BSE INQUIRY

BSE INQUIRY DFA 18 COSMETICS

2010-07-22T12:56:00.000-07:00

From: TSS

Subject: Use of Materials Derived From Cattle in Human Food and Cosmetics [Docket No. 2004N-0081] RIN 0910-AF47

Date: April 17, 2008 at 2:41 pm PST

http://www.fda.gov/OHRMS/dockets/98fr/05-17693.htm

http://www.fda.gov/ohrms/DOCKETS/dockets/04n0081/04N-0081_emc1148-02.pdf

http://www.fas.usda.gov/info/fr/2004/071404BSEFDA1.htm

http://edocket.access.gpo.gov/2005/pdf/05-17693.pdf

In experimentally infected cattle, brain and spinal cord were again been confirmed to be infectious, but in addition the distal ileum (lower small intestine) also contained significant amounts of infectivity(31, 32). Two key ganglia, which are key intermediate points linking the central and peripheral nervous systems, namely TAFS 3 the trigeminal and dorsal root ganglia (DRG), were also clearly infectious(32, 33). This is not surprising given their close association with central nervous tissue. Peripheral nerves have also been demonstrated to become positive after the brain and spinal cord(1, 19). Completion of bioassay studies has also enabled a better understanding of the sequence of events, and rate of accumulation of infectivity, especially in relation to ileum, brain and spinal cord(1,2), and have confirmed the basic assumptions upon risk management policy were based.

PAGE 3

http://www.tseandfoodsafety.org/position_papers/TAFS_POSITION_PAPER_SPECIFIED%20RISK%20MATERIALS_2009_feb.pdf

Thursday, April 17, 2008

Use of Materials Derived From Cattle in Human Food and Cosmetics [Docket No. 2004N-0081] RIN 0910-AF47 [Federal Register: April 17, 2008 (Volume 73, Number 75)] [Rules and Regulations] [Page 20785-20794] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr17ap08-7]

http://cjdmadcowbaseoct2007.blogspot.com/2008/04/use-of-materials-derived-from-cattle-in.html

Monday, February 01, 2010

Import Alert 17-04 BSE CJD HIGH RISK TISSUES, Nutritional Supplements and Cosmetics

http://creutzfeldt-jakob-disease.blogspot.com/2010/02/import-alert-17-04-bse-cjd-high-risk.html

SEE HISTORY OF COSMETICS AND MAD COW TYPE DISEASE

-------- Original Message --------

Subject: Docket No. 2004N-0081 and or RIN number RIN-0910-AF47 Use of Materials Derived From Cattle in Human Food and Cosmetics [comment submission]

Date: Tue, 13 Jul 2004 16:08:38 -0500

From: "Terry S. Singeltary Sr." T

o: fdadockets@oc.fda.gov

CC: burt.pritchett@fda.gov, Agriculture@mail.house.gov

COMMENT SUBMISSION [Docket No. 2004N-O081] RIN-0910--AF47 Use of Materials Derived From Cattle in Human Food and Cosmetics

http://www.fda.gov/OHRMS/DOCKETS/98fr/04n-0081-nir0001.pdf

Greetings FDA,

I would kindly like to comment on the potential for TSE transmission from cosmetics to humans and why I think that ALL animal by-products should be excluded from cosmetics. IF we look at the TSE 'KURU'. Kuru is a transmissible spongiform encephalopathy that was identified in Papua New Guinea in the late 1950s. Several thousand cases of the disease occurred during a period of several decades. Epidemiologic investigations implicated ritual endocannibalistic funeral feasts as the likely route through which the infectious agent was spread. The incubation period in females was estimated to be shorter than that in males. The shortest incubation periods were estimated in adult women, who may have been exposed to the largest doses of infectious material. MY question is, was the woman exposed to larger doses, are was it the route of the agent that may have been the factor of shorter incubation in woman, or both?

What is Kuru? Kuru is a rare and fatal brain disorder that occurred at epidemic levels during the 1950s-60s among the Fore people in the highlands of New Guinea. The disease was the result of the practice of ritualistic cannibalism among the Fore, in which relatives prepared and consumed the tissues (including brain) of deceased family members. Brain tissue from individuals with kuru was highly infectious, and the disease was transmitted either through eating or by contact with open sores or wounds. Government discouragement of the practice of cannibalism led to a continuing decline in the disease, which has now mostly disappeared.

snip...

PLEASE NOTE the later ''or by contact with open sores or wounds.''

and the disease was transmitted either through eating or by contact with open sores or wounds.

http://www.ninds.nih.gov/health_and_medical/disorders/kuru.htm

the Fore women would scoop the brains of their dead relatives out of their skulls by hand before cooking. They then wiped the residual liquid and cadaver tissue over their paint-daubed bodies, leaving it caked in their hair and on their bodies for weeks after a mortuary feast.

Jennifer Cooke: kuru deaths continue in 1999

Sydney Morning Herald, Saturday, August 28, 1999

TSE INFECTION does takes place when the skin surface has been broken by scarification (Taylor et al, 1996).

The transmission of KURU into animals supported the belief that the disease had been transmitted through ceremonial cannibalistic rituals in New Guinea with a possible route of spread involving handling fresh tissue and inoculation through mucous membranes and wounds including skin abrasions (Gajdusek, 1977)

Masters, C.J., Gajdusek, D.C. and Gibbs, C.J., (1980). The spongiform encephalopathies: the natural history of CJD and its relationship to kuru and scrapie.

* Gajdusek D.C. (1996). Kuru: From the New Guinea field journals 1957-1962. Grand Street, 15:6-33

* Gajdusek D.C. (1973). Kuru in the New Guinea Highlands. In Spillane JD (ed): Tropical Neurology. New York, Oxford University Press.

* Gajdusek D.C., Gibbs C.J., and M. Alpers (1966). Experimental transmission of a kuru-like syndrome to chimpanzees. Nature, 209:794.

* Lindenbaum S. (1979). Kuru Sorcery. Mountain View, Ca, Mayfield Publishing Company.

SCCNFP/0724/03, final THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS OPINION CONCERNING USE OF SPECIFIED RISK MATERIAL IN COSMETICS CLARIFICATION FOR TALLOW DERIVATIVES adopted by the SCCNFP on 30 July 2003 by means of the written procedure SCCNFP/0724/03, final Opinion on the Use of specified risk material in cosmetics - Clarification for tallow derivatives

____________________________________________________________________________ _________________

2 1. Background

snip...

http://europa.eu.int/comm/health/ph_risk/committees/sccp/documents/out229_en.pdf

4. For GBR-C III and IV countries, tallow derivatives are safe if, in addition to the above (3), the specific risk materials have been removed and are not used for the production of tallow/tallow derivatives.

PLEASE NOTE, under the old BSE GBR, the USA would be re-classified as at least a GBR III risk assessment, if not a GBR IV in my opinion due to the misgivings from USDA/APHIS et al, some documented below in my references from Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission).

Report on the Assessment of the Geographical BSE - Risk of USA (July 2000) (220kb)

http://europa.eu.int/comm/food/fs/sc/ssc/out137_en.pdf

snip...end

Subject: DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A., a prime market for Jersey cattle]

From: "Terry S. Singeltary Sr."

Reply-To: Bovine Spongiform Encephalopathy

Date: Mon, 1 Nov 1999 09:28:04 -0600

Content-Type: text/plain

Parts/Attachments: text/plain (66 lines)

Reply

Terry S. Singeltary Sr., Bacliff, Texas USA --

Greetings,

I have been reading over the latest DFA 18, about cosmetics, and the possible route of BSE, through this source. Several interesting comments I find, that have brought several questions in mind, ones in which I have asked before, and still no answer. The CDC refuses to answer any of my questions through their site, and no one else seems to know the answer. Is the U.S.A. considered to be B.S.E. free, by other Countries? I asked this question to Dr. Detwiler, her reply was; "To the best of my knowledge there are no countries in the world which restrict any animals or animal products from the United States due to a risk from BSE. I am not sure if all such countries are using the term BSE free"...

The reason in bringing this up, I find several statements in this draft, that pertains to this, statements that I find quite interesting;

Page 24, DFA 18, -- "the line taken on cosmetics including sourcing from overseas was based on that given for licensed medicinal products by a group that included Drs. Kimberlin, Watson and Will, as well as other MAFF officials. There is no question that the UK is an "infected area": the only question is whether other countries should be included too. The Licensing Authority, quite reasonably in my view, feels they can only insist on sourcing in Countries where there is no evidence of BSE and the veterinary service and reporting system is adequate to detect it were it is present. Most manufacturers of mainline pharmaceuticals are not risking having to change sources yet again and so are looking to Australasia. If the CVO thinks he has enough evidence, _say concerning the USA_, to persuade the CSM, CDSM etc to advise more strongly against sourcing there too, he should present that evidence in a convincing form and in writing. I do not see this as a matter for our group, since there are statutory responsibilities under the Medicines Act. What we should do is ensure consistent advice is given for those borderline products (like these "cosmetics" with medicinal claims) that currently fall outside that Act."

Page 60, DFA 18, cosmetics -- 4. If it is possible for humans to contract "mad cow" disease from cosmetics, the risk is greater from "exotica" products because, unlike soap ingredients, the ingredients are not subject to repeated boiling and some are just merely chilled. MAFF have advised the CTPA that the only safe source is Australasia. Along with other European countries, France and Germany have imported from the UK infected feedstuff and live cattle. There have been reports of BSE outbreaks in Germany and France and _even in the USA_, a prime market for Jersey cattle. The Germans claim that they have "cured" their infected cattle by bathing them in a special dip they have developed but MAFF say there is no magic German cure. The French are masters at suppressing bad news. However, their higher scientific committee has issued "approved BSE guidelines" for French industry to follow. These guidelines cover, amongst other things, cosmetic products and are based on guidelines issued by MAFF. The French have not credited MAFF at all and are touting their guidelines around the Commission.

I suppose my question would still be, does the EU, and or all the rest of the European Countries, consider the U.S.A. to be B.S.E. Free?

------------------ http://www.uni-karlsruhe.de/~listserv/ -------------------

https://lists.aegee.org/cgi-bin/wa?A2=ind9911&L=BSE-L&P=R270&1=BSE-L&9=A&I=-3&J=on&X=2D25604264697D83A3&Y=flounder9%40verizon.net&d=No+Match%3BMatch%3BMatches&z=4

Subject: COSMETICS, TOILETRY AND THE PERFUME INDUSTRY & B.S.E.

From: "Terry S. Singeltary Sr."

Reply-To: Bovine Spongiform Encephalopathy

Date: Sun, 3 Sep 2000 10:55:19 -0700

Content-Type: text/plain

Parts/Attachments: text/plain (305 lines)

Reply

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

Greetings List Members,

Human transmission: There are some in the media and even the medical profession who are trying to make connections between BSE and the human disorder CJD. There is _no_ evidence of any association nor would we expect any cases by now even were BSE to be transmissible to humans. Dr Wills' study (see 2i above) will monitor the situation for the next decade or two.

I thought i would break off the vaccines & BSE related issues just briefly, to show you another fine example of the, hmmmmmmmm, i will not use _cover-ups_, because people cannot accept that, even if that is where the truth lies. So i will call them, the _purposely miss judgements_, or _happen-stances of mega-ignorance_.

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

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

dti

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

Dear Marion

As you know there is no record of bovine spongiform encepalopathy crossing to humans, but we need to take precautions to avoid any risk.

There a number of cosmetric products on sale in the United Kingdom such as anti-ageing creams that contain extracts of bovine offal, primarily from spleen and Thymus.

The purpose of this letter is to ask you to ask your members to eliminate any risk by reformulating such products to eliminate these extracts, or alternatively to use material derived from cattle reared outside the UK, Eire or the Channel Islands.

Please let me know if you have any trouble persuading your members to do so.

Yours sincerely

R J ROSCOE

CONSUMER SAFETY UNIT

ROOM 407

90/02.01/14.1

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

BSE110/1 0080

DEPARTMENT OF HEALTH AND SOCIAL SECURITY HANNIBAL HOUSE Room No ELEPHANT AND CASTLE LONDON SE1 6TE

1 February 1990

Mr R Roscoe Consumer Affairs Department of Trade and Industry 10-18 Victoria Street London SW1

Dear Richard

USE OF BOVINE OFFAL IN COSMETICS

I am replying to your request for advice on the safety of the use of extracts of bovine offal in certain cosmetics, such as skin products claimed to have 'anti-ageing' properties with respect to bovine spongiform encephalopathy (BSE). As you are aware there are a number of cosmetic products on sale in the UK that contain small amounts of such extracts, primarily from spleen and thymus.

we accept that the risk of transmission is likely to be remote, but believe that it would be prudent to eliminate any risk by reformulating such products. Alternatively if the incorporation of bovine extracts is retained, material derived from cattle reared outside the UK, Eire or the Channel Islands should be used.

We would be grateful if you would transmit these recommendations to industry via the Trade Association CTPA.

I attach background briefing prepared by medical colleagues from those sections most involved with consideration of BSE in DH, together with a copy of the Southwood report.

Please let me know if you need any further information.

Yours sincerely

DR R J FIELDER

Enclosure

90/2.1/7.1

===========

BSE110/1 0081

BACKGROUND BRIEFING

presence of Bovine Offals in Cosmetics and Bovine Spongiform Encephalopathy

(1) Extracts of bovine spleen and thymus are present at between ca 0.1 and 5% in certain cosmetic preparations, for example certain products claimed to delay the signs of ageing of skin. The concern about the increasing incidence of BSE in cattle in the UK has made it necessary to reconsider the safety of such products.

The disease

BSE is a progressive neurological disorder in cattle, which results from infection with an "unconventional viral' agent. The first case was described in cows in 1986. By 19 January 1990 there had been 9436 confirmed cases in the UK on 5474 farms. There are no confirmed cases outside the British Isles, apart from a case in a cow recently exported from England. BSE is one of a family of spongiform encephalopathies which also include scrapie in sheep and kuru and Creutzfeldt Jakob disease (CJD) in man. The infection which leads to BBE appears to have been introduced into cattle from the contaminated feeding stuff, meat and bone meal, made partly from sheep offal: scrapie is endemic in sheep in the UK.

The causative agents of these diseases are thought to be unconventional transmissible agents (referred to variously as prions, virinos, filamentous viruses or slow viruses). They are extremely resistant to most denaturing processes eg heat, UV, high salt concentration, formalin and alkylating agents. The current DH guideline for treating items used on CJD patients is a temperature of 134-138 C (at 2 atmospheres) held for 18 minutes. They are also not removed by normal microbiological filters. It is thus unlikely that the mild processing techniques used to obtain the extracts used in cosmetics would remove the causative agents.

(2) Government action to date includes:

a. An expert working party was set up under Sir Richard Southwood and reported in February 1989. All their recommendations have been acted upon.

b. The disease has been made notifiable in cattle.

c. All suspect animals are slaughtered and carcases destroyed (50% compensation policy but 100% if diagnosis not confirmed); milk from such animals is also destroyed.

d. Sale or supply of animal protein from ruminants for feeding to ruminants prohibited - hopefully to prevent any new infections in cattle. This has had a major effect on the rendering industry.

e. Another committee was set up under Dr David Tyrrell to report on research needs. An interim report was published in January 1990 together with an announcement about additional funding. Much research work into the disease is currently in progress and additional studies are being planned.

Regulations in November 1989 introduced a ban on various

90/2.1/7.2

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BSEllO/1 0082

bovine offal for human consumption, going wider than the Southwood recommendations which were for such a ban to affect baby food only.

The Medicines Control Agency have gathered information from pharmaceutical companies about use of bovine ingredients in parenteral pharmaceuticals and issued interim guidelines. Many biological products and vaccines use such ingredients. The MCA are considering whether action on specific products is appropriate.

h. The Health and Safety Executive (HSE) is reviewing its guidance to those who come into direct contact with bovine 'risk' tissues. A press release for those who handle BSE carcases has been issued and one for abattoir workers is in preparation. The HSE ara also discussing risks from BSE exposure with the veterinary profession.

i. All UK cases of CJD will be monitored in a study to be conducted by Dr R G Will in Edinburgh, funded by the Department of Health: this should allow detection of any spread of infection to hummans, although this possibility is considered remote.

(3) Current live issues

Research: Dr Tyrell's interim report identified a large research programme classed as high priority. Almost all of this research falls to MAFF {Central Veterinary Labs} or the AFRC, although the MRC also has an interest. Substantial money has been made available for this work but research will be laborious and results will come slowly.

Food: There has been constant pressure on MAFF about the supposed risk to humans from eating beef and beef products. Infected animals who are incubating the disease but do not show any abnormalities cannot be detected at present and will be entering the human food chain. The offal ban removes the highest 'risk' tissues. Some critics may not be satisfied by this. However, others may argue the action to date is over the top, not demanded by the experts, and illogical since scrapie-infected sheep can still be eaten and doing so for the last 200 years has not caused harm to humans. We expect BSE agent to be resistant to irradiation as applied to food, as well as relatively resistant to cooking.

Other animals: There is no evidence that animals other than cattle (and domesticated, deer) have been or could be affected by BSE, other than experimentally, but there are pressures to extend the ruminant protein ban: at present pigs and poultry receive this sort of feed. Such action, as well as being hard to justify scientifically, would increase costs for the industry and cause perhaps insurmountable problems for abattoirs, who would find renderers no longer willing to accept offal. Many 1000's of tons of offal need to be disposed of daily.

Compensation: This has been set at 50% for BSE, although for some other diseases it is higher. Some critics believe this encourages evasion, with cows affected minimally being sent for human consumption. Even the current level of compensation is proving expensive for MAFF.

Exports: Some foreign countries have banned British exports of seman, embryos and livestock. The EC now no longer accepts live cattle over 6 months of age. The Germans are creating difficulties over beef exports too. The EC are also considering making BSE

90/2.1/7.3

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BSE110/1 0083

notifiable and banning ruminant protein feeding to rminants, as we have done here. At present, British meat and bone meat can still be exported and might spread infection overseas (MAFF claim importers have been warned that it is not regarded suitable for feeding to ruminants).

Human transmission: There are some in the media and even the medical profession who are trying to make connections between BSE and the human disorder CJD. There is _no_ evidence of any association nor would we expect any cases by now even were BSE to be transmissible to humans. Dr Wills' study (see 2i above) will monitor the situation for the next decade or two.

90/2.1/7.4

=========== [like i have said, they really did miss the boat on this whole ordeal. from day one, to date, and they still continue to deny the inevitable.] TSS

=========== [also, found this in this pile, so will just add...tss] ===========

BOVINE SPONGIFORM ENCEPHALOPATHY

I have been asked to provide a draft reply to the attached letter from Sir Richard Southwood to the Minister. The Minister has indicated that we must meet Sir Richard's points (a} on the need for him to be fully briefed as to developments and (b) on the urgency of making progress with the transmission study.

On (a), I would suggest that the draft reply should indicate that you will be in touch with Sir Richard regularly to keep him in the picture. On (b), I hope we can now tell Sir Richard that the arrangements for the purchase and relocation of the animals are under way.

A R Cruickshank

20 June 1989

Mr A J Lawrence

AH

cc Mr K C Meldrum Dr W A Watson Mr R C Lowson

89/6.20/8.1

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

https://lists.aegee.org/cgi-bin/wa?A2=ind0009&L=BSE-L&P=R2540&1=BSE-L&9=A&I=-3&J=on&X=57C86A263C194B4411&Y=flounder9%40verizon.net&d=No+Match%3BMatch%3BMatches&z=4

From: TSS (216-119-138-155.ipset18.wt.net)

Subject: FAT LIPS/SHINY HAIR/Creams (Cosmetics) PRETTY WOMEN $ MOVIE STARS $ MAD COW DISEASE ...

Date: June 10, 2001 at 8:24 am PST

Greetings ALL,

was reading a 'smut' magazine about the 'babes' and came across this article about the different movie stars 'fat lips' (collagen injections). something in the article caught my eye. ONE was Collagen and the other was HASK PLACENTA No-Rinse Treatment. (if containing animal tissues, and then running down into the eye's, seems like a potential transmission route, if you consider kuru and the fact transmission of that TSE agent via topical applications {rubbing of organs etc on skin, cuts etc...TSS}).

""Attention, Goldie Hawn: You might want to forget about more collagen infections for that full-lipped look. Collagen for the procedure usually comes from cows -- as in "mad cow disease". So what's a girl to do? Some docs are using an acid found in roosters' combs instead of collagen. Others use collagen from 'ELITE' herds that don't mix with common bovines. And one scientist is awaiting approval for a human collagen from the foreskin of infant boys -- further proof that beauty is only skin deep""-- 'The National Enquirer' 5/6/01

are these babes in far a 'rude' awakening. firstly, these so called 'ELITE' herds they speak of, are what they call, 'tissue donor herds', that are suppose to be fed 'only' certain products that _do not_ include ruminant feed of any sort. AND from the exact question i asked at the infamous '50 STATE EMERGENCY CONFERENCE CALL' of Jan, 9, 2001, sadly we find, there is absolutley, NO SUCH THING. It was all a joke. The 'partial' ruminant to ruminant feed ban of August 4, 1997, never was enforced, and most knew nothing about it, and/or chose to ignore it.

http://bseusa.blogspot.com/2010/04/upcoming-bse-webinar-on-thursday-april.html

Hask Placenta® No-Rinse Hair Repair Treatment

Nature's protein treatment. Excellent for hair that is abused by relaxing, tinting, bleaching and exposure to the sun.

Price: US$4.95 Package: 5 fl oz (150 ml) Item No.: P8225 **discontinued** - replaced by Perm-Aid® No-Rinse Conditioning Treatment

Placenta, the most powerful natural protein for the hair instantly restores life and luster to day brittle hair.

Directions:

Shake well. Apply after shampooing. Use pump and spray until hair is saturated. Massage thoroughly. Do not rinse. Wait 3 minutes: proceed as usual with setting or styling.

Ingredients:

Water, SD Alcohol 40, Placental Protein, Cetrimonium Bromide, Lactic Acid, Fragrance, Stearamide MEA, Polysorbate 80, Phenoxyethanol, Methylparaben, Butylparaben, Propylparaben, Stearyl Imidazoline, Cetearyl Alcohol, Dimethicone, FD&C Yellow #5.

http://www.folica.com/shampoos/haskplacenta.htm

Hask Perm-Aid® Revitalizing Treatment

Special care for permed hair, also for chemically damaged and extremely abused hair.

Price: US$3.95 Package: 2.5 oz (70.94 grams) Item No.: P8216 Availability: **discontinued** recommend Perm-Aid No Rinse Conditioning Treatment

This product had been discontinued by the manufacturer, we recommend Perm-Aid® No Rinse Conditioning Treatment, which is more potent!

http://www.folica.com/shampoos/haskpermaid_revtre.htm

Part No : 1227 Description : Hask Placenta Treat.Vial 24/unit

This product is in stock, and will ships in one to two business day. If the order is received before 1:00 pm Pacific Time, usually ships on same business day.

http://www.beautycentury.com/mall/stockIS.asp?sku=1227

HASK PLACENTA products are leaders in the Deep Conditioner segment of Hair Care. Henna-n-Placenta Pacs are #13 in Unit Sales of ALL conditioners and #1 of all DEEP conditioners in the Drug Class*. Hask Placenta Instant Hair Repair, with No-Rinse treatment, is a top-10 unit seller*. National Media Support drives the brand and Hask’s strong professional heritage has consumer recognition.

http://www.ecrm-epps.com/Expose/V4_7/Table_Profiles/Alleghany.html

BSE INQUIRY

Use of Bovine offal in Cosmetics;

http://collections.europarchive.org/tna/20081105233036/http://www.bseinquiry.gov.uk/files/yb/1990/02/01004001.pdf

http://web.archive.org/web/20040625033734/www.bseinquiry.gov.uk/files/yb/1990/02/01007001.pdf

6. Information on the transfer of spongiform encephalopathies indicates that the risks from parenternal exposure are greater than orally; though the transfer through intact skin is probably unlikely, the effect of a cut or abrasion to the skin is unknown. ...

http://web.archive.org/web/20030516061153/http://www.bseinquiry.gov.uk/files/yb/1990/01/26018001.pdf

http://collections.europarchive.org/tna/20080102164040/http://www.bseinquiry.gov.uk/files/yb/1990/01/29001001.pdf

http://web.archive.org/web/20030526094945/http://www.bseinquiry.gov.uk/files/yb/1990/01/29015001.pdf

http://web.archive.org/web/20030515204421/http://www.bseinquiry.gov.uk/files/yb/1990/01/31014001.pdf

*** (Third paragraph: The wording of this paragraph will raise NEW concerns which cannot be scientifically answered. We would ask that the third paragraph be OMITTED.)

http://collections.europarchive.org/tna/20081105233038/http://www.bseinquiry.gov.uk/files/yb/1990/01/31014001.pdf

NOT FOR PUBLICATION

http://collections.europarchive.org/tna/20080102164021/http://www.bseinquiry.gov.uk/files/yb/1991/06/00005001.pdf

(there may still be some strange products administered by injection that are trying to _evade_ the Medicines Act by calling themselves cosmetics. If _any_ of those involve bovine ingredients, they need to _comply_ with the CSM guidelines)...

http://collections.europarchive.org/tna/20080102164014/http://www.bseinquiry.gov.uk/files/yb/1991/07/25003001.pdf

http://collections.europarchive.org/tna/20081105233044/http://www.bseinquiry.gov.uk/files/yb/1991/06/26003001.pdf

http://web.archive.org/web/20030529120226/http://www.bseinquiry.gov.uk/files/yb/1991/06/30001001.pdf

http://collections.europarchive.org/tna/20080102164053/http://www.bseinquiry.gov.uk/files/yb/1991/10/15002001.pdf

http://collections.europarchive.org/tna/20080102164025/http://www.bseinquiry.gov.uk/files/yb/1991/10/31009001.pdf

BSE110/1 0180

RUMINANT-DERIVED MATERIAL IN COSMETICS

The Department of Health wishes to reinforce the advice given to the Cosmetics Industry in February 1990 (ref.)

It is possible that some ruminant-derived materials are being incorporated into cosmetics or beauty treatments which are then marketed as 'natural products.

The particular materials that should not under _ANY_ circumstances be used in the manufacturer of cosmetics or beauty treatments are:

1. bovine (cattle)-derived offals, or proteins derived from these offals. These offals are: brain, spinal cord, spleen, thymus, tonsils, intestines of Bovine offal (prohibition) regulations

2. ovine (sheep)-derived offals and ovine placenta.

In view of the current uncertainty about the incidence of infection with spongiform encephalopathy agents it is probably advisable that these recommendations apply to the above ruminant-derived materials of ANY COUNTRY OF ORIGIN...

31 October 1991

91/10.31/9.1

It also emerged from the 16- volume report of Lord Phillips, released on Thursday, that people who bought anti-aging cream may have exposed themselves to BSE unwittingly.

The report describes their use as “a potential pathway to infection” because some creams may have included cattle brain placenta.

http://www.sesahs.nsw.gov.au/albionstcentre/infection_control/newsletter6.htm

A CONSIDERATION OF THE POSSIBLE HAZARD OF GELATIN TO MAN IN RELATION TO THE TRANSMISSION OF BSE

http://collections.europarchive.org/tna/20080102120826/http://www.bseinquiry.gov.uk/files/sc/seac13/tab07.pdf

Subject: BSE aka MAD COW DISEASE AND TOPICAL APPLICATIONS COSMETICS (cuts/abrasions etc.)

From: "Terry S. Singeltary Sr."

Reply-To: Bovine Spongiform Encephalopathy

Date: Wed, 12 Sep 2001 16:51:36 -0700

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

Greetings everyone,

since the debate on this ended abruptly, i thought some might be interested in the following;

TOSS =====

DOA 18

Cosmetics

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73. On 29 January 1990 Dr Pickles sent a minute to Dr Singh, copied to Mr Love and Mr Maslin. Dr Pickles referred to a conversation about Dr Singh’s draft letter to Mr Roscoe, and stated:[73]

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But I think application to broken skin is getting rather close to parenteral administration. Together with problems of policing the 6 month limit, and the fact that the ‘benefit’ from such material is so dubious, I would prefer to see a complete ban.’

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75. On 29 January 1990 Mr Sloggem replied to Mrs Shersby’s minute of the same date. He said:[75]

“1. The advice from Dr Fielder seems fine to me. There could be a problem with abraded skin providing a route of entry. Spleen and placenta could well have high titres, assuming the analogy with scrapie holds good. Sourcing abroad would seem the sensible thing to do. Some tissues may have higher titres earlier than brain tissue eg gut, hence these are best avoided from British sources.

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“… the line taken on cosmetics including sourcing from overseas was based on that given for licensed medicinal products by a group that included Drs Kimberlin, Watson and Will, as well as other MAFF officials. There is no question that the UK is an “infected area”: the only question is whether other countries should be included too. The Licensing Authority, quite reasonably in my view, feels they can only insist on sourcing in countries where there is no evidence of BSE and the veterinary service and reporting system is adequate to detect it were it present. Most manufacturers of mainline pharmaceuticals are not risking having to change sources yet again and so are looking to Australasia. If the CVO thinks he has enough evidence, say concerning the USA, to persuade the CSM, CDSM etc to advise more strongly against sourcing there too, he should present that evidence in a convincing form and in writing. I do not see this as a matter for our group, since there are statutory responsibilities under the Medicines Act. What we should do is ensure consistent advice is given for those borderline products (like these “cosmetics” with medicinal claims) that currently fall outside that Act.”

http://www.bse.org.uk/dfa/dfa18.htm

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136. On 25 July 1991, Dr Pickles replied to Mr Murray’s request. She agreed that the geographical aspects needed updating. She said ‘[the] background briefing is not really appropriate in that form (it was not something I had intended should have gone to DTI in any case).’ She also suggested that it could be pointed out that there were potential concerns:[142]

‘* for workers in the cosmetic industry who may be exposed frequently to these materials, especially if inoculation injuries might occur and

* those who by repeated application particularly to thinned, scarified or diseased skin might absorb material including infective agent that way, also

* there may still be some strange products administered by injection that are trying to evade the Medicines Act by calling themselves cosmetics. If any of those involve bovine ingredients, they need to comply with the CSM guidelines.’

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‘I have the feeling we are far too remote from the industry to make meaningful comments. Contacts via DOH/DTI do not inspire me with confidence. I would advise we need to know what bovine materials are really used in cosmetics and for what purposes. We either need to send someone into the industry (as I did for tripe, casings and rennet) or have a closer contact via the trade association. I am not satisfied yet that the industry is ‘in the clear’ and it is us that may shoulder some blame if it is later found ladies are rubbing cow brain or placenta on to their faces. It may not be our job but if we have any responsibility we need to get at the facts.’

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‘Cosmetics

3. In February 1990 the Department of Health wrote to the Department of Trade and Industry, following a request for advice on the safety of using extracts of bovine offal in certain cosmetics. Placenta is used for its supposed anti-ageing properties. Gangliosides, spleen and thymus may also be used, although there is no firm knowledge on this.

4. DTI issued advice to the industry, via the Trade Association, to the effect that even though the risks were remote it would be prudent to reformulate these products or source from countries free from BSE. In this context it was agreed at the Tyrrell committee meeting on 28 June that DTI would be reminded that since BSE had been found in other countries their guidance to cosmetic manufacturers needed to be updated.

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‘MK and JS said that the cosmetics of concern can be divided into two – 10% expensive ‘exotica’ which could contain the particular tissues of concern to DH such as cerebrocides, placenta (either human or other animal) and 90% are the routine products, many of which are based on collagen, elastin and gelatin. …

MK explained that the French cosmetics industry was soon to hold discussions with their Department of Health and it was likely that the use of placental material, particularly human, would be discontinued in any cosmetics. The main producers of ‘exotica’ were French and American, the products very expensive and therefore the companies would have the resources to ensure the safety of their products by safe sourcing eg from Australasia where there is no scrapie and no BSE. Small UK manufacturers would not be producing products containing animal materials but would rely on vegetable materials. They were not thought to be likely to be incorporating materials of concern, and this was also true for those producers of ‘natural’ products who would not necessarily be members of the CTPA.’

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The delegation thought that cosmetic products applied to the mucous membranes or around the eyes were the most dangerous.

http://www.bse.org.uk/dfa/dfa18.htm

https://lists.aegee.org/cgi-bin/wa?A2=ind0109&L=BSE-L&P=R4117&1=BSE-L&9=A&I=-3&J=on&X=57C86A263C194B4411&Y=flounder9%40verizon.net&d=No+Match%3BMatch%3BMatches&z=4

Subject: Use of Materials Derived From Cattle in Human Food and Cosmetics [Docket No. 2004N-0081] RIN 0910-AF47

From: "Terry S. Singeltary Sr."

Reply-To: Bovine Spongiform Encephalopathy

Date: Thu, 17 Apr 2008 12:46:56 -0500

Content-Type: text/plain

https://lists.aegee.org/cgi-bin/wa?A2=ind0804&L=BSE-L&P=R7115&1=BSE-L&9=A&I=-3&J=on&X=4C5F74434D94442225&Y=flounder9%40verizon.net&d=No+Match%3BMatch%3BMatches&z=4

Subject: CHINA TO START IMPORTING COSMETICS FROM COUNTRIES WITH BSE

From: "Terry S. Singeltary Sr."

Reply-To: Bovine Spongiform Encephalopathy

Date: Sun, 1 Apr 2007 13:05:42 -0500

Volume 7 Medicines and Cosmetics 8. Cosmetics and toiletries Introduction Exotica Standard topical products Collagen implants How the issue was handled

8.1 In this chapter we consider the Government's response to the risks posed by the use of bovine material in cosmetics. Cosmetics, as defined by the Cosmetics Products (Safety) Regulations 1996, include:

any substance or preparation intended to be placed in contact with any part of the external surfaces of the human body (that is to say, the epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours except where such cleaning, perfuming, protecting, changing, keeping or correcting is wholly for the purpose of treating or preventing disease. 1

8.2 Cosmetics using bovine materials fell into three categories: (i) products using lightly treated high-risk bovine offals: 'exotica'; (ii) standard topically applied products using heavily processed bovine by-products; and (iii) implants using bovine collagen.

Exotica

8.3 Concern about a risk of possible BSE contamination focused mainly on those cosmetic products commonly described as 'exotica'. These included 'premium priced facial skin care products' such as certain anti-ageing and anti-wrinkle creams. There was no ban on the use in them of animal material such as 'cellular extracts' that was deemed an unacceptable risk in food and medicines, and accordingly proscribed under the food safety and medicines safety legislation. Such material might be only lightly processed or simply chilled. Possible ingredients identified relatively early on were gangliocides extracted from the brain; and placental material, spleen and thymus. 2

Standard topical products

8.4 Although never considered a serious risk, questions were also raised about how to ensure the safety of more standard cosmetic products. These included the full range of topically applied cosmetics, ie, creams and toiletries applied to the skin, lips and eyelids, and included soaps, skin creams, shaving sticks and stick deodorants. Many of these used heavily processed bovine by-products such as collagen, elastin, gelatine and tallow derivatives. 3

Collagen implants

8.5 Concern was also expressed about bovine collagen used in implants. Although not mentioned in the highly condensed minutes of the CSM/BSC meeting of 2 November 1988, Dr Pickles's own note at the time records that this came up at the meeting as an area of concern: 'Some collagen implants of bovine origin as used by cosmetic clinics are not even licensed.' 4 Collagen products intended for correction of contour deficiencies of the skin were considered licensable under the Surgical Materials Order SI 1971 No. 1276. DH has told us that although collagen implants might have been used for 'cosmetic' reasons, this would have been under medical supervision as they were 'prescription only' medicines. 5

How the issue was handled

8.6 Although specifically identified in the Tyrrell Report in June 1989 as a small-scale user that might not be covered by the regulations and guidelines then in place, 6 the cosmetics industry was not itself the subject of advice or guidance until February 1990.

8.7 In January of that year Mr Richard Roscoe of the Department of Trade and Industry (DTI), the Department with policy responsibility for the safety of cosmetics, had on his own initiative asked DH for advice about the risk from BSE associated with the use of bovine offal in certain cosmetics. 7 DH's advice was that although the risk of transmission of BSE was remote, it would be prudent to reformulate, or source bovine material from cattle reared outside the British Isles. 8 DTI passed this advice on to the cosmetics industry trade association, the Cosmetics, Toiletries and Perfumery Association (CTPA), which in turn informed its members. 9

8.8 SEAC considered the use of bovine material in non-food products generally in June 1991. 10 By that time, BSE had been identified in countries other than the UK, and it was suggested that the advice issued to the cosmetics industry in February 1990 should be updated to take this into account. Updated advice was not sent to the CTPA until April 1992. 11

8.9 One approach that was considered within DH was the introduction of a voluntary ban on bovine materials from countries in which cases of BSE had been reported. Such a ban, if it were to be introduced, would have to be implemented at EU level, so as not to fall foul of European law. The question of BSE and cosmetics was therefore taken forward in the EC Working Party on Cosmetics (ECWPC). Progress at EC/EU level was slow; by the end of October 1994 the Scientific Committee on Cosmetology (SCC) had produced only an interim statement suggesting that material from animals with the potential to transmit infectious agents should not be used in the manufacture of cosmetics. 12 In February 1995 the ECWPC decided that the existing Cosmetics Directive did not need alteration. 13 This decision was based in part on assurance by COLIPA, the European cosmetics trade association, that its members were following certain approved basic precautions on a voluntary basis. 14

8.10 When, in March 1996, the EU ban on the export from the UK of bovine products destined for use in cosmetic, medicinal and pharmaceutical products was introduced, 15 the CTPA conducted a survey of its members and reported that almost all had been using non-UK-sourced bovine material for some time. 16

8.11 In the sections that follow we look first at the regulatory framework on cosmetics safety, which was markedly different from that on either food or medicinal products safety. The sponsoring Department for the industry, which was also responsible for its regulation, was DTI. As we shall see, there was some confusion at various points in the sequence of events about the respective responsibilities of DTI and DH for minimising risks to human health from the production and use of cosmetic products.

8.12 In the final section of the chapter we review some lessons that emerge from the way BSE was handled.

http://web.archive.org/web/20010218202403/http://www.bseinquiry.gov.uk/report/volume7/chapter8.htm#416223

Volume 7 Medicines and Cosmetics 8. Cosmetics and toiletries Regulatory framework Enforcement DTI handling of cosmetics DH's role in cosmetics safety

8.13 The regulation of cosmetics is based on the EU Cosmetics Directive (1976), which was implemented in the UK by regulations made under the Consumer Protection Act 1987. Under this system, cosmetic products must meet various safety requirements, but, unlike medicinal products, they do not require a licence.

8.14 The Cosmetics Directive seeks to ensure the safety of cosmetics and their unhindered trade throughout the EU. In relation to safety, Article 2 provides:

Cosmetic products put on the market within the Community must not be liable to cause damage to human health when applied under normal conditions of use. 1

8.15 Dr Robin Fielder of DH told us that the Cosmetics Directive places the onus on manufacturers and suppliers to ensure that the product is safe for the use intended. 2

8.16 Member States have a duty to 'take all necessary measures to ensure that only cosmetic products which conform to [the Directive] may be put on the market'. 3 The Annexes to the Cosmetics Directive list substances that must not be used in cosmetics and substances whose use is regulated. They also contain lists of substances ('the prescribed lists') permitted for certain uses (preservatives, colourants, sun screens) and only these substances may be used for those purposes in cosmetic products. 4 The prescribed lists may be amended following consideration by the European Commission's Cosmetic Products Working Party, which consists of representatives from the Member States and the industry. DTI led for the UK on this with DH also having a role. The final decision is taken by the Committee on the Adaptation to Technical Progress, which is chaired by the Commission and consists of representatives from Member States. Both the Working Party and the Commission have access to the opinions of the Scientific Committee on Cosmetology (SCC), an independent multidisciplinary body of scientists appointed by the Commission to assess the safety of cosmetics ingredients, as well as to advice from their own national scientific advisers. 5

8.17 The Cosmetics Directive limits the action individual Member States can take to regulate cosmetics. 6 If a product complies with the relevant Annex, the UK Government cannot prohibit its use unless, on the basis of a 'substantiated justification', it represents a hazard to health. 7

8.18 Regulations made, in part, under section 11 of the Consumer Protection Act 1987 give effect to the Cosmetics Directive in UK law. The Cosmetic Products (Safety) Regulations 1984 (made under a predecessor of the Act) were replaced on 1 January 1990 by the Cosmetic Products (Safety) Regulations 1989 ('the 1989 Regulations').

8.19 The main provisions of the 1989 Regulations are as follows: 8

1.A cosmetic product shall not be liable to cause damage to human health when it is applied under normal conditions of use (reg. 3(1)). 2.No cosmetic product may contain any substance listed in column 2 of Schedule 1, unless it is only a trace that could not reasonably have been removed during or after manufacture (reg. 4(2)). 3.A cosmetic product must not contain any substance listed in column 2 of Schedule 2 unless specified requirements in that schedule are satisfied (reg. 4(3)). 4.The Secretary of State may authorise the use in a cosmetic product of any substance not listed in either schedule 1 or 2 (reg. 5(1)). In giving authorisation the Secretary of State may impose conditions relating to the use of the substance (reg. 5(2)). 5.There are various conditions and standards for labelling and packaging (reg. 6).

8.20 The Consumer Protection Act imposes a general safety requirement on all consumer goods. Section 10 of the Act makes it an offence to supply consumer goods that fail to comply with the general safety requirement. For this purpose, consumer goods fail to comply with the safety requirement if they are not reasonably safe having regard to all the circumstances. 'Safe' means that there is no risk (apart from one reduced to a minimum) that the goods will (whether immediately or later) cause death or personal injury to any person. 9

8.21 The Cosmetics Directive and the 1989 Regulations left only limited scope for the application of section 10 of the Act. Since the introduction of the General Product Safety Regulations 1994 10 there has been virtually no scope for its application.

8.22 In practice informal contact and voluntary cooperation played an important part in the regulation of the cosmetics industry.

Enforcement

8.23 DTI had policy responsibility for the safety of cosmetics in the UK. Day-to-day enforcement of safety regulations such as the 1989 Regulations fell to the trading standards departments of local authorities. 11

8.24 Supplying consumer goods that failed to comply with the general safety requirement or with certain requirements of safety regulations was an offence and punishable in the courts. 12

8.25 In addition, enforcement authorities (which for these purposes meant DTI and the trading standards departments of local authorities) had power to serve a suspension notice prohibiting the person on whom it was served from supplying goods for up to six months; power to apply to the court for a forfeiture order; 13 and power for an authorised officer of the enforcement authority to enter any premises, inspect any goods, or examine any procedure, or in appropriate circumstances to seize and detain goods. 14

8.26 The Secretary of State also had the power to serve a notice on a person prohibiting the person from selling consumer goods if the Secretary of State considered them to be unsafe (a prohibition notice), or requiring the person to publish a warning about such goods (a notice to warn). 15 However, these powers applied only to the person on whom the notice was served or against whom the order was sought, rather than to a general category of goods, and no power existed to recall products under these provisions. 16

8.27 DTI told us that it was unaware of any instance in which these powers had been used in respect of a BSE risk in cosmetics. 17

DTI handling of cosmetics

8.28 Within DTI overall responsibility for the safety of cosmetics lay with the Consumer Safety Unit (CSU). Within the CSU, the Chemical Hazards Section (CHS) had day-to-day responsibility for cosmetics. 18

8.29 Mr David Jones, a Grade 5 official, was Head of the CSU until 1995. Mr Roscoe, a Grade 7 official, was Head of the CHS from 1983 to 1992, with specific responsibility for ensuring the safety of cosmetics sold in the UK. 19 He was succeeded by Mr John Walker. Mrs M L Payne, a Higher Executive Officer in the CSU from 1990, was responsible for developing policy on regulation covering chemicals, including ingredients used in cosmetics. 20

8.30 The CTPA was the peak representative body for the UK cosmetics industry and the channel through which DTI distributed cautionary guidance on BSE to cosmetics manufacturers.

DH's role in cosmetics safety

8.31 Although DTI had overall regulatory responsibility for cosmetics, DH also played a role as DTI's adviser on toxicity. 21 The relevant Division in DH was MED TEP (Medical Toxicology Environmental Protection), 22 later evolving into the HEF M (Health Aspects of Environment and Food Medical), 23 which would give advice when necessary.

8.32 Mr Roscoe told us that whenever the CHS was alerted to the presence of a potentially 'risky' ingredient in a particular cosmetic product it would refer the matter to DH. 24 Upon receipt of advice from DH, the CHS would then decide on a course of action. According to Mr Roscoe, DTI would always act on this advice 'unless there were very strong reasons for not doing so'. 25

8.33 Mr Roscoe also told the Inquiry that he believed that when DH encountered a new risk it was its responsibility to pass on the information to DTI. 26

8.34 The DH adviser on toxicology over the period of concern was Dr Fielder, who was assisted by Dr Dewhurst (1988-90), Dr Gott (1991-93) and Ms Mulholland (1993-97). 27

http://web.archive.org/web/20010218200336/http://www.bseinquiry.gov.uk/report/volume7/chapteg2.htm

COSMETICS-further reading from the inquiry on this subject;

http://web.archive.org/web/20010218201247/http://www.bseinquiry.gov.uk/report/volume7/chapteg3.htm

http://web.archive.org/web/20010218201548/http://www.bseinquiry.gov.uk/report/volume7/chaptef4.htm

http://web.archive.org/web/20010624184106/http://www.bseinquiry.gov.uk/report/volume7/chapted5.htm

http://web.archive.org/web/20020328132354/http://www.bseinquiry.gov.uk/report/volume7/chapteb6.htm

http://web.archive.org/web/20010624172330/http://www.bseinquiry.gov.uk/report/volume7/chapteb7.htm

http://web.archive.org/web/20010624184940/http://www.bseinquiry.gov.uk/report/volume7/chaptea8.htm

Volume 7: Medicines and Cosmetics 8. Cosmetics and toiletries 1997/98

8.145 Although outside the period covered by the Inquiry, it is of interest to note the Cosmetics Directive was subsequently amended by Commission Directive 97/1/EC on 10 January 1997 to prohibit the use in cosmetics of:

Bovine, ovine and caprine tissues and fluids from the encephalon, the spinal cord and the eyes, and ingredients derived therefrom. 1 8.146 The Cosmetics Directive was further amended by Commission Directive 98/16/EC on 5 March 1998 to prohibit the use in cosmetics of: 2

(a) the skull, including the brain and eyes, tonsils and spinal cord of: - bovine animals aged 12 months, - ovine and caprine animals which are aged over 12 months or have a permanent incisor tooth erupted through the gum; (b) the spleens of ovine and caprine animals and ingredients derived therefrom. However, tallow derivatives may be used provided that the following methods have been used and strictly certified by the producer: - Transesterification or Hydrolysis at at least: 200ºC, 40 bars (40,000 hPa) for 20 minutes (glycerol and fatty acids and esters); - Saponification with NaOH 12 M (glycerol and soap); - Batch process: at 95ºC for three hours, or - Continuous process: at 140ºC, two bars (2000 hPa) for eight minutes or equivalent conditions.

http://web.archive.org/web/20010218200025/http://www.bseinquiry.gov.uk/report/volume7/chapteri.htm

http://web.archive.org/web/20020328151016/http://www.bseinquiry.gov.uk/report/volume7/chapte10.htm

8.227 These matters stretch well beyond our remit. However, it appears to us, as it did to the Tyrrell Committee, that cosmetics were indeed a potential pathway for pathogens, and that not enough was known about this. Future occasions could arise when, as with BSE, there needs to be a means of turning off the tap at source, rather than catching droplets downstream. Consideration might usefully be given to what powers and processes would assist this.

http://web.archive.org/web/20030702111440/http://www.bseinquiry.gov.uk/report/volume7/chapter9.htm

http://web.archive.org/web/20020328140201/http://www.bseinquiry.gov.uk/report/volume7/chapteh2.htm

http://web.archive.org/web/20010218201146/http://www.bseinquiry.gov.uk/report/volume7/chapteh3.htm

9.63 Mr Bradley replied by letter dated 17 June 1990 to Dr Pickles's letter of 11 June. He stated in relation to A1d:

I have not got far with this. Where do fetal calves, placenta and uteri go and are any uses made of lymph nodes? Cosmetics, ointments, oils, indeed anything that is used on the skin (it could have a lesion) could presen an increased hazard. I have some concern over mesenteric lymph nodes though they are not eaten, though DOH/MAFF agreed earlier there was no need to include them in the offal ban. This is one to discuss in Committee. 34

I understand that there is concern on the Tyrrell Committee recommendation A1d on pharmaceuticals and cosmetics. This has never been considered a primary responsibility of MAFF although collaboration with the principals (DOH and industry) was anticipated.

I suspect the VMD approach will be to avoid or selectively reduce use of bovine tissues in medicinal products for animals. Presumably the authorities responsible for human medicinal products and cosmetics have taken similar action. 35

http://web.archive.org/web/20010624174011/http://www.bseinquiry.gov.uk/report/volume7/chapteg4.htm

(iii) Non-food uses of bovine material. The Committee asked for a note on the use of bovine material for cosmetics in particular, although it might make sense to cover all the non-food uses that we can think of (harp strings, tennis rackets etc). I think that all that is required is a factual note about the range of uses, and quantities, together with an assessment of possible risk factors. It looks to me like a job for Dr Pickles. 1

http://web.archive.org/web/20010624170118/http://www.bseinquiry.gov.uk/report/volume7/chaptee5.htm

http://web.archive.org/web/20010218184950/http://www.bseinquiry.gov.uk/report/volume7/chaptec6.htm

http://web.archive.org/web/20010624181038/http://www.bseinquiry.gov.uk/report/volume7/chaptec7.htm

http://web.archive.org/web/20010624173202/http://www.bseinquiry.gov.uk/report/volume7/chapteb8.htm

http://web.archive.org/web/20030506095053/http://www.bseinquiry.gov.uk/report/volume7/chaptea9.htm

Annex 2 to Chapter 9: Uses made of the cattle carcass

Item Products derived Additional comments

HEAD

Brain Human food Laboratory reagents Veterinary medicines Pharmaceuticals Cosmetics

http://web.archive.org/web/20010218201535/http://www.bseinquiry.gov.uk/report/volume7/glossary.htm

http://web.archive.org/web/20020328150145/http://www.bseinquiry.gov.uk/report/volume7/whoswho.htm

http://web.archive.org/web/20010624175300/http://www.bseinquiry.gov.uk/report/volume7/index.htm

http://web.archive.org/web/20010221160942/http://www.bseinquiry.gov.uk/report/volume7/volume72.htm

http://web.archive.org/web/20010221160108/http://www.bseinquiry.gov.uk/report/volume7/volume73.htm

http://web.archive.org/web/20030907100258/www.bseinquiry.gov.uk/report/volume7/volume74.htm

http://web.archive.org/web/20010221160018/http://www.bseinquiry.gov.uk/report/volume7/volume75.htm

4.4 On 10.1.90 I attended the second meeting of the CSM BSE Working Party. The discussions which took place and the conclusions reached can be found in the Minutes of the meeting [YB 90/1.10/1.1-1.24]. I provided comments to Dr Singh in Med TEH on his draft letter to DTI which responded to a request for advice on the safety of the use of bovine offal (in particular, spleen and thymus) in cosmetics [YB 90/1.29/1.1-1.2]. My briefing notes were used to accompany the reply to DTI [YB 90/2.1/4.1]. I indicated I was not happy about the use of bovine offal from calves under 6 months in cosmetics (in contrast to foods) because on damaged skin such use could be close to parenteral administration so the nearest parallel might be injectable medicines. Besides there were no compensating benefits.

57. April 1990

57.1 The formation of SEAC was announced by Mr Gummer on 3.4.90 [YB 90/5.24/4.1-4.2]. As requested, I supplied comments on the draft Agenda prepared by Mr Lowson for SEAC's first meeting [YB 90/4.6/4.1-4.3] and I supplied a list of documents to accompany the formal papers for background information. I offered to put together a discussion paper on bovine eyeballs and the use of bovine material in cosmetics. This draft paper entitled Routes of Possible Transmission into Man was later sent to Mr Lowson for comment [YB 90/4.12/1.1-1.4]. It met with the approval of Mr Lowson but it was not submitted to SEAC at that time as CVO indicated he thought a more detailed paper was needed [YB 90/4.24/3.1-3.2 and see YB 90/4.23/1.1].

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

http://www.telegraph.co.uk:80/et?ac=003789727059657&rtmo=weoeinKb&atmo=rrrrrrrq&pg=/et/96/9/7/wbse07.html

http://www.telegraph.co.uk:80/et?ac=003789727059657&rtmo=weoeinKb&atmo=rrrrrrrq&pg=/et/99/11/2/nbse02.html

http://www.telegraph.co.uk:80/et?ac=003789727059657&rtmo=weoeinKb&atmo=rrrrrrrq&pg=/et/00/10/29/nbse129.html

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BSE Inquiry report criticises ex-Tory ministers

Sat, Sep 2, 2000 PA News

Conservative former ministers and Whitehall officials face strong criticism in the official report into the BSE crisis, it was reported tonight. The inquiry chairman Lord Phillips is believed to have notified several former health and agriculture ministers that they are facing criticism in the 13-volume report he is to publish in a few weeks.

Reports in several Sunday newspapers suggested the former ministers would be taken to task for being "too adamant" in their assurances that British beef was safe, and for failing to react swiftly enough to scientists' findings that the disease could spread to humans. Scientists first suspected that there was a risk to humans eating BSE-infected offal in the mid-80s, but it was not until March 1996 that Tory ministers admitted that there was a danger to the public.

But the ex-ministers could come off lightly compared with senior civil servants who ran the two departments as the decade-long saga unfolded.

Lord Phillips' two-year inquiry is said to have concluded that too much importance was attached to the interests of the livestock industry, and not enough to those of consumers. The BSE affair led to a worldwide ban on British beef exports which is estimated to have cost the taxpayer 4.6 billion.

Comment (webmaster): It is unclear why the judge released the findings prior to publication. What purpose is served anyway with polite criticism (1, 2) of long-departed political figures and retired civil servants? Keith Meldrin, who masterminded the coverup within MAFF for 10 years, also receives a wrist-slap for a leading role in 82 human deaths. His successor at MAFF who continued these abominable policies was forced into retirement this year but given a handsome 400,000 pound retirement package. MAFF itself has spent 7 million pounds of public money on lawyers even and successfully fought the Inquiry practise of publishing fulltext of government memos on the Internet.

However, these documents can still be obtained in print form. Terry S. Singeltary Sr. of Bacliff, Texas, has obtained many of the documents alluded to in the Inquiry but never released. These have been optically character read into electronic form and distributed to the German BSE listserve archive as well as to this web site:

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

Dear Marion

As you know there is no record of bovine spongiform encepalopathy crossing to humans, but we need to take precautions to avoid any risk.

There a number of cosmetric products on sale in the United Kingdom such as anti-ageing creams that contain extracts of bovine offal, primarily from spleen and thymus. [Two of the highest risk tissues. Note the epidemic has been raging for 4 years by the time of the non-binding voluntary suggestions here. -- webmaster]

The purpose of this letter is to ask you to ask your members to eliminate any risk by reformulating such products to eliminate these extracts, or alternatively to use material derived from cattle reared outside the UK, Eire or the Channel Islands. [Eire, Channel Islands, and many other countries were thoroughly infected by then -- webmaster]

Please let me know if you have any trouble persuading your members to do so.

Yours sincerely

R J ROSCOE CONSUMER SAFETY UNIT ROOM 407

90/02.01/14.1 ==============

BSE110/1 0080

DEPARTMENT OF HEALTH AND SOCIAL SECURITY HANNIBAL HOUSE Room No ELEPHANT AND CASTLE LONDON SE1 6TE

1 February 1990

Mr R Roscoe Consumer Affairs Department of Trade and Industry 10-18 Victoria Street London SW1

Dear Richard

USE OF BOVINE OFFAL IN COSMETICS

I am replying to your request for advice on the safety of the use of extracts of bovine offal in certain cosmetics, such as skin products claimed to have 'anti-ageing' properties with respect to bovine spongiform encephalopathy (BSE). As you are aware there are a number of cosmetic products on sale in the UK that contain small amounts of such extracts, primarily from spleen and thymus.

We accept that the risk of transmission is likely to be remote, but believe that it would be prudent to eliminate any risk by reformulating such products. Alternatively if the incorporation of bovine extracts is retained, material derived from cattle reared outside the UK, Eire or the Channel Islands should be used.

We would be grateful if you would transmit these recommendations to industry via the Trade Association CTPA.

I attach background briefing prepared by medical colleagues from those sections most involved with consideration of BSE in DH, together with a copy of the Southwood report.

Please let me know if you need any further information.

Yours sincerely DR R J FIELDER Enclosure 90/2.1/7.1 ===========

BSE110/1 0081

BACKGROUND BRIEFING

Presence of Bovine Offals in Cosmetics and Bovine Spongiform Encephalopathy

(1) Extracts of bovine spleen and thymus are present at between ca 0.1 and 5% in certain cosmetic preparations, for example certain products claimed to delay the signs of ageing of skin. The concern about the increasing incidence of BSE in cattle in the UK has made it necessary to reconsider the safety of such products.

BSE is a progressive neurological disorder in cattle, which results from infection with an "unconventional viral' agent. The first case was described in cows in 1986. By 19 January 1990 there had been 9436 confirmed cases in the UK on 5474 farms. There are no confirmed cases outside the British Isles, apart from a case in a cow recently exported from England. BSE is one of a family of spongiform encephalopathies which also include scrapie in sheep and kuru and Creutzfeldt Jakob disease (CJD) in man. The infection which leads to BBE appears to have been introduced into cattle from the contaminated feeding stuff, meat and bone meal, made partly from sheep offal: scrapie is endemic in sheep in the UK.

The causative agents of these diseases are thought to be unconventional transmissible agents (referred to variously as prions, virinos, filamentous viruses or slow viruses). They are extremely resistant to most denaturing processes eg heat, UV, high salt concentration, formalin and alkylating agents. The current DH guideline for treating items used on CJD patients is a temperature of 134-138 C (at 2 atmospheres) held for 18 minutes. They are also not removed by normal microbiological filters. It is thus unlikely that the mild processing techniques used to obtain the extracts used in cosmetics would remove the causative agents.

(2) Government action to date includes:

a. An expert working party was set up under Sir Richard Southwood and reported in February 1989. All their recommendations have been acted upon.

b. The disease has been made notifiable in cattle.

c. All suspect animals are slaughtered and carcases destroyed (50% compensation policy but 100% if diagnosis not confirmed); milk from such animals is also destroyed.

d. Sale or supply of animal protein from ruminants for feeding to ruminants prohibited - hopefully to prevent any new infections in cattle. This has had a major effect on the rendering industry.

e. Another committee was set up under Dr David Tyrrell to report on research needs. An interim report was published in January 1990 together with an announcement about additional funding. Much research work into the disease is currently in progress and additional studies are being planned.

Regulations in November 1989 introduced a ban on various bovine offal for human consumption, going wider than the Southwood recommendations which were for such a ban to affect baby food only.

The Medicines Control Agency have gathered information from pharmaceutical companies about use of bovine ingredients in parenteral pharmaceuticals and issued interim guidelines. Many biological products and vaccines use such ingredients. The MCA are considering whether action on specific products is appropriate.

h. The Health and Safety Executive (HSE) is reviewing its guidance to those who come into direct contact with bovine 'risk' tissues. A press release for those who handle BSE carcases has been issued and one for abattoir workers is in preparation. The HSE ara also discussing risks from BSE exposure with the veterinary profession.

i. All UK cases of CJD will be monitored in a study to be conducted by Dr R G Will in Edinburgh, funded by the Department of Health: this should allow detection of any spread of infection to hummans, although this possibility is considered remote.

(3) Current live issues

Research: Dr Tyrell's interim report identified a large research programme classed as high priority. Almost all of this research falls to MAFF {Central Veterinary Labs} or the AFRC, although the MRC also has an interest. Substantial money has been made available for this work but research will be laborious and results will come slowly.

Food: There has been constant pressure on MAFF about the supposed risk to humans from eating beef and beef products. Infected animals who are incubating the disease but do not show any abnormalities cannot be detected at present and will be entering the human food chain. The offal ban removes the highest 'risk' tissues. Some critics may not be satisfied by this. However, others may argue the action to date is over the top, not demanded by the experts, and illogical since scrapie-infected sheep can still be eaten and doing so for the last 200 years has not caused harm to humans. We expect BSE agent to be resistant to irradiation as applied to food, as well as relatively resistant to cooking.

Other animals: There is no evidence that animals other than cattle (and domesticated, deer) have been or could be affected by BSE, other than experimentally, but there are pressures to extend the ruminant protein ban: at present pigs and poultry receive this sort of feed. Such action, as well as being hard to justify scientifically, would increase costs for the industry and cause perhaps insurmountable problems for abattoirs, who would find renderers no longer willing to accept offal. Many 1000's of tons of offal need to be disposed of daily.

Compensation: This has been set at 50% for BSE, although for some other diseases it is higher. Some critics believe this encourages evasion, with cows affected minimally being sent for human consumption. Even the current level of compensation is proving expensive for MAFF.

Exports: Some foreign countries have banned British exports of seman, embryos and livestock. The EC now no longer accepts live cattle over 6 months of age. The Germans are creating difficulties over beef exports too. The EC are also considering making BSE notifiable and banning ruminant protein feeding to rminants, as we have done here. At present, British meat and bone meat can still be exported and might spread infection overseas (MAFF claim importers have been warned that it is not regarded suitable for feeding to ruminants).

Human transmission: There are some in the media and even the medical profession who are trying to make connections between BSE and the human disorder CJD. There is _no_ evidence of any association nor would we expect any cases by now even were BSE to be transmissible to humans. Dr Wills' study (see 2i above) will monitor the situation for the next decade or two.

I have been asked to provide a draft reply to the attached letter from Sir Richard Southwood to the Minister. The Minister has indicated that we must meet Sir Richard's points (a} on the need for him to be fully briefed as to developments and (b) on the urgency of making progress with the transmission study.

On (a), I would suggest that the draft reply should indicate that you will be in touch with Sir Richard regularly to keep him in the picture. On (b), I hope we can now tell Sir Richard that the arrangements for the purchase and relocation of the animals are under way.

A R Cruickshank 20 June 1989 Mr A J Lawrence AH cc Mr K C Meldrum Dr W A Watson Mr R C Lowson 89/6.20/8.1

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

update

http://europa.eu.int/comm/food/fs/sc/ssc/out109_en.html

http://europa.eu.int/comm/food/fs/sc/ssc/out80_en.pdf

P.S. -- one must consider 'accumulation' of agent over time. ...

2009

To date the OIE/WAHO assumes that the human and animal health standards set out in the BSE chapter for classical BSE (C-Type) applies to all forms of BSE which include the H-type and L-type atypical forms. This assumption is scientifically not completely justified and accumulating evidence suggests that this may in fact not be the case. Molecular characterization and the spatial distribution pattern of histopathologic lesions and immunohistochemistry (IHC) signals are used to identify and characterize atypical BSE. Both the L-type and H-type atypical cases display significant differences in the conformation and spatial accumulation of the disease associated prion protein (PrPSc) in brains of afflicted cattle. Transmission studies in bovine transgenic and wild type mouse models support that the atypical BSE types might be unique strains because they have different incubation times and lesion profiles when compared to C-type BSE. When L-type BSE was inoculated into ovine transgenic mice and Syrian hamster the resulting molecular fingerprint had changed, either in the first or a subsequent passage, from L-type into C-type BSE. In addition, non-human primates are specifically susceptible for atypical BSE as demonstrated by an approximately 50% shortened incubation time for L-type BSE as compared to C-type. Considering the current scientific information available, it cannot be assumed that these different BSE types pose the same human health risks as C-type BSE or that these risks are mitigated by the same protective measures.

http://www.prionetcanada.ca/detail.aspx?menu=5&dt=293380&app=93&cat1=387&tp=20&lk=no&cat2

I ask Professor Kong ;

Thursday, December 04, 2008 3:37 PM Subject: RE: re--Chronic Wating Disease (CWD) and Bovine Spongiform Encephalopathies (BSE): Public Health Risk Assessment

''IS the h-BSE more virulent than typical BSE as well, or the same as cBSE, or less virulent than cBSE? just curious.....''

Professor Kong reply ;

.....snip

''As to the H-BSE, we do not have sufficient data to say one way or another, but we have found that H-BSE can infect humans. I hope we could publish these data once the study is complete.

Thanks for your interest.''

Best regards,

Qingzhong Kong, PhD Associate Professor Department of Pathology Case Western Reserve University Cleveland, OH 44106 USA

END...TSS

P02.35

Molecular Features of the Protease-resistant Prion Protein (PrPres) in H-type BSE

Biacabe, A-G1; Jacobs, JG2; Gavier-Widén, D3; Vulin, J1; Langeveld, JPM2; Baron, TGM1 1AFSSA, France; 2CIDC-Lelystad, Netherlands; 3SVA, Sweden

Western blot analyses of PrPres accumulating in the brain of BSE-infected cattle have demonstrated 3 different molecular phenotypes regarding to the apparent molecular masses and glycoform ratios of PrPres bands. We initially described isolates (H-type BSE) essentially characterized by higher PrPres molecular mass and decreased levels of the diglycosylated PrPres band, in contrast to the classical type of BSE. This type is also distinct from another BSE phenotype named L-type BSE, or also BASE (for Bovine Amyloid Spongiform Encephalopathy), mainly characterized by a low representation of the diglycosylated PrPres band as well as a lower PrPres molecular mass. Retrospective molecular studies in France of all available BSE cases older than 8 years old and of part of the other cases identified since the beginning of the exhaustive surveillance of the disease in 20001 allowed to identify 7 H-type BSE cases, among 594 BSE cases that could be classified as classical, L- or H-type BSE. By Western blot analysis of H-type PrPres, we described a remarkable specific feature with antibodies raised against the C-terminal region of PrP that demonstrated the existence of a more C-terminal cleaved form of PrPres (named PrPres#2 ), in addition to the usual PrPres form (PrPres #1). In the unglycosylated form, PrPres #2 migrates at about 14 kDa, compared to 20 kDa for PrPres #1. The proportion of the PrPres#2 in cattle seems to by higher compared to the PrPres#1. Furthermore another PK–resistant fragment at about 7 kDa was detected by some more N-terminal antibodies and presumed to be the result of cleavages of both N- and C-terminal parts of PrP. These singular features were maintained after transmission of the disease to C57Bl/6 mice. The identification of these two additional PrPres fragments (PrPres #2 and 7kDa band) reminds features reported respectively in sporadic Creutzfeldt-Jakob disease and in Gerstmann-Sträussler-Scheinker (GSS) syndrome in humans.

http://www.neuroprion.com/pdf_docs/conferences/prion2007/abstract_book.pdf

Monday, October 19, 2009

Atypical BSE, BSE, and other human and animal TSE in North America Update October 19, 2009

http://bse-atypical.blogspot.com/2009/10/atypical-bse-bse-and-other-human-and.html

14th International Congress on Infectious Diseases H-type and L-type Atypical BSE January 2010 (special pre-congress edition)

18.173 page 189

Experimental Challenge of Cattle with H-type and L-type Atypical BSE

A. Buschmann1, U. Ziegler1, M. Keller1, R. Rogers2, B. Hills3, M.H. Groschup1. 1Friedrich-Loeffler-Institut, Greifswald-Insel Riems, Germany, 2Health Canada, Bureau of Microbial Hazards, Health Products & Food Branch, Ottawa, Canada, 3Health Canada, Transmissible Spongiform Encephalopathy Secretariat, Ottawa, Canada

Background: After the detection of two novel BSE forms designated H-type and L-type atypical BSE the question of the pathogenesis and the agent distribution of these two types in cattle was fully open. From initial studies of the brain pathology, it was already known that the anatomical distribution of L-type BSE differs from that of the classical type where the obex region in the brainstem always displays the highest PrPSc concentrations. In contrast in L-type BSE cases, the thalamus and frontal cortex regions showed the highest levels of the pathological prion protein, while the obex region was only weakly involved.

Methods:We performed intracranial inoculations of cattle (five and six per group) using 10%brainstemhomogenates of the two German H- and L-type atypical BSE isolates. The animals were inoculated under narcosis and then kept in a free-ranging stable under appropriate biosafety conditions.At least one animal per group was killed and sectioned in the preclinical stage and the remaining animals were kept until they developed clinical symptoms. The animals were examined for behavioural changes every four weeks throughout the experiment following a protocol that had been established during earlier BSE pathogenesis studies with classical BSE.

Results and Discussion: All animals of both groups developed clinical symptoms and had to be euthanized within 16 months. The clinical picture differed from that of classical BSE, as the earliest signs of illness were loss of body weight and depression. However, the animals later developed hind limb ataxia and hyperesthesia predominantly and the head. Analysis of brain samples from these animals confirmed the BSE infection and the atypical Western blot profile was maintained in all animals. Samples from these animals are now being examined in order to be able to describe the pathogenesis and agent distribution for these novel BSE types. Conclusions: A pilot study using a commercially avaialble BSE rapid test ELISA revealed an essential restriction of PrPSc to the central nervous system for both atypical BSE forms. A much more detailed analysis for PrPSc and infectivity is still ongoing.

http://www.isid.org/14th_icid/

http://ww2.isid.org/Downloads/IMED2009_AbstrAuth.pdf

http://www.isid.org/publications/ICID_Archive.shtml

14th ICID International Scientific Exchange Brochure -

Final Abstract Number: ISE.114

Session: International Scientific Exchange

Transmissible Spongiform encephalopathy (TSE) animal and human TSE in North America

update October 2009

T. Singeltary

Bacliff, TX, USA

Background:

An update on atypical BSE and other TSE in North America. Please remember, the typical U.K. c-BSE, the atypical l-BSE (BASE), and h-BSE have all been documented in North America, along with the typical scrapie's, and atypical Nor-98 Scrapie, and to date, 2 different strains of CWD, and also TME. All these TSE in different species have been rendered and fed to food producing animals for humans and animals in North America (TSE in cats and dogs ?), and that the trading of these TSEs via animals and products via the USA and Canada has been immense over the years, decades.

Methods:

12 years independent research of available data

Results:

I propose that the current diagnostic criteria for human TSEs only enhances and helps the spreading of human TSE from the continued belief of the UKBSEnvCJD only theory in 2009. With all the science to date refuting it, to continue to validate this old myth, will only spread this TSE agent through a multitude of potential routes and sources i.e. consumption, medical i.e., surgical, blood, dental, endoscopy, optical, nutritional supplements, cosmetics etc.

Conclusion:

I would like to submit a review of past CJD surveillance in the USA, and the urgent need to make all human TSE in the USA a reportable disease, in every state, of every age group, and to make this mandatory immediately without further delay. The ramifications of not doing so will only allow this agent to spread further in the medical, dental, surgical arena's. Restricting the reporting of CJD and or any human TSE is NOT scientific. Iatrogenic CJD knows NO age group, TSE knows no boundaries. I propose as with Aguzzi, Asante, Collinge, Caughey, Deslys, Dormont, Gibbs, Gajdusek, Ironside, Manuelidis, Marsh, et al and many more, that the world of TSE Transmissible Spongiform Encephalopathy is far from an exact science, but there is enough proven science to date that this myth should be put to rest once and for all, and that we move forward with a new classification for human and animal TSE that would properly identify the infected species, the source species, and then the route.

http://ww2.isid.org/Downloads/14th_ICID_ISE_Abstracts.pdf

Wednesday, March 31, 2010

Atypical BSE in Cattle

http://bse-atypical.blogspot.com/2010/03/atypical-bse-in-cattle-position-post.html

Tuesday, March 16, 2010

COMMONWEALTH OF AUSTRALIA Hansard Import restrictions on beef FRIDAY, 5 FEBRUARY 2010 AUSTRALIA

COMMONWEALTH OF AUSTRALIA

Proof Committee Hansard

RRA&T 2 Senate Friday, 5 February 2010

RURAL AND REGIONAL AFFAIRS AND TRANSPORT

[9.03 am]

BELLINGER, Mr Brad, Chairman, Australian Beef Association

CARTER, Mr John Edward, Director, Australian Beef Association

CHAIR—Welcome. Would you like to make an opening statement?

Mr Bellinger—Thank you. The ABA stands by its submission, which we made on 14 December last year, that the decision made by the government to allow the importation of beef from BSE affected countries is politically based, not science based. During this hearing we will bring forward compelling new evidence to back up this statement. When I returned to my property after the December hearing I received a note from an American citizen. I will read a small excerpt from the mail he sent me in order to reinforce the dangers of allowing the importation of beef from BSE affected countries. I have done a number of press releases on this topic, and this fellow has obviously picked my details up from the internet. His name is Terry Singeltary and he is from Bacliff, Texas. He states, and rightfully so:

You should be worried. Please let me explain. I’ve kept up with the mad cow saga for 12 years today, on December 14th 1997, some four months post voluntary and partial mad cow feed ban in the USA, I lost my mother to the Heinemann variant Creutzfeldt-Jakob disease (CJD). I know this is just another phenotype of the infamous sporadic CJDs. Here in the USA, when USA sheep scrapie was transmitted to USA bovine, the agent was not UK BSE—it was a different strain. So why then would human TSE from USA cattle look like UK CJD from UK BSE? It would not. So this accentuates that the science is inconclusive still on this devastating disease. He goes on to state:

The OIE— the International Organisation of Epizootics, the arm of the WTO— is a failed global agent that in my opinion is bought off via bogus regulations for global trade and industry reps. I have done this all these years for nothing but the truth. I am a consumer, I eat meat, but I do not have to sit idly by and see the ignorance and greed of it all while countless numbers of humans and animals are being exposed to the TSE agents. All the USA is interested in is trade, nothing else matters.

Even Dr Stanley Prusiner, who incidentally won the Nobel Health Prize in 1997 for his work on the prion—he invented the word ‘prion’, or it came from him—states:

The BSC policy was set up for one purpose only, trade—the illegal trading of all strains of TSE globally throughout North America, which is home to CBSC, IBSC and HBSC, many scrapie strains and two strains of CJD to date. (please note typo error, those should have read cBSE, lBSE, and hBSE...tss)

I would also like, while I have the opportunity, to explain the beef-off-the-shelves myth. At the first Senate hearing on 14 December, it was explained that the reason why they allowed BSC beef into Australia was the beef-off-the-shelves policy, whereby if we found a case of BSC in Australia they would have to recall all—

Friday, 5 February 2010 Senate RRA&T 3

RURAL AND REGIONAL AFFAIRS AND TRANSPORT

Senator HEFFERNAN—Which of course is total BS.

Mr Bellinger—Correct. This is written in the FSANZ document—Food Standards Australia New Zealand. Why isn’t this same policy in New Zealand? It is not—it is only in Australia. We are the only country in the world to have this idiotic policy. So we again call for the tabling of the WTO obligations paperwork. We do not believe that exists.

snip...see full text 110 pages ;

http://www.aph.gov.au/hansard/senate/commttee/S12742.pdf

for those interested, please see much more here ;

http://docket-aphis-2006-0041.blogspot.com/2010/03/commonwealth-of-australia-hansard.html

http://transmissiblespongiformencephalopathy.blogspot.com/

Thursday, July 08, 2010

Nosocomial transmission of sporadic Creutzfeldt-Jakob disease: results from a risk-based assessment of surgical interventions Public release date: 8-Jul-2010

http://creutzfeldt-jakob-disease.blogspot.com/2010/07/nosocomial-transmission-of-sporadic.html

Thursday, July 08, 2010

GLOBAL CLUSTERS OF CREUTZFELDT JAKOB DISEASE - A REVIEW 2010

http://creutzfeldt-jakob-disease.blogspot.com/2010/07/global-clusters-of-creutzfeldt-jakob.html

TSS

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

2008-05-19T09:03:00.000-07:00

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

snip...

‘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

snip...

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

snip...

‘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.

snip...

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.

snip..

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

snip...

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.

snip...

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://collections.europarchive.org/tna/20080102111737/http://www.bseinquiry.gov.uk/pdf/volume8/chapter5.pdf

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

http://collections.europarchive.org/tna/20080102141416/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://web.archive.org/web/20030331213802/http://www.bseinquiry.gov.uk/files/yb/1995/10/23006001.pdf

cover-up of 4th farm worker ???

http://web.archive.org/web/20030516083454/http://www.bseinquiry.gov.uk/files/yb/1995/10/23006001.pdf

http://web.archive.org/web/20030330175323/http://www.bseinquiry.gov.uk/files/yb/1995/10/20006001.pdf

CONFIRMATION OF CJD IN FOURTH FARMER

http://collections.europarchive.org/tna/20080102203608/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://web.archive.org/web/20030728074919/http://www.bseinquiry.gov.uk/files/yb/1995/11/13010001.pdf

4th farmer, and 1st teenager

http://collections.europarchive.org/tna/20080102235004/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://web.archive.org/web/20030516181226/http://www.bseinquiry.gov.uk/files/yb/1995/01/31004001.pdf

CJD FARMERS WIFE 1989

http://collections.europarchive.org/tna/20080103005651/http://www.bseinquiry.gov.uk/files/yb/1989/10/13007001.pdf

http://collections.europarchive.org/tna/20080102155149/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://web.archive.org/web/20030330212925/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

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

2008-05-18T18:02:00.000-07:00

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

2. We have identified one problem over where we are unable to act and this is the use of gonadotrophins in embryo transfer work. Some veterinary surgeons are quite legally using this exemption from the Medicines Act contained in Section 9(2) to prepare gonadotrophins from pituitary glands from various species, including cattle. These hormones are used to stimulate superovulation in donor cows.

http://collections.europarchive.org/tna/20080102164806/http://www.bseinquiry.gov.uk/files/yb/1988/06/10001001.pdf

http://collections.europarchive.org/tna/20080102164811/http://www.bseinquiry.gov.uk/files/yb/1988/06/13010001.pdf

http://collections.europarchive.org/tna/20080103031215/http://www.bseinquiry.gov.uk/files/yb/1988/06/14006001.pdf

COMMERCIAL IN CONFIDENCE

3.2 Minute 5.3 - 5.4 Bovine Spongiform Encephalopathy

It was reported that some replies had been received from Companies using pituitary glands in their products. Copies of the BSE document had also been sent to DHSS and NIBSC.

and then another 3 + pages of blank space. ...TSS

http://collections.europarchive.org/tna/20080102164813/http://www.bseinquiry.gov.uk/files/yb/1988/09/06005001.pdf

COMMERCIAL IN CONFIDENCE

BSE - CURRENT POSITION WITH VETERINARY LICENCED PRODUCTS (MA.1968)

There are three areas of particular concern, vaccines (including emergency vaccines), pharmaceuticals which are covered by MA licences and unlicenses hormonal products produced under exemptions claimed under (Section 9(2) Medicines Act).

1) Vaccines

http://collections.europarchive.org/tna/20080103033809/http://www.bseinquiry.gov.uk/files/yb/1988/10/06005001.pdf

NOT FOR PUBLICATION

another 6 pages of blank space. ...TSS

http://collections.europarchive.org/tna/20080103032658/http://www.bseinquiry.gov.uk/files/yb/1988/11/01012001.pdf

http://collections.europarchive.org/tna/20080103032631/http://www.bseinquiry.gov.uk/files/yb/1988/11/04003001.pdf

http://collections.europarchive.org/tna/20080103033926/http://www.bseinquiry.gov.uk/files/yb/1988/04/00007001.pdf

COMMERCIAL IN CONFIDENCE

http://collections.europarchive.org/tna/20080103034137/http://www.bseinquiry.gov.uk/files/yb/1988/07/00007001.pdf

COMMERCIAL IN CONFIDENCE

Medicines Act - Veterinary Products Committee

http://collections.europarchive.org/tna/20080103034140/http://www.bseinquiry.gov.uk/files/yb/1988/09/00004001.pdf

COMMERCIAL IN CONFIDENCE

http://collections.europarchive.org/tna/20080102164744/http://www.bseinquiry.gov.uk/files/yb/1988/10/00003001.pdf

MANAGEMENT IN CONFIDENCE

CERTIFIED BSE-FREE HERDS FOR SOURCE OF MATERIAL FOR BIOLOGICAL PRODUCTS

http://collections.europarchive.org/tna/20080102184729/http://www.bseinquiry.gov.uk/files/yb/1989/01/04001001.pdf

COMMERCIAL IN CONFIDENCE

NOT FOR PUBLICATION

http://collections.europarchive.org/tna/20080102185137/http://www.bseinquiry.gov.uk/files/yb/1989/01/26007001.pdf

http://web.archive.org/web/20030515185220/http://www.bseinquiry.gov.uk/files/yb/1989/01/30001001.pdf

COMMERCIAL IN CONFIDENCE

NOT FOR PUBLICATION

http://web.archive.org/web/20030704202503/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://collections.europarchive.org/tna/20090114045856/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://web.archive.org/web/20030526124448/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)

CONCERN ABOUT BSE IN HUMAN MEDICINE

http://collections.europarchive.org/tna/20080103002832/http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf

http://collections.europarchive.org/tna/20081105201818/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://collections.europarchive.org/tna/20080102164725/http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf

http://collections.europarchive.org/tna/20090505223756/http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf

COMMERCIAL IN CONFIDENCE

http://collections.europarchive.org/tna/20080102164736/http://www.bseinquiry.gov.uk/files/yb/1988/06/07010001.pdf

TWA LITTLE STATEMENT 331

http://collections.europarchive.org/tna/20080102163939/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://collections.europarchive.org/tna/20080103032631/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).

CONFIDENTIAL

http://collections.europarchive.org/tna/20080102164642/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

http://bseinquiry.blogspot.com/2008/05/bse-inquiry-draft-factual-account-dfa.html

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.

COMMERCIAL IN CONFIDENCE

NOT FOR PUBLICATION

http://web.archive.org/web/20030704202503/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).

CONFIDENTIAL

http://collections.europarchive.org/tna/20080102164642/http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf

CONFIDENTIAL

http://collections.europarchive.org/tna/20080103002544/http://www.bseinquiry.gov.uk/files/yb/1989/02/14011001.pdf

more on the 1968 medicine act, they forgot to follow

http://web.archive.org/web/20030526124448/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://collections.europarchive.org/tna/20080103002832/http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf

http://collections.europarchive.org/tna/20080102155758/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://collections.europarchive.org/tna/20080102132706/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

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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)

2008-05-18T17:21:00.000-07:00

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

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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)

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

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)

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

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)

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

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=" p="R15856&X=" 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)

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

Hello Terry and Everyone,

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

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

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)

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

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)

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

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)

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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)

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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

https://lists.aegee.org/cgi-bin/wa?A2=ind0110&L=BSE-L&P=R12236&X=4F0C9B3D9F1736BD9D&Y=flounder9%40verizon.net

===================== *** 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://collections.europarchive.org/tna/20080102185118/http://www.bseinquiry.gov.uk/files/yb/1989/05/00002001.pdf

http://collections.europarchive.org/tna/20080102185203/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://collections.europarchive.org/tna/20080102185207/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://collections.europarchive.org/tna/20080102185215/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://collections.europarchive.org/tna/20090506060319/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://web.archive.org/web/20030506230546/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://collections.europarchive.org/tna/20080102140603/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://collections.europarchive.org/tna/20080103002304/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://collections.europarchive.org/tna/20080103002829/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 42:107 108 (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 (41:78 81, 2004), PrPres was not detected in striated muscle of experimentally infected elk, cattle, sheep, and raccoons by immunohistochemistry (IHC). Negative IHC, however, does not exclude the presence of PrPSc. For example, PrPres was detected in skeletal muscle in 8 of 32 humans with the prion disease, sporadic Creutzfeldt-Jakob disease (CJD), using sodium phosphotungstic acid (NaPTA) precipitation and western blot.1 The NaPTA precipitation, described by Wadsworth et al.,3 concentrates the abnormal isoform of the prion, PrPres, from a large tissue homogenate volume before western blotting. This technique has increased the sensitivity of the western blot up to three orders of magnitude and could be included in assays to detect PrPres. Extremely conspicuous deposits of PrPres in muscle were detected by IHC in a recent case report of an individual with inclusion body myositis and CJD.2 Here, PrPres was detected in the muscle by immunoblotting, IHC, and paraf- fin-embedded tissue blot. We would therefore caution that, in addition to IHC, highly sensitive biochemical assays and bioassays of muscle are needed to assess the presence or absence of prions from muscle in experimental and natural TSE cases. Christina Sigurdson, Markus Glatzel, and Adriano Aguzzi Institute of Neuropathology University Hospital of Zurich Zurich, Switzerland References 1 Glatzel M, Abela E, et al: Extraneural pathologic prion protein in sporadic Creutzfeldt-Jakob disease. N Engl J Med 349(19):1812 1820, 2003 2 Kovacs GG, Lindeck-Pozza E, et al: Creutzfeldt-Jakob disease and inclusion body myositis: abundant diseaseassociated prion protein in muscle. Ann Neurol 55(1): 121 125, 2004 3 Wadsworth JDF, Joiner S, et al: Tissue distribution of protease resistant prion protein in variant CJD using a highly sensitive immuno-blotting assay. Lancet 358:171 180, 2001tss

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://collections.europarchive.org/tna/20080103002321/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://collections.europarchive.org/tna/20080103002614/http://www.bseinquiry.gov.uk/files/yb/1989/02/24015001.pdf

http://collections.europarchive.org/tna/20080103002506/http://www.bseinquiry.gov.uk/files/yb/1989/02/24016001.pdf

http://web.archive.org/web/20030516041446/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://collections.europarchive.org/tna/20080102143408/http://www.bseinquiry.gov.uk/files/yb/1989/02/28006001.pdf

NEWSPAPER ARTICLE ABOUT BABY FOOD WARNING

http://collections.europarchive.org/tna/20080103002737/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://web.archive.org/web/20030714134945/http://www.bseinquiry.gov.uk/files/yb/1989/03/03003001.pdf

MANIPULATING AND MANAGING STATEMENTS TO THE MEDIA

http://collections.europarchive.org/tna/20080103005917/http://www.bseinquiry.gov.uk/files/yb/1989/03/03009001.pdf

http://collections.europarchive.org/tna/20080103010010/http://www.bseinquiry.gov.uk/files/yb/1989/03/09001001.pdf

IN CONFIDENCE

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://collections.europarchive.org/tna/20080103010144/http://www.bseinquiry.gov.uk/files/yb/1989/03/04001001.pdf

STILL CONCERNS OF TAIL MEAT IN BABY FOOD

http://collections.europarchive.org/tna/20080103010345/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://collections.europarchive.org/tna/20090114064151/http://www.bseinquiry.gov.uk/files/yb/1989/03/28001001.pdf

THE BABY FOOD (PROHIBITED OFFAL) REGULATIONS 1989

http://collections.europarchive.org/tna/20080102185118/http://www.bseinquiry.gov.uk/files/yb/1989/05/00002001.pdf

http://collections.europarchive.org/tna/20080102185203/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://collections.europarchive.org/tna/20090506014316/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://collections.europarchive.org/tna/20081106023518/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://collections.europarchive.org/tna/20080102143359/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://collections.europarchive.org/tna/20081105215137/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://collections.europarchive.org/tna/20081105215142/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://collections.europarchive.org/tna/20080102195408/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://collections.europarchive.org/tna/20080103005147/http://www.bseinquiry.gov.uk/files/yb/1989/05/05009001.pdf

IN CONFIDENCE

http://collections.europarchive.org/tna/20080103005355/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://collections.europarchive.org/tna/20080102200106/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

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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

P.S. check out the USDA CERTIFIED DEAD STOCK DOWNER COW SCHOOL LUNCH PROGRAM IN THE USA (biggest long term case study in the USA of children exposed to the deadly mad cow disease atypical BSE, more virulent to humans)

DEAD STOCK DOWNER COW SCHOOL LUNCH PROGRAM USDA

http://downercattle.blogspot.com/

http://downercattle.blogspot.com/2008/04/gao-report-on-humane-methods-of.html

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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