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

Posted Apr 09 2009 7:13pm
[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]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 189 and 700

[Docket No. 2004N-0081] RIN 0910-AF47

Use of Materials Derived From Cattle in Human Food and Cosmetics

AGENCY: Food and Drug Administration, HHS.

ACTION: Interim final rule and request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is amending its regulations on the use of materials derived from cattle in human food and cosmetics. In these regulations, FDA has designated certain materials from cattle as ``prohibited cattle materials'' and has banned the use of such materials in human food, including dietary supplements, and in cosmetics. Prohibited cattle materials include specified risk materials (SRMs), the small intestine of all cattle unless the distal ileum is removed, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, or mechanically separated (MS) (Beef). Specified risk materials include the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months of age and older, and the tonsils and distal ileum of the small intestine of all cattle. FDA is amending its regulations so that FDA may designate a country as not subject to certain bovine spongiform encephalopathy (BSE)-related restrictions applicable to FDA regulated human food and cosmetics. A country seeking to be so designated must send a written request to the Director of FDA's Center for Food Safety and Applied Nutrition, including information about the country's BSE case history, risk factors, measures to prevent the introduction and transmission of BSE, and any other relevant information.

DATES: This interim final rule is effective July 16, 2008. Submit written or electronic comments on this interim final rule by July 16, 2008. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by May 19, 2008 (see the ``Paperwork Reduction Act of 1995'' section of this document).

snip...

Table 1.--Top 10 Countries Exporting Specified North American Industry Classification System (NAICS) Code Products to United States for 2006 NAICS 311611\1\--Meat Products (Excluding Quantity (thousands of Poultry) kilograms)\2\ ¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤ Canada 681,899 ------------------------------------------------------------------------ Australia 376,585 ------------------------------------------------------------------------ New Zealand 211,873 ------------------------------------------------------------------------ Uruguay 103,305 ------------------------------------------------------------------------ Brazil 83,897 ------------------------------------------------------------------------ Denmark 46,652 ------------------------------------------------------------------------ Mexico 35,553 ------------------------------------------------------------------------ China 28,530 ------------------------------------------------------------------------ Argentina 22,353 ------------------------------------------------------------------------ Nicaragua 21,303 ¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤ NAIC 311613--Animal Fats, Oils, & By- (thousands of Products kilograms)\3\ ¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤ Canada 94,306 ------------------------------------------------------------------------ New Zealand 32,550 ------------------------------------------------------------------------ China 7,809 ------------------------------------------------------------------------ Australia 6,807 ------------------------------------------------------------------------ Brazil 6,589 ------------------------------------------------------------------------ Mexico 2,130 ------------------------------------------------------------------------ Colombia 1,826 ------------------------------------------------------------------------ Germany 1,642 ------------------------------------------------------------------------ Ecuador 1,149 ------------------------------------------------------------------------ Japan 1,138 ------------------------------------------------------------------------ \1\ The NAIC code 31161 covers the animal slaughtering and processing industry. The industry is composed of establishments that are primarily engaged in one or more of the following: (1) Slaughtering animals, (2) preparing processed meats and meat by-products, and (3) rendering and refining animal fat, bones, and meat scraps. The subcategory 311611 comprises those establishments primarily engaged in slaughtering animals (except poultry and small game). Establishments that slaughter and prepare meats are included in this classification. (Ref. 5) We use this data as an indicator of the countries that are most likely to petition FDA regarding their BSE status. \2\ These figures do not include exports measured in ``clean yield kilograms'' and ``pieces.'' \3\ These figures do not include exports measured in ``grams,'' ``liters,'' ``metric tons,'' and ``pieces.''

We do not know how many countries might petition the FDA. However, taking into consideration the previous information on countries officially recognized as having a negligible BSE risk or being provisionally free of BSE under OIE, as well as the information in table 1 on countries that export large amounts of meat products and animal fats, oils, and byproducts to the United States, we are estimating for this analysis that 10 countries may be interested in petitioning FDA to be excepted from certain BSE-related restrictions applicable to human food and cosmetics. Our estimate is not intended to suggest that all of these countries would be able to qualify for a designation under Sec. Sec. 189.5(e) and 700.27(e). 3. Costs and Benefits of Exemption Provision

snip...$$$

http://edocket.access.gpo.gov/2008/08-1142.htm


http://edocket.access.gpo.gov/2008/pdf/08-1142.pdf


GWs BSE MRR policy, the legal trading of all strains of TSE globally $$$ DEATH FOR PROFIT, commodities and futures i.e. trade over human health and sound science, the exporting from the USA, all strains of TSE globally. ...tss

-------- 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." To: 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

-------- Original Message -------- Subject: Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission) Date: Sun, 11 Jul 2004 21:34:22 -0500 From: "Terry S. Singeltary Sr." To: fdadockets@oc.fda.gov CC: regulations@aphis.usda.gov, burt.pritchett@fda.gov

Docket No. 04-047-l No. 04-021ANPR No. 2004N-0264 NEW BSE SAFEGUARDS Federal Measures to Mitigate BSE Risks: Considerations for Further Action http://www.fda.gov/cvm/index/updates/bseanprm.htm


Greetings FDA,

USDA and APHIS et al, I would kindly like to comment on the continued delay of the regulations that have been proposed for years to reduce the risk of BSE/TSE in the USA. Each day that is wasted debating this issue allows this agent to spread, and many many more humans and animals become needlessly exposed to this agent via a multitude of potential routes and sources right here in the USA. TO continue to ignore the new findings from several scientists about the fact that BSE is not the only strain of TSE in cattle, the fact that new atypical strains of TSE are showing up in not only cattle, but sheep and the fact that the new strain of TSE in cattle seems to be more similar to sporadic CJD as opposed to the nv/v CJD, to continue to ignore these findings will only further spread this agent. CWD and Scrapie have been running rampant in the USA for decades. BOTH of which have been rendered and fed back to animals for human/animal consumption for decades. All of which transmits to primates by the natural and non-forced oral consumption of TSE scrapie, CJD, Kuru agent (and CWD by inoculation). Strong Scientific evidence discovered back in the 80s support the fact that a TSE has been prevalent in the USA bovine for decades, either undetected or ignored. IF you consider the recent stumbling and staggering TEXAS cow that was showing all signs of a CNS/TSE disorder that was ordered to be rendered without BSE/TSE test, brains, spinal cord, head and all (as to no possible evidence left of TSE), I would think the 'ignored' or 'covered up' to be the better terminology. Then you have the Downer in Washington state that was actually a good walker and then all the banned Canadian products that some how found it's way across the border into the USA, considering all this, it is very difficult for me to believe that the FDA/USDA/APHIS et al are doing everything possible to protect the 'consumer'. Hardly the case;

Congressman Henry Waxmans Letter to the Honorable Ann Veneman

http://www.house.gov/reform/min/pdfs_108_2/pdfs_inves/pdf_food_usda_mad_cow_may_13_let.pdf


snip...

From: TSS () Subject: Re: Docket No. 2004N-0081 Use of Materials Derived From Cattle in Human Food and Cosmetics [TSS SUBMISSION] Date: September 7, 2005 at 7:35 pm PST

In Reply to: Docket No. 2004N-0081 Use of Materials Derived From Cattle in Human Food and Cosmetics posted by TSS on September 7, 2005 at 7:07 am
----- Original Message ----- From: Terry S. Singeltary Sr. To: fdadockets@oc.fda.gov Sent: Wednesday, September 07, 2005 9:44 PM Subject: Use of Materials Derived From Cattle in Human Food and Cosmetics [Docket No. 2004N-0081] RIN 0910-AF47

Greetings FDA,

I would kindly like to comment on ;

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

SUMMARY: The Food and Drug Administration (FDA) is amending the interim final rule on use of materials derived from cattle in human food and cosmetics published in the Federal Register of July 14, 2004. In the July 14, 2004, interim final rule, FDA designated certain materials from cattle, including the entire small intestine, as ``prohibited cattle materials'' and banned the use of such materials in human food, including dietary supplements, and in cosmetics. FDA is taking this action in response to comments received on the interim final rule. Information was provided in comments that persuaded the agency that the distal ileum, one of three portions of the small intestine, could be consistently and effectively removed from the small intestine, such that the remainder of the small intestine, formerly a prohibited cattle material, could be used for human food or cosmetics. We (FDA) are also clarifying that milk and milk products, hide and hide-derived products, and tallow derivatives are not prohibited cattle materials. Comments also led the agency to reconsider the method cited in the interim final rule for determining insoluble impurities in tallow and to cite instead a method that is less costly to use and requires less specialized equipment. FDA issued the interim final rule to minimize human exposure to materials that scientific studies have demonstrated are highly likely to contain the bovine spongiform encephalopathy (BSE) agent in cattle infected with the disease. FDA believes that the amended provisions of the interim final rule provide the same level of protection from human exposure to the agent that causes BSE as the original provisions. ...

I would kindly like to submit the following ;

I find it very very disturbing that FDA now takes the position;

Information was provided in comments that persuaded the agency that the distal ileum, one of three portions of the small intestine, could be consistently and effectively removed from the small intestine, such that the remainder of the small intestine, formerly a prohibited cattle material, could be used for human food or cosmetics.

<<< href="http://www.seac.gov.uk/statements/tonsil211002.pdf">http://www.seac.gov.uk/statements/tonsil211002.pdf<


UPDATE OF THE OPINION ON TSE INFECTIVITY DISTRIBUTION IN RUMINANT TISSUES INITIALLY ADOPTED BY THE SCIENTIFIC STEERING COMMITTEE AT ITS MEETING OF 10-11 JANUARY 2002 AND AMENDED AT ITS MEETING OF 7-8 NOVEMBER 2002

following the submission of (1) a risk assessment by the German Federal Ministry of Consumer Protection, food and Agriculture and (2) new scientific evidence regarding BSE infectivity distribution in tonsils

http://europa.eu.int/comm/food/fs/sc/ssc/out296_en.pdf


3. New work, work still in progress and future work The infectivity of neural and non-neural tissues by intracerebral inoculation of cattle is being assayed in projects M03006 and M03007. These studies are important since it is possible that some tissues may not yet have been found to be infective, due to the fact that infectivity in these tissues is below the detection limits of the tests applied so far. To date, this study has shown infectivity in CNS tissues, the distal ileum, tonsil tissue and the nictitating membrane (the nictitating membrane is also known as the third eyelid). Other challenged and control cattle continue to be closely monitored for clinical signs of BSE. Research is ongoing to determine the susceptibility of other food animal species to TSEs. These include a project to determine the susceptibility of pigs to scrapie through oral exposure (M03005) and a project to further study the transmission of BSE to pigs (M03010). Project M03024 aims to determine whether UK red deer are susceptible to BSE by oral exposure. These studies are important since it is highly probable that pigs and deer were historically exposed to ruminant derived meat and bone meal (MBM). ...

http://www.food.gov.uk/multimedia/pdfs/annualresearchrpt04.pdf


TSEs And The Environment

The LANCET

Volume 351, Number 9110 18 April 1998 BSE: the final resting place

snip...

The first matter to consider is the distribution of infectivity in the bodies of infected animals. The brain (and more generally, the central nervous system) is the primary target in all transmissible spongiform encephalopathies (TSE), and it contains by far the highest concentration of the infectious agent. In naturally occuring disease, infectivity may reach levels of up to about one million lethal doses per gram of brain tissue, whether the disease be kuru, CJD, scrapie, or BSE. The infectious agent in BSE-infected cattle has so far been found only in brain, spinal cord, cervical and thoracic dorsal root ganglia, trigeminal ganglia, distal ileum, and bone marrow.4 However, the much more widespread distribution of low levels of infectivity in human beings with kuru or CJD, and in sheep and goats with scrapie, suggests that caution is advisable in prematurely dismissing as harmless other tissues of BSE-infected cattle. snip...end...TSS snip... BY reducing or weakening the SRM list due to the Economic Impact of BSE on the U.S. Beef Industry and while doing so, ignoring all 'sound science', again the FDA/USDA et al are willing to put every human and animal out there at risk to further exposure to this TSE agent, all for a buck. this is not 'sound science' this is what i call 'corporate science', and it is and will continue to expose people. some of these people will die from this agent either directly or indirectly via a multitude of scientific proven routes and sources. WE must remove all political and corporate science from TSE research. I find it disturbing that products that carry SRMs are still on the market for humans such as nutritional supplements ;

ODD, I just picked up a catalog from STANDARD PROCESS INC. 2003 - 2004 Product Catalog (a chiropractor had just left this catalog in my wife's foot doctors office 4/5/05) and it's full of THOSE SRMS FOR HUMANS. I wonder how much is still left on the market, and how much is still in production, how much crosses the borders? 5 pages of products full of SRMs for humans. THIS is a really fine catalog, i am just now going over. LOADED with SRMs for humans. NO wonder my neighbors mom died from CJD while taking these damn mad cow pills. THEY even have a candy bars loaded with SRMs.

HERE is one ;

NATURAL COCOA STANDARDBAR (mad cow candy bar) (i will just list animal organs) bovine adrenal, bovine liver, bovine spleen, ovine spleen, bovine kidney...

NATURAL PEANUT BUTTER STANDARDBAR bovine adrenal, bovine liver, bovine spleen, ovine spleen, bovine kidney...

USF (MAD COW) OINTMENT (RUB A DUB DUB, KURU ETC) ; bovine orhic glandular extract UTROPHIN PMG bovine uterus PMG VASCULIN bovine heart PMG extract, veal bone PMG extract, bovine liever, porcine duodenum, bovine adrenal Cytosol extract, bovine spleen, ovine spleen (some yummy stuff)

IPLEX (neighbors mom died from CJD while taking these pills for years) bovine eye PMG extract, veal bone PMG, bovine liver, porcine stomach, bovine adrenal, bovine kidney, bovine adrenal Cytosol extract, BOVINE BRAIN, bovine bone, veal bone meal MYO-PLUS bovine heart PMG, bovine liver, porcine stomach, bovine orchic extract, bovine spleen, ovine spleen, bovine adrenal Cytosol extract,

BOVINE BRAIN NEUROPLEX bovine orchic Cytosol extract, bovine spleen, BOVINE BRAIN PMG EXTRACT, BOVINE ANTERIOR PITUITARY, bovine liver, BOVINE PITUITARY PMG EXTRACT, AND MORE BOVINE BRAIN...

HOLY MAD COW IN A PILL !!! NEUROTROPHIN PMG BOVINE BRAIN PMG NIACINAMIDE B6 VM bovine liver, porcine stomach, bovine spleen ovine spleen, BOVINE BRAIN OCULOTROPHIN PMG BOVINE EYE PMG ORCHEX bovine liver, bovine orchic Cytosol extract, porcine stomch, bovine spleen, ovine spleen, BOVINE BRAIN OSTARPLEX veal bone PMG extract, veal bone PMG extract, bovine liver, porcine stomach, bovine adrenal, bovine spleen, ovine spleen, BOVINE BRAIN PARAPLEX bovine pancreas PMG extract, porcine duodenum, bovine adrenal PMG, BOVINE PITUITARY PMG EXTRACT, bovine thyroid PMG extract PITUITROPHIN PMG RUMAPLEX BOVINE BRAIN, veal bone PMG extract, bovine adrenal, bovine prostate Cytosol extract, veal bone meal, bovine liver PMG extract, bovine spleen, ovine spleen, bovine liver SENAPLEX bovine liver PMG extract, bovine adrenal, BOVNE BRAIN, veal bone meal, bovine kidney, bovine orchic extract, bovine spleen, ovine spleen ..........

THESE are just a few of MANY of just this ONE COMPANY.

Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients a Comment Number: EC -2 Accepted - Volume 7 253 1

DR. BOLTON: I have an additional question about 2 that. What is the assurance that additional locally sourced 3 tracheas are not added into that manufacturing process, thus 4 boosting the yield, if you will, but being returned to the 5 U.S. as being produced from U.S.-sourced raw material? 6 DR. McCURDY: Are there data to indicate how many 7 grams, or whatever, of infected brain are likely to infect 8 an organism, either animal or man, when taken orally? 9 DR. BROWN: If I am not mistaken, and I can be 10 corrected, I think a half a gram is enough in a cow, orally; 11 in other words, one good dietary-supplement pill. 12 DR. McCURDY: What I am driving at is the question 13 we are asked is really not do we wish to regulate these 14 things coming in. I think the statements about difficulties 15 in regulating things in the future or near future for new 16 regulations were probably accurate. 17 But I think that we could exhibit some quite 18 reasonable concern about blood donors who are taking dietary 19 supplements that contain a certain amount of unspecified- 20 origin brain, brain-related, brain and pituitary material. 21 If they have done this for more than a sniff or something 22 like that, then, perhaps, they should be deferred as blood 23 donors. 24 That is probably worse than spending six months in 25 the U.K. 254 1 DR. BROWN: That is exactly right. I think that 2 is why the discussion has apparently been on things that are 3 not directly related to these questions because, in order to 4 think about deferrals for blood donors who are taking 5 dietary supplements with things like bovine brain in them, 6 it is very important that we know that those products are 7 safe. 8 I think we have heard enough to suggest that they 9 may not be. 10 DR. McCURDY: There is one other item that needs 11 to be considered and that is what proportion of blood donors 12 are doing this; that is, how many blood donors would you 13 lose, and I don't know what the demographics--there is 14 fairly good information on the demography of blood donors. 15 I have no idea what the demography of people who take these 16 supplements is. Maybe they are old men like me and aren't 17 going to be blood donors anymore. 18 DR. BROWN: The wording of the question is not as 19 demanding as the wording of other deferral questions; that 20 is, the question here is consider recommending. We are 21 not even recommending at this point. We are saying to the 22 FDA, please think about this. It is worth thinking about. 23 DR. DETWILER: One point about brain from Europe, 24 and Jean Philippe is still here, those are considered 25 specified risk material and it is not correct to be 255 1 incinerated; correct? Or destroyed? Brain and spinal cord 2 and other high-risk tissues in Europe? 3 DR. NORTON: In tomorrow morning's British Medical 4 Journal, which has appeared on-line today, there is an 5 article called U.S. Takes Precautions against BSE. One 6 paragraph says, Even though the U.S. and U.K. governments 7 ban the practice of feeding cattle products to cows, in the 8 early 1990s, some U.K. renderers continued to manufacture 9 and ship contaminated meat and bonemeal around the world. 10 British export statistics show that thirty-seven tons of 11 meal made from offal was sent to the United States in 1997, 12 well after the U.S. government banned imports of such risky 13 meat. The ultimate use of these imports has not been 14 identified. 15 That will appear tomorrow morning. 16 DR. DETWILER: That actually was in The New York 17 Times. That is a direct quote out of The New York Times 18 article. We called the reporter on that. That statement, 19 the thirty-seven tons, was taken out of the U.S. 20 Geographical BSE Risk Assessment. What they didn't put in 21 there, in the statement, was the remainder of the GBR is at 22 that time, the big labeling for that category in the U.K., 23 because it was illegal for them to ship it to us from their 24 own regs. It is illegal for us to get that. 25 We did go and try and trace that so that wasn't

[FULL TEXT ABOUT 600 PAGES] 3681t2.rtf

http://www.fda.gov/ohrms/dockets/ac/cber01.htm


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


IN fact, we are now finding that as little as 1 mg (or 0.001 gm) caused 7% (1 of 14) of the cows to come down with BSE ; Published online January 27, 2005 Risk of oral infection with bovine spongiform encephalopathy agent in primates Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog, Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe Deslys The uncertain extent of human exposure to bovine spongiform encephalopathy (BSE)—which can lead to variant Creutzfeldt-Jakob disease (vCJD)—is compounded by incomplete knowledge about the ef.ciency of oral infection and the magnitude of any bovine-to-human biological barrier to transmission. We therefore investigated oral transmission of BSE to non-human primates. We gave two macaques a 5 g oral dose of brain homogenate from a BSE-infected cow. One macaque developed vCJD-like neurological disease 60 months after exposure, whereas the other remained free of disease at 76 months. On the basis of these .ndings and data from other studies, we made a preliminary estimate of the food exposure risk for man, which provides additional assurance that existing public health measures can prevent transmission of BSE to man. snip...

BSE bovine brain inoculum 100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg Primate (oral route)* 1/2 (50%) Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%) 1/15 (7%) RIII mice (icip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%) PrPres biochemical detection

The comparison is made on the basis of calibration of the bovine inoculum used in our study with primates against a bovine brain inoculum with a similar PrPres concentration that was inoculated into mice and cattle.8 *Data are number of animals positive/number of animals surviving at the time of clinical onset of disease in the .rst positive animal (%). The accuracy of bioassays is generally judged to be about plus or minus 1 log. icip=intracerebral and intraperitoneal. Table 1: Comparison of transmission rates in primates and cattle infected orally with similar BSE brain inocula snip...end www.thelancet.com Published online January 27, 2005 THEN you must consider cross contamination at feed mills and such. this has been well proven in both the UK and the USA to date via r-to-r feed ban violations. IT was proven in the UK that they indeed put profits before human health; [PDF]

The BSE Inquiry / Statement No. 14 Issued 20 March 1998 THE ...

The BSE Inquiry / Statement No. 14. Issued 20 March 1998 ...

number of feed compounders and it became clear that cross contamination of feeds could occur. ...

http://www.bseinquiry.gov.uk/files/ws/s014.pdf


[PDF] The BSE Inquiry / Statement No 76F (Supplementary) Mr Alan ... But the mainbut the main problem was probably cross-contamination. ...

http://www.bseinquiry.gov.uk/files/ws/s076f.pdf


STRICTLY PRIVATE AND CONFIDENTIAL 25, AUGUST 1995

snip...

To minimise the risk of farmers' claims for compensation from feed compounders. To minimise the potential damage to compound feed markets through adverse publicity. To maximise freedom of action for feed compounders, notably by maintaining the availability of meat and bone meal as a raw material in animal feeds, and ensuring time is available to make any changes which may be required.

snip...

THE FUTURE 4..........

MAFF remains under pressure in Brussels and is not skilled at handling potentially explosive issues. 5. Tests _may_ show that ruminant feeds have been sold which contain illegal traces of ruminant protein. More likely, a few positive test results will turn up but proof that a particular feed mill knowingly supplied it to a particular farm will be difficult if not impossible. 6. The threat remains real and it will be some years before feed compounders are free of it. The longer we can avoid any direct linkage between feed milling _practices_ and actual BSE cases, the more likely it is that serious damage can be avoided. ...

SEE full text ;

http://www.bseinquiry.gov.uk/files/yb/1995/08/24002001.pdf


snip...

From: TSS Subject: Inspector to file charges against USDA for them charging him with misconduct on telling the truth about SRM mad cow violations Date: September 7, 2005 at 1:37 pm PST

Consumer Health Inspector to file charges against USDA

By Steve Mitchell Sep 6, 2005, 22:46 GMT WASHINGTON, DC, United States (UPI) --

The federal meat inspector who was charged with misconduct by the U.S. Department of Agriculture after he claimed mad cow disease safeguards were being violated at slaughterhouses told United Press International he plans to file charges against the agency. Stan Painter, a USDA inspector and chair of the National Joint Council of Food Inspection Locals, the inspectors union, notified the agency`s management in a letter last December he was aware of instances where the riskiest parts of older cows were not being marked or removed from processing. Painter worried these risky parts -- known as specified risk materials, or SRMs -- could enter the food supply and infect people, causing a fatal brain illness called variant Creutzfeldt Jakob disease. Two cases of mad cow have been detected in U.S. herds, and some suspect there are more. The USDA put the SRM safeguards in place in 2004 to protect the public from mad cow disease -- also known as bovine spongiform encephalopathy or BSE -- if more cases are detected. The USDA did not respond to Painter`s concerns until he made his letter known to news outlets. On Dec. 28, 2004, the agency charged Painter with personal misconduct for not revealing the names of the inspectors who told him of the SRM violations. Officials also told him he was under a formal investigation, which was dropped last month after the release of internal documents revealing more than 1,000 violations of the USDA`s SRM regulations. Painter said he thinks the USDA was attempting 'to harass and intimidate him (and) to have a chilling effect' on other inspectors. 'I plan to file charges against the agency,' he told UPI, adding he has not yet decided if he will go through the legal system, through internal USDA procedures or another avenue. Asked about Painter`s intent to bring charges, agency spokesman Steven Cohen told UPI the documents -- called noncompliance reports, or NRs -- demonstrate 'that BSE safeguard regulations are being enforced and prohibited materials did not reach the public.' Mad cow disease remains a sensitive topic for the USDA because it can have significant economic ramifications. The U.S. beef industry lost billions of dollars because more than 60 nations closed their borders in 2003 to American beef after the report of the first detected case in U.S. herds. Japan, formerly the largest importer of American beef, still has not reopened its borders. For months, USDA officials denied Painter`s allegations in media reports, saying they had investigated and found no evidence to substantiate his claims. The NRs released last month under the Freedom of Information Act, however, showed 1,036 violations of SRM regulations in at least 35 states, Puerto Rico and the Virgin Islands, with some plants being cited repeatedly for infractions. The USDA delayed releasing the documents for eight months despite a federal law mandating a response within 30 days. Patty Lovera, of the watchdog group Public Citizen, which requested the USDA documents, said some of the violations cited in the NRs are egregious. In one, an employee at a plant in Michigan was not properly marking older cows to have their SRMs removed because he did not have a pencil. In another, an employee in a Missouri plant was loading cow heads onto his pickup truck to take home to feed to his dog. Lovera charged the USDA with attempting to silence Painter and failing to address problems with the SRM ban. 'Their behavior through this whole thing is appalling,' she told UPI. 'Stan brought them concerns about a policy and instead of investigating the policy, they investigated him.' Last December, after Painter made his letter known publicly, the USDA sent an officer to Painter`s house while he was on leave to question him about the allegations in his letter. Later, USDA officials interrogated Painter twice, asking him for the names of the inspectors who told him about the violations. Painter said he intentionally was kept ignorant of the inspectors` names because he feared the agency would retaliate against them. Painter also said USDA officials did ot need the inspectors` names because they could determine where the infractions were occurring by looking at their database of NRs. Sometime around June the U.S. Embassy in Japan posted a notice on its Web site stating USDA officials had found no evidence to substantiate Painter`s claims and had requested a criminal investigation into his actions. The notice was removed in July after UPI reported its existence. Although Cohen acknowledged more than 1,000 NRs were written by USDA inspectors, he minimized their significance, saying they 'amount to less than one-half of one percent of the total written for all reasons by (USDA) inspection program personnel.' Lovera said any infraction of mad cow safeguards should be of concern, because this disease always is fatal in humans and cooking does not destroy the pathogen. 'You have very little margin of error for something you don`t want to get because you can`t cook it away and you can`t disinfect it,' she said. Painter said his concern now is what the agency will do to fix what he sees as shortcomings in the SRM policy. 'It`s a failed policy,' he said. 'It doesn`t protect the consumer.' Cohen did not respond to whether the USDA planned to change the SRM regulations. The USDA`s Office of Inspector General has launched an investigation to determine whether the regulations are being implemented effectively, and results are due out soon.

E-mail: sciencemail@upi.com Copyright 2005 by United Press International

http://washingtontimes.com/upi/20050906-050340-6793r.htm


*** makes no difference, GW will change the SRM rules like he has the BSE GBR risk assessment to the terribly flawed BSE MRR policy, the legal trading of all strains of TSE, the 'gold card'. ...TSS

IN a time when FDA/USDA et al should be strengthening the TSE regulations, it seems corporate interest has won out again over sound science and consumer protection from an agent that is 100% fatal for the ones that go clinical. With the many different atypical TSEs showing up in different parts of the world, and with GWs BSE MRR policy (the legal policy of trading all strains of TSEs), the battle that has waged for the last 25 years to eradicate this agent from this planet will be set back decades, if not lost for good. ...TSS

snip...

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


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


http://www.fda.gov/ohrms/DOCKETS/dockets/04n0081/04n-0081-ref0001-Tab-A-vol6.pdf


APHIS-2006-0041-0006 TSE advisory committee for the meeting December 15, 2006

http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8


Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE)

http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf


[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirement for the Disposition of Non-Ambulatory Disabled Cattle 9/13/2005

http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf


BSE; MRR; IMPORTATION OF LIVE BOVINES AND PRODUCTS DERIVED FROM BOVINES [Docket No. APHIS-2006-0041] RIN 0579-AC01 [Federal Register: January 9, 2007 (Volume 72, Number 5)] [Proposed Rules] [Page 1101-1129] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr09ja07-21]

http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064801f8152


BSE; MRR; IMPORTATION OF LIVE BOVINES AND PRODUCTS DERIVED FROM BOVINES [Docket No. APHIS-2006-0041] RIN 0579-AC01 Date: January 9, 2007 at 9:08 am PST

http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064801f3412


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


SCHOOL LUNCH PROGRAM FROM DOWNER CATTLE UPDATE

http://downercattle.blogspot.com/


SRM MAD COW RECALL 406 THOUSAND POUNDS CATTLE HEADS WITH TONSILS KANSAS

http://cjdmadcowbaseoct2007.blogspot.com/2008/04/srm-mad-cow-recall-406-thousand-pounds.html


SPECIFIED RISK MATERIALS

http://madcowspontaneousnot.blogspot.com/2008/02/specified-risk-materials-srm.html


CJD USA

*Acquired in UK ** Acquired in Saudi Arabia *** Includes 17 inconclusive and 9 pending (1 from 2006, 8 from 2007. **** 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). Notes: -- Cases are listed based on the year of death when available. If the year of death is not available, the year of sample receipt is used. -- Referrals: Cases with possible or probable prion disease from which brain tissue or blood in the case of familial disease were submitted. -- Inconclusive: Cases in which the samples were not sufficient to make a diagnosis. -- Non-vCJD type unknown are cases in which the tissue submitted was adequate to establish the presence but not the type; in all cases, vCJD could be excluded. -- Communicated by: Terry S. Singeltary Sr.

[In submitting these data, Terry S. Singeltary Sr. draws attention to the steady increase in the "type unknown" category, which, according to their definition, comprises cases in which vCJD could be excluded. The total of 26 cases for the current year (2007) is disturbing, possibly symptomatic of the circulation of novel agents. Characterization of these agents should be given a high priority. - Mod.CP]

http://www.promedmail.org/pls/askus/f?p=2400:1001:6833194127530602005::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1010,39963


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


ALL animals for human/animal consumption must be tested for TSE.

ALL human TSEs must be made reportable Nationally and Internationally, OF ALL AGES. ...TSS

Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518
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