SPORADIC CJD IN FARMERS, FARMERS WIVES, FROM FARMS WITH BSE HERD AND ABATTOIRS

SPORADIC CJD IN FARMERS, FARMERS WIVES, FROM FARMS WITH BSE HERD AND ABATTOIRS

‘The first farmer’ – August 1992 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 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 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 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 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 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 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 EMERGENCE OF VARIANT CJD 35 5.11 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. 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 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 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. 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

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‘The second farmer’ – July 1993 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 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 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. 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 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 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. 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 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

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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

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‘The third farmer’ – December 1994 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 5.34 On 1 December 1994, the case was reported in the local newspaper, The Cornishman, while the patient was still in hospital.225 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 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 The report formed Annex 2 to the CJDSU’s Third Annual Report (IBD2 tab 8) 224 YB94/12.19/3.1 225 YB94/12.19/3.4 226 YB94/12.19/5.1 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. 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 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. 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 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 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.

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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). 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 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

The fourth farmer – September 1995 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 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. 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 YB95/9.29/12.1; YB95/9.29/10.1; YB95/9.29/14.1 256 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 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.) 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. 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. 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 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 VARIANT CJD 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. 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 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. 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.

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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. 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 YB96/1.5/1.6–1.8; S61D Will paras 19–22 EMERGENCE OF VARIANT CJD 51 risk’ occupations was getting full compared to expectation on pure chance and could not be dismissed.293

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Update on cases of CJD in farmers 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. 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.

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Is occupation a risk factor in vCJD? 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. 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. EMERGENCE OF VARIANT CJD 79 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. 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.

http://www.bseinquiry.gov.uk/pdf/volume8/chapter5.pdf


This was not simply another farmer but the third farmer......

http://www.bseinquiry.gov.uk/files/yb/1995/06/21002001.pdf


suspect case of CJD in a farmer who has had a case of BSE in his beef suckler herd.

http://www.bseinquiry.gov.uk/files/yb/1995/10/00003001.pdf


cover-up of 4th farm worker ???

http://www.bseinquiry.gov.uk/files/yb/1995/10/23006001.pdf

http://www.bseinquiry.gov.uk/files/yb/1995/10/20006001.pdf


CONFIRMATION OF CJD IN FOURTH FARMER

http://www.bseinquiry.gov.uk/files/yb/1995/11/03008001.pdf


now story changes from;

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.

to;

This is not unexpected...

was another farmer expected?

http://www.bseinquiry.gov.uk/files/yb/1995/11/13010001.pdf



4th farmer, and 1st teenager

http://www.bseinquiry.gov.uk/files/yb/1996/02/27003001.pdf



2. snip...

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.

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...


http://www.bseinquiry.gov.uk/files/yb/1995/01/31004001.pdf


CJD FARMERS WIFE 1989

http://www.bseinquiry.gov.uk/files/yb/1989/10/13007001.pdf

http://www.bseinquiry.gov.uk/files/yb/1989/10/13003001.pdf


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....

http://www.bseinquiry.gov.uk/files/yb/1995/10/04004001.pdf


USA 2008

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.

snip...

Atypical forms of BSE have emerged which, although rare, appear to be more virulent than the classical BSE that causes vCJD.

please see full text with additional comments and links @ ;

http://prionunitusaupdate2008.blogspot.com/


SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM 1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype of 'UNKNOWN' strain growing. ...

http://www.cjdsurveillance.com/resources-casereport.html


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.

He estimates that it may be up to 14 or 15 persons which display selectively SPRPSC and practically no detected RPRPSC proteins.

http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm

http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf


PLEASE NOTE IN USA CJD UPDATE AS AT JUNE 2007, please note steady increase in ''TYPE UNKNOWN''. ...TSS

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,

*** 26 from 2007)

http://www.cjdsurveillance.com/pdf/case-table.pdf


Diagnosis and Reporting of Creutzfeldt-Jakob Disease

Singeltary, Sr et al. JAMA.2001; 285: 733-734.

http://jama.ama-assn.org/http://www.neurology.org/cgi/eletters/60/2/176#535


JOURNAL OF NEUROLOGY

MARCH 26, 2003

RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob

disease in the United States

Email Terry S. Singeltary:

flounder@wt.net

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?

http://www.neurology.org/cgi/eletters/60/2/176#535


THE PATHOLOGICAL PROTEIN

Hardcover, 304 pages plus photos and illustrations. ISBN 0-387-95508-9

June 2003

BY Philip Yam

CHAPTER 14 LAYING ODDS

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.

http://www.thepathologicalprotein.com/


USA 2007-2008 sporadic CJD statistics revised to 1 in 9,000 in ages 55 and older !

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.

http://www.cjdfoundation.org/fact.html


Sent: Monday May 28, 2007

Subject: THE BIG LIE SPORADIC CJD AND MAD COW DISEASEs i.e. TSE

http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0705&L=sanet-mg&T=0&P=25276


Sunday, March 16, 2008

MAD COW DISEASE terminology UK c-BSE (typical), atypical BSE H or L, and or Italian L-BASE

http://bse-atypical.blogspot.com/2008/03/mad-cow-disease-terminology-uk-c-bse.html


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

Comments sent via JAMA Feedback Page ------------------------------------------------------------ NAME: Terry S. Singeltary Sr. E-MAIL: flounder9@verizon.net IP ADDRESS: xxxxxxxx HOSTNAME: xxxxxxxx PREVIOUS PAGE: http://jama.ama-assn.org/misc/authors.dtl BROWSER: Mozilla/5.0 (Windows; U; Win98; en-US; rv:1.0.2) Gecko/20030208 Netscape/7.02 PROMOTIONAL USE: (not answered)

HUMAN and ANIMAL TSE Classifications i.e. mad cow disease and the UKBSEnvCJD only theory

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.

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.

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. ...

Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518 flounder9@verizon.net

MAD COW DISEASE BSE CJD CHILDREN VACCINES

Sunday, May 18, 2008

MAD COW DISEASE BSE CJD CHILDREN VACCINES

TIP740203/l 0424 CONFIDENTIAL

http://www.mad-cow.org/00/may00_news.html#aaa


TWA LITTLE minute

http://www.bseinquiry.gov.uk/files/yb/1988/06/10001001.pdf


http://www.bseinquiry.gov.uk/files/yb/1988/06/13010001.pdf


http://www.bseinquiry.gov.uk/files/yb/1988/06/14006001.pdf


COMMERCIAL IN CONFIDENCE

http://www.bseinquiry.gov.uk/files/yb/1988/09/06005001.pdf


http://www.bseinquiry.gov.uk/files/yb/1988/10/06005001.pdf


NOT FOR PUBLICATION

http://www.bseinquiry.gov.uk/files/yb/1988/11/01012001.pdf


http://www.bseinquiry.gov.uk/yb/1988/11/04003001.pdf


http://www.bseinquiry.gov.uk/files/yb/1988/04/00007001.pdf


http://www.bseinquiry.gov.uk/files/yb/1988/07/00007001.pdf


http://www.bseinquiry.gov.uk/files/yb/1988/09/00004001.pdf


http://www.bseinquiry.gov.uk/files/yb/1988/10/00003001.pdf


http://www.bseinquiry.gov.uk/files/yb/1989/01/04001001.pdf


http://www.bseinquiry.gov.uk/files/yb/1989/01/26007001.pdf


http://www.bseinquiry.gov.uk/files/yb/1989/01/30001001.pdf


http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf


NON-LICENSED HUMAN TISSUE DEVICES WERE NOT COMMERCIALLY AVAILABLE

snip...

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.

snip...

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...

http://www.bseinquiry.gov.uk/files/ws/s467bx.pdf


more on the 1968 medicine act, they forgot to follow i.e. no Scrapie-like disease. ...TSS

http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf


Draft cover letter to product licence holders (considered by Human and Vet Medicines including deer)

http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf


http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf


(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.)

http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf


http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf


http://www.bseinquiry.gov.uk/files/yb/1988/06/07010001.pdf


TWA LITTLE STATEMENT 331

http://www.bseinquiry.gov.uk/files/ws/s331.pdf


snip...

http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm


http://www.bseinquiry.gov.uk/files/yb/1988/11/04003001.pdf


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).

http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf


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

Health: vCJD Lord Morris of Manchester asked Her Majesty's Government:

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]

19 Dec 2006 : Column WA291

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.

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.

Lord Morris of Manchester asked Her Majesty's Government:

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]

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.

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.

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:

from December 1997, blood components, plasma products or tissues obtained from any individual who later develops vCJD, were withdrawn/recalled;

19 Dec 2006 : Column WA292

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.

http://www.publications.parliament.uk/pa/ld200607/ldhansrd/text/61219w0004.htm#06121940000034


http://www.whale.to/v/singeltary7.html


http://www.microbes.info/forums/index.php?s=6f1dd87fff0c5b970fc8b8fe838f7ee5&showtopic=377&pid=477&st=0&#entry477


Subject: Re: VACCINES/CHILDREN/TSE'S -- 'CONFIDENTIAL' Date: Wed, 6 Sep 2000 18:20:09 -0800 From: tom Reply-To: Bovine Spongiform Encephalopathy To: BSE-L@uni-karlsruhe.de References: 1

######### Bovine Spongiform Encephalopathy #########

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: http://www.google.com/ This works quite well to search the entire http://www.mad-cow.org 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 http://www.bse.org.uk/

Thus for louping ill (unnecessary cites suppressed):

http://www.bse.org.uk/witness/htm/stat537.htm


Witness Statements 537 - Coulthard

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.

http://www.mad-cow.org/~tom/fda_late.html#ill


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]

http://www.foodsafety.org/consumer/ht/ht294.htm


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.

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.

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)

Terry was reading Draft Factual Account 17

http://www.bse.org.uk/dfa/dfa17.htm


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: ...

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. ---------------------------- 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]. -------------------------- Medicines and medical devises;

Subject: 2 known incidents of iatrogenic scrapie Date: Thu, 7 Sep 2000 09:51:14 -0800 From: tom Reply-To: Bovine Spongiform Encephalopathy To: BSE-L@uni-karlsruhe.de References: 1

######### Bovine Spongiform Encephalopathy #########

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.

I found a better source for needed references for iatrogenic scrapie in a nice review by Ray Bradley at http://www.iica.org.ar/Bse/6-%20Bradley.html. 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.

If anyone has the first 3, I would appreciate a fax 542-484-0669 US.

tom

GORDON , W.S., 1959. Scrapie panel. In: Proceedings of 63rd Annual Meeting of the US Livestock Sanitary Association, 63, 286-294. [no medline record]

GORDON, W.S., 1946. Advances in Veterinary Research: Louping ill, tick-borne fever and scrapie. Veterinary Record, 58, 516-525. [no medline record]

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]

-=-=--=

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]

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]

IATROGENIC DISEASE IN ANIMALS
http://www.iica.org.ar/Bse/6-%20Bradley.html
Ray Bradley Private BSE Consultant Veterinary Laboratories Agency, United Kingdom

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

Louping-ill vaccine documents from November 23rd, 1946 FULL TEXT

THE VETERINARY RECORD 516 No 47. Vol. 58 November 23rd, 1946

NATIONAL VETERINARY MEDICAL ASSOCIATION OF GREAT BRITAIN AND IRELAND

ANNUAL CONGRESS, 1946

The annual Congress, 1946, was held at the Royal Veterinary College, Royal College Street, London, N.W.I. from September 22nd to September 27th.

Opening Meeting

[skip to scrapie vaccine issue...tss]

Papers Presented to Congress

SNIP...FULL TEXT ;

http://whale.to/v/singeltary.html


although 176 products do _not_ conform to the CSM/VPC guidelines.

http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf


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).

http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf


http://www.bseinquiry.gov.uk/files/yb/1989/02/14011001.pdf


more on the 1968 medicine act, they forgot to follow

http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf


Draft cover letter to product licence holders (considered by Human and Vet Medicines including deer)

http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf


http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf


2.3.Iatrogenic exposure

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.

http://ec.europa.eu/food/fs/sc/ssc/out170_en.pdf


http://ec.europa.eu/food/fs/sc/ssc/out247_en.pdf


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.

http://www.bseinquiry.gov.uk/files/ib/ibd1/tab02.pdf


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

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

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

http://www.mad-cow.org/00/sep00_news.html#bbb


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

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.

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.

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.

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:

http://www.mad-cow.org/00/sep00_news.html#hhh


England worried briefly about infecting other countries 27 Aug 00 confidential correspondence obtained by Terry S. Singeltary Sr.

BSE11/2 020;

SC1337p

DEPARTMENT OF HEALTH AND SOCIAL SECURITY Richmond House, 79 Whitehall, London SWIA 2NS Telephone 01-210 3000 From the Chief Medical Officer Sir Donald Achson KBE DM DSc FRCP FFCM FFOM

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

Dear Mr Meldrum

BOVINE SPONGIFORM ENCEPHALOPATHY

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.

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.

http://www.mad-cow.org/00/aug00_last_news.html#fff


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.

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

http://www.mad-cow.org/00/may00_news.html#aaa


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

[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?

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.

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.]

10 January 1990 COMMERCIAL IN CONFIDENCE

NOT FOR PUBLICATION

COMMITTEE ON SAFETY OF MEDICINES WORKING PARTY ON BOVINE SPONGIFORM ENCEPHALOPATHY

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;

http://www.mad-cow.org/00/jul00_dont_eat_sheep.html#hhh


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.

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.

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.

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:

"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."

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).....

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

89/02.15/11.2 MF580439/1 0584 SOUTHWOOD REPORT: BSE AND MEDICINAL PRODUCTS

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. ..

MF580439/1 0585 Question

1. Which medicines are affected? (person to provide reply) Dr. Jefferys

2. Are the risks greater with some medicines than others? Dr. Jefferys

3. Why are medicines affected? Dr. Jefferys

4. Are some affected products available over the counter from pharmacies or shops? Dr. Purves

5. Are only UK products at risk? Dr. Jefferys

6. Are existing stocks safe? Dr. Jefferys

7. Are pre 1980 stocks available? Mr. Burton

8. Are these alternatives to the use of bovine material? Dr. Purves

9. Why can't we throw away suspect stock and import or manufacture safe medicines? Dr. Jefferys

10. Which patients are at risk? Dr. Jefferys

11. Are some patients particularly vulnerable? Dr Jefferys

12. What risks exist to those who have already used these medicines? Dr. Jefferys

13. HOW might patients be affected? Dr. Jefferys

14. Can BSE be transmitted to patients by medicines? Dr. Jefferys

15. How long will it be before risks are quantified? Dr. Jefferys

100 89/02.17/10.2 MF580439/1 0586

16. What research is going on to find out if medicines can transmit this disease and if any patients have been affected? Dr Jefferys

17. Could recent cases of Creuuzfeld Jacob Disease have been caused by transmission of BSE through medicines? Dr. Jefferys

18. What action is the Licensing Authority taking to ensure proper scrutinising of source materials and manufacturing processes? Dr. Jefferys/Dr. Purves

19. Are the guidelines practical? Dr. Jefferys/Dr. Purves

20. Will the guidelines remove the risk? Dr. Jefferys

21. How will the guidelines be enforced? Dr. Jefferys/Dr. Purves

22. How soon will they come into force? Dr. Jefferys

23. Will the guidelines be published? Mr. Hagger

24. What is being done to reassure patients, parents etc? Mr. Hagger/Dr. Salisbury

25. What advice is being given to doctors, pharmacists etc? Mr. Hagger

26. What advice is the Government giving about its vaccination programme? Dr. Salisbury

27. Is the vaccination programme put at risk because of BSE? Dr. Salisbury

89/02.17/10.3

Q. Will government act on this?

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.

VETERINARY MEDICINES

Q. Can medicines spread BSE to other cattle/animals?

A. The report describes any risks as remote.

Q. How can risks be avoided?

A. In liaison with the DOH the Veterinary Products Committee is examining guidelines for the veterinary pharmaceutical industry which will be issued shortly.

Q. What will Guidelines say?

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.

89/02.17/10.4 MF580439/1 0588

A. Bovine source material is used in [garbled, cannot read...TSS] and some other medicines.

Q. How many medicines are involved?

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.

89/06.19/8.1 BSE3/1 0191 Hr J Maslin (MAFF) Ref: Maslin3g

From: Dr H Pickles Med SEB/B Date: 3 July 1989

CATTLE BY-PRODUCTS AND BSE

I was interested to see the list of by-products sent to the HSE. Those of particular concern included:

* small intestines: sutures (I thought the source was ovine but you are checking this)

* spinal cord: pharmaceuticals

* thymus: pharmaceuticals

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.

Id No. 1934/RD/1 89/08.10/6.1 117A

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:

ID 2267/NRE/1 89/08.21/10.1

1. Products with Bovine brain/lymph tissue administered by injection.

2. Products with bovine tissue other than brain/lymph administered by inection.

3. Tissue implants/open wound dressing/surgical materials/dental and ophthlamic products with bovine ingredients.

4. Products with bovine ingredients administered topically.

5. Products with bovine ingredients administered orally.

6. Products with other animal/fish/insect/bird ingredients administered by injection/topically/oral routes.

7. Products with ingredients derived from animal material by chemical processing (eg stearic acid, gelatine, lanolin ext.

The BSE working group will decide which of these are important, and should be examined more closely, and which categories can be eliminated.

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.

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.

9. Re-editing of the Paper on "Incubation of Scrapie-like Agents"

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....

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.

2334q/RD/4 89/08.21/10.7

BOVINE MATERIAL USED IN THE MANUFACTURE OF SURGICAL IMPLANTS AND BLOOD CONTACT MEDICAL DEVICES

Glutaraldehyde, formaldehyde, and ethylene oxide are used in the sterilization of these devices.

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.

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.

2334q/RD/7 89/08.21/10.10 BSE11/2 020 SC1337

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

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

Dear Mr. Meldrum,

BOVINE SPONGIFORM ENCEPHALOPATHY

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.

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.

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.

Signed Sincerely Donald Acheson

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)

<--- 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)

<--- 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)

<--- 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


http://www.mad-cow.org/00/may00_news.html


Procedures Manual

Bovine Spongiform Encephalopathy (BSE)

Ongoing Surveillance Plan

Ongoing Surveillance Plan Implementation July 20, 2006

snip...

Personal Safety

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

http://www.aphis.usda.gov/vs/nvsl/PDFs/BSE%20Ongoing%20Surveillance%20SOP%207-20-06.doc


SO, looks like to me the most likely route of transmission of BSE to humans would be through inoculation i.e.

the most likely routes would be through contact with infective tissues through wounds or open lesions on the skin,

IF you look at all the successful transmission studies in the lab with TSE, inoculations was the most successful route.

BSE-L@LISTS.AEGEE.ORG

Bovine Spongiform Encephalopathy

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

LISTS.AEGEE.ORG ( BSE-L: 484 matches (only the first 50 will be shown).. )

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From: TSS (216-119-138-163.ipset18.wt.net) Subject: Louping-ill vaccine documents from November 23rd, 1946 Date: September 10, 2000 at 8:57 am PST

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

######### Bovine Spongiform Encephalopathy #########

THE VETERINARY RECORD 516 No 47. Vol. 58 November 23rd, 1946

NATIONAL VETERINARY MEDICAL ASSOCIATION OF GREAT BRITAIN AND IRELAND

ANNUAL CONGRESS, 1946

The annual Congress, 1946, was held at the Royal Veterinary College, Royal College Street, London, N.W.I. from September 22nd to September 27th.

Opening Meeting

[skip to scrapie vaccine issue...tss]

Papers Presented to Congress

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.

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."

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.

Advances in Veterinary Research

by

W.S. GORDON, PH.D., M.R.C.V.S., F.R.S.E.

Agriculteral Research Council, Field Station, Compton, Berks.

Louping-ill, Tick-borne Fever and Scrapie

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.

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.

Dr. Gordon illustrated this portion of his paper by means of graphs and diagrams projected by the epidiascope.

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.

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.

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.

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:-

(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.

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.

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.

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. ==================================================================

Greetings List Members,

pretty disturbing document. now, what would stop this from happening with the vaccineCJD in children???

kind regards,

Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518

BSE, CJD, and Baby foods (the great debate 1999 to 2005)

BSE, CJD, and Baby foods (the great debate 1999 to 2005)

Bovine Spongiform Encephalopathy

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

LISTS.AEGEE.ORG ( BSE-L: 61 matches baby foods (only the first 50 will be shown).. )

https://lists.aegee.org/cgi-bin/wa?S2=BSE-L&X=1D1B9A2D19721D3331&Y=flounder9@verizon.net&q=baby+foods&s=&f=&a=&b=


CJD and Baby foods (the great debate 1999)

Subject: Re: Girl, 13, shows CJD symptoms. From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy Date: Wed, 24 Nov 1999 11:35:44 -0600 Content-Type: text/plain Parts/Attachments: text/plain (67 lines)

######### Bovine Spongiform Encephalopathy #########

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..............

Debora MacKenzie wrote:

######### Bovine Spongiform Encephalopathy #########

GIRL, 13, SHOWS CJD SYMPTOMS November 23, 1999 PA News John von Radowitz, Medical Correspondent, PA News 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. ... 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.

Debora MacKenzie, Europe correspondent, New Scientist. tel: +32-2-245-0412 fax: +32-2-245-0552 email: d.mackenzie@chello.be

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Subject: Re: Girl, 13, shows CJD symptoms. [re-baby food] From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy Date: Thu, 25 Nov 1999 11:21:52 -0600 Content-Type: text/plain Parts/Attachments: text/plain (66 lines)

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Hello Robert and All,

I would like to point out in DFA 9

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.

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. 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...

Kind Regards, Terry S. Singeltary Sr., Bacliff, Texas USA

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Subject: Re: Girl, 13, shows CJD symptoms. [re-baby food] From: J Ralph Blanchfield Reply-To: Bovine Spongiform Encephalopathy Date: Thu, 25 Nov 1999 22:30:36 +0000 Content-Type: text/plain Parts/Attachments: text/plain (168 lines)

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Hello Robert, Terry and Everyone,

On Thu, 25 Nov 1999 13:17:45 -0500, Robert LaBudde wrote:

######### Bovine Spongiform Encephalopathy #########

At 11:21 AM 11/25/99 -0600, Terry wrote: I would like to point out in DFA 9

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.

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. 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...

Thanks for the relevant information, Terry.

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.

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.

Perhaps JRalph could help us out with an authoritative comment on this issue.

I'll do my best. You really are keeping me hard at work today here and elsewhere, aren't you, Robert?

_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.

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:

7. Rendering food injurious to health ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ (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.

Section 8 contains two provisions -- 8(2)(b) and 8(2)(c) -- not in the predecessors of the 1990 Act:

8 Selling food not complying with food safety requirements ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ (1) Any person who- (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 (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. (2) For the purposes of this Part food fails to comply with food safety requirements if- (a) it has been rendered injurious to health by means of any of the operations mentioned in section 7(1) above; (b) it is unfit for human consumption; or (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. (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. (4) For the purposes of this Part, any part of, or product derived wholly or partly from, an animal- (a) which has been slaughtered in a knacker’s yard, or of which the carcase has been brought into a knacker’s yard; or (b) in Scotland, which has been slaughtered otherwise than in a slaughterhouse, shall be deemed to be unfit for human consumption. (5) In subsection (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.

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).

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.

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.

I happen to know Heather well in an entirely different connection, and a more honest and conscientious person it would be hard to find.

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.

Regards Ralph ****************************************************************** 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 e-mail: ICQ# 6254687. ICQ Web page ******************************************************************

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Subject: Re: Girl, 13, shows CJD symptoms. [re-baby food] From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy Date: Fri, 26 Nov 1999 10:36:34 -0600 Content-Type: text/plain Parts/Attachments: text/plain (210 lines)

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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.

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.........

Kind Regards, Terry

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Subject: Re: Girl, 13, shows CJD symptoms. [re-baby food] From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy Date: Sat, 27 Nov 1999 18:54:39 -0600 Content-Type: text/plain Parts/Attachments: text/plain (397 lines)

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Thanks Ralph,

re-Heather<>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.

guilt by association, and U.K. laws about nutritional supplements<>the manufactures".< a2="ind9911&L="BSE-L&P="R15856&X="1D1B9A2D19721D3331&Y="flounder9%40verizon.net">Reply-To: Bovine Spongiform Encephalopathy Date: Sun, 28 Nov 1999 11:46:07 +0000 Content-Type: text/plain Parts/Attachments: text/plain (119 lines)

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Hello Terry and Everyone,

On Sat, 27 Nov 1999 18:54:39 -0600, Terry wrote:

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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;

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 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.

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.

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".

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,.

Dear Ralph

Further to our telephone conversation yesterday here is a brief summary of my discussion with the journalist John Radowitz re BSE and babyfoods.

The journalist was mainly interested in MRM and asked me if the baby food industry used MRM to 'bulk out' baby foods!

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.

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.

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.

Hope this helps

Heather

Dear Ralph

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.

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.

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.

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.

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!

All the best

Heather

Regards Ralph ****************************************************************** 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 e-mail: ICQ# 6254687. ICQ Web page ******************************************************************

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Subject: Baby Food * June 23, 1999 BSE Inquiry From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy Date: Tue, 30 Nov 1999 11:16:54 -0600 Content-Type: text/plain Parts/Attachments: text/plain (125 lines)

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Terry S. Singeltary Sr., Bacliff, Texas USA

> Greetings everyone, I thought these comments were interesting. Thought
> some of you might find some interest in them...
>
> 2 MR LAWRENCE: Yes.
> 3 MR WALKER: I think you thank Mr Cockbill later for help on
> 4 the idiosyncracies of the meat products regulations. Is
> 5 that what he helped on?
> 6 MR LAWRENCE: I think that is right. But I think in
> 7 conjunction with what I was being asked to do, I think
> 8 Charles Cockbill was considering, am I right, the
> 9 possible regulations in relation to baby food?
> 10 MR WALKER: Yes.
> 11 MR LAWRENCE: So he was also making an assessment of those
> 12 tissues which might contain infective agent for that
> 13 piece of legislation.
> 14 MR WALKER: Yes. He was head of Food Standards Division,
> 15 reporting to Mrs Attridge.
> 16 MR LAWRENCE: Yes.
> 17 MR WALKER: And I think we have seen documents which
> 18 suggest he was in correspondence with Dr Pickles at the
> 19 Department of Health in relation to the baby food
> 20 regulations.
> 21 MR LAWRENCE: I think I have seen some of those, yes.
> 22 MR WALKER: Can you recall whether he was helping you on
> 23 the tissues, then, that might be infective?
> 24 MR LAWRENCE: It may well be. I cannot quite recall.
> 25 I mean there were a lot of documents at the time. But
> 1 obviously I gleaned information from various different
> 2 sources because, you know, I did produce a draft,
> 3 I think of 27th April. So whether I took on board some
> 4 of the information that I had seen from Charles or not,
> 5 I do not know. It may well have been, yes.
> _______________________________________________________
>
> 15 Could you just help us on the manuscript that we
> 16 see here? Is this from Mr Meldrum to you dated 14th
> 17 May?
> 18 MR LAWRENCE: Yes, I think that is.
> 19 MR WALKER: And he said:
> 20 "Thank you for a chance to comment. I think there
> 21 is some danger of Don fusing the proposed legislation on
> 22 baby foods and a wider ban on brains, spinal cord et
> 23 cetera. I am a little uneasy about some of the
> 24 assumptions made because I am advised that some bovine
> 25 brains are used for human consumption."
>
> 1 Have I deciphered that correctly?
> 2 MR LAWRENCE: Yes, I think that is right.
> 3 MR WALKER: We see on the left, against that reference to
> 4 some bovine brains being used for human consumption:
> 5 "But not in meat products".
> 6 MR LAWRENCE: I think that is my writing.
>
> 4 MR WALKER: That is very helpful. Thank you very much.
> 5 That comment, is that something that, from your point of
> 6 view, you simply took at face value?
> 7 MR LAWRENCE: Well, yes. I mean, as a non-scientist I was
> 8 really relying on their expertise to advise me, you
> 9 know, in what I should be putting up to the Minister in
> 10 the way of advice, yes.
> 11 MR WALKER: Did you see it as your role to seek to identify
> 12 what the level was in animals suffering from the disease
> 13 and how much lower the level was in these sub-clinically
> 14 infected animals?
> 15 MR LAWRENCE: No.
> 16 MR WALKER: From your point of view, that was a matter for
> 17 the expert advisers?
> 18 MR LAWRENCE: Yes. I mean, I think I have said in perhaps
> 19 a rather simplistic way I simply wanted to know from
> 20 these blokes which tissues they felt should be banned
> 21 from human consumption. And it did not concern me, you
> 22 know, about titre levels or anything else. It was
> 23 really yes or no.
> 24 MR WALKER: Yes, thank you.
> _____________________________________________________
>
> 1 MR WALKER: Why was it you were saying to UKASTA that the
> 2 SBO ban was simply to maintain public confidence?
> 3 MR LAWRENCE: Well, can I again read out what I intend to
> 4 say in...
> 5 MR WALKER: Yes.
> 6 MR LAWRENCE: I am saying in response to what you are
> 7 asking me I think the answer to that is that it was. As
> 8 I have already stated, the risks from BSE were regarded
> 9 as remote so the SBO ban was a measure of additional
> 10 reassurance against that remote risk. The determination
> 11 of which tissues to proscribe was a scientific
> 12 assessment based on the scrapie analogy of those offals
> 13 which might contain the agent in cattle with
> 14 pre-clinical disease.
> 15 My minute, again, may be a bit of shorthand
> 16 because I wanted to refer, and I will do when I send the
> 17 supplementary note, to another document I sent out on
> 18 that very same day; and that was the consultation letter
> 19 in relation to the proposed SBO ban, which is reference
> 20 YB 89/7.26/1.1.
> 21 In that what I am saying, in the letter, amongst
> 22 other things, is that scientific advice, including that
> 23 reflected in Southwood Report, is that in clinically
> 24 diseased animals and those which may be incubating the
> 25 disease, the BSE agent might be present in the brain,
> lawrence
>
> 1 spinal cord, spleen, thymus, tonsils and intestines.
> 2 The Southwood Working Party suggested, merely as a
> 3 precautionary measure, that manufacturers of baby food
> 4 should refrain from using certain offals in their
> 5 products.
> 6 In all the circumstances, Ministers have decided
> 7 that the most effective way of ensuring the protection
> 8 of public health would be to make regulations under the
> 9 Food Act 1984, those regulations being the SBO ban.
> 10 So, yes, you know, my minute in the way it is
> 11 worded -- sorry, the minute you are referring to, yes,
> 12 does look as if it was simply maintaining public
> 13 confidence. But I think in the letter I sent the same
> 14 day, the consultation letter, I am explaining it in more
> 15 detail, you know, the reasoning behind it that there was
> 16 a scientific reason for going a bit further..................


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Subject: Southwood Working Party advice on baby food. >witness statement 184e - Meldrum issued 10/14/99 From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy Date: Tue, 30 Nov 1999 12:32:34 -0600 Content-Type: text/plain Parts/Attachments: text/plain (872 lines)

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Terry S. Singeltary SR., Bacliff, Texas USA

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

(or hoping), that BSE could not be transmitted to humans. Unfortunately, they found out different... ___________________________________________________________

Southwood Working Party advice on baby food

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….".

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).

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.

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.

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).

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).

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).

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.

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).

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.

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).

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.

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).

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:

(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).

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.

(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).

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.

Development of the SBO ban

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.

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.

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".

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.

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".

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).

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.

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).

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.

Approach taken to the Southwood Working Party advice

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:

"(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;

(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.

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".)

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.

24.In the context of this section, I have also been asked to consider the following matters: a.Southwood Report "unnatural practices" recommendation.

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).

b.Southwood Report advice for baby food manufacturers.

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"

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*** BABY FOODS 2001

Subject: FSA ADMITS ERROR OVER BABY FOOD - BABY FOODS AND MAD COW DISEASE back on table... From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy Date: Sat, 20 Oct 2001 10:19:30 -0700 Content-Type: text/plain Parts/Attachments: text/plain (203 lines)

######## Bovine Spongiform Encephalopathy #########

Saturday, 20 October, 2001, 02:24 GMT 03:24 UK

FSA admits error over baby food

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.

Sir John Krebs said lamb from the UK was not being used in baby food.

He suggested there was a voluntary agreement by the food industry to use lamb only from countries like New Zealand.

Sir John hoped the assertion would be reassuring for those who feared sheep might harbour BSE.

But a spokesman for the baby food industry, Heather Payne, told the BBC manufacturers are still using British lamb.

"The lamb that baby food manufacturers use comes from a number of different sources. But it includes the UK, New Zealand, France and Germany.

"We had a meeting earlier this year with the Food Standards Agency and we explained all our procedures and all our operations to them.

"They advised us there was no need to change our source of lamb."

Lethal illness

There have been fears that BSE could be present in the national flock, sparking fears of a mass slaughter.

BSE-infected meat is widely believed to be the source of the lethal vCJD illness in humans

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.

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.

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.

http://news.bbc.co.uk/hi/english/health/newsid_1609000/1609832.stm

Greetings list members,

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...

with kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA

Re: Girl, 13, shows CJD symptoms. [re-baby food]

Date: Thu, 25 Nov 1999 22:30:36 +0000

J Ralph Blanchfield

snip...

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.

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.

I happen to know Heather well in an entirely different connection, and a more honest and conscientious person it would be hard to find.

snip...

===================================

At 11:35 AM 11/24/99 -0600, Terry wrote:

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;

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.

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.

Babies of all species have more porous intestinal membranes, so uptake of prions would be expected to be more efficient.

snip...

========================================

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.

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. 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...

snip...



========================================

for anyone interested and wanting to search data of this thread, search BSE-L archive NOVEMBER 1999. towards the bottom, #35.

kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA

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Subject: Re: FSA ADMITS ERROR OVER BABY FOOD - BABY FOODS AND MAD COW DISEASE back on table... From: J Ralph Blanchfield Reply-To: Bovine Spongiform Encephalopathy Date: Sat, 20 Oct 2001 19:15:48 +0100 Content-Type: text/plain Parts/Attachments: text/plain (249 lines)

######## Bovine Spongiform Encephalopathy #########

Hello Terry and Everyone,

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").

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").

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.

Best wishes Ralph ****************************************************** 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 Personal Web address ******************************************************

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Subject: Re: FSA ADMITS ERROR OVER BABY FOOD - BABY FOODS AND MAD COW DISEASE back on table... From: Brian MATTHEWS Reply-To: Bovine Spongiform Encephalopathy Date: Mon, 22 Oct 2001 15:33:42 +0100 Content-Type: text/plain Parts/Attachments: text/plain (270 lines)

######## Bovine Spongiform Encephalopathy #########

Ralph,

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.

Given the latest display of ineptitude on the part of UK scientists, what faith can be placed in the data?

Regards,

Brian Matthews lt09@dial.pipex.com

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Subject: Re: FSA ADMITS ERROR OVER BABY FOOD - BABY FOODS AND MAD COW DISEASE back on table... From: J Ralph Blanchfield Reply-To: Bovine Spongiform Encephalopathy Date: Mon, 22 Oct 2001 19:00:08 +0100 Content-Type: text/plain Parts/Attachments: text/plain (311 lines)

######## Bovine Spongiform Encephalopathy #########

Hello Brian and Everyone,

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

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.

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.

Best wishes Ralph ****************************************************** 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 Personal Web address ******************************************************

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Subject: Re: FSA ADMITS ERROR OVER BABY FOOD - BABY FOODS AND MAD COW DISEASE back on table... From: Brian MATTHEWS Reply-To: Bovine Spongiform Encephalopathy Date: Mon, 22 Oct 2001 19:22:09 +0100 Content-Type: text/plain Parts/Attachments: text/plain (334 lines)

######## Bovine Spongiform Encephalopathy #########

Dear Ralph,

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!

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.

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.

Regards,

Brian Matthews lt09@dial.pipex.com

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===================== *** BABY FOOD 2005 *** ===================== ===============: BSE 'may have entered baby food in 70s' ===================

LISTS.AEGEE.ORG ( BSE-L: 61 matches (only the first 50 will be shown).. )

Subject: Re: BSE 'may have entered baby food in 70s' From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy Date: Fri, 4 Mar 2005 17:09:14 -0600 Content-Type: text/plain Parts/Attachments: text/plain (956 lines)

##################### Bovine Spongiform Encephalopathy #####################

THE BABY FOOD (PROHIBITED OFFAL) REGULATIONS 1989

http://www.bseinquiry.gov.uk/files/yb/1989/05/00002001.pdf


http://www.bseinquiry.gov.uk/files/yb/1989/05/00001001.pdf


BABY FOODS

There are 4 brands available for a quick survey - Boots, Cow & Gate, Heinz and Robinson.

None of the meat dishes included 'offal' in the ingredients.

Steak & Kidney and Beef and Oxtail did, however, include kidney and oxtail.....

snip...

http://www.bseinquiry.gov.uk/files/yb/1989/01/17006001.pdf


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.......

http://www.bseinquiry.gov.uk/files/yb/1989/01/25001001.pdf


BSE SOUTHWOOD REPORT

CONFIDENTIAL

snip...

BABY FOODS

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...

snip...

http://www.bseinquiry.gov.uk/files/yb/1989/02/17005001.pdf


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.

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...

snip...

http://www.bseinquiry.gov.uk/files/yb/1989/02/15002001.pdf


BSE AND BABY FOOD

snip...

1. We spoke about MacGregor's concern about baby food and how, if asked about beef liver and kidney, he was proposing replying:

"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."

2. Whilst we agreed this clearly was passing the buck, I guess it's the best MacGregor can do.....

snip...

http://www.bseinquiry.gov.uk/files/yb/1989/02/20006001.pdf


POWERS TO REGULATE BABY FOODS

DEFINITION OF BABY FOOD

1. There is no definition of baby food (nor of baby) for food legislation purposes...

snip...

http://www.bseinquiry.gov.uk/files/yb/1989/02/23014001.pdf


Heinz Baby Foods

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.

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.

PICTURE OF BABY FOOD JAR NAMED STEAK AND KIDNEY LUNCH

INGREDIENTS - WATER, BEEF, CARROTS, POTATOES, KIDNEY, MODIFIED CORN FLOUR, SPLIT GREEN PEAS, FLOUR, TOMATO PUREE, LIVER, .....

snip...

ANOTHER PICTURE OF BABY FOOD JAR NAMED BEEF AND OXTAIL DINNER

ingredients listed also, but difficult to read, name self explanitory, contains beef and OXTAIL...TSS

ANOTHER BABY FOOD JAR NAMED LIVER AND BACON DINNER, ingredients listed

ANOTHER BABY FOOD JAR NAMED STEAK AND KIDNEY DINNER, ingredients listed

ANOTHER BABY FOOD JAR NAMED BRAISED STEAK AND KIDNEY, ingredients listed

ANOTHER BABY FOOD JAR NAMED LAMB AND LIVER CASSEROLE, NO INGREDIENTS LISTED (WHAT ABOUT LAMB AND BSE ??? TSS)

http://www.bseinquiry.gov.uk/files/yb/1989/02/23015001.pdf


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;

107 Vet Pathol 42:107108 (2005) Letters to the Editor Editor: Absence of evidence is not always evidence of absence. 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 (41:7881, 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):18121820, 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): 121125, 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 358:171180, 2001tss

COW AND GATE BABY FOODS

snip...

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...

snip...

http://www.bseinquiry.gov.uk/files/yb/1989/02/23016001.pdf


ANNEX 2

Dear Dr. Woolfe,

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.

We do not use any other offal material, such as liver, brain, intestines, spinal cord etc...

snip...

http://www.bseinquiry.gov.uk/files/yb/1989/02/24015001.pdf


http://www.bseinquiry.gov.uk/files/yb/1989/02/24016001.pdf


http://www.bseinquiry.gov.uk/files/yb/1989/02/27015001.pdf


BABY FOODS WARNING

snip...

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........

snip...

http://www.bseinquiry.gov.uk/files/yb/1989/02/28006001.pdf


NEWSPAPER ARTICLE ABOUT BABY FOOD WARNING

http://www.bseinquiry.gov.uk/files/yb/1989/02/28007001.pdf


HERE IS A MOST DISTURBING DOCUMENT.

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.

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?

snip...

http://www.bseinquiry.gov.uk/files/yb/1989/03/03003001.pdf


MANIPULATING AND MANAGING STATEMENTS TO THE MEDIA

http://www.bseinquiry.gov.uk/files/yb/1989/03/03009001.pdf


http://www.bseinquiry.gov.uk/files/yb/1989/03/09001001.pdf


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...

R BRADLEY MARCH 4, 1989

http://www.bseinquiry.gov.uk/files/yb/1989/03/04001001.pdf


STILL CONCERNS OF TAIL MEAT IN BABY FOOD

http://www.bseinquiry.gov.uk/files/yb/1989/03/07005001.pdf


THE BABY FOOD (PROHIBITED OFFAL) REGULATIONS

SNIP...

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. .........

snip...

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. ...

snip...

http://www.bseinquiry.gov.uk/files/yb/1989/03/28001001.pdf


THE BABY FOOD (PROHIBITED OFFAL) REGULATIONS 1989

http://www.bseinquiry.gov.uk/files/yb/1989/05/00002001.pdf


http://www.bseinquiry.gov.uk/files/yb/1989/05/00001001.pdf


BABY FOODS

There are 4 brands available for a quick survey - Boots, Cow & Gate, Heinz and Robinson.

None of the meat dishes included 'offal' in the ingredients.

Steak & Kidney and Beef and Oxtail did, however, include kidney and oxtail.....

snip...

http://www.bseinquiry.gov.uk/files/yb/1989/01/17006001.pdf


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.......

http://www.bseinquiry.gov.uk/files/yb/1989/01/25001001.pdf


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...

snip...

5. I had some reservations about TAILMEAT because of its close association with the spinal cord.

http://www.bseinquiry.gov.uk/files/yb/1989/03/03008001.pdf


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...

http://www.bseinquiry.gov.uk/files/yb/1989/03/08002001.pdf


COMMENTS FROM Dr. Hilary Pickles;

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).

RENNET SHOULD BE OF NO CONCERN SINCE IT IS AN EXTRACT OF STOMACH ............

http://www.bseinquiry.gov.uk/files/yb/1989/04/13002001.pdf


THE BABY FOOD (PROHIBITED OFFAL) REGULATIONS 1989

BSE-BABY FOODS R BRADELY

(written letter hard to read...TSS)

info- and to ensure we DO NOT GET THE BLAME FOR LEGISLATION THAT CAN BE ??? ON A SCIENTIFIC BASIS.

snip...

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...

http://www.bseinquiry.gov.uk/files/yb/1989/05/05002001.pdf


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.

SNIP...

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;

http://www.bseinquiry.gov.uk/files/yb/1989/05/05009001.pdf


IN CONFIDENCE

http://www.bseinquiry.gov.uk/files/yb/1989/05/09001001.pdf


They classify offals into two groups as follows:-

(i) Diaphragm, head meat (muscle only), heart, kideny, liver, pancreas, tail meat, thymus, tongue.

(ii) Brains, feet, intestine, lungs, oesophagus, rectum, spinal cord, spleen, stomach, texticles udder.

Group (i) can be used in ALL MEAT PRODUCTS AND CAN COUNT TOWARD THE MEAT CONTENT OF THOSE PRODUCTS

Group (ii) can only be used in cooked meat products and cannot count towards meat content.......

21 pages;

http://www.bseinquiry.gov.uk/files/yb/1989/05/23004001.pdf


Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518

Terry S. Singeltary Sr. wrote:

##################### Bovine Spongiform Encephalopathy #####################

BSE 'may have entered baby food in 70s'

James Meikle, health correspondent Friday March 4, 2005 The Guardian

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.

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.

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.

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.

But the hypothesis advanced by Stephen Dealler, a microbiologist at Lancaster Royal infirmary, suggests that only the "first wave" is declining.

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.

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.

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.

Dr Dealler put his ideas to the Spongiform Encephalopathy Advisory Committee, a government advisory body, which greeted them with scepticism.

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.

Extrapolation from studies of otherwise healthy appendixes have suggested that as many as 3,800 people may be carrying the infection.

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.

This raised the fear that far more people may yet go down with the disease while displaying different symptoms.

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.

"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."

Proving his ideas will be difficult, and food manufacturers have refused to give him data from the 1970s and 1980s.

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.

Other scientists question his assumptions about the incubation periods in animals and humans.

Professor James Ironside, of the CJD surveillance unit in Edinburgh, was cautious, but admitted: "Exposure to baby food is indeed a possibility."

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.

"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."

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".

http://www.guardian.co.uk/bse/article/0,2763,1430267,00.html

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=


From: "Terry S. Singeltary Sr."

Subject: Re: Girl, 13, shows CJD symptoms. [re-baby food]



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.

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.

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...

Kind Regards, Terry S. Singeltary Sr., Bacliff, Texas USA

"Robert A. LaBudde" wrote:

> > At 11:35 AM 11/24/99 -0600, Terry wrote:
> >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;
> > 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.
> > 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.

Babies of all species have more porous intestinal membranes, so uptake of prions would be expected to be more efficient. > > ================================================================ > 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" > ================================================================ >

snip...

Date: Sat, 27 Nov 1999 12:03:22 +0000 Reply-To: BSE-L Sender: BSE-L From: J Ralph Blanchfield Organization: Consultant Subject: Re: Girl, 13, shows CJD symptoms. [re-baby food] In-Reply-To:

BSE-L

Hello Terry and Everyone,

On Fri, 26 Nov 1999 10:36:34 -0600, Terry wrote:

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.

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.

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".

snip...end

SNIP....

From: J Ralph Blanchfield Organization: Consultant Subject: Re: Girl, 13, shows CJD symptoms. [re-baby food]

In-Reply-To: <38407d4f.68838e7b@wt.net>

Hello Terry and Everyone, On Sat, 27 Nov 1999 18:54:39 -0600, Terry wrote:

snip...end...2008...tss

SOME GOOD READING AND DEBATING IN NOV. 1999 ;

1. Girl, 13, could be youngest BSE case * Girl, 13, could be youngest BSE case



(99 lines) From: tom Date: Tue, 23 Nov 1999 14:38:18 -0700 * Re: Girl, 13, could be youngest BSE case



(116 lines) From: Terry S. Singeltary Sr. Date: Wed, 24 Nov 1999 10:18:39 -0600 * Re: Girl, 13, could be youngest BSE case



(36 lines) From: Roland Heynkes Date: Fri, 26 Nov 1999 00:29:44 +0100 * Re: Girl, 13, could be youngest BSE case



(56 lines) From: Terry S. Singeltary Sr. Date: Fri, 26 Nov 1999 10:54:41 -0600 * Re: Girl, 13, could be youngest BSE case



(58 lines) From: Roland Heynkes Date: Fri, 26 Nov 1999 22:37:08 +0100 * Re: Girl, 13, could be youngest BSE case



(217 lines) From: Terry S. Singeltary Sr. Date: Fri, 26 Nov 1999 21:27:12 -0600 * Re: Girl, 13, could be youngest BSE case



(227 lines) From: Univ.-Prof.Dr.Herbert Budka Date: Sat, 27 Nov 1999 12:28:31 +0100 * Re: Girl, 13, could be youngest BSE case



(115 lines) From: Terry S. Singeltary Sr. Date: Sat, 27 Nov 1999 10:12:21 -0600 * Re: Girl, 13, could be youngest BSE case



(49 lines) From: Roland Heynkes Date: Sun, 28 Nov 1999 09:18:50 +0100 * Re: Girl, 13, could be youngest BSE case



(57 lines) From: Roland Heynkes Date: Sun, 28 Nov 1999 14:07:20 +0100 * Re: Girl, 13, could be youngest BSE case



(37 lines) From: Terry S. Singeltary Sr. Date: Sun, 28 Nov 1999 16:17:42 -0600 * Re: Girl, 13, could be youngest BSE case



(76 lines) From: Univ.-Prof.Dr.Herbert Budka Date: Mon, 29 Nov 1999 16:31:24 +0100 2. Girl, 13, shows CJD symptoms. * Girl, 13, shows CJD symptoms.



(80 lines) From: Debora MacKenzie Date: Tue, 23 Nov 1999 23:05:33 +0100 * Re: Girl, 13, shows CJD symptoms.



(90 lines) From: Terry S. Singeltary Sr. Date: Wed, 24 Nov 1999 11:35:44 -0600 * Re: Girl, 13, shows CJD symptoms.



(55 lines) From: Robert A. LaBudde 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]



(90 lines) From: Terry S. Singeltary Sr. Date: Thu, 25 Nov 1999 11:21:52 -0600 * Re: Girl, 13, shows CJD symptoms. [re-baby food]



(82 lines) From: Robert A. LaBudde Date: Thu, 25 Nov 1999 13:17:45 -0500 * Re: Girl, 13, shows CJD symptoms. [re-baby food]



(214 lines) From: J Ralph Blanchfield Date: Thu, 25 Nov 1999 22:30:36 +0000 * Re: Girl, 13, shows CJD symptoms. [re-baby food]



(47 lines) From: Roland Heynkes Date: Fri, 26 Nov 1999 00:27:17 +0100 * Re: Girl, 13, shows CJD symptoms. [re-baby food]



(50 lines) From: Rachel Shepherd Date: Thu, 25 Nov 1999 15:41:51 PST * Re: Girl, 13, shows CJD symptoms. [re-baby food]



(42 lines) From: Tim Sly Date: Thu, 25 Nov 1999 22:12:01 -0500 * Re: Girl, 13, shows CJD symptoms. [re-baby food]



(48 lines) From: Roland Heynkes Date: Fri, 26 Nov 1999 10:04:47 +0100 * Re: Girl, 13, shows CJD symptoms. [re-baby food]



(60 lines) From: Roland Heynkes Date: Fri, 26 Nov 1999 10:15:47 +0100 * Re: Girl, 13, shows CJD symptoms. [re-baby food]



(303 lines) From: Terry S. Singeltary Sr. Date: Fri, 26 Nov 1999 10:36:34 -0600 * Re: Girl, 13, shows CJD symptoms. [re-baby food]



(84 lines) From: Robert A. LaBudde Date: Fri, 26 Nov 1999 17:36:12 -0500 * Re: Girl, 13, shows CJD symptoms. [re-baby food]



(100 lines) From: Tam Garland Date: Fri, 26 Nov 1999 16:47:54 -0600 * Re: Girl, 13, shows CJD symptoms. [re-baby food]



(402 lines) From: J Ralph Blanchfield Date: Sat, 27 Nov 1999 12:03:22 +0000 * Re: Girl, 13, shows CJD symptoms. [re-baby food]



(588 lines) From: Terry S. Singeltary Sr. Date: Sat, 27 Nov 1999 18:54:39 -0600 * Re: Girl, 13, shows CJD symptoms. [re-baby food]



(179 lines) From: J Ralph Blanchfield Date: Sun, 28 Nov 1999 11:46:07 +0000 * Re: Girl, 13, shows CJD symptoms. [re-baby food]



(79 lines) From: Roland Heynkes Date: Sun, 28 Nov 1999 16:43:01 +0100 * Re: Girl, 13, shows CJD symptoms. [re-baby food]



(55 lines) From: Rachel Shepherd Date: Sun, 28 Nov 1999 15:12:27 PST * Re: Girl, 13, shows CJD symptoms. [re-baby food]



(73 lines) From: Torsten Brinch Date: Mon, 29 Nov 1999 14:06:54 +0100 * Re: Girl, 13, shows CJD symptoms. [re-baby food]



(69 lines) From: Roland Heynkes Date: Mon, 29 Nov 1999 07:24:48 +0100 * Re: Girl, 13, shows CJD symptoms. [re-baby food]



(64 lines) From: Rachel Shepherd Date: Mon, 29 Nov 1999 19:44:26 PST * Re: Girl, 13, shows CJD symptoms. [re-baby food]



(95 lines) From: Roland Heynkes Date: Tue, 30 Nov 1999 22:56:04 +0100

TSS

######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html ##########

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More Hits

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

https://lists.aegee.org/cgi-bin/wa?S2=BSE-L&X=1D1B9A2D19721D3331&Y=flounder9@verizon.net&q=baby+foods&s=&f=&a=&b=


END...TSS...2008

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http://downercattle.blogspot.com/2008/03/house-committee-subpoenas.html


http://downercattle.blogspot.com/2008/03/california-lists-possible-recipients-of.html


http://downercattle.blogspot.com/2008/03/to-hard-working-employees-of-usda-and.html


http://downercattle.blogspot.com/2008/02/beef-recall-nationwide-school-lunch.html


http://downercattle.blogspot.com/2008/02/transcript-technical-briefing.html


http://downercattle.blogspot.com/2008/05/humane-society-releases-new-video-of.html


http://madcowfeed.blogspot.com/2008/04/substances-prohibited-from-use-in.html


http://prionunitusaupdate2008.blogspot.com/


Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518

BSE Inquiry DRAFT FACTUAL ACCOUNT DFA

Subject: BSE INQUIRY DRAFT FACTUAL ACCOUNTS
Sunday, May 18, 2008 BSE Inquiry DRAFT FACTUAL ACCOUNT DFA BSE Inquiry DRAFT FACTUAL ACCOUNTS DFA's

May 18, 2008

Greetings,

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

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)

Part 1 of 2

TEMPORARY COMMITTEE OF INQUIRY INTO BSE

19 December 1996 DRAFT REPORT

Part B:RESULTS OF THE INVESTIGATION OF THE TEMPORARY COMMITTEE OF INQUIRY INTO BSE

Rapporteur: Mr Manuel Medina Ortega -----------------------------------

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'.

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.

I.1. RESPONSIBILITY AND NEGLIGENCE IMPUTABLE TO THE UK

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.

1.It failed to ensure an effective ban on the feeding of meat- and bone-meal to ruminants:

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);

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.

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):

'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'.

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).

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).

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).

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).

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.

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.

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.

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.

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.

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.

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.

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.

I.2. DETERMINATION AND ATTRIBUTION OF RESPONSIBILITY AND POSSIBLE NEGLIGENCE ON THE PART OF THE COUNCIL AND COMMISSION

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:

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.

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.

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).

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).

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.

I.3. RESPONSIBILITY AND NEGLIGENCE ON THE PART OF THE COUNCIL

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.

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:

- 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);

-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);

-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);

-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).

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. 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.

The following statements may accordingly be made:

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.

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.

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.

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.

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.

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.

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.

I.4. RESPONSIBILITY AND NEGLIGENCE ON THE PART OF THE COMMISSION

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:

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:

-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;

-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';

-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;

-the exchange of correspondence between Mr Legras and Mr Perissich, Director-General of DG III, on baby food (Annex 21).

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:

-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;

-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.

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.

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.

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.

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).

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.

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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.

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.

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;

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).

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.

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.

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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.

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.

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.

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).

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.

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.

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.

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to be continued....

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)

BSE Inquiry report (Part 1 of 3)

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7 February 1997 A4-0020/97/A

REPORT

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

Part A:

I. RESULTS OF THE INQUIRY

II. RECOMMENDATIONS FOR THE FUTURE

III. MINORITY OPINIONS (published separately)

Temporary committee of inquiry into BSE

Rapporteur: Mr Manuel Medina Ortega

C O N T E N T S

Page

Procedural page 3

I.RESULTS Of THE INQUIRY

EVIDENCE OF NEGLIGENCE, RESPONSIBILITIES AND PRESUMPTIONS OF MALADMINISTRATION 4

1. INTRODUCTION:

A) BRIEF OF THE COMMITTEE OF INQUIRY 4

B) DIFFICULTIES ENCOUNTERED IN THE COURSE OF THE WORK OF THE COMMITTEE OF INQUIRY 5

C) MISHANDLING OF THE CRISIS DURING THE PERIOD WHEN THE DISEASE WAS AT ITS HEIGHT 5

2. RESPONSIBILITIES IMPUTABLE TO THE UK GOVERNMENT 6

3. DETERMINATION AND ATTRIBUTION OF RESPONSIBILITIES AS BETWEEN THE COUNCIL AND COMMISSION 15

4. RESPONSIBILITIES OF THE COUNCIL 18

5. RESPONSIBILITIES OF THE COMMISSION 22

6. POLITICAL RESPONSIBILITIES OF THE COMMISSION 36

ANNEXES (published separately)

II. RECOMMENDATIONS FOR THE FUTURE 38

III.MINORITY OPINIONS (published separately)

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.

On 3 September 1996 the temporary committee of inquiry held its constituent meeting and appointed Mr Medina Ortega rapporteur.

At its sitting of 26 October 1996 Parliament decided to prolong the mandate of the temporary committee of inquiry for a further three months.

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.

At its meetings of 13, 15, 20-21 and 28 January and 5-6 February 1997 the committee examined the draft report.

At the last meeting it adopted the results of the inquiry and the recommendations unanimously.

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.

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.

The results of the inquiry and the recommendations for the future were submitted on 7 February 1997.

I RESULTS OF THE INQUIRY

EVIDENCE OF NEGLIGENCE, RESPONSIBILITIES AND PRESUMPTIONS OF MALADMINISTRATION

1. INTRODUCTION

A) BRIEF OF THE COMMITTEE OF INQUIRY

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'.

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.

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.

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..

B) DIFFICULTIES ENCOUNTERED IN THE COURSE OF THE WORK OF THE COMMITTEE OF INQUIRY

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.

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.

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.

C) MISHANDLING OF THE CRISIS DURING THE PERIOD WHEN THE DISEASE WAS AT ITS HEIGHT

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.

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.

- 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.

- Between 1990 and 1994 veterinary checks on BSE in the UK were suspended.

- Between 1990 and 1994 Community legislative activity in the field of BSE was suspended, with the exception of the regulation on embryos.

- Between 1990 and 1994 the Council held no debates on BSE.

Consequently, although the Commission denies the existence of the policy of disinformation suggested by the written notes, the facts show that:

- the most important sources of information were not available; and

- the Council and Commission began to neglect their duties.

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.

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.

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.

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.

2. RESPONSIBILITIES IMPUTABLE TO THE UK

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.

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.

1. The UK authorities and the rendering industry

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.

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.

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

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.

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

2. The UK Government failed to ensure an effective ban on the feeding of meat-and-bone meal to ruminants:

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);

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;

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:

' ... 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.'

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):

'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 [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'.

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).

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.

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).

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.

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.

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).

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.

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.

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:

'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.

But we say that there is no risk, or indeed any proof of such a risk.'

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).

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):

- 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)

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.

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.

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.

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).

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).

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).

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.

The fact that the UK at no moment acted on this undertaking puts it in breach of Article 5 of the Treaty.

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.

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.

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.

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.

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.

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.

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.

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.

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'.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

3. DETERMINATION AND ATTRIBUTION OF RESPONSIBILITIES AS BETWEEN THE COUNCIL AND THE COMMISSION

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:

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.

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 gelatin.

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.

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.

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.

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.

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.

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.

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).

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.

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).

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.

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.

4. RESPONSIBILITIES OF THE COUNCIL

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.

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.

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'.

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.

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.

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:

- 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);

- 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);

- 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);

- 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).

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.

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.

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.

(end of part 1 of 3)

Tom.....

27 Month delay in nyala case

Draft Factual Account #5

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.

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 )

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 )

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.

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. )

Spongiform encephalopathy in a nyala (Tragelaphus angasi).

Vet Pathol 1988 Sep;25(5):398-9 Jeffrey M, Wells GA Lasswade Veterinary Laboratory, Midlothian.

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)

Draft Factual Account #4

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.

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 )

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)

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.'

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 )

"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"

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.

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 )

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 )

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 )

================================================

BSE Inquiry site Draft Factual Account 13 extracts related to zoo animals:

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.]

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.

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.]

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:

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)

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.

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.

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.

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.

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.

=-=-=-=-=-=-=-=-

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 )

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)

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 )

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 )

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)

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.

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.

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.

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.

...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.

==-=-=-=-

bibliography:

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.

Proc Soc Exp Biol Med 1996 Apr;211(4):306-22 Narang H Origin and implications of bovine spongiform encephalopathy. [tiger]

Vet Rec. 1994 Nov 12;135(20):488. Benbow G. Spongiform encephalopathies in zoo animals. comment

Vet Rec 1994 Oct 29;135(18):440 Swainston J. comment

Vet Rec 1994 Sep 24;135(13):296-303 Kirkwood JK, Cunningham AA Epidemiological observations on spongiform encephalopathies

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

Vet Rec. 1993 Oct 9;133(15):360-4. Kirkwood JK, et al. Spongiform encephalopathy in a herd of greater kudu

Vet Rec. 1993 Jan 16;132(3):68. Cunningham AA, et al. Transmissible spongiform encephalopathy in greater kudu

Vet Rec. 1992 Nov 7;131(19):431-4. Willoughby K, et al. Spongiform encephalopathy in a captive puma

Aust Vet J 1992 Jul;69(7):171 Peet RL, Curran JM Spongiform encephalopathy in an imported cheetah

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

Acta Neuropathol (Berl) 1992;84(5):559-69 Jeffrey M, Scott JR, Williams A, Fraser H Ultrastructural features of spongiform encephalopathy

Vet Rec. 1991 Oct 5;129(14):320 Synge BA, et al. Spongiform encephalopathy in a Scottish cat.

Vet Rec 1991 Sep 14;129(11):233-6 Wyatt JM, Pearson GR, Naturally occurring scrapie-like s

Vet Rec. 1991 Jun 1;128(22):532. Pearson GR, et al. Feline spongiform encephalopathy.

Vet Rec. 1991 Mar 30;128(13):311. Kock R. Spongiform encephalopathies in ungulates.

Vet Rec. 1991 Feb 2;128(5):115. Gibson PH. Spongiform encephalopathies in ungulates. comment

Vet Rec 1990 Dec 15;127(24):586-8 Leggett MM, Dukes J, Pirie HM A spongiform encephalopathy in a cat.

Done JT. Vet Rec. 1990 Nov 10;127(19):484. Spongiform encephalopathy in pigs.

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.

Vet Rec. 1990 Sep 29;127(13):338. Dawson M, et al. Primary parenteral transmission of bovine spongiform encephalopathy to the pig.

Vet Rec. 1990 May 19;126(20):513 no authors listed Spongiform encephalopathy in a cat.

Vet Rec 1990 May 12;126(19):489-90 Gibson PH Spongiform encephalopathy in an eland.

Nature. 1990 Mar 15;344(6263):183 Aldhous P. Antelopes die of "mad cow" disease.

Vet Rec 1990 Apr 21;126(16):408-9 Fleetwood AJ, Furley CW Spongiform encephalopathy in an eland.

Vet Pathol. 1988 Sep;25(5):398-9 Jeffrey M, Wells GA Spongiform encephalopathy in a nyala (Tragelaphus angasi) Lasswade Veterinary Laboratory, Midlothian

=================================================

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)

Tom wrote:

And I don't like the sound of this at all: "From the end of May, Draft

Factual Accounts (DFAs) will no longer be available on the BSE Inquiry

website." It is a poor idea to take things down from the web even if they

are someday more or less replaced by revised factual accounts, because

people want to see and respond to what the lawyers were able to get

altered.

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.

I archived all the draft factual accounts already onto servers in Asia and

am ready to mirror the lost data the day that these go down in Britain.

Roland:

I fully agree that this documents should stay available on the british

server and I really can not imagine why they want to remove this

information from the web. Can you please tell me, how many MB

I need to copy the whole stuff on my PC?

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.

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


http://209.41.3.198/witness/ +


http://209.41.3.198/witness/htm/


and


http://209.41.3.198/transcripts


respectively. The draft account index is at


http://209.41.3.198/dfa/ .

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.

Best regards,

Torsten Brinch

===============================================

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)

######### Bovine Spongiform Encephalopathy #########

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:


http://www.google.com/


This works quite well to search the entire


http://www.mad-cow.org 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


http://www.bse.org.uk/



Thus for louping ill (unnecessary cites suppressed):


http://www.bse.org.uk/witness/htm/stat537.htm


Witness Statements 537 - Coulthard

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.



http://www.mad-cow.org/~tom/fda_late.html#ill



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]




http://www.foodsafety.org/consumer/ht/ht294.htm





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.

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.

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)

Terry was reading Draft Factual Account 17



http://www.bse.org.uk/dfa/dfa17.htm




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: ...

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.

----------------------------

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].

--------------------------

Medicines and medical devises;

############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############



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

######### Bovine Spongiform Encephalopathy #########

THE VETERINARY RECORD 516 No 47. Vol. 58 November 23rd, 1946

NATIONAL VETERINARY MEDICAL ASSOCIATION OF GREAT BRITAIN AND IRELAND

ANNUAL CONGRESS, 1946

The annual Congress, 1946, was held at the Royal Veterinary College, Royal College Street, London, N.W.I. from September 22nd to September 27th.

Opening Meeting

[skip to scrapie vaccine issue...tss]

Papers Presented to Congress

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.

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."

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.

Advances in Veterinary Research

by

W.S. GORDON, PH.D., M.R.C.V.S., F.R.S.E.

Agriculteral Research Council, Field Station, Compton, Berks.

Louping-ill, Tick-borne Fever and Scrapie

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.

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.

Dr. Gordon illustrated this portion of his paper by means of graphs and diagrams projected by the epidiascope.

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.

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.

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.

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:-

(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.

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.

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.

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.

==================================================================

Greetings List Members,

pretty disturbing document. now, what would stop this from happening with the vaccineCJD in children???

kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA



http://www.whale.to/v/singeltary.html



http://www.whale.to/v/cjd2.html





Subject: Re: TREATMENT OF BY PRODUCTS OF BOVINE SLAUGHTER From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy Date: Sun, 8 Oct 2000 17:18:47 -0700 Content-Type: text/plain Parts/Attachments: text/plain (121 lines)

######### Bovine Spongiform Encephalopathy #########

Hello Torsten and Group,

Torsten Brinch wrote:

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.

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...



http://www.vegsource.com/talk/madcow/messages/7569.html



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.

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;



http://www.bse.org.uk/witness/htm/stat115.htm




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...

kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA

Terry wrote:

thank you Torsten. and i can't for the life of me keep this document

in correct order, to resubmit to the group. is there an online version

of this document, other than just the reference numbers? if not, if

anyone has any suggestions, please write my private email and i will

try to scan again, but the letters are to small, unless there is some

setting to change. or maybe just fax to tom or someone???

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.

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.

"July 1989

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. "

From the Draft factual account 17:

***

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:

- intestines: sutures ( I thought the source was ovine but you are

checking this)

- *spinal cord: pharmaceuticals

- *thymus: pharmaceuticals

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."

A handwritten note on Dr Pickles' minute from Mr Mark Hawkins,

Higher Executive Officer at MAFF, to "John" said:

"A few companies make sutures out of intestinal

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

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?"

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!"

***

Best regards,

Torsten Brinch

############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############


Subject: Re: TREATMENT OF BY PRODUCTS OF BOVINE SLAUGHTER From: Torsten Brinch Reply-To: Bovine Spongiform Encephalopathy Date: Sun, 8 Oct 2000 21:06:58 +0200 Content-Type: text/plain Parts/Attachments: text/plain (79 lines)

######### Bovine Spongiform Encephalopathy #########

Terry wrote:

thank you Torsten. and i can't for the life of me keep this document

in correct order, to resubmit to the group. is there an online version

of this document, other than just the reference numbers? if not, if

anyone has any suggestions, please write my private email and i will

try to scan again, but the letters are to small, unless there is some

setting to change. or maybe just fax to tom or someone???

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.

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.

"July 1989

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. "

From the Draft factual account 17:

***

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:

- intestines: sutures ( I thought the source was ovine but you are checking this)

- *spinal cord: pharmaceuticals

- *thymus: pharmaceuticals

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."

A handwritten note on Dr Pickles' minute from Mr Mark Hawkins, Higher Executive Officer at MAFF, to "John" said:

"A few companies make sutures out of intestinal 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 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?"

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!"

***

Best regards,

Torsten Brinch

############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############


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)

######### Bovine Spongiform Encephalopathy #########

Terry wrote:

thank you Torsten unless there is some

setting to change. or maybe just fax to tom or someone???

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.

-=-=-=-

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 http://www.google.com/ to see commentary on it.

tom



http://www.bse.org.uk/witness/htm/stat115.htm



Searched the web using http://www.google.com/ for Hilary Pickles spinal cord.

Witness Statement 71b - Mr Raymond Bradley

... tallow. Mr Cockbill wrote to Hilary Pickles (a medical doctor from DoH ... through abattoirs.

However, brain, spinal cord, spleen, lymphoid tissues and ...



www.bse.org.uk/witness/htm/stat071b.htm



WITNESS STATEMENT OF ALAN JOHN LAWRENCE

... John Wilesmith and Dr Hilary Pickles available to provide

... of the Report) Dr Pickles recognised that the

... refers to brain, spinal cord, spleen and intestines



... www.bse.org.uk/witness/htm/stat076.htm



Prion disease

... brain and eyes in the scull, spinal cord and tonsils of cattle), are collected

... worried. A memo from Dr Hilary Pickles at the department of health ...




www.mad-cow.org/~tom/mar99_mid_news.html




48. July 1989

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.

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.

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].

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].

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.

"July 1989

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. "

From the Draft factual account 17:

***

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:

- intestines: sutures ( I thought the source was ovine but you are

checking this)

- *spinal cord: pharmaceuticals

- *thymus: pharmaceuticals

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."

A handwritten note on Dr Pickles' minute from Mr Mark Hawkins,

Higher Executive Officer at MAFF, to "John" said:

"A few companies make sutures out of intestinal

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

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?"

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!"

***

Best regards,

Torsten Brinch

############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html

############

############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html

############

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)

######### Bovine Spongiform Encephalopathy #########

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.

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.

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).

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.

MARC BARBIER

---------------extract 1. of the DFAL "Early days"----------------

THE EARLY DAYS

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.

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.

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.

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.

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.

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.

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.

7. When Mr Watkin-Jones forwarded Mrs Richardson's report to Mr David Bee, Mr Stent's vet, he wrote:

"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."

8 Ms Richardson did not remember having a conversation about the case with Mr Watkin-Jones.

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'.

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.

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).

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.

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.

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.

------- Extract 2. of the CVL Draft Factual Account---------

Pathology Department

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.

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:

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".

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':

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.

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.

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."

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.

----------- Extract 3 of the CVL DFA about The controversy about the examination of BSE------

Examination of a case of BSE

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.

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:

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."

Conflict of Evidence

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.

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:

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. "

24. Ms Richardson did not remember having a conversation about the case with Mr Watkin-Jones.

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.

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.

27. In his statement to the BSE Inquiry Mr Wells noted:

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."

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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)

######### Bovine Spongiform Encephalopathy #########

Hello Karin,

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. ===============

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:

Country Tonnes

1980

1981 12

1982

1983

1984 10

1985 2

1986

1987

1988

1989 20

1990

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).

Overseas trade statistics Stats (C&F)C

kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA



mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:Karin.Irgens@DYREHELSETILSYNET.NO wrote:

######### Bovine Spongiform Encephalopathy #########

Hello list members!

I have only just started to read the first volume of the BSE Inquiry report.

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.

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).



http://www.bseinquiry.gov.uk/report/volume1/chapte35.htm#643752



.... (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.

Those interested might also have a look at _figure 7.1_ on exports of MBM

from the UK:



http://www.bseinquiry.gov.uk/report/volume10/chaptef2.htm#260106



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.

Best regards

Karin Irgens



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Subject: exports of MBM from the UK From: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:Karin.Irgens@DYREHELSETILSYNET.NO Reply-To: Bovine Spongiform Encephalopathy Date: Fri, 10 Nov 2000 20:56:36 +0100 Content-Type: text/plain Parts/Attachments: text/plain (43 lines)

######### Bovine Spongiform Encephalopathy #########

Hello list members!

I have only just started to read the first volume of the BSE Inquiry report.

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.

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).



http://www.bseinquiry.gov.uk/report/volume1/chapte35.htm#643752



.... (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.

Those interested might also have a look at _figure 7.1_ on exports of MBM from the UK:



http://www.bseinquiry.gov.uk/report/volume10/chaptef2.htm#260106




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.

Best regards Karin Irgens

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Subject: SV: SV: Changes to UK Rendering System? From: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:Karin.Irgens@DYREHELSETILSYNET.NO Reply-To: Bovine Spongiform Encephalopathy Date: Fri, 1 Dec 2000 22:11:59 +0100 Content-Type: text/plain Parts/Attachments: text/plain (58 lines)

######### Bovine Spongiform Encephalopathy #########

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.

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: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:BSE-L@UNI-KARLSRUHE.DE

Emne: Re: SV: Changes to UK Rendering System?

TRUE But The UK invented MRM in the mid-nineteen

seventies, that is the industrial processing of whole

heads of cows and sheep plus skeletal waste on a huge

scale. The process was made viable by the collection

of hundreds of heads etc. That were then crushed,

shattered and centrifuged to extract the brains,

tongues, eyes, and spinal chord from the bone matrix.

A material was made from this slurry that could be

added to pies, sausages, burgers and baby filler as

cheap filler. The balance was used as a protein

supplement in animal feed.

Could you have a better way of spreading infectivity

? Did the BSE Inquiry describe or draw attention to

this process? I understand there was a HMSO

publication on MRM in 1980 but as yet I have not been

able to obtain a copy.

Best regards john

__________________________________________________



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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)

######### Bovine Spongiform Encephalopathy #########

Hello Karin

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.


<<< ######### Bovine Spongiform Encephalopathy ######### 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. 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: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:BSE-L@UNI-KARLSRUHE.DE

Emne: Re: SV: Changes to UK Rendering System?

TRUE But The UK invented MRM in the mid-nineteen

seventies, that is the industrial processing of

whole

heads of cows and sheep plus skeletal waste on a

huge

scale. The process was made viable by the

collection

of hundreds of heads etc. That were then crushed,

shattered and centrifuged to extract the brains,

tongues, eyes, and spinal chord from the bone

matrix.

A material was made from this slurry that could be

added to pies, sausages, burgers and baby filler

as

cheap filler. The balance was used as a protein

supplement in animal feed.

Could you have a better way of spreading

infectivity

? Did the BSE Inquiry describe or draw attention

to

this process? I understand there was a HMSO

publication on MRM in 1980 but as yet I have not

been

able to obtain a copy.

Best regards john

__________________________________________________

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Subject: Re: SV: SV: Changes to UK Rendering System? From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy Date: Tue, 5 Dec 2000 11:25:56 -0800 Content-Type: text/plain Parts/Attachments: text/plain (191 lines)

######### Bovine Spongiform Encephalopathy #########

Greetings John, Karin, and other list Members,

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]

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]

MRMs



http://www.bse.org.uk/dfa/dfa14.htm



kind regards,

Terry S. Singeltary Sr., Bacliff, Texas USA

john hazelwood wrote:

######### Bovine Spongiform Encephalopathy #########

Hello Karin

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.<<<< >

Yes I understand the difference how ever the process

was cost /profit driven any MRM that was surplus ( the

balance) was passed back for use in animal feed - they

would not waste it!

Besides, I doubt that it would be very practical to

_extract_ brain and

spinal cord after "crushing and shattering" of heads

and spines !<<< >

Sorry I should have been more explicit - I was trying

to emphasise that this material included BRAIN etc.

and was a part of the general mush or "slurry" that

was extracted for HUMAN/animal consumption. -- Surely

this was the best practical way of processing the

WHOLE HEAD from a cost /profit point of view.

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.<<< >

So they only tell a part of truth!

The major source of MRM was the spinal

column"...<<< >

So OK They just did not mention that the "head meat"

and that BRAIN was a VERY significant component prior

to 1989 at some of the plants.

The BSE Inquiry certainly drew attention to this

process. I think they even wrote a "draft factual

account" on MRM last year. <<< >

Not the process I described and they have done there

best to cover up the inclusion of BRAINS in MRM .

*******************************************************

Bovine heads.

4.26 Although a representative of the Chartered

Institute of Environmental Health (CIEH) suggested

that heads were used in the MRM process. The weight of

evidence was against this proposition.

WHO SAYS SO?

*******************************************************

Best regards, JOHN

--- mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:Karin.Irgens@DYREHELSETILSYNET.NO wrote:

######### Bovine Spongiform Encephalopathy

#########

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.

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: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:BSE-L@UNI-KARLSRUHE.DE

Emne: Re: SV: Changes to UK Rendering System?

TRUE But The UK invented MRM in the mid-nineteen

seventies, that is the industrial processing of whole

heads of cows and sheep plus skeletal waste on a

huge scale. The process was made viable by the collection

of hundreds of heads etc. That were then crushed,

shattered and centrifuged to extract the brains,

tongues, eyes, and spinal chord from the bone matrix.

A material was made from this slurry that could be

added to pies, sausages, burgers and baby filler

as cheap filler. The balance was used as a protein

supplement in animal feed.

Could you have a better way of spreading

infectivity ? Did the BSE Inquiry describe or draw attention

to this process? I understand there was a HMSO

publication on MRM in 1980 but as yet I have not

been able to obtain a copy.

Best regards john

__________________________________________________

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Subject: Re: SV: SV: Changes to UK Rendering System? From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy Date: Tue, 5 Dec 2000 11:39:50 -0800 Content-Type: text/plain Parts/Attachments: text/plain (253 lines)

######### Bovine Spongiform Encephalopathy #########

Karin and John,

forgot to add this;

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.

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’.

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]

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.’

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.’

MRMs


http://www.bse.org.uk/dfa/dfa14.htm



kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA

john hazelwood wrote:

######### Bovine Spongiform Encephalopathy

#########

Hello Karin

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.<<<<>

Reply-To: Bovine Spongiform Encephalopathy Date: Fri, 26 Mar 2004 15:22:01 -0600 Content-Type: multipart/related Parts/Attachments: text/plain (1957 lines)

Bovine Spongiform Encephalopathy (BSE) - Updated Vaccine Information

Posted: 3/24/2004

Bovine Spongiform Encephalopathy (BSE)

horizontal rule

snip...tss...2008

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.

Extract from Phillips enquiry, draft factual account 17, 8 Oct 99

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:

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.

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.

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.

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.

Tetanus; this involves bovine material from UK mainly Scottish. There are 21,000 litres of stock.

Pertussis; uses bovine material from the UK. There are 63,000 litres of stock.

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.

3. E have measles, mumps, MMR, rubella vaccines. These are sourced from the USA and the company believes that US material only is used.

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.

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.

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).

7. M have influenza vaccines which are made up in egg medium.

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).

9. N have acellular triple vaccine in which I material of UK bovine source has been used.

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.

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):"

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.

... 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.

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.

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.

snip...end...2008...TSS



https://lists.aegee.org/cgi-bin/wa?A2=ind0403&L=BSE-L&P=R48065&X=46104545F4D3582B66&Y=flounder9%40verizon.net



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 From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy Date: Thu, 21 Dec 2006 11:32:40 -0600 Content-Type: text/plain Parts/Attachments: text/plain (781 lines)

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:

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]

19 Dec 2006 : Column WA291

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.

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.

Lord Morris of Manchester asked Her Majesty’s Government:

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]

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.

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.

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:

from December 1997, blood components, plasma products or tissues obtained from any individual who later develops vCJD, were withdrawn/recalled;

19 Dec 2006 : Column WA292

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.



http://www.publications.parliament.uk/pa/ld200607/ldhansrd/text/61219w0004.htm#06121940000034



http://www.whale.to/v/singeltary7.html



http://www.microbes.info/forums/index.php?s=6f1dd87fff0c5b970fc8b8fe838f7ee5&showtopic=377&pid=477&st=0&#entry477



Subject: Re: VACCINES/CHILDREN/TSE'S -- 'CONFIDENTIAL' Date: Wed, 6 Sep 2000 18:20:09 -0800 From: tom Reply-To: Bovine Spongiform Encephalopathy To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:BSE-L@uni-karlsruhe.de References: 1

######### Bovine Spongiform Encephalopathy #########

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: http://www.google.com/ This works quite well to search the entire http://www.mad-cow.org 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 http://www.bse.org.uk/

Thus for louping ill (unnecessary cites suppressed):



http://www.bse.org.uk/witness/htm/stat537.htm




Witness Statements 537 - Coulthard

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.



http://www.mad-cow.org/~tom/fda_late.html#ill



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]



http://www.foodsafety.org/consumer/ht/ht294.htm



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.

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.

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)

Terry was reading Draft Factual Account 17


http://www.bse.org.uk/dfa/dfa17.htm

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: ...

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.

----------------------------

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].

--------------------------

Medicines and medical devises;

Subject: 2 known incidents of iatrogenic scrapie Date: Thu, 7 Sep 2000 09:51:14 -0800 From: tom Reply-To: Bovine Spongiform Encephalopathy To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:BSE-L@uni-karlsruhe.de References: 1

######### Bovine Spongiform Encephalopathy #########

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.

I found a better source for needed references for iatrogenic scrapie in a nice review by Ray Bradley at http://www.iica.org.ar/Bse/6-%20Bradley.html. 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.

If anyone has the first 3, I would appreciate a fax 542-484-0669 US.

tom

GORDON , W.S., 1959. Scrapie panel. In: Proceedings of 63rd Annual Meeting of the US Livestock Sanitary Association, 63, 286-294. [no medline record]

GORDON, W.S., 1946. Advances in Veterinary Research: Louping ill, tick-borne fever and scrapie. Veterinary Record, 58, 516-525. [no medline record]

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]

-=-=--=

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]

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]

IATROGENIC DISEASE IN ANIMALS



http://www.iica.org.ar/Bse/6-%20Bradley.html



Ray Bradley Private BSE Consultant Veterinary Laboratories Agency, United Kingdom

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

Louping-ill vaccine documents from November 23rd, 1946 FULL TEXT

THE VETERINARY RECORD 516 No 47. Vol. 58 November 23rd, 1946

NATIONAL VETERINARY MEDICAL ASSOCIATION OF GREAT BRITAIN AND IRELAND

ANNUAL CONGRESS, 1946

The annual Congress, 1946, was held at the Royal Veterinary College, Royal College Street, London, N.W.I. from September 22nd to September 27th.

Opening Meeting

[skip to scrapie vaccine issue...tss]

Papers Presented to Congress

SNIP...FULL TEXT ;



http://whale.to/v/singeltary.html



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

######### Bovine Spongiform Encephalopathy #########

THE VETERINARY RECORD 516 No 47. Vol. 58 November 23rd, 1946

NATIONAL VETERINARY MEDICAL ASSOCIATION OF GREAT BRITAIN AND IRELAND

ANNUAL CONGRESS, 1946

The annual Congress, 1946, was held at the Royal Veterinary College, Royal College Street, London, N.W.I. from September 22nd to September 27th.

Opening Meeting

[skip to scrapie vaccine issue...tss]

Papers Presented to Congress

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.

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."

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.

Advances in Veterinary Research

by

W.S. GORDON, PH.D., M.R.C.V.S., F.R.S.E.

Agriculteral Research Council, Field Station, Compton, Berks.

Louping-ill, Tick-borne Fever and Scrapie

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.

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.

Dr. Gordon illustrated this portion of his paper by means of graphs and diagrams projected by the epidiascope.

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.

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.

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.

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:-

(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.

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.

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.

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. ==================================================================

Greetings List Members,

pretty disturbing document. now, what would stop this from happening with the vaccineCJD in children???

kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA



http://www.whale.to/v/singeltary.html



http://www.whale.to/v/cjd2.html




although 176 products do _not_ conform to the CSM/VPC guidelines.



http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf



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).



http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf



http://www.bseinquiry.gov.uk/files/yb/1989/02/14011001.pdf



more on the 1968 medicine act, they forgot to follow



http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf




Draft cover letter to product licence holders (considered by Human and Vet Medicines including deer)




http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf




http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf




2.3.Iatrogenic exposure

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.



http://ec.europa.eu/food/fs/sc/ssc/out170_en.pdf



http://ec.europa.eu/food/fs/sc/ssc/out247_en.pdf


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.



http://www.bseinquiry.gov.uk/files/ib/ibd1/tab02.pdf




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.

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.

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.

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:

"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."

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).....

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

89/02.15/11.2 MF580439/1 0584 SOUTHWOOD REPORT: BSE AND MEDICINAL PRODUCTS

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. ..

MF580439/1 0585 Question

1. Which medicines are affected? (person to provide reply) Dr. Jefferys

2. Are the risks greater with some medicines than others? Dr. Jefferys

3. Why are medicines affected? Dr. Jefferys

4. Are some affected products available over the counter from pharmacies or shops? Dr. Purves

5. Are only UK products at risk? Dr. Jefferys

6. Are existing stocks safe? Dr. Jefferys

7. Are pre 1980 stocks available? Mr. Burton

8. Are these alternatives to the use of bovine material? Dr. Purves

9. Why can't we throw away suspect stock and import or manufacture safe medicines? Dr. Jefferys

10. Which patients are at risk? Dr. Jefferys

11. Are some patients particularly vulnerable? Dr Jefferys

12. What risks exist to those who have already used these medicines? Dr. Jefferys

13. HOW might patients be affected? Dr. Jefferys

14. Can BSE be transmitted to patients by medicines? Dr. Jefferys

15. How long will it be before risks are quantified? Dr. Jefferys

100 89/02.17/10.2 MF580439/1 0586

16. What research is going on to find out if medicines can transmit this disease and if any patients have been affected? Dr Jefferys

17. Could recent cases of Creuuzfeld Jacob Disease have been caused by transmission of BSE through medicines? Dr. Jefferys

18. What action is the Licensing Authority taking to ensure proper scrutinising of source materials and manufacturing processes? Dr. Jefferys/Dr. Purves

19. Are the guidelines practical? Dr. Jefferys/Dr. Purves

20. Will the guidelines remove the risk? Dr. Jefferys

21. How will the guidelines be enforced? Dr. Jefferys/Dr. Purves

22. How soon will they come into force? Dr. Jefferys

23. Will the guidelines be published? Mr. Hagger

24. What is being done to reassure patients, parents etc? Mr. Hagger/Dr. Salisbury

25. What advice is being given to doctors, pharmacists etc? Mr. Hagger

26. What advice is the Government giving about its vaccination programme? Dr. Salisbury

27. Is the vaccination programme put at risk because of BSE? Dr. Salisbury

89/02.17/10.3

Q. Will government act on this?

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.

VETERINARY MEDICINES

Q. Can medicines spread BSE to other cattle/animals?

A. The report describes any risks as remote.

Q. How can risks be avoided?

A. In liaison with the DOH the Veterinary Products Committee is examining guidelines for the veterinary pharmaceutical industry which will be issued shortly.

Q. What will Guidelines say?

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.

89/02.17/10.4 MF580439/1 0588

A. Bovine source material is used in [garbled, cannot read...TSS] and some other medicines.

Q. How many medicines are involved?

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.

89/06.19/8.1 BSE3/1 0191 Hr J Maslin (MAFF) Ref: Maslin3g

From: Dr H Pickles Med SEB/B Date: 3 July 1989

CATTLE BY-PRODUCTS AND BSE

I was interested to see the list of by-products sent to the HSE. Those of particular concern included:

* small intestines: sutures (I thought the source was ovine but you are checking this)

* spinal cord: pharmaceuticals

* thymus: pharmaceuticals

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.

Id No. 1934/RD/1 89/08.10/6.1 117A

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:

ID 2267/NRE/1 89/08.21/10.1

1. Products with Bovine brain/lymph tissue administered by injection.

2. Products with bovine tissue other than brain/lymph administered by inection.

3. Tissue implants/open wound dressing/surgical materials/dental and ophthlamic products with bovine ingredients.

4. Products with bovine ingredients administered topically.

5. Products with bovine ingredients administered orally.

6. Products with other animal/fish/insect/bird ingredients administered by injection/topically/oral routes.

7. Products with ingredients derived from animal material by chemical processing (eg stearic acid, gelatine, lanolin ext.

The BSE working group will decide which of these are important, and should be examined more closely, and which categories can be eliminated.

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.

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.

9. Re-editing of the Paper on "Incubation of Scrapie-like Agents"

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....

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.

2334q/RD/4 89/08.21/10.7

BOVINE MATERIAL USED IN THE MANUFACTURE OF SURGICAL IMPLANTS AND BLOOD CONTACT MEDICAL DEVICES

Glutaraldehyde, formaldehyde, and ethylene oxide are used in the sterilization of these devices.

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.

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.

2334q/RD/7 89/08.21/10.10 BSE11/2 020 SC1337

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

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

Dear Mr. Meldrum,

BOVINE SPONGIFORM ENCEPHALOPATHY

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.

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 ma