that could not, according to all accounts I have seen, undertake a DNA test to confirm the source of the materials sent to them. It seems surprising that the work should continue for so long without such a basic test of veracity being applied.<br /><br />Regards,<br /><br />Brian Matthews lt09@dial.pipex.com<br /><br /><a fg_scanned="1" href="https://lists.aegee.org/cgi-bin/wa?A2=ind0110&L=BSE-L&P=R12236&X=4F0C9B3D9F1736BD9D&Y=flounder9%40verizon.net" style="color: #473624; cursor: pointer;">https://lists.aegee.org/cgi-bin/wa?A2=ind0110&L=BSE-L&P=R12236&X=4F0C9B3D9F1736BD9D&Y=flounder9%40verizon.net</a><br /><br /><br />===================== *** BABY FOOD 2005 *** =====================<br /><br /><br />===============: BSE 'may have entered baby food in 70s' ===================<br /><br /><br />LISTS.AEGEE.ORG ( BSE-L: 61 matches (only the first 50 will be shown).. )<br /><br />Subject: Re: BSE 'may have entered baby food in 70s'<br /><br />From: "Terry S. Singeltary Sr."<br /><br />Reply-To: Bovine Spongiform Encephalopathy<br /><br />Date: Fri, 4 Mar 2005 17:09:14 -0600 Content-Type: text/plain Parts/Attachments: text/plain (956 lines)<br /><br />##################### Bovine Spongiform Encephalopathy #####################<br /><br />THE BABY FOOD (PROHIBITED OFFAL) REGULATIONS 1989<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102185118/http://www.bseinquiry.gov.uk/files/yb/1989/05/00002001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080102185118/http://www.bseinquiry.gov.uk/files/yb/1989/05/00002001.pdf</a></bse-l></bse-l></lt09></www></www></bse-l></bse-l></www></www></bse-l></http:></jralphb></bse-l></http:></bse-l></bse-l></flounder></jralphb></www></bse-l></bse-l></bse-l></bse-l></bse-l></jralphb></www></http:></bse-l></bse-l></http:></bse-l></bse-l></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de="">NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><www .ifst.org=""><jralphb easynet.co.uk=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><www .ifst.org=""><jralphb easynet.co.uk=""><flounder wt.net=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><bse-l uni-karlsruhe.de=""><jralphb easynet.co.uk=""><http:><bse-l uni-karlsruhe.de=""><www .ifst.org=""><www .jralphb.co.uk=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><www .ifst.org=""><www .jralphb.co.uk=""><lt09 dial.pipex.com=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090506014439/http://www.bseinquiry.gov.uk/files/yb/1989/05/00002001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506014439/http://www.bseinquiry.gov.uk/files/yb/1989/05/00002001.pdf</a></bse-l></bse-l></lt09></www></www></bse-l></bse-l></www></www></bse-l></http:></jralphb></bse-l></http:></bse-l></bse-l></flounder></jralphb></www></bse-l></bse-l></bse-l></bse-l></bse-l></jralphb></www></http:></bse-l></bse-l></http:></bse-l></bse-l></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /><br /><a href="http://collections.europarchive.org/tna/20080102185203/http://www.bseinquiry.gov.uk/files/yb/1989/05/00001001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080102185203/http://www.bseinquiry.gov.uk/files/yb/1989/05/00001001.pdf</a><br /><br /><br />NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090506014328/http://www.bseinquiry.gov.uk/files/yb/1989/05/00001001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506014328/http://www.bseinquiry.gov.uk/files/yb/1989/05/00001001.pdf</a><br /><br /><br />UK EXPORTS BOVINE SEMEN</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /><br /><a href="http://web.archive.org/web/20030331015257/http://www.bseinquiry.gov.uk/files/mb/m11g/tab04.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20030331015257/http://www.bseinquiry.gov.uk/files/mb/m11g/tab04.pdf</a><br /><br /><br />BABY FOODS<br /><br />There are 4 brands available for a quick survey - Boots, Cow & Gate, Heinz and Robinson.<br /><br />None of the meat dishes included 'offal' in the ingredients.<br /><br />Steak & Kidney and Beef and Oxtail did, however, include kidney and oxtail.....<br /><br />snip...<br /><br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102185207/http://www.bseinquiry.gov.uk/files/yb/1989/01/17006001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080102185207/http://www.bseinquiry.gov.uk/files/yb/1989/01/17006001.pdf</a></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de="">NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090506014316/http://www.bseinquiry.gov.uk/files/yb/1989/01/17006001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506014316/http://www.bseinquiry.gov.uk/files/yb/1989/01/17006001.pdf</a><br /><br /><br /><a href="http://web.archive.org/web/20090506001348/http://www.bseinquiry.gov.uk/files/mb/m11g/tab04.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506001348/http://www.bseinquiry.gov.uk/files/mb/m11g/tab04.pdf</a><br /><br /><br />About the only item it seems many remain to be decided next week is what if anything we say about offal in baby food. I enclose now in confidence the draft as it stands at present concerning this aspect. It might be that no action is recommened. On the other hand, the working party, PERSUADED BY THE ANIMAL EVIDENCE THAT IMMATURE ANIMALS ARE MORE SUSCEPTIBLE TO INFECTION WITH THE AGENTS OF SPONGIFORM ENCEPHALOPATHY, may make some recommendations either about labelling or about banning offal in baby food.......<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102185215/http://www.bseinquiry.gov.uk/files/yb/1989/01/25001001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080102185215/http://www.bseinquiry.gov.uk/files/yb/1989/01/25001001.pdf</a><br /><br /><br />NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090506014808/http://www.bseinquiry.gov.uk/files/yb/1989/01/25001001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506014808/http://www.bseinquiry.gov.uk/files/yb/1989/01/25001001.pdf</a><br /><br /><br />BSE SOUTHWOOD REPORT<br /><br />CONFIDENTIAL<br /><br />snip...<br /><br />BABY FOODS<br /><br />7. The working Party consider that manufacturers of baby foods should, as a precautionary measure, avoid the use of ruminant offals and thymus. Sir Richard Southwood has told the Minister of Agriculture, Fisheries and Food that the likelihood of problems arising through the use of these products in baby food is very low indeed and that this suggestion is counsel of ''extreme prudence''. In practice thymus is not used in the preperation of baby foods, kidneys and liver are because of their nutritional value. Officials will contact manufacturers urgently to seek their reaction to the suggestion...<br /><br />snip...<br /><br /><br /><a href="http://collections.europarchive.org/tna/20090506060319/http://www.bseinquiry.gov.uk/files/yb/1989/02/17005001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20090506060319/http://www.bseinquiry.gov.uk/files/yb/1989/02/17005001.pdf</a><br /><br /><br />NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090506060319/http://www.bseinquiry.gov.uk/files/yb/1989/02/17005001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506060319/http://www.bseinquiry.gov.uk/files/yb/1989/02/17005001.pdf</a><br /><br /><br />This would enable us to assess more fully what the actual risks are and what the risks are of any ban on liver and kidney in baby foods.<br /><br />We do not wish to create problems for young children and ethnic minorities simply on the basis of poorly substantiated speculation. On the other hand, if there is clear evidence this must be taken into account. My understanding is that the evidence is not clear-cut and does need further consideration...<br /><br />snip...<br /><br /><br /><a href="http://web.archive.org/web/20030506230546/http://www.bseinquiry.gov.uk/files/yb/1989/02/15002001.pdf" style="color: #473624; cursor: pointer;">http://web.archive.org/web/20030506230546/http://www.bseinquiry.gov.uk/files/yb/1989/02/15002001.pdf</a><br /><br /><br />NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090505215622/http://www.bseinquiry.gov.uk/files/yb/1989/02/15002001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090505215622/http://www.bseinquiry.gov.uk/files/yb/1989/02/15002001.pdf</a><br /><br /><br />BSE AND BABY FOOD<br /><br />snip...<br /><br />1. We spoke about MacGregor's concern about baby food and how, if asked about beef liver and kidney, he was proposing replying:<br /><br />"I understand that the committee (Southwood's) did not have the opportunity to examine thoroughly all the scientific evidence relating to offal particularly liver and kidney in human and baby food. I therefore propose to refer the matter to the CMO to seek his advice before taking any further action."<br /><br />2. Whilst we agreed this clearly was passing the buck, I guess it's the best MacGregor can do.....<br /><br />snip...<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102140603/http://www.bseinquiry.gov.uk/files/yb/1989/02/20006001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080102140603/http://www.bseinquiry.gov.uk/files/yb/1989/02/20006001.pdf</a><br /><br /><br />NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090505220053/http://www.bseinquiry.gov.uk/files/yb/1989/02/20006001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090505220053/http://www.bseinquiry.gov.uk/files/yb/1989/02/20006001.pdf</a><br /><br /><br />POWERS TO REGULATE BABY FOODS<br /><br />DEFINITION OF BABY FOOD<br /><br />1. There is no definition of baby food (nor of baby) for food legislation purposes...<br /><br />snip...<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103002304/http://www.bseinquiry.gov.uk/files/yb/1989/02/23014001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080103002304/http://www.bseinquiry.gov.uk/files/yb/1989/02/23014001.pdf</a><br /><br /><br />NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090506060217/http://www.bseinquiry.gov.uk/files/yb/1989/02/23014001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506060217/http://www.bseinquiry.gov.uk/files/yb/1989/02/23014001.pdf</a><br /><br /><br />Heinz Baby Foods<br /><br />WE guarantee that __________________ are free from offal OTHER THAN that which is named in any product description and in particular contain no thymus, brains, spinal chord, spleen, and intestine.<br /><br />THE ONLY OFFALS USED IN __________________ ARE KIDNEY, LIVER, AND OXTAIL when they are always identified on the lable, both in the product description and in the list of ingredients.<br /><br />PICTURE OF BABY FOOD JAR NAMED STEAK AND KIDNEY LUNCH<br /><br />INGREDIENTS - WATER, BEEF, CARROTS, POTATOES, KIDNEY, MODIFIED CORN FLOUR, SPLIT GREEN PEAS, FLOUR, TOMATO PUREE, LIVER, .....<br /><br />snip...<br /><br />ANOTHER PICTURE OF BABY FOOD JAR NAMED BEEF AND OXTAIL DINNER<br /><br />ingredients listed also, but difficult to read, name self explanitory, contains beef and OXTAIL...TSS<br /><br />ANOTHER BABY FOOD JAR NAMED LIVER AND BACON DINNER, ingredients listed<br /><br />ANOTHER BABY FOOD JAR NAMED STEAK AND KIDNEY DINNER, ingredients listed<br /><br />ANOTHER BABY FOOD JAR NAMED BRAISED STEAK AND KIDNEY, ingredients listed<br /><br />ANOTHER BABY FOOD JAR NAMED LAMB AND LIVER CASSEROLE, NO INGREDIENTS LISTED (WHAT ABOUT LAMB AND BSE ??? TSS)<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103002829/http://www.bseinquiry.gov.uk/files/yb/1989/02/23015001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080103002829/http://www.bseinquiry.gov.uk/files/yb/1989/02/23015001.pdf</a><br /><br /><br />NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><www .ifst.org=""><jralphb easynet.co.uk=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><www .ifst.org=""><jralphb easynet.co.uk=""><flounder wt.net=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><bse-l uni-karlsruhe.de=""><jralphb easynet.co.uk=""><http:><bse-l uni-karlsruhe.de=""><www .ifst.org=""><www .jralphb.co.uk=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><www .ifst.org=""><www .jralphb.co.uk=""><lt09 dial.pipex.com=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090506060105/http://www.bseinquiry.gov.uk/files/yb/1989/02/23015001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506060105/http://www.bseinquiry.gov.uk/files/yb/1989/02/23015001.pdf</a></bse-l></bse-l></lt09></www></www></bse-l></bse-l></www></www></bse-l></http:></jralphb></bse-l></http:></bse-l></bse-l></flounder></jralphb></www></bse-l></bse-l></bse-l></bse-l></bse-l></jralphb></www></http:></bse-l></bse-l></http:></bse-l></bse-l></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><br /></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br />for someone to claim no risk from these products to young children with todays science and with the documented pictures of the baby food jars with ingredients, is like johann saying there is NO RISK from canadian beef. just aint so folks...CASE IN POINT;<br /><br />107 Vet Pathol 42:107 108 (2005) Letters to the Editor Editor:<br /><br />Absence of evidence is not always evidence of absence.<br /><br />In the article Failure to detect prion protein (PrPres) by immunohistochemistry in striated muscle tissues of animals experimentally inoculated with agents of transmissible spongiform encephalopathy, recently published in Veterinary Pathology (41:78 81, 2004), PrPres was not detected in striated muscle of experimentally infected elk, cattle, sheep, and raccoons by immunohistochemistry (IHC). Negative IHC, however, does not exclude the presence of PrPSc. For example, PrPres was detected in skeletal muscle in 8 of 32 humans with the prion disease, sporadic Creutzfeldt-Jakob disease (CJD), using sodium phosphotungstic acid (NaPTA) precipitation and western blot.1 The NaPTA precipitation, described by Wadsworth et al.,3 concentrates the abnormal isoform of the prion, PrPres, from a large tissue homogenate volume before western blotting. This technique has increased the sensitivity of the western blot up to three orders of magnitude and could be included in assays to detect PrPres. Extremely conspicuous deposits of PrPres in muscle were detected by IHC in a recent case report of an individual with inclusion body myositis and CJD.2 Here, PrPres was detected in the muscle by immunoblotting, IHC, and paraf- fin-embedded tissue blot. We would therefore caution that, in addition to IHC, highly sensitive biochemical assays and bioassays of muscle are needed to assess the presence or absence of prions from muscle in experimental and natural TSE cases. Christina Sigurdson, Markus Glatzel, and Adriano Aguzzi Institute of Neuropathology University Hospital of Zurich Zurich, Switzerland References 1 Glatzel M, Abela E, et al: Extraneural pathologic prion protein in sporadic Creutzfeldt-Jakob disease. N Engl J Med 349(19):1812 1820, 2003 2 Kovacs GG, Lindeck-Pozza E, et al: Creutzfeldt-Jakob disease and inclusion body myositis: abundant diseaseassociated prion protein in muscle. Ann Neurol 55(1): 121 125, 2004 3 Wadsworth JDF, Joiner S, et al: Tissue distribution of protease resistant prion protein in variant CJD using a highly sensitive immuno-blotting assay. Lancet 358:171 180, 2001tss<br /><br />COW AND GATE BABY FOODS<br /><br />snip...<br /><br />Further to our telephone conversation today, I would like to confirm to you that ____________________ babyfoods do not contain brain, bowels, feet, testicles or lever (oh my...TSS). WE DO have a babymeal variety which contains kidney, but I can confirm that this is correctly labelled in line with current UK legislation...<br /><br />snip...<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103002321/http://www.bseinquiry.gov.uk/files/yb/1989/02/23016001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080103002321/http://www.bseinquiry.gov.uk/files/yb/1989/02/23016001.pdf</a><br /><br /><br />NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090506060350/http://www.bseinquiry.gov.uk/files/yb/1989/02/23016001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506060350/http://www.bseinquiry.gov.uk/files/yb/1989/02/23016001.pdf</a><br /><br /><br />ANNEX 2<br /><br />Dear Dr. Woolfe,<br /><br />This is to confirm that the only offal used in ____________________ beef kidney, which is used in Steak and Kidney Junior Meal. The kidney is purchased to a tight specification and is checked for quality.<br /><br />We do not use any other offal material, such as liver, brain, intestines, spinal cord etc...<br /><br />snip...<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103002614/http://www.bseinquiry.gov.uk/files/yb/1989/02/24015001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080103002614/http://www.bseinquiry.gov.uk/files/yb/1989/02/24015001.pdf</a></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de="">NEW URL LINK 2022<br /><br /><br /><a href="http://web.archive.org/web/20090506060408/http://www.bseinquiry.gov.uk/files/yb/1989/02/24015001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506060408/http://www.bseinquiry.gov.uk/files/yb/1989/02/24015001.pdf</a><br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103002506/http://www.bseinquiry.gov.uk/files/yb/1989/02/24016001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080103002506/http://www.bseinquiry.gov.uk/files/yb/1989/02/24016001.pdf</a><br /><br /><br />NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090506060349/http://www.bseinquiry.gov.uk/files/yb/1989/02/24016001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506060349/http://www.bseinquiry.gov.uk/files/yb/1989/02/24016001.pdf</a><br /><br /><br /><a href="http://web.archive.org/web/20030516041446/http://www.bseinquiry.gov.uk/files/yb/1989/02/27015001.pdf" style="color: #473624; cursor: pointer;">http://web.archive.org/web/20030516041446/http://www.bseinquiry.gov.uk/files/yb/1989/02/27015001.pdf</a><br /><br /><br />NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090506060100/http://www.bseinquiry.gov.uk/files/yb/1989/02/27015001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506060100/http://www.bseinquiry.gov.uk/files/yb/1989/02/27015001.pdf</a><br /><br /><br />BABY FOODS WARNING<br /><br />snip...<br /><br />Although we are aware from Dr. Woolfe's enquiries that none of these particular offals are CURRENTLY used in baby food... nonetheless the Ministers wishes to go ahead urgently........<br /><br />snip...<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102143408/http://www.bseinquiry.gov.uk/files/yb/1989/02/28006001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080102143408/http://www.bseinquiry.gov.uk/files/yb/1989/02/28006001.pdf</a><br /><br /><br />NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090505235833/http://www.bseinquiry.gov.uk/files/yb/1989/02/28006001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090505235833/http://www.bseinquiry.gov.uk/files/yb/1989/02/28006001.pdf</a><br /><br /><br />NEWSPAPER ARTICLE ABOUT BABY FOOD WARNING<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103002737/http://www.bseinquiry.gov.uk/files/yb/1989/02/28007001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080103002737/http://www.bseinquiry.gov.uk/files/yb/1989/02/28007001.pdf</a><br /><br /><br />NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><www .ifst.org=""><jralphb easynet.co.uk=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><www .ifst.org=""><jralphb easynet.co.uk=""><flounder wt.net=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><bse-l uni-karlsruhe.de=""><jralphb easynet.co.uk=""><http:><bse-l uni-karlsruhe.de=""><www .ifst.org=""><www .jralphb.co.uk=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><www .ifst.org=""><www .jralphb.co.uk=""><lt09 dial.pipex.com=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090506060342/http://www.bseinquiry.gov.uk/files/yb/1989/02/28007001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506060342/http://www.bseinquiry.gov.uk/files/yb/1989/02/28007001.pdf</a></bse-l></bse-l></lt09></www></www></bse-l></bse-l></www></www></bse-l></http:></jralphb></bse-l></http:></bse-l></bse-l></flounder></jralphb></www></bse-l></bse-l></bse-l></bse-l></bse-l></jralphb></www></http:></bse-l></bse-l></http:></bse-l></bse-l></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /><br />HERE IS A MOST DISTURBING DOCUMENT.<br /><br />2. In his fourth paragraph, Mr. Cockbill says that in notifying the EC Commission we can claim the need for urgent action on the basis of a ''KNOWN HEALTH RISK''. I am concerned that this might be misinterpreted by the Commission and others. The Southwood Report concluded that, from present evidence, cattle are likely to prove a dead-end host for the BSE agent and that BSE is most unlikely to have any implications for human health. Our action in banning offal in baby foods is therefore a precautionary measure and not one to deal with a known risk.<br /><br />3. In view of the sensitivity of this issue could I ask that you keep us in close touch with developments at your end and let us HAVE THE OPPORTUNITY TO SEE DRAFTS OF THE NOTIFICATION, SUBMISSION ETC?<br /><br />snip...<br /><br /><br /><a href="http://web.archive.org/web/20030714134945/http://www.bseinquiry.gov.uk/files/yb/1989/03/03003001.pdf" style="color: #473624; cursor: pointer;">http://web.archive.org/web/20030714134945/http://www.bseinquiry.gov.uk/files/yb/1989/03/03003001.pdf</a><br /><br /><br />NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090506061709/http://www.bseinquiry.gov.uk/files/yb/1989/03/03003001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506061709/http://www.bseinquiry.gov.uk/files/yb/1989/03/03003001.pdf</a><br /><br /><br />MANIPULATING AND MANAGING STATEMENTS TO THE MEDIA<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103005917/http://www.bseinquiry.gov.uk/files/yb/1989/03/03009001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080103005917/http://www.bseinquiry.gov.uk/files/yb/1989/03/03009001.pdf</a><br /><br /><br />NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090506061930/http://www.bseinquiry.gov.uk/files/yb/1989/03/03009001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506061930/http://www.bseinquiry.gov.uk/files/yb/1989/03/03009001.pdf</a><br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103010010/http://www.bseinquiry.gov.uk/files/yb/1989/03/09001001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080103010010/http://www.bseinquiry.gov.uk/files/yb/1989/03/09001001.pdf</a><br /><br /><br />NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><www .ifst.org=""><jralphb easynet.co.uk=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><www .ifst.org=""><jralphb easynet.co.uk=""><flounder wt.net=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><bse-l uni-karlsruhe.de=""><jralphb easynet.co.uk=""><http:><bse-l uni-karlsruhe.de=""><www .ifst.org=""><www .jralphb.co.uk=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><www .ifst.org=""><www .jralphb.co.uk=""><lt09 dial.pipex.com=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090506061808/http://www.bseinquiry.gov.uk/files/yb/1989/03/09001001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506061808/http://www.bseinquiry.gov.uk/files/yb/1989/03/09001001.pdf</a></bse-l></bse-l></lt09></www></www></bse-l></bse-l></www></www></bse-l></http:></jralphb></bse-l></http:></bse-l></bse-l></flounder></jralphb></www></bse-l></bse-l></bse-l></bse-l></bse-l></jralphb></www></http:></bse-l></bse-l></http:></bse-l></bse-l></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /><br />IN CONFIDENCE<br /><br /><br />5. IT might be PRUDENT to advise that where bovine or ovine bones are required for food purposes PARTICULARLY FOR BABY FOODS THEY SHOULD BE OBTAINED FROM LIMB BONES ALONE...<br /><br />R BRADLEY MARCH 4, 1989<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103010144/http://www.bseinquiry.gov.uk/files/yb/1989/03/04001001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080103010144/http://www.bseinquiry.gov.uk/files/yb/1989/03/04001001.pdf</a></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de="">NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090506061713/http://www.bseinquiry.gov.uk/files/yb/1989/03/04001001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506061713/http://www.bseinquiry.gov.uk/files/yb/1989/03/04001001.pdf</a><br /><br /><br />STILL CONCERNS OF TAIL MEAT IN BABY FOOD<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103010345/http://www.bseinquiry.gov.uk/files/yb/1989/03/07005001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080103010345/http://www.bseinquiry.gov.uk/files/yb/1989/03/07005001.pdf</a><br /><br /><br />NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><www .ifst.org=""><jralphb easynet.co.uk=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><www .ifst.org=""><jralphb easynet.co.uk=""><flounder wt.net=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><bse-l uni-karlsruhe.de=""><jralphb easynet.co.uk=""><http:><bse-l uni-karlsruhe.de=""><www .ifst.org=""><www .jralphb.co.uk=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><www .ifst.org=""><www .jralphb.co.uk=""><lt09 dial.pipex.com=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090506061605/http://www.bseinquiry.gov.uk/files/yb/1989/03/07005001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506061605/http://www.bseinquiry.gov.uk/files/yb/1989/03/07005001.pdf</a></bse-l></bse-l></lt09></www></www></bse-l></bse-l></www></www></bse-l></http:></jralphb></bse-l></http:></bse-l></bse-l></flounder></jralphb></www></bse-l></bse-l></bse-l></bse-l></bse-l></jralphb></www></http:></bse-l></bse-l></http:></bse-l></bse-l></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /><br />THE BABY FOOD (PROHIBITED OFFAL) REGULATIONS<br /><br />SNIP...<br /><br />WE need however to consider those offals that are included in Part Heart, liver and kidney have all been discussed and agreed as suitable for use in baby foods. Diaphragm, head meat (muscle meat) and tongue are not offals in the accepted sense. This leaves pancreas and tail meat to be considered. .........<br /><br />snip...<br /><br />IN reaching your views on these issues, could I please draw to your attention the relationship that they will have for meat products general. Although the Southwood Report confined itself to offals baby foods, opinions are already being expressed publicly (some medical practitioners) that similar prohibitions should extend to all meat products. SINCE SOME MEAT PRODUCTS WILL UNDOUBTEDLY BE CONSUMED BY BY YOUNG CHILDREN OR TEENAGERS, IT MAY BE DIFFICULT TO DRAW A LINE BETWEEN BABY FOODS AND OTHERS. ...<br /><br />snip...<br /><br /><br /><a href="http://collections.europarchive.org/tna/20090114064151/http://www.bseinquiry.gov.uk/files/yb/1989/03/28001001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20090114064151/http://www.bseinquiry.gov.uk/files/yb/1989/03/28001001.pdf</a><br /><br /><br />NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090505235819/http://www.bseinquiry.gov.uk/files/yb/1989/03/28001001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090505235819/http://www.bseinquiry.gov.uk/files/yb/1989/03/28001001.pdf</a><br /><br /><br />THE BABY FOOD (PROHIBITED OFFAL) REGULATIONS 1989<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102185118/http://www.bseinquiry.gov.uk/files/yb/1989/05/00002001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080102185118/http://www.bseinquiry.gov.uk/files/yb/1989/05/00002001.pdf</a></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de="">NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090506014439/http://www.bseinquiry.gov.uk/files/yb/1989/05/00002001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506014439/http://www.bseinquiry.gov.uk/files/yb/1989/05/00002001.pdf</a><br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102185203/http://www.bseinquiry.gov.uk/files/yb/1989/05/00001001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080102185203/http://www.bseinquiry.gov.uk/files/yb/1989/05/00001001.pdf</a><br /><br /><br />NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><www .ifst.org=""><jralphb easynet.co.uk=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><www .ifst.org=""><jralphb easynet.co.uk=""><flounder wt.net=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><bse-l uni-karlsruhe.de=""><jralphb easynet.co.uk=""><http:><bse-l uni-karlsruhe.de=""><www .ifst.org=""><www .jralphb.co.uk=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><www .ifst.org=""><www .jralphb.co.uk=""><lt09 dial.pipex.com=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090506014328/http://www.bseinquiry.gov.uk/files/yb/1989/05/00001001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506014328/http://www.bseinquiry.gov.uk/files/yb/1989/05/00001001.pdf</a></bse-l></bse-l></lt09></www></www></bse-l></bse-l></www></www></bse-l></http:></jralphb></bse-l></http:></bse-l></bse-l></flounder></jralphb></www></bse-l></bse-l></bse-l></bse-l></bse-l></jralphb></www></http:></bse-l></bse-l></http:></bse-l></bse-l></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /><br />BABY FOODS<br /><br />There are 4 brands available for a quick survey - Boots, Cow & Gate, Heinz and Robinson.<br /><br />None of the meat dishes included 'offal' in the ingredients.<br /><br />Steak & Kidney and Beef and Oxtail did, however, include kidney and oxtail.....<br /><br />snip...<br /><br /><a href="http://collections.europarchive.org/tna/20090506014316/http://www.bseinquiry.gov.uk/files/yb/1989/01/17006001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20090506014316/http://www.bseinquiry.gov.uk/files/yb/1989/01/17006001.pdf</a><br /><br /><br />NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><www .ifst.org=""><jralphb easynet.co.uk=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><www .ifst.org=""><jralphb easynet.co.uk=""><flounder wt.net=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><bse-l uni-karlsruhe.de=""><jralphb easynet.co.uk=""><http:><bse-l uni-karlsruhe.de=""><www .ifst.org=""><www .jralphb.co.uk=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><www .ifst.org=""><www .jralphb.co.uk=""><lt09 dial.pipex.com=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090506014316/http://www.bseinquiry.gov.uk/files/yb/1989/01/17006001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506014316/http://www.bseinquiry.gov.uk/files/yb/1989/01/17006001.pdf</a></bse-l></bse-l></lt09></www></www></bse-l></bse-l></www></www></bse-l></http:></jralphb></bse-l></http:></bse-l></bse-l></flounder></jralphb></www></bse-l></bse-l></bse-l></bse-l></bse-l></jralphb></www></http:></bse-l></bse-l></http:></bse-l></bse-l></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /><br />About the only item it seems many remain to be decided next week is what if anything we say about offal in baby food. I enclose now in confidence the draft as it stands at present concerning this aspect. It might be that no action is recommened. On the other hand, the working party, PERSUADED BY THE ANIMAL EVIDENCE THAT IMMATURE ANIMALS ARE MORE SUSCEPTIBLE TO INFECTION WITH THE AGENTS OF SPONGIFORM ENCEPHALOPATHY, may make some recommendations either about labelling or about banning offal in baby food.......<br /><br /><br /><a href="http://collections.europarchive.org/tna/20081106023518/http://www.bseinquiry.gov.uk/files/yb/1989/01/25001001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20081106023518/http://www.bseinquiry.gov.uk/files/yb/1989/01/25001001.pdf</a><br /><br /><br />NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><www .ifst.org=""><jralphb easynet.co.uk=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><www .ifst.org=""><jralphb easynet.co.uk=""><flounder wt.net=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><bse-l uni-karlsruhe.de=""><jralphb easynet.co.uk=""><http:><bse-l uni-karlsruhe.de=""><www .ifst.org=""><www .jralphb.co.uk=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><www .ifst.org=""><www .jralphb.co.uk=""><lt09 dial.pipex.com=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090506014808/http://www.bseinquiry.gov.uk/files/yb/1989/01/25001001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506014808/http://www.bseinquiry.gov.uk/files/yb/1989/01/25001001.pdf</a></bse-l></bse-l></lt09></www></www></bse-l></bse-l></www></www></bse-l></http:></jralphb></bse-l></http:></bse-l></bse-l></flounder></jralphb></www></bse-l></bse-l></bse-l></bse-l></bse-l></jralphb></www></http:></bse-l></bse-l></http:></bse-l></bse-l></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /><br />2. The Southwood report recommended that baby foods manufactureres should not use ruminant offal and thymus in baby foods. This was interpreted as any offal listed in Schedule 2 Part 2 of the Meat Product Regulations. The Committee, in effect, are advising the Ministry that ANY offal which carries ANY risk of transmitting the BSE agent to baby foods should not be used in their manufacture. The offal listed in Part 2 Schedule 2 of the MPSFPR is by NO MEANS EXHAUSTIVE, and OTHER ORGANS EXIST e.g. ENDOCRINE AND PITUITARY GLANDS, which are HIGH 'RISK' from the point of view of the presence of BSE or Scrapie agent. Therefore I feel that any regulations should widen the scope of the definition of offal to include any of these organs NOT mentioned in Part 2...<br /><br />snip...<br /><br />5. I had some reservations about TAILMEAT because of its close association with the spinal cord.<br /><br /><a href="http://collections.europarchive.org/tna/20080102143359/http://www.bseinquiry.gov.uk/files/yb/1989/03/03008001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080102143359/http://www.bseinquiry.gov.uk/files/yb/1989/03/03008001.pdf</a><br /><br /><br />NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><www .ifst.org=""><jralphb easynet.co.uk=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><www .ifst.org=""><jralphb easynet.co.uk=""><flounder wt.net=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><bse-l uni-karlsruhe.de=""><jralphb easynet.co.uk=""><http:><bse-l uni-karlsruhe.de=""><www .ifst.org=""><www .jralphb.co.uk=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><www .ifst.org=""><www .jralphb.co.uk=""><lt09 dial.pipex.com=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090505235837/http://www.bseinquiry.gov.uk/files/yb/1989/03/03008001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090505235837/http://www.bseinquiry.gov.uk/files/yb/1989/03/03008001.pdf</a></bse-l></bse-l></lt09></www></www></bse-l></bse-l></www></www></bse-l></http:></jralphb></bse-l></http:></bse-l></bse-l></flounder></jralphb></www></bse-l></bse-l></bse-l></bse-l></bse-l></jralphb></www></http:></bse-l></bse-l></http:></bse-l></bse-l></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /><br />WE need however to be wary of casting the net too wide in case we catch products for which there is no justification on restricting them. What I have in mind here is your suggestion that we should also cover all products produced from offals. Rennet is of course produced from CALVES STOMACHS and LARD or TALLOW may be produced from mammalian offals. SO far as I am aware thse are produced at sufficiently high temperature that there is no need to restrict their use in baby foods...<br /><br /><br /><a href="http://collections.europarchive.org/tna/20081105215137/http://www.bseinquiry.gov.uk/files/yb/1989/03/08002001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20081105215137/http://www.bseinquiry.gov.uk/files/yb/1989/03/08002001.pdf</a><br /><br /><br />NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090505235831/http://www.bseinquiry.gov.uk/files/yb/1989/03/08002001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090505235831/http://www.bseinquiry.gov.uk/files/yb/1989/03/08002001.pdf</a><br /><br /><br />COMMENTS FROM Dr. Hilary Pickles;<br /><br />To pick out some of these tissues but not others would be difficult to justify. Within this group I would include pancreas (sweetbread) and PERIPHERAL NERVES (which brings in oxtail) and possibly liver too. I WOULD NOT RECOMMEND INCLUDING THESE IN ANY BAN AT PRESENT, but it should perhaps be recognised that the level of suspicion is somewhat higher than with other tissues such as muscle mass (steaks etc).<br /><br />RENNET SHOULD BE OF NO CONCERN SINCE IT IS AN EXTRACT OF STOMACH ............<br /><br /><a href="http://collections.europarchive.org/tna/20081105215142/http://www.bseinquiry.gov.uk/files/yb/1989/04/13002001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20081105215142/http://www.bseinquiry.gov.uk/files/yb/1989/04/13002001.pdf</a><br /><br /><br />NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><www .ifst.org=""><jralphb easynet.co.uk=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><www .ifst.org=""><jralphb easynet.co.uk=""><flounder wt.net=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><http:><bse-l uni-karlsruhe.de=""><jralphb easynet.co.uk=""><http:><bse-l uni-karlsruhe.de=""><www .ifst.org=""><www .jralphb.co.uk=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><www .ifst.org=""><www .jralphb.co.uk=""><lt09 dial.pipex.com=""><bse-l uni-karlsruhe.de=""><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090505215637/http://www.bseinquiry.gov.uk/files/yb/1989/04/13002001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090505215637/http://www.bseinquiry.gov.uk/files/yb/1989/04/13002001.pdf</a></bse-l></bse-l></lt09></www></www></bse-l></bse-l></www></www></bse-l></http:></jralphb></bse-l></http:></bse-l></bse-l></flounder></jralphb></www></bse-l></bse-l></bse-l></bse-l></bse-l></jralphb></www></http:></bse-l></bse-l></http:></bse-l></bse-l></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br />THE BABY FOOD (PROHIBITED OFFAL) REGULATIONS 1989<br /><br />BSE-BABY FOODS R BRADELY<br /><br />(written letter hard to read...TSS)<br /><br />info- and to ensure we DO NOT GET THE BLAME FOR LEGISLATION THAT CAN BE ??? ON A SCIENTIFIC BASIS.<br /><br />snip...<br /><br />4. An important OMISSION IS LYMPH NODE. This was NOT identified specifically in previous regulations but IS A HIGH RISK TISSUE IF BSE FOLLOWS THE LINE OF SCRAPIE...<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102195408/http://www.bseinquiry.gov.uk/files/yb/1989/05/05002001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080102195408/http://www.bseinquiry.gov.uk/files/yb/1989/05/05002001.pdf</a><br /><br /><br />NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090506015918/http://www.bseinquiry.gov.uk/files/yb/1989/05/05002001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506015918/http://www.bseinquiry.gov.uk/files/yb/1989/05/05002001.pdf</a><br /><br />The idea therefore that the Richmond Committee should now examine the wider issue of offals in foods and the risks of BSE does NOT seem to me to be a logical consequence from Dr Pickles letter of 13 April.<br /><br />SNIP...<br /><br />I think any reference to that in the letter should be deleted and we should stick firmly to the line that we have from Alan Lawrence that the Richmond Committee should leave this TOPIC WELL ALONE;<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103005147/http://www.bseinquiry.gov.uk/files/yb/1989/05/05009001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080103005147/http://www.bseinquiry.gov.uk/files/yb/1989/05/05009001.pdf</a></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de="">NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090506055116/http://www.bseinquiry.gov.uk/files/yb/1989/05/05009001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506055116/http://www.bseinquiry.gov.uk/files/yb/1989/05/05009001.pdf</a><br /><br /><br />IN CONFIDENCE<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103005355/http://www.bseinquiry.gov.uk/files/yb/1989/05/09001001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080103005355/http://www.bseinquiry.gov.uk/files/yb/1989/05/09001001.pdf</a><br /><br /><br />NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090506055245/http://www.bseinquiry.gov.uk/files/yb/1989/05/09001001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506055245/http://www.bseinquiry.gov.uk/files/yb/1989/05/09001001.pdf</a><br /><br /><br />They classify offals into two groups as follows:-<br /><br />(i) Diaphragm, head meat (muscle only), heart, kideny, liver, pancreas, tail meat, thymus, tongue.<br /><br />(ii) Brains, feet, intestine, lungs, oesophagus, rectum, spinal cord, spleen, stomach, texticles udder.<br /><br />Group (i) can be used in ALL MEAT PRODUCTS AND CAN COUNT TOWARD THE MEAT CONTENT OF THOSE PRODUCTS<br /><br />Group (ii) can only be used in cooked meat products and cannot count towards meat content.......<br /><br />21 pages;<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102200106/http://www.bseinquiry.gov.uk/files/yb/1989/05/23004001.pdf" style="color: #473624; cursor: pointer;">http://collections.europarchive.org/tna/20080102200106/http://www.bseinquiry.gov.uk/files/yb/1989/05/23004001.pdf</a><br /><br /><br />NEW URL LINK 2022</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><a href="http://web.archive.org/web/20090506015920/http://www.bseinquiry.gov.uk/files/yb/1989/05/23004001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506015920/http://www.bseinquiry.gov.uk/files/yb/1989/05/23004001.pdf</a><br /><br /><br />Terry S. Singeltary Sr. P.O. Box Bacliff, Texas USA 77518<br /><br /><br />Terry S. Singeltary Sr. wrote:<br /><br /><br />##################### Bovine Spongiform Encephalopathy #####################<br /><br />BSE 'may have entered baby food in 70s'<br /><br />James Meikle, health correspondent Friday March 4, 2005 The Guardian<http:><br /><br />Scientists are to test a hypothesis that young people who have died from the human form of BSE were infected by contaminated baby foods as far back as 1970.<br /><br />The controversial idea supposes that some meat products were harmful to people 16 years before BSE in cows was even recognised, and 25 years before young adults began dying from its dreadful human equivalent.<br /><br />Should this prove true, it will mean rethinking the likely future course of the disease, which is predominantly British, although cases have occurred in other countries.<br /><br />Variant CJD here appears to be on the wane. Only nine people died in 2004, the fewest since 1995, its first recorded year, giving rise to the hope that no more than a few hundred may eventually succumb to it. Since 1995, 154 Britons have been identified with the disease, a handful of whom are still alive.<br /><br />But the hypothesis advanced by Stephen Dealler, a microbiologist at Lancaster Royal infirmary, suggests that only the "first wave" is declining.<br /><br />He argues that there were further infections in the mid- to late-1980s, when teenagers and others ate contaminated meat, including burgers. By then hundreds of thousands of cattle were carrying BSE and the tissues most likely to contain infection were not banned in food until 1989.<br /><br />Babies are more susceptible to infection because their gut walls are more permeable, Dr Dealler said yesterday. But even in them the disease took about 25 years to take its course.<br /><br />People infected later would take far longer, up to 40 or 50 years, to develop the clinical disease, indeed might never do so at all, but could still be in fectious; a nightmare for blood transfusion services, which depend on the under 40s for donations.<br /><br />Dr Dealler put his ideas to the Spongiform Encephalopathy Advisory Committee, a government advisory body, which greeted them with scepticism.<br /><br />But even doubters are concerned that the average age of victims at death is still in the late 20s, an average which ought to be getting higher as more years pass since the food controls introduced in the late 1980s.<br /><br />Extrapolation from studies of otherwise healthy appendixes have suggested that as many as 3,800 people may be carrying the infection.<br /><br />Moreover, all those who have died from the disease so far have been from one genetic group, but evidence of vCJD infection in the spleen has been found in a patient who died from another cause and had a different genetic make-up.<br /><br />This raised the fear that far more people may yet go down with the disease while displaying different symptoms.<br /><br />Dr Dealler claims that his hypothesis fits the evidence from animals with similar diseases, and from cannibals in Papua New Guinea acciden tally infected with a brain disease.<br /><br />"It has been shown that neonatal animals are more easily infected, and with lower doses of disease, than older animals," he said. "The real epidemic of BSE in humans has not actually started. What we are just seeing is the beginning with young children."<br /><br />Proving his ideas will be difficult, and food manufacturers have refused to give him data from the 1970s and 1980s.<br /><br />The possible drawbacks to his hypothesis include the fact that many of the 15 people infected with vCJD recorded abroad had never been to Britain, and only one, from the US, was a baby in Britain.<br /><br />Other scientists question his assumptions about the incubation periods in animals and humans.<br /><br />Professor James Ironside, of the CJD surveillance unit in Edinburgh, was cautious, but admitted: "Exposure to baby food is indeed a possibility."<br /><br />Professor Chris Higgins of Imperial College London, who chairs Seac, was blunter: "There is a lot of anecdote there, rather than hard and fast data.<br /><br />"We really need to go away and assess that before anyone jumps to any conclusions. I think we would all accept there is some age range during which infection probably occurs. But I am not at all convinced at the moment, until we have looked at all the details, that the idea that it is first the very young, and secondly pre-the main epidemic is likely to be right at all."<br /><br />The Infant and Dietetic Foods Association, representing baby food manufacturers, insists on its website that manufacturers "have never used any of the high risk materials banned as a result of the controls on BSE".<br /><br /><br /><a fg_scanned="1" href="http://www.guardian.co.uk/bse/article/0,2763,1430267,00.html" style="color: #473624; cursor: pointer;">http://www.guardian.co.uk/bse/article/0,2763,1430267,00.html</a><br /><br /><br /><a fg_scanned="1" href="https://lists.aegee.org/cgi-bin/wa?S2=BSE-L&X=4F0C9B3D9F1736BD9D&Y=flounder9@verizon.net&q=FSA+ADMITS+ERROR+OVER+BABY+FOOD+&s=&f=&a=&b" style="color: #473624; cursor: pointer;">https://lists.aegee.org/cgi-bin/wa?S2=BSE-L&X=4F0C9B3D9F1736BD9D&Y=flounder9@verizon.net&q=FSA+ADMITS+ERROR+OVER+BABY+FOOD+&s=&f=&a=&b</a>=<br /><br /><br />From: "Terry S. Singeltary Sr."<flounder wt.net=""><br /><br /><br /><https: a2="ind9911&L=bse-l&D=0&T" p="15626" x="29A3306307B3034108&Y=">Subject: Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><br /><https: a2="ind9911&L=bse-l&D=0&T" p="14637" x="29A3306307B3034108&Y="><br /><bse-l>99. Mr. Lawrence wrote a letter to Sir Richard on 6 January 1989 (110) explaining that there were _no_ special regulations with regard to the composition of baby food except in relation to additives, and that there was therefore _nothing_ in the rules that would exclude certain parts of animal being incorporated into baby foods as long as they were fit for human consumption.<br /><br />152. There is _no_ evidence of written assurances from the manufacturers supplied to either MAFF or the Department of Health asserting that Baby Food did not contain bovine brain, spinal cord, spleen, intestines or thymus. 155. The reply also outlined the following actions already taken or to be taken by the Government in response to the Working Party's recommendations.<br /><br />1) As a precautionary measure the Government would enact secondary legislation to ensure it was illegal to sell Baby Food containing brain, spinal cord, spleen and intestines. 165. On 23 May 1989 Mr. Cockbill prepared draft regulations prohibiting the use of certain _specified offals_ in Baby Foods...<br /><br />Kind Regards, Terry S. Singeltary Sr., Bacliff, Texas USA<br /><br />"Robert A. LaBudde" wrote:<br /><br />> > At 11:35 AM 11/24/99 -0600, Terry wrote:<br />> >Heather Paine should be educated on the products she over-sees. These<br />> >children's<br />> >health are at risk, and if she does not know what has and has not been<br />> >going into<br />> >baby-foods, she does not need to hold that position. The Inquiry was very<br />> >concerned about baby foods, and at one point said something about;<br />> > It is very unlikely that baby food would contain SBO's, since baby food is<br /><br />> the most highly regulated and safest of all commercial foods.<br />> > So, if baby food is suspected as a vehicle for BSE-<br />>ukCJD, then it would be<br />> base on its containing normal cuts of meat. Baby foods contain more liver<br />> than the general population eats, so perhaps there could be a correlation<br />> there.<br /><br />Babies of all species have more porous intestinal membranes, so uptake of prions would be expected to be more efficient. > ><br /><br />================================================================ > Robert A. LaBudde, PhD, PAS, Dpl. ACAFS e-mail: ral@lcfltd.com > Least Cost Formulations, Ltd. URL: http://lcfltd.com/ > 824 Timberlake Drive Tel: 757-467-0954 > Virginia Beach, VA 23464-3239 Fax: 757-467-2947 > "Vere scire est per causae scire" > ================================================================ ><br /><br />snip...<br /><br />Date: Sat, 27 Nov 1999 12:03:22 +0000<br /><br />Reply-To: BSE-L Sender: BSE-L<br /><br />From: J Ralph Blanchfield Organization: Consultant<br /><br />Subject: Re: Girl, 13, shows CJD symptoms. [re-baby food] In-Reply-To:<br /><br />BSE-L<br /><br />Hello Terry and Everyone,<br /><br />On Fri, 26 Nov 1999 10:36:34 -0600, Terry wrote:<br /><br />Hello Ralph and All,<br /><br />>I think you are correct Ralph, after reading back over my comments, I was a bit >hasty, and in a friends eyes, may have even seemed rude.<br /><br />>For that I would like to apologize to Heather and You.<br /><br />Thank you. I shall forward your post on to Heather, and invite her to send me a response, which I shall forward to BSE-L.<br /><br />It still does not change my position on the matter. It would have been better<br /><br />>directed, if I would have directed my haste, to the _whole_ industry involved, as<br /><br />>opposed to Heather and the Baby Food industry. For obvious reasons, if the DFA's are accurate, and the statements within from the Working Party and the Gov. and the statement from the manufacturers of Baby Foods,<br /><br />>where they are stating in DFA 9;<br /><br />>"152. There is no evidence of written assurances from the manufacturers supplied >to either Maff or the Department of Health asserting that Baby Food did not<br /><br />>contain bovine brain, spinal cord, spleen, intestines or thymus".<br /><br />snip...end<br /><br />SNIP....<br /><br />From: J Ralph Blanchfield <jralphb easynet.co.uk="">Organization: Consultant<br /><br />Subject: Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><br /><https: a2="ind9911&L=bse-l&D=0&T" p="17249" x="29A3306307B3034108&Y=">In-Reply-To: <38407d4f.68838e7b@wt.net><br /><br />Hello Terry and Everyone, On Sat, 27 Nov 1999 18:54:39 -0600, Terry wrote:<br /><br />snip...end...2008...tss<br /><br /><br />SOME GOOD READING AND DEBATING IN NOV. 1999 ;<br /><br /><br />1. Girl, 13, could be youngest BSE case * Girl, 13, could be youngest BSE case<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(99 lines) From: tom <tom cyber-dyne.com="">Date: Tue, 23 Nov 1999 14:38:18 -0700 * Re: Girl, 13, could be youngest BSE case<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(116 lines) From: Terry S. Singeltary Sr. <flounder wt.net="">Date: Wed, 24 Nov 1999 10:18:39 -0600 * Re: Girl, 13, could be youngest BSE case<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(36 lines) From: Roland Heynkes <roland heynkes.de="">Date: Fri, 26 Nov 1999 00:29:44 +0100 * Re: Girl, 13, could be youngest BSE case<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(56 lines) From: Terry S. Singeltary Sr. <flounder wt.net="">Date: Fri, 26 Nov 1999 10:54:41 -0600 * Re: Girl, 13, could be youngest BSE case<br /><br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br />(58 lines) From: Roland Heynkes <roland heynkes.de="">Date: Fri, 26 Nov 1999 22:37:08 +0100 * Re: Girl, 13, could be youngest BSE case<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(217 lines) From: Terry S. Singeltary Sr. <flounder wt.net="">Date: Fri, 26 Nov 1999 21:27:12 -0600 * Re: Girl, 13, could be youngest BSE case<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(227 lines) From: Univ.-Prof.Dr.Herbert Budka <h .budka="" akh-wien.ac.at="">Date: Sat, 27 Nov 1999 12:28:31 +0100 * Re: Girl, 13, could be youngest BSE case<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(115 lines) From: Terry S. Singeltary Sr. <flounder wt.net="">Date: Sat, 27 Nov 1999 10:12:21 -0600 * Re: Girl, 13, could be youngest BSE case<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(49 lines) From: Roland Heynkes <roland heynkes.de="">Date: Sun, 28 Nov 1999 09:18:50 +0100 * Re: Girl, 13, could be youngest BSE case<br /><br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br />(57 lines) From: Roland Heynkes <roland heynkes.de="">Date: Sun, 28 Nov 1999 14:07:20 +0100 * Re: Girl, 13, could be youngest BSE case<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(37 lines) From: Terry S. Singeltary Sr. <flounder wt.net="">Date: Sun, 28 Nov 1999 16:17:42 -0600 * Re: Girl, 13, could be youngest BSE case<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(76 lines) From: Univ.-Prof.Dr.Herbert Budka <h .budka="" akh-wien.ac.at="">Date: Mon, 29 Nov 1999 16:31:24 +0100 2. Girl, 13, shows CJD symptoms. * Girl, 13, shows CJD symptoms.<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(80 lines) From: Debora MacKenzie <d .mackenzie="" chello.be="">Date: Tue, 23 Nov 1999 23:05:33 +0100 * Re: Girl, 13, shows CJD symptoms.<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(90 lines) From: Terry S. Singeltary Sr. <flounder wt.net="">Date: Wed, 24 Nov 1999 11:35:44 -0600 * Re: Girl, 13, shows CJD symptoms.<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(55 lines) From: Robert A. LaBudde <ral lcfltd.com="">Date: Thu, 25 Nov 1999 06:30:22 -0500 3. Girl, 13, shows CJD symptoms. [re-baby food] * Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(90 lines) From: Terry S. Singeltary Sr. <flounder wt.net="">Date: Thu, 25 Nov 1999 11:21:52 -0600 * Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(82 lines) From: Robert A. LaBudde <ral lcfltd.com="">Date: Thu, 25 Nov 1999 13:17:45 -0500 * Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(214 lines) From: J Ralph Blanchfield <jralphb easynet.co.uk="">Date: Thu, 25 Nov 1999 22:30:36 +0000 * Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(47 lines) From: Roland Heynkes <roland heynkes.de="">Date: Fri, 26 Nov 1999 00:27:17 +0100 * Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br />(50 lines) From: Rachel Shepherd <rachelshepherd hotmail.com="">Date: Thu, 25 Nov 1999 15:41:51 PST * Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(42 lines) From: Tim Sly <tsly acs.ryerson.ca="">Date: Thu, 25 Nov 1999 22:12:01 -0500 * Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(48 lines) From: Roland Heynkes <roland heynkes.de="">Date: Fri, 26 Nov 1999 10:04:47 +0100 * Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(60 lines) From: Roland Heynkes <roland heynkes.de="">Date: Fri, 26 Nov 1999 10:15:47 +0100 * Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(303 lines) From: Terry S. Singeltary Sr. <flounder wt.net="">Date: Fri, 26 Nov 1999 10:36:34 -0600 * Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br />(84 lines) From: Robert A. LaBudde <ral lcfltd.com="">Date: Fri, 26 Nov 1999 17:36:12 -0500 * Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br />(100 lines) From: Tam Garland <tgarland cvm.tamu.edu="">Date: Fri, 26 Nov 1999 16:47:54 -0600 * Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br />(402 lines) From: J Ralph Blanchfield <jralphb easynet.co.uk="">Date: Sat, 27 Nov 1999 12:03:22 +0000 * Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(588 lines) From: Terry S. Singeltary Sr. <flounder wt.net="">Date: Sat, 27 Nov 1999 18:54:39 -0600 * Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(179 lines) From: J Ralph Blanchfield <jralphb easynet.co.uk="">Date: Sun, 28 Nov 1999 11:46:07 +0000 * Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(79 lines) From: Roland Heynkes <roland heynkes.de="">Date: Sun, 28 Nov 1999 16:43:01 +0100 * Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(55 lines) From: Rachel Shepherd <rachelshepherd hotmail.com="">Date: Sun, 28 Nov 1999 15:12:27 PST * Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(73 lines) From: Torsten Brinch <iaotb inet.uni2.dk="">Date: Mon, 29 Nov 1999 14:06:54 +0100 * Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(69 lines) From: Roland Heynkes <roland heynkes.de="">Date: Mon, 29 Nov 1999 07:24:48 +0100 * Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(64 lines) From: Rachel Shepherd <rachelshepherd hotmail.com="">Date: Mon, 29 Nov 1999 19:44:26 PST * Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><https: a2="ind9911&L=bse-l&T=0&F" s="&X=" y="flounder%40wt%2Enet&P="><br /><br />(95 lines) From: Roland Heynkes <roland heynkes.de="">Date: Tue, 30 Nov 1999 22:56:04 +0100<br /><br />TSS<br /><br />######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html ##########<br /><br />######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html ##########<br /><br />More Hits<br /><br />Item # Date Time Lines Subject 013326 2003-12-06 20:23 1837 O'Reilly FACTOR HELPING SPECIAL FORCES WAR HERO DYING HIDEOS DEATH AFTER BEING DEMOTED CJD (AKA MAD COW DISEASE) 012876 2003-08-07 11:09 922 SPONGIFORM ENCEPHALOPATHY ADVISORY COMMITTEE 6th August 2003 - The draft minutes 78th SEAC (pdf) 011869 2002-10-12 12:56 490 Re: BABY FOODS MAY HAVE BEEN CONTAMINATED WITH SRMs/MRMs and BSE 011866 2002-10-11 17:20 160 Re: BABY FOODS MAY HAVE BEEN CONTAMINATED WITH SRMs/MRMs and BSE 011864 2002-10-11 16:51 642 Re: BABY FOODS MAY HAVE BEEN CONTAMINATED WITH SRMs/MRMs and BSE 011867 2002-10-11 13:21 314 Re: BABY FOODS MAY HAVE BEEN CONTAMINATED WITH SRMs/MRMs and BSE 011863 2002-10-11 09:04 248 BABY FOODS MAY HAVE BEEN CONTAMINATED WITH SRMs/MRMs and BSE 011354 2002-05-06 16:48 861 TRANSMISSION STUDIES OF BSE TO DOMESTIC FOWL BY ORAL EXPOSURE TO BRAIN HOMOGENATE & other issues of TSEs 010916 2001-10-22 19:22 423 Re: FSA ADMITS ERROR OVER BABY FOOD - BABY FOODS AND MAD COW DISEASE back on table... 010915 2001-10-22 19:00 383 Re: FSA ADMITS ERROR OVER BABY FOOD - BABY FOODS AND MAD COW DISEASE back on table... 010913 2001-10-22 15:33 328 Re: FSA ADMITS ERROR OVER BABY FOOD - BABY FOODS AND MAD COW DISEASE back on table... 010911 2001-10-20 19:15 299 Re: FSA ADMITS ERROR OVER BABY FOOD - BABY FOODS AND MAD COW DISEASE back on table... 010910 2001-10-20 10:19 225 FSA ADMITS ERROR OVER BABY FOOD - BABY FOODS AND MAD COW DISEASE back on table... 010721 2001-08-11 16:01 210 ''Baby Foods'' and CJD * June 23, 1999 BSE Inquiry 010561 2001-06-21 21:42 90 Re: Doctors FEAR girl, 14, has vCJD 010560 2001-06-21 12:32 60 Re: Doctors FEAR girl, 14, has vCJD 010558 2001-06-21 09:13 107 Doctors FEAR girl, 14, has vCJD 009182 2000-11-23 11:11 186 Re: the gospel according to st francis 009181 2000-11-23 08:19 80 the gospel according to st francis 009067 2000-11-13 10:26 127 Re: Inquiry links cluster of CJD deaths to common source of meat 009054 2000-11-09 13:08 76 Inquiry links cluster of CJD deaths to common source of meat 009034 2000-11-06 22:16 116 Re: Baby food in Germany 009029 2000-11-06 13:21 102 Baby food in Germany 008591 2000-09-08 13:35 391 Questions and Answers and other BSE Medicines related issues (1989) 008500 2000-08-23 08:42 133 Re: SRM's amended regulations? 008452 2000-08-10 12:52 94 Re: ProMED (new var.), iatrogenic dental transmission risk 008274 2000-07-18 03:13 122 BSE in Baby food 008268 2000-07-17 21:04 191 Re: School meals linked to CJD deaths 008253 2000-07-15 20:00 115 School meals linked to CJD deaths 007982 2000-05-08 12:10 932 Vaccines, TSE's, what they knew, what they did or did not do... 007166 1999-11-30 22:56 95 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007164 1999-11-30 12:32 898 Southwood Working Party advice on baby food. >witness statement 184e - Meldrum issued 10/14/99 007163 1999-11-30 11:16 147 Baby Food * June 23, 1999 BSE Inquiry 007160 1999-11-29 19:44 64 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007155 1999-11-29 07:24 69 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007144 1999-11-28 11:46 179 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007142 1999-11-27 18:54 588 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007140 1999-11-27 12:03 402 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007135 1999-11-26 17:36 84 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007136 1999-11-26 16:47 100 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007133 1999-11-26 10:36 303 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007132 1999-11-26 10:15 60 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007126 1999-11-25 22:30 214 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007129 1999-11-25 15:41 50 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007125 1999-11-25 13:17 82 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007124 1999-11-25 11:21 90 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007123 1999-11-25 06:30 55 Re: Girl, 13, shows CJD symptoms. 007122 1999-11-24 11:35 90 Re: Girl, 13, shows CJD symptoms. 002357 1997-02-25 21:28 1068 EP BSE Inquiry report (part 1 of 3) 002248 1997-01-14 20:44 755 BSE Inquiry draft report part 1<br /><br /><a fg_scanned="1" href="https://lists.aegee.org/cgi-bin/wa?S2=BSE-L&X=1D1B9A2D19721D3331&Y=flounder9@verizon.net&q=baby+foods&s=&f=&a=&b" style="color: #473624; cursor: pointer;">https://lists.aegee.org/cgi-bin/wa?S2=BSE-L&X=1D1B9A2D19721D3331&Y=flounder9@verizon.net&q=baby+foods&s=&f=&a=&b</a>=<br /><br /><br />END...TSS...2008</roland></https:></rachelshepherd></https:></roland></https:></iaotb></https:></rachelshepherd></https:></roland></https:></jralphb></https:></flounder></https:></jralphb></https:></tgarland></https:></ral></https:></flounder></https:></roland></https:></roland></https:></tsly></https:></rachelshepherd></https:></roland></https:></jralphb></https:></ral></https:></flounder></https:></ral></https:></flounder></https:></d></https:></h></https:></flounder></https:></roland></https:></roland></https:></flounder></https:></h></https:></flounder></https:></roland></https:></flounder></https:></roland></https:></flounder></https:></tom></https:></https:></jralphb></bse-l></https:></https:></flounder></http:></bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""><br /><br />P.S. check out the USDA CERTIFIED DEAD STOCK DOWNER COW SCHOOL LUNCH PROGRAM IN THE USA (biggest long term case study in the USA of children exposed to the deadly mad cow disease atypical BSE, more virulent to humans)<br /><br />DEAD STOCK DOWNER COW SCHOOL LUNCH PROGRAM USDA<br /><br /><a fg_scanned="1" href="http://downercattle.blogspot.com/" style="color: #473624; cursor: pointer;">http://downercattle.blogspot.com/</a><br /><br /><br /><a fg_scanned="1" href="http://downercattle.blogspot.com/2008/04/gao-report-on-humane-methods-of.html" style="color: #473624; cursor: pointer;">http://downercattle.blogspot.com/2008/04/gao-report-on-humane-methods-of.html</a><br /><br /><br /><a fg_scanned="1" href="http://downercattle.blogspot.com/2008/03/usda-certified-dead-stock-downer-cow.html" style="color: #473624; cursor: pointer;">http://downercattle.blogspot.com/2008/03/usda-certified-dead-stock-downer-cow.html</a><br /><br /><br /><br /><a fg_scanned="1" href="http://downercattle.blogspot.com/2008/03/usda-still-pandering-to-industry-still_27.html" style="color: #473624; cursor: pointer;">http://downercattle.blogspot.com/2008/03/usda-still-pandering-to-industry-still_27.html</a><br /><br /><br /><a fg_scanned="1" href="http://downercattle.blogspot.com/2008/03/usda-still-pandering-to-industry-still.html" style="color: #473624; cursor: pointer;">http://downercattle.blogspot.com/2008/03/usda-still-pandering-to-industry-still.html</a><br /><br /><br /><a fg_scanned="1" href="http://downercattle.blogspot.com/2008/03/recalled-beef-from-chino-slaughterhouse.html" style="color: #473624; 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cursor: pointer;">http://prionunitusaupdate2008.blogspot.com/</a><br /><br /><br />Terry S. Singeltary Sr. P.O. Box</bse-l></div><div class="post-body entry-content" id="post-body-7271254713492646846" itemprop="description articleBody"><bse-l uni-karlsruhe.de=""> Bacliff, Texas USA 77518</bse-l></div></div></div></div>Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-4687453285836897153.post-56806897853306015032008-05-18T17:37:00.000-05:002022-08-17T15:46:54.504-05:00BSE Inquiry DRAFT FACTUAL ACCOUNT DFA<h2 class="date-header" style="background-color: #fff3db; color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 11.7px; font-weight: normal; letter-spacing: 0.1em; margin: 0px; padding: 0px; text-transform: uppercase;">SUNDAY, MAY 18, 2008</h2><div class="date-posts" style="background-color: #fff3db;"><div class="post-outer"><div class="post hentry uncustomized-post-template" itemprop="blogPost" itemscope="itemscope" itemtype="http://schema.org/BlogPosting" style="margin: 8px 0px 24px;"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif; font-size: 13.3333px;"><span style="font-size: 13px;"><a name="5680689785330601503" style="color: #0096ef; cursor: pointer;"></a></span></span><h3 class="post-title entry-title" itemprop="name" style="color: #1b0431; font-family: Georgia, "Times New Roman", sans-serif; font-size: 18.2px; font-weight: normal; margin: 0px; padding: 0px;">BSE Inquiry DRAFT FACTUAL ACCOUNT DFA</h3><div style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-header" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><div class="post-header-line-1"></div></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""></mailto:flounder></mailto:sillaste><mailto:sillaste cybercable.fr="">Subject: BSE INQUIRY DRAFT FACTUAL ACCOUNTS</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br />Sunday, May 18, 2008 </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">BSE Inquiry DRAFT FACTUAL ACCOUNT DFA BSE Inquiry DRAFT FACTUAL ACCOUNTS DFA's<br /><br />May 18, 2008<br /><br />Greetings,<br /><br />I thought I might document the DFAs i had in my files (what parts i have documented). damn shame i let them slip by me. ...TSS<br /><br />Subject: BSE Inquiry draft report part 1 From: Torsten Brinch Reply-To: Bovine Spongiform Encephalopathy Date: Tue, 14 Jan 1997 20:44:26 +0100 Content-Type: TEXT/PLAIN Parts/Attachments: TEXT/PLAIN (734 lines)<br /><br />Part 1 of 2<br /><br />TEMPORARY COMMITTEE OF INQUIRY INTO BSE<br /><br />19 December 1996 DRAFT REPORT<br /><br />Part B:RESULTS OF THE INVESTIGATION OF THE TEMPORARY COMMITTEE OF INQUIRY INTO BSE<br /><br />Rapporteur: Mr Manuel Medina Ortega -----------------------------------<br /><br />The decision of the European Parliament, adopted on 17 July 1996, footnote 1 which set up the present temporary committee of inquiry into BSE mandated the committee to 'investigate alleged contraventions or maladministration in the implementation of Community law in relation to BSE'.<br /><br />In accordance with this mandate, the examination of the allegations of contraventions or maladministration has been divided into five chapters: three concerning responsibilities and negligence in respect of the UK, the Council and the Commission respectively; one concerning the possible determination and attribution of responsibilities as between the Council and the Commission; and a final chapter assessing the Commission's political responsibility.<br /><br />I.1. RESPONSIBILITY AND NEGLIGENCE IMPUTABLE TO THE UK<br /><br />All accounts thus far have coincided in singling out the UK as bearing the greatest degree of responsibility: even the Permanent Secretary, Mr Packer, and the Chief Veterinary Officer, Mr Meldrum, have accepted part of the blame for the development of the BSE crisis. The main elements demonstrating negligence on the part of the UK may be summarized under the following headings.<br /><br />1.It failed to ensure an effective ban on the feeding of meat- and bone-meal to ruminants:<br /><br />a)the production techniques used for making feedingstuffs did not include sterilization and deactivation of the BSE or scrapie agents, and failed to prevent cross-contamination with mammal-derived proteins of all types of meal intended for livestock (the latter, although outlawed for ruminants, were still being used in the production of feedingstuffs for other animal species);<br /><br />b)the absence of control measures (until August 1996, there were no legal penalties in the UK for the storage or administration of such feedingstuffs) encouraged the continued illegal administration to ruminants of existing stocks of feedingstuffs containing ruminant-derived proteins.<br /><br />The above is corroborated from the attestations of (among others) Mr Hoelgaard (Director, DG VI), Mr Pocchiari, Mr Dormont and Mr Riedinger. In addition, according to the documents forwarded to the committee, the subject has been discussed on numerous occasions on the Scientific Veterinary Committee (SVC). The European Renderers' Association (EURA) expressed its concern over the functioning of feedmills in the UK at a number of meetings in 1990. In this connection, one may draw attention to paragraphs 4 and 5 of the communication sent by EURA to the SVC on 27 February 1990 (Annex 1):<br /><br />'4. From investigations in other countries in the EEC it appears very difficult to secure a complete separation in the feedmills between feed produced for ruminants and other feedingstuffs. 5. From the rendering industry it seems strange, that although brains, spinal cord, spleens and other organs recognized as material with high potential of BSE-agent, these wastes are still processed in a rendering plant and used for feeding purposes, although in principle not for ruminants. The possibilities for mistakes in the feed-industry exist. The use of such end-products as for instance fertilizer could be recognized as a necessary alternative'.<br /><br />2.It failed to respect the national prohibitive legislation outlawing imports of flour from the UK, or, at the least, failure to take action to control the exports concerned. This implies failure to observe the principle of cooperation which should govern relations between all Member States. The data supplied by Mr Packer, Permanent Secretary at the Ministry of Agriculture, Fisheries and Food, are highly significant. In 1989, just after the ban on feeding meat-based meal to ruminants in the UK, exports to the EU rose to 25 005 tonnes (as opposed to 12 553 in 1988). In 1990, when, it may be assumed, the national import bans were already in force, 10 072 tonnes were exported, and subsequent figures were: 2720 tonnes (1991), 1494 (1992), 2226 (1993) and 2343 (1994) (see Annex2). On this point, there is a contradiction between, on the one hand, the statements by Mr Packer and Mr Meldrum, who admit to inadequacies over labelling but claim that regulation for international trade purposes was a matter for the EEC rather than the Member States, and, on the other, the Commission's justification of its failure to act on the grounds that no suitable legal basis existed. One cannot, however, accept Mr Meldrum's argument that the UK should therefore be exonerated from all responsibility (he claims that the UK government had written to the relevant Member State and third country authorities, informing them of its BSE problem and urging them to ban the feeding of mammal protein to ruminants).<br /><br />3.It put pressure on the Commission not to include anything related to BSE in its general inspections of slaughterhouses, as regularly carried out between 1990 and 1994 in the context of their adaptation to the internal market. This point may be illustrated by Mr Hoelgaard's declarations at the hearing of 28 October 1996. Mr Hoelgaard's words may usefully be reproduced verbatim (see pp. 13 and 14 of the minutes of the hearings): 'I, therefore, do not know why this kind of inspection, that is slaughterhouse inspection with BSE on the side, did not continue in the subsequent years, although there is one piece of information which is perhaps relevant and which I have only recently become aware of. At the end of the inspection a discussion took place with the UK veterinary services on 29 June 1990. When BSE was raised by the inspectors about the deficiencies, Mr Keith Meldrum, Chief UK Veterinary Officer, apparently reacted angrily, stating that the Commission inspectors had no authority to investigate BSE matters; that BSE was not a technical but a political matter; the UK provided the best certificates in the world and the Ministry of Agriculture was reluctant to install computers in abattoirs due to issues of cost and confidentiality'(Annex 32).<br /><br />4.It tightened this pressure on the Commission, as described in paragraph 3, via the substantial numerical presence of British officials and scientists acting, to a greater or lesser degree, within the orbit and under the control of the UK Ministry of Agriculture. The Commission has justified the massive presence of UK nationals on the committees on the grounds that BSE effectively concerned the UK alone. Nonetheless, the BSE subgroup of the Scientific Veterinary Committee has almost invariably been chaired by a UK national, and one may therefore reasonably harbour doubts as to its objectivity and impartiality. The minutes, in addition, are drawn up by a temporary Commission official of British nationality. The records of attendance attached to some of the minutes which we have received are sufficiently indicative (see Annex 3): -meeting of 5 February 1990: 9 participants (4 British); -meeting of 28 May 1990: 9 participants (5 British); -meeting of 28 September 1994: 10 participants (4 British); -meeting of 19 June 1995: 9 participants (4 British).<br /><br />5.It made a biased reading of the advice and warnings of the scientists. The views of certain scientists who could be considered as more critical were not taken into account, and the serious and imminent risk of the disease spreading to humans was recognized only on 20 March 1996. The necessary research effort was not carried out, nor were correct priority fields for research defined; indeed, obstacles were put in the path of scientists adopting more critical attitudes to the inadequacy of the precautions being taken. At all events, the responsibility for negligence must be considered to be shared with the EU: the UK has spent only £ 60 m on BSE research, according to Ministry of Agriculture figures, and the EU has spent ECU 3 745 000 (see Annex 4).<br /><br />6.It did not honour its undertakings made at the extraordinary Council meeting of 6 and 7 July 1990, held to deal with the initial BSE crisis. The conclusions of the minutes of that Council meeting state: 'The Council notes the United Kingdom's intention to introduce a surveillance mechanism of herds in which BSE has been detected, including inspection in approved slaughterhouses of cattle and carcasses from these herds. The results will be transmitted to the Commission and Member States for evaluation by the Standing Veterinary Committee.' (Annex 10). This is particularly serious, since the UK at no moment acted on its undertaking to identify the herds affected, which would have been a necessary first step towards eradicating the disease.<br /><br />7.It did not implement the legislation by which bovine animals should have been identified and branded and their movements registered. Formally, there were strict and specific obligations, set out in the 'Bovine Animals Order 1990' (SI 1990/1867), which came into force on 15 October 1990 in implementation of Commission Decision 90/261. Article 1(2) of this decision stipulates that the UK is to make exhaustive use of computer registers for ensuring identification of animals. The terms of this decision were, furthermore, strengthened in 1995. In addition, Article 11 of Directive 92/102 on the identification and registration of animals obliges the Member States, in the case of bovine animals and as from 1 February 1992, to operate computerized registers and an identification system complying with the requisites laid down in the directive.<br /><br />8.It failed to implement the provisions of Directive 89/662 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market. According to this directive, the country of origin (the UK, in respect of its exports) is obliged to ensure strict compliance with the conditions of health policy and inspection for all animal products leaving its territory for the Community market. The same directive sets out specific obligations in case of epidemics, including the submission to the Commission of a programme including the controls to be carried out. One can only be surprised by Mr Packer's declaration that his government should be exempted from blame, on the grounds that there are no proofs of non-compliance: if no checks are carried out, contraventions are very difficult to prove.<br /><br />9.It took a blocking attitude within the Community institutions, with the aim of pressing the Commission and Council to lift or ease the embargo. This is clear from the minutes of the Commissioners' meeting of 5 June 1996 (Annex 5), in which Mr Fischler stated his intention to adopt the decision on the partial lifting of the embargo: the matter should be viewed in relation to what has come to be seen as the UK's abuse of its rights and blackmailing attitude towards the Community institutions, contrary to the obligations of each Member State as laid down in Article 5 of the EC Treaty. It is stated in the minutes concerned that the Commission asked Mr Santer to write to Mr Major to inform him of its intentions and call on him to review his decision concerning non-cooperation in the EU's decision-making process.<br /><br />10.It did not display sufficient zeal in monitoring the maintenance of the embargo on meat and by-products. This is clear from Mr Fischler's letter of 10 September 1996 to the UK Minister of Agriculture and Mr Hogg's reply of 25 October 1996 (Annex 6). Mr Fischler's letter sets out the Commission's concerns in relation to the inspection mission carried out in the UK from 22 to 26 July 1996, when a visit to the port of Dover revealed the non-existence of the checks on shipments of beef products to the Member States required by Decision 96/239/EEC.<br /><br />11.It did not abide by the agreements reached at the Florence summit: the selective culling programme was suspended, and no alternative proposal was formally put forward. The Florence agreements provide for the possibility of modifying the culling programme in the light of new scientific data; however, whatever the circumstances, a new programme substituting the old one has to be submitted and approved by the Commission and the Standing Veterinary Committee. According to the Commission's replies of September 1996, the selective culling programme had still to be approved by the British Parliament. We do not, to date, possess any documents formally attesting to progress having been made in implementing the programme, although it appears that culling is continuing in the UK, which has recently told the media that it intends to undertake a large-scale cull which could even go beyond the initial Florence proposals. At all events, there is still a procedural problem, insofar as British actions in this field should be agreed jointly with the EU, not carried out unilaterally: they should accordingly be approved by the Standing Veterinary Committee and the Commission, if the embargo is to be lifted at the earliest opportunity.<br /><br />12.The UK Minister of Agriculture, Mr Hogg, demonstrated an unwillingness to cooperate, refusing to appear before Parliament's committee of inquiry. This is clear from his letters to the committee dated 25 September 1996 and 10 October 1996 (Annex 7). According to the report drawn up for the committee by Parliament's Legal Service on 8 October 1996 (Annex 8), 'a Permanent Secretary' attached to a British ministry could not be considered in legal terms to be a 'member of the government' within the meaning of Article 3(2) of the joint decision of the European Parliament, the Council and the Commission (No 95/177) of 19 April 1995 on the detailed provisions governing the exercise of the European Parliament's right of inquiry.<br /><br />13.All in all, since 1988 the UK authorities have introduced a considerable amount of legislation covering the various aspects of protection against possible BSE risks. The problem, therefore, lies not in any lack of appropriate legislative measures, but in the attitude of the government, which has failed to ensure the proper application of those measures and has not carried out the necessary checks. In addition, doubtless under pressure from the meat industry, the UK government has, in its turn, exerted pressure on the Commission's veterinary services with the objective of keeping the matter within the national orbit, thus avoiding Community inspections and preventing publicization of the extent of the epidemic, since this would have provoked unilateral action by some Member States on public health grounds.<br /><br />I.2. DETERMINATION AND ATTRIBUTION OF RESPONSIBILITY AND POSSIBLE NEGLIGENCE ON THE PART OF THE COUNCIL AND COMMISSION<br /><br />The determination and attribution of responsibility as between the Community institutions, namely the Council and the Commission, is an extremely complex question, for a number of reasons:<br /><br />1.One reason is the nature of the problem itself. It was initially thought that BSE was a variant of scrapie which had infected cows instead of sheep. On the basis of the parallel with scrapie - an illness which was well-known and considered harmless to humans - it was supposed that BSE was an animal health matter alone. However, once it began to look increasingly certain that BSE was a phenomenon different from scrapie, which could, in addition, jump the species barrier (having also been detected in cats), the matter took on a new dimension: it was no longer merely a veterinary and animal health problem, and the protection of consumer health became the first priority.<br /><br />2.One must also bear in mind the decision-making system on veterinary matters and the respective roles of the Scientific Veterinary Committee and the Standing Veterinary Committee. As a rule, the Commission bases its legislative proposals on the opinions of the Scientific Veterinary Committee, whose members are appointed by the Commission on the basis of nominations by the Member States. This committee acts as a consultative organ of the Commission. A Commission proposal drawn up on the basis of recommendations by the Scientific Veterinary Committee is then forwarded for adoption to the Standing Veterinary Committee, which operates as a regulatory committee of the 'safety-net' (contre-filet') type - i.e. the Commission proposal is adopted provided it obtains the necessary majority. If that majority is not obtained, the Commission has to take the matter to the Council. It may happen that a sufficient majority for rejecting the Commission proposal is not reached in Council: at this point, the Commission is empowered to adopt the proposal under its own responsibility, in the absence of a decision from the Council that it should be withdrawn. This was the adoption procedure which applied to Commission Decision 96/362 lifting the embargo on semen, tallow and gelatine. It follows that responsibility must be seen, in general terms, as being shared, on a non-absolute basis, between the Council, the Commission, the Standing Veterinary Committee and the Scientific Veterinary Committee. The complexity of the commitology system makes it even more difficult to apportion responsibility, be it with respect to the institutions or to the committees.<br /><br />3.Another factor is the operation of the principle of subsidiarity in public health matters. On this subject, it is essential to distinguish between the situations prevailing before and after the entry into force of the Treaty of Maastricht. Since 1 November 1993, competence in the field of public health protection has been a joint matter for the Union and the Member States, pursuant to Article 129 of the TEU. Nonetheless, as is pointed out in the report drawn up for this committee by Parliament's Legal Service on 25 November 1996 (Annex 9), legislation already existed before Maastricht obliging the Commission to take account of health protection implications in the context of the proper functioning of the COMs under the CAP. The Commission's powers in the field of public health protection have recently been confirmed by the Court of Justice (see: ECJ decision of 12 July 1996 - Case C-180/96; decision of the President of the Court of First Instance of 13 July 1996 - Case T-76/96).<br /><br />4.Public health protection competences are compartmentalized between a number of different Commission departments (as regards possible food product risks). The BSE affair has been handled variously by: DG VI (Agriculture), DG III (ex-Internal Market, now Industry), the Consumer Protection Service (currently DG XXIV), and the Directorate for Health and Safety (DG V).<br /><br />This compartmentalization has hampered the coordination and efficiency of the services concerned, and points up the lack of an integrated approach, such as would have been possible were there a body similar to the Food and Drug Administration in the US or the health administrations in the Member States.<br /><br />I.3. RESPONSIBILITY AND NEGLIGENCE ON THE PART OF THE COUNCIL<br /><br />Given the Council's character as a representative organ of the Member States, it should be assumed that implicit reference is being made here to the general responsibilities of the Member States, without prejudice to the question of the specific responsibility of the UK, which, in view of its importance, has been dealt with in a separate chapter. In relation to the activities of the Council and the Standing Veterinary Committee, we have been helped by the testimonies of Mr Yates, the Irish Minister of Agriculture, in his capacity as President-in-Office of the Agriculture Council, and Mrs Amendrup, assistant director of the Danish national veterinary services and member of the Standing Veterinary Committee.<br /><br />Mr Yates endeavoured to define the sphere of competence of the Council, pointing out that legislative powers in the veterinary field and, even more so, in that of public health are shared between the Commission, the Council and the Member State governments. However, he argued, the Council was responsible for a specific activity of political guidance and impetus, and was also obliged to cooperate closely with the Commission. He stressed that the Council was not to be held responsible in a number of important areas, stating: '... dissemination of information about BSE, publication of research findings about BSE, controls on the production and export of recycled animal protein and controls on the temporary ban on exports of cattle, beef and meat-based productions do not fall within the Council's sphere of responsibility, as they come under the powers of the Commission or the Member States'. Prior to the March 1996 crisis, the Agriculture Council had specifically examined BSE at its meetings of 6 and 7 June 1990 and 18 and 19 July 1994 (see Annex 10). Both meetings were called to deal with the threats of unilateral measures by certain delegations (France and Germany) which were calling for tougher guarantees on meat imports from the UK. In addition, at several other Council meetings, according to the minutes supplied to us, certain delegations expressed the following requests:<br /><br />- BSE should be included on the agenda, for assessment of the most recent scientific data (German delegation to the Council, 25 and 26 April 1994, 30 and 31 May 1994 and 20, 21, 22, 23 and 24 June 1994) (Annex 11);<br /><br />-the Council of Health Ministers should be asked to participate in possible public health protection measures (German delegation to the Council, 28 and 29 March 1994) (Annex 12);<br /><br />-there should be reinforced controls on feedingstuffs given to ruminants and on the use of potentially dangerous tissue in the manufacture of cosmetics and medicines (French delegation to the Council, 28 and 29 March 1994 and 25 and 26 April 1994) (Annexes 11 and 12);<br /><br />-action should be taken on the request of the French delegation, forwarded to the Council of Health Ministers, for extension to all the Member States of France's unilateral measures banning the use of at-risk bovine tissue in the manufacture of cosmetics, medicines and baby-foods (meeting of 30 and 31 May 1994) (Annex 11).<br /><br />Following the statement by the UK government of 20 March 1996 concerning new scientific data, the Agriculture Council held two extraordinary meetings, on 1-3 April and 29 and 30 April 1996 (Annex 13). At these meetings, it recognized the seriousness of the situation and urged the adoption of a number of urgent measures for health protection and support of the beef market.<br /><br />The subject was discussed again on numerous occasions throughout 1996, with the Council awaiting the statements of the UK delegation concerning the evolution of the situation, with a view to resolving the crisis. On 30 March 1994 the Council of Health Ministers met to discuss the proposal by the German delegation concerning discussion of the possible risks of transmission of BSE to humans. The German delegation insisted on making a separate statement, in which it urged the adoption of further protection measures (Annex 14). Over 1994 and after March the Council of Health Ministers discussed the subject several more times. One may cite, as visible proof of the attention which has been paid to the subject in various policy areas, the discussions in the Council of Research Ministers, at its meeting of 7 October 1996, as well as the statements by Commissioner Cresson included in the minutes of the Commissioners' meeting of 9 October 1996 (Mrs Cresson reported on the disappointing outcome of the discussions in the Council of Research Ministers on this subject, and drew attention to the inconsistent position of the ministers, who had called for a greater research effort but had refused to provide the necessary resources) (Annexes 15 and 16). Following this Council meeting, the Commission submitted a communication to the Council and Parliament (COM(96)0582) allocating an additional ECU 50 m for BSE research. The subject was to be re-examined at the Research Council meeting of 5 December 1996.<br /><br />The following statements may accordingly be made:<br /><br />1.Responsibility for the problem is divided between the authorities concerned with agriculture and animal health and those concerned with public health protection. This applies at both EU and national level, with the division of responsibilities varying from one Member State to another. The situation is aggravated by the effects of the principle of subsidiarity, which has operated in this field, following the entry into force of the TEU, since November 1993, and by the fragile state of progress in the exercise of Community powers in the public health field.<br /><br />2.With the exception of the statements by certain delegations since March 1994, as referred to above, the Agriculture Council did not deal with BSE at all between June 1990 and its meeting of 18 and 19 July 1994, at which the subject returned to the agenda, in response to the threats to the marketing of British meat in the wake of the complaints of the German government demanding tougher guarantees for the extraction of nerve and lymph tissue from deboned meat and a longer non-contamination period for herds before the export of carcasses. At this meeting, the Council endorsed the Commission's proposals.<br /><br />3.The absence of a debate in Council, either to examine the state of affairs or to verify compliance with the June 1990 conclusions, in view of their importance, may be considered to imply neglect by omission on the Council's part; or it may be interpreted as passing the responsibility to the Standing Veterinary Committee. The 1990 conclusions mandated the Commission to adopt a number of measures to control and monitor the disease, to examine the risks arising from the manufacture of feedingstuffs for ruminants containing animal proteins, and to launch a wide-ranging programme of research. In addition, the Council had taken note of the undertakings of the UK delegation concerning the inspection of slaughterhouses and the identification of cattle. It is surely surprising that the Council should at no moment have acted to ascertain the degree of compliance with these conclusions, and that it should not have asked to be informed of the results of any inspections carried out by the Commission or the national authorities.<br /><br />4.As is clear from the testimony of Mrs Amendrup and the documents in our possession, the question of the Council's responsibility should also be considered in relation to the actions of the Standing Veterinary Committee. This committee is made up of representatives of the Member States (the heads of the national veterinary services), and acts, in a certain sense, by delegation of the Council. According to Mrs Amendrup, a number of technical debates took place on the committee, based on the evaluation of the documents supplied by the Scientific Veterinary Committee. Once a subject had become of significant political interest, it was forwarded to the Council. The Standing Veterinary Committee should, it may be argued, have, on certain occasions, called for the debate on the subject to be transferred to the Council, in view of its major political significance, going well beyond purely technical considerations.<br /><br />5.It is extremely difficult to evaluate the actions of the Standing Veterinary Committee: as it seems, no minutes are kept of its meetings, other than brief summaries, which have not been forwarded to the present committee of inquiry, despite repeated requests to this effect by its chairman. The sole available information consists of the minutes of the meetings drawn up by the Danish delegation and forwarded by Mrs Amendrup.<br /><br />6.The view that the Council has tried to leave the responsibility in the hands of the Commission is confirmed by Mrs Amendrup's statement that in practice, other than in exceptional circumstances, the Council only considers veterinary subjects, whether affecting animal health or public health, when their political interest is such as to exceed the 'technical' competences of the Standing Veterinary Committee. The fact that this committee, in its turn, bases its work on the opinions of the Scientific Veterinary Committee, which is essentially a consultative committee of the Commission, and on which, as far as BSE is concerned, the British influence has been considerable, points up the ineffectiveness of the existing system of committees with respect to the protection of public and consumer health.<br /><br />7.Another aspect which we have been able to establish, on the basis of information provided by Parliament's Committee on Budgets, is the Council's position with regard to the budgetary procedure: the tendency has been to reduce the sums initially earmarked by the Commission in the preliminary draft budget, for the headings relating to programmes for the eradication of diseases and measures concerning veterinary and phytosanitary inspections and controls. This is in contradiction to the Commission's pledges made in response to Parliament's positions in the various debates over the last few financial years.<br /><br />I.4. RESPONSIBILITY AND NEGLIGENCE ON THE PART OF THE COMMISSION<br /><br />From the examination of the testimonies received by the present committee, the Commission's written replies and the documentation supplied to us, we may state that, in general, the Commission's actions may be characterized as follows:<br /><br />1.It has given priority to the interests of market management, as opposed to the potential human health risks existing in the light of the numerous scientific uncertainties concerning the possible effects of BSE on humans. There is a considerable body of material confirming this attitude. The most important evidence includes the following:<br /><br />-the attitude of the then Commissioner, Mr MacSharry, in the days leading up to the extraordinary Council of 6 and 7 June 1990, including public threats to take out infringement proceedings against Member States introducing unilateral measures against British beef exports, or even to take such Member States to the Court of Justice (as confirmed in internal Commission notes - see Annex 17). In addition, Commissioner Van Miert, in his testimony, has confirmed his disagreement with Mr MacSharry on a number of points during the preparation of the extraordinary Council;<br /><br />-the attitude of Mr MacSharry at the extraordinary Council, at which, as stated in the note of 28 October 1996 from Mr Berlingieri to Mr Hoelgaard (Annex 18), the then Commissioner received from Mr Mansito, Assistant Director-General for Agriculture, a proposal drawn up by the veterinary services of DG VI (Annex 19) to the effect that, in view of the existing difficulties relating to animal identification and checks, exports of British beef should be permitted only in deboned form. The third paragraph of Mr Berlingieri's note states: 'This approach has been presented to the Commissioner by Mr. Mansito, yourself and myself in the Council on 7 June 1990. The reaction has been quite rough and we have not got any longer the possibility of discussing it because we had been excluded from the meeting room';<br /><br />-the instructions issued on 18 September 1990 by Mr MacSharry to Mr Legras, Director-General for Agriculture, which have been publicized in the press in the form of an annotation by Mr Legras: 'BSE: Stop any meeting' (Annex 20). Mr Legras states in his testimony of 1 October 1996 that this instruction should be interpreted as a manifestation of bad temper on the part of Mr MacSharry; however, in view of the Commission's management approach to the issue and the former Commissioner's admitted interest in averting disturbances of the beef market, this supposed interpretation is scarcely credible;<br /><br />-the exchange of correspondence between Mr Legras and Mr Perissich, Director-General of DG III, on baby food (Annex 21).<br /><br />2.It has tried to follow a policy of downplaying the problem which can, at certain moments, be interpreted as amounting to a policy of disinformation, with the aim of averting disturbances on the beef market. In this connection, the background note of 12 October 1990 (Annex 22) by Mr Castille, then an official of the Consumer Policy service (now DG XXIV), on the statements by representatives of DG VI at the meeting of the Standing Veterinary Committee of 9 October 1990 constitutes evidence of the Commission's attitude to the matter. It may be deduced from Mr Legras' annotation, as reproduced in Annex 20 and quoted in the third indent of the preceding paragraph, that the representative of DG VI was acting under instructions from his superiors. It should be pointed out that no proofs exist that the statements in question were made in the terms of Mr Castille's note, and the Commission representatives, in their testimonies to the present committee, offer the following qualifications:<br /><br />-there was no need to discuss BSE at every meeting of the Standing Veterinary Committee, since, given that it was a notifiable illness, the Member States were automatically kept informed;<br /><br />-the Commission wanted to be informed of the results of the work of the British scientists before its publication, so as to be able to make its evaluation immediately, since this work could contain new elements tending to favour changes in the existing legislation.<br /><br />At all events, according to Mr Legras' testimony, the note has never been officially contested by DG VI. That the Commission's handling of the BSE affair has been lacking in transparency is obvious from the contradictions existing in the ex-Commissioners' and DG VI officials' testimonies and in numerous pieces of written evidence which have appeared in the press or have been supplied by the Commission to the present committee.<br /><br />3.There has been a lack of cooperation and coordination among all the departments with responsibility for food products (DG VI - agriculture; DG III - internal market/industry; DGV - health; DG XXIV - consumer protection). This is confirmed by the testimonies of Commissioner Van Miert and Mr Perissich, the former Director of DG III.<br /><br />Mr Van Miert says there was a lack of coordination between his office and that of the then Commissioner MacSharry during the preparation of the extraordinary Agriculture Council of 6 and 7 June 1990.<br /><br />Mr Perissich informed us of the initial difficulties which he encountered in DG VI in relation to his initiatives on baby food, which, however, later bore fruit in cooperation and joint activity on the part of the Scientific Committee for Food (DG III) and the Scientific Veterinary Committee (DG VI).<br /><br />4.Too much weight was placed on the role of the Scientific Veterinary Committee. This is clear from the testimonies of the senior DG VI officials, especially that of Mr Legras, Director-General for Agriculture, who has repeatedly stated that the Commission could not go beyond the recommendations of the Scientific Veterinary Committee since, should it try to do so, it would not have the support of the Member States on the Standing Veterinary Committee. It may be deduced from this that the Commission was unwilling to make a further political effort to take public health protection measures going beyond the recommendations of the Scientific Veterinary Committee: this is particularly serious in view of the strong pressures exerted by the British members of that committee.<br /><br />-----------------------------------<br /><br />Further, there are no clear channels of communication between the Scientific Veterinary Committee and the Standing Veterinary Committee. This means that there are no guarantees that a scientific position of the Scientific Veterinary Committee will necessarily be adequately represented on the Standing Veterinary Committee; responsibility for ensuring the flow of information appears to lie with the Commission. In this connection, it is surprising that the Commission does not possess detailed minutes of the meetings of the Standing Veterinary Committee; if there are no minutes of the decisions and debates, it is scarcely possible to carry out effective monitoring of the policy lines expressed by the delegations on the Standing Veterinary Committee.<br /><br />5.Criticisms may be made of the workings of the Scientific Veterinary Committee. This committee consists of experts appointed by the Commission from a list of names put forward by the Member States. In principle, the criteria for appointment have to be based on professional qualifications, and there is therefore no criterion of nationality balance in its membership.<br /><br />In the BSE affair there has been, at the least, a lack of transparency. This should appear clearer if one recalls that BSE has been the subject of an ongoing analysis by the BSE Subgroup of the Scientific Veterinary Committee. This subgroup has, almost throughout, been chaired by a UK national (first Mr Plowright and then Mr Bradley), and has included a substantial number of British scientists. Mr Bradley, who from 1969 to 1991 was head of the UK's Central Veterinary Laboratory and was subsequently an adviser to the British Ministry of Agriculture, has acted as rapporteur on BSE at the full meetings of the Scientific Veterinary Committee;<br /><br />it emerges, furthermore, from some of the minutes of the committee meetings that a number of members have suggested that Mr Bradley may have withheld information (see minutes of the meeting of the public health section of the Scientific Veterinary Committee, 11 May 1995 - Annex 23).<br /><br />Mr Marchant, a temporary Commission official entrusted by DG VI with the day-to-day management of the BSE affair, who was formerly an official of the British Ministry of Agriculture, has been responsible for drawing up the minutes and providing Commission administrative support for the BSE Subgroup, in close cooperation with Mr Bradley. The letter of 31 January 1992 in which Mr Bradley provides Mr Marchant with instructions, which is in the possession of the present committee (Annex 24), clearly reveals the nature of the professional relationship between the two. It is a typical example of correspondence between two officials (one from the Commission, one from a national government), rather than an instance of cooperation between an independent scientist and a Community institution.<br /><br />In addition, the arrangements practised by the Commission for reimbursing expenses incurred by participants in the meetings are such that, as is recognized by Mr Pocchiari in his testimony, scientists from certain Member States may be unable to attend the meetings on a regular basis for cash-flow reasons, thus only being able to monitor matters at a distance.<br /><br />-----------------------------------<br /><br />6.The Commission has no provision for consulting independent, multidisciplinary advisory committees; had this been the case, it would have been easier to make a correct assessment of the evolution of the epidemic and the possible public health risks.<br /><br />The chairmen of the animal health and public health sections of the Scientific Veterinary Committee, Mr Meurier and Mr Del Real, have expressed strong reactions in a communication to the present committee, arguing that the collaborators and the work of their committee should be treated with respect and trust. However, the recent creation, in the wake of the March 1996 crisis, of the multidisciplinary 'Weismann' and 'Interservices' committees (on the respective initiatives of Commissioners Fischler and Bonino) may be interpreted as a response to the need to fill a gap not covered by the previously-existing system of committees.<br /><br />7.It has not encouraged the expression of views by scientists holding minority opinions: in principle, the opinions of the Scientific Veterinary Committee are adopted by consensus. In this connection, one may examine the disagreement which arose between Mr Somogyi and the Director-General for Agriculture, Mr Legras.<br /><br />It is nonetheless also necessary to consider the testimony and documentation provided by Mr Legras in reply to Mr Somogyi's charges. The third paragraph of the report of the meeting of the Scientific Veterinary Committee (animal health and public health sections) of 3 November 1994 states that Mr Somogyi's dissenting view was communicated through the Commission representative, and that his letter, containing comments addressed to Mr Legras, was annexed to the minutes of the meeting (see Annex 25).<br /><br />Another instance of the difficulties involved in registering the positions of the participants in the meetings of the Scientific Veterinary Committee is provided by the note of 28 November 1996 from Mrs Berge (of DG VI), which is in the possession of the present committee (Annex 26). This note states, inter alia: ' ... this is a consensus document and it is impossible to get the agreement on every point, since opinions are sometimes diverging'.The note from Dr Ahl (Annex 27) may be interpreted along similar lines. 8.It has not made efforts to adapt its staffing policy to the real needs arising from the establishment of the internal market.<br /><br />This is clear from the note of 26 February 1991 from Commissioner MacSharry to his fellow Commissioners, the fourth paragraph of which describes the staffing situation in the inspection departments as 'particularly fragile' (Annex 28). The Commissioners did not act on Mr MacSharry's requests.<br /><br />However, in the documents relating to staff requirements in DG VI, and, in particular, in a report on the internal situation of the veterinary services which has been made available to the present committee, while reference is repeatedly made to the urgent need for more human resources for tasks arising from the internal market or relating to certain priority illnesses such as foot-and-mouth disease, we have not found any reference to the need for staff to improve the monitoring of BSE.<br /><br />-----------------------------------<br /><br />to be continued....<br /><br />Subject: EP BSE Inquiry report (part 1 of 3) From: Torsten Brinch Reply-To: Bovine Spongiform Encephalopathy Date: Tue, 25 Feb 1997 21:28:09 +0100 Content-Type: TEXT/PLAIN Parts/Attachments: TEXT/PLAIN (1030 lines)<br /><br />BSE Inquiry report (Part 1 of 3)<br /><br />----------------------------------------------------------------------<br /><br />7 February 1997 A4-0020/97/A<br /><br />REPORT<br /><br />on alleged contraventions or maladministration in the implementation of Community law in relation to BSE, without prejudice to the jurisdiction of the Community and national courts<br /><br />Part A:<br /><br />I. RESULTS OF THE INQUIRY<br /><br />II. RECOMMENDATIONS FOR THE FUTURE<br /><br />III. MINORITY OPINIONS (published separately)<br /><br />Temporary committee of inquiry into BSE<br /><br />Rapporteur: Mr Manuel Medina Ortega<br /><br />C O N T E N T S<br /><br />Page<br /><br />Procedural page 3<br /><br />I.RESULTS Of THE INQUIRY<br /><br />EVIDENCE OF NEGLIGENCE, RESPONSIBILITIES AND PRESUMPTIONS OF MALADMINISTRATION 4<br /><br />1. INTRODUCTION:<br /><br />A) BRIEF OF THE COMMITTEE OF INQUIRY 4<br /><br />B) DIFFICULTIES ENCOUNTERED IN THE COURSE OF THE WORK OF THE COMMITTEE OF INQUIRY 5<br /><br />C) MISHANDLING OF THE CRISIS DURING THE PERIOD WHEN THE DISEASE WAS AT ITS HEIGHT 5<br /><br />2. RESPONSIBILITIES IMPUTABLE TO THE UK GOVERNMENT 6<br /><br />3. DETERMINATION AND ATTRIBUTION OF RESPONSIBILITIES AS BETWEEN THE COUNCIL AND COMMISSION 15<br /><br />4. RESPONSIBILITIES OF THE COUNCIL 18<br /><br />5. RESPONSIBILITIES OF THE COMMISSION 22<br /><br />6. POLITICAL RESPONSIBILITIES OF THE COMMISSION 36<br /><br />ANNEXES (published separately)<br /><br />II. RECOMMENDATIONS FOR THE FUTURE 38<br /><br />III.MINORITY OPINIONS (published separately)<br /><br />At its sitting of 18 July 1996 the European Parliament adopted, pursuant to its powers under Rule 136 of its Rules of Procedure, the decision to set up a temporary committee of inquiry into bovine spongiform encephalopathy.<br /><br />On 3 September 1996 the temporary committee of inquiry held its constituent meeting and appointed Mr Medina Ortega rapporteur.<br /><br />At its sitting of 26 October 1996 Parliament decided to prolong the mandate of the temporary committee of inquiry for a further three months.<br /><br />At its meetings of 3 and 19 September, 1-2, 8-9, 21, 24 and 28-29 October, 4, 11-12, 14, 18-19 and 25-26 November and 3, 9-10, 12 and 16-17 December 1996, the temporary committee of inquiry organized hearings with witnesses and experts in the field, and held a number of internal evaluation meetings.<br /><br />At its meetings of 13, 15, 20-21 and 28 January and 5-6 February 1997 the committee examined the draft report.<br /><br />At the last meeting it adopted the results of the inquiry and the recommendations unanimously.<br /><br />The following took part in the vote: Böge, chairman; Santini and Kofoed, vice-chairmen; Medina Ortega, rapporteur; Barthet-Mayor, Bébéar, Dell'Alba (for Barthet-Mayor, pursuant to Rule 136(4, second paragraph)), Gillis (for Plumb, pursuant to Rule 136(4, second paragraph)), Goepel (for Böge, pursuant to Rule 136(4, second paragraph)), Graefe zu Baringdorf, Happart, Jensen (for Roth- Behrendt, pursuant to Rule 136(4, second paragraph)), Jové Peres, Laignel, Martin P., Martinez, des Places, Redondo Jiménez, Rosado Fernandes (for P. Martin, pursuant to Rule 136(4, second paragraph)), Roth-Behrendt, Thyssen (for Bébéar, pursuant to Rule 136(4, second paragraph)), Trakatellis and Whitehead.<br /><br />The minority opinions (of the following Members: Happart, P. Martin, Martinez, des Places, Plumb and Whitehead) will be published separately from the results and recommendations of the committee of inquiry.<br /><br />The results of the inquiry and the recommendations for the future were submitted on 7 February 1997.<br /><br />I RESULTS OF THE INQUIRY<br /><br />EVIDENCE OF NEGLIGENCE, RESPONSIBILITIES AND PRESUMPTIONS OF MALADMINISTRATION<br /><br />1. INTRODUCTION<br /><br />A) BRIEF OF THE COMMITTEE OF INQUIRY<br /><br />The decision of the European Parliament, adopted on 18 July 1996 (note 1), which set up the present temporary committee of inquiry into BSE mandated it to 'investigate alleged contraventions or maladministration in the implementation of Community law in relation to BSE, without prejudice to the jurisdiction of the Community and national courts'.<br /><br />The committee's exercise of the functions entrusted to it is, according to its brief, to be carried out 'without prejudice to the jurisdiction of the Community and national courts'. It is, therefore, not for Parliament to determine individual responsibilities which must be the subject of actions brought before criminal and civil courts by the victims of the crisis. The attribution of political responsibility, and whether the committee should propose initiatives to that end to the plenary of Parliament, is another matter altogether.<br /><br />In accordance with this mandate, the examination of the allegations of contraventions or maladministration has been divided into six chapters. The first chapter is introductory in nature and concerns the brief of the Committee of Inquiry and the difficulties encountered in the course of its work. The second concerns the responsibilities of the UK. The third attempts to establish the possible determination and attribution of responsibilities as between the Council and Commission. The fourth and fifth concern the responsibilities of the Council and the Commission respectively. The sixth and last concerns the Commission's political responsibilities. Section II sets out recommendations for the future.<br /><br />It has become clear from the work of the Committee of Inquiry that the determination and attribution of responsibility as between the UK Government, the Council and the Commission is an extremely complex question. This difficulty is increased by the fact that BSE is a new and very strange disease. The pathogen has not been definitively identified and there is no live test for the condition..<br /><br />B) DIFFICULTIES ENCOUNTERED IN THE COURSE OF THE WORK OF THE COMMITTEE OF INQUIRY<br /><br />All Community officials who gave evidence to the Committee of Inquiry did so in accordance with Article 3(3) of the joint Decision of 19 April 1995 of the European Parliament, the Council and the Commission on the detailed provisions governing the exercise of the European Parliament's right of inquiry. Accordingly, officials gave evidence not as individuals but on behalf of their institution, acting in accordance with the Commission's instructions.<br /><br />This presented an obstacle to the work of the Committee of Inquiry. In the first place, obtaining written replies was extremely slow. In addition, and more seriously, the Commission used blocking tactics, concealing the truth on various sensitive issues. The UK Government also adopted blocking tactics, right from the moment when its Minister for Agriculture refused to appear before the Committee of Inquiry. Consequently, the need to complete the work of the Committee of Inquiry within the deadlines laid down meant that a number of questions remained unanswered.<br /><br />The pressure of time and the wording of the 1995 Interinstitutional Agreement made it impossible to attribute individual responsibility for maladministration. The Committee of Inquiry confined itself to the institutional framework, although it remains aware that, in addition to political responsibilities, there may also be administrative responsibilities which can be attributed to individuals who work and hold or have held office in the various institutions.<br /><br />C) MISHANDLING OF THE CRISIS DURING THE PERIOD WHEN THE DISEASE WAS AT ITS HEIGHT<br /><br />The main evidence of mismanagement of the BSE crisis can be traced to the period 1990-1994. In order to obtain a global view of events and attribute responsibility, consideration must be given both to the successes and failures of that period.<br /><br />75% of the cases of BSE recorded in the UK occurred between 1990 and 1994. Towards the middle of 1990, France and Germany sought to introduce trade restrictions on British beef. Although these two countries were able to invoke the provisions of Article 36 of the EC Treaty, Commissioner MacSharry threatened to bring proceedings before the Court of Justice. In 1990 various internal notes were written which point to the existence of a policy of disinformation by the Commission. Although the Commission has denied on various occasions that such a policy was in force, written proof exists (see Annexes 20 and 22), as confirmed in the years that followed by a series of events which demonstrate how the problem was concealed.<br /><br />- In 1990 scientific evidence was found that the infection could cross the barrier between species. There was evidence that the disease could be transmitted to cats and pigs. This was a serious development and should have prompted efforts to speed up the scientific research. However, from 1990 onwards the scientific research produced scant results.<br /><br />- Between 1990 and 1994 veterinary checks on BSE in the UK were suspended.<br /><br />- Between 1990 and 1994 Community legislative activity in the field of BSE was suspended, with the exception of the regulation on embryos.<br /><br />- Between 1990 and 1994 the Council held no debates on BSE.<br /><br />Consequently, although the Commission denies the existence of the policy of disinformation suggested by the written notes, the facts show that:<br /><br />- the most important sources of information were not available; and<br /><br />- the Council and Commission began to neglect their duties.<br /><br />These two facts are connected, since if the flow of information is cut off and the Commission fails to fulfil its role in initiating legislation, the Council is sidelined. It is clear that the policy of disinformation was not confined to misleading public opinion, but played a full part in relations between the Community institutions.<br /><br />The question of information is therefore of vital importance. There are two main sources of information, namely the results of veterinary inspections and the scientific evidence obtained from research. As far as veterinary inspections are concerned, it should be pointed out that, although the Commission sought to conceal the truth and attribute to the European Parliament the suspension of BSE inspection missions to the UK, this was a decision taken by the Commission in response to British pressure.<br /><br />Research can be carried out when some stimulus exists, in other words where there is a problem and when there is sufficient raw material to carry out such research, in this case the organs of diseased animals. Although both these conditions were present in the UK during the years when the disease was at its height, no scientific findings were made. This is a further area where responsibility can be seen to lie with the UK.<br /><br />A crucial factor before the legislative process gets under way is the work of the Scientific Veterinary Committee and the Standing Veterinary Committee. Once the sources of information had been cut off, both committees had little scope for action. Although the matter was taken up at a later date, it must be said that the BSE subgroup of the Scientific Veterinary Committee was chaired by a British official and that a large number of those who attended the meetings were of the same nationality.<br /><br />2. RESPONSIBILITIES IMPUTABLE TO THE UK<br /><br />BSE stemmed from the introduction from the United States of the 'Carver-Greenfield' system of manufacturing meat-and-bone meal. The UK Government, unlike those of other Member States, authorized the change in the system for manufacturing meat-and-bone meal. This led to the emergence of BSE. It also created conditions favourable to the spread of other diseases. In other states, when the process was changed, the introduction of a sterilization period was required.<br /><br />Most of the testimonies and the greater part of the evidence supplied to the Committee of Inquiry suggest that the UK bears the greatest degree of responsibility. Even the Permanent Secretary, Mr Packer, and the Chief Veterinary Officer, Mr Meldrum, have admitted that mistakes were made in the management of the BSE crisis. The main elements demonstrating negligence on the part of the UK may be summarized under the following headings.<br /><br />1. The UK authorities and the rendering industry<br /><br />a) The UK authorities and the rendering industry paid insufficient attention to the risks involved in rendering a high proportion of sheep remains into meat-and-bone meal when scrapie was endemic in the British sheep population and the Carver- Greenfield rendering plants provided inadequate safeguards for the destruction of infectivity, although existing research results suggested that transmission to other species was possible.<br /><br />However, by choosing to adopt new production techniques for animal meal, deemed more profitable, some manufacturers in the animal feedingstuffs sector bear a greater share of responsibility for the dissemination of the pathogen.<br /><br />b) The UK authorities and the rendering industry continued to assume that, since scrapie was harmless to humans and BSE was a variant of scrapie in cattle, BSE must be purely an animal health matter<br /><br />As early as 1979 a UK Royal Commission under Lord Zuckerman, set up to examine pathogenic transmission in general in the rendering process, warned about the wisdom, from an epidemiological viewpoint, of feeding rendered animal remains to ruminants.<br /><br />c) In June 1987, British ministers were already aware of the existence of BSE and of the fact that scientists could not determine whether it could or could not be transmitted to other species or to humans. However, they decided to do nothing until 18 July 1988 when the ban on cattle feed was applied (this ban did not affect existing stocks). In December 1988, the UK prohibited the use of milk from suspect cattle for any purpose other than that of cows feeding their own calves. That action proves clearly that, in 1988, the British authorities suspected that there was a risk to public health if people ate meat from animals affected by BSE<br /><br />2. The UK Government failed to ensure an effective ban on the feeding of meat-and-bone meal to ruminants:<br /><br />a) the production techniques used for making feedingstuffs did not include sterilization and inactivation of the BSE or scrapie agents, and failed to prevent cross-contamination with mammal-derived proteins of all types of meal intended for livestock (the latter, although outlawed for ruminants, were still being used in the production of feedingstuffs for other animal species);<br /><br />b) the absence of adequate control and recall measures (until August 1996 there were no legal penalties in the UK to back up the ruminant-protein feed ban) led to a failure to ensure the total disappearance of meat-and-bone meal (MBM) from ruminant feed;<br /><br />c) The UK Government did not ask its own scientific advisers about the consequences of using stocks of meat- and-bone meal as animal feedingstuffs elsewhere where other ruminant animals might be exposed to it. Sir Richard Southwood told the Committee that he was not asked about these consequences:<br /><br />' ... if you ask me whether in 1988 the working party [of which I was chairman] would have considered there was a risk to herds in other countries if UK-produced meal (with meat-and- bone meal) was exported I am totally confident that we would have answered in the affirmative. Knowing that the meal was almost certainly the cause of the outbreak in the UK it is clear that it was irresponsible (whatever the law) to make it available as cattle food elsewhere.'<br /><br />The above is corroborated from the attestations of (among others) Mr Hoelgaard (Director, DG VI), Mr Pocchiari, Mr Dormont and Mr Riedinger. In addition, according to the documents forwarded to the Committee, the subject has been discussed on numerous occasions on the Scientific Veterinary Committee. The European Renderers' Association (EURA) expressed its concern over the functioning of feedmills in the UK at a number of meetings in 1990. In this connection, one may draw attention to paragraphs 4 and 5 of the communication sent by EURA to the Scientific Veterinary Committee on 27 February 1990 (Annex 1):<br /><br />'4. From investigations in other countries in the EEC it appears very difficult to secure a complete separation in the feedmills between feed produced for ruminants and other feedingstuffs.<br /><br />5. From the rendering industry it seems strange, that although brains, spinal cord, spleens and other organs [are] recognized as material with high potential of BSE-agent, these wastes are still processed in a rendering plant and used for feeding purposes, although in principle not for ruminants. The possibilities for mistakes in the feed-industry exist. The use of such end-products as for instance fertilizer could be recognized as a necessary alternative'.<br /><br />3. It failed to respect the national prohibitive legislation outlawing imports of meal from the UK, or, at the least, it failed to take action to control the exports concerned. The liberalization of intra-Community trade cannot justify this serious failure to observe the principle of cooperation which should govern relations between all Member States. The data supplied by Mr Packer, Permanent Secretary at the Ministry of Agriculture, Fisheries and Food, are highly significant. In 1989, just after the ban on feeding meat-based meal to ruminants in the UK, exports to the EU rose to 25 005 tonnes (as opposed to 12 553 in 1988). In 1990, when, it may be assumed, the national import bans were already in force, 10 072 tonnes were exported, and subsequent figures were: 2720 tonnes (1991), 1494 (1992), 2226 (1993) and 2343 (1994) (see Annex 2).<br /><br />It is disturbing, to say the least, that UK animal feed producers continued to export their product to third countries (exports to the EU doubled after the ban in 1989) in spite of the then alleged links to BSE and unclear labelling of the origin of the ingredients. It is surprising that the responsibility of producing a defective product, and thereby causing a catastrophe on the beef market, has not been laid more firmly at the feet of the animal feed producers in the UK. Furthermore, the increase of exports of British animal-based meal at low prices following the ban imposed by the British Government on their use in the UK for feeding ruminants may be treated as a case of dumping.<br /><br />On this point, there is a contradiction between, on the one hand, the statements by Mr Packer and Mr Meldrum, who admit to inadequacies over labelling but claim that regulation for international trade purposes was a matter for the EEC rather than the Member States, and, on the other, the Commission's justification of its failure to act on the grounds that no suitable legal basis existed. One cannot, however, accept Mr Meldrum's argument that the UK should therefore be exonerated from all responsibility (he claims that the UK government had written to the relevant Member State and third- country authorities, informing them of its BSE problem and urging them to ban the feeding of mammal protein to ruminants).<br /><br />Given the fact that large amounts of possibly infected ruminant feed were exported to other EU countries, and that in evidence the Committee heard that up to 57 000 animals were also exported between 1985 and 1989 to EU Member States, it was the opinion of the Commission’s representative to the Committee, Mr Hoelgaard (Director, DG VI) and Dr Galo, of the National Veterinary Laboratory of Portugal, that there could be as many as 1600 cases of BSE in other Member States.<br /><br />4. It put pressure on the Commission not to include anything related to BSE in its general inspections of slaughterhouses, as periodically carried out between 1990 and 1994 in the context of their adaptation to the internal market. This point may be illustrated by Mr Hoelgaard's declarations at the hearing of 28 October 1996.<br /><br />Mr Hoelgaard's words may usefully be reproduced verbatim (see pp. 13 and 14 of the minutes of the hearings): 'I, therefore, do not know why this kind of inspection, that is slaughterhouse inspection with BSE on the side, did not continue in the subsequent years, although there is one piece of information which is perhaps relevant and which I have only recently become aware of. At the end of the inspection a discussion took place with the UK veterinary services on 29 June 1990. When BSE was raised by the inspectors about the deficiencies, Mr Keith Meldrum, Chief UK Veterinary Officer, apparently reacted angrily, stating that the Commission inspectors had no authority to investigate BSE matters; that BSE was not a technical but a political matter; the UK provided the best certificates in the world and the Ministry of Agriculture was reluctant to install computers in abattoirs due to issues of cost and confidentiality' (Annex 32).<br /><br />The lack of BSE-related inspections between 1990 and 1994 seems symptomatic of an assumption by the British witnesses before the Committee that they knew all there was to know and could handle the problem without outside 'interference'. There was also an attitude of 'benign neglect' of the issue (a willingness to let a British problem be dealt with by the British) on the part of the Commission and, through the veterinary committees, by the other Member States.<br /><br />One cannot but deplore the fact that top-ranking officials in DG VI in particular bowed to the wishes of Mr K. Meldrum, Chief UK Veterinary Officer, i.e. that Commission inspectors had no authority to investigate BSE matters in the UK even though these same inspectors had uncovered BSE-related deficiencies in some slaughterhouses.<br /><br />The tape-recording of the meeting of the Standing Veterinary Committee of 5 September 1999 also provides evidence of Mr Meldrum's lack of awareness of the problem:<br /><br />'Given that there is no risk to human beings, what we are now proposing is once again based on an extremely cautious approach, because there is public concern. People are worried about this new disease and, to tell the truth, it is more an issue of consumer confidence than consumer protection.<br /><br />But we say that there is no risk, or indeed any proof of such a risk.'<br /><br />5. The influence of British thinking on the Commission was obviously increased by the preponderance of British experts and Ministry of Agriculture officials on the BSE Subgroup of the Scientific Veterinary Committee. This initially derived from the fact that the UK had far more experience of BSE than any other Member State. With other diseases the experts came predominantly from the Member State concerned (for example with swine fever).<br /><br />Nonetheless, the BSE Subgroup of the Scientific Veterinary Committee has almost invariable been chaired by a UK national, which made considerations of objectivity and impartiality particularly important. The minutes, in addition, are drawn up by a temporary Commission official of British nationality. The records of attendance attached to some of the minutes which we have received are sufficiently indicative (see Annex 3):<br /><br />- meeting of 5 February 1990: 9 participants (4 British) - meeting of 28 May 1990: 9 participants (5 British) - meeting of 28 September 1994: 10 participants (4 British) - meeting of 19 June 1995: 9 participants (4 British)<br /><br />The preponderance of UK scientists and officials, therefore, meant that the Scientific Veterinary Committee tended to reflect current thinking at the British Ministry of Agriculture, Fisheries and Food.<br /><br />6. It made a partial and biased reading of the advice and warnings of the scientists. The views of certain scientists who could be considered as more critical were not taken into account. Some members of the Southwood Committee have said publicly that the minutes of its meetings were drawn up by a UK Ministry of Agriculture official and contain omissions and discrepancies.<br /><br />The UK Government only recognized the serious and imminent risk of the disease spreading to humans on 20 March 1996. Research was for too long influenced by the belief that the disease was a form of scrapie in cattle: this meant there was insufficient research in the area of transmissible spongiform encephalopathies and their possible connection to Creutzfeldt-Jakob disease in humans.<br /><br />The necessary research effort was not carried out, nor were the research fields properly defined so as to obtain information rapidly and determine the risk to humans; indeed, obstacles were put in the path of scientists adopting more critical attitudes to the inadequacy of the precautions being taken. At all events, the responsibility for negligence must be considered to be shared with the EU: the UK has spent £ 60 m on BSE research, according to Ministry of Agriculture figures, and the EU has spent ECU 3 745 000 (see Annex 4).<br /><br />Although the UK Government has said that it has always accepted scientific advice, Professor Southwood has confirmed that in 1988 his working party was especially concerned with the possible risk to infants from the presence of homogenized meat products in infant food, and recommended that specific bovine residues (SBO/SBM) should not be permitted in infant food. It took the UK Government over a year to accept this recommendation (see letter from Professor Southwood to Mr Böge, PE 220.549).<br /><br />7. The UK Government did not honour its undertakings made at the extraordinary Council meeting of 6 and 7 July 1990, held to deal with the initial BSE crisis. The conclusions of the minutes of that Council meeting state: 'The Council notes the United Kingdom's intention to introduce a surveillance mechanism of herds in which BSE has been detected, including inspection in approved slaughterhouses of cattle and carcasses from these herds. The results will be transmitted to the Commission and Member States for evaluation by the Standing Veterinary Committee.' (Annex 10).<br /><br />This is particularly serious, since the UK at no moment acted on its undertaking to identify the herds affected, which would have been a necessary first step towards eradicating the disease. In addition, the failure to monitor trade in animals between BSE-free and BSE-affected herds is still hindering a proper eradication policy.<br /><br />The fact that the UK at no moment acted on this undertaking puts it in breach of Article 5 of the Treaty.<br /><br />8. It did not implement the legislation by which bovine animals should have been identified and branded and their movements registered. Formally, there were strict and specific obligations, set out in the 'Bovine Animals Order 1990' (SI 1990/1867), which came into force on 15 October 1990 in implementation of Commission Decision 90/261. Article 1(2) of this decision stipulates that the UK is to make exhaustive use of computer registers for ensuring identification of animals. The terms of this decision were, furthermore, strengthened in 1995.<br /><br />In addition, Article 11 of Directive 92/102 on the identification and registration of animals obliges the Member States, in the case of bovine animals and as from 1 February 1992, to operate computerized registers and an identification system complying with the requisites laid down in the directive.<br /><br />On 7 June 1990 restrictions were introduced on the export of meat from herds where cases of BSE had been detected in the previous two years (Commission Decision 90/261/EEC, amending Decisions 89/469/EEC and 90/200/EEC). Shortcomings in the British registration system led to the appearance of 'cesspool' farms (a question debated in the UK parliament). These farms, which already had a high incidence of BSE, bought animals in the first stages of the disease and received compensation for the slaughter of the diseased cattle. The farms which sold the sick animals eluded the restrictions by concealing their true health situation.<br /><br />This undermined the reliability of statistics on the disease and made it difficult to study and control it. In addition, it reduced the effectiveness of the Community regulations, subjecting consumers to a risk that could have been avoided. The failure to apply the rules on branding, registration and control raises doubts as to the validity of any selective cull programme of the kind envisaged at the Florence summit.<br /><br />The fact that the UK did not comply with this legislation puts it in breach of Article 5 of the Treaty. It is also to be regretted that the Commission did not use the means of redress provided for in the Treaty, in particular Article 169 thereof, in order to ensure the actual implementation of Community legislation.<br /><br />9. It failed to implement the provisions of Directive 89/662 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market. According to this directive, the country of origin (the UK, in respect of its exports) is obliged to ensure strict compliance with the conditions of health policy and inspection for all animal products leaving its territory for the Community market. The same directive sets out specific obligations in case of epidemics, including the submission to the Commission of a programme including the controls to be carried out.<br /><br />One can only be surprised by Mr Packer's declaration that his government should be exempted from blame, on the grounds that there are no proofs of non-compliance: if no checks are carried out, contraventions are very difficult to prove.<br /><br />The fact that the UK did not comply with this legislation puts it in breach of Article 5 of the Treaty. It is also to be regretted that the Commission did not use the means of redress provided for in the Treaty, in particular Article 169 thereof, in order to ensure the actual implementation of Community legislation.<br /><br />10. It took a blocking attitude within the Community institutions, with the aim of pressing the Commission and Council to lift or ease the embargo. Clear evidence of the explicit threat of political repercussions should the export ban on gelatin not be lifted is provided by the letter of 3 May 1996 from the British Prime Minister to the President of the Commission and from the reply of 8 May 1996 from Mr Santer (Annex 3, part B). Mr Major's letter to Mr Santer specifically urges the Commission to lift the embargo on gelatin, tallow and semen, calling on the Commission to submit a proposal to the Council to this effect. At one point the letter says: 'May I therefore underline the imperative need for the ban on gelatin, tallow and semen to be fully lifted and the stage clearly set for further rapid relaxation and a lifting of the whole ban on a speedy timetable. The first requirement for this is a proposal from the Commission. I hope very much that you will ensure that such a proposal is put forward for next week's meeting, as Franz Fischler told us he intended. We will put our full weight into persuading other Member States to support it'.<br /><br />President Santer told the Committee in his hearing before it that he regarded the attitude of the British Government as a form of blackmail, amounting to an abuse of the rights and obligations of a Member State as laid down in Article 5 of the EC Treaty.<br /><br />The approach taken by the Commission in response to UK pressure is clear from the minutes of the Commissioners' meeting of 5 June 1996 (Annex 5), at which Mr Fischler stated his intention to adopt the decision on the partial lifting of the embargo: the matter should be viewed in relation to what has come to be seen as the UK's abuse of its rights and blackmailing attitude towards the Community institutions, contrary to the obligations of each Member State as laid down in Article 5 of the EC Treaty. It is stated in the minutes concerned that the Commission asked Mr Santer to write to Mr Major to inform him of its intentions and call on him to review his decision concerning non-cooperation in the EU's decision- making process.<br /><br />The outcome of the pressure brought to bear on the Commission and the Council by the UK, in that the UK was able to secure at the last moment the support of delegations which had previously been strongly opposed to a partial lifting of the ban, was the adoption by the Commission of its decision on the partial lifting of the ban. This turn of events was condemned by a number of Members during the debate with Commissioner Fischler in Parliament on 6 June 1996.<br /><br />It should be remarked that the outrage caused by the embargo is in marked contrast to the UK’s muted response to earlier bans on British beef by the United States and other countries including Australia, Canada and even the UK's own Crown Colony of Hong Kong.<br /><br />11. It did not display sufficient zeal in monitoring the maintenance of the embargo on meat and by-products. This is clear from Mr Fischler's letter of 10 September 1996 to the UK Minister of Agriculture and Mr Hogg's reply of 25 October 1996 (Annex 6). Mr Fischler's letter sets out the Commission's concerns in relation to the inspection mission carried out in the UK from 22 to 26 July 1996, when a visit to the port of Dover revealed the non-existence of the checks on shipments of beef products to the Member States required by Decision 96/239/EEC.<br /><br />Similar instances of negligence by the UK had occurred earlier. The British Government, the principal victim but also bearing the bulk of the responsibility for the damage caused by this epidemic, must admit that it was negligent in some obvious areas; after underestimating the risks of BSE for years, having fought for the lifting of the embargo on gelatin for political reasons (Annex 3, part B), and yet not content with this lax approach, the British Government did not comply with the prohibitions on meal issued in 1989 and between 1990 and 1994, since beef and veal under prohibition and derived products were subject to inadequate inspections.<br /><br />12. It did not abide by the timetable reached at the Florence summit: the selective culling programme was suspended, and no alternative proposal was formally put forward. The Florence agreements provide for the possibility of modifying the culling programme in the light of new scientific data; however, whatever the circumstances, a new programme substituting the old one has to be submitted and approved by the Commission and the Standing Veterinary Committee. According to the Commission's replies of September 1996, the selective culling programme had still to be approved by the British Parliament. The programme was finally acknowledged as necessary and practicable at the end of 1996 and is now in progress. It was, then, not until 16 December 1996 that the British Government decided to carry out the culling programme agreed in Florence. At all events, there is still a procedural problem, insofar as British actions in this field should be agreed jointly with the EU, not carried out unilaterally: they should accordingly be approved by the Standing Veterinary Committee and the Commission, if the embargo is to be lifted at the earliest opportunity.<br /><br />The fact that the UK did not fully comply with the undertakings it gave at the Florence summit for a period of six months put it in breach of Article 5 of the Treaty.<br /><br />13. The refusal by the UK Minister of Agriculture, Mr Hogg, to give evidence to the Committee of Inquiry represents a breach by the British Government of the Member States' obligations under Article 3(2) of the Interinstitutional Decision of 19 April 1995). This is clear from his letters to the Committee dated 25 September 1996 and 10 October 1996 (Annex 7). According to the report drawn up for the Committee by Parliament's Legal Service on 8 October 1996 (Annex 8), 'a Permanent Secretary' attached to a British ministry could not be considered in legal terms to be a 'member of the government' within the meaning of Article 3(2) of the above- mentioned joint decision of the European Parliament, the Council and the Commission on the detailed provisions governing the exercise of the European Parliament's right of inquiry.<br /><br />The unwillingness of the British Government to release documents and thereby help to clarify where responsibility for the BSE crisis lies severely hampered the work of the Committee of Inquiry. Moreover, the unwillingness of the UK Minister of Agriculture to appear before the Committee displays a blatant lack of interest in defending the interests of UK farmers.<br /><br />14. All in all, since 1988 the UK authorities have introduced a considerable amount of legislation covering the various aspects of protection against possible BSE risks. The problem, therefore, lies not in any lack of appropriate legislative measures, but in the attitude of the government, which has failed to ensure the proper application of those measures and has not carried out the necessary checks. In addition, doubtless under pressure from the meat industry, the UK Government has, in its turn, exerted pressure on the Commission's veterinary services with the objective of keeping the matter within the national orbit, thus avoiding Community inspections and preventing publicization of the extent of the epidemic, since this would have provoked unilateral action by some Member States on public health grounds.<br /><br />To sum up, the attitude of successive British governments may often be interpreted as a refusal to 'play the game' of the proper and transparent cooperation which must govern relations between the Member States of the European Union, even beyond the terms of the Treaty.<br /><br />Finally, the Committee recognizes that there are regions of the UK that have low incidence of BSE, and have had strict monitoring and traceability of animals.<br /><br />3. DETERMINATION AND ATTRIBUTION OF RESPONSIBILITIES AS BETWEEN THE COUNCIL AND THE COMMISSION<br /><br />The determination and attribution of responsibility as between the Community institutions, namely the Council and the Commission, is an extremely complex question, for a number of reasons:<br /><br />1. One reason is the nature of the problem itself. It was initially thought that BSE was a variant of scrapie which had infected cows instead of sheep. On the basis of the parallel with scrapie - an illness which was well-known and considered harmless to humans - it was supposed that BSE was an animal health matter alone.<br /><br />However, once it began to look increasingly certain that BSE was a phenomenon different from scrapie, which could, in addition, jump the species barrier (having also been detected in cats), the matter took on a new dimension: it was no longer merely a veterinary and animal health problem, and the protection of consumer health became the first priority.<br /><br />2. One must also bear in mind the decision-making system on veterinary matters and the respective roles of the Scientific Veterinary Committee and the Standing Veterinary Committee.<br /><br />As a rule, the Commission bases its legislative proposals on the opinions of the Scientific Veterinary Committee, whose members are appointed by the Commission on the basis of nominations by the Member States. This committee acts as a consultative organ of the Commission.<br /><br />A Commission proposal drawn up on the basis of recommendations by the Scientific Veterinary Committee is then forwarded for adoption to the Standing Veterinary Committee, which operates as a regulatory committee of the 'safety-net' (contre-filet') type - i.e. the Commission proposal is adopted provided it obtains the necessary majority. If that majority is not obtained, the Commission has to take the matter to the Council. It may happen that a sufficient majority for rejecting the Commission proposal is not reached in Council: at this point, the Commission is empowered to adopt the proposal under its own responsibility, in the absence of a decision from the Council that it should be withdrawn. This was the adoption procedure which applied to Commission Decision 96/362 lifting the embargo on semen, tallow and gelatin.<br /><br />It follows that the responsibilities must be seen, in general terms, as being shared, on a non-absolute basis, between the Council, the Commission, the Standing Veterinary Committee and the Scientific Veterinary Committee. The complexity of the commitology system and the lack of transparency of the procedures inherent therein make it even more difficult to apportion responsibilities, be it with respect to the institutions or to the committees, and enables one institution to shift political and administrative responsibilities on to another.<br /><br />The Standing Veterinary Committee enjoys by delegation powers which are the preserve of the Council. Nevertheless, the Commission convenes the committee and draws up its agendas. Provision is made at the Commission for posts in Unit B.II.2 for officials to act as the secretariat of the Standing Veterinary Committee with regard to animal health matters and the Scientific Veterinary Committee with regard to public health matters. In 1995 these posts had not yet been filled. It is known from the testimony of Mrs Amendrup that the Standing Veterinary Committee was subject to political pressures and was only partially aware of the information coming out of the Scientific Veterinary Committee.<br /><br />Although the powers of the Standing Veterinary Committee were delegated by the Council, it is the Commission that exerts control over it. However, the committee's work is based on the opinions of the Scientific Veterinary Committee, and it is clear that the UK was able to control this latter committee through the convening of the meetings, the agendas and attendance, and the drafting of minutes.<br /><br />Ceding control of the committee to another body and failing to monitor it could be seen as mismanagement on the part of the Council. In any case, the greatest share of responsibility must lie with those bodies which sought to exercise control over these procedures.<br /><br />3. Another factor is the operation of the principle of subsidiarity in public health matters. On this subject, it is essential to distinguish between the situations prevailing before and after the entry into force of the Treaty of Maastricht. Since 1 November 1993, competence in the field of public health protection has been a joint matter for the Union and the Member States, pursuant to Article 129 of the TEU, but the EU has not to date been able to introduce a Community public health policy.<br /><br />Nonetheless, as is pointed out in the report by Parliament's Legal Service dated 25 November 1996 (Annex 9), legislation already existed before Maastricht obliging the Commission to take account of health protection implications in the context of the proper functioning of the COMs under the CAP.<br /><br />The Commission's powers in the field of public health protection have recently been confirmed by the Court of Justice (see: ECJ decision of 12 July 1996 - Case C-180/96; decision of the President of the Court of First Instance of 13 July 1996 - Case T- 76/96).<br /><br />It is unacceptable, therefore, that the subsidiarity principle should be used as a pretext for shifting from one institution to another responsibility for errors such as the failure on the part of the Council or Commission to implement or monitor Community law. However, this happened repeatedly during the work of the Committee of Inquiry.<br /><br />4. Public health protection competences are compartmentalized between a number of different Commission departments (as regards possible food product risks). The BSE affair has been handled variously by: DG VI (Agriculture), DG III (ex- Internal Market, now Industry), the Consumer Protection Service (currently DG XXIV), and the Directorate for Health and Safety (DG V).<br /><br />This compartmentalization has hampered the coordination and efficiency of the services concerned, has facilitated the shifting of responsibility for maladministration between the various services of the Commission, and points up the lack of an integrated approach, a phenomenon exacerbated by DG VI's arrogating primary management of the BSE issue to itself. A coordinated policy would have been possible were there a body similar to the Food and Drug Administration in the US or the health administrations in some Member States, or even had a European Health Agency been created.<br /><br />Nevertheless, it must be remembered that there were staff in all the directorates and services mentioned who should have dealt with the question and should have sought to prevent and eliminate any risks to animal and human health. Lack of coordination and malfunctioning are no excuse for the shortcomings in management and dissemination of information for which responsibility lies at individual and administrative level rather than at institutional level.<br /><br />4. RESPONSIBILITIES OF THE COUNCIL<br /><br />Given the Council's character as a representative organ of the Member States, the responsibilities that can be attributed to it at institutional level should be examined. There are some Member States to which individual responsibilities can be attributed. This is true of the United Kingdom, which, in view of its importance, has been dealt with in a separate chapter. Other Member States, such as France and Portugal, or Community institutions have set up committees of inquiry. These will be responsible for determining where responsibility lies in the states concerned. This does not mean that there were not other Member States responsible to a lesser or greater extent for the management of the crisis, but it is appropriate that such responsibility should be determined by the relevant parliamentary bodies.<br /><br />In relation to the activities of the Council and the Standing Veterinary Committee, we have been helped by the testimonies of Mr Yates, the Irish Minister of Agriculture, in his capacity as President-in-Office of the Agriculture Council, and Mrs Amendrup, assistant director of the Danish national veterinary services and member of the Standing Veterinary Committee.<br /><br />Mr Yates endeavoured to define the sphere of competence of the Council, pointing out that legislative powers in the veterinary field and, even more so, in that of public health are shared between the Commission, the Council and the Member State governments. However, he argued, the Council was responsible for a specific activity of political guidance and impetus, and was also obliged to cooperate closely with the Commission. He stressed that the Council was not to be held responsible in a number of important areas, stating: '... dissemination of information about BSE, publication of research findings about BSE, controls on the production and export of recycled animal protein and controls on the temporary ban on exports of cattle, beef and meat-based productions do not fall within the Council's sphere of responsibility, as they come under the powers of the Commission or the Member States'.<br /><br />This committee, however, takes the view that the Council cannot evade its responsibility in this way. In view of the shortcomings, as set out in this report, in the work of the Standing Veterinary Committee, which also acts on behalf of the Council through the representatives of the Member States, the Council shares responsibility for the inaction and delays in connection with the control of the epidemic in the UK, the wrong decisions and poor coordination as regards health protection, and the disinformation supplied to the public.<br /><br />Despite clear evidence of the failure to comply with the export bans and control measures which it itself had imposed with a view to protecting public health, the Council took no effective steps to enforce those bans and measures and failed to make representations to the Commission to ensure that they were complied with. With a view to the completion of the internal market, the Council also gave the economic interests of the meat industry political priority over health protection. It was particularly culpable in giving in to the British efforts at political blackmail between 1995 and 1996.<br /><br />Prior to the March 1996 crisis, the Agriculture Council had specifically examined BSE at its meetings of 6 and 7 June 1990 and 18 and 19 July 1994 (see Annex 10). Both meetings were called to deal with the threats of unilateral measures by certain delegations (France and Germany) which were calling for tougher guarantees on meat imports from the UK.<br /><br />In addition, at several other Council meetings, according to the minutes supplied to us, certain delegations expressed the following requests:<br /><br />- BSE should be included on the agenda, for assessment of the most recent scientific data (German delegation to the Council, 25 and 26 April 1994, 30 and 31 May 1994 and 20, 21, 22, 23 and 24 June 1994) (Annex 11);<br /><br />- the Council of Health Ministers should be asked to participate in possible public health protection measures (German delegation to the Council, 28 and 29 March 1994) (Annex 12);<br /><br />- there should be reinforced controls on feedingstuffs given to ruminants and on the use of potentially dangerous tissue in the manufacture of cosmetics and medicines (French delegation to the Council, 28 and 29 March 1994 and 25 and 26 April 1994) (Annexes 11 and 12);<br /><br />- action should be taken on the request of the French delegation, forwarded to the Council of Health Ministers, for extension to all the Member States of France's unilateral measures banning the use of at- risk bovine tissue in the manufacture of cosmetics, medicines and baby-foods (meeting of 30 and 31 May 1994) (Annex 11).<br /><br />Following the statement by the UK Government of 20 March 1996 concerning new scientific data, the Agriculture Council held two extraordinary meetings, on 1-3 April and 29 and 30 April 1996 (Annex 13). At these meetings, it recognized the seriousness of the situation and urged the adoption of a number of urgent measures for health protection and support of the beef market. The subject was discussed again on numerous occasions throughout 1996, with the Council awaiting the statements of the UK delegation concerning the evolution of the situation, with a view to resolving the crisis.<br /><br />On 30 March 1994 the Council of Health Ministers met to discuss the proposal by the German delegation concerning discussion of the possible risks of transmission of BSE to humans. The German delegation insisted on making a separate statement, in which it urged the adoption of further protection measures (Annex 14). Over the rest of 1994 after March the Council of Health Ministers discussed the subject several more times.<br /><br />One may cite, as visible proof of the attention which has been paid to the subject in various policy areas, the discussions in the Council of Research Ministers, at its meeting of 7 October 1996, as well as the statements by Commissioner Cresson included in the minutes of the Commissioners' meeting of 9 October 1996 (Mrs Cresson reported on the disappointing outcome of the discussions in the Council of Research Ministers on this subject, and drew attention to the inconsistent position of the ministers, who had called for a greater research effort but had refused to provide the necessary resources) (Annexes 15 and 16). Following this Council meeting, the Commission submitted a communication to the Council and Parliament (COM(96)0582) allocating an additional ECU 50 m for BSE research. The subject was to be re-examined at the Research Council meeting of 5 December 1996.<br /><br />(end of part 1 of 3)<br /><br />Tom.....<br /><br />27 Month delay in nyala case<br /><br />Draft Factual Account #5<br /><br />10. On 28 June 1986 Mr Jeffrey examined tissue sections taken from the brain of a nyala which had been kept at Marwell Zoo.(S Jeffrey para 6; YB86/7.8/1.1 ) This examination, and subsequent consideration of the report, are described in the CVL DFA.<br /><br />51. On 10 June 1987 Mr Bradley sent a BSE update to Dr Watson. It discussed, amongst other things, the nyala case and subsequent paper, the work of Mr Wilesmith, the upcoming BCVA meeting and the work of Dr Kimberlin.(YB 87/6.10/1.1 )<br /><br />63. On 22 June 1987 Mr Bradley sent a memo to Mr Wells detailing actions taken to date. It noted that publication has been discussed with the CVO and halted and that there were now at least 9 suspect herds and a case in a gemsbok at Marwell.(YB 87/6.22/2.1 )<br /><br />74. On 1 July 1987, Mr Bradley wrote to Mr Jeffrey to tell him that his article on spongiform encephalopathy in a nyala was not authorised for publication, and that while he made comparisons with scrapie, the CVO was unlikely to give his approval.(YB87/6.29/3.1; YB87/7.1/2.1; YB87/7.1/3.1-3.10 ) This is further discussed in the CVL DFA.<br /><br />153. On 11 December 1987, Mr Jeffrey's paper on the nyala was submitted for publication in the journal Veterinary Pathology. The paper had first been drafted the paper in autumn 1986. (S 64 Jeffrey para 10) The title of the paper was changed from 'A scrapie-like disorder in a nyala' to 'A spongiform encephalopathy in a nyala.' Other references to scrapie were also amended.( S Jeffrey para 10; S 65 Wells para 55; YB87/11.11/2.1; YB87/11.17/3.1; YB87/11.23/2.1. )<br /><br />Spongiform encephalopathy in a nyala (Tragelaphus angasi).<br /><br />Vet Pathol 1988 Sep;25(5):398-9 Jeffrey M, Wells GA Lasswade Veterinary Laboratory, Midlothian.<br /><br />166. In January 1988, Mr Wilesmith was informed of the June 1987 case of SE in the gemsbok. He discovered from the Winchester VIC that both the >nyala and the gemsbok had received rations containing MBM and this provided further support for his hypothesis.( S Wilesmith para. 37)<br /><br />Draft Factual Account #4<br /><br />28. On 28 June 1986 Dr Jeffrey examined tissue sections taken from the brain of a nyala which had been kept at Marwell Zoo. (S Jeffrey para 6; YB86/7.8/1.1 ) The nyala had shown unusual nervous symptoms two weeks prior to being put down on welfare grounds. These symptoms included 'weaving with the head and neck, holding the head on its side and frequent nibbling near the tailbone.'(YB86/6.23/1.1 ) The sections were originally necropsied by Mr Geoff Holmes at the Winchester VIC.(YB86/5.29/1.1; YB86/6.18/1.1 ) The nyala (tragelaphus angasi) is not an antelope but belongs to the same family (species group) as cattle.<br /><br />29. Dr Jeffrey observed that the brain showed taxonomic lesions of spongiform encephalopathy and that the similarity of the lesions to natural sheep scrapie was striking, and indeed he thought that in comparison to natural sheep scrapie the lesions were particularly florid.(YB86/7.2/1.1; S Jeffrey para 9 ) The sites (neuroanatomical location) and cellular location (grey matter neuropil and neuronal cytoplasmic vacuolation) were distinctive and characteristic of the TSEs. Dr Jeffrey sent a slide of the nyala brain to Dr Richard Kimberlin at the NPU in the latter quarter of 1986 who 'vividly recollect[ed] seeing the results down the microscope because the pathology was so striking'.(YB 98/11.18/1.1 )<br /><br />30. Following a field visit to Marwell Zoo on 21 July 1986,(YB86/7.24/1.1 ) a report was compiled by Mr Holmes at Winchester VIC and a scientific paper prepared for publication in a journal.(S Jeffrey para 10 ) Dr Jeffrey conferred with Mr Wells, his line manager at the CVL, in the preparation of the paper.(S Jeffrey para 9; S Wells 1st para 55 ) Dr Jeffrey was not sure of the exact date he submitted the paper to the Animal Health and Veterinary Group (AHVG) for publication but said it was some time in Autumn 1986.(S Jeffrey para 10; YB86/11.00/1.1 ) Dr Jeffrey did not form any conclusions about the origins of the disease in this animal, but he discussed the case with the CVL Epidemiology Department, and they agreed to keep a 'watching brief' on the situation.(S Wilesmith para 11)<br /><br />89. On 17 June 1987 the Annual Report of the CVO for 1986 was published, having been submitted for publication on 1 June 1987.( M24 Tab 2 at 69 ) The Report described the discovery of a 'Scrapie-like disease in a captive nyala' and noted that 'Transmissible spongiform encephalopathies have been reported in man, sheep and goats (scrapie), mule deer and mink.'<br /><br />91. On 19 June 1987 Mr Bradley sent Dr Watson a BSE Update. Amongst other things it was noted:(YB 87/6.19/3.1-3.2 )<br /><br />"The final draft Vet Rec paper has been prepared and submitted for authority to publish. This has been rejected by CVO whilst scrapie is mentioned. For this and other reasons the paper is temporarily withdrawn until further information is available"<br /><br />92. On 19 June 1987 Dr S.H. Done diagnosed spongiform encephalopathy in a gemsbok from Marwell Park.(YB87/6.19/3.2; YB876.8/3.1; YB87/6.10/3.1; YB87/6.25/1.1 ) This was the zoo was from which the SE-infected nyala had come. While the nyala was from the same species group as cattle, the gemsbok is an African antelope.<br /><br />100. On 1 July 1987 Mr Bradley wrote to Dr Jeffrey to tell him that his article on spongiform encephalopathy in a nyala was not authorised for publication, and that while he made comparisons with scrapie, the CVO was unlikely to give his approval.(YB87/7.1/3.2; YB87/6.29/3.1; YB87/7.1/2.1 ) The initial title of the paper was 'Scrapie-like disorder in a nyala'.( S Jeffrey para 12 ) At the request of Tolworth, the title of the paper was eventually changed to 'Spongiform encephalopathy in a nyala'.( YB87/11.00/1.1 ) Because of the original references to the scrapie-like nature of the disorder the paper was delayed for publication and was not published until September 1988.( J/VP/25/398 ) Dr Jeffrey told the BSE Inquiry that he resisted the move to alter his paper because it 'would have been negligent to try and publish that without a reference to scrapie'.(T25 at 32 )<br /><br />157. On 17 November 1987 Mr Bradley minuted Dr Jeffrey noting that the title to his nyala paper was likely to be unacceptable to "senior management" for "veterinary political reasons". He also recommended that where comparisons were made with scrapie the emphasis ought to be altered.(YB 87/11.17/1.1 )<br /><br />433. On 23 October 1989 Dr Watson told Mr Wells that the CVL were to supply material from the kudu and nyala to the NPU for transmission to mice. Dr Watson said this was an important transmission experiment designed to establish the relationship between the disease in zoo animals and cattle.(S Watson 1st para 134 ) Mr Bradley provided Dr Watson with a list of tissues that were to be sent to the NPU on 24 November 1989.(YB89/10.24/4.1 )<br /><br />================================================<br /><br />BSE Inquiry site Draft Factual Account 13 extracts related to zoo animals:<br /><br />19. On 24 January 1990 Mr Bradley sent to Dr Watson a summary of the main points of a meeting held with the Minister the same day.(20) The minute noted: "The Minister played Devil's advocate in relation to: ... 5. MBM exports unethical. All should be labelled & a letter should be sent to all countries to which MBM was exported should be sent." [No such letter was sent.]<br /><br />28. By 12 February 1990 the nyala and kudu tissues and the placenta had been inoculated into mice at the NPU.(33) After his investigations into the alimentary tract, ... Mr Bradley said in a minute dated 12 February 1990 that:(36) "It is very clear that it is important to initiate studies now in a much wider range of tissues and in multiple specimens than can be accommodated in the annual quota of 30 for the next two years." Mr Bradley attached a table showing the progress of infectivity studies:..fixed nyala brain, fixed kudu brain, buffy coat.<br /><br />57. On 17 September 1990 Mr Bradley circulated a minute with regards to an offer by Dr Schellekers of the Netherlands to collaborate on attempting to transmit BSE to chimpanzees.(YB90/9.17/1.1) Mr Wells and Dr Rosalind Ridley, who was conducting the marmoset experiment, told Mr Bradley that they did not feel there was any greater justification for an attempted transmission in chimpanzees than marmosets.(S Bradley 3rd para 40 ) Mr Bradley passed on this view to the CVO.(YB90/9.23/1.1; YB90/9.26/3.1 ). [This is ignorant beyond belief.]<br /><br />67. In Spring 1991 Mr McGill performed a review of 200 brains that had, using the obex histopathological method, been deemed BSE-negative.(110) This diagnostic approach, that had been developed for use within the VIS, used a single section from the medulla to look for spongiform change. In his review Mr McGill examined other parts of the brain.(111) In his statement to the BSE Inquiry Mr McGill said:<br /><br />Upon closer examination, three of the 200 'BSE-negative' brains proved positive for spongiform changes diagnostic of BSE.(112) This represents an overall diagnostic accuracy of 99.85%, exceeding the 99.6% previously published for the same standard diagnostic technique. Despite this, at the behest of MAFF managers, the emphasis of the study and its provisional title had to be changed, from accurately representing the whole negative 10%, to a study examining this 10% minus any mention whatsoever of BSE-affected cattle going undiagnosed. I therefore had to reluctantly locate and analyse three new BSE-negative suspect brains.(113)<br /><br />76. In mid-1991 it was decided that a proposed survey of 300 deer brains would proceed.(124) As with the hound survey, there were difficulties in collecting the material in a manner optimal for histopathological examinations.(See YB92/11.4/2.1) During the period 1986 to 1996, 26 deer brains were referred for examination to the Consultant Pathology Unit at the CVL, but none of these showed evidence of an SE.<br /><br />103. On 16 July 1992 a meeting was held at CVL to discuss the research proposals relating to the studies on SEs in a greater kudu at a zoo. (S Bradley 3rd para 65 ) Three main experiments were proposed: to determine the distribution of agent in tissues; to study the epidemiology; and to strain type isolates from a brain of a new case of spongiform encephalopathy. Formal proposals were later drawn up and Mr Bradley became the Project Officer for the experiments.<br /><br />108. Mr Bradley and Mr Dawson met staff at London Zoo on 23 March 1993 to discuss tissue selection for the proposed transmission studies on BSE-infected kudu material.(166) The Zoo did not want to keep the kudu, but moving them to the CVL was ruled out because of inadequate facilities to care for them. The investigations into the distribution of the SE agent in various tissues began in June 1993.<br /><br />121. On 9 October 1993 Mr Wilesmith and others published a paper on the additional cases of TSE in the herd of greater kudu at London Zoo.(S Wilesmith 2nd para 95 ) On the basis of feeding histories, the authors concluded that horizontal transmission had occurred. However, subsequent investigations based at the zoo revealed that the affected animals were most likely to have been infected from the feedborne source.<br /><br />143. On 3 July 1994 Mr Bradley was informed that two more kudu were to be culled.( Bradley 3rd para 86 ) He visited the London Zoo on 21 July 1994 to review the progress of the studies on TSEs in zoo animals. Necropsies were to be carried out on the kudu and tissues collected for further transmission studies. At this stage the mice that had been inoculated with kudu tissues in August and September 1993 had not succumbed to spongiform encephalopathy. The Zoo authorities wanted to move the kudu because of the possibility of bad publicity.(YB95/2.10/1.6) This was discussed at a SEAC meeting on 2 February 1995. The meeting agreed that the risk to Zoo visitors was minuscule or non-existent. Mr Bradley's case control study indicated that infected feed was the most probable cause of the BAB kudu SE cases.<br /><br />=-=-=-=-=-=-=-=-<br /><br />46. On 28 June 1990 Mr Bradley informed Mr Wells that a survey of hounds was to commence.(68) The hound survey arose because the Tyrrell Committee had recognised that domestic pets might prove susceptible to the unconventional agent of BSE and recommended monitoring the health of animals fed offal, carcases or meat and bone meal.(M11a Tab 8 )<br /><br />47. A total of 444 hound brains of mixed breeds from 101 kennels across the United Kingdom were collected and examined. Histopathological changes consistent with a florid spongiform encephalopathy similar to that reported in cats was not observed. However, the report of the survey identified serious flaws in the survey's design. Mr Wells said in a minute to Mr Bradley in October 1991 that 'the survey as designed has little to offer scientifically'.(YB91/10.17/1.1)<br /><br />54. On 20 August 1990 Mr Wells confirmed the parenteral transmission of BSE to a pig.(YB90/7.20/2.1) The pig was inoculated in February/March of 1989 and was slaughtered in July 1990.(S Wells 2nd para 40) An interim report was prepared for SEAC(84) and a press conference was held on 24 September 1990 to announce the parenteral transmission of BSE to pigs.(85) The transmission of BSE to pigs was a major factor in the ban on SBOs being extended to all animal feed. Experiments were also conducted by orally dosing pigs with BSE infected material but when the pigs were killed after seven years they were not found to be incubating the disease.(S Wells 2nd para 40 )<br /><br />55. By August 1990 a total of 10 cases of FSE in domestic cats had been confirmed.(S Wilesmith 2nd para 109 ) Mr Wilesmith designed a questionnaire to be completed by the veterinarians who clinically identified FSE for the purposes of an epidemiological investigation. In addition to this investigation, the University of Bristol was subsequently granted a MAFF contract for a study in collaboration with the NPU to ascertain whether the condition in cats was transmissible to mice and, if so, to undertake strain typing of the agent.(S Wells 2nd para 104; YB 92/6.19/5.1 ) Mr Wells was appointed Project Officer to monitor the study. When the study was completed it showed that the disease in cats was transmissible and that similarities in the biological characteristics of FSE and BSE on transmission to mice indicated that the two diseases probably arose from a common source.(J/VR/134/449 )<br /><br />64. In February 1991 Mr Mark Robinson began studies on the transmission of BSE to mink.(S Wilesmith 2nd paras 117-118 ) This study was done in collaboration with the United States Department of Agriculture (USDA), the Agricultural Research Service (ARS), and the Department of Veterinary Science at the University of Wisconsin, USA. The results of this study were discussed at the 10th CVL/NPU BSE R&D meeting held on 27 April 1993.(YB93/4.27/1.1) The results indicated that mink were susceptible to BSE, and in contrast to previous attempts to transmit scrapie to the species, were susceptible by the oral route of challenge.(J/JVIR /75/2151)<br /><br />99. On 11 April 1992 Mr Bradley prepared a paper for the Lamming Expert Committee on Animal Feedingstuffs.(153) Some of the areas covered in the paper were tallow, the danger of BSE to pigs, the effect of the species barrier, tissue infectivity of lambs and calves, scrapie incidence and the danger of dogs developing SEs.<br /><br />116. In July 1993 studies involving the oral exposure of pigs to scrapie were started the CVL.(179) Such studies were recommended by the expert committee on feedingstuffs chaired by Professor Lamming, because it was found that pigs had been orally exposed not only to BSE but also to scrapie. The pigs were orally exposed to scrapie-infected brain material in November 1993 and while the experiment remains in progress, no pigs have been shown to have developed the disease to date.<br /><br />123. In December 1993 Dr Ken Charlton of the Animal Disease Research Institute, Nepean, Ontario, Canada, visited the CVL bringing material from a suspect case of BSE in Canada. The CVL confirmed that the case was a BSE case and reported it to the Canadian authorities.(189) in 1994.<br /><br />152. On 13-16 February 1995 ... ...BSE to pigs - Further work to clarify the finding of non-specific vacuolation in the brains of control pigs was needed.<br /><br />...BSE to chickens - Sub-passage in chickens and mice of various tissues from experimentally infected birds was needed to clarify the findings of neurological signs without neuropathology in inoculated birds.<br /><br />==-=-=-=-<br /><br />bibliography:<br /><br />Vet Rec 1997 Sep 13;141(11):270-1 Baron-T, Belli-P Madec-J-Y Moutou-F Vitaud-C Savey-M Spongiform encephalopathy in an imported cheetah in France. CNEVA-Lyon, Laboratoire de Pathologie Bovine, France.<br /><br />Proc Soc Exp Biol Med 1996 Apr;211(4):306-22 Narang H Origin and implications of bovine spongiform encephalopathy. [tiger]<br /><br />Vet Rec. 1994 Nov 12;135(20):488. Benbow G. Spongiform encephalopathies in zoo animals. comment<br /><br />Vet Rec 1994 Oct 29;135(18):440 Swainston J. comment<br /><br />Vet Rec 1994 Sep 24;135(13):296-303 Kirkwood JK, Cunningham AA Epidemiological observations on spongiform encephalopathies<br /><br />Vet Rec 1994 Feb 12;134(7):167-8 Kirkwood JK, Cunningham AA, Austin AR, Wells GA, Sainsbury AW Spongiform encephalopathy in a greater kudu<br /><br />Vet Rec. 1993 Oct 9;133(15):360-4. Kirkwood JK, et al. Spongiform encephalopathy in a herd of greater kudu<br /><br />Vet Rec. 1993 Jan 16;132(3):68. Cunningham AA, et al. Transmissible spongiform encephalopathy in greater kudu<br /><br />Vet Rec. 1992 Nov 7;131(19):431-4. Willoughby K, et al. Spongiform encephalopathy in a captive puma<br /><br />Aust Vet J 1992 Jul;69(7):171 Peet RL, Curran JM Spongiform encephalopathy in an imported cheetah<br /><br />Vet Rec 1992 Apr 25;130(17):365-7 Kirkwood JK, Wells GA, Cunningham AA, Jackson SI, Scott AC, Dawson M, Wilesmith JW Scrapie-like encephalopathy in a greater kudu<br /><br />Acta Neuropathol (Berl) 1992;84(5):559-69 Jeffrey M, Scott JR, Williams A, Fraser H Ultrastructural features of spongiform encephalopathy<br /><br />Vet Rec. 1991 Oct 5;129(14):320 Synge BA, et al. Spongiform encephalopathy in a Scottish cat.<br /><br />Vet Rec 1991 Sep 14;129(11):233-6 Wyatt JM, Pearson GR, Naturally occurring scrapie-like s<br /><br />Vet Rec. 1991 Jun 1;128(22):532. Pearson GR, et al. Feline spongiform encephalopathy.<br /><br />Vet Rec. 1991 Mar 30;128(13):311. Kock R. Spongiform encephalopathies in ungulates.<br /><br />Vet Rec. 1991 Feb 2;128(5):115. Gibson PH. Spongiform encephalopathies in ungulates. comment<br /><br />Vet Rec 1990 Dec 15;127(24):586-8 Leggett MM, Dukes J, Pirie HM A spongiform encephalopathy in a cat.<br /><br />Done JT. Vet Rec. 1990 Nov 10;127(19):484. Spongiform encephalopathy in pigs.<br /><br />Vet Rec. 1990 Oct 27;127(17):418-20. Kirkwood JK, et al. Spongiform encephalopathy in an arabian oryx (Oryx leucoryx) and a greater kudu.<br /><br />Vet Rec. 1990 Sep 29;127(13):338. Dawson M, et al. Primary parenteral transmission of bovine spongiform encephalopathy to the pig.<br /><br />Vet Rec. 1990 May 19;126(20):513 no authors listed Spongiform encephalopathy in a cat.<br /><br />Vet Rec 1990 May 12;126(19):489-90 Gibson PH Spongiform encephalopathy in an eland.<br /><br />Nature. 1990 Mar 15;344(6263):183 Aldhous P. Antelopes die of "mad cow" disease.<br /><br />Vet Rec 1990 Apr 21;126(16):408-9 Fleetwood AJ, Furley CW Spongiform encephalopathy in an eland.<br /><br />Vet Pathol. 1988 Sep;25(5):398-9 Jeffrey M, Wells GA Spongiform encephalopathy in a nyala (Tragelaphus angasi) Lasswade Veterinary Laboratory, Midlothian<br /><br />=================================================<br /><br />Subject: Re: BSE Inquiry report delayed until 31 Mar 2000 From: Torsten Brinch Reply-To: Bovine Spongiform Encephalopathy Date: Wed, 26 May 1999 19:58:30 +0200 Content-Type: text/plain Parts/Attachments: text/plain (59 lines)<br /><br />Tom wrote:<br /><br />And I don't like the sound of this at all: "From the end of May, Draft<br /><br />Factual Accounts (DFAs) will no longer be available on the BSE Inquiry<br /><br />website." It is a poor idea to take things down from the web even if they<br /><br />are someday more or less replaced by revised factual accounts, because<br /><br />people want to see and respond to what the lawyers were able to get<br /><br />altered.<br /><br />Maybe there will be better time for that kind of metastudies later on, Tom. IMO, if one wants to respond to affect the completeness of the factual accounts in a decent fashion to the good Inquriy staff, an earlier and more proactive approach from interested members of the public is necessary -- building on the first versions of the draft factual accounts, and of course, the evidence itself, which has come out of Phase 1.<br /><br />I archived all the draft factual accounts already onto servers in Asia and<br /><br />am ready to mirror the lost data the day that these go down in Britain.<br /><br />Roland:<br /><br />I fully agree that this documents should stay available on the british<br /><br />server and I really can not imagine why they want to remove this<br /><br />information from the web. Can you please tell me, how many MB<br /><br />I need to copy the whole stuff on my PC?<br /><br />The draft factual accounts in their present form take up less than 2.5 MB (html). I can't work myself up over that they are taken down from the server. Otoh, it is just 2.5 MB. The first version of the draft factual drafts will of course be replaced by complemented/corrected versions as should be expected from their name, form and content. I am quite pleased that it has been announced, that 'medicines' will be the subject of an additional draft factual account. This is good, necessary and quite relevant for one predictable area of inquiry during the Phase 2 proceeding.<br /><br />The accumulated web-published evidence on the BSE-Inquiry site is quite large, appr. 34 MB html (appr equally divided between witness statements and transcripts of the Phase 1 hearings, total indexes to which are at</mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""></mailto:flounder></mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""></mailto:flounder></mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://209.41.3.198/witness/" style="color: #473624; cursor: pointer;">http://209.41.3.198/witness/</a> +</mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""></mailto:flounder></mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""></mailto:flounder></mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""><a fg_scanned="1" href="http://209.41.3.198/witness/htm/" style="color: #473624; cursor: pointer;">http://209.41.3.198/witness/htm/</a></mailto:flounder></mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""></mailto:flounder></mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""></mailto:flounder></mailto:sillaste><br /><mailto:sillaste cybercable.fr="">and</mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""></mailto:flounder></mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""></mailto:flounder></mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""><a fg_scanned="1" href="http://209.41.3.198/transcripts" style="color: #473624; cursor: pointer;">http://209.41.3.198/transcripts</a></mailto:flounder></mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""></mailto:flounder></mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""></mailto:flounder></mailto:sillaste><br /><mailto:sillaste cybercable.fr="">respectively. The draft account index is at</mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""></mailto:flounder></mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""></mailto:flounder></mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://209.41.3.198/dfa/" style="color: #473624; cursor: pointer;">http://209.41.3.198/dfa/</a> .<br /><br />I plan to get a few metalinks pages up on the web soon, which have proved useful for my personal interest, working on downloaded stuff on my home base. Essentially they are just one way to structure links to transcripts and statements according to the key involved persons and their placement in the hierarchies of MAFF and DOH. On the Inquiry web-site the evidence is basically arranged according to the time schedule of the Inquiry. Don't expect anything fancy, these structured metalinks pages will be raw _drafts_, and they will bl.... be replaced without warning, whenever and if I can spare the time.<br /><br />Best regards,<br /><br />Torsten Brinch<br /><br />===============================================<br /><br />Subject: Re: VACCINES/CHILDREN/TSE'S -- 'CONFIDENTIAL' From: tom Reply-To: Bovine Spongiform Encephalopathy Date: Wed, 6 Sep 2000 18:20:09 -0800 Content-Type: text/plain Parts/Attachments: text/plain (110 lines)<br /><br />######### Bovine Spongiform Encephalopathy #########<br /><br />Just when I was thinking the Internet had reached a terminal condition of shallow pages and broken links, some young people come along and invent a really effective Internet search engine:</mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""></mailto:flounder></mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""></mailto:flounder></mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""><a href="https://www.google.com/" style="color: #473624; cursor: pointer;">http://www.google.com/</a></mailto:flounder></mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""></mailto:flounder></mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""></mailto:flounder></mailto:sillaste><br /><mailto:sillaste cybercable.fr="">This works quite well to search the entire</mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""></mailto:flounder></mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""></mailto:flounder></mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://www.mad-cow.org/" style="color: #473624; cursor: pointer;">http://www.mad-cow.org</a> site (or find 393 web sites such as GenBank that link to it, or 936 sites that cite it in text) back to 1996 as well as the BSE Inquiry</mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""></mailto:flounder></mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""></mailto:flounder></mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><a fg_scanned="1" href="http://www.bse.org.uk/" style="color: #473624; cursor: pointer;">http://www.bse.org.uk/</a><br /><br /></mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""></mailto:flounder></mailto:sillaste><br /><mailto:sillaste cybercable.fr="">Thus for louping ill (unnecessary cites suppressed):</mailto:sillaste><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste><mailto:sillaste cybercable.fr=""><br /><br /><a fg_scanned="1" href="http://www.bse.org.uk/witness/htm/stat537.htm" style="color: #473624; cursor: pointer;">http://www.bse.org.uk/witness/htm/stat537.htm</a><br /></mailto:sillaste><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""></mailto:flounder></mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""></mailto:flounder></mailto:sillaste><br /><mailto:sillaste cybercable.fr="">Witness Statements 537 - Coulthard<br /><br />29.Pituitary FSH from pigs has been used in the USA prior to its use in the UK and much more extensively there and Canada.... 30.Thousands of embryos were exported from this country to the USA prior to the ban being imposed... 42. No cow pituitaries were used in the preparation of FSH [follicular stimulating hormone] products compared with the case of louping ill vaccine for scrapie.</mailto:sillaste><br /><mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""></mailto:flounder></mailto:sillaste><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste><mailto:sillaste cybercable.fr=""><br /><br /><a fg_scanned="1" href="http://www.mad-cow.org/~tom/fda_late.html#ill" style="color: #473624; cursor: pointer;">http://www.mad-cow.org/~tom/fda_late.html#ill</a><br /><br /><br /><br />In the 1930's: 18,000 UK sheep were inoculated against louping ill, a brain inflammatory illness spread by ticks. Despite formalin-treatment of the inoculated agent, the procedure gave rise to 1,500 cases of scrapie. Louping is a Scottish word for fleeing or leaping, related to loping. In humans, louping ill is called Russian spring-summer encephalitis, a meningo-encephalitis with muscular tremors and spasms followed by varying degrees of paralysis.... [John Lanchester 2 Dec 96 New Yorker]<mailto:sillaste cybercable.fr=""><mailto:flounder wt.net=""><br /></mailto:flounder></mailto:sillaste></mailto:sillaste><mailto:sillaste cybercable.fr=""><br /><br /><br /><br /><a fg_scanned="1" href="http://www.foodsafety.org/consumer/ht/ht294.htm" style="color: #473624; cursor: pointer;">http://www.foodsafety.org/consumer/ht/ht294.htm</a><br /><br /><br /><br /><br /><br />In what the story calls a grand historical irony, this landmark series of experiments was being confirmed at the same time in England as a result of an outbreak of scrapie in several hundred sheep that had been immunized against louping ill with a vaccine prepared from tissue from the brain, spinal cord, and spleen of sheep that were belatedly discovered to have been exposed to natural scrapie infection.[6.Gordon WS. Advances in veterinary research. Vet Rec 1946; 58: 516-520] The transmissible nature of the scrapie agent was thus established beyond any doubt. [P Brown, 1755 and All That: A Historical Primer of TSE.<br /><br />We need to look at the full text of the article and its cites to see how they actually made the vaccine, whether they exported vaccine-infected sheep to Canada and the US, and what became of the vaccinated flocks. Perhaps there is still sample available, Moredun Institute is still around.<br /><br />Gordon WS. Advances in veterinary research. Vet Rec 1946; 58: 516-520 (not covered by Medline) Gordon, Bronlee and Wilson 1939 [full cite is available only in a letter we don't have)<br /><br />Terry was reading Draft Factual Account 17<br /><br /><br /><br /><a fg_scanned="1" href="http://www.bse.org.uk/dfa/dfa17.htm" style="color: #473624; cursor: pointer;">http://www.bse.org.uk/dfa/dfa17.htm</a><br /><br /><br />NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a fg_scanned="1" href="http://web.archive.org/web/20001219215500/http://www.bse.org.uk/dfa/dfa17.htm" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20001219215500/http://www.bse.org.uk/dfa/dfa17.htm</a><br /><br />236. Mrs Alderman replied on 3 June 1988, listing products containing bovine insulin and noting there were two rabies vaccines listed but the species used in manufacture was not shown.[282] 237. On 6 June 1988 Mr Lawrence wrote to Sir Richard Southwood and enclosed some brief answers to the questions that had been tabled at the meeting on 19 May.[283] In relation to Q6, which asked ŒWhat is meat and other material from scrapie infected sheep used for - does it include pet food and material for biological products?¹ Part of the answer stated: ...<br /><br />There has been one instance of inadvertant [sic] transmission of the<br /><br />scrapie agent to sheep through louping ill vaccine (Gordon, Bronlee and<br /><br />Wilson 1939). One of the three batches of vaccine made in 1935 at the<br /><br />Moredun Institute contained the scrapie agent resulting in 7% of the<br /><br />recipients of the 18, 000 doses in the batch developing scrapie. This<br /><br />vaccine was made from formalin-inactivated sheep brain, and brought to<br /><br />the attention of research workers that formalin, at a concentration of<br /><br />0.35% for at least 3 months, which inactivated conventional viruses, did<br /><br />not totally inactivate the scrapie agent.<br /><br />----------------------------<br /><br />4. Questions we might want to have answered are:<br /><br />the highest risk would be from parenterals prepared from brain (eg<br /><br />rabies vaccine). Any species in which transmissible spongiform<br /><br />encephalopathies have been described would be suspect (“natural”<br /><br />infections in sheep, goats, cattle, deer, mink, but can be transmitted<br /><br />to hamster, mouse, guinea-pig etc). Are sterilisation processes<br /><br />adequate for the most resistant strain of scrapie agent or for CJD<br /><br />agent? Should companies be asked to include investigation for inclusion<br /><br />of scrapie agent (eg mouse innoculation [sic]) in at least some batches?<br /><br />If BSE behaves like scrapie, then we might expect other nervous tissue,<br /><br />spleen, lymph nodes and placenta to be contaminated. Infection has been<br /><br />described in other tissues too, eg gut wall, and we can not [sic] be<br /><br />sure blood is free. Do we know what bovine materials are used in which<br /><br />products, both as the active ingredient and in production? Bovine active<br /><br />ingredients in human products include insulin, vasopressin, bone, immune<br /><br />globulins, fibrin, dermal collagen, albumin. Bovine serum albumin and<br /><br />fetal calf serum must be used in preparation of very many products. For<br /><br />each of these products would any “BSE agent” be destroyed or eliminated<br /><br />in processing? If not, and the product is administered parenterally or<br /><br />topically into an open wound, might there be a risk? [For oral<br /><br />products, there would only be a trivially increased load on top of that<br /><br />taken in food in omnivores/carnivores including man. But for some<br /><br />herbivores, this might allow the agent to be introduced into yet another<br /><br />species].<br /><br />--------------------------<br /><br />Medicines and medical devises;<br /><br />############ <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html" style="color: #473624; cursor: pointer;">http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html</a> ############<br /><br /><br /><br />Subject: Louping-ill vaccine documents from November 23rd, 1946<br />Date: Sat, 9 Sep 2000 17:44:57 -0700<br />From: "Terry S. Singeltary Sr."<br />Reply-To: Bovine Spongiform Encephalopathy To: <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000143/!x-usc:mailto:BSE-L@uni-karlsruhe.de" style="color: #473624; cursor: pointer;">BSE-L@uni-karlsruhe.de</a><br /><br />######### Bovine Spongiform Encephalopathy #########<br /><br />THE VETERINARY RECORD 516 No 47. Vol. 58 November 23rd, 1946<br /><br />NATIONAL VETERINARY MEDICAL ASSOCIATION OF GREAT BRITAIN AND IRELAND<br /><br />ANNUAL CONGRESS, 1946<br /><br />The annual Congress, 1946, was held at the Royal Veterinary College, Royal College Street, London, N.W.I. from September 22nd to September 27th.<br /><br />Opening Meeting<br /><br />[skip to scrapie vaccine issue...tss]<br /><br />Papers Presented to Congress<br /><br />The papers presented to this year's Congress had as their general theme the progressive work of the profession during the war years. Their appeal was clearly demonstrated by the large and remarkably uniform attendance in the Grand Hall of the Royal Veterinary College throughout the series; between 200 and 250 members were present and they showed a keen interest in every paper, which was reflected in the expression of some disappointment that the time available for discussion did not permit of the participation of more than a small proportion of would-be contributors.<br /><br />In this issue we publish (below) the first to be read and discussed, that by Dr. W. S. Gordon, M.R.C.V.S., F.R.S.E., "Advances in Veterinary Research." Next week's issue will contain the paper on "Some Recent Advances in Veterinary Medicine and Surgery in Large-Animal Practice" by Mr. T. Norman Gold, M.R.C.V.S. In succeeding numbers of the Record will be reproduced, also with reports of discussions, that by Mr. W. L. Weipers, M.R.C.V.S., D.V.S.M., on the same subject as relating to small-animal practice, and the papers by Mr. J. N. Ritchie, B.SC., M.R.C.V.S., D.V.S.M., and Mr. H.W. Steele-Bodger, M.R.C.V.S., on "War-time Achievements of the British Home Veterinary Services."<br /><br />The first scientific paper of Congress was read by Dr. W. S. Gordon, M.R.C.V.S., F.R.S.E. on Monday, September 23rd, 1946, when Professor J. Basil Buxton, M.A., F.R.C.V.S, D.V.H., Prinicipal of the Royal Veterinary College, presided.<br /><br />Advances in Veterinary Research<br /><br />by<br /><br />W.S. GORDON, PH.D., M.R.C.V.S., F.R.S.E.<br /><br />Agriculteral Research Council, Field Station, Compton, Berks.<br /><br />Louping-ill, Tick-borne Fever and Scrapie<br /><br />In 1930 Pool, Browniee & Wilson recorded that louping-ill was a transmissible disease. Greig et al, (1931) showed that the infective agent was a filter-passing virus with neurotropic characters and Browniee & Wilson (1932) that the essential pathology was that of an encephalomyelitis. Gordon, Browniee, Wilson & MacLeod (1932) and MacLeod & Gordon (1932) confirmed and extended this work. It was shown that on louping-ill farms the virus was present in the blood of many sheep which did not show clinical symptoms indicating involvement of the central nervous system and that for the perpetuation and spread of the disease these subclinical cases were probably of greater importance that the frank clinical cases because, in Nature, the disease was spread by the tick, lxodes ricinus L. More recently Wilson (1945, 1946) has described the cultivation of the virus in a chick embryo medium, the pathogenic properties of this culture virus and the preparation of louping-ill antiserum.<br /><br />Between 1931 and 1934 I carried out experiments which resulted in the development of an effective vaccine for the prevention of louping-ill.* This vaccine has been in general use since 1935 and in his annual report to the Animal Diseases Research Association this year, Dr. Greig stated that about 227,000 doses of vaccine had been issued from Moredun alone.<br /><br />Dr. Gordon illustrated this portion of his paper by means of graphs and diagrams projected by the epidiascope.<br /><br />This investigation, however, did not begin and end with the study of louping-ill; it had, by good fortune, a more romantic turn and less fortunately a final dramtic twist which led almost to catastrope. After it had been established that a solid immunity to louping-ill could be induced in sheep, a group of immunized and a group of susceptible animals were placed together on the tick-infected pasture of a louping-ill farm. Each day all the animals were gathered and their temperatures were recorded. It was anticipated that febrile reactions with some fatalities would develop in the controls while the louping-ill immunes would remain normal. Contrary to expectation, however, every sheep, both immune and control, developed a febrile reaction. This unexpected result made neccessary further investigation which showed that the febrile reaction in the louping-ill immunes was due to a hitherto undescribed infective agent, a Rickettsia-like organism which could be observed in the cytoplasm of the grannular leucocytes, especially the neutrophil polymorphs (MacLeod (1932), Gordon, Browniee, Wilson & MacLeod. MacLeod & Gordon (1933). MacLeod (1936). MacLeod collected ticks over many widely separated parts of Scotland and all were found to harbour the infective agent of tick-borne fever, and it is probable that all sheep on tick-infested farms develop this disease, at least on the first occasion that they become infested with ticks. When the infection is passed in series through susceptible adult sheep it causes a sever, febrile reaction, dullness and loss of bodily condition but it rarely, if ever, proves fatal. It is clear, however, that it aggravates the harmful effects of a louping-ill infection and it is a serious additional complication to such infections as pyaemia and the anacrobic infections which beset lambs on the hill farms of Northern Britain.<br /><br />Studying the epidemiology of louping-ill on hill farms it became obvious that the pyaemic condition of lambs described by M'Fadyean (1894) was very prevalent on tick infested farms Pyaemia is a crippling condition of lambs associated with tick-bite and is often confused with louping-ill. It is caused by infection with Staphylococcus aureus and affected animals may show abscess formation on the skin, in the joints, viscera, meninges and elsewhere in the body. It was thought that tick-borne fever might have ben a predisposing factor in this disease and unsuccessful attempts were made by Taylor, Holman & Gordon (1941) to reproduce the condition by infecting lambs subcutaneously with the staphylococcus and concurrently produceing infections with tickborne fever and louping-ill in the same lambs. Work on pyaemia was then continued by McDiarmid (1946a, 1946b, 1946c), who succeeded in reproducing a pyaemic disease in mice, guinea-pigs and lambs similar to the naturally occuring condition by intravenous inoculation of Staphylococcus aureus. He also found a bacteraemic form of the disease in which no gross pyaemic lesions were observed. The prevention or treatment of this condition presents a formidable problem. It is unlikely that staphylococcal ???oid will provide an effective immunity and even if penicillin proved to be a successful treatment, the difficulty of applying it in adequate and sustained dosage to young lambs on hill farms would be almost insurmountable.<br /><br />From 1931 to 1934 field trials to test the immunizing value and harmlessness of the loup-ill vaccine were carried out on a gradually increasing scale. Many thousands of sheep were vaccinated and similar numbers, living under identical conditions were left as controls. The end result showed that an average mortability of about 9 percent in the controls was reduced to less than 1 percent in the vaccinated animals. While the efficiency of the vaccine was obvious after the second year of work, previous bitter experience had shown the wisdom of withholding a biological product from widespread use until it had been successfully produced in bulk, as opposed to small-scale experimental production and until it had been thoroughly tested for immunizing efficiency and freedom from harmful effects. It was thought that after four years testing this stage had been reached in 1935, and in the spring of that year the vaccine was issued for general use. It comprised a 10 percent saline suspension of brain, spinal cord and spleen tissues taken from sheep five days after infection with louping-ill virus by intracerebral inoculation. To this suspension 0-35 percent of formalin was added to inactivate the virus and its safety for use as a vaccine was checked by intracerbral inoculation of mice and sheep and by the inoculation of culture medium. Its protective power was proved by vaccination sheep and later subjecting them, along with controls, to a test dose of living virus.<br /><br />Vaccine for issue had to be free from detectable, living virus and capable of protecting sheep against a test dose of virus applied subcutaneously. The 1935 vaccine conformed to these standards and was issued for inoculation in March as three separate batches labelled 1, 2, and 3. The tissues of 140 sheep were employed to make batch 1 of which 22,270 doses were used; 114 to make batch 2 of which 18,000 doses were used and 44 to make batch 3 of which 4,360 doses were used. All the sheep tissues incorporated in the vaccine were obtained from yearling sheep. During 1935 and 1936 the vaccine proved highly efficient in the prevention of loup-ill and no user observed an ill-effect in the inoculated animals. In September, 1937, two and a half years after vaccinating the sheep, two owners complained that scrapie, a disease which had not before been observed in the Blackface breed, was appearing in their stock of Blackface sheep and further that it was confined to animals vaccinated with louping-ill vaccine in 1935. At that stage it was difficult to conceive that the occurrence could be associated with the injection of the vaccine but in view of the implications, I visited most of the farms on which sheep had been vaccinated in 1935. It was at this point that the investigation reached its dramatic phase; I shall not forget the profound effect on my emotions when I visited these farms and was warmly welcomed because of the great benefits resulting from the application of louping-ill vaccine, wheras the chief purpose of my visit was to determine if scrapie was appearing in the inoculated sheep. The enquiry made the position clear. Scrapie was developing in the sheep vaccinated in 1935 and it was only in a few instances that the owner was associating the occurrence with louping-ill vaccination. The disease was affecting all breeds and it was confined to the animals vaccinated with batch 2. This was clearly demonstrated on a number of farms on which batch 1 had been used to inoculate the hoggs in 1935 and batch 2 to inoculate the ewes. None of the hoggs, which at this time were three- year-old ewes. At this time it was difficult to forecast whether all of the 18,000 sheep which had received batch 2 vaccine would develop scrapie. It was fortunate, however, that the majority of the sheep vaccinated with batch 2 were ewes and therfore all that were four years old and upwards at the time of vaccination had already been disposed of and there only remained the ewes which had been two to three years old at the time of vaccination, consequently no accurate assessment of the incidence of scrapie could be made. On a few farms, however, where vaccination was confined to hoggs, the incidence ranged from 1 percent, to 35 percent, with an average of about 5 percent. Since batch 2 vaccine had been incriminated as a probable source of scrapie infection, an attempt was made to trace the origin of the 112 sheep whose tissues had been included in the vaccine. It was found that they had been supplied by three owners and that all were of the Blackface or Greyface breed with the exception of eight which were Cheviot lambs born in 1935 from ewes which had been in contact with scrapie infection. Some of these contact ewes developed scrapie in 1936-37 and three surviving fellow lambs to the eight included in the batch 2 vaccine of 1935 developed scrapie, one in September, 1936, one in February, 1937, and one in November, 1937. There was, therefore, strong presumptive evidence that the eight Cheviot lambs included in the vaccine althought apparently healthy were, in fact, in the incubative stage of a scrapie infection and that in their tissues there was an infective agent which had contaminated the batch 2 vaccine, rendering it liable to set up scrapie. If that assumption was correct then the evidence indicated that:-<br /><br />(1) the infective agent of scrapie was present in the brain, spinal cord and or spleen of infected sheep: (2) it could withstand a concentration of formalin of 0-35 percent, which inactivated the virus of louping-ill: (3) it could be transmitted by subcutaneous inoculation; (4) it had an incubative period of two years and longer.<br /><br />Two Frenchmen, Cuille & Chelle (1939) as the result of experiments commenced in 1932, reported the successful infection of sheep by inoculation of emulsions of spinal cord or brain material by the intracerebral, epidural, intraocular and subcutaneous routes The incubation period varied according to the route employed, being one year intracerebrally, 15 months intraocularly and 20 months subcutaneously. They failed to infect rabbits but succeeded in infecting goats. Another important part of their work showed that the infective agent could pass throught a chamberland 1.3 filter, thus demonstrating that the infective agent was a filtrable virus. It was a curious coincidence that while they were doing their transmission experiments their work was being confirmed by the unforeseeable infectivity of a formalinized tissue vaccine.<br /><br />As a result of this experience a large-scale transmision experiment involving the ue of 788 sheep was commenced in 1938 on a farm specially taken for the purpose by the Animal Diseases Research Association with funds provided by the Agricultural Research Council. The experiment was designed to determine the nature of the infective agent and the pathogenesis of the disease. It is only possible here to give a summary of the result which showed that (1) saline suspensions of brain and spinal cord tissue of sheep affected with scrapie were infective to normal sheep when inoculatted intracerebrally or subcutaneously; (2) the incubation period after intracerebral inoculation was seven months and upwards and only 60 percent of the inoculated sheep developed scrapie during a period of four and a half years; (3) the incubation period after subcutaneous inoculation was 15 months and upwards and only about 30 percent of the inoculated sheep developed the disease during the four and a half years: (4) the infective agent was of small size and probably a filtrable virus.<br /><br />The prolonged incubative period of the disease and the remarkable resistance of the causal agent to formalin are features of distinct interest. It still remains to determine if a biological test can be devised to detect infected animals so that they can be killed for food before they develop clinical symptoms and to explore the possibilities of producing an immunity to the disease.<br /><br />==================================================================<br /><br />Greetings List Members,<br /><br />pretty disturbing document. now, what would stop this from happening with the vaccineCJD in children???<br /><br />kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA<br /><br /><br /><br /><a fg_scanned="1" href="http://www.whale.to/v/singeltary.html" style="color: #473624; cursor: pointer;">http://www.whale.to/v/singeltary.html</a><br /><br /><br /><br /><a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000143/!x-usc:http://www.whale.to/v/cjd2.html" style="color: #473624; cursor: pointer;">http://www.whale.to/v/cjd2.html</a><br /><br /><br />Subject: Re: TREATMENT OF BY PRODUCTS OF BOVINE SLAUGHTER </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">From: "Terry S. Singeltary Sr." </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Reply-To: Bovine Spongiform Encephalopathy </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Date: Sun, 8 Oct 2000 17:18:47 -0700 </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Content-Type: text/plain Parts/Attachments: text/plain (121 lines)<br /><br />######### Bovine Spongiform Encephalopathy #########<br /><br />Hello Torsten and Group,<br /><br />Torsten Brinch wrote:<br /><br />What might be more interesting could be the document<br /><br />referenced as 89/7.3/4.1 in Dr. Pickles' witness statement,<br /><br />if you have it. What you posted was apparently the corresponding<br /><br />4.2 and 4.3.<br /><br />the document in question '89/7.3/4.1', i submitted this document to the BSE-L already. plus, if interested the minute was posted at the following url, with other data on sutures etc...<br /><br /><br /><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102185236mp_/http://www.bseinquiry.gov.uk/files/yb/1989/07/03004001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://webarchive.nationalarchives.gov.uk/ukgwa/20080102185236mp_/http://www.bseinquiry.gov.uk/files/yb/1989/07/03004001.pdf</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /><br />all it consists of, is what you posted below. the minute you speak of, where Dr. Pickles minuted Mr. Maslin on 3 july 1989. This is document 89/7.3/4.1. then you have 4.2 and 4.3 which are the by-products list.<br /><br />you are correct, this is what i was reading when i referenced this minute. so in answer to Rolands question the by-products list would have come from MAFF and submitted to HSE, and is referenced at 48.1 statement 115 as Torsten said, and thanks again;<br /><br /><br /><a fg_scanned="1" href="http://www.bse.org.uk/witness/htm/stat115.htm" style="color: #473624; cursor: pointer;">http://www.bse.org.uk/witness/htm/stat115.htm</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /><br />URL LINK CORRECTED 2022 WITH 115 A-I</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><table border="1" style="background-color: white; font-family: Arial, Helvetica, sans-serif; width: 550px;"><tbody><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">115</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Pickles, Dr Hilary</span></td><td style="outline: none;"> </td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120858mp_/http://www.bseinquiry.gov.uk/files/ws/s115.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">115A</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Pickles, Dr Hilary</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Issued 07/06/1999.</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120858mp_/http://www.bseinquiry.gov.uk/files/ws/s115a.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">115B</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Pickles, Dr Hilary</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Proposed revisions to the transcript for Day 47. Issued 29/10/1999.</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120858mp_/http://www.bseinquiry.gov.uk/files/ws/s115b.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">115C</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Pickles, Dr Hilary</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Issued 23/09/1999.</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120858mp_/http://www.bseinquiry.gov.uk/files/ws/s115c.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">115D</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Pickles, Dr Hilary</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Issued 08/10/1999.</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120858mp_/http://www.bseinquiry.gov.uk/files/ws/s115d.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">115E</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Pickles, Dr Hilary</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Issued 12/10/1999.</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120858mp_/http://www.bseinquiry.gov.uk/files/ws/s115e.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">115F</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Pickles, Dr Hilary</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Issued 23/11/1999.</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120858mp_/http://www.bseinquiry.gov.uk/files/ws/s115f.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">115G</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Pickles, Dr Hilary</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Proposed ammenments to the transcript for Day</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120858mp_/http://www.bseinquiry.gov.uk/files/ws/s115g.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">115H</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Pickles, Dr Hilary</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Issued 23/12/1999.</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120858mp_/http://www.bseinquiry.gov.uk/files/ws/s115h.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">115I</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Pickles, Dr Hilary</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Issued 12/01/2000.</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120858mp_/http://www.bseinquiry.gov.uk/files/ws/s115i.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr></tbody></table></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br />what happened was, i got the documents mixed up and posted separately, the minutes a month or two ago, and the by-products list recently. sorry for the confusion, should have kept them together. but if someone could only see the pile of B.S.eee i have gathered, well, on second thought, it probably would not matter, it was just a thought...<br /><br />kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA<br /><br />Terry wrote:<br /><br />thank you Torsten. and i can't for the life of me keep this document<br /><br />in correct order, to resubmit to the group. is there an online version<br /><br />of this document, other than just the reference numbers? if not, if<br /><br />anyone has any suggestions, please write my private email and i will<br /><br />try to scan again, but the letters are to small, unless there is some<br /><br />setting to change. or maybe just fax to tom or someone???<br /><br />Although the text you posted did appear rather bungled,<br /><br />I think anyone with interest in the content will be able<br /><br />to glean it accurately despite all the tabulator and<br /><br />linebreak noise. I don't think you need to do more to<br /><br />get it out.<br /><br />What might be more interesting could be the document<br /><br />referenced as 89/7.3/4.1 in Dr. Pickles' witness statement,<br /><br />if you have it. What you posted was apparently the corresponding<br /><br />4.2 and 4.3.<br /><br />"July 1989<br /><br />48.1 Having seen a list of bovine by-products sent by MAFF to HSE, I<br /><br />asked for more information from MAFF on which UK pharmaceutical<br /><br />manufacturers used spinal cord, thymus and small intestines<br /><br />[YB 89/7.3/4.1-4.3]. I copied this to colleagues responsible for<br /><br />licensed and unlicensed products and devices for human medicinal<br /><br />use, for their information. "<br /><br />From the Draft factual account 17:<br /><br />***<br /><br />On 3 July 1989 Dr Pickles minuted Mr Maslin about cattle<br /><br />by-products and BSE. The minute said: "I was interested to see<br /><br />the list of by-products sent to the HSE. Those of particular concern<br /><br />included:<br /><br />- intestines: sutures ( I thought the source was ovine but you are<br /><br />checking this)<br /><br />- *spinal cord: pharmaceuticals<br /><br />- *thymus: pharmaceuticals<br /><br />Are you able to give me more information on which UK<br /><br />manufacturers use these materials? Our proposed ban<br /><br />on bovine offal for human consumption would not affect<br /><br />these uses, I assume."<br /><br />A handwritten note on Dr Pickles' minute from Mr Mark Hawkins,<br /><br />Higher Executive Officer at MAFF, to "John" said:<br /><br />"A few companies make sutures out of intestinal<br /><br />linings, worth around 3300 k p.a; probably some sheep used as well, but minimal. Virtually all spinal cord goes for rendering, with just a<br /><br />very small amount going for pharmaceutical use.<br /><br />About 30 % of thymus production goes for pharmaceutical<br /><br />use (approx 3132 K p.a). Incidentally, some spleen also<br /><br />goes for pharmaceutical uses (approx 3170 K p.a.<br /><br />The main company involved with pharmaceuticals is Y<br /><br />[company referred to as Y] (MLC is trying to find a contact).<br /><br />Is Hilary serious about her final sentence? I would have thought<br /><br />that a) the staining would make these materials unusable (this<br /><br />is also MLC's view) and b) if they are unfit for consumption,<br /><br />they are certainly unfit for medication. Has she forgotten<br /><br />iatrogenic CJD?"<br /><br />On 4 July 1989 Dr Adams minuted Dr Raine about BSE. He said:<br /><br />"Having seen Mr Armstrong's print-out of the responses from<br /><br />the BSE questionnaire, the Z Catgut product seems to be the<br /><br />only UK source material and we would need a very strong<br /><br />justification to allow it to remain on the market.Until now<br /><br />we had been of the view that many of the other catgut products<br /><br />were UK sourced as well. This is now shown not to be the case<br /><br />and I think Z and we have a problem!"<br /><br />***<br /><br />Best regards,<br /><br />Torsten Brinch<br /><br />############ <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html" style="color: #473624; cursor: pointer;">http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html</a> ############<br /><br /><br />Subject: Re: TREATMENT OF BY PRODUCTS OF BOVINE SLAUGHTER </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">From: Torsten Brinch </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Reply-To: Bovine Spongiform Encephalopathy </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Date: Sun, 8 Oct 2000 21:06:58 +0200 </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Content-Type: text/plain Parts/Attachments: text/plain (79 lines)<br /><br />######### Bovine Spongiform Encephalopathy #########<br /><br />Terry wrote:<br /><br />thank you Torsten. and i can't for the life of me keep this document<br /><br />in correct order, to resubmit to the group. is there an online version<br /><br />of this document, other than just the reference numbers? if not, if<br /><br />anyone has any suggestions, please write my private email and i will<br /><br />try to scan again, but the letters are to small, unless there is some<br /><br />setting to change. or maybe just fax to tom or someone???<br /><br />Although the text you posted did appear rather bungled, I think anyone with interest in the content will be able to glean it accurately despite all the tabulator and linebreak noise. I don't think you need to do more to get it out.<br /><br />What might be more interesting could be the document referenced as 89/7.3/4.1 in Dr. Pickles' witness statement, if you have it. What you posted was apparently the corresponding 4.2 and 4.3.<br /><br />"July 1989<br /><br />48.1 Having seen a list of bovine by-products sent by MAFF to HSE, I<br /><br />asked for more information from MAFF on which UK pharmaceutical<br /><br />manufacturers used spinal cord, thymus and small intestines<br /><br />[YB 89/7.3/4.1-4.3]. I copied this to colleagues responsible for<br /><br />licensed and unlicensed products and devices for human medicinal<br /><br />use, for their information. "<br /><br />From the Draft factual account 17:<br /><br />***<br /><br />On 3 July 1989 Dr Pickles minuted Mr Maslin about cattle by-products and BSE. The minute said: "I was interested to see the list of by-products sent to the HSE. Those of particular concern included:<br /><br />- intestines: sutures ( I thought the source was ovine but you are checking this)<br /><br />- *spinal cord: pharmaceuticals<br /><br />- *thymus: pharmaceuticals<br /><br />Are you able to give me more information on which UK manufacturers use these materials? Our proposed ban on bovine offal for human consumption would not affect these uses, I assume."<br /><br />A handwritten note on Dr Pickles' minute from Mr Mark Hawkins, Higher Executive Officer at MAFF, to "John" said:<br /><br />"A few companies make sutures out of intestinal linings, worth around 3300 k p.a; probably some sheep used as well, but minimal.<br /><br />Virtually all spinal cord goes for rendering, with just a very small amount going for pharmaceutical use. About 30 % of thymus production goes for pharmaceutical use (approx 3132 K p.a). Incidentally, some spleen also goes for pharmaceutical uses (approx 3170 K p.a. The main company involved with pharmaceuticals is Y [company referred to as Y] (MLC is trying to find a contact). Is Hilary serious about her final sentence? I would have thought that a) the staining would make these materials unusable (this is also MLC's view) and b) if they are unfit for consumption, they are certainly unfit for medication. Has she forgotten iatrogenic CJD?"<br /><br />On 4 July 1989 Dr Adams minuted Dr Raine about BSE. He said: "Having seen Mr Armstrong's print-out of the responses from the BSE questionnaire, the Z Catgut product seems to be the only UK source material and we would need a very strong justification to allow it to remain on the market.Until now we had been of the view that many of the other catgut products were UK sourced as well. This is now shown not to be the case and I think Z and we have a problem!"<br /><br />***<br /><br />Best regards,<br /><br />Torsten Brinch<br /><br />############ <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html" style="color: #473624; cursor: pointer;">http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html</a> ############<br /><br /><br />Subject: Re: TREATMENT OF BY PRODUCTS OF BOVINE SLAUGHTER From: tom Reply-To: Bovine Spongiform Encephalopathy Date: Tue, 10 Oct 2000 16:52:53 -0800 Content-Type: text/plain Parts/Attachments: text/plain (164 lines)<br /><br />######### Bovine Spongiform Encephalopathy #########<br /><br />Terry wrote:<br /><br />thank you Torsten unless there is some<br /><br />setting to change. or maybe just fax to tom or someone???<br /><br />Although the text you posted did appear rather bungled,<br /><br />I think anyone with interest in the content will be able<br /><br />to glean it accurately despite all the tabulator and<br /><br />linebreak noise. I don't think you need to do more to<br /><br />get it out.<br /><br />-=-=-=-<br /><br />Agreed, these postings work fine and are a valuable contribution. But note that the Inquiry used systematic URLs for these witness statements, so just plug in the 3-digit number, here 115 to see Pickles' statement and then jump with the browser find to 'Having seen" or use <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://www.google.com/" style="color: #473624; cursor: pointer;">http://www.google.com/</a> to see commentary on it.<br /><br />tom<br /><br /><br /><br /><a fg_scanned="1" href="http://www.bse.org.uk/witness/htm/stat115.htm" style="color: #473624; cursor: pointer;">http://www.bse.org.uk/witness/htm/stat115.htm</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /><br /><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120858mp_/http://www.bseinquiry.gov.uk/files/ws/s115.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120858mp_/http://www.bseinquiry.gov.uk/files/ws/s115.pdf</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /><br />Searched the web using <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://www.google.com/" style="color: #473624; cursor: pointer;">http://www.google.com/</a> for Hilary Pickles spinal cord.<br /><br />Witness Statement 71b - Mr Raymond Bradley<br /><br />... tallow. Mr Cockbill wrote to Hilary Pickles (a medical doctor from DoH ... through abattoirs.<br /><br />However, brain, spinal cord, spleen, lymphoid tissues and ...<br /><br /><br /><br /><a fg_scanned="1" href="http://www.bse.org.uk/witness/htm/stat071b.htm" style="color: #473624; cursor: pointer;">www.bse.org.uk/witness/htm/stat071b.htm</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s071b.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s071b.pdf</a><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><table border="1" style="background-color: white; font-family: Arial, Helvetica, sans-serif; width: 550px;"><tbody><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">71</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Bradley, Dr. Raymond</span></td><td style="outline: none;"> </td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s071.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">71A</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Bradley, Dr. Raymond</span></td><td style="outline: none;"> </td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s071a.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">71B</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Bradley, Dr. Raymond</span></td><td style="outline: none;"> </td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s071b.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">71C</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Bradley, Dr. Raymond</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Proposed amendments to the Transcript for Day</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s071c.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">71D</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Bradley, Dr. Raymond</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Issued 15/07/1999.</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s071d.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">71E</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Bradley, Dr. Raymond</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Issued 01/12/1999.</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s071e.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">71F</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Bradley, Dr. Raymond</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Proposed amendments to the Transcript for Day</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s071f.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">71l</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Bradley, Dr. Raymond</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Letter to Juliet Evans from N C Fussel regarding</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s071l.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">71lx</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Bradley, Dr. Raymond</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Amendments to Transcript of the Statement of</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s071lx.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">71t</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Bradley, Dr. Raymond</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Transcript for Day 42, 06/07/1998.</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s071t.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr></tbody></table></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /><br /><br /><br />WITNESS STATEMENT OF ALAN JOHN LAWRENCE<br /><br />... John Wilesmith and Dr Hilary Pickles available to provide<br /><br />... of the Report) Dr Pickles recognised that the<br /><br />... refers to brain, spinal cord, spleen and intestines<br /><br /><br /><br />... <a fg_scanned="1" href="http://www.bse.org.uk/witness/htm/stat076.htm" style="color: #473624; cursor: pointer;">www.bse.org.uk/witness/htm/stat076.htm</a><br /><br /><br />NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s076a.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s076a.pdf</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><table border="1" style="background-color: white; font-family: Arial, Helvetica, sans-serif; width: 550px;"><tbody><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">76A</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Lawrence, Mr Alan</span></td><td style="outline: none;"> </td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s076a.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">76B</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Lawrence, Mr Alan</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Letter to the Inquiry stating attachment of a note that</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s076b.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">76Bx</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Lawrence, Mr Alan</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Annex to statement no. 76B. Proposed corrections for the</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s076bx.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">76C</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Lawrence, Mr Alan</span></td><td style="outline: none;"> </td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s076c.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">76C</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Lawrence, Mr Alan</span></td><td style="outline: none;"> </td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s076c.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">76D</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Lawrence, Mr Alan</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Proposed corrections to the transcript for Day 43.</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s076d.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">76E</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Lawrence, Mr Alan</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Issued 16/06/1999.</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s076e.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">76F</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Lawrence, Mr Alan</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">21/06/1999.</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s076f.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">76Fx</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Lawrence, Mr Alan</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Annex A to statement no. 76F.</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s076fx.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">76G</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Lawrence, Mr Alan</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Issued 23/06/1999.</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s076g.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">76Gx</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Lawrence, Mr Alan</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Annex to statement no. 76G.</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s076gx.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">76H</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Lawrence, Mr Alan</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Proposed corrections to transcript for Day</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s076h.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr><tr valign="top"><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">76I</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Lawrence, Mr Alan</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;">Issued 15/09/1999.</span></td><td style="outline: none;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: x-small;"><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120908mp_/http://www.bseinquiry.gov.uk/files/ws/s076i.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">click here to download</a></span></td></tr></tbody></table><br /><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Prion disease<br /><br />... brain and eyes in the scull, spinal cord and tonsils of cattle), are collected<br /><br />... worried. A memo from Dr Hilary Pickles at the department of health ...<br /><br /><br /><a fg_scanned="1" href="http://www.mad-cow.org/~tom/mar99_mid_news.html" style="color: #473624; cursor: pointer;">www.mad-cow.org/~tom/mar99_mid_news.html</a><br /><br /><br />NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a fg_scanned="1" href="http://www.mad-cow.org/mar99_mid_news.html#ggg" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://www.mad-cow.org/mar99_mid_news.html#ggg</a><br /><br /><br /><br />48. July 1989<br /><br />48.1 Having seen a list of bovine by-products sent by MAFF to HSE, I asked for more information from MAFF on which UK pharmaceutical manufacturers used spinal cord, thymus and small intestines [YB 89/7.3/4.1-4.3]. I copied this to colleagues responsible for licensed and unlicensed products and devices for human medicinal use, for their information.<br /><br />48.2 I advised CMO that we did not need to enter into the debate on funding the Tyrrell Report's research proposals as almost all of these fell to MAFF to organise although I felt that DH should be involved in any discussions with Dr Tyrrell relating to which of the high priority work should be given highest priority and on the future of the Tyrrell Research Committee [YB 89/7.3/3.1-3.2]. I also set out some pros and cons in relation to the future of the group for CMO to consider. I drafted a reply to Mr Andrews' letter for CMO agreeing to an interdepartmental meeting with Dr Tyrrell and indicating that either Dr Metters or myself would attend.<br /><br />48.3 A consultation letter on the proposed offal ban was prepared by MAFF and I suggested some changes to it before it was sent out by MAFF, having also copied it to others for comment [YB 89/7.5/2.1-2.14]. An early version of the letter had excluded sausage casings from the ban without explanation. Accordingly I asked MAFF for written confirmation that all lymphoid tissue was stripped in the preparation of sausage casings from bovine intestines [YB 89/7.7/4.1]. An assistant to CVO informed Dr Metters on 18.7.89 by telephone that CVL had investigated the lymphoid constituents of bovine intestines and concluded that neither tripe nor sausage casings need be included in the ban. We accepted these assurances at that time [YB 89/7.19/7.1-7.2 & YB 89/8.3/3.1-3.2]. CVO wrote to Dr Metters to confirm MAFF's reasoning in writing at my request [YB 89/7.24/2.1-2.2].<br /><br />48.4 During July, I also received a pre-publication copy of the proposed HSE document on the handling of BSE carcasses and made a contribution on BSE to the forthcoming CMO's annual report [YB 89/7.24/4.1].<br /><br />What might be more interesting could be the document<br /><br />referenced as 89/7.3/4.1 in Dr. Pickles' witness statement,<br /><br />if you have it. What you posted was apparently the corresponding<br /><br />4.2 and 4.3.<br /><br />"July 1989<br /><br />48.1 Having seen a list of bovine by-products sent by MAFF to HSE, I<br /><br />asked for more information from MAFF on which UK pharmaceutical<br /><br />manufacturers used spinal cord, thymus and small intestines<br /><br />[YB 89/7.3/4.1-4.3]. I copied this to colleagues responsible for<br /><br />licensed and unlicensed products and devices for human medicinal<br /><br />use, for their information. "<br /><br />From the Draft factual account 17:<br /><br />***<br /><br />On 3 July 1989 Dr Pickles minuted Mr Maslin about cattle<br /><br />by-products and BSE. The minute said: "I was interested to see<br /><br />the list of by-products sent to the HSE. Those of particular concern<br /><br />included:<br /><br />- intestines: sutures ( I thought the source was ovine but you are<br /><br />checking this)<br /><br />- *spinal cord: pharmaceuticals<br /><br />- *thymus: pharmaceuticals<br /><br />Are you able to give me more information on which UK<br /><br />manufacturers use these materials? Our proposed ban<br /><br />on bovine offal for human consumption would not affect<br /><br />these uses, I assume."<br /><br />A handwritten note on Dr Pickles' minute from Mr Mark Hawkins,<br /><br />Higher Executive Officer at MAFF, to "John" said:<br /><br />"A few companies make sutures out of intestinal<br /><br />linings, worth around 3300 k p.a; probably some sheep<br /><br />used as well, but minimal.<br /><br />Virtually all spinal cord goes for rendering, with just a<br /><br />very small amount going for pharmaceutical use.<br /><br />About 30 % of thymus production goes for pharmaceutical<br /><br />use (approx 3132 K p.a). Incidentally, some spleen also<br /><br />goes for pharmaceutical uses (approx 3170 K p.a.<br /><br />The main company involved with pharmaceuticals is Y<br /><br />[company referred to as Y] (MLC is trying to find a contact).<br /><br />Is Hilary serious about her final sentence? I would have thought<br /><br />that a) the staining would make these materials unusable (this<br /><br />is also MLC's view) and b) if they are unfit for consumption,<br /><br />they are certainly unfit for medication. Has she forgotten<br /><br />iatrogenic CJD?"<br /><br />On 4 July 1989 Dr Adams minuted Dr Raine about BSE. He said:<br /><br />"Having seen Mr Armstrong's print-out of the responses from<br /><br />the BSE questionnaire, the Z Catgut product seems to be the<br /><br />only UK source material and we would need a very strong<br /><br />justification to allow it to remain on the market.Until now<br /><br />we had been of the view that many of the other catgut products<br /><br />were UK sourced as well. This is now shown not to be the case<br /><br />and I think Z and we have a problem!"<br /><br />***<br /><br />Best regards,<br /><br />Torsten Brinch<br /><br />############ <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html" style="color: #473624; cursor: pointer;">http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html</a><br /><br />############<br /><br />############ <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html" style="color: #473624; cursor: pointer;">http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html</a><br /><br />############<br /><br />Subject: Some factual accounts about Mrs. Richardson's early observation of BSE From: Marc Barbier Reply-To: Bovine Spongiform Encephalopathy Date: Fri, 27 Oct 2000 15:11:32 +0200 Content-Type: text/enriched Parts/Attachments: text/enriched (371 lines)<br /><br />######### Bovine Spongiform Encephalopathy #########<br /><br />A message just to bring some more information about the way Mrs. Richardson's testimony is 'more or less contested' in the UK Enquiry report.<br /><br />See here under the extract 1. of the document "Early days", a draft factual account of the actions of MAFF and DH in relation to events up to the decision to establish the Southwood Working Party. This DFAL is one of the big amount of documents that the Enquiry is supposed to have used to deliver an opinion on the way the BSE was assessed and managed.<br /><br />It appears in this document that a controversy exist about what Mrs.Richardson may have said or not, and almost about what has been heard or not from her (see extract 3) . As far as the CVL DFA is concerned it seems that it exist some oppositions within the CVL organisation. see (Extract 2).<br /><br />It seems to me that the institutional deafness is not only a matter of policy-making in the present but also in the way factual accounts of the past are used in this kind of report of enquiry. Too many people seem to have forgotten what they might have said or not done.<br /><br />MARC BARBIER<br /><br />---------------extract 1. of the DFAL "Early days"----------------<br /><br />THE EARLY DAYS<br /><br />This is a Draft Factual Account of the actions of MAFF and DH in relation to events up to the decision to establish the Southwood Working Party. SCDFA refers to the Slaughter and Compensation Draft Factual Account (DFA 6), CVLDFA refers to the CVL Draft Factual Account (DFA 4) and the RFBDFA refers to the Ruminant Feed Ban Part 1 Draft Factual Account (DFA 7), all of which should be read in conjunction with this document.<br /><br />1. On 22 December 1984, Mr David Bee, a veterinarian, was called to examine Cow 133, belonging to farmer Mr Peter Stent of Pitsham Farm in Sussex. She had an arched back and had lost weight. Mr Bee returned to the farm on numerous occasions to see more cattle with unusual symptoms.<br /><br />2. On 11 February 1985, Cow 133 died, having developed head tremor and lack of co-ordination. By the end of April 1985, five more cows had died on the farm.<br /><br />3. During Spring 1985 Mr Bee contacted Mr Watkin-Jones of the local Veterinary Investigation Centre (VIC) at Winchester, Hampshire, regarding the problems at Pitsham farm. The animals were showing aggression and were difficult to milk. Mr Bee said that they had a peculiar gait and arched backs.<br /><br />4. In April 1985, veterinarian Mr Colin Whitaker was called to Plurenden Manor Farm, Kent, to examine some of Mr R Sternberg's cows showing symptoms including changes of behaviour, aggression and lack of co-ordination.<br /><br />5. On 2 September 1985 a cow with these symptoms was sent from Pitsham Farm to Winchester VIC for slaughter. The VIC sent the brain and other specimens to the Central Veterinary Laboratory (CVL) at Weybridge, Surrey. This was the fourth Stent cow to be referred to the CVL, however the previous three referrals had not included brain samples.<br /><br />6. The samples, received on 10 September 1985, were first examined by Ms Carol Richardson, who was the pathologist on duty. This, the subsequent examinations of these samples, and the conflict of evidence about the conclusions reached, are dealt with in the CVL DFA.<br /><br />7. When Mr Watkin-Jones forwarded Mrs Richardson's report to Mr David Bee, Mr Stent's vet, he wrote:<br /><br />"I enclose a histological report carried out by my colleague Carol Richardson. I have discussed her findings with her at some length and she comments that the pathological changes found would be consistent with bacterial toxin."<br /><br />8 Ms Richardson did not remember having a conversation about the case with Mr Watkin-Jones.<br /><br />9 Mr Bee did not accept this diagnosis. He believed there had been a fungal toxin in the cattle feed. He told the BSE Inquiry that on 4 October 1985, 'a fungal toxin called citrinin had been found in the feed. In any case, by this time, new cases had ceased to develop. I imagined that the problem had run its course'.<br /><br />10 On 28 June 1986 Mr Jeffrey examined tissue sections taken from the brain of a nyala which had been kept at Marwell Zoo. This examination, and subsequent consideration of the nyala, are described in the CVL DFA.<br /><br />11. Since his first callout in April 1985, Mr Whitaker had seen several more strange cases at Plurenden Manor Farm. Cattle had been exhibiting symptoms which included changes in character and in behaviour. The cattle became more nervous and aggressive. They also experienced a gradual deterioration of voluntary physical control, including lack of co-ordination and ataxia (inability to move). Mr Whitaker sought assistance from the local VIC at Wye. On referrals from Wye VIC by Mr Carl Johnson, three brain samples from the herd of Mr R. Sternberg of Plurenden Manor Farm were received at CVL (two on 27 November 1986 and one on 23 December 1986).<br /><br />12. BSE was first recognised as a new disease by pathologists at the CVL in December 1986, and by 19 December 1986 CVL had identified possible repercussions for the export trade and for humans.<br /><br />13. In the period after its (BSE) recognition in December 1986 and prior to BSE being made a notifiable disease on 21 June 1988 the VI Service collaborated closely with the CVL in identifying suspect BSE cases on farm, characterising the clinical signs of the disease, collecting brains from suspect BSE cases and passing these to CVL for detailed histopathological examination, and undertaking visits to farms with suspect cases of disease to collect information in support of the studies being undertaken by epidemiologists at the CVL. The VIS had primary responsibility for surveillance in the early days of the disease, and until it became a notifiable disease, the involvement of the field staff (VFS) was limited.<br /><br />14. A few days after it was first identified in December 1986 Dr Watson telephoned Mr Howard Rees, MAFF's Chief Veterinary Officer (CVO), to inform him of the new disease. Watson reported that a case of spongiform encephalopathy had been diagnosed in a Fresian/Holstein cow on a farm in Kent. Mr Rees met with Dr Watson in early December to discuss the incidence and implications of BSE. At that time there was just one isolated case, and no way of testing live cattle to see if any others on the farm were infected. The belief was that BSE had a long incubation period, and therefore they had no idea how many cases would develop. No conclusions could therefore be drawn as to the possible course of future events.<br /><br />------- Extract 2. of the CVL Draft Factual Account---------<br /><br />Pathology Department<br /><br />11. Mr Ray Bradley was Head of Pathology at the CVL from 1 August 1983 to October 1991. In addition, from June 1987 Mr Bradley was the CVL's BSE R&D Co-ordinator.<br /><br />12. Mr Bradley set up a rota system in the Pathology Department in 1984, about which Ms Carol Richardson, a pathologist in the department, wrote in her statement to the BSE Inquiry:<br /><br />left"In the Pathology Department, the policy of species specialisation initiated in 1945 was reversed in 1984 so that pathologists were expected to know everything about everything. All seven pathologists began to look for other work. By 1986 two had transferred within the Ministry and two had left for other employment; there were no replacement staff recruited and the remaining pathologists were left to cover the same workload and to take on cases in which they had limited experience. This lead to an overall lowering of expertise and fragmentation within the Department with very little intercommunication".<br /><br />13. In his statement to the BSE Inquiry Mr Bradley explained the structure of the Pathology Department before and after his appointment as head of Pathology, which included the introduction of the 'rota system':<br /><br />left"Historically the Department had been organised into two separate units, one dealing with research and the other dealing with service work for the Veterinary Investigation Service. Each of these units was then sub-divided into two sections along species lines, one dealing with pigs and the other dealing with ruminants. The system was relatively inflexible and for example, those employed in the service section often had little or no opportunity to become involved in research (and it was the opportunity to become involved in research which attracted many people to work at CVL). The system also meant that people specialised in a species although it had become generally recognised by 1983 that there was little to be gained in specialising in a species beyond the clinical level. This was because science had advanced to the point where it made more sense to specialise in organ systems because a specialist neuropathologist could acquire in-depth knowledge and use the same specialised techniques for the examination of pig brains and ruminant brains, but a pig or ruminant specialist could not develop the in-depth knowledge of all the organ systems with which he would be confronted.<br /><br />When I was appointed Head of the Department, some thought was given as to how the efficiency of the Department, and in particular the Department's surveillance role for new diseases and consultation service for the VIS, could be improved. The intention was to ensure that new diseases were recognised as quickly as possible and improve the consistency and speed of reporting of pathological examinations carried out for the VIS. Consultation and discussion took place with members of the Department to see how these objectives could best be met and plans were then drawn up and the reorganisation effected.<br /><br />The new concept following the reorganisation was to develop specialisation in organ systems, as is the norm for human medicine and this was along the lines on which the veterinary learned societies were organised. Various sub-units specialising in particular organ systems were set up along with a consultant pathology unit (CPU) which operated the consulting service for the VIS. The CPU was staffed on a rota system and all members of the Department took turns working in the CPU. The idea was that cases which came into the CPU would be referred to people specialising in that particular area, but where that was not possible for any reason the person on duty in the CPU would deal with the case. The fact that everyone was involved in the CPU was intended to improve communication in the Department, to ensure cases were referred to those best qualified to deal with them and provide a back up to deal with cases which could not be referred for whatever reason to allow a rapid response to the VIS. In my experience, the new system was more flexible and allowed CVL to provide a better service to the VIS."<br /><br />14. The Consultative Pathology Unit (CPU) was staffed by six pathologists drawn from various sections of the Pathology Department on rota. Ms Richardson expressed her concerns about the rota system to the BSE Inquiry - she preferred a system that focused on particular species of animals rather than focussing on organ systems across species. She stated that "By working with species, you do get a feeling for that particular species, and exactly the problems that can be encountered in that species." Ms Richardson also said that the introduction of the CPU meant that the time she had to devote to research was reduced from 50% of her time to 10%. By way of contrast Mr Gerald Wells, who was appointed head of the CPU in November 1984, thought that the introduction of the CPU was an improvement as it provided a means of experiencing new or unusual problems and gave individual members of staff access to a greater diversity of material.<br /><br />----------- Extract 3 of the CVL DFA about The controversy about the examination of BSE------<br /><br />Examination of a case of BSE<br /><br />20. On 10 September 1985 specimens from a cow owned by Mr Stent of Pitsham Farm were referred to the Central Veterinary Laboratory (CVL) by Mr Watkin-Jones at the Winchester VIC for histopathological examination. This was the fourth Stent cow to be referred to the CVL. Referrals from the VICs were dealt with on a rota system by the CPU.<br /><br />21. Ms Richardson examined the sections on 13 September 1985. The history of the Stent cases was that seven out of a herd of 130 cows had been showing nervous symptoms over the previous five months; most had gone for casualty slaughter and no gross abnormality had been seen in the viscera. The Pathology Department had examined pieces of liver, kidney, heart and lung from three previous cases (2 adults and 1 calf) from this farm. Among the samples from the three cattle they had found chronic mild hepatitis, acute hepatic necrosis, moderate pulmonary oedema and chronic mild interstitial nephritis. Ms Richardson described her examination of the sections in the following terms:<br /><br />left"I examined the frontal cerebrum first and progressed caudally scanning each section from dorsal to ventral surface. In this case there seemed to be a mild vacuolation of the cerebral neuropil. At this time Gerald Wells had been investigating the possibility that prolonged exposure of nervous tissue to 70% alcohol could produce neuropil vacuolation. Such prolonged exposure would occur over the week-end but I checked with the technician to ensure that such exposure had not occurred in this case before resuming my examination. I noted finding a mild multifocal non-suppurative peri-vascular infiltration with some eosinophils and in the caudal cerebrum mild focal gliosis. No abnormality was found in the thalamus (cranial midbrain) but mild neuropil vacuolation of the reticular formation in the colliculi. The medulla (a pathognomic site for scrapie in sheep) showed moderate neuronal and neuropil vacuolation. I found no abnormality in the cerebellum but the section of lumbar spinal cord showed mild neuropil vacuolation of the dorsal horns. There were two types of lesion in the section of kidney; a chronic mild /moderate non-suppurative interstitial reaction with tubular regeneration and fibrosis; a peracute reaction of a mild multifocal tubular necrosis with hydropic change (protein reabsorption). … Although I had never seen this type of lesion before in a cow I had frequently seen the combination of neuronal and neuropil vacuolation with this distribution in scrapie. To me, this was scrapie in a cow."<br /><br />Conflict of Evidence<br /><br />22. Ms Richardson said that she sought Dr Martin Jeffrey's opinion before writing the report. She explained how she left the slides and a request for a re-examination on Dr Jeffrey's unattended work-bench and when she returned she found a note that said 'bovine scrapie'. On her way out of Dr Jeffrey's room Ms Richardson said that she met Dr Jeffrey who said to her that Gerald Wells had examined two cases and was expecting another two. Dr Jeffrey does not remember this discussion.<br /><br />23. The report was sent to Mr Watkin-Jones on 19 September 1985. Ms Richardson's diagnosis was 'Moderate spongiform encephalopathy - acute' and 'Mild renal nephrosis - peracute'. In the section of the pathology report for remarks she wrote: 'These acute changes suggest a toxicity of some description. The non-suppurative reactions are far more chronic, mild and non specific.' Ms Richardson asked a technician to cross-reference the case with the two cases that Mr Wells had seen. She recalled the technician telling her that Mr Wells had not reported any cases. Ms Richardson said she heard nothing further about the case. When Mr Watkin-Jones forwarded the report to Mr David Bee, Mr Stent's vet, he wrote:<br /><br />left"I enclose a histological report carried out by my colleague Carol Richardson. I have discussed her findings with her at some length and she comments that the pathological changes found would be consistent with bacterial toxin. "<br /><br />24. Ms Richardson did not remember having a conversation about the case with Mr Watkin-Jones.<br /><br />25. Mr Wells re-examined the case at Ms Richardson's request. His re-examination of the sections was generally consistent with Ms Richardson's original diagnosis in that he agreed with her overall observations and that the observations on the sections were not artefactual i.e. caused as a result of post-mortem changes or in the preparation of sections. Mr Wells concluded that this was not a case of a specific disease but could possibly be the result of chronic bacteraemia or endotoxaemia. Ms Richardson said in her evidence to the BSE Inquiry that she would not have agreed with this assessment: bacteraemia would be 'either the production of bacterial toxins within the bacteria that we call endotoxins or actual production of toxins, exotoxins' and the clinical signs were not similar.<br /><br />26. Mr Wells reviewed the cases from Stent Farm following a telephone conversation with Mr Watkin-Jones on 26 September 1985. None of the samples for the three earlier cases included brain tissue and the main post-mortem finding in these cases was internal bleeding. Mr Wells said in his statement to the BSE Inquiry that in the light of the history of the Stent herd, which indicated the occurrence of complex metabolic problems, the September case did not suggest that a new disease had been identified, though with hindsight, this was the case. He believed that the fact that seven out of 130 cows were nervous, did not equate necessarily to the occurrence of a specific neurological disorder.<br /><br />27. In his statement to the BSE Inquiry Mr Wells noted:<br /><br />left"Had Carol Richardson felt strongly that the observations she originally made were those of scrapie in cattle, I would have expected that she should have come back to me to discuss the matter subsequently or take the matter further herself."<br /><br />############ <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html" style="color: #473624; cursor: pointer;">http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html</a> ############<br /><br /><br />Subject: Re: exports of MBM from the UK From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy Date: Fri, 10 Nov 2000 14:31:39 -0800 Content-Type: text/plain Parts/Attachments: text/plain (85 lines)<br /><br />######### Bovine Spongiform Encephalopathy #########<br /><br />Hello Karin,<br /><br />here is some that the United States imported, 'GREAVES'. but, there may be a source reference, that may be of some help to you, (maybe not), but thought i would pass it on in case it was. ===============<br /><br />Meat and bonemeal is not specifically classified for overseas trade purposes. The nearest equivalent is listed as "flours and meals of meat or offals (including tankage), unfit for human consumption; greaves". UK exports of this to the US are listed below:<br /><br />Country Tonnes<br /><br />1980<br /><br />1981 12<br /><br />1982<br /><br />1983<br /><br />1984 10<br /><br />1985 2<br /><br />1986<br /><br />1987<br /><br />1988<br /><br />1989 20<br /><br />1990<br /><br />Data for exports between 1975 and 1979 are not readily available. These can be obtained (at a charge) from data retailers appointed by HM Customs and Excise: BTSL (Tel: 01372 463121) or Abacus (01245 252222).<br /><br />Overseas trade statistics Stats (C&F)C<br /><br />kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA<br /><br /><br /><br /><a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:Karin.Irgens@DYREHELSETILSYNET.NO" style="color: #473624; cursor: pointer;">mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:Karin.Irgens@DYREHELSETILSYNET.NO</a> wrote:<br /><br />######### Bovine Spongiform Encephalopathy #########<br /><br />Hello list members!<br /><br />I have only just started to read the first volume of the BSE Inquiry report.<br /><br />It was already known from Draft Factual Account nr. 25 that the feed ban had<br /><br />been notified very late (1990) by Mr. Meldrum to non-EU- member-countries,<br /><br />and I thought this was going to be an important point of criticism of the<br /><br />Inquiry. I even thought, very naively, that 'risky exports' might be the<br /><br />subject of one of the 16 volumes.<br /><br />I was obviously wrong. If you are interested in this aspect of the Inquiry,<br /><br />you should read chapter 3, the ruminant feed ban, _exports_ , especially<br /><br />(paragraphs 217 and 218).<br /><br /><br /><a fg_scanned="1" href="http://www.bseinquiry.gov.uk/report/volume1/chapte35.htm#643752" style="color: #473624; cursor: pointer;">http://www.bseinquiry.gov.uk/report/volume1/chapte35.htm#643752</a><br /><br /><br />NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a fg_scanned="1" href="http://web.archive.org/web/20090505195251/http://www.bseinquiry.gov.uk/report/volume1/chapte35.htm" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090505195251/http://www.bseinquiry.gov.uk/report/volume1/chapte35.htm</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /><br />.... (218) : "In February 1990 Mr Gummer, by now the Minister of<br /><br />Agriculture, Fisheries and Food, insisted that Mr Meldrum take the further<br /><br />step of writing a letter of warning to Chief Veterinary Officers of all<br /><br />countries which imported MBM from the UK. There is scope for arguing that Mr<br /><br />Meldrum should have done this earlier. We think the argument is academic.<br /><br />The only country outside the EU where it is suspected that cattle were<br /><br />infected with BSE as a result of importing MBM is Switzerland, and it seems<br /><br />that the MBM in question reached Switzerland via Belgium. If this occurred<br /><br />after the ruminant feed ban, both Belgium and Switzerland were aware that<br /><br />ruminant protein was suspected to be the cause of BSE. Accordingly we have<br /><br />seen no need to pursue this issue further.<br /><br />Those interested might also have a look at _figure 7.1_ on exports of MBM<br /><br />from the UK:<br /><br /><br /><br /><a fg_scanned="1" href="http://www.bseinquiry.gov.uk/report/volume10/chaptef2.htm#260106" style="color: #473624; cursor: pointer;">http://www.bseinquiry.gov.uk/report/volume10/chaptef2.htm#260106</a><br /><br /><br /><br />NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a fg_scanned="1" href="http://web.archive.org/web/20090505201716/http://www.bseinquiry.gov.uk/report/volume10/chaptef2.htm" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090505201716/http://www.bseinquiry.gov.uk/report/volume10/chaptef2.htm</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /><br />I am very worried that several third countries may have imported BSE, and do<br /><br />not have the financial capacity to start BSE surveillance programmes or<br /><br />slaughter policies or even nvCJD surveillance.<br /><br />Best regards<br /><br />Karin Irgens<br /><br /><br /><br />############ <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html" style="color: #473624; cursor: pointer;">http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html</a><br /><br />############<br /><br />############ <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html" style="color: #473624; cursor: pointer;">http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html</a> ############<br /><br /><br /><br />Subject: exports of MBM from the UK </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">From: <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:Karin.Irgens@DYREHELSETILSYNET.NO" style="color: #473624; cursor: pointer;">mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:Karin.Irgens@DYREHELSETILSYNET.NO</a> </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Reply-To: Bovine Spongiform Encephalopathy </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Date: Fri, 10 Nov 2000 20:56:36 +0100 </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Content-Type: text/plain Parts/Attachments: text/plain (43 lines)<br /><br />######### Bovine Spongiform Encephalopathy #########<br /><br />Hello list members!<br /><br />I have only just started to read the first volume of the BSE Inquiry report.<br /><br />It was already known from Draft Factual Account nr. 25 that the feed ban had been notified very late (1990) by Mr. Meldrum to non-EU- member-countries, and I thought this was going to be an important point of criticism of the Inquiry. I even thought, very naively, that 'risky exports' might be the subject of one of the 16 volumes.<br /><br />I was obviously wrong. If you are interested in this aspect of the Inquiry, you should read chapter 3, the ruminant feed ban, _exports_ , especially (paragraphs 217 and 218).<br /><br /><br /><br /><a fg_scanned="1" href="http://www.bseinquiry.gov.uk/report/volume1/chapte35.htm#643752" style="color: #473624; cursor: pointer;">http://www.bseinquiry.gov.uk/report/volume1/chapte35.htm#643752</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a fg_scanned="1" href="http://web.archive.org/web/20090505195251/http://www.bseinquiry.gov.uk/report/volume1/chapte35.htm" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090505195251/http://www.bseinquiry.gov.uk/report/volume1/chapte35.htm</a><br /><br /><br /><br />.... (218) : "In February 1990 Mr Gummer, by now the Minister of Agriculture, Fisheries and Food, insisted that Mr Meldrum take the further step of writing a letter of warning to Chief Veterinary Officers of all countries which imported MBM from the UK. There is scope for arguing that Mr Meldrum should have done this earlier. We think the argument is academic. The only country outside the EU where it is suspected that cattle were infected with BSE as a result of importing MBM is Switzerland, and it seems that the MBM in question reached Switzerland via Belgium. If this occurred after the ruminant feed ban, both Belgium and Switzerland were aware that ruminant protein was suspected to be the cause of BSE. Accordingly we have seen no need to pursue this issue further.<br /><br />Those interested might also have a look at _figure 7.1_ on exports of MBM from the UK:<br /><br /><br /><a fg_scanned="1" href="http://www.bseinquiry.gov.uk/report/volume10/chaptef2.htm#260106" style="color: #473624; cursor: pointer;">http://www.bseinquiry.gov.uk/report/volume10/chaptef2.htm#260106</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a fg_scanned="1" href="http://web.archive.org/web/20090505201716/http://www.bseinquiry.gov.uk/report/volume10/chaptef2.htm" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090505201716/http://www.bseinquiry.gov.uk/report/volume10/chaptef2.htm</a><br /><br /><br />I am very worried that several third countries may have imported BSE, and do not have the financial capacity to start BSE surveillance programmes or slaughter policies or even nvCJD surveillance.<br /><br />Best regards Karin Irgens<br /><br />############ <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html" style="color: #473624; cursor: pointer;">http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html</a><br /><br />############<br /><br /><br />Subject: SV: SV: Changes to UK Rendering System? </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">From: <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:Karin.Irgens@DYREHELSETILSYNET.NO" style="color: #473624; cursor: pointer;">mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:Karin.Irgens@DYREHELSETILSYNET.NO</a> </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Reply-To: Bovine Spongiform Encephalopathy </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Date: Fri, 1 Dec 2000 22:11:59 +0100 </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Content-Type: text/plain Parts/Attachments: text/plain (58 lines)<br /><br />######### Bovine Spongiform Encephalopathy #########<br /><br />Hello John Although MRM was probably one of the most important sources of contamination of human foods until it was banned in 1995 in the UK, the MRM problem has nothing to do with rendering and MBM for animal feed.<br /><br />Besides, I doubt that it would be very practical to _extract_ brain and spinal cord after "crushing and shattering" of heads and spines !<br /><br />According to the BSE Inquiry's final report, MRM was produced by :<br /><br />..." high pressure being applied to bones to separate them from anything that was still adhering. The resultant slurry was used in a range of meat products for human consumption, including lower grade sausages, burgers an pies. The major source of MRM was the spinal column"...<br /><br />The BSE Inquiry certainly drew attention to this process. I think they even wrote a "draft factual account" on MRM last year.<br /><br />Best regards, Karin<br /><br />-----Opprinnelig melding-----<br /><br />Fra: john hazelwood [SMTP:j_hazelwood@YAHOO.COM]<br /><br />Sendt: 1. desember 2000 18:17<br /><br />Til: <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:BSE-L@UNI-KARLSRUHE.DE" style="color: #473624; cursor: pointer;">mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:BSE-L@UNI-KARLSRUHE.DE</a><br /><br />Emne: Re: SV: Changes to UK Rendering System?<br /><br />TRUE But The UK invented MRM in the mid-nineteen<br /><br />seventies, that is the industrial processing of whole<br /><br />heads of cows and sheep plus skeletal waste on a huge<br /><br />scale. The process was made viable by the collection<br /><br />of hundreds of heads etc. That were then crushed,<br /><br />shattered and centrifuged to extract the brains,<br /><br />tongues, eyes, and spinal chord from the bone matrix.<br /><br />A material was made from this slurry that could be<br /><br />added to pies, sausages, burgers and baby filler as<br /><br />cheap filler. The balance was used as a protein<br /><br />supplement in animal feed.<br /><br />Could you have a better way of spreading infectivity<br /><br />? Did the BSE Inquiry describe or draw attention to<br /><br />this process? I understand there was a HMSO<br /><br />publication on MRM in 1980 but as yet I have not been<br /><br />able to obtain a copy.<br /><br />Best regards john<br /><br />__________________________________________________<br /><br /><br />############ <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html" style="color: #473624; cursor: pointer;">http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html</a><br /><br />############<br /><br />############ <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html" style="color: #473624; cursor: pointer;">http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html</a> ############<br /><br />Subject: Re: SV: SV: Changes to UK Rendering System? From: john hazelwood Reply-To: Bovine Spongiform Encephalopathy Date: Tue, 5 Dec 2000 08:43:56 -0800 Content-Type: text/plain Parts/Attachments: text/plain (152 lines)<br /><br />######### Bovine Spongiform Encephalopathy #########<br /><br />Hello Karin<br /><br />Although MRM was probably one of the most important sources of contamination of human foods until it was banned in 1995 in the UK, the MRM problem has nothing to do with rendering and MBM for animal feed.<<<< Besides, I doubt that it would be very practical to _extract_ brain and spinal cord after "crushing and shattering" of heads and spines !<<< According to the BSE Inquiry's final report, MRM was produced by : ..." high pressure being applied to bones to separate them from anything that was still adhering. The resultant slurry was used in a range of meat products for human consumption, including lower grade sausages, burgers and pies.<<< The major source of MRM was the spinal column"...<<< The BSE Inquiry certainly drew attention to this process. I think they even wrote a "draft factual account" on MRM last year.<br /><br /><br /><<< ######### Bovine Spongiform Encephalopathy ######### </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Hello John </mailto:sillaste>Although MRM was probably one of the most important sources of contamination of human foods until it was banned in 1995 in the UK, the MRM problem has nothing to do with rendering and MBM for animal feed. Besides, I doubt that it would be very practical to _extract_ brain and spinal cord after "crushing and shattering" of heads and spines ! According to the BSE Inquiry's final report, MRM was produced by : ..." high pressure being applied to bones to separate them from anything that was still adhering. The resultant slurry was used in a range of meat products for human consumption, including lower grade sausages, burgers an pies. The major source of MRM was the spinal column"... The BSE Inquiry certainly drew attention to this process. I think they even wrote a "draft factual account" on MRM last year. Best regards, Karin -----Opprinnelig melding----- Fra: john hazelwood [SMTP:j_hazelwood@YAHOO.COM] Sendt: 1. desember 2000 18:17 Til: <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:BSE-L@UNI-KARLSRUHE.DE" style="color: #473624; cursor: pointer;">mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:BSE-L@UNI-KARLSRUHE.DE</a></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br />Emne: Re: SV: Changes to UK Rendering System?<br /><br />TRUE But The UK invented MRM in the mid-nineteen<br /><br />seventies, that is the industrial processing of<br /><br />whole<br /><br />heads of cows and sheep plus skeletal waste on a<br /><br />huge<br /><br />scale. The process was made viable by the<br /><br />collection<br /><br />of hundreds of heads etc. That were then crushed,<br /><br />shattered and centrifuged to extract the brains,<br /><br />tongues, eyes, and spinal chord from the bone<br /><br />matrix.<br /><br />A material was made from this slurry that could be<br /><br />added to pies, sausages, burgers and baby filler<br /><br />as<br /><br />cheap filler. The balance was used as a protein<br /><br />supplement in animal feed.<br /><br />Could you have a better way of spreading<br /><br />infectivity<br /><br />? Did the BSE Inquiry describe or draw attention<br /><br />to<br /><br />this process? I understand there was a HMSO<br /><br />publication on MRM in 1980 but as yet I have not<br /><br />been<br /><br />able to obtain a copy.<br /><br />Best regards john<br /><br />__________________________________________________<br /><br />############<br /><br /><a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html" style="color: #473624; cursor: pointer;">http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html</a><br /><br />############<br /><br />############<br /><br /><a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html" style="color: #473624; cursor: pointer;">http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html</a><br /><br />############<br /><br />############ <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html" style="color: #473624; cursor: pointer;">http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html</a><br /><br />############<br /><br />Subject: Re: SV: SV: Changes to UK Rendering System? </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">From: "Terry S. Singeltary Sr." </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Reply-To: Bovine Spongiform Encephalopathy </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Date: Tue, 5 Dec 2000 11:25:56 -0800 </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Content-Type: text/plain Parts/Attachments: text/plain (191 lines)<br /><br />######### Bovine Spongiform Encephalopathy #########<br /><br />Greetings John, Karin, and other list Members,<br /><br />3. The issue of the use of heads for MRM processing has been raised on several occasions during the Inquiry hearings. Mr Soul told the Inquiry that “heads are not really suitable for the production of MRM...because the enamel of the teeth was such as to damage the machine.”[3] Mr Hibbett agreed with the Chairman that heads would go off for MRM production after removal of the brain; he had not come across the suggestion that “the machine could not cope with the teeth”.[4] Mr Oberst (MLC) thought that “if they went in at all it was in a very small number of cases.”[5] Mr Clark (then a Deputy Senior Meat Hygiene Inspector for South Holland DC) told the Inquiry that "I believe that heads are not used in the production of MRM...As far as I am aware heads would damage the machinery...and they would not be used.”[6]<br /><br />4. Mr Maslin replied to Ms Jones on 12 December 1989 (copying to recipients of her minute), having discussed the matters raised with Mr K Taylor. He explained that: ‘On the splitting of heads, or spinal columns, we agree with your reaction. Some contamination is bound to occur but we have already gone further than Southwood suggested in tackling an already remote risk from offals. Through the prohibition we have taken all practical steps and an amendment to the Regulations is neither necessary nor practical.’[7]<br /><br />MRMs<br /><br /><br /><a fg_scanned="1" href="http://www.bse.org.uk/dfa/dfa14.htm" style="color: #473624; cursor: pointer;">http://www.bse.org.uk/dfa/dfa14.htm</a><br /><br /><br />DFA 14</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br /></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="font-family: arial; font-size: 13.3333px;"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Consideration of the Risk from Mechanically Recovered Meat (MRM) in 1989-1990</span></span><br /></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="font-family: arial; font-size: 13.3333px;"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="font-family: arial; font-size: 13.3333px;"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">NEW URL LINK 2022</span></span></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="font-family: arial; font-size: 13.3333px;"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="font-family: arial; font-size: 13.3333px;"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><a fg_scanned="1" href="http://web.archive.org/web/20001219041200/http://www.bse.org.uk/dfa/dfa14.htm" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20001219041200/http://www.bse.org.uk/dfa/dfa14.htm</a></span></span></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="font-family: arial; font-size: 13.3333px;"><mailto:sillaste cybercable.fr="" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><br />kind regards,<br /><br />Terry S. Singeltary Sr., Bacliff, Texas USA<br /><br />john hazelwood wrote:<br /><br />######### Bovine Spongiform Encephalopathy #########<br /><br />Hello Karin<br /><br />Although MRM was probably one of the most important<br /><br />sources of contamination<br /><br />of human foods until it was banned in 1995 in the UK,<br /><br />the MRM problem has nothing to do with rendering and<br /><br />MBM for animal feed.<<<< ><br /><br />Yes I understand the difference how ever the process<br /><br />was cost /profit driven any MRM that was surplus ( the<br /><br />balance) was passed back for use in animal feed - they<br /><br />would not waste it!<br /><br />Besides, I doubt that it would be very practical to<br /><br />_extract_ brain and<br /><br />spinal cord after "crushing and shattering" of heads<br /><br />and spines !<<< ><br /><br />Sorry I should have been more explicit - I was trying<br /><br />to emphasise that this material included BRAIN etc.<br /><br />and was a part of the general mush or "slurry" that<br /><br />was extracted for HUMAN/animal consumption. -- Surely<br /><br />this was the best practical way of processing the<br /><br />WHOLE HEAD from a cost /profit point of view.<br /><br />According to the BSE Inquiry's final report, MRM<br /><br />was produced by :<br /><br />..." high pressure being applied to bones to separate<br /><br />them from anything that was still adhering. The<br /><br />resultant slurry was used in a range of meat products<br /><br />for human consumption, including lower grade sausages,<br /><br />burgers and pies.<<< ><br /><br />So they only tell a part of truth!<br /><br />The major source of MRM was the spinal<br /><br />column"...<<< ><br /><br />So OK They just did not mention that the "head meat"<br /><br />and that BRAIN was a VERY significant component prior<br /><br />to 1989 at some of the plants.<br /><br />The BSE Inquiry certainly drew attention to this<br /><br />process. I think they even wrote a "draft factual<br /><br />account" on MRM last year. <<< ><br /><br />Not the process I described and they have done there<br /><br />best to cover up the inclusion of BRAINS in MRM .<br /><br />*******************************************************<br /><br />Bovine heads.<br /><br />4.26 Although a representative of the Chartered<br /><br />Institute of Environmental Health (CIEH) suggested<br /><br />that heads were used in the MRM process. The weight of<br /><br />evidence was against this proposition.<br /><br />WHO SAYS SO?<br /><br />*******************************************************<br /><br />Best regards, JOHN<br /><br />--- <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:Karin.Irgens@DYREHELSETILSYNET.NO" style="color: #473624; cursor: pointer;">mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:Karin.Irgens@DYREHELSETILSYNET.NO</a> wrote:<br /><br />######### Bovine Spongiform Encephalopathy<br /><br />#########</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Hello John<br /><br />Although MRM was probably one of the most important<br /><br />sources of contamination<br /><br />of human foods until it was banned in 1995 in the<br /><br />UK, the MRM problem has<br /><br />nothing to do with rendering and MBM for animal<br /><br />feed.<br /><br />Besides, I doubt that it would be very practical to<br /><br />_extract_ brain and<br /><br />spinal cord after "crushing and shattering" of heads<br /><br />and spines !<br /><br />According to the BSE Inquiry's final report, MRM was<br /><br />produced by :<br /><br />..." high pressure being applied to bones to<br /><br />separate them from anything<br /><br />that was still adhering. The resultant slurry was<br /><br />used in a range of meat<br /><br />products for human consumption, including lower<br /><br />grade sausages, burgers an<br /><br />pies. The major source of MRM was the spinal<br /><br />column"...<br /><br />The BSE Inquiry certainly drew attention to this<br /><br />process. I think they even<br /><br />wrote a "draft factual account" on MRM last year.<br /><br />Best regards, Karin<br /><br />-----Opprinnelig melding-----<br /><br />Fra: john hazelwood [SMTP:j_hazelwood@YAHOO.COM]<br /><br />Sendt: 1. desember 2000 18:17<br /><br />Til: <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:BSE-L@UNI-KARLSRUHE.DE" style="color: #473624; cursor: pointer;">mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:BSE-L@UNI-KARLSRUHE.DE</a><br /><br />Emne: Re: SV: Changes to UK Rendering System?<br /><br />TRUE But The UK invented MRM in the mid-nineteen<br /><br />seventies, that is the industrial processing of whole<br /><br />heads of cows and sheep plus skeletal waste on a<br /><br />huge scale. The process was made viable by the collection<br /><br />of hundreds of heads etc. That were then crushed,<br /><br />shattered and centrifuged to extract the brains,<br /><br />tongues, eyes, and spinal chord from the bone matrix.<br /><br />A material was made from this slurry that could be<br /><br />added to pies, sausages, burgers and baby filler<br /><br />as cheap filler. The balance was used as a protein<br /><br />supplement in animal feed.<br /><br />Could you have a better way of spreading<br /><br />infectivity ? Did the BSE Inquiry describe or draw attention<br /><br />to this process? I understand there was a HMSO<br /><br />publication on MRM in 1980 but as yet I have not<br /><br />been able to obtain a copy.<br /><br />Best regards john<br /><br />__________________________________________________<br /><br />############<br /><br /><a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html" style="color: #473624; cursor: pointer;">http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html</a><br /><br />############<br /><br />############<br /><br /><a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html" style="color: #473624; cursor: pointer;">http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html</a><br /><br />############<br /><br />############ <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html" style="color: #473624; cursor: pointer;">http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html</a><br /><br />############<br /><br />############ <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html" style="color: #473624; cursor: pointer;">http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html</a><br /><br />############<br /><br />Subject: Re: SV: SV: Changes to UK Rendering System? </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">From: "Terry S. Singeltary Sr." </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Reply-To: Bovine Spongiform Encephalopathy </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Date: Tue, 5 Dec 2000 11:39:50 -0800 </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Content-Type: text/plain Parts/Attachments: text/plain (253 lines)<br /><br />######### Bovine Spongiform Encephalopathy #########<br /><br />Karin and John,<br /><br />forgot to add this;<br /><br />57. On 22 June 1990, the APS/Parliamentary Secretary (Mr Curry) sent a minute to Dr Denner, copied to Mr Capstick, Mr Meldrum, Mr Crawford, Mr Baker, Mr Griffiths, Mr Lawrence and others, in which he explained that at a demonstration of the MRM process which Mr Curry had seen at a slaughterhouse, traces of spinal tissue had been found in the product and as a result the Parliamentary Secretary was ‘very unhappy about MRM’.[53] A suggestion had been made to Mr Curry that an efficient method of removing the spinal tissue would be to apply a suction pump to the spinal canal after the head had been removed and before the carcase was split. The Parliamentary Secretary asked for a short note on the feasibility of such a method.<br /><br />58. On 25 June 1990, Mr Bremner sent a minute to Mr Meldrum, copied to Dr Denner, Mr Crawford, Mr D Taylor and Mr Griffiths. Mr Bremner reported that he was ‘very surprised’ that the Parliamentary Secretary had seen traces of spinal tissue in MRM and that ‘it is so unlikely that I suspect he was misinformed’.[54] Mr Bremner explained that what the slaughterhouse operators had said was that ‘they were not happy to sell MRM because of the risk of contamination of the vertebrae with the spinal cord. Unfortunately not all the spinal cord was being removed by the meat inspectors although only small pieces were left’. He went on to say that although the idea of using a suction pump was being pushed by the operators, he found it difficult to imagine how it would work, and that ‘my own view was that if the meat inspectors had done their job correctly, there would have been little risk and if the vertebrae were excluded from MRM, there should be no further risk’.<br /><br />59. In a manuscript minute dated 28 June 1990, Mr Meldrum asked Mr Bremner to find out from his trade contacts whether any suction pumps were actually available on the market.[55]<br /><br />60. Dr Denner wrote to APS/Mr Curry on 26 June 1990 regarding the visit to Canvin International Ltd. His minute was copied to PS/Minister, Private Offices, Mr Capstick, Mr Packer, Mr Meldrum, Mrs Attridge, Mr Wentworth, Mr Crawford, Mr Baker, Mr Griffiths and Mr Lawrence amongst others.[56] Dr Denner explained that:- ‘There are two separate issues arising from the Parliamentary Secretary’s (Mr Curry) visit to the abattoir. The first is the efficacy of removing spinal cord from the carcase, which is a mandatory requirement of the Bovine Offals (Prohibition) Regulations 1989. This issue is related to other problems of abattoir practice such as the removal of the head meat and brains from cattle heads, and the prevention of cross contamination from spinal fluids and tissue during carcase dressing. The second problem is the safety of MRM prepared from spinal column bones. Since legislation already exists for the removal of spinal cord, any further consideration must stem from the risk posed by using spinal column with the spinal cord removed in MRM piston type machines. Any policy decision on BSE must be based on the best technical evidence available to be consistent with previous MAFF policy. The CVO is already organising a study to improve abattoir practice of splitting carcases. The use of a suction tube for removal of spinal cord after splitting the carcase is an effective technique already in use in some plants producing MRM from lamb spinal column bones. This may be one of several possible techniques that can be studied. I understand the Tyrrell Committee will discuss the use of spinal column in the preparation of MRM at their next meeting on 2 July. Subject to their recommendation, Food Science Division would be prepared to commission a study into verifying whether central nervous system fluid or tissue is extracted into MRM during the preparation in piston type machines when spinal column with the cord removed is used. The results of such a study would give Ministers the basis for any further action.’<br /><br />61. The APS/Mr Curry replied to Dr Denner on 2 July 1990[57]. She explained that:- ‘The MRM [at Canvins] was produced using a machine which used a piston under hydraulic pressure. The traces of spinal tissue were identified by eye by Canvin’s vet. However, Mr Bremner - who accompanied the Parliamentary Secretary on this visit - said that it was possible that the material in question could have been cartilage tissue. Mr Bremner felt that the machine was not working properly as the MRM it produced was in larger pieces than normal.’<br /><br />MRMs<br /><br /><br /><a fg_scanned="1" href="http://www.bse.org.uk/dfa/dfa14.htm" style="color: #473624; cursor: pointer;">http://www.bse.org.uk/dfa/dfa14.htm</a><br /><br /><br /><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody"><mailto:sillaste cybercable.fr="">DFA 14</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody"><br /></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: black; font-family: arial; font-size: 13.3333px;"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">Consideration of the Risk from Mechanically Recovered Meat (MRM) in 1989-1990</span></span><br /></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: black; font-family: arial; font-size: 13.3333px;"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: black; font-family: arial; font-size: 13.3333px;"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;">NEW URL LINK 2022</span></span></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: black; font-family: arial; font-size: 13.3333px;"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><br /></span></span></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: black; font-family: arial; font-size: 13.3333px;"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><span style="font-size: 13px;"><a fg_scanned="1" href="http://web.archive.org/web/20001219041200/http://www.bse.org.uk/dfa/dfa14.htm" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20001219041200/http://www.bse.org.uk/dfa/dfa14.htm</a></span></span></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: black; font-family: arial; font-size: 13.3333px;"><span style="color: #29303b; font-family: Georgia, Times New Roman, sans-serif;"><br /></span></div><br />kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA<br /><br />john hazelwood wrote:<br /><br />######### Bovine Spongiform Encephalopathy<br /><br />#########<br /><br />Hello Karin<br /><br />Although MRM was probably one of the most important<br /><br />sources of contamination<br /><br />of human foods until it was banned in 1995 in the UK,<br /><br />the MRM problem has nothing to do with rendering and<br /><br />MBM for animal feed.<<<<><br /><br />Reply-To: Bovine Spongiform Encephalopathy </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Date: Fri, 26 Mar 2004 15:22:01 -0600 </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Content-Type: multipart/related Parts/Attachments: text/plain (1957 lines)<br /><br />Bovine Spongiform Encephalopathy (BSE) - Updated Vaccine Information<br /><br />Posted: 3/24/2004<br /><br />Bovine Spongiform Encephalopathy (BSE)<br /><br />horizontal rule<br /><br />snip...tss...2008<br /><br />Opinion (webmaster): This is good step forward to name the compaines and specific vaccines though it is a pity that England doesn't keep records of who received what vaccine the way normal countries do. The previous two mass outbreaks of TSE attributed to vaccines involved louping ill in the 1930's and a 1999 vaccine in Italy, both produced in sheep or goat brain. An Indian physician has also expressed concern about a widely used human rabies vaccines produced in scrapies-endemic sheep brain in India; CJD surveillance there is minimal. No details are provided above on what part of the bovine is used in producing the vaccines, apparently fetal calf serum or bovine serum albumen are used in human cell culture to grow the viruses. The vaccines had been previously discussed in a Phillips Inquiry memo: bovine blood serum, ox heart infusion, casein (milk protein), fetal calf serum, beef muscle infusion, veal, and unspecified sheep use.<br /><br />Extract from Phillips enquiry, draft factual account 17, 8 Oct 99<br /><br />14 February 1989 Dr Adams minuting Dr Harris Vaccines: We have contacted all the major vaccine product licence holders whose products are likely to be used in children. Many manufacturers use bovine material. As can be seen, this information is diverse and incomplete. Each company stressed that they could not give an accurate assessment without detailed researches, given the complexity of sourcing/purchasing arrangements. All the licences are detailed in appendix 1 [unavailable]; the overview is as follows:<br /><br />1. D have polio, measles, mumps, rubella, rotavirus vaccines. All use bovine serum from a UK source and bovine commercial product from unknown source. Some agent comes from the USA and New Zealand.<br /><br />2. I gave most information (see Appendix 2 [unavailable]). All their vaccines apart from yellow fever, cholera and typhoid contain bovine material: Oral polio; up to 1988, foetal calf serum was used from UK and New Zealand (pooled); since 1988 foetal calf serum only from New Zealand. Large stocks are held.<br /><br />Rubella; bulk was made before 1979 from foetal calf serum from UK and New Zealand. None has been made as there are some 15 years stock.<br /><br />Diphtheria; UK bovine beef muscle and ox heart is used but since the end of 1988 this has been sourced from Eire. There are 1,250 litres of stock.<br /><br />Tetanus; this involves bovine material from UK mainly Scottish. There are 21,000 litres of stock.<br /><br />Pertussis; uses bovine material from the UK. There are 63,000 litres of stock.<br /><br />They consider that to switch to a non-UK source will take a minimum of 6-18 months and to switch to a non-bovine source will take a minimum of five years.<br /><br />3. E have measles, mumps, MMR, rubella vaccines. These are sourced from the USA and the company believes that US material only is used.<br /><br />4. J have a measles vaccine using bovine serum from the UK. There are 440,000 units of stock. They have also got MMR using bovine serum from the UK.<br /><br />5. K have influenza, rubella, measles, MMR vaccines likely to be used in children. Of those they think that only MMR contains bovine material which is probably a French origin.<br /><br />6. L have diphtheria/tetanus and pertussis on clinical trial [redacted]; These use veal material, some of which has come from the UK and has been made by I (see above).<br /><br />7. M have influenza vaccines which are made up in egg medium.<br /><br />8. The Secretary of State has a number of licences. We understand that the inactivated polio vaccine is no longer being used. There is a stock of smallpox vaccine. We have not been able to determine the source material. (Made in sheep very unlikely to certain bovine ingredients).<br /><br />9. N have acellular triple vaccine in which I material of UK bovine source has been used.<br /><br />As far as I can see Company I is the sole supplier of pertussis vaccine which uses bovine casein digest. You should also be aware that DH has made arrangements for meningococal vaccine to be available, on a named patient basis, from D and K. Both companies use bovine media in production." The Parliamentary Under-Secretary of State, Department of Health (Lord Hunt of Kings Heath): No vaccines or other injectable medicines in use in the United Kingdom contain bovine serum derivatives as ingredients in the finished products.<br /><br />Comment (Kelly ): "It seems clear that no bovine derivatives are used in FINISHED products, however they are often used in the culture process. Does this also present a possible risk? Below is the packaging insert for one routine vaccine (inactivated injectable polio vaccine)made by Pasteur Merieux S?ms & Vaccins S. A. Lyon, France (now called Aventis):"<br /><br />IPOL? Poliovirus Vaccine Inactivated, produced by Pasteur M?eux S?ms Vaccins S.A., is a sterile suspension of three types of poliovirus: Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). IPOL?is a highly purified, inactivated poliovirus vaccine produced by microcarrier culture. This culture technique and improvements in purification, concentration and standardization of poliovirus antigen produce a more potent and consistent immunogenic vaccine than the IPV available in the US prior to 1988. The viruses are grown in cultures of V.R. cells, a continuous line of monkey kidney cells, by the microcarrier technique. The cells are grown in Eagle MEM modified medium, supplemented with newborn calf serum tested for adventitious agents prior to use, originated from countries free of bovine spongiform encephalopathy. For viral growth the culture medium is replaced by M-199, without calf serum.<br /><br />... Neomycin, streptomycin and polymyxin B are used in vaccine production, and although purification procedures eliminate measurable amounts, less than 5 ng neomycin, 200 ng streptomycin and 25 ng polymyxin B per dose may still be present. The residual calf serum protein is less than 1 ppm in the final vaccine. The vaccine is clear and colorless and should be administered intramuscularly or subcutaneously.<br /><br />The documents below were provided by Terry S. Singeltary Sr on 8 May 2000. They are optically character read (scanned into computer) and so may contain typos and unreadable parts.<br /><br />TIP740203/l 0424 CONFIDENTIAL Mr Cunningham CMP3 From: D O Hagger MBI Dr Salisbury MED/IMCD3 Mr Burton PD/STB/PG1B B/17/2 Date: 15.02.1989 Mr Dudley PD/AD4 BOVINE SPONGIFORM ENCEPHALOPATHY 1. The purpose of this minute is to alert you to recent developments on BSE as they affect medicines and to invite representatives to a meeting in Market Towers on 22 February 1989.<br /><br />snip...end...2008...TSS<br /><br /><br /><a fg_scanned="1" href="https://lists.aegee.org/cgi-bin/wa?A2=ind0403&L=BSE-L&P=R48065&X=46104545F4D3582B66&Y=flounder9%40verizon.net" style="color: #473624; cursor: pointer;">https://lists.aegee.org/</a>................................<br /><br /><br /><br />Subject: How many NHS patients identified by the National Blood Service as having received blood from a donor who later developed vCJD were people with haemophilia Lord Morris of Manchester </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">From: "Terry S. Singeltary Sr." </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Reply-To: Bovine Spongiform Encephalopathy </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Date: Thu, 21 Dec 2006 11:32:40 -0600 </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Content-Type: text/plain Parts/Attachments: text/plain (781 lines)<br /><br />Subject: How many NHS patients as having received blood from a donor who later developed vCJD were people with haemophilia Date: December 21, 2006 at 9:13 am PST Health: vCJD Lord Morris of Manchester asked Her Majesty’s Government:<br /><br />How many NHS patients identified by the National Blood Service as having received blood from a donor who later developed vCJD were people with haemophilia. [HL750]<br /><br />19 Dec 2006 : Column WA291<br /><br />The Minister of State, Department of Health (Lord Warner): No patient with haemophilia or other bleeding disorders have been identified as having received blood from a blood donor who subsequently developed vCJD, nor have there been any reported cases of vCJD associated with receipt of plasma products.<br /><br />However, all haemophilia patients who received plasma products between 1980 and 2001 sourced from UK donor plasma have been designated as “at risk of vCJD for public purposes”. All plasma products are now sourced from non-UK plasma. The United Kingdom Haemophilia Centre Doctors’ Organisation is collecting data that will provide an estimate of the number of haemophilia patients who have been exposed to plasma products which may be implicated with vCJD.<br /><br />Lord Morris of Manchester asked Her Majesty’s Government:<br /><br />What is their response to the findings of Professor John Collinge in the December 2006 edition of the Lancet on the transmission by infected blood of variant CJD; and what action they are planning to take. [HL751]<br /><br />Lord Warner: The Lancet article refers to the third known case of vCJD transmission via blood transfusion from a vCJD-infected donor. This case was originally notified to the department in January 2006 and announced by the Health Protection Agency in a press release on 9 February 2006, a copy of which has been placed in the Library.<br /><br />There are 24 living patients in a group of people who had received blood components from donors subsequently known to have developed vCJD. They were all notified in 2005 or earlier, through their GPs, of their risk status and have been provided with information and support. The Health Protection Agency contacted the GPs earlier in the year to notify them of this third case and the agency has ensured that the GPs are fully informed and briefed about the subsequent Lancet publication.<br /><br />The department has implemented a series of measures to reduce the risk of vCJD being transmitted through the blood supply. Shortly after vCJD was first identified in 1996, the possibility of human-to-human transmission through blood was considered, and the department implemented precautionary measures to reduce what was, at that time, a theoretical risk. These measures have been strengthened since evidence of transmission via blood began to emerge from animal studies, and following the first case of transfusion-associated transmission in humans, reported in December 2003. An important additional step, introduced in March 2004, was to exclude from blood donation those people who had themselves received a blood transfusion since January 1980. Other precautionary measures include:<br /><br />from December 1997, blood components, plasma products or tissues obtained from any individual who later develops vCJD, were withdrawn/recalled;<br /><br />19 Dec 2006 : Column WA292<br /><br />in July 1998, it was announced that plasma for the manufacture of blood products, such as clotting factors, would be obtained from non-UK sources;from November 1999, white blood cells, which may carry a significant risk of transmitting vCJD, were removed from all blood used for transfusion;in August 2002, it was announced that fresh frozen plasma for treating babies and young children born on or after 1 January 1996 would be obtained from the USA; in July 2004, the exclusion criteria for blood donation were extended to include previously transfused platelet donors, and donors who were unsure if they had previously had a blood transfusion;in September 2004, the department announced further precautionary measures for patients who had received certain batches of plasma products;in July 2005, the use of USA-sourced fresh frozen plasma was extended to all children up to the age of 16;in July 2005, the department announced further precautionary measures for those patients who donated blood to three people who later developed vCJD. The department continues to keep all the evidence in relation to transmission of vCJD by blood under close review.<br /><br /><br /><a fg_scanned="1" href="http://www.publications.parliament.uk/pa/ld200607/ldhansrd/text/61219w0004.htm#06121940000034" style="color: #473624; cursor: pointer;">http://www.publications.parliament.uk/pa/ld200607/ldhansrd/text/61219w0004.htm#06121940000034</a><br /><br /><br />NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a fg_scanned="1" href="http://web.archive.org/web/20210610062608/https://www.publications.parliament.uk/pa/ld200607/ldhansrd/text/61219w0004.htm" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20210610062608/https://www.publications.parliament.uk/pa/ld200607/ldhansrd/text/61219w0004.htm</a><br /><br /><br /><a fg_scanned="1" href="http://www.whale.to/v/singeltary7.html" style="color: #473624; cursor: pointer;">http://www.whale.to/v/singeltary7.html</a><br /><br /><br />Subject: Re: VACCINES/CHILDREN/TSE'S -- 'CONFIDENTIAL' </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Date: Wed, 6 Sep 2000 18:20:09 -0800 </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">From: tom </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Reply-To: Bovine Spongiform Encephalopathy </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">To: <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:BSE-L@uni-karlsruhe.de" style="color: #473624; cursor: pointer;">mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:BSE-L@uni-karlsruhe.de</a> </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">References: 1<br /><br />######### Bovine Spongiform Encephalopathy #########<br /><br />Just when I was thinking the Internet had reached a terminal condition of shallow pages and broken links, some young people come along and invent a really effective Internet search engine: <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://www.google.com/" style="color: #473624; cursor: pointer;">http://www.google.com/</a> This works quite well to search the entire <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://www.mad-cow.org/" style="color: #473624; cursor: pointer;">http://www.mad-cow.org</a> site (or find 393 web sites such as GenBank that link to it, or 936 sites that cite it in text) back to 1996 as well as the BSE Inquiry <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://www.bse.org.uk/" style="color: #473624; cursor: pointer;">http://www.bse.org.uk/</a><br /><br />Thus for louping ill (unnecessary cites suppressed):<br /><br /><br /><a fg_scanned="1" href="http://www.bse.org.uk/witness/htm/stat537.htm" style="color: #473624; cursor: pointer;">http://www.bse.org.uk/witness/htm/stat537.htm</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120836mp_/http://www.bseinquiry.gov.uk/files/ws/s537.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120836mp_/http://www.bseinquiry.gov.uk/files/ws/s537.pdf</a><br /><br /><br />Witness Statements 537 - Coulthard<br /><br />29.Pituitary FSH from pigs has been used in the USA prior to its use in the UK and much more extensively there and Canada.... 30.Thousands of embryos were exported from this country to the USA prior to the ban being imposed... 42. No cow pituitaries were used in the preparation of FSH [follicular stimulating hormone] products compared with the case of louping ill vaccine for scrapie.<br /><br /><br /><br /><a fg_scanned="1" href="http://www.mad-cow.org/~tom/fda_late.html#ill" style="color: #473624; cursor: pointer;">http://www.mad-cow.org/~tom/fda_late.html#ill</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a href="https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120836mp_/http://www.bseinquiry.gov.uk/files/ws/s537.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">https://webarchive.nationalarchives.gov.uk/ukgwa/20080102120836mp_/http://www.bseinquiry.gov.uk/files/ws/s537.pdf</a><br /><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br />In what the story calls a grand historical irony, this landmark series of experiments was being confirmed at the same time in England as a result of an outbreak of scrapie in several hundred sheep that had been immunized against louping ill with a vaccine prepared from tissue from the brain, spinal cord, and spleen of sheep that were belatedly discovered to have been exposed to natural scrapie infection.[6.Gordon WS. Advances in veterinary research. Vet Rec 1946; 58: 516-520] The transmissible nature of the scrapie agent was thus established beyond any doubt. [P Brown, 1755 and All That: A Historical Primer of TSE.<br /><br />We need to look at the full text of the article and its cites to see how they actually made the vaccine, whether they exported vaccine-infected sheep to Canada and the US, and what became of the vaccinated flocks. Perhaps there is still sample available, Moredun Institute is still around.<br /><br />Gordon WS. Advances in veterinary research. Vet Rec 1946; 58: 516-520 (not covered by Medline) Gordon, Bronlee and Wilson 1939 [full cite is available only in a letter we don't have)<br /><br />Terry was reading Draft Factual Account 17<br /><br /><br /><a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://www.bse.org.uk/dfa/dfa17.htm" style="color: #473624; cursor: pointer;">http://www.bse.org.uk/dfa/dfa17.htm</a><br /><br />236. Mrs Alderman replied on 3 June 1988, listing products containing bovine insulin and noting there were two rabies vaccines listed but the species used in manufacture was not shown.[282] 237. On 6 June 1988 Mr Lawrence wrote to Sir Richard Southwood and enclosed some brief answers to the questions that had been tabled at the meeting on 19 May.[283] In relation to Q6, which asked ŒWhat is meat and other material from scrapie infected sheep used for - does it include pet food and material for biological products?¹ Part of the answer stated: ...<br /><br />There has been one instance of inadvertant [sic] transmission of the<br /><br />scrapie agent to sheep through louping ill vaccine (Gordon, Bronlee and<br /><br />Wilson 1939). One of the three batches of vaccine made in 1935 at the<br /><br />Moredun Institute contained the scrapie agent resulting in 7% of the<br /><br />recipients of the 18, 000 doses in the batch developing scrapie. This<br /><br />vaccine was made from formalin-inactivated sheep brain, and brought to<br /><br />the attention of research workers that formalin, at a concentration of<br /><br />0.35% for at least 3 months, which inactivated conventional viruses, did<br /><br />not totally inactivate the scrapie agent.<br /><br />----------------------------<br /><br />4. Questions we might want to have answered are:<br /><br />the highest risk would be from parenterals prepared from brain (eg<br /><br />rabies vaccine). Any species in which transmissible spongiform<br /><br />encephalopathies have been described would be suspect (“natural”<br /><br />infections in sheep, goats, cattle, deer, mink, but can be transmitted<br /><br />to hamster, mouse, guinea-pig etc). Are sterilisation processes<br /><br />adequate for the most resistant strain of scrapie agent or for CJD<br /><br />agent? Should companies be asked to include investigation for inclusion<br /><br />of scrapie agent (eg mouse innoculation [sic]) in at least some batches?<br /><br />If BSE behaves like scrapie, then we might expect other nervous tissue,<br /><br />spleen, lymph nodes and placenta to be contaminated. Infection has been<br /><br />described in other tissues too, eg gut wall, and we can not [sic] be<br /><br />sure blood is free. Do we know what bovine materials are used in which<br /><br />products, both as the active ingredient and in production? Bovine active<br /><br />ingredients in human products include insulin, vasopressin, bone, immune<br /><br />globulins, fibrin, dermal collagen, albumin. Bovine serum albumin and<br /><br />fetal calf serum must be used in preparation of very many products. For<br /><br />each of these products would any “BSE agent” be destroyed or eliminated<br /><br />in processing? If not, and the product is administered parenterally or<br /><br />topically into an open wound, might there be a risk? [For oral<br /><br />products, there would only be a trivially increased load on top of that<br /><br />taken in food in omnivores/carnivores including man. But for some<br /><br />herbivores, this might allow the agent to be introduced into yet another<br /><br />species].<br /><br />--------------------------<br /><br />Medicines and medical devises;<br /><br />Subject: 2 known incidents of iatrogenic scrapie Date: Thu, 7 Sep 2000 09:51:14 -0800 From: tom Reply-To: Bovine Spongiform Encephalopathy To: <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:BSE-L@uni-karlsruhe.de" style="color: #473624; cursor: pointer;">mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:BSE-L@uni-karlsruhe.de</a> References: 1<br /><br />######### Bovine Spongiform Encephalopathy #########<br /><br />One really has to wonder what went on in veterinary products produced during the peak BSE years. At this point, there are only 2 known incidents, both involving sheep brain vaccines.<br /><br />I found a better source for needed references for iatrogenic scrapie in a nice review by Ray Bradley at <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://www.iica.org.ar/Bse/6-%20Bradley.html" style="color: #473624; cursor: pointer;">http://www.iica.org.ar/Bse/6-%20Bradley.html</a>. Disclosure has been meagre on the 1998 vaccine incident in Italy. Note 3 of the 5 references are totally off Medline and the other 2 fail to have abstracts or links, due to journal ineptness, burial in conference proceedings, and age of article.<br /><br />If anyone has the first 3, I would appreciate a fax 542-484-0669 US.<br /><br />tom<br /><br />GORDON , W.S., 1959. Scrapie panel. In: Proceedings of 63rd Annual Meeting of the US Livestock Sanitary Association, 63, 286-294. [no medline record]<br /><br />GORDON, W.S., 1946. Advances in Veterinary Research: Louping ill, tick-borne fever and scrapie. Veterinary Record, 58, 516-525. [no medline record]<br /><br />GORDON , W.S., BROWNLEE, A.& WILSON, D.R., 1939. Studies in louping-ill, tick-borne fever and scrapie. 3rd International Congress for microbiology, 362-363. [no medline record]<br /><br />-=-=--=<br /><br />CAPUCCHIO, M.T., GUARDA,F., ISAIA,M.C., CARACAPPÀ, S. & DiMARCO,V., 1998. Natural occurrence of scrapie in goats in Italy. Veterinary Record, 143, 452-453. [title only]<br /><br />AGRIMI, U., GLUSOPPE, R.U., CARDONE, F., POCCHIARI, M. & CARAMELLI, M., 1999. Epidemic transmissible spongiform encephalopathy in sheep and goats in Italy. Lancet, 353, 560-561. [title only]<br /><br />IATROGENIC DISEASE IN ANIMALS<br /><br /><br /><br /><a fg_rewritten="1" fg_scanned="1" href="http://www.iica.org.ar/Bse/6-%20Bradley.html" style="background-color: rgb(200, 26, 0) !important; color: #473624; cursor: pointer; padding-bottom: 3px; padding-left: 3px; padding-right: 3px;">http://www.iica.org.ar/Bse/6-%20Bradley.html</a><br /><br /><br /><br />Ray Bradley Private BSE Consultant Veterinary Laboratories Agency, United Kingdom<br /><br />There have been two reported incidents of iatrogenic disease in animals, both involving scrapie. One was in Great Britain (Gordon, Brownlee and Wilson, 1939, Gordon 1946, 1959) the other in Italy (Capucchio et al, 1998, Agrimi et al, 1999). Both resulted from infection being introduced into vaccines, louping ill vaccine in Great Britain, Mycoplasma agalactiae vaccine in Italy. Each of these vaccines was prepared from tissues that included sheep brain. In both episodes it seems most likely that natural scrapie infection was present unknowingly in some brains used for the purpose. Once prepared and having passed all the conventional vaccine tests large numbers of sheep in Great Britain, and goats and some sheep in Italy were inoculated. After the necessary incubation period large numbers (> 1,000 in each case) of inoculated animals came down with scrapie. In the meantime some inoculated clinically healthy goats and sheep may have entered food and feed chains or have been used for other purposes. In the British outbreak there appears to have been no consequence for humans who may have consumed infected sheep. It is too early to say what may be the consequences in Italy but measures have been taken to reduce any risk there may have been. .........end<br /><br />Louping-ill vaccine documents from November 23rd, 1946 FULL TEXT<br /><br />THE VETERINARY RECORD 516 No 47. Vol. 58 November 23rd, 1946<br /><br />NATIONAL VETERINARY MEDICAL ASSOCIATION OF GREAT BRITAIN AND IRELAND<br /><br />ANNUAL CONGRESS, 1946<br /><br />The annual Congress, 1946, was held at the Royal Veterinary College, Royal College Street, London, N.W.I. from September 22nd to September 27th.<br /><br />Opening Meeting<br /><br />[skip to scrapie vaccine issue...tss]<br /><br />Papers Presented to Congress<br /><br />SNIP...FULL TEXT ;<br /><br /><br /><br /><a fg_scanned="1" href="http://whale.to/v/singeltary.html" style="color: #473624; cursor: pointer;">http://whale.to/v/singeltary.html</a><br /><br /><br /><br />Subject: Louping-ill vaccine documents from November 23rd, 1946 Date: Sat, 9 Sep 2000 17:44:57 -0700 From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To: <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000143/!x-usc:mailto:BSE-L@uni-karlsruhe.de" style="color: #473624; cursor: pointer;">BSE-L@uni-karlsruhe.de</a><br /><br />######### Bovine Spongiform Encephalopathy #########<br /><br />THE VETERINARY RECORD 516 No 47. Vol. 58 November 23rd, 1946<br /><br />NATIONAL VETERINARY MEDICAL ASSOCIATION OF GREAT BRITAIN AND IRELAND<br /><br />ANNUAL CONGRESS, 1946<br /><br />The annual Congress, 1946, was held at the Royal Veterinary College, Royal College Street, London, N.W.I. from September 22nd to September 27th.<br /><br />Opening Meeting<br /><br />[skip to scrapie vaccine issue...tss]<br /><br />Papers Presented to Congress<br /><br />The papers presented to this year's Congress had as their general theme the progressive work of the profession during the war years. Their appeal was clearly demonstrated by the large and remarkably uniform attendance in the Grand Hall of the Royal Veterinary College throughout the series; between 200 and 250 members were present and they showed a keen interest in every paper, which was reflected in the expression of some disappointment that the time available for discussion did not permit of the participation of more than a small proportion of would-be contributors.<br /><br />In this issue we publish (below) the first to be read and discussed, that by Dr. W. S. Gordon, M.R.C.V.S., F.R.S.E., "Advances in Veterinary Research." Next week's issue will contain the paper on "Some Recent Advances in Veterinary Medicine and Surgery in Large-Animal Practice" by Mr. T. Norman Gold, M.R.C.V.S. In succeeding numbers of the Record will be reproduced, also with reports of discussions, that by Mr. W. L. Weipers, M.R.C.V.S., D.V.S.M., on the same subject as relating to small-animal practice, and the papers by Mr. J. N. Ritchie, B.SC., M.R.C.V.S., D.V.S.M., and Mr. H.W. Steele-Bodger, M.R.C.V.S., on "War-time Achievements of the British Home Veterinary Services."<br /><br />The first scientific paper of Congress was read by Dr. W. S. Gordon, M.R.C.V.S., F.R.S.E. on Monday, September 23rd, 1946, when Professor J. Basil Buxton, M.A., F.R.C.V.S, D.V.H., Prinicipal of the Royal Veterinary College, presided.<br /><br />Advances in Veterinary Research<br /><br />by<br /><br />W.S. GORDON, PH.D., M.R.C.V.S., F.R.S.E.<br /><br />Agriculteral Research Council, Field Station, Compton, Berks.<br /><br />Louping-ill, Tick-borne Fever and Scrapie<br /><br />In 1930 Pool, Browniee & Wilson recorded that louping-ill was a transmissible disease. Greig et al, (1931) showed that the infective agent was a filter-passing virus with neurotropic characters and Browniee & Wilson (1932) that the essential pathology was that of an encephalomyelitis. Gordon, Browniee, Wilson & MacLeod (1932) and MacLeod & Gordon (1932) confirmed and extended this work. It was shown that on louping-ill farms the virus was present in the blood of many sheep which did not show clinical symptoms indicating involvement of the central nervous system and that for the perpetuation and spread of the disease these subclinical cases were probably of greater importance that the frank clinical cases because, in Nature, the disease was spread by the tick, lxodes ricinus L. More recently Wilson (1945, 1946) has described the cultivation of the virus in a chick embryo medium, the pathogenic properties of this culture virus and the preparation of louping-ill antiserum.<br /><br />Between 1931 and 1934 I carried out experiments which resulted in the development of an effective vaccine for the prevention of louping-ill.* This vaccine has been in general use since 1935 and in his annual report to the Animal Diseases Research Association this year, Dr. Greig stated that about 227,000 doses of vaccine had been issued from Moredun alone.<br /><br />Dr. Gordon illustrated this portion of his paper by means of graphs and diagrams projected by the epidiascope.<br /><br />This investigation, however, did not begin and end with the study of louping-ill; it had, by good fortune, a more romantic turn and less fortunately a final dramtic twist which led almost to catastrope. After it had been established that a solid immunity to louping-ill could be induced in sheep, a group of immunized and a group of susceptible animals were placed together on the tick-infected pasture of a louping-ill farm. Each day all the animals were gathered and their temperatures were recorded. It was anticipated that febrile reactions with some fatalities would develop in the controls while the louping-ill immunes would remain normal. Contrary to expectation, however, every sheep, both immune and control, developed a febrile reaction. This unexpected result made neccessary further investigation which showed that the febrile reaction in the louping-ill immunes was due to a hitherto undescribed infective agent, a Rickettsia-like organism which could be observed in the cytoplasm of the grannular leucocytes, especially the neutrophil polymorphs (MacLeod (1932), Gordon, Browniee, Wilson & MacLeod. MacLeod & Gordon (1933). MacLeod (1936). MacLeod collected ticks over many widely separated parts of Scotland and all were found to harbour the infective agent of tick-borne fever, and it is probable that all sheep on tick-infested farms develop this disease, at least on the first occasion that they become infested with ticks. When the infection is passed in series through susceptible adult sheep it causes a sever, febrile reaction, dullness and loss of bodily condition but it rarely, if ever, proves fatal. It is clear, however, that it aggravates the harmful effects of a louping-ill infection and it is a serious additional complication to such infections as pyaemia and the anacrobic infections which beset lambs on the hill farms of Northern Britain.<br /><br />Studying the epidemiology of louping-ill on hill farms it became obvious that the pyaemic condition of lambs described by M'Fadyean (1894) was very prevalent on tick infested farms Pyaemia is a crippling condition of lambs associated with tick-bite and is often confused with louping-ill. It is caused by infection with Staphylococcus aureus and affected animals may show abscess formation on the skin, in the joints, viscera, meninges and elsewhere in the body. It was thought that tick-borne fever might have ben a predisposing factor in this disease and unsuccessful attempts were made by Taylor, Holman & Gordon (1941) to reproduce the condition by infecting lambs subcutaneously with the staphylococcus and concurrently produceing infections with tickborne fever and louping-ill in the same lambs. Work on pyaemia was then continued by McDiarmid (1946a, 1946b, 1946c), who succeeded in reproducing a pyaemic disease in mice, guinea-pigs and lambs similar to the naturally occuring condition by intravenous inoculation of Staphylococcus aureus. He also found a bacteraemic form of the disease in which no gross pyaemic lesions were observed. The prevention or treatment of this condition presents a formidable problem. It is unlikely that staphylococcal ???oid will provide an effective immunity and even if penicillin proved to be a successful treatment, the difficulty of applying it in adequate and sustained dosage to young lambs on hill farms would be almost insurmountable.<br /><br />From 1931 to 1934 field trials to test the immunizing value and harmlessness of the loup-ill vaccine were carried out on a gradually increasing scale. Many thousands of sheep were vaccinated and similar numbers, living under identical conditions were left as controls. The end result showed that an average mortability of about 9 percent in the controls was reduced to less than 1 percent in the vaccinated animals. While the efficiency of the vaccine was obvious after the second year of work, previous bitter experience had shown the wisdom of withholding a biological product from widespread use until it had been successfully produced in bulk, as opposed to small-scale experimental production and until it had been thoroughly tested for immunizing efficiency and freedom from harmful effects. It was thought that after four years testing this stage had been reached in 1935, and in the spring of that year the vaccine was issued for general use. It comprised a 10 percent saline suspension of brain, spinal cord and spleen tissues taken from sheep five days after infection with louping-ill virus by intracerebral inoculation. To this suspension 0-35 percent of formalin was added to inactivate the virus and its safety for use as a vaccine was checked by intracerbral inoculation of mice and sheep and by the inoculation of culture medium. Its protective power was proved by vaccination sheep and later subjecting them, along with controls, to a test dose of living virus.<br /><br />Vaccine for issue had to be free from detectable, living virus and capable of protecting sheep against a test dose of virus applied subcutaneously. The 1935 vaccine conformed to these standards and was issued for inoculation in March as three separate batches labelled 1, 2, and 3. The tissues of 140 sheep were employed to make batch 1 of which 22,270 doses were used; 114 to make batch 2 of which 18,000 doses were used and 44 to make batch 3 of which 4,360 doses were used. All the sheep tissues incorporated in the vaccine were obtained from yearling sheep. During 1935 and 1936 the vaccine proved highly efficient in the prevention of loup-ill and no user observed an ill-effect in the inoculated animals. In September, 1937, two and a half years after vaccinating the sheep, two owners complained that scrapie, a disease which had not before been observed in the Blackface breed, was appearing in their stock of Blackface sheep and further that it was confined to animals vaccinated with louping-ill vaccine in 1935. At that stage it was difficult to conceive that the occurrence could be associated with the injection of the vaccine but in view of the implications, I visited most of the farms on which sheep had been vaccinated in 1935. It was at this point that the investigation reached its dramatic phase; I shall not forget the profound effect on my emotions when I visited these farms and was warmly welcomed because of the great benefits resulting from the application of louping-ill vaccine, wheras the chief purpose of my visit was to determine if scrapie was appearing in the inoculated sheep. The enquiry made the position clear. Scrapie was developing in the sheep vaccinated in 1935 and it was only in a few instances that the owner was associating the occurrence with louping-ill vaccination. The disease was affecting all breeds and it was confined to the animals vaccinated with batch 2. This was clearly demonstrated on a number of farms on which batch 1 had been used to inoculate the hoggs in 1935 and batch 2 to inoculate the ewes. None of the hoggs, which at this time were three- year-old ewes. At this time it was difficult to forecast whether all of the 18,000 sheep which had received batch 2 vaccine would develop scrapie. It was fortunate, however, that the majority of the sheep vaccinated with batch 2 were ewes and therfore all that were four years old and upwards at the time of vaccination had already been disposed of and there only remained the ewes which had been two to three years old at the time of vaccination, consequently no accurate assessment of the incidence of scrapie could be made. On a few farms, however, where vaccination was confined to hoggs, the incidence ranged from 1 percent, to 35 percent, with an average of about 5 percent. Since batch 2 vaccine had been incriminated as a probable source of scrapie infection, an attempt was made to trace the origin of the 112 sheep whose tissues had been included in the vaccine. It was found that they had been supplied by three owners and that all were of the Blackface or Greyface breed with the exception of eight which were Cheviot lambs born in 1935 from ewes which had been in contact with scrapie infection. Some of these contact ewes developed scrapie in 1936-37 and three surviving fellow lambs to the eight included in the batch 2 vaccine of 1935 developed scrapie, one in September, 1936, one in February, 1937, and one in November, 1937. There was, therefore, strong presumptive evidence that the eight Cheviot lambs included in the vaccine althought apparently healthy were, in fact, in the incubative stage of a scrapie infection and that in their tissues there was an infective agent which had contaminated the batch 2 vaccine, rendering it liable to set up scrapie. If that assumption was correct then the evidence indicated that:-<br /><br />(1) the infective agent of scrapie was present in the brain, spinal cord and or spleen of infected sheep: (2) it could withstand a concentration of formalin of 0-35 percent, which inactivated the virus of louping-ill: (3) it could be transmitted by subcutaneous inoculation; (4) it had an incubative period of two years and longer.<br /><br />Two Frenchmen, Cuille & Chelle (1939) as the result of experiments commenced in 1932, reported the successful infection of sheep by inoculation of emulsions of spinal cord or brain material by the intracerebral, epidural, intraocular and subcutaneous routes The incubation period varied according to the route employed, being one year intracerebrally, 15 months intraocularly and 20 months subcutaneously. They failed to infect rabbits but succeeded in infecting goats. Another important part of their work showed that the infective agent could pass throught a chamberland 1.3 filter, thus demonstrating that the infective agent was a filtrable virus. It was a curious coincidence that while they were doing their transmission experiments their work was being confirmed by the unforeseeable infectivity of a formalinized tissue vaccine.<br /><br />As a result of this experience a large-scale transmision experiment involving the ue of 788 sheep was commenced in 1938 on a farm specially taken for the purpose by the Animal Diseases Research Association with funds provided by the Agricultural Research Council. The experiment was designed to determine the nature of the infective agent and the pathogenesis of the disease. It is only possible here to give a summary of the result which showed that (1) saline suspensions of brain and spinal cord tissue of sheep affected with scrapie were infective to normal sheep when inoculatted intracerebrally or subcutaneously; (2) the incubation period after intracerebral inoculation was seven months and upwards and only 60 percent of the inoculated sheep developed scrapie during a period of four and a half years; (3) the incubation period after subcutaneous inoculation was 15 months and upwards and only about 30 percent of the inoculated sheep developed the disease during the four and a half years: (4) the infective agent was of small size and probably a filtrable virus.<br /><br />The prolonged incubative period of the disease and the remarkable resistance of the causal agent to formalin are features of distinct interest. It still remains to determine if a biological test can be devised to detect infected animals so that they can be killed for food before they develop clinical symptoms and to explore the possibilities of producing an immunity to the disease. ==================================================================<br /><br />Greetings List Members,<br /><br />pretty disturbing document. now, what would stop this from happening with the vaccineCJD in children???<br /><br />kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA<br /><br /><br /><a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000143/!x-usc:http://www.whale.to/v/singeltary.html" style="color: #473624; cursor: pointer;">http://www.whale.to/v/singeltary.html</a><br /><br /><br /><a fg_scanned="1" href="http://www.whale.to/v/cjd2.html" style="color: #473624; cursor: pointer;">http://www.whale.to/v/cjd2.html</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">COMMERCIAL IN CONFIDENCE</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">NOT FOR PUBLICATION<br /><br /><br />although 176 products do _not_ conform to the CSM/VPC guidelines.<br /><br /><br /><a href="http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf" style="color: #473624; cursor: pointer;">http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a href="http://web.archive.org/web/20090718143231/http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090718143231/http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf</a><br /><br /><br />8. The Secretary of State has a number of licences. We understand that the inactivated polio vaccine is no longer being used. There is a stock of smallpox vaccine. We have not been able to determine the source material. (Made in sheep very unlikely to contain bovine ingredients).<br /><br /><br /><a href="http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf" style="color: #473624; cursor: pointer;">http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf</a><br /><br /><br />NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a href="http://web.archive.org/web/20090505223918/http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090505223918/http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf</a><br /><br /><br /><a href="http://www.bseinquiry.gov.uk/files/yb/1989/02/14011001.pdf" style="color: #473624; cursor: pointer;">http://www.bseinquiry.gov.uk/files/yb/1989/02/14011001.pdf</a><br /><br /><br />NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a href="http://web.archive.org/web/20090506060303/http://www.bseinquiry.gov.uk/files/yb/1989/02/14011001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506060303/http://www.bseinquiry.gov.uk/files/yb/1989/02/14011001.pdf</a><br /><br />more on the 1968 medicine act, they forgot to follow<br /><br /><br /><a href="http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf" style="color: #473624; cursor: pointer;">http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf</a><br /><br /><br />NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a href="http://web.archive.org/web/20090718143216/http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090718143216/http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /><br />Draft cover letter to product licence holders (considered by Human and Vet Medicines including deer)<br /><br /><br /><a href="http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf" style="color: #473624; cursor: pointer;">http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf</a><br /><br /><br />NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a href="http://web.archive.org/web/20090718143224/http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090718143224/http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /><br /><a href="http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf" style="color: #473624; cursor: pointer;">http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf</a><br /><br /><br />NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a href="http://web.archive.org/web/20090718143228/http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090718143228/http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /><br />2.3.Iatrogenic exposure<br /><br />Iatrogenic exposure of scrapie has probably occurred twice. The first report determined that<br /><br />the vehicle was a louping ill vaccine prepared from sheep tissues and this infected a large<br /><br />number of sheep sheep (Gordon, 1946, Greig, 1950). The second was more recent and in this<br /><br />case a vaccine against Mycoplasma agalactiae prepared from sheep tissues was incriminated<br /><br />(Agrimi et al 1999, Capucchio, 1998) but not all outbreaks could be linked to the use of the<br /><br />vaccine. In this episode goats were predominantly affected10.<br /><br /><br /><br /><a href="http://ec.europa.eu/food/fs/sc/ssc/out170_en.pdf" style="color: #473624; cursor: pointer;">http://ec.europa.eu/food/fs/sc/ssc/out170_en.pdf</a><br /><br /><br /><br /><a href="http://ec.europa.eu/food/fs/sc/ssc/out247_en.pdf" style="color: #473624; cursor: pointer;">http://ec.europa.eu/food/fs/sc/ssc/out247_en.pdf</a><br /><br /><br />5.3.3 The greatest risk, in theory, would be from parenteral injection of material derived from bovine brain or lymphoid tissue. Medicinal products for injection or surgical implantation which are prepared from bovine tissues, or which utilise bovine serum albumin or similar agents in their manufacture, might also be capable of transmitting infectious agents. All medicinal products are licensed under the Medicines Act by the Licensing Authority following guidance, for example from the Committee on Safety of Medicines (CSM), the Committee on Dental and Surgical Materials (CDSM) and their subcommittees. The Licensing Authority have been alerted to potential concern about BSE in medicinal products and will ensure that scrutiny of source materials and manufacturing processes now takes account of BSE agent.<br /><br /><br /><a href="http://www.bseinquiry.gov.uk/files/ib/ibd1/tab02.pdf" style="color: #473624; cursor: pointer;">http://www.bseinquiry.gov.uk/files/ib/ibd1/tab02.pdf</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a href="http://web.archive.org/web/20090530225750/http://www.bseinquiry.gov.uk/files/ib/ibd1/tab02.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090530225750/http://www.bseinquiry.gov.uk/files/ib/ibd1/tab02.pdf</a><br /><br /><br />The documents below were provided by Terry S. Singeltary Sr on 8 May 2000. They are optically character read<br /><br />(scanned into computer) and so may contain typos and unreadable parts.<br /><br />TIP740203/l 0424 CONFIDENTIAL<br /><br />Mr Cunningham CMP3 From: D O Hagger MBI Dr Salisbury MED/IMCD3 Mr Burton PD/STB/PG1B B/17/2 Date: 15.02.1989 Mr Dudley PD/AD4<br /><br />BOVINE SPONGIFORM ENCEPHALOPATHY<br /><br />1. The purpose of this minute is to alert you to recent developments on BSE as they affect medicines and to invite representatives to a meeting in Market Towers on 22 February 1989.<br /><br />2. The report of the Working Party on Bovine Spongiform Encephalopathy (BSE) was submitted by the CMO to the Secretary of State for Health and Minister for Agriculturer on 9 February.<br /><br />3. The summary at the end of the report records, inter alia: 'we have drawn the attention of the Licensing Authority to the potential of transfer of BSE agent in human and veterinary medicinal products. In paragraph 7 of his submission (Annex A), the CMO notes:<br /><br />"I am also putting work urgently in hand to satisfy myself that everything possible has been done to ensure .... that transfer of the BSE agent in human and veterinary medicinal products does not occur."<br /><br />4. The Veterinary products Committee meets on 16 February and The committee on Safety of Medicines on 23 February when each will be considering a draft of some joint guidelines for manufacturers of medicinal products which use bovine material as an ingredient or an intermediate in the manufacturing process (Annex B).....<br /><br />6. Although a wide range of medicines may be implicated - and the present proposal is to write to companies for more information - an "instant" telephone survey of manufacturer of vaccines used for children has already been undertaken in response to a request from Dr Harris. The results are in Dr Adams' minute of 14 February (Annex C) - the proviso in his second paragraph, last sentence should be noted. 89/02.15/11.1<br /><br />89/02.15/11.2 MF580439/1 0584 SOUTHWOOD REPORT: BSE AND MEDICINAL PRODUCTS<br /><br />1. I attach a list of questions on BSE and medicines compiled with the aim of providing question and answer briefing to DH and MAFF Ministers upon publication of the Southwood Report. I have suggested names of those who may be able to provide answers. All recipients are invited to consider which if any important areas have been missed. Also attached is copy QA briefing being proposed by MAFF. I understand MAFF have produced General QA briefing on the reports as a whole. ..<br /><br />MF580439/1 0585 Question<br /><br />1. Which medicines are affected? (person to provide reply) Dr. Jefferys<br /><br />2. Are the risks greater with some medicines than others? Dr. Jefferys<br /><br />3. Why are medicines affected? Dr. Jefferys<br /><br />4. Are some affected products available over the counter from pharmacies or shops? Dr. Purves<br /><br />5. Are only UK products at risk? Dr. Jefferys<br /><br />6. Are existing stocks safe? Dr. Jefferys<br /><br />7. Are pre 1980 stocks available? Mr. Burton<br /><br />8. Are these alternatives to the use of bovine material? Dr. Purves<br /><br />9. Why can't we throw away suspect stock and import or manufacture safe medicines? Dr. Jefferys<br /><br />10. Which patients are at risk? Dr. Jefferys<br /><br />11. Are some patients particularly vulnerable? Dr Jefferys<br /><br />12. What risks exist to those who have already used these medicines? Dr. Jefferys<br /><br />13. HOW might patients be affected? Dr. Jefferys<br /><br />14. Can BSE be transmitted to patients by medicines? Dr. Jefferys<br /><br />15. How long will it be before risks are quantified? Dr. Jefferys<br /><br />100 89/02.17/10.2 MF580439/1 0586<br /><br />16. What research is going on to find out if medicines can transmit this disease and if any patients have been affected? Dr Jefferys<br /><br />17. Could recent cases of Creuuzfeld Jacob Disease have been caused by transmission of BSE through medicines? Dr. Jefferys<br /><br />18. What action is the Licensing Authority taking to ensure proper scrutinising of source materials and manufacturing processes? Dr. Jefferys/Dr. Purves<br /><br />19. Are the guidelines practical? Dr. Jefferys/Dr. Purves<br /><br />20. Will the guidelines remove the risk? Dr. Jefferys<br /><br />21. How will the guidelines be enforced? Dr. Jefferys/Dr. Purves<br /><br />22. How soon will they come into force? Dr. Jefferys<br /><br />23. Will the guidelines be published? Mr. Hagger<br /><br />24. What is being done to reassure patients, parents etc? Mr. Hagger/Dr. Salisbury<br /><br />25. What advice is being given to doctors, pharmacists etc? Mr. Hagger<br /><br />26. What advice is the Government giving about its vaccination programme? Dr. Salisbury<br /><br />27. Is the vaccination programme put at risk because of BSE? Dr. Salisbury<br /><br />89/02.17/10.3<br /><br />Q. Will government act on this?<br /><br />A. Yes - thymus is not used in preparation of baby foods but it is contacting all manufacturers to seek their urgent views on use of kidneys and liver from ruminants. Will consider any necessary measures in the light of their response.<br /><br />VETERINARY MEDICINES<br /><br />Q. Can medicines spread BSE to other cattle/animals?<br /><br />A. The report describes any risks as remote.<br /><br />Q. How can risks be avoided?<br /><br />A. In liaison with the DOH the Veterinary Products Committee is examining guidelines for the veterinary pharmaceutical industry which will be issued shortly.<br /><br />Q. What will Guidelines say?<br /><br />A. In essence they call for non-bovine sources to be used if possible, including synthetic material of biotechnological origin. Where this is not possible the industry should look for sources which are free of BSE and which are collected in a manner which avoids risk of contamination by the BSE agent.<br /><br />89/02.17/10.4 MF580439/1 0588<br /><br />A. Bovine source material is used in [garbled, cannot read...TSS] and some other medicines.<br /><br />Q. How many medicines are involved?<br /><br />A. Computer records show that about 300 of the 3,050 veterinary medicines licensed in the U.K. are manufactured directly from bovine source material. However, other medicines may be produced from bovine sources and a letter is going to all license holders so that a comprehensive list can be drawn up.<br /><br />89/06.19/8.1 BSE3/1 0191 Hr J Maslin (MAFF) Ref: Maslin3g<br /><br />From: Dr H Pickles Med SEB/B Date: 3 July 1989<br /><br />CATTLE BY-PRODUCTS AND BSE<br /><br />I was interested to see the list of by-products sent to the HSE. Those of particular concern included:<br /><br />* small intestines: sutures (I thought the source was ovine but you are checking this)<br /><br />* spinal cord: pharmaceuticals<br /><br />* thymus: pharmaceuticals<br /><br />Are you able to give me more information on which UK manufacturers use these materials? Our proposed ban on bovine offal for human consumption would not affect these uses, I assume.<br /><br />Id No. 1934/RD/1 89/08.10/6.1 117A<br /><br />BOVINE SPONGIFORM ENCEPHALAPATHY MEETING HELD ON 21 AUGUST 1989 AT 2;15 IN ROOM 720 Miss M Duncan (Chairman) Mr W Burton Dr E Hoxey Mrs J Dhell Ms K Turner Dr S Whittle Mr N Weatherhead ... 5. The MCA had sent 2700 questionnaires out, 1,124 had made valid returns; of these 122 use animal material of some kind and there are 582 products involved. ... 6. The MCA/BSE working group will meet on 6th September. Their aim is to review responses from professional officers in MCA who have suggested seven categories of importance (with 1 being the most important} for medical products:<br /><br />ID 2267/NRE/1 89/08.21/10.1<br /><br />1. Products with Bovine brain/lymph tissue administered by injection.<br /><br />2. Products with bovine tissue other than brain/lymph administered by inection.<br /><br />3. Tissue implants/open wound dressing/surgical materials/dental and ophthlamic products with bovine ingredients.<br /><br />4. Products with bovine ingredients administered topically.<br /><br />5. Products with bovine ingredients administered orally.<br /><br />6. Products with other animal/fish/insect/bird ingredients administered by injection/topically/oral routes.<br /><br />7. Products with ingredients derived from animal material by chemical processing (eg stearic acid, gelatine, lanolin ext.<br /><br />The BSE working group will decide which of these are important, and should be examined more closely, and which categories can be eliminated.<br /><br />The responses by the companies were presented by Ms Turner and were categorised by MCA standards, the products that were discussed were all low volume usage products eg sutures, heart valves.<br /><br />8. As the responses included some materials of human origin it was decided that more information should be sought about CJD. There had been 2 recent deaths reported associated with human growth hormone. These were being investigated.<br /><br />9. Re-editing of the Paper on "Incubation of Scrapie-like Agents"<br /><br />It was suggested that the document could be sent out to companies with the non-standard sterilization Document. The document could have severe implications on the companies whose products have a high risk factor as decided by the MCA working group....<br /><br />11. The Need for a list of High Priority Implantables The commitee decided that no list is necessary as all implantables, including ones from a human source are of high priority. Concern was shown over Killingbeck who use human material but had not yet responded. The company will be chased for a response. Concern was shown over the fact that there may be other scrapie-like organisms in other animals and further enquiries should be made.<br /><br />2334q/RD/4 89/08.21/10.7<br /><br />BOVINE MATERIAL USED IN THE MANUFACTURE OF SURGICAL IMPLANTS AND BLOOD CONTACT MEDICAL DEVICES<br /><br />Glutaraldehyde, formaldehyde, and ethylene oxide are used in the sterilization of these devices.<br /><br />However, glutaraldehyde 4,10,12,19 formaldehyde 5,10,11,13,19 and ethylene oxide 19,23 are all reported to be ineffective methods for sterilization of material infected with the agents of CJD or scrapie.<br /><br />Previous advice and research using the agents of CJD and scrapie, has concentrated on the decontamination of equipment; protection of health care workers from contaminated human material; human growth hormone; and dura mater. The methods developed may not be directly applicable or transferable to material of bovine origin for use in human implantation.<br /><br />2334q/RD/7 89/08.21/10.10 BSE11/2 020 SC1337<br /><br />DEPARTMENT OF HEALTH AND SOCIAL SECURITY Richmood House 79 Whitehall, London SW1A 2NS Telephone 01-210-3000 From the Chief Medical Officer Sir Donald Acheson KBE DM DSc FRCP FFCM FFOM<br /><br />Mr K C Meldrum Chief Veterinary Officer Ministry of Agriculture, Fisheries and Food Government Buildings Hook Rise South Tolworth Surbiton Surrey KT6 7NG<br /><br />3 January 1990<br /><br />Dear Mr. Meldrum,<br /><br />BOVINE SPONGIFORM ENCEPHALOPATHY<br /><br />You will recall that we have previously discussed the potential risks of BSE occurring in other Countries as a result of the continuing export from the UK of meat and bone that may be contaminated by scrapie or possibly BSE.<br /><br />I remain concerned that we are not being consistent in our attempts to contain the risks of BSE. Having banned the feeding of meat and bone meal to ruminants in 1988, we should take steps to prevent these UK products being fed to ruminants in other countries. This could be achieved either through a ban on the export of meat and bone meal, or at least by the proper labelling of these products to make it absolutely clear they should not be fed to ruminants. Unless some such action is taken the difficult problems we have faced with BSE may well occur in other countries who import UK meat and bone meal. Surely it is short sighted for us to risk being seen in future as having been responsible for the introduction of BSE to the food chain in other countries.<br /><br />I would be very interested to hear how you feel this gap in the present prcautionary measures to eliminate BSE should be closed. We should be aiming at the global elimination of this new bovine disease. The export of our meat and bone meal is a continuing risk to other countries.<br /><br />Signed Sincerely Donald Acheson<br /><br />Did the US import fetal calf serum and vaccines from BSE-affected countries? 3002.10.0040: FETAL BOVINE SERUM (FBS) U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date (Customs Value, in Thousands of Dollars) (Units of Quantity: Kilograms)<br /><br /><--- Dec 1998 ---> <--- 1998 YTD ---> Country Quantity Value Quantity Value ================================================================= WORLD TOTAL . . . . . . . 2,727 233 131,486 8,502 Australia . . . . . . . . --- --- 19,637 2,623 Austria . . . . . . . . . --- --- 2,400 191 Belgium . . . . . . . . . --- --- 17 32 Canada . . . . . . . . . 900 110 30,983 3,220 Costa Rica . . . . . . . 500 20 4,677 169 Federal Rep. of Germany --- --- 105 21 Finland . . . . . . . . . 1 8 9 83 France . . . . . . . . . --- --- 73 7 Guatemala . . . . . . . . --- --- 719 42 Honduras . . . . . . . . --- --- 1,108 88 Israel . . . . . . . . . --- --- 24 165 Netherlands . . . . . . . --- --- 1 5 New Zealand . . . . . . . 26 5 65,953 913 Panama . . . . . . . . . --- --- 1,195 64 Switzerland . . . . . . . 971 8 1,078 23 United Kingdom . . . . . 329 82 743 756 Uruguay . . . . . . . . . --- --- 2,764 98 ------------------------------------------------------------------ 3002.20.0000: VACCINES FOR HUMAN MEDICINE U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date (Customs Value, in Thousands of Dollars) (Units of Quantity: Kilograms)<br /><br /><--- Dec 1998 ---> <--- 1998 YTD ---> Country Quantity Value Quantity Value ================================================================= WORLD TOTAL . . . . . . . 25,702 26,150 550,258 378,735 Austria . . . . . . . . . --- --- 45 225 Belgium . . . . . . . . . 14,311 12,029 248,041 199,036 Canada . . . . . . . . . 1,109 1,527 15,798 16,305 Denmark . . . . . . . . . 80 234 246 682 Federal Rep. of Germany 1,064 4,073 12,001 6,329 France . . . . . . . . . 3,902 4,859 87,879 92,845 Ireland . . . . . . . . . --- --- 120 478 Italy . . . . . . . . . . --- --- 2,359 81 Japan . . . . . . . . . . 445 1,903 11,350 11,298 Netherlands . . . . . . . --- --- 94 6 Republic Of South Africa --- --- 2 1 Spain . . . . . . . . . . --- --- 60 30 Switzerland . . . . . . . 716 353 9,303 4,271 United Kingdom . . . . . 4,075 1,172 162,960 47,148 ------------------------------------------------------------------ 3002.30.0000: VACCINES FOR VETRINARY MEDICINE U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date (Customs Value, in Thousands of Dollars) (Units of Quantity: Kilograms)<br /><br /><--- Dec 1998 ---> <--- 1998 YTD ---> Country Quantity Value Quantity Value ================================================================= WORLD TOTAL . . . . . . . 6,528 237 87,149 2,715 Canada . . . . . . . . . --- --- 2,637 305 Federal Rep. of Germany --- --- 104 5 Netherlands . . . . . . . 138 64 472 192 New Zealand . . . . . . . 6,390 173 83,882 1,895 United Kingdom . . . . . --- --- 54 318<br /><br /><br /><a fg_scanned="1" href="http://www.mad-cow.org/00/may00_news.html" style="color: #473624; cursor: pointer;">http://www.mad-cow.org/00/may00_news.html</a><br /><br /><br />Procedures Manual<br /><br />Bovine Spongiform Encephalopathy (BSE)<br /><br />Ongoing Surveillance Plan<br /><br />Ongoing Surveillance Plan Implementation July 20, 2006<br /><br />snip...<br /><br />Personal Safety<br /><br />If BSE is transmissible to humans in the occupational setting, the most likely routes would be through contact with infective tissues through wounds or open lesions on the skin, contact with mucous membranes (eyes and mouth), or exceptionally, by swallowing.<br /><br />.....snip...end<br /><br /><br /><br /><a fg_scanned="1" href="http://www.aphis.usda.gov/vs/nvsl/PDFs/BSE%20Ongoing%20Surveillance%20SOP%207-20-06.doc" style="color: #473624; cursor: pointer;">http://www.aphis.usda.gov/vs/nvsl/PDFs/BSE%20Ongoing%20Surveillance%20SOP%207-20-06.doc</a><br /><br /><br /><br />SO, looks like to me the most likely route of transmission of TSE to humans might be through inoculations that would contain the TSE agent.<br /><br />IF you look at all the successful transmission studies in the lab with TSE agent, inoculations was the most successful route. ...<br /><br />Terry S. Singeltary Sr.<br /><br />P.O. Box 42<br /><br />Bacliff, Texas USA 77518<br /><br />=============================================<br /><br />Subject: Re: 100 Diabetics warned about mad cow exposure tissue came from cattle in the U.S. From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy Date: Sat, 21 Apr 2007 20:46:06 -0500 Content-Type: text/plain Parts/Attachments: text/plain (2171 lines)<br /><br />greetings,<br /><br />i thougt some might want to read some old data on this topic ;<br /><br />36. On 5 June 1989 I sent a minute to the CMO’s Private Secretary [169] (YB 89/06.05/3.1)<br /><br /><br /><a href="http://www.bseinquiry.gov.uk/files/yb/1989/06/05003001.pdf" style="color: #473624; cursor: pointer;">http://www.bseinquiry.gov.uk/files/yb/1989/06/05003001.pdf</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a href="http://web.archive.org/web/20090505223707/http://www.bseinquiry.gov.uk/files/yb/1989/06/05003001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090505223707/http://www.bseinquiry.gov.uk/files/yb/1989/06/05003001.pdf</a><br /><br /><br />reporting on progress. This was unusual for me but I assume I did this I had minuted him previously and because of the degree of involvement the CMO had in the issues. The minute explained that most responses to questionnaires had been received and were currently being reviewed, and a preliminary scan of the data so far available had not identified any information requiring immediate special action. Further, the MCA were applying the new guidelines to licence applications and renewals. The use of bovine insulin in a small group of mainly elderly patients was noted and it was recognised that alternative products for this group were not considered satisfactory. (I seem to recall that later some of these patients did become quite ill when transferred to other forms of insulin.)<br /><br />37. I received a copy of Dr Metters’ minute to Mr Clarke of 7 June 1989 on further measures MAFF were proposing to take to extend the offal ban [170-172] (YB 89/06.07/6.1-6.3).<br /><br /><br /><a href="http://www.bseinquiry.gov.uk/files/yb/1989/06/07006001.pdf" style="color: #473624; cursor: pointer;">http://www.bseinquiry.gov.uk/files/yb/1989/06/07006001.pdf</a><br /><br /><br />NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a href="http://web.archive.org/web/20090505223716/http://www.bseinquiry.gov.uk/files/yb/1989/06/07006001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090505223716/http://www.bseinquiry.gov.uk/files/yb/1989/06/07006001.pdf</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /><br />This advised of the effect this would have of drawing attention to the continued use of bovine material in medicines and brought to Mr Clarke’s attention my minute of 5 June 1989. The following day Dr Metters sent a minute to the CMO’s private secretary which he described as a follow up minute for officials only and it was copied widely to colleagues in the Medicines Division [173-174] (YB 89/06.08/7.1-7.2).<br /><br /><br /><br /><a href="http://www.bseinquiry.gov.uk/files/yb/1989/06/08001001.pdf" style="color: #473624; cursor: pointer;">http://www.bseinquiry.gov.uk/files/yb/1989/06/08001001.pdf</a><br /><br /><br />NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a href="http://web.archive.org/web/20090506060501/http://www.bseinquiry.gov.uk/files/yb/1989/06/08001001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506060501/http://www.bseinquiry.gov.uk/files/yb/1989/06/08001001.pdf</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /><br /><a href="http://www.bseinquiry.gov.uk/files/yb/1989/06/08007001.pdf" style="color: #473624; cursor: pointer;">http://www.bseinquiry.gov.uk/files/yb/1989/06/08007001.pdf</a><br /><br /><br />NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a href="http://web.archive.org/web/20090505220133/http://www.bseinquiry.gov.uk/files/yb/1989/06/08007001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090505220133/http://www.bseinquiry.gov.uk/files/yb/1989/06/08007001.pdf</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /><br />38. On 9 June Dr Metters similarly updated the CMO on developments [175-186] (YB 89/06.07/6.1-6.3 ; 89/06.07/7.1-7.2 ; 89/06.05/3.1 ; 89/06.09/5.1-5.4) .<br /><br /><br /><a href="http://www.bseinquiry.gov.uk/files/yb/1989/06/09005001.pdf" style="color: #473624; cursor: pointer;">http://www.bseinquiry.gov.uk/files/yb/1989/06/09005001.pdf</a><br /><br /><br />NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a href="http://web.archive.org/web/20090505220106/http://www.bseinquiry.gov.uk/files/yb/1989/06/09005001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090505220106/http://www.bseinquiry.gov.uk/files/yb/1989/06/09005001.pdf</a><br /><br /><br />The same day in a minute to Mr Wilson and various other colleagues [187] (YB 89/06.09/14.1)<br /><br /><br /><a href="http://www.bseinquiry.gov.uk/files/yb/1989/06/09014001.pdf" style="color: #473624; cursor: pointer;">http://www.bseinquiry.gov.uk/files/yb/1989/06/09014001.pdf</a><br /><br /><br />NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a href="http://web.archive.org/web/20090505223301/http://www.bseinquiry.gov.uk/files/yb/1989/06/09014001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090505223301/http://www.bseinquiry.gov.uk/files/yb/1989/06/09014001.pdf</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /><br /><a href="http://www.bseinquiry.gov.uk/files/yb/1989/06/27008001.pdf" style="color: #473624; cursor: pointer;">http://www.bseinquiry.gov.uk/files/yb/1989/06/27008001.pdf</a><br /><br /><br />NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a href="http://web.archive.org/web/20090506060722/http://www.bseinquiry.gov.uk/files/yb/1989/06/27008001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506060722/http://www.bseinquiry.gov.uk/files/yb/1989/06/27008001.pdf</a><br /><br /><br />I relayed the information about the proposed offal ban and also sought comments on the recommendations on pharmaceutical research issues that had been provided in draft by the Tyrrell Committee. (The report was submitted to Ministers on 13 June 1989.) On 7 September Dr Pickles sent me a minute regarding the Tyrrell report and its implication for medicinal products [196-197] (YB 89/09.07/3.1-3.2).<br /><br />Subsequently there was a fair amount of correspondence between the Departments and their ministers about funding Tyrrell’s research proposals. I was not involved in this issue.<br /><br />39. Questionnaire responses were analysed and outstanding replies were requested so that papers were ready for the BSE Working Party chaired by Professor Collee to consider them at a meeting on 6 September 1989 [188-195] (YB 89/09.06/10.1-10.8). I did not attend but I would have seen the minutes or the recommendations, which would have been available for the CSM’s meeting on 28 September 1989 [198-205] (YB<br /><br />89/09.28/10.1-10.8). (I was not involved in the deliberations over the sourcing of bovine material for a particular licensed surgical suture because this was the remit of the CDSM which, at that time, fell outside my area of responsibility.) The recommendations of the BSE Working Party were:-<br /><br />"1. That no licensing action is required at present in regard to products produced from bovine material or using prepared bovine brain in nutrient media and sourced from outside the United Kingdom, the Channel Isles and the Republic of Ireland provided that the country of origin is known to be free of BSE, has competent veterinary advisers and is known to practise good animal husbandry.<br /><br />2. The Joint CSM/VPC guidelines should apply to all bovine material sourced from UK, Channel Islands and the Republic of Ireland and any other area known to have BSE. Companies which at present cannot comply should be encouraged to do so as soon as possible. The timescale should be agreed with the Licensing Authority for each individual product as appropriate.<br /><br />3. No licensing action is required at present with respect to products containing material from animals other than cattle.<br /><br />4. The Licensing Authority should continue to review scientific progress in<br /><br />the field of BSE, so as to be in a position to take licensing action in the future should this be necessary."<br /><br />The CSM endorsed these recommendations.<br /><br />40. I discussed the action to be taken following the CSM meeting with Dr Jefferys, Dr Adams and Dr Purves around 13 October as documented in a memo from Dr Jefferys to Mr Love of that date [206] (YB 90/10.13/6.1). We agreed that the further advice of the BSE Working Group was needed and a meeting was planned for January 1990.<br /><br />41. I later received a copy of a minute dated 14 November from Mr Robertson, who at that time was responsible for administrative issues relating to the CDSM (and therefore for products such as sutures which were considered by the CDSM) to Mr Davey, the private secretary to the Minister for Health and copied to the private secretaries to the other relevant ministers and to the CMO, regarding the possibility of media comment following a scientific conference on BSE to be held at the RSM the following day. The minute reiterated the advice of the Southwood report that the risk to man from medicinal products was theoretical and remote, referred to the CSM/VPC guidelines on manufacturing issued in March 1989 and confirmed that the CSM and MCA were continuing to monitor the position [207-209]. (YB 89/11.14/13.1-13.3)<br /><br />1990<br /><br />42. I did not attend the January 1990 meeting of the CSM BSE Working Group [210-233] (YB 90/01.10/7.1-7.7 ; 89/09.06/15.1-15.3) 221-233 (L2 Tab 3B) or the February CSM meeting [234-237] (YB 90/02.21/10.1-10.8); as a result of the MCA reorganisation (see below) my responsibilities had changed and these matters were no longer in my area. I cannot remember whether I would have seen the papers circulated for these meetings. By about February the new shadow businesses had been formed in the MCA, I had become co-ordinator for Business E (which was to take on responsibility for the Medicines Commission and the Medicines database but otherwise had no responsibilities for licensing matters, the CSM or other committees, or BSE) and Mr Bewley, the CSM Secretary, had become part of the management trio for Business A. In the Department's Distribution of Business, however, I continued to be shown as MB1 until October 1990 and so continued to receive some Departmental correspondence. Where I received material that was not for Business E or, later, B I would have passed it on to the appropriate person for action.<br /><br />43. On 13 March the European Commission gave a decision regarding BSE, banning the export of certain bovine tissues and organs for human consumption and certain other bovine tissues and organs (including foetal calf serum, lymphoid tissue and cell cultures) for uses other than human consumption. Dr Metters subsequently sent a minute to Mr Bewley, copied to me, commenting on the possible effect of this decision on UK pharmaceuticals. He asked whether the CSM BSE Working Party had considered whether licensed products that still used bovine constituents should be asked to transfer to non-UK bovine source material [238] (YB 90/03.26/6.1). Mr Bewley (ex-MB1C but now Business A and Secretary to the CSM) responded to Dr Metters by a minute of 27 April 1990 (copied to various people including me) [244-254] (YB 90/04.27/5.1-5.4) which provided an update as to the current position on the few licensed medicines using bovine material sourced from the UK including stocks of vaccines; all new products were required to meet the guidelines. Dr Metters was also informed of the advice of the BSE Working Group. In a further minute of 1 May, Dr Metters indicated that he had noted the recommendations of the Working Group; he commented that even though any risk of transmissions of BSE through vaccination was remote, it would be desirable to replace existing vaccine stocks with New Zealand sourced products as soon as possible [255] (YB 90/5.1/8.1). He requested to be kept abreast of developments and would have discussed the issue with CMO if he had considered this appropriate.<br /><br />44. On 26 April 1990 I attended a CSM meeting [239-243] (YB 90/04.26/9.1-9.5) at which a letter from the British Diabetic Association concerning the safety of bovine insulin was considered and a response approved confirming there was no insulin sourced from cattle in the UK or Ireland and that the situation in other countries was being monitored. By this time, I would have been aware of my impending appointment to Business B (Abridged Licensing) and that I would be establishing new links with the CSM.<br /><br /><br /><a href="http://www.bseinquiry.gov.uk/files/ws/s476.pdf" style="color: #473624; cursor: pointer;">http://www.bseinquiry.gov.uk/files/ws/s476.pdf</a><br /><br /><br />NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a href="http://web.archive.org/web/20090927120250/http://www.bseinquiry.gov.uk/files/ws/s476.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090927120250/http://www.bseinquiry.gov.uk/files/ws/s476.pdf</a><br /><br /><br />Bovine insulin<br /><br />From: "Terry S. Singeltary Sr."<br /><br />Hello , it might be beneficial for you to read the DFA 17. it has some valuable information in it, but some is outdated. there is disturbing news on the DOSE, and just how much infectivity it takes to infect an individual. i will post next. meanwhile, the url to DFA 17 is below the short article........<br /><br />regards, Terry<br /><br />--------------<br /><br />207. On 17 March 1988 Dr Watson and Mr Alastair Cruickshank, Under Secretary of MAFF, attended a meeting with the CMO and senior medical officials at the DHSS to discuss BSE.[249] The minute of the meeting records:<br /><br />6. Biological products were produced of bovine origin and this applied to a significant proportion of insulin despite genetically manufactured sources. In addition, cell cultures for many vaccines used a bovine serum medium. Dr Harris undertook to speak to the Director of NIBSC about biological products. 13. Mr Cruickshank thought it necessary to assess the risk in humans in order to justify the cost of any control measures taken by MAFF. Although it would be possible to monitor diabetics, it could take 20 years or more before we would be able to assess whether any risk existed from bovine insulin. In the meantime, with some 40 or so new cases in cattle a month, the disease would become newsworthy and it was important that both government departments arrange appropriate action before this happened. 14. In conclusion it was agreed that urgent advice was necessary on biological products and the disposal of sick animals. The options would be outlined to Ministers (of both government departments) and they would be asked to agree the setting up of an expert advisory group.<br /><br />----------------<br /><br />Medicines and medical devises;<br /><br />----------------<br /><br />235. On 2 June 1988, Dr Pickles responded to Mrs Alderman requesting a further database search and asking about bovine insulin, which was not on the list of products, although licensed. She also asked about the species used in the manufacture of any licensed rabies vaccines.[281] 236. Mrs Alderman replied on 3 June 1988, listing products containing bovine insulin and noting there were two rabies vaccines listed but the species used in manufacture was not shown.[282]<br /><br />-----------------------<br /><br />‘There has been one instance of inadvertant [sic] transmission of the scrapie agent to sheep through louping ill vaccine (Gordon, Bronlee and Wilson 1939). One of the three batches of vaccine made in 1935 at the Moredun Institute contained the scrapie agent resulting in 7% of the recipients of the 18, 000 doses in the batch developing scrapie. This vaccine was made from formalin-inactivated sheep brain, and brought to the attention of research workers that formalin, at a concentration of 0.35% for at least 3 months, which inactivated conventional viruses, did not totally inactivate the scrapie agent.<br /><br />----------------------------<br /><br />4. Questions we might want to have answered are: the highest risk would be from parenterals prepared from brain (eg rabies vaccine). Any species in which transmissible spongiform encephalopathies have been described would be suspect (“natural” infections in sheep, goats, cattle, deer, mink, but can be transmitted to hamster, mouse, guinea-pig etc). ..........<br /><br />Subject: Re: Bovine Insulin CJD/BSE $ Ignorant Doctors (Part 2) Date: December 6, 2000 at 8:05 am PST<br /><br />In Reply to: Bovine Insulin CJD/BSE $ Ignorant Doctors posted by TSS on December 6, 2000 at 8:03 am:<br /><br />4. Questions we might want to have answered are: the highest risk would be from parenterals prepared from brain (eg rabies vaccine). Any species in which transmissible spongiform encephalopathies have been described would be suspect (“natural” infections in sheep, goats, cattle, deer, mink, but can be transmitted to hamster, mouse, guinea-pig etc). Are sterilisation processes adequate for the most resistant strain of scrapie agent or for CJD agent? Should companies be asked to include investigation for inclusion of scrapie agent (eg mouse innoculation [sic]) in at least some batches? If BSE behaves like scrapie, then we might expect other nervous tissue, spleen, lymph nodes and placenta to be contaminated. Infection has been described in other tissues too, eg gut wall, and we can not [sic] be sure blood is free. Do we know what bovine materials are used in which products, both as the active ingredient and in production? Bovine active ingredients in human products include insulin, vasopressin, bone, immune globulins, fibrin, dermal collagen, albumin. Bovine serum albumin and fetal calf serum must be used in preparation of very many products. For each of these products would any “BSE agent” be destroyed or eliminated in processing? If not, and the product is administered parenterally or topically into an open wound, might there be a risk? [For oral products, there would only be a trivially increased load on top of that taken in food in omnivores/carnivores including man. But for some herbivores, this might allow the agent to be introduced into yet another species].<br /><br />--------------------------<br /><br />271. The second part of the paper, entitled ‘Bovine Spongiform Encephalopathy – Action by Medicines Division’ states: 1.Product Licence Situation The computer list shows 53 product licences extant for preparations of bovine origin and of these 42 are for insulin. It is not clear how complete this list is, particularly on the review side where there may be grounds for concern, especially with regard to products for cellular therapy.<br /><br />-----------------------------<br /><br />3.1 Parenteral use There are three products in this category: i. Insulin ii. Bovine collagen implants iii. Bovine fibrin implants. The latter two are used in surgery and are the province of the CDSM.<br /><br />------------------------------<br /><br />6.2 Parenteral products<br /><br />The major problem here appears to be with insulin. The use of bovine insulin is rapidly declining and maybe restricted to those patients who have antibodies to the human preparation, or who cannot tolerate it. In this case bovine insulin is life saving, and the risk to benefit would currently be in favour of retaining its use.<br /><br />In addition to this for parenteral products in general:<br /><br />i. All cattle used for the preparation of these products should come from certified healthy herds, and not to have been given food supplements containing material of animal origin. ii. No brain or lymphoid tissue should be used in parenteral products. iii. Manufacturers of parenteral products should show that their manufacturing procedure is capable of inactivating scrapie-like agents. iv. While the agent of BSE is not known it is not possible to advise specific inactivation processes.<br /><br />7. Recommendations for action<br /><br />i. No licensing action should be taken against oral products. ii. All bovine products should come from cattle from healthy herds, which have not been given food supplements containing material of animal origin. No brain or lymphoid tissue should be used in parenteral products. iii. Manufacturers of parenteral products should show that their manufacturing processes are capable of inactivating scrapie-like agents. iv. All licences for new products from bovine material should comply with the above. v. The Review/CDSM Sections should carry out a search for preparations containing bovine material. vi. There should be an article in MAIL requesting manufacturers to identify bovine preparations used in the manufacturing process. Bovine albumin and foetal calf serum should come from healthy herds. vii. The ADR database should be searched for ADRs to bovine products. viii. The Committee is asked to consider whether to take any action against bovine insulin or whether the risk/benefit ratio is appropriate.’[319]<br /><br />------------------------------<br /><br />hope this helps out.<br /><br />HUMAN/ANIMAL TSE's ARE A 'WORLD' PROBLEM.....<br /><br />TSS<br /><br />BSE Inquiry Draft Factual Account 17<br /><br /><br /><a fg_scanned="1" href="http://www.bse.org.uk/dfa/dfa17.htm" style="color: #473624; cursor: pointer;">http://www.bse.org.uk/dfa/dfa17.htm</a><br /><br /><br />NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a fg_scanned="1" href="http://web.archive.org/web/20000830205627/http://www.bse.org.uk/dfa/dfa17.htm" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20000830205627/http://www.bse.org.uk/dfa/dfa17.htm</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /><br />Q-3. What are FDA s concerns regarding the importation of beef insulin for my personal use?<br /><br />A. There is a possible threat of bovine spongiform encephalopathy (BSE) or "mad cow disease" transmission through the use of beef insulin if derived from tissue contaminated with BSE agent.<br /><br /><br /><a fg_scanned="1" href="http://www.fda.gov/cder/drug/beefinsulin/default.htm#Q-3" style="color: #473624; cursor: pointer;">http://www.fda.gov/cder/drug/beefinsulin/default.htm#Q-3</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a fg_scanned="1" href="http://web.archive.org/web/20040322010413/http://www.fda.gov/cder/drug/beefinsulin/default.htm#Q-3" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20040322010413/http://www.fda.gov/cder/drug/beefinsulin/default.htm#Q-3</a><br /><br /><br />BOVINE INSULIN AND BSE</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /><br /><a href="http://www.bseinquiry.gov.uk/files/yb/1990/04/30006001.pdf" style="color: #473624; cursor: pointer;">http://www.bseinquiry.gov.uk/files/yb/1990/04/30006001.pdf</a><br /><br /><br />NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a href="http://web.archive.org/web/20090505222623/http://www.bseinquiry.gov.uk/files/yb/1990/04/30006001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090505222623/http://www.bseinquiry.gov.uk/files/yb/1990/04/30006001.pdf</a><br /><br /><br /><a fg_scanned="1" href="http://www.mad-cow.org/00/may00_news.html" style="color: #473624; cursor: pointer;">http://www.mad-cow.org/00/may00_news.html</a><br /><br /><br />Human vaccine prepared in animal brains<br /><br /><br /><a fg_scanned="1" href="http://www.mad-cow.org/00/nov00_late_news.html#fff" style="color: #473624; cursor: pointer;">http://www.mad-cow.org/00/nov00_late_news.html#fff</a><br /><br /><br /><a fg_scanned="1" href="http://www.whale.to/v/singeltary7.html" style="color: #473624; cursor: pointer;">http://www.whale.to/v/singeltary7.html</a><br /><br /><br /><a fg_scanned="1" href="http://www.mad-cow.org/00/jul00_dont_eat_sheep.html#hhh" style="color: #473624; cursor: pointer;">http://www.mad-cow.org/00/jul00_dont_eat_sheep.html#hhh</a><br /><br /><br />COMMERCIAL IN CONFIDENCE NOT FOR PUBLICATION SUB COMMITTEE ON BIOLOGICALS. COMMITTEE ON SAFETY OF MEDICINES<br /><br />CSM/SEAR/88 10TH MEETING. BIOLS/88/6TH MEETING<br /><br />This paper was discussed by the Biological Sub-Committee on 2 November 1988, when the following recommendations were made;<br /><br />1. No immediate licensing action should be taken against oral products, in which bovine material has been used.<br /><br />2. All bovine materials should come from cattle from appropriately certified healthy herds, which have not been given food supplements containing material of animal origin. No brain or lymphoid tissue should be used in parenteral products.'<br /><br />3. Manufacturers of parenteral products should show that their manufacturing processes are capable of eliminating scrapie-like agents.<br /><br />4. All licences for new products from bovine materials should comply with the above.<br /><br />5. There should be an article in MAIL requesting manufacturers to identify products in which bovine materials have been used. Bovine albumin and foetal calf serum should come from appropriately certified healthy herds.<br /><br />6. The above should be drawn to the attention of the review/CDSM sections along with the need to search for preparations containing bovine material.<br /><br />7. The above should be drawn to the attention of the ADR Section and SEAR along with the need to search the ADR database for reactions to bovine products.<br /><br />REMARK.<br /><br />1. The Licensing Authority's attention was drawn to the need to give ongoing consideration to whether action was required on bovine insulin and heparin products.<br /><br />88/11.02/5.1<br /><br /><br /><a href="http://www.bseinquiry.gov.uk/files/yb/1988/11/02005001.pdf" style="color: #473624; cursor: pointer;">http://www.bseinquiry.gov.uk/files/yb/1988/11/02005001.pdf</a><br /><br /><br />NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a href="http://web.archive.org/web/20090506070201/http://www.bseinquiry.gov.uk/files/yb/1988/11/02005001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090506070201/http://www.bseinquiry.gov.uk/files/yb/1988/11/02005001.pdf</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /><br />'political risk of worrying large number of diabetic patients'<br /><br /><br /><a href="http://www.bseinquiry.gov.uk/files/yb/1988/05/24003001.pdf" style="color: #473624; cursor: pointer;">http://www.bseinquiry.gov.uk/files/yb/1988/05/24003001.pdf</a><br /><br /><br />NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a href="http://web.archive.org/web/20090505224016/http://www.bseinquiry.gov.uk/files/yb/1988/05/24003001.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090505224016/http://www.bseinquiry.gov.uk/files/yb/1988/05/24003001.pdf</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br />207. On 17 March 1988 Dr Watson and Mr Alastair Cruickshank, Under Secretary of MAFF, attended a meeting with the CMO and senior medical officials at the DHSS to discuss BSE.[249] The minute of the meeting records: 6. Biological products were produced of bovine origin and this applied to a significant proportion of insulin despite genetically manufactured sources. In addition, cell cultures for many vaccines used a bovine serum medium. Dr Harris undertook to speak to the Director of NIBSC about biological products. 13. Mr Cruickshank thought it necessary to assess the risk in humans in order to justify the cost of any control measures taken by MAFF. Although it would be possible to monitor diabetics, it could take 20 years or more before we would be able to assess whether any risk existed from bovine insulin. In the meantime, with some 40 or so new cases in cattle a month, the disease would become newsworthy and it was important that both government departments arrange appropriate action before this happened. 14. In conclusion it was agreed that urgent advice was necessary on biological products and the disposal of sick animals. The options would be outlined to Ministers (of both government departments) and they would be asked to agree the setting up of an expert advisory group.<br /><br />----------------<br /><br />Medicines and medical devises;<br /><br /><br /><a fg_scanned="1" href="http://www.bse.org.uk/dfa/dfa17.htm" style="color: #473624; cursor: pointer;">http://www.bse.org.uk/dfa/dfa17.htm</a><br /><br /><br />NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a fg_scanned="1" href="http://web.archive.org/web/20001219215500/http://www.bse.org.uk/dfa/dfa17.htm" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20001219215500/http://www.bse.org.uk/dfa/dfa17.htm</a><br /><br />----------------<br /><br />235. On 2 June 1988, Dr Pickles responded to Mrs Alderman requesting a further database search and asking about bovine insulin, which was not on the list of products, although licensed. She also asked about the species used in the manufacture of any licensed rabies vaccines.[281]<br /><br />236. Mrs Alderman replied on 3 June 1988, listing products containing bovine insulin and noting there were two rabies vaccines listed but the species used in manufacture was not shown.[282]<br /><br />-----------------------<br /><br />‘There has been one instance of inadvertant [sic] transmission of the scrapie agent to sheep through louping ill vaccine (Gordon, Bronlee and Wilson 1939). One of the three batches of vaccine made in 1935 at the Moredun Institute contained the scrapie agent resulting in 7% of the recipients of the 18, 000 doses in the batch developing scrapie. This vaccine was made from formalin-inactivated sheep brain, and brought to the attention of research workers that formalin, at a concentration of 0.35% for at least 3 months, which inactivated conventional viruses, did not totally inactivate the scrapie agent.<br /><br />----------------------------<br /><br />4. Questions we might want to have answered are: the highest risk would be from parenterals prepared from brain (eg rabies vaccine). Any species in which transmissible spongiform encephalopathies have been described would be suspect (“natural” infections in sheep, goats, cattle, deer, mink, but can be transmitted to hamster, mouse, guinea-pig etc). Are sterilisation processes adequate for the most resistant strain of scrapie agent or for CJD agent? Should companies be asked to include investigation for inclusion of scrapie agent (eg mouse innoculation [sic]) in at least some batches? If BSE behaves like scrapie, then we might expect other nervous tissue, spleen, lymph nodes and placenta to be contaminated. Infection has been described in other tissues too, eg gut wall, and we can not [sic] be sure blood is free. Do we know what bovine materials are used in which products, both as the active ingredient and in production? Bovine active ingredients in human products include insulin, vasopressin, bone, immune globulins, fibrin, dermal collagen, albumin. Bovine serum albumin and fetal calf serum must be used in preparation of very many products. For each of these products would any “BSE agent” be destroyed or eliminated in processing? If not, and the product is administered parenterally or topically into an open wound, might there be a risk? [For oral products, there would only be a trivially increased load on top of that taken in food in omnivores/carnivores including man. But for some herbivores, this might allow the agent to be introduced into yet another species].<br /><br />--------------------------<br /><br />271. The second part of the paper, entitled ‘Bovine Spongiform Encephalopathy – Action by Medicines Division’ states: 1.Product Licence Situation The computer list shows 53 product licences extant for preparations of bovine origin and of these 42 are for insulin. It is not clear how complete this list is, particularly on the review side where there may be grounds for concern, especially with regard to products for cellular therapy.<br /><br />-----------------------------<br /><br />3.1 Parenteral use There are three products in this category: i. Insulin ii. Bovine collagen implants iii. Bovine fibrin implants. The latter two are used in surgery and are the province of the CDSM.<br /><br />------------------------------<br /><br />6.2 Parenteral products The major problem here appears to be with insulin. The use of bovine insulin is rapidly declining and maybe restricted to those patients who have antibodies to the human preparation, or who cannot tolerate it. In this case bovine insulin is life saving, and the risk to benefit would currently be in favour of retaining its use. In addition to this for parenteral products in general: i. All cattle used for the preparation of these products should come from certified healthy herds, and not to have been given food supplements containing material of animal origin. ii. No brain or lymphoid tissue should be used in parenteral products. iii. Manufacturers of parenteral products should show that their manufacturing procedure is capable of inactivating scrapie-like agents. iv. While the agent of BSE is not known it is not possible to advise specific inactivation processes. 7. Recommendations for action i. No licensing action should be taken against oral products. ii. All bovine products should come from cattle from healthy herds, which have not been given food supplements containing material of animal origin. No brain or lymphoid tissue should be used in parenteral products. iii. Manufacturers of parenteral products should show that their manufacturing processes are capable of inactivating scrapie-like agents. iv. All licences for new products from bovine material should comply with the above. v. The Review/CDSM Sections should carry out a search for preparations containing bovine material. vi. There should be an article in MAIL requesting manufacturers to identify bovine preparations used in the manufacturing process. Bovine albumin and foetal calf serum should come from healthy herds. vii. The ADR database should be searched for ADRs to bovine products. viii. The Committee is asked to consider whether to take any action against bovine insulin or whether the risk/benefit ratio is appropriate.’[319]<br /><br />------------------------------<br /><br />hope this helps out........TSS<br /><br />Rick Wolf wrote:<br /><br />From: "Rick Wolf"<br /><br />My mother who died of CJD in 1998 was an diabetic requiring insulin<br /><br />since the 1960s. She used a bovine based insulin for many years. I<br /><br />read in the newpaper yesterday that blood banks are screening<br /><br />people who may have used bovine base insulin before 1985 because of<br /><br />potential risk of CJD/TSE.<br /><br />Does anyone have any more info on this? For those that lost a loved<br /><br />one to CJD, did they use bovine based insulin?<br /><br />Robin<br /><br />----------------------------------------------------------------------<br /><br />Eileen MacArthur wrote:<br /><br />From: Eileen MacArthur<br /><br />Terry...<br /><br />Just got your info on beef insulin..what a blow to read it in<br /><br />print. Strange we always suspected a connection with it to Mom who died July<br /><br />17/98. She took it for 27 years...now I really am wondering. I too take<br /><br />insulin but not that one.<br /><br />Eileen<br /><br />Reading your emails about vaccines brought something to mind.<br /><br />Although my mom was the one that died on Dec. 10, 98 from CJD....... my dad died on June 20, 83 from complications with diabeties. I remember dad saying insulin was made from pork. Is this still true?<br /><br />Could diabetics be at a higher risk for CJD?<br /><br />Terry, would you know anything about this? Just wondering......<br /><br />Thanks, Suzanne riptss<br /><br />Terry...<br /><br />Just got your info on beef insulin..what a blow to read it in print. Strange we always suspected a connection with it to Mom who died July<br /><br />17/98. She took it for 27 years...now I really am wondering. I too take insulin but not that one. Eileen<br /><br />Greetings Voice members, after reading over Paul Brown statement to Robin, I find them most interesting, hope he is correct... Terry<br /><br />____________________________________________________________<br /><br />Another thing....I asked Dr. Brown about the Hep. B. shot and it being manufactured in the U.K. and Belgium and here was his reply......<br /><br />Dear Robin:<br /><br />Thanks for the name and address.<br /><br />As for vaccines, I'm not an expert, but Hepatitis B can under some circumstances be transmitted from person to person without needle or sexual penetration, and so for public health purposes I suppose it is justified to require vaccination.<br /><br />As for risk of CJD, you would not need to worry, even if the vaccine was stabilized with albumin from a cow with BSE! Blood from BSE-infected cattle is not infectious, and even if it were, the albumin extracted from it would not be infectious. Both of these statements are based on experimental evidence.<br /><br />Hope this helps Paul<br /><br />----------------------------------------------------------------oooops...........tss<br /><br />9663 Re: [CJDVoice] Your help again [CJD QUESTIONNAIRE PART 3] ... date, name of the medication, the reason for taking it, and route of administration) prompt for prescription drugs, including insulin and type. _ _ _ Prompt for hormone therapy or nutritional supplements including oral contraceptives and hormone replacement ... </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Terry S. Singeltary Sr. Nov 18, 2001 9:09 pm 19662 </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Re: [CJDVoice] Your help again [CJD QUESTIONNAIRE PART 2] ... the date, name of the medication, the reason for taking it, and route of administration) prompt for prescription drugs, including insulin and type. _ _ _ Prompt for hormone therapy or nutritional supplements including oral contraceptives and hormone replacement therapy ... Terry S. Singeltary Sr. Nov 18, 2001 8:59 pm<br /><br /><a href="http://health.groups.yahoo.com/group/cjdvoice/msearch?query=insulin&pos=100&cnt=10" style="color: #473624; cursor: pointer;">http://health.groups.yahoo.com/group/cjdvoice/msearch?query=insulin&pos=100&cnt=10</a><br /><br /><a href="http://health.groups.yahoo.com/group/cjdvoice/message/22712" style="color: #473624; cursor: pointer;">http://health.groups.yahoo.com/group/cjdvoice/message/22712</a><br /><br /><a href="http://health.groups.yahoo.com/group/cjdvoice/message/22711" style="color: #473624; cursor: pointer;">http://health.groups.yahoo.com/group/cjdvoice/message/22711</a><br /><br /><a href="http://health.groups.yahoo.com/group/cjdvoice/message/22695" style="color: #473624; cursor: pointer;">http://health.groups.yahoo.com/group/cjdvoice/message/22695</a><br /><br /><br />22717 CJD QUESTIONNAIRE... updated version II...TSS ... date, name of the medication, the reason for taking it, and route of administration) prompt for prescription drugs, including insulin and type. _ _ _ Prompt for hormone therapy or nutritional supplements including oral contraceptives and hormone replacement ... Terry S. Singeltary Sr. flounder@... madson1 Nov 5, 2002 12:51 pm 22716 RE: [CJDVoice] CJD QUESTIONNAIRE...TSS ... date, name of the medication, the reason for taking it, and route of administration) prompt for prescription drugs, including insulin and type. No known routine medications to my knowledge._ _ _ Prompt for hormone therapy or nutritional supplements including ... Helen Severietti helen@... Nov 5, 2002 12:51 pm 22715 CJD QUESTIONNAIRE... updated version...TSS ... date, name of the medication, the reason for taking it, and route of administration) prompt for prescription drugs, including insulin and type. _ _ _ Prompt for hormone therapy or nutritional supplements including oral contraceptives and hormone replacement ... Terry S. Singeltary Sr. flounder@... madson1 Nov 5, 2002 11:46 am<br /><br /><a href="http://health.groups.yahoo.com/group/cjdvoice/msearch?query=insulin&pos=80&cnt=10" style="color: #473624; cursor: pointer;">http://health.groups.yahoo.com/group/cjdvoice/msearch?query=insulin&pos=80&cnt=10</a><br /><br />Tracie Kedzierski wrote:<br /><br />Terry,<br /><br />The only problem is that having it on our messageboard conflicts with the information I have on our home page about the surveillance project and the report form I send out to the families.-----it is confusing. In fact..I'm sorry but we (The Foundation) have to pull it off.<br /><br /><br /><a href="http://health.groups.yahoo.com/group/cjdvoice/message/22778" style="color: #473624; cursor: pointer;">http://health.groups.yahoo.com/group/cjdvoice/message/22778</a><br /><br /><br /><a href="http://health.groups.yahoo.com/group/cjdvoice/message/36030" style="color: #473624; cursor: pointer;">http://health.groups.yahoo.com/group/cjdvoice/message/36030</a><br /><br /><br />CWRU CJD QUESTIONNAIRE HISTORY<br /><br /><a fg_scanned="1" href="http://cjdquestionnaire.blogspot.com/" style="color: #473624; cursor: pointer;">http://cjdquestionnaire.blogspot.com/</a><br /><br />years ago, ARMOUR use to sell a BOVINE based thyroid drug. i don't believe they sell it anymore. i think it was called thylar or something. wonder how many women used that one ??? its documented in the voice archive years back somewhere. ...terry<br /><br />Q. The Claim: Synthroid is the Best Thyroid Hormone Replacement Drug<br /><br />If you are hypothyroid, your doctor will probably prescribe Synthroid. This levothyoxine (synthetic thyroxine) drug, made by Abbott Labs, is the top-selling thyroid drug in the U.S., commanding some two-thirds of the market for thyroid replacement. Synthroid is, however, often more costly than its competitors. Some doctors won't hear of prescribing anything but Synthroid however, and claim unequivocally that "Synthroid is the best." Is That So? A. Levothyroxine is the synthetic form of T4, one of the two main hormones the thyroid produces. The most widely prescribed levothyroxine product is the brand name Synthroid. Given that levothyroxine is the conventional medical world's accepted treatment for hypothyroidism, most patients will find themselves prescribed<br /><br />levothyroxine, and usually Synthroid. Synthroid's manufacturer has at times claimed their drug to be better than its competitors, but research proved Synthroid to be merely bioequivalent -- or equal, in terms of what function they perform in the body -- to their competition, rather than better. This claim of superiority, therefore, actually has no merit. Many doctors, however, still erroneously believe that Synthroid is "better," after being subject to years of this misleading advertising message. All the major brandname levothyroxine products, Synthroid, Unithroid, Levoxyl and Levothroid, have different fillers and binders, so people may have different allergic responses to the different brands.<br /><br /><a fg_scanned="1" href="http://pagead2.googlesyndication.com/" style="color: #473624; cursor: pointer;">http://pagead2.googlesyndication.com/</a><br /><br /><br />So, if you react to one levothyroxine, your doctor might want to try other brands to see if you react to those brands as well.<br /><br />Some people who are on levothyroxine also need the addition of the second key hormone, T3. Among that group, some people do best with the T3 drug Cytomel. Anecdotally, however, some patients have reported allergic reactions to Cytomel. The option, compounded or time-released compounded T3, has been used successfully by other patients, but there have been concerns about these products, due to inconsistent production. Other doctors and patients prefer a product known as Thyrolar, a synthetic combination of T4 and T3. Some patients do best on natural desiccated thyroid drugs, such as Armour thyroid, or, in some cases, people find the hypoallergenic formula of natural drug, Nature-throid, works best for them. (Pork allergies, however, may make these products problematic for some patients. There are some patients and practitioners who are also concerned about these products due to fears of prion-related diseases such as Mad Cow Disease, despite manufacturer assurances that these products are safe.) So is Synthroid, or any thyroid drug, better than the others? I think Dr. Richard Shames, a Boca Raton, Florida holistic practitioner and co-author of Thyroid Power and Fat, Fuzzy and Frazzled? -- who has treated thyroid conditions for a quarter century -- has the best advice for patients. "In 25 years of practice, I have found that it doesn't necessarily matter which kind of thyroid hormone you start with so much, as which kind you end up with after trying several different types to see which one works best for you. Initially, I typically recommend whatever type they have either heard about, have a "gut-feeling" about, know family members who have a good response to a particular kind of medicine, or have a philosophical inclination for one kind or another. Sometimes it it the combination of two or three of the above medicines that proves to be the magic solution for a particular person. If the initial item tried does not give 85-95% improvement, I then encourage the person to either add something to their first choice product or discontinue it and start something totally new. It is my firm belief that the state of the art in finding the optimal medicine is still trial and error." The answer is, the best drug is the drug which safely makes you feel your best. And there's no predetermined formula to tell which drug will be the best for you, until you try them, find optimal doses, and see how you do over time.<br /><br />Mary Shomon, About.com's Thyroid Guide since 1997, is a nationally-known patient advocate and best-selling author of 10 books on health, including "The Thyroid Hormone Breakthrough: Overcoming Sexual and Hormonal Problems at Every Age," "The Thyroid Diet: Manage Your Metabolism for Lasting Weight Loss," "Living Well With Hypothyroidism: What Your Doctor Doesn't Tell You...That You Need to Know," "Living Well With Graves' Disease and Hyperthyroidism," "Living Well With Autoimmune Disease," and "Living Well With Chronic Fatigue Syndrome and Fibromyalgia." Click _here_<br /><br />(<a fg_scanned="1" href="http://thyroid.about.com/mbiopage.htm" style="color: #473624; cursor: pointer;">http://thyroid.about.com/mbiopage.htm</a>)<br /><br />for more information on Mary Shomon.<br /><br /><br />From: Terry S. Singeltary Sr. (wt-d4-166.wt.net) </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Subject: Re: THYROID MEDICATION, PIGS , PIG FEED, AND MADCOW </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Date: August 16, 1998 at 14:14:48 EST<br /><br />In Reply to: THYROID MEDICATION, PIGS , PIG FEED, AND MADCOW posted by Terry S. Singeltary Sr. on July 28, 1998 at 14:12:38:<br /><br />I am having a hard time getting information on ingrediants of these drugs. Nobody wants to cooperate. Although I have found the names and ingrediants of some with DESICCATED ANIMAL (T4/T3). ARMOUR Thyroid tablets for oral use are natural preparations derived from porcine (Pork) thyroid glands. From the late 1890's until relatively recently, physicians worldwide have treated hypothroid patients with tablets containing desiccated (dried and powdered) animal thyroid glands. These tablets contained both levothyroxine (T4) and triiodothyronine (T3). In 1958, the first synthetic levothyroxine tablets were marketed in the United States. Because thyroid hormones were on the market before the Food and Drug Admimistration (FDA) laws were in place, manufacturers of these hormones were not required to meet the extensive testing requirements of safety and effectiveness required of all new drugs introduced after 1938. In other words, thyroid hormone replacements, such as synthetic levothyroxine, were "GRANDFATHERED" into the system, consequently, there are no FDA approved procedures or standards for testing these preparations other than specifying that each pill contain betwee 90% to 110% of the standard chemical content. Also Thyrolar contains synthetic T3. There is also Cytomel. I believe all these contain desiccated animal. I am still searching. Maybe the Thyroid Society could find time to list these drugs and their Ingrediants. None of the Drug company's will cooperate. You start talking about dessicated animals in these drugs and asking for ingrediants from people and they lose their tounge./<br /><br />MADCOWDEADMOMMADSON/TERRY<br /><br />PLUS, ARMOUR MADE A BOVINE THYROID MEDICATION SOME TIME BACK CALLED "THYRAR" MADE FROM DESSICATED BOVINE THYROID GLAND...<br /><br />Subject: Mad Cow / Mad Pig and Thyroid Risks Date: November 10, 2000 at 2:24 pm PST Mad Cow / Mad Pig and Thyroid Risks<br /><br />Could food supplements and medications be inadvertent media for the spread of prion based brain diseases? Multiple sources would suggest this is possible, even likely, due to the use of animal gelatins. This probability goes up even more when the medication itself is a glandular extract.<br /><br />Importance<br /><br />BSE / Mad Cow / TSE (Transmissible Spongiform Encephalopathies) are NOT a small topic!<br /><br />Nobel Prize awarded to Carleton Gajdusek for Kuru/TSE research Nobel Prize awarded to Stanley Prusiner for TSE/Prion research Pulitzer prize winning author Richard Rhodes wrote "Deadly Feasts" on the controversy ISBN 0-684-84425-7 (Mentioned on 259 web pages) Oprah dedicated a show to BSE/Mad Cow, was sued by Texas cattlemen, Courts upheld her 1st Amendment right to Freedom of Speech! Cows, Sheep, Pigs, Mink, Humans have all caught and died of TSE's Prions can not be killed by mere boiling or cooking Over 200,000 deaths/year by 2015 predicted by Prof. Lacey (below) Over 30,700 web pages mention Mad Cow (AltaVista) Web pages on Chaperonins, chemicals possibly preventing the mis-folding of proteins which are the basis for TSE's and Alzheimer's, jumped from 2 to over 6,000 in one year!<br /><br />Clearly, Transmissible Spongiform Encephalopathies, such as BSE and CJD (one human form,) are a topic of some controversy, one we should all become more aware of.<br /><br />Mad Cow Censorship<br /><br />Some questions were raised on the Thyroid mailing list out of StJohns.EDU regarding where the various natural thyroid supplements come from, and how safe they may be with respect to Mad Cow Disease. The basic text of this article was conveniently "discarded" by the moderator, as it seems are a number posts questioning the safety of natural thyroid extracts, or discussing non-prescription alternatives to them. Such pro-prescription medication biases are not new to certain moderated mailing lists... some of which may be rabidly pro something, others against, at the whims of biased or subsidized moderators. (The biases of that list are mild, compared to some other lists, such as an ozone list several years back.) Always look for biases when considering internet, and any other information sources.<br /><br />Researchers on BSE / TSE say this kind of censorship is not new. Dr. Harash Narang, a British microbiologist and CJD researcher, says he first detected variant CJD in humans back in 1988. He claims that he was ordered to stop work on BSE in 1990, and subsequently "laid off". He believes that British authorities have blocked and undermined such research and detection efforts. (British press articles)<br /><br />Thyroid Supplements and Mad Cow / BSE<br /><br />There are natural thyroid extracts, such as Armour Thyroid, and synthetics such as Cytomel and Synthroid. The natural ones are taken from the thyroid glands of animals, such as pigs.<br /><br />On page 220 of Rhodes' book, Nobel Price winner Dr. Carleton Gajdusek is quoted saying pigs are routinely slaughtered before the disease would become evident in them. Carleton Gajdusek is one of the foremost researchers of Kuru and other "Transmissible Spongiform Encephalopathies", TSE, of which Bovine Spongiform Encephalopathy, Scrapie, CJD, and Kuru are variants.<br /><br />In the book, Dr. Gajdusek is quoted: "the disease hasn't turned up in pigs only because you don't keep pigs alive for seven or eight years; they're killed after two or three years at the most. When we kept pigs we'd inoculated in our laboratory for eight years, they came down with scrapie. [a TSE variant] Probably all the pigs in England are infected. And that means not only pork, it means your pigskin wallet. It means catgut surgical suture, because that's made of pig tissue. All the chickens fed on meat-and-bone meal; they're probably infected. You put that stuff in a chicken and it goes right through"... And in America, beef cattle are killed at or before age two, before they are likely to show outward symptoms. (Page 228)<br /><br />Mad Cow in America<br /><br />In America, chicken excreta is fed to cattle as a good source of nitrogen. (Page 258.) As for the American FDA's ban on feeding meat and animal by-products to cattle, Rhodes writes "That's a ban with exclusions big enough to drive a cortege of hearses through." Their own TSE advisory committee urged the FDA take stronger measures. (Page 257.)<br /><br />According to the book, Bovine Spongiform Encephalopathy has been detected in America, and not just in cattle; the American form is yet another variant TSE, which does not cause the staggers and other behaviors found in British cattle, but results in a more "sedate" collapse of the victim, referred to as "downer cattle". The nature of the brain damage is also distinct; a spongiform with differently shaped and oriented vacancies. Other forms have been transmitted via eating wild squirrels, and wild bear. Some zoos have lost animals to TSE's.<br /><br />Human Epidemic<br /><br />Dr. John Pattison, Chairman of the British government's Spongiform Encephalopathy Advisory Committee (SEAC), Dean of the University College of London Medical School, believes 500,000 people may already be incubating CJD in Britain. [Dr. Alsleben.] Dr. Alsleben, in his excellent Mad Cow web site, states that prions can be found in white blood cells contaminating milk, and even in the animal grease used in lipstick. (URL at end) Professor Richard Lacey of the Microbiology Department of Chapel Allerton Hospital, Leeds, points out on page 222 of the book that "there was no certainty that the source of infection had been cut off."... "'If it seems that the incubation-period average for CJD in humans begins to be about twenty five years, maybe thirty years,' he told me grimly, 'then the peak human epidemic will come around the year 2015. If the current numbers of variant CJD cases [the main human TSE,] increases by fifty percent per year compound, as they well might, that would take it to about two hundred thousand cases a year by then'. Human cases, that is 200,000 deaths per year" (In Britain.)<br /><br />Others suggest that 5% OR MORE of the Alzheimer's cases in America may be due to CJD and other TSE variants. If so, are we already seeing the beginning of a growing tide of TSE related deaths?<br /><br />Limiting Factors<br /><br />It is noted that amongst the Fore, the cannibals who got kuru, another TSE variant similar to CJD, only some one percent of the population seemed affected.<br /><br />This one percent figure suggests a genetic bias, and some genetic biases have been detected. This may serve as a model for predicting human death rates. Evidence suggest a one in a million rate of spontaneous occurrence among susceptible species. Once inserted into a food chain that recycles animal protein, one in a hundred may get it.<br /><br />In America, that one percent would translate to well over two and a half million slow, expensive deaths, a far worse epidemic<br /><br />than AIDS! But... not the end of civilization as we know it.<br /><br />One is reminded that there have been many plagues in human history; plagues like the Black Plague, the Justinian Plague, and many others. Humanity has thus far survived, even if reduced in numbers. No need to panic; just act wisely.<br /><br />Prions and Counters<br /><br />Several Prion variants have been found, some of which act quickly, some of which act far more slowly, so the 25 year estimate may be considerably off. There is also recent research on chaperonins, biochemicals that assist in folding proteins, which may be related to resistance to prion diseases. (Prion diseases are believed to involve folding of proteins, and what is similar to crystal growth of the mis-folded proteins.) See <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://www.mad-cow.org/" style="color: #473624; cursor: pointer;">http://www.mad-cow.org/</a> and look up chaperonin at <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://www.altavista.digital.com/" style="color: #473624; cursor: pointer;">http://www.AltaVista.Digital.com</a> , a term that only had two pages on the web last year, and now has over six thousand!<br /><br />Will we find a cure for Spongiform Encephalopathy? Unlikely, since the spongiform phase is caused by massive death of neural tissue; tissue which can not regrow. That said, we might yet find ways of preventing the degeneration where it has not already occurred. So caution might be well advised.<br /><br />Incubation<br /><br />Twenty five years incubation time is a long time.... If one ends up with thyroid supplements in one's late thirties, it might be age 65 when some of the more noticeable effects begin to become evident. Those with less resistant genetics may display effects much sooner. Others may die of other dis-eases before the effects of TSE would become clearly visible. And most... may even avoid coming down with the disease.<br /><br />And yet... Science News ran an article on Alzheimer's research in which some researchers claimed they could often detect the condition decades early simply by noting the manner of speech and writing of a person. People with pre-Alzheimer's conditions seem to rely more on lists and relationships, than logic and cause-and-effect reasoning about the world. They also tend to write shorter, simpler sentences long before clinical neurological deficits become evident. (Research was done using nuns, comparing their original statements of intent to become nuns, with their conditions decades later.)<br /><br />Is Alzheimer's a form of TSE? Some would say yes, others would say no. And still others have suggested many cases of Alzheimer's are really TSE, but not all. The lesions in the brain are similar, but not identical.<br /><br />Weigh the Risks<br /><br />We must all weigh risks v.s. benefits ourselves. I am not a doctor, I can not advise you; you have to think for yourself. Like Oprah, I have stopped eating beef; as well as all other animal meats and animal products like gelatin. I dump the contents of all my gelatin capsules into a spoon, and discard the empty capsules. I also avoid "ranched" fish like catfish and salmon. Is that enough? I don't know. With luck, I may never find out.<br /><br />A one percent rate sounds considerably better than other estimates I have run across. However, the real question I have is, what are the subtle effects long before the final destruction? If these prions are indeed the rod-like structures researcher Patricia Merz describes on page 156, then they would likely impede cellular machinery long before they became long enough to break cell membranes and kill the cells. Thus it is possible that long before that final break, subtle neurological effects could<br /><br />become evident. Dr. Merz findings of prions in spleen tissue and elsewhere is quite disturbing, as it suggests prions may travel freely in the blood of these animals, and thus would imply that all tissue is likely to harbor some prions, not just brain tissue. Thus, over 25 million of us may be at grave risk to our health; and our relatives, at risk for extreme emotional and financial stresses as they contribute to our care as we slowly go mad and die of CJD.<br /><br />Your health is your responsibility, not your doctor's. It is you who must decide what behaviors, and risks, are acceptable to you.<br /><br />Books and Resources<br /><br />"Deadly Feasts", by Pulitzer prize winner Richard Rhodes. ISBN0-684-84425-7. Worth reading! <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://www.mad-cow.org/" style="color: #473624; cursor: pointer;">http://www.mad-cow.org/</a> Mentioned by Rhodes as a valuable current record on this developing topic. Dr. Harry Alsleben, a preventative medicine researcher, calls this "Our Greatest Biological Catastrophe", His excellent web site is dedicated to warning people about prion diseases; and exposing the policies that warn "officials", while attempting to minimize public concerns and short term financial impact to industry. What is more, he use to sell animal collagen products. He stopped and accepted the financial loss when he learned about BSE. I salute him for his responsible actions. Resources from PBS - Nova The Brain Eaters episode on Mad Cow disease. (Presumably, this site will not be up forever.)<br /><br /><a fg_scanned="1" href="http://www.mall-net.com/mcs/madcow.html" style="color: #473624; cursor: pointer;">http://www.mall-net.com/mcs/madcow.html</a><br /><br /><br />From: Terry S. Singeltary Sr. (wt-d4-166.wt.net) </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Subject: Re: THYROID MEDICATION, PIGS , PIG FEED, AND MADCOW </mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">Date: August 16, 1998 at 14:14:48 EST<br /><br />In Reply to: THYROID MEDICATION, PIGS , PIG FEED, AND MADCOW posted by Terry S. Singeltary Sr. on July 28, 1998 at 14:12:38:<br /><br />I am having a hard time getting information on ingrediants of these drugs. Nobody wants to cooperate. Although I have found the names and ingrediants of some with DESICCATED ANIMAL (T4/T3). ARMOUR Thyroid tablets for oral use are natural preparations derived from porcine (Pork) thyroid glands. From the late 1890's until relatively recently, physicians worldwide have treated hypothroid patients with tablets containing desiccated (dried and powdered) animal thyroid glands. These tablets contained both levothyroxine (T4) and triiodothyronine (T3). In 1958, the first synthetic levothyroxine tablets were marketed in the United States. Because thyroid hormones were on the market before the Food and Drug Admimistration (FDA) laws were in place, manufacturers of these hormones were not required to meet the extensive testing requirements of safety and effectiveness required of all new drugs introduced after 1938. In other words, thyroid hormone replacements, such as synthetic levothyroxine, were "GRANDFATHERED" into the system, consequently, there are no FDA approved procedures or standards for testing these preparations other than specifying that each pill contain betwee 90% to 110% of the standard chemical content. Also Thyrolar contains synthetic T3. There is also Cytomel. I believe all these contain desiccated animal. I am still searching. Maybe the Thyroid Society could find time to list these drugs and their Ingrediants. None of the Drug company's will cooperate. You start talking about dessicated animals in these drugs and asking for ingrediants from people and they lose their tounge./MADCOWDEADMOMMADSON/TERRY<br /><br />PLUS, ARMOUR MADE A BOVINE THYROID MEDICATION SOME TIME BACK CALLED "THYRAR" MADE FROM DESSICATED BOVINE THYROID GLAND...<br /><br />TSS<br /><br />WONDER if any of our loved ones had taken "THYRAR" ??? (way back)<br /><br />don't ask, don't find, cjd questionnaire. .............TSS<br /><br /><a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:BSE-L@LISTS.AEGEE.ORG" style="color: #473624; cursor: pointer;">mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:BSE-L@LISTS.AEGEE.ORG</a><br /><br />Bovine Spongiform Encephalopathy<br /><br />BSE-L is a discussion forum for scientists who are interested in Bovine Spongiform Encephalopathy (BSE). BSE-L has been created on 20th July, 1994 by Siegfried Schmitt. Impressum: <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://www.kaliv.de/impressum.html" style="color: #473624; cursor: pointer;">http://www.kaliv.de/impressum.html</a><br /><br />DRAFT FACTUAL ACCOUNT<br /><br />LISTS.AEGEE.ORG ( BSE-L: 28 matches.. )<br /><br /><a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:https://lists.aegee.org/cgi-bin/wa?S2=BSE-L&X=46104545F4D3582B66&Y=flounder9@verizon.net&q=draft+factual+account&s=&f=&a=&b" style="color: #473624; cursor: pointer;">mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:https://lists.aegee.org/cgi-bin/wa?S2=BSE-L&X=46104545F4D3582B66&Y=flounder9@verizon.net&q=draft+factual+account&s=&f=&a=&b</a>=<br /><br />LISTS.AEGEE.ORG ( BSE-L: 42 matches.. )<br /><br />Item # Date Time Lines Subject 017701 2007-04-21 20:46 2210 Re: 100 Diabetics warned about mad cow exposure tissue came from cattle in the U.S. 015613 2005-03-04 17:09 1001 Re: BSE 'may have entered baby food in 70s' 015611 2005-03-04 08:18 594 BSE 'may have entered baby food in 70s' 014989 2004-10-28 15:03 1080 Re: IFST updated Information Statement on BSE and Variant 014138 2004-03-31 22:02 538 'Babyfood CJD killed lad' ? 011869 2002-10-12 12:56 490 Re: BABY FOODS MAY HAVE BEEN CONTAMINATED WITH SRMs/MRMs and BSE 011864 2002-10-11 16:51 642 Re: BABY FOODS MAY HAVE BEEN CONTAMINATED WITH SRMs/MRMs and BSE 011867 2002-10-11 13:21 314 Re: BABY FOODS MAY HAVE BEEN CONTAMINATED WITH SRMs/MRMs and BSE 011863 2002-10-11 09:04 248 BABY FOODS MAY HAVE BEEN CONTAMINATED WITH SRMs/MRMs and BSE 011785 2002-09-23 22:03 830 deer hunters and farmers and TSEs (a comparison) & a small survey of sCJD/CWD? 011493 2002-06-27 12:00 961 TSS/CWD/NEWS + state by state overview of game farms 010721 2001-08-11 16:01 210 ''Baby Foods'' and CJD * June 23, 1999 BSE Inquiry 009325 2000-12-04 16:20 285 'BSE/EXPORT COVER-UP' a review of 'the wrong' priorities $$$ 008889 2000-10-27 15:11 393 Some factual accounts about Mrs. Richardson's early observation of BSE 008452 2000-08-10 12:52 94 Re: ProMED (new var.), iatrogenic dental transmission risk 008440 2000-08-09 09:47 340 United States gets 'free' ride on level II of the GBR's $$$ 007229 1999-12-16 09:34 86 Re: U.S.'s application for assessment of BSE-status that was sentto the E.U.??? 007153 1999-11-29 14:06 73 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007144 1999-11-28 11:46 179 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007142 1999-11-27 18:54 588 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007140 1999-11-27 12:03 402 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007133 1999-11-26 10:36 303 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007126 1999-11-25 22:30 214 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007125 1999-11-25 13:17 82 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007124 1999-11-25 11:21 90 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007016 1999-11-03 20:37 68 Re: DFA 18 Cosmetics...[There have been reports ofBSEoutbreaks in Germany, France,and even in the U.S.A.,a prime market for Jersey cattle] 007017 1999-11-03 20:31 80 Re: DFA 18 Cosmetics...[There have been reportsofBSEoutbreaks in Germany,France,and even in the U.S.A.,a prime market for Jersey cattle] 007010 1999-11-03 08:36 141 Re: DFA 18 Cosmetics...[There have been reports ofBSEoutbreaks in Germany, France,and even in the U.S.A.,a prime market for Jersey cattle] 007008 1999-11-03 00:07 127 Re: DFA 18 Cosmetics...[There have been reports of BSEoutbreaks in Germany, France, and even in the U.S.A.,a prime market for Jersey cattle] 007006 1999-11-02 11:49 142 Re: DFA 18 Cosmetics...[There have been reports of BSEoutbreaks in Germany, France, and even in the U.S.A.,a prime market for Jersey cattle] 007003 1999-11-02 00:22 74 Re: DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A., a prime market for Jersey cattle] 006998 1999-11-01 09:28 90 DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A., a prime market for Jersey cattle] 006940 1999-10-14 16:36 44 Drugs may have been made from BSE infected cattle 006312 1999-04-16 00:04 385 Monkey business at Marwell Zoo 006091 1999-02-14 20:21 116 Re: DFA 11 "The Touch Test" 006085 1999-02-13 10:46 91 Re: DFA 11 "The Touch Test" 006066 1999-02-11 00:04 90 Re: DFA 11 "The Touch Test" 006065 1999-02-10 05:56 55 Re: DFA 11 "The Touch Test" 006062 1999-02-09 11:37 49 DFA 11 "The Touch Test" 006027 1999-01-28 05:28 59 Re: History of BSE in UK 006022 1999-01-27 00:08 74 Re: History of BSE in UK 005892 1999-01-04 07:46 147 Inquiry Draft Factual Account of Southwood Committee<br /><br />Item #17701 (21 Apr 2007 20:46) - Re: 100 Diabetics warned about mad cow exposure tissue came from cattle in the U.S.<br /><br />Hello , it might be beneficial for you to read the DFA 17. it has some valuable information in it, but some is outdated. takes to infect an individual. i will post next. meanwhile, the url to DFA 17 is below the short article........<br /><br />Item #15613 (4 Mar 2005 17:09) - Re: BSE 'may have entered baby food in 70s'<br /><br />99. Mr. Lawrence wrote a<br /><br />industry involved, as<br /><br />opposed to Heather and the Baby Food industry.<br /><br />For obvious reasons, if the DFA's are accurate, and the statements<br /><br />within from the<br /><br />Working Party and the Gov. and the statement from the<br /><br />manufacturers of Baby Foods,<br /><br />where they are stating in DFA 9;<br /><br />"152.<br /><br />There is no evidence of written assurances from the manufacturers<br /><br />cord, spleen intestines and thymus;<br /><br />What would you understand this<br /><br />to mean? Firstly, the DFA paragraph 152 does _not_ say "the<br /><br />manufactures could not supply this information to the Gov". It says<br /><br />that there is no written evidence that they did -- not the same thing<br /><br />at all. I do _not_ understand the DFA paragraph 152 to mean "the<br /><br />statement made by the manufacturers to the Gov." and nor should you.<br /><br />Item #15611 (4 Mar 2005 08:18) - BSE 'may have entered baby food in 70s'<br /><br />99. Mr. Lawrence wrote a letter industry involved, as >opposed to Heather and the Baby Food industry. For obvious reasons, if the DFA's are accurate, and the statements within from the >Working Party and the Gov. and the statement from the manufacturers of Baby Foods, >where they are stating in DFA 9; >"152. There is no evidence of written assurances from the manufacturers spleen intestines >and thymus; > >What would you understand this to mean? Firstly, the DFA paragraph 152 does _not_ say "the manufactures could not supply this information to the Gov". It says that there is no written evidence that they did -- not the same thing at all. I do _not_ understand the DFA paragraph 152 to mean "the statement made by the manufacturers to the Gov." and nor should you. Paragraph 152 refers to<br /><br />Item #14989 (28 Oct 2004 15:03) - Re: IFST updated Information Statement on BSE and Variant industry involved, as >opposed to Heather and the Baby Food industry. For obvious reasons, if the DFA's are accurate, and the statements within from the >Working Party and the Gov. and the statement from the manufacturers of Baby Foods, >where they are stating in DFA 9; >"152. There is no evidence of written assurances from the manufacturers<br /><br />Item #14138 (31 Mar 2004 22:02) - 'Babyfood CJD killed lad' ?<br /><br />I would like to point out in DFA 9<br /><br />Item #11869 (12 Oct 2002 12:56) - Re: BABY FOODS MAY HAVE BEEN CONTAMINATED WITH SRMs/MRMs and BSE<br /><br />I would like to point out in DFA 9<br /><br />Item #11864 (11 Oct 2002 16:51) - Re: BABY FOODS MAY HAVE BEEN CONTAMINATED WITH SRMs/MRMs and BSE<br /><br />I would like to point out in DFA 9<br /><br />Item #11867 (11 Oct 2002 13:21) - Re: BABY FOODS MAY HAVE BEEN CONTAMINATED WITH SRMs/MRMs and BSE industry involved, as opposed to Heather and the Baby Food industry. For obvious reasons, if the DFA's are accurate, and the statements within from the Working Party and the Gov. and the statement from the manufacturers of Baby Foods, where they are stating in DFA 9; "152. There is no evidence of written assurances from the manufacturers<br /><br />Item #11863 (11 Oct 2002 09:04) - BABY FOODS MAY HAVE BEEN CONTAMINATED WITH SRMs/MRMs and BSE<br /><br />I would like to point out in DFA 9<br /><br />Item #11785 (23 Sep 2002 22:03) - deer hunters and farmers and TSEs (a comparison) & a small survey of sCJD/CWD?<br /><br />DFA 16<br /><br />Item #11493 (27 Jun 2002 12:00) - TSS/CWD/NEWS + state by state overview of game farms and issues the permits required for possession. Department of Food & Agriculture (DFA) becomes the lead over captive cervids only if a disease outbreak occurs which could impact livestock (TB and<br /><br />Item #10721 (11 Aug 2001 16:01) - ''Baby Foods'' and CJD * June 23, 1999 BSE Inquiry<br /><br />I would like to point out in DFA 9<br /><br /><a fg_scanned="1" href="http://www.bse.org.uk/dfa/dfa09gs.htm" style="color: #473624; cursor: pointer;">http://www.bse.org.uk/dfa/dfa09gs.htm</a><br /><br /><br />BSE INQUIRY DFAs<br /><br /><br /><a fg_scanned="1" href="http://bseinquiry.blogspot.com/" style="color: #473624; cursor: pointer;">http://bseinquiry.blogspot.com/</a><br /><br /><br />Sunday, May 18, 2008<br /><br />BSE Inquiry DRAFT FACTUAL ACCOUNT DFA<br /><br />BSE Inquiry DRAFT FACTUAL ACCOUNTS DFA's<br /><br /><a fg_scanned="1" href="http://bseinquiry.blogspot.com/2008/05/bse-inquiry-draft-factual-account-dfa.html" style="color: #473624; cursor: pointer;">http://bseinquiry.blogspot.com/2008/05/bse-inquiry-draft-factual-account-dfa.html</a><br /><br /><br />Sunday, May 18, 2008 BSE, CJD, and Baby foods (the great debate 1999 to 2005)<br /><br /><br /><a fg_scanned="1" href="http://bseinquiry.blogspot.com/2008/05/bse-cjd-and-baby-foods-great-debate.html" style="color: #473624; cursor: pointer;">http://bseinquiry.blogspot.com/2008/05/bse-cjd-and-baby-foods-great-debate.html</a><br /><br /><br />Sunday, May 18, 2008 MAD COW DISEASE BSE CJD CHILDREN VACCINES<br /><br /><br /><a fg_scanned="1" href="http://bseinquiry.blogspot.com/2008/05/mad-cow-disease-bse-cjd-children.html" style="color: #473624; cursor: pointer;">http://bseinquiry.blogspot.com/2008/05/mad-cow-disease-bse-cjd-children.html</a><br /><br /><br />Item #9325 (4 Dec 2000 16:20) - 'BSE/EXPORT COVER-UP' a review of 'the wrong' priorities $$$ 46. Mr Wilesmith's early work, the involvement of NPU, and the establishment of a BSE Group are dealt with in the CVL DFA.<br /><br />Item #8889 (27 Oct 2000 15:11) - Some factual accounts about Mrs. Richardson's early observation of BSE Mrs.Richardson may have said or not, and almost about what has been heard or not from her (see extract 3) . As far as the CVL DFA is concerned it seems that it exist some oppositions within the CVL organisation. see to events up to the decision to establish the Southwood Working Party. SCDFA refers to the Slaughter and Compensation Draft Factual Account (DFA 6), CVLDFA refers to the CVL Draft Factual Account (DFA 4) and the RFBDFA refers to the Ruminant Feed Ban Part 1 Draft Factual Account (DFA 7), all of which should be read in conjunction with this document. examinations of these samples, and the conflict of evidence about the conclusions reached, are dealt with in the CVL DFA.<br /><br />brain of a nyala which had been kept at Marwell Zoo. This examination, and subsequent consideration of the nyala, are described in the CVL DFA.<br /><br />----------- Extract 3 of the CVL DFA about The controversy about the examination of BSE------<br /><br />Item #8452 (10 Aug 2000 12:52) - Re: ProMED (new var.), iatrogenic dental transmission risk I remember reading, (please don't ask me to reference, because i am seeing double now), but it was in one of the DFA's and the threat to children via baby-foods. But i remember someone stating in the DFA, of the risk from infected gums in children, teething in children, and the lesions of the gums, and the potential<br /><br />Item #8440 (9 Aug 2000 09:47) - United States gets 'free' ride on level II of the GBR's $$$<br /><br />RE-DRACONIAN MEASURES; DFA 5<br /><br />Item #7229 (16 Dec 1999 09:34) - Re: U.S.'s application for assessment of BSE-status that was sentto the E.U.???<br /><br />Also, if you will read DFA-25 about exports, paragraph 69;<br /><br />Item #7153 (29 Nov 1999 14:06) - Re: Girl, 13, shows CJD symptoms. [re-baby food] sought by MAFF from the baby food manufacturers. And it is in _that_ context, that the DFA says that any such written assurances have not been found in the papers submitted to the BSE Inquiry.<br /><br />Item #7144 (28 Nov 1999 11:46) - Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><br />Firstly, the DFA paragraph 152 does _not_ say "the manufactures could not supply this<br /><br />I do _not_ understand the DFA paragraph 152 to mean "the statement made by the<br /><br />Item #7142 (27 Nov 1999 18:54) - Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><br />opposed to Heather and the Baby Food industry. For obvious reasons, if the DFA's are accurate, and the statements wit hin from the Baby Foods, where they are stating in DFA 9; "152. There is no evidence of written assurances from the manufacturer At 11:21 AM 11/25/99 -0600, Terry wrote: I would like to point out in DFA 9<br /><br />Item #7140 (27 Nov 1999 12:03) - Re: Girl, 13, shows CJD symptoms. [re-baby food] opposed to Heather and the Baby Food industry. For obvious reasons, if the DFA's are accurate, and the statements within from the Baby Foods, where they are stating in DFA 9; "152. There is no evidence of written assurances from the manufacturers At 11:21 AM 11/25/99 -0600, Terry wrote: I would like to point out in DFA 9<br /><br />Item #7133 (26 Nov 1999 10:36) - Re: Girl, 13, shows CJD symptoms. [re-baby food] opposed to Heather and the Baby Food industry. For obvious reasons, if the DFA's are accurate, and the statements within from the by Foods, where they are stating in DFA 9; "152. There is no evidence of written assurances from the manufacturers s At 11:21 AM 11/25/99 -0600, Terry wrote: I would like to point out in DFA 9<br /><br />Item #7126 (25 Nov 1999 22:30) - Re: Girl, 13, shows CJD symptoms. [re-baby food] At 11:21 AM 11/25/99 -0600, Terry wrote: I would like to point out in DFA 9<br /><br />Item #7125 (25 Nov 1999 13:17) - Re: Girl, 13, shows CJD symptoms. [re-baby food] At 11:21 AM 11/25/99 -0600, Terry wrote: I would like to point out in DFA 9<br /><br />Item #7124 (25 Nov 1999 11:21) - Re: Girl, 13, shows CJD symptoms. [re-baby food]<br /><br />I would like to point out in DFA 9<br /><br />Item #7016 (3 Nov 1999 20:37) - Re: DFA 18 Cosmetics...[There have been reports ofBSEoutbreaks in Germany, France,and even in the U.S.A.,a prime market for Jersey cattle] From: Roland Heynkes Subject: Re: DFA 18 Cosmetics...[There have been reports ofBSEoutbreaks in Germany,<br /><br />Item #7017 (3 Nov 1999 20:31) - Re: DFA 18 Cosmetics...[There have been reportsofBSEoutbreaks in Germany,France,and even in the U.S.A.,a prime market for Jersey cattle] From: "Terry S. Singeltary Sr." Subject: Re: DFA 18 Cosmetics...[There have been reportsofBSEoutbreaks in Germany,France,and even in the U.S.A.,a prime<br /><br />Item #7010 (3 Nov 1999 08:36) - Re: DFA 18 Cosmetics...[There have been reports ofBSEoutbreaks in Germany, France,and even in the U.S.A.,a prime market for Jersey cattle] From: "Terry S. Singeltary Sr." Subject: Re: DFA 18 Cosmetics...[There have been reports ofBSEoutbreaks in Germany,<br /><br />Item #7008 (3 Nov 1999 00:07) - Re: DFA 18 Cosmetics...[There have been reports of BSEoutbreaks in Germany, France, and even in the U.S.A.,a prime market for Jersey cattle] From: Roland Heynkes Subject: Re: DFA 18 Cosmetics...[There have been reports of BSEoutbreaks in Germany, France,<br /><br />Item #7006 (2 Nov 1999 11:49) - Re: DFA 18 Cosmetics...[There have been reports of BSEoutbreaks in Germany, France, and even in the U.S.A.,a prime market for Jersey cattle] From: "Terry S. Singeltary Sr." Subject: Re: DFA 18 Cosmetics...[There have been reports of BSEoutbreaks in Germany, France,<br /><br />Item #7003 (2 Nov 1999 00:22) - Re: DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A., a prime market for Jersey cattle] From: Roland Heynkes Subject: Re: DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A.,<br /><br />Item #6998 (1 Nov 1999 09:28) - DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A., a prime market for Jersey cattle] From: "Terry S. Singeltary Sr." Subject: DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A., Terry S. Singeltary Sr., Bacliff, Texas USA -- Greetings, I have been reading over the latest DFA 18, about cosmetics, and the possible route of BSE, through this source. Several interesting comments<br /><br />Page 24, DFA 18, -- "the line taken on cosmetics including sourcing from overseas was based on that given for licensed medicinal products by a<br /><br />Page 60, DFA 18, cosmetics -- 4. If it is possible for humans to contract<br /><br />Item #6940 (14 Oct 1999 16:36) - Drugs may have been made from BSE infected cattle Also, the new DFA 17, Medicines and Medical devices, has been published at the BSE Inquiry site below,<br /><br />Item #6312 (16 Apr 1999 00:04) - Monkey business at Marwell Zoo YB86/7.8/1.1 ) This examination, and subsequent consideration of the report, are described in the CVL DFA.<br /><br />unlikely to give his approval.(YB87/6.29/3.1; YB87/7.1/2.1; YB87/7.1/3.1-3.10 ) This is further discussed in the CVL DFA.<br /><br />6; YB86/7.8/1.1 ) This examination, and subsequent consideration of the report, are described in the CVL DFA.<br /><br />CVO was unlikely to give his approval.(YB87/6.29/3.1; YB87/7.1/2.1; YB87/7.1/3.1-3.10 ) This is further discussed in the CVL DFA.<br /><br />Item #6091 (14 Feb 1999 20:21) - Re: DFA 11 "The Touch Test" Organization: consultant Subject: Re: DFA 11 "The Touch Test" In-Reply-To: <<a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:006201be5736$1fe05a80$272d9c3e@pentium" style="color: #473624; cursor: pointer;">mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:006201be5736$1fe05a80$272d9c3e@pentium</a>><br /><br />Bear in mind that each DFA is an collation of evidence on a specific topic given by different Inquiry witnesses, and, as the introduction to each states, "The Draft Factual Accounts are intended to help the Committee of Inquiry in their further work." All of the references in a DFA are to statements, evidence transcripts, and documents which the three members of The complete reference is actually (49) . M37/91/3.15/1.1-1.4 and it is the only reference in DFA 11 prefixed "M".The Committee of Inquiry will know, but I have no idea what M37 stands for (at a guess, Memo 37?? But then why isn't it in the 1991 YB?). The reference (49) relates to paragraph 34 of DFA 11 which reads<br /><br />Item #6085 (13 Feb 1999 10:46) - Re: DFA 11 "The Touch Test" From: "Roland Heynkes @ T-Online" Subject: Re: DFA 11 "The Touch Test"<br /><br />Bear in mind that each DFA is an collation of evidence on a specific topic<br /><br />given by different Inquiry witnesses, and, as the introduction to each<br /><br />states, "The Draft Factual Accounts are intended to help the Committee of<br /><br />Inquiry in their further work." All of the references in a DFA are to<br /><br />statements, evidence transcripts, and documents which the three members of<br /><br />Item #6066 (11 Feb 1999 00:04) - Re: DFA 11 "The Touch Test" Organization: consultant Subject: Re: DFA 11 "The Touch Test" In-Reply-To: <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:002201be54b5$2da11de0$eebd9ec1@pentium" style="color: #473624; cursor: pointer;">mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:002201be54b5$2da11de0$eebd9ec1@pentium</a><br /><br />DFA 11 "The touch test", one of the four latest additions to the BSE<br /><br />Inquiry Web site, is in fact a bringing together of all the evidence at the<br /><br />Presumably there will be a sequel DFA relating to the evidence relating to<br /><br />the post-1993 period and his claims for ante-mortem tests for BSE and CJD.<br /><br />Bear in mind that each DFA is an collation of evidence on a specific topic given by different Inquiry witnesses, and, as the introduction to each states, "The Draft Factual Accounts are intended to help the Committee of Inquiry in their further work." All of the references in a DFA are to statements, evidence transcripts, and documents which the three members of<br /><br />Item #6065 (10 Feb 1999 05:56) - Re: DFA 11 "The Touch Test" From: "Roland Heynkes @ T-Online" Subject: Re: DFA 11 "The Touch Test"<br /><br />DFA 11 "The touch test", one of the four latest additions to the BSE<br /><br />Inquiry Web site, is in fact a bringing together of all the evidence at the<br /><br />Presumably there will be a sequel DFA relating to the evidence relating to<br /><br />the post-1993 period and his claims for ante-mortem tests for BSE and CJD.<br /><br />Item #6062 (9 Feb 1999 11:37) - DFA 11 "The Touch Test" Organization: consultant Subject: DFA 11 "The Touch Test"<br /><br />DFA 11 "The touch test", one of the four latest additions to the BSE Inquiry Web site, is in fact a bringing together of all the evidence at the<br /><br />Presumably there will be a sequel DFA relating to the evidence relating to the post-1993 period and his claims for ante-mortem tests for BSE and CJD.<br /><br />Item #6027 (28 Jan 1999 05:28) - Re: History of BSE in UK Emily Green, formerly a cookery writer, has merely put together her story from a newly issued DFA on the BSE Inquiry Web site, one of six that I drew attention to in a message here yesterday.<br /><br />Item #6022 (27 Jan 1999 00:08) - Re: History of BSE in UK Emily Green, formerly a cookery writer, has merely put together her story from a newly issued DFA on the BSE Inquiry Web site, one of six that I drew attention to in a message here yesterday. But she displays<br /><br />Item #5892 (4 Jan 1999 07:46) - Inquiry Draft Factual Account of Southwood Committee In response to the Inquiry request for comments on the three Draft Factual Accounts so far published, I have sent the following comment on the DFA on the Southwood Committee -- I haven't had time to study the other two yet misunderstanding and debate in the intervening years. It is the first sentence of sub-paragraph 2 of paragraph 9, shown in the DFA section 371--<br /><br />We now have, in evidence to the Inquiry, quoted in the DFA, incontrovertible proof that, in its deliberations, the Southwood Committee the benefit of public understanding, I suggest that, after section 371 of the DFA, a note should be inserted, drawing attention to the Southwood Committee's understanding of the meaning of "dead end host" as exemplified<br /><br /><a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:https://lists.aegee.org/cgi-bin/wa?S2=BSE-L&X=46104545F4D3582B66&Y=flounder9@verizon.net&q=DFA&s=&f=&a=&b" style="color: #473624; cursor: pointer;">mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:https://lists.aegee.org/cgi-bin/wa?S2=BSE-L&X=46104545F4D3582B66&Y=flounder9@verizon.net&q=DFA&s=&f=&a=&b</a>=<br /><br />LISTS.AEGEE.ORG ( BSE-L: 12 matches.. )<br /><br />Item # Date Time Lines Subject 007016 1999-11-03 20:37 68 Re: DFA 18 Cosmetics...[There have been reports ofBSEoutbreaks in Germany, France,and even in the U.S.A.,a prime market for Jersey cattle] 007017 1999-11-03 20:31 80 Re: DFA 18 Cosmetics...[There have been reportsofBSEoutbreaks in Germany,France,and even in the U.S.A.,a prime market for Jersey cattle] 007010 1999-11-03 08:36 141 Re: DFA 18 Cosmetics...[There have been reports ofBSEoutbreaks in Germany, France,and even in the U.S.A.,a prime market for Jersey cattle] 007008 1999-11-03 00:07 127 Re: DFA 18 Cosmetics...[There have been reports of BSEoutbreaks in Germany, France, and even in the U.S.A.,a prime market for Jersey cattle] 007006 1999-11-02 11:49 142 Re: DFA 18 Cosmetics...[There have been reports of BSEoutbreaks in Germany, France, and even in the U.S.A.,a prime market for Jersey cattle] 007003 1999-11-02 00:22 74 Re: DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A., a prime market for Jersey cattle] 006998 1999-11-01 09:28 90 DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A., a prime market for Jersey cattle] 006091 1999-02-14 20:21 116 Re: DFA 11 "The Touch Test" 006085 1999-02-13 10:46 91 Re: DFA 11 "The Touch Test" 006066 1999-02-11 00:04 90 Re: DFA 11 "The Touch Test" 006065 1999-02-10 05:56 55 Re: DFA 11 "The Touch Test" 006062 1999-02-09 11:37 49 DFA 11 "The Touch Test"<br /><br />Item #7016 (3 Nov 1999 20:37) - Re: DFA 18 Cosmetics...[There have been reports ofBSEoutbreaks in Germany, France,and even in the U.S.A.,a prime market for Jersey cattle] From: Roland Heynkes Subject: Re: DFA 18 Cosmetics...[There have been reports ofBSEoutbreaks in Germany,<br /><br />Item #7017 (3 Nov 1999 20:31) - Re: DFA 18 Cosmetics...[There have been reportsofBSEoutbreaks in Germany,France,and even in the U.S.A.,a prime market for Jersey cattle] From: "Terry S. Singeltary Sr." Subject: Re: DFA 18 Cosmetics...[There have been reportsofBSEoutbreaks in Germany,France,and even in the U.S.A.,a prime Item #7010 (3 Nov 1999 08:36) - Re: DFA 18 Cosmetics...[There have been reports ofBSEoutbreaks in Germany, France,and even in the U.S.A.,a prime market for Jersey cattle] From: "Terry S. Singeltary Sr." Subject: Re: DFA 18 Cosmetics...[There have been reports ofBSEoutbreaks in Germany,<br /><br />Item #7008 (3 Nov 1999 00:07) - Re: DFA 18 Cosmetics...[There have been reports of BSEoutbreaks in Germany, France, and even in the U.S.A.,a prime market for Jersey cattle] From: Roland Heynkes Subject: Re: DFA 18 Cosmetics...[There have been reports of BSEoutbreaks in Germany, France,<br /><br />Item #7006 (2 Nov 1999 11:49) - Re: DFA 18 Cosmetics...[There have been reports of BSEoutbreaks in Germany, France, and even in the U.S.A.,a prime market for Jersey cattle] From: "Terry S. Singeltary Sr." Subject: Re: DFA 18 Cosmetics...[There have been reports of BSEoutbreaks in Germany, France,<br /><br />Item #7003 (2 Nov 1999 00:22) - Re: DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A., a prime market for Jersey cattle] From: Roland Heynkes Subject: Re: DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A.,<br /><br />Item #6998 (1 Nov 1999 09:28) - DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A., a prime market for Jersey cattle] From: "Terry S. Singeltary Sr." Subject: DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A., Terry S. Singeltary Sr., Bacliff, Texas USA -- Greetings, I have been reading over the latest DFA 18, about cosmetics, and the possible route of BSE, through this source. Several interesting comments<br /><br />Page 24, DFA 18, -- "the line taken on cosmetics including sourcing from overseas was based on that given for licensed medicinal products by a<br /><br />Page 60, DFA 18, cosmetics -- 4. If it is possible for humans to contract<br /><br />Item #6091 (14 Feb 1999 20:21) - Re: DFA 11 "The Touch Test" Organization: consultant Subject: Re: DFA 11 "The Touch Test" In-Reply-To: <<a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:006201be5736$1fe05a80$272d9c3e@pentium" style="color: #473624; cursor: pointer;">mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:006201be5736$1fe05a80$272d9c3e@pentium</a>><br /><br />Bear in mind that each DFA is an collation of evidence on a specific topic given by different Inquiry witnesses, and, as the introduction to each states, "The Draft Factual Accounts are intended to help the Committee of Inquiry in their further work." All of the references in a DFA are to statements, evidence transcripts, and documents which the three members of The complete reference is actually (49) . M37/91/3.15/1.1-1.4 and it is the only reference in DFA 11 prefixed "M".The Committee of Inquiry will know, but I have no idea what M37 stands for (at a guess, Memo 37?? But then why isn't it in the 1991 YB?). The reference (49) relates to paragraph 34 of DFA 11 which reads<br /><br />Item #6085 (13 Feb 1999 10:46) - Re: DFA 11 "The Touch Test" From: "Roland Heynkes @ T-Online" Subject: Re: DFA 11 "The Touch Test"<br /><br />Bear in mind that each DFA is an collation of evidence on a specific topic given by different Inquiry witnesses, and, as the introduction to each states, "The Draft Factual Accounts are intended to help the Committee of Inquiry in their further work." All of the references in a DFA are to statements, evidence transcripts, and documents which the three members of<br /><br />Item #6066 (11 Feb 1999 00:04) - Re: DFA 11 "The Touch Test" Organization: consultant Subject: Re: DFA 11 "The Touch Test" In-Reply-To: <<a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:002201be54b5$2da11de0$eebd9ec1@pentium" style="color: #473624; cursor: pointer;">mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:002201be54b5$2da11de0$eebd9ec1@pentium</a>><br /><br />DFA 11 "The touch test", one of the four latest additions to the BSE Inquiry Web site, is in fact a bringing together of all the evidence at the<br /><br />Presumably there will be a sequel DFA relating to the evidence relating to the post-1993 period and his claims for ante-mortem tests for BSE and CJD.<br /><br />Bear in mind that each DFA is an collation of evidence on a specific topic given by different Inquiry witnesses, and, as the introduction to each states, "The Draft Factual Accounts are intended to help the Committee of Inquiry in their further work." All of the references in a DFA are to statements, evidence transcripts, and documents which the three members of<br /><br />Item #6065 (10 Feb 1999 05:56) - Re: DFA 11 "The Touch Test" From: "Roland Heynkes @ T-Online" Subject: Re: DFA 11 "The Touch Test"<br /><br />DFA 11 "The touch test", one of the four latest additions to the BSE Inquiry Web site, is in fact a bringing together of all the evidence at the<br /><br />Presumably there will be a sequel DFA relating to the evidence relating to the post-1993 period and his claims for ante-mortem tests for BSE and CJD.<br /><br />Item #6062 (9 Feb 1999 11:37) - DFA 11 "The Touch Test" Organization: consultant Subject: DFA 11 "The Touch Test"<br /><br />DFA 11 "The touch test", one of the four latest additions to the BSE Inquiry Web site, is in fact a bringing together of all the evidence at the<br /><br />Presumably there will be a sequel DFA relating to the evidence relating to the post-1993 period and his claims for ante-mortem tests for BSE and CJD.<br /><br /><a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:https://lists.aegee.org/cgi-bin/wa?S2=BSE-L&X=40522815A4EA0CEA99&Y=flounder9@verizon.net&q=DFA&s=DFA&f=&a=&b" style="color: #473624; cursor: pointer;">mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:https://lists.aegee.org/cgi-bin/wa?S2=BSE-L&X=40522815A4EA0CEA99&Y=flounder9@verizon.net&q=DFA&s=DFA&f=&a=&b</a>=<br /><br />The BSE Inquiry / Statement No 527 Mr M B Baker Issued 30/09/1999 (not scheduled to give oral evidence) STATEMENT OF M B BAKER 1. I am replying to a request from the BSE Inquiry for information on my involvement in the issue of guidance to educational establishments on the dissection of bovine eyeballs. In particular this statement addresses concerns that there was undue delay on the part of the Department for Education and Science (now the Department for Education and Employment) in issuing guidance to schools after SEAC had recommended on 2 July 1990 that the practice of bovine eyeball dissection should be avoided [YB90/7.2/3.4]. 2. My comments relate specifically to a draft of a ‘Draft Factual Account’ (‘DFA’) which the Inquiry’s secretariat sent me, and of which I understand a revised version is to be published. I told the Inquiry secretariat that to the best of my recollection the version of the account that I saw seemed to me accurate and comprehensive, though the events occurred between six and nine years ago and my memory was not infallible. 3. I was a Head of Division (Grade 5 Officer) in Schools Branch 3 (responsible for school curriculum and assessment matters) during most of the period covered by the draft factual account and until my retirement from the Department and the public service in February 1994. My involvement with the subject of the account – guidance on the dissection of bovine eyeballs – 2 began in July 1990 and ended in June 1993 when responsibility for the subject was transferred to another Branch of the Department. 4. I was the senior officer who at the time was given and accepted responsibility for the issue of advice to schools on the dissection of bovine eyeballs. It is clear from the draft factual account that there was delay in the issue of such advice, and I do not disclaim my major share of responsibility for that delay. 5. I accepted that responsibility when the handling of the bovine eyeballs business was reviewed within the Department by senior colleagues at the end of 1992, in response to ministers’ concerns about the delay in issuing advice. It was then concluded that I had made significant errors in judgement in dealing with this piece of business; in particular in not ensuring that the matter was brought to the early attention of Ministers, and in taking a view on questions of public sensitivity that were probably a matter for Ministers. The outcome for me was a reprimand and a caution as to my future conduct. 6. Against this background, I shall not attempt a detailed defence of myself and my actions or inaction. However, I want to help the Inquiry as far as I can, so I attach a commentary on the main chronological phases of the story. It is subject to the same qualification: that my memory is fallible. 7. The main purpose of this commentary is to indicate the work preoccupations of myself and my Division over the periods in question. With hindsight, it is clear that the issue of advice to schools should have been regarded as urgent 3 and given a high priority. However, that was less clear to me and others at the time – before any new variant of CJD associated with bovine spongiform encephalopathy had been identified. The advice we had been given was that infection by the BSE agent through accidental inoculation in the course of dissecting bovine eyeballs was a remote theoretical risk. There was no epidemiological evidence of the transmission of the disease to humans, and the scientific literature seemed to suggest that transmission was highly unlikely. I recognise that we were not competent to make our own judgement on these matters and should never have been trying to do so. But my point is that I never believed in any real risk to pupils and saw the issue of advice to schools as an ultra-precautionary measure. 8. At that time the Branch, and my Division within it, was under very heavy and unrelenting pressure to introduce a statutory national curriculum and associated assessment measures, subject by subject, to an exacting and inflexible timetable determined by Ministers. At t e beginning of the timeframe of the DFA this had just been further complicated by a decision to revise completely the statutory orders for science and mathematics almost as soon as they had come into operation: a task that fell on Mr Jacobs and his team under my oversight. Later unexpected work requirements falling on myself and my Division included a review of the English curriculum order and an overhaul of the GCSE examining arrangements. 9. In this context, I saw the subject of precautionary guidance on bovine eyeball dissection as a distraction from our main agenda, and gave it a lower priority. 4 With hindsight again, it is now obvious that I attached too much weight to the reservations expressed by HMI and medical advisers about the public sensitivity of the subject and the possible implications of causing alarm or dismay. Such reservations should not have delayed a submission to Ministers, but rather formed a part of that submission. That was my major mistake, and I attribute it to the fact that as a result of my policy preoccupations I was giving insufficient attention to the subject. Of course those preoccupations reflected my perception of the DFEE Ministers’ own priorities. Health Ministers would have had different priorities, but the fact is that for a long time officials of the Department of Health did little to bring pressure on my Department. It was not until very late in the story (October 1992) that they made quite clear the importance their Ministers attached to the issue of guidance to schools on the dissection of bovine eyeballs and pressed us strongly for action. It was only then that I realised that there was a clear political imperative and public commitment to action. COMMENTARY ON THE DRAFT FACTUAL ACCOUNT July 1990 to 1991 The story began, so far as the Department and myself were concerned, with the approach by our Senior Medical Officer, Dr Ernaelsteen, who told us of the decision of the Tyrrell Committee. We were not directly approached with any request for action by officials of the Department of Health. 5 It seemed to us, or at least to me, that there was an initial issue whether it was necessary and appropriate to give advice to schools at all, and we consulted HMI in accordance with established Departmental practice. As to the nature of that advice, there was much discussion with officials of DH and MAFF, and a certain amount of vacillation and indecision. Should we also be advising against the use of sheep’s eyeballs? Should we advise on alternative resources (pigs, horses – and what about calves?) Should teachers continue to be able to demonstrate the dissection of eyeballs to their pupils? And there were arguments about the dangers of ingestion (as opposed to parenteral inoculation). During this period I was preoccupied with bringing to a successful conclusion the establishment of History in the National Curriculum: possibly the most contentious of all our tasks. The team under Mr Jacobs concerned with the bovine eyeball guidance was given the unbudgeted task of reviewing the national curriculum orders for both mathematics and science, which involved working overtime and at weekends. May 1991 to May 1992 By May 1991, although the first stage of consultation appeared to be complete the process had lost impetus. HMI had circulated extracts from the scientific press and were questioning the need to proceed. My Division was heavily engaged in priority curriculum tasks. Mr Jacob’s team was still engaged in the review of the mathematics and science orders. I had been given responsibility for the establishment of music in the National Curriculum, was trying to salvage an expensive curriculum materials development project on ‘Language in the Curriculum’, and was fighting a rearguard 6 defence of the English curriculum order against critics inside and outside Government. By about April 1992 it would seem from the DFA that we should have been in a position to issue the advice so long in gestation. However, delay itself had bred indecision and vacillation. HMI expressed doubts about the educationa advantages and the political implications of issuing advice at that point in time. And in May Dr Ernaelsteen expressed the view that the issue of advice was no longer timely, and the advantages would be outweighed by the disadvantages. June to September 1992 In my mind the exercise had taken a new direction, and the task was now to draft a submission to Ministers advising them against the issue of advice on the dissection of bovine eyeballs. However, the wording of a submission was obviously going to be tricky, and I found the draft put up by Miss Casbon unconvincing [YB92/6.8/3.1-3.3]. I did not find the time to produce my own draft. I now had other problems. In June I took over responsibility for the conduct of GCSE examining, which raised questions for urgent resolution about compatibility with National Curriculum assessment. Then the publication of GCSE results in August was followed by a published report from HMI calling in question the integrity of examining standards, and Ministers demanded immediate action. 7 September 1992 onwards In September and October officials of DH made clear to us the importance that their Ministers attached to the issue of advice to schools on bovine eyeball dissection. I learned for the first time of Mr Gummer’s commitment to the House to act on all the Tyrrell recommendations on BSE. From then on we acted with speed. Issued on behalf of the witness by: The BSE Inquiry Press Office 6th Floor Hercules House Hercules Road London SE1 7DU Fax: 0171 803 0893 Website: <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:http://www.bse.org.uk/" style="color: #473624; cursor: pointer;">http://www.bse.org.uk</a> email: <a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:inquiry@bse.org.uk" style="color: #473624; cursor: pointer;">mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:inquiry@bse.org.uk</a> 8<br /><br /><br /><a href="http://www.bseinquiry.gov.uk/files/ws/s527.pdf" style="color: #473624; cursor: pointer;">http://www.bseinquiry.gov.uk/files/ws/s527.pdf</a><br /><br /><br />NEW URL LINK 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a href="http://web.archive.org/web/20090505215136/http://www.bseinquiry.gov.uk/files/ws/s527.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090505215136/http://www.bseinquiry.gov.uk/files/ws/s527.pdf</a><br /><br />11.52 We acknowledge the difficulties faced by those called on to make public comments in relation to BSE and the delicate balance between providing necessary information and not creating unwarranted alarm. However, we thought Dr Kendell’s arguments were inconsistent. Whatever action was being taken to tighten up enforcement in December 1995, and in particular to ban MRM, it remained the case that seven years had now passed during which gaps or failures in enforcement had impinged on the food eaten by millions of people. As quoted above, Dr Kendell told us that by 1995 he did not regard the possibility of transmission to man as remote. He had not been following the scientific experiments on BSE, and we saw no evidence that Professor Collinge’s latest experiments on mice would have carried such weight with him at this point as to remove his concerns. 11.53 Having decided to make his statement, Dr Kendell should not have done so without making it plain that the safety of eating beef was dependent on strict compliance with the precautionary measures introduced by the Government in response to the emergence of BSE. At this point in the heated and increasingly polarised public debate, Dr Kendell’s statement is unlikely to have changed anybody’s basic perceptions. However, as we have observed elsewhere, such public statements by a CMO have a special authority of their own and their terms are crucial. They become keystones for judgements not only in the world at large, but within Government Departments and by Ministers, who rely on them as an authoritative basis for policy-making. Notes to editors or supplementary observations in newspaper interviews are ephemeral and not the considered and substantive core material being communicated. Indeed, they can sometimes contribute to the message becoming diluted and wrenched out of context.<br /><br /><br /><a href="http://www.bseinquiry.gov.uk/pdf/volume9/chapter11.pdf" style="color: #473624; cursor: pointer;">http://www.bseinquiry.gov.uk/pdf/volume9/chapter11.pdf</a></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr="">NEW LINK URL 2022</mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div><div class="post-body entry-content" id="post-body-5680689785330601503" itemprop="description articleBody" style="color: #29303b; font-family: Georgia, "Times New Roman", sans-serif; font-size: 13px;"><mailto:sillaste cybercable.fr=""><a href="http://web.archive.org/web/20090505195904/http://www.bseinquiry.gov.uk/pdf/volume9/Chapter11.pdf" style="color: #0096ef; cursor: pointer; text-decoration-line: none;">http://web.archive.org/web/20090505195904/http://www.bseinquiry.gov.uk/pdf/volume9/Chapter11.pdf</a><br /><br /><br />to be continued. ...TSS<br /><br /><br />Sunday, May 10, 2009<br /><br /><br />Identification and characterization of bovine spongiform encephalopathy cases diagnosed and not diagnosed in the United States<br /><br /><br /><a fg_scanned="1" href="http://bse-atypical.blogspot.com/2009/05/identification-and-characterization-of.html" style="color: #473624; cursor: pointer;">http://bse-atypical.blogspot.com/2009/05/identification-and-characterization-of.html</a><br /><br /><br />Thursday, December 04, 2008 2:37 PM<br /><br /><br />"we have found that H-BSE can infect humans."<br />personal communication with Professor Kong. ...TSS<br /><br /><br />see full text ;<br /><br /><br /><a fg_scanned="1" href="http://bse-atypical.blogspot.com/2009/02/atypical-bse-north-america-update.html" style="color: #473624; cursor: pointer;">http://bse-atypical.blogspot.com/2009/02/atypical-bse-north-america-update.html</a><br /><br /><br />Friday, November 30, 2007<br /><br /><br />CJD QUESTIONNAIRE USA CWRU AND CJD FOUNDATION<br /><br /><br /><a fg_scanned="1" href="http://cjdquestionnaire.blogspot.com/" style="color: #473624; cursor: pointer;">http://cjdquestionnaire.blogspot.com/</a><br /><br /><br />Sunday, April 12, 2009 BSE MAD COW TESTING USA 2009<br /><br /><br />FIGURES Month Number of Tests<br /><br />Feb 2009 -- 1,891<br /><br />Jan 2009 -- 4,620<br /><br /><br /><a fg_scanned="1" href="http://www.aphis.usda.gov/newsroom/hot_issues/bse/surveillance/ongoing_surv_results.shtml" style="color: #473624; cursor: pointer;">http://www.aphis.usda.gov/newsroom/hot_issues/bse/surveillance/ongoing_surv_results.shtml</a><br /><br /><br />see full text ;<br /><br /><br /><a fg_scanned="1" href="http://madcowtesting.blogspot.com/2009/04/bse-mad-cow-testing-usa-2009-figures.html" style="color: #473624; cursor: pointer;">http://madcowtesting.blogspot.com/2009/04/bse-mad-cow-testing-usa-2009-figures.html</a><br /><br /><br />Monday, May 4, 2009<br /><br /><br />Back to the Past With New TSE Testing Agricultural Research/May-June 2009<br /><br /><br /><a fg_scanned="1" href="http://madcowtesting.blogspot.com/2009/05/back-to-past-with-new-tse-testing.html" style="color: #473624; cursor: pointer;">http://madcowtesting.blogspot.com/2009/05/back-to-past-with-new-tse-testing.html</a><br /><br /><br />Saturday, April 11, 2009<br /><br />CJD FOUNDATION SIDES WITH R-CALFERS NO BSE OR HUMAN TSE THERE OF IN USA 'don't be fooled'<br /><br />Greetings CJD Voice,<br /><br />PLEASE be aware, R-CALFERS don't believe the USA has mad cow disease. R-CALFERS believe that the only problem in North America is in Canada, and that it's all Canada's fault. R-CALFERS ALSO believe that no human TSE in the USA is caused by eating beef. R-CALFERS only believe in the UKBSEnvCJD only theory. so in my humble opinion, they kinda mirror the CJD Foundations beliefs. dont' be fooled. fool me once, shame on you, fool me twice, shame on me. oh, it looks pretty, but please, i urge everyone here, do not be fooled. 569 members of CJDVOICE and only a few in a click communicates amongst themselves with the cjd foundation (the new one, not cele's old cjd foundation). why was this not posted on the cjd foundation web site (i may have missed it, but could not find it on homepage)? are they not proud that they have now sided with a cattle group that refuses to acknowledge the problem with mad cow disease in the USA, or a human TSE there of ? or maybe this is why it took over a decade or more to get a cjd questionnaire that would ask real questions pertaining to route and source of agent, as opposed to just how and by whom it was diagnosed?<br /><br /><br />i do not now, and will not ever support a partnership with R-CALF about any TSE, until they stand up and look at themselves in a mirror and admit that the USA is in the same boat as Canada, and that the USA also has a mad cow problem. the sham that took place in 2004, the so called extensive USA BSE surveillance program, was just that, a sham, and proved to be just that. the feed ban was just as much a sham, and proven to be so.<br /><br /><br />do not be fooled cjdvoice, please do not be fooled.<br /><br /><br />Bullard and r-calf et al, should stop worrying about Canada, and worry about their own back yard. stop covering up mad cow disease and using the SSS policy. if they would have taken care of business back in 1997, we would not be discussing this. Until a BSE Inquiry is addressed here in the USA against the USDA/FDA et al, and a true enhanced BSE Surveillance and testing program be put forth, we still will never no how many mad cows the USA really have $$$ the last enhanced BSE surveillance program was put forth, even the top prion Scientist said it was terribly flawed, and still is.<br /><br /><br />i said it a long time ago, ALL CATTLE FOR HUMAN AND ANIMAL CONSUMPTION SHOULD BE TESTED FOR 5 YEARS IN A ROW, before we know to a true extent, just what kind of problem we have. and all the rules and regulations on the mad cow feed ban will not work, unless they are strongly enforced, with severe ramifications when the rules are broke. stupidity is not acceptable anymore. ...<br /><br /><br />see full text ;<br /><br /><br /><a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000176/!x-usc:http://prionunitusaupdate2008.blogspot.com/2009/04/cjd-foundation-sides-with-r-calfers-no.html" style="color: #473624; cursor: pointer;">http://prionunitusaupdate2008.blogspot.com/2009/04/cjd-foundation-sides-with-r-calfers-no.html</a><br /><br /><br />Sunday, April 12, 2009<br /><br />r-calf and the USA mad cow problem, don't look, don't find, and then blame Canada<br /><br /><a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000176/!x-usc:http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html" style="color: #473624; cursor: pointer;">http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html</a><br /><br /><br />Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed<br /><br /><a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000176/!x-usc:http://madcowfeed.blogspot.com/2009/04/docket-no-fda2002n0031-formerly-docket.html" style="color: #473624; cursor: pointer;">http://madcowfeed.blogspot.com/2009/04/docket-no-fda2002n0031-formerly-docket.html</a><br /><br /><br />CJDVOICE AND CJDFOUNDATION MEMBERS,<br /><br />FOR all these reasons, is why i oppose the CJD Foundation decision to side with a cattle company that over the years, was as responsible for exposing the USA consumer to mad cow disease as was Canada, and then submit a letter that was written and in support of blaming only Canada. This letter the CJD Foundation supports and ask you to write, is only in support of R-CALF and a closed market to Canada beef, ALL THE WHILE IGNORING AND NOT SAYING A WORD OF PAST AND PRESENT FAILLURES OF THE SAME THING HERE IN THE USA. don't be fooled CJDVOICE. if you support this letter the way it was written, you are only fooling yourselves. you are being played like a pawn. write your own letter/comment, tell them the rest of the story. THIS IS NOT ABOUT CANADA ! the only reason we don't find mad cow disease in the USA, is because they did everything they could do in NOT finding BSE in those some 800,000 cattle that were tested. even Paul Brown called it flawed. dont be fooled cjdvoice and cjd foundation members, don't be fooled. ...<br /><br />CANADA DID NOT KILL MY MOTHER, AND HER DEATH WAS NO SPONTANEOUS EVENT, OR HAPPENSTANCE OF BAD LUCK. ...<br /><br />r-calf talks the talk NOW, but they need to practice what they preach at home. clean up their own backyards, stop worrying about Canada. the USA and Canadian cattle market, feed market, import and export between the two, were so intertwined, it was one market. Canada is just being honest, they are testing to find, and finding. the USDA et al did just the opposite, and or years and years that was o.k. with R-CALF. Canada's feed ban is stronger that the USA's feed ban. the only reason the USA is not finding mad cow cases of any phenotype is because of the SSS policy of shoot, shovel, and shut the hell up. ...<br /><br /><br />Sunday, May 10, 2009<br /><br />Identification and characterization of bovine spongiform encephalopathy cases diagnosed and not diagnosed in the United States<br /><br /><br /><a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000176/!x-usc:http://bse-atypical.blogspot.com/2009/05/identification-and-characterization-of.html" style="color: #473624; cursor: pointer;">http://bse-atypical.blogspot.com/2009/05/identification-and-characterization-of.html</a><br /><br /><br /><br />Thursday, March 19, 2009<br /><br /><br />MILLIONS AND MILLIONS OF POUNDS OF MAD COW FEED IN COMMERCE USA<br /><br /><br /><a href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000176/!x-usc:http://madcowfeed.blogspot.com/2009/03/millions-and-millions-of-pounds-of-mad.html" style="color: #473624; cursor: pointer;">http://madcowfeed.blogspot.com/2009/03/millions-and-millions-of-pounds-of-mad.html</a><br /><br /><br />Sunday, May 10, 2009<br /><br /><br />Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009 (Singeltary submission)<br /><br /><br /><a fg_scanned="1" href="http://tseac.blogspot.com/2009/05/meeting-of-transmissible-spongiform.html" style="color: #956839; cursor: pointer;">http://tseac.blogspot.com/2009/05/meeting-of-transmissible-spongiform.html</a><br /><br /><br /><br />TSS<br /></mailto:sillaste></div><div><mailto:sillaste cybercable.fr=""><br /></mailto:sillaste></div></div></div></div>Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0