Thursday, March 19, 2009

Chronic Wasting Disease Prions in Elk Antler Velvet (Nutritional Supplements and CJD)

10.3201/eid1505.081458 Suggested citation for this article: Angers RC, Seward TS, Napier D, Green M, Hoover E, Spraker T, et al. Chronic wasting disease prions in elk antler velvet. Emerg Infect Dis. 2009 May; [Epub ahead of print]

Chronic Wasting Disease Prions in Elk Antler Velvet

Rachel C. Angers,1 Tanya S. Seward, Dana Napier, Michael Green, Edward Hoover, Terry Spraker, Katherine O’Rourke, Aru Balachandran, and Glenn C. Telling Author affiliations: University of Kentucky Medical Center, Lexington, Kentucky, USA (R.C. Angers, T.S. Seward, D. Napier, M. Green, G.C. Telling); Colorado State University, Fort Collins, Colorado, USA (E. Hoover, T. Spraker); US Department of Agriculture, Pullman, Washington, USA (K. O’Rourke); and Canadian Food Inspection Agency, Ottawa, Ontario, Canada (A. Balachandran) 1Current affiliation: MRC Laboratory of Molecular Biology, Cambridge, UK.

Chronic wasting disease (CWD) is a contagious, fatal prion disease of deer and elk that continues to emerge in new locations. To explore the means by which prions are transmitted with high efficiency among cervids, we examined prion infectivity in the apical skin layer covering the growing antler (antler velvet) by using CWD-susceptible transgenic mice and protein misfolding cyclic amplification. Our finding of prions in antler velvet of CWD-affected elk suggests that this tissue may play a role in disease transmission among cervids. Humans who consume antler velvet as a nutritional supplement are at risk for exposure to prions. The fact that CWD prion incubation times in transgenic mice expressing elk prion protein are consistently more rapid raises the possibility that residue 226, the sole primary structural difference between deer and elk prion protein, may be a major determinant of CWD pathogenesis.

snip...

Discussion

The transmission of CWD prions in antler velvet from 2 naturally affected elk to mice in 2 Tg models demonstrates that this tissue contains low, but detectable, amounts of CWD prions. In addition, serial PMCA amplified otherwise undetectable levels of PrPSc in antler velvet. We characterized CWD prion infectivity by end-point titration. The .6 log i.c.ID50/g CWD prion titer estimated by this method contrasts with .9 log i.c.ID50/g titers of mouse-adapted scrapie prions in rodent brains (9) and .7.7.7 log i.c.ID50/g titers of BSE prions estimated by bioassay in transgenic mice (10,11). The linear relationship between dose and incubation time (12) provides an opportunity to estimate the level of prions in materials containing an unknown amount of infectivity. The attack rates of <100%>30 months (28). Prion strain properties are also critical when considering the potential for interspecies transmission. The existence of multiple CWD strains has been suggested by several studies (4,25,29,30), but strain isolation and host range characterization have not been reported. Finally, it is worth considering that if CWD were to cross the species barrier into humans, this transmission source might not be recognized if the disease profile overlapped with one of the forms of sporadic CJD reported in North America.

Possible Role for Residue 226 in CWD Pathogenesis

Previous studies that demonstrated more rapid CWD prion incubation times in Tg mice expressing elk PrP (24,29) than in Tg(CerPrP)1536+/. mice (4) raised the possibility that the single amino acid difference at residue 226 between elk and deer PrP (5) may influence CWD pathogenesis (29). However, when the transmission characteristics of CWD isolates were directly compared in Tg mice expressing differing levels of deer or elk PrP, Tamguney et al.

Page 8 of 17

concluded that CWD incubation times were related solely to the level of PrP transgene expression (25). We compared CWD transmission in Tg(CerPrP-E226)5037+/. and Tg(CerPrP)1536+/. mice, which express PrP at levels .5-fold higher than PrP in wild type mouse brain (Figure 1A), and found that CWD transmission was consistently and substantially more rapid in Tg(CerPrP-E226)5037+/. mice. Our results appear compatible with more efficient CWD prion propagation by elk cellular prion protein (CerPrPC) containing E at residue 226 than by deer CerPrPC containing Q at this position. Consistent with this interpretation, despite 5-fold lower levels of transgene expression in Tg(CerPrP-E226)5029+/. than in Tg(CerPrP)1536+/. mice, mean incubation times of the D92 isolate were equivalent in these 2 lines (Table). Nonetheless, undetected differences in CerPrPC expression, for example in particular cell types, might result in more rapid disease and/or altered pathologic changes. The generation of transgenic mice expressing elk and deer coding sequences using gene replacement strategies would seem to be an excellent approach for resolving this issue. The different responses to CWD in Tg mice also appear to recapitulate aspects of CWD pathogenesis in the natural hosts. Previous limited comparative transmission studies indicated that CWD developed .25% more rapidly in orally challenged elk than deer (31). Although plaques were not detected in brains of CWD-affected elk, florid plaques have been observed in the brains of diseased deer (32,33). Similar differences in pathologic changes were observed in Tg(CerPrP-E226)5037+/. and Tg(CerPrP)1536+/. mice (Figure 4). Structural analyses suggest that residue 226 is located within a region of PrPC proposed to interact with a factor (34), possibly equivalent to the postulated protein X (35). Although mutation of the equivalent residue from Q to lysine (K) in epitope-tagged mouse PrP had no effect on PrPSc formation in transfected chronically infected ScN2A cells, the effects of the Q-to-E substitution were not assessed (36).

Acknowledgments We thank Dongyue Zhuang for excellent technical assistance. This work was supported by grants 2RO1NS040334-04 from the National Institute



http://www.cdc.gov/eid/content/15/5/pdfs/08-1458.pdf



old news. ...



http://www.mad-cow.org/00/dec00_late_news.html#hhh



http://www.mad-cow.org/00/jan01_late.html#ggg



http://www.organicconsumers.org/meat/elkvelvet.cfm



Terry S. Singeltary Sr. [flounder@wt.net] ... CJDIBSE (aka madcow) Human/Animal TSE’s--U.S.--Submission .... such as 'nutritional supplements' containing various extracts ... US cattle/sheep/cervids. ("antler velvet" extracts!) should be forbidden ... suggest that CWD transmissions to humans would be as limited ...



http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf



Volume 361, Number 9368 03 May 2003

Correspondence

Tighter regulation needed for dietary supplements in USA

Sir--Mary Palmer and colleagues (Jan 11, p 101)1 found that dietary supplements have the potential to cause serious adverse effects. The investigators state that research on the hazards and risks ofdietarysupplements should be a priority. The safety of individuals who consume these products is important, and organisations such as the US Food and Drug Administration (FDA) need to take initiative by enforcing stricter regulations on supplements. Several commonly used products--for example ginkgo biloba, St John's Wort, and ephedrine--can have serious adverse effects.2 Although the FDA requires multiple studies on the safety and efficacy for pharmaceutical products before placing them on the market, standards are less robust for dietary supplements. In the USA, under the Dietary Supplement Health and Education Act (DSHEA) of 1994, supplements are subject to the same regulatory requirements as food. There are no provisions that require FDA approval for the safety or effectiveness of supplements,3 which leaves consumers and manufacturers essentially responsible for the health effects of these products. The DSHEA of 1994 needs to be revised so that dietary supplements are subject to the same regulations as pharmacological drugs. The FDA needs to review clinical studies on the safety and efficacy of dietary supplements. Organisations such as Public Citizen and the American Medical Association are already taking steps to achieve these changes. However, they face immense opposition from groups such as the National Nutritional Foods Association, the American Herbal Association, and the Council for Responsible Nutrition. To overcome such resistance, consumer organisations, health-care providers, and government agencies need to approach this subject in unison. The public needs to be able to assess the risks and benefits of dietary supplements before consuming them. Health-care providers and the more than 100 million Americans who consume these products4 should encourage the FDA to treat supplements with the stringent regulations it enforces on pharmaceutical products.

Nipa Kinariwala ------------------------------------------------------------------------ 700 Bolinwood Drive, Apartment 12A, Chapel Hill, NC 27514, USA 1 Palmer ME, Haller C, McKinney PE, et al. Adverse events associated with dietary supplements: an observational study. Lancet 2003; 361: 101-06. [Text <http://www.thelancet.com/journal/vol361/iss9368/full/llan.361.9352.original_research.23936.1>] 2 Cupp MJ. Herbal remedies: adverse effects and drug interactions. Am Fam Physician 1999; 59: 1239-45. [PubMed <http://www.ncbi.nlm.nih.gov/htbin-post/PubMed/wgetcit?journal=Am+Fam+Physician+&volume=59&year=1999&page=1239&display=abstract>] 3 Unites States Food and Drug Administration. Overview of dietary supplements. Jan 3, 2001. http://www.cfsan.fda.gov/~dms/ds-oview.html <http://www.cfsan.fda.gov/%7Edms/ds-oview.html%20>(accessed Feb 20, 2002). 4 Pear R. Feds call for tighter control over nutritional supplements. Organic Consumers Association, April 17, 2001. http://www.organicconsumers.org/Organic/dietsupp.cfm <http://www.organicconsumers.org/Organic/dietsupp.cfm%20>(accessed Feb 20, 2002). http://www.thelancet.com/journals/lancet/article/PIIS0140673603132072/fulltext

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TSEs i.e. mad cow disease's BSE/BASE and NUTRITIONAL SUPPLEMENTS

IPLEX, mad by standard process;

vacuum dried bovine BRAIN, bone meal, bovine EYE, veal Bone, bovine liver powder, bovine adrenal, vacuum dried bovine kidney, and vacuum dried porcine stomach.

also;

i will only list animal ingredients of the following Nutritional Supplements by only ONE company;

Standard Process Co.

IPLEX; bovine EYE PMG Extract, veal bone PMG Extract, bovine liver powder, vaccuum dried porcine stomach, vacuum dried bovine adrenal, vacuum dried bovine kidney, bovine adrenal, vacuum dried BOVINE BRAIN, bone meal, vacuum dried veal bone.

A-FBetafood R vacuum dried bovine prostate, bovine liver powder, vacuum dried bovine kidney, bovine orchic glandular extract, bovine liver fat extract.

Arginex R bovine liver powder.

Adrenal, Desiccated TM Vacuum dried bovine adrenal.

Albaplex R bovine liver PMG Extract, vacuum dried bovine adrenal, bovine kidney PMF Extract, bovine thymus Cytosol Extract, bovine liver powder, bone meal, vacuum dried bovine kidney, veal bone meal.

Allerplex TM bovine lung PMF Extract, bovine adrenal PMF Extract, bovine liver fat extract (yakriton), bone meal, vacuum dried bovine kidney, vacuum dried veal bone.

Immuplex R Bovine liver PMG Extract, bovine liver powder, veal bone PMF Extract, bovine spleen PMF Extract, vacuum dried bovine and ovine spleen, bovine thymus PMF Extract, bovine thymus Cytosol Extract.

Vasculin R Bovine Heart PMG Extract, veal bone PMF Extract, bovine liver powder, vacuum dried porcine duodenum, bovine adrenal Cytosol Extract, vacuum dried bovine and ovine spleen.

Zypan R bovine pancreas Cytosol Extract, vacuum dried bovine and ovine spleen.

last i heard, they were getting sued;

Suit Filed Over Mad Cow Disclaimer

By Jason Hoppin The Recorder March 23, 2001

A small San Francisco litigation firm has teamed up with Milberg, Weiss, Bershad, Hynes & Lerach to sue a health supplements manufacturer, alleging the company misrepresents the danger of acquiring mad cow disease through its products.

The suit, filed under California's unfair business practices statute, alleges that Wisconsin's Standard Process Inc. uses, in part, crackpot science to allay customers' fears about the transmission of bovine spongiform encephalopathy, also known as mad cow disease.

"Standard Process either knowingly or recklessly has omitted a material fact by failing to inform consumers that the overwhelming majority of reputable scientists and physicians have concluded that mad-cow disease is transmitted to humans by prions in bovine meat and/or bovine organs," Bushnell, Caplan & Fielding's Alan Caplan wrote.

The complaint points to a statement by the company about the safety of its products which suggests that pesticides may be to blame for mad cow outbreaks, not the consumption of meat.

"It's probably loosely referred to as research," deadpanned Jan Novakofski, a University of Illinois researcher who studies thedisease. "The evidence for that kind of concept [versus the consumption theory] is about an ounce to a pound."

No cases of mad cow have ever been reported in the United States, and the plaintiff in the case, James Gorman, does not suffer from the disease. Instead, he is seeking damages for misrepresentation, fraud, unfair advertising and unfair business practices.

The case was filed in San Francisco Superior Court.

The product, a vitamin supplement called Iplex 5100, is sold through licensed health professionals, including acupuncturists, nutritionists and the like.

Iplex 5100 is made in part, with cow parts: eyes, kidneys, livers, bonesand brains, where BSE is most highly concentrated.

Standard Process did not return a phone call seeking comment, but the company's Web site says it purchases bovine products only from U.S.government-inspected facilities.

"Standard Process has never used any glandular substances or bovine tissue derivatives from animals in any BSE-infected country," the company states.

The human manifestation of BSE -- variant Creutzfeld-Jakob disease --has killed more than 80 people in Great Britain, and new outbreaks have recently been reported in several European countries.

U.S. officials have worried that dietary supplements may provide an entry point for the disease, which has been detected here in animals other than cows.

"The health food industry is totally unregulated," Novakofski said. "You go to the health food store and no one's ever tested anything."

However, Standard Process says its Wisconsin production facility is regulated by the U.S. Food and Drug Administration, and that its cow products are certified by the government.

© 2001 law.com Inc. ======================= Supplements Association Moves to Eliminate Bovine Parts From Products

WASHINGTON (Reuters Health) Mar 16 - The nation's largest dietary supplements industry group has issued new guidance to manufacturers amid concerns that some alternative health products containing bovine materials pose a risk of transmitting bovine spongiform encephalopathy (BSE) to humans.

The guidance, published by the National Nutritional Foods Association (NNFA), encourages manufacturers to eliminate all neurological bovine materials from their products. Consumption of brains and spinal cords from cows infected with BSE are widely believed to be the source of new variant Creutzfeldt-Jakob disease (vCJD) in humans........

snip... full text at;

http://id.medscape.com/

Letter to Manufacturers of Biological Products - Recommendations Regarding Bovine Spongiform Encephalopathy (BSE)

Department of Health and Human Services Public Health Service Food and Drug Administration 1401 Rockville Pike Rockville, MD 20852-1448

April 19, 2000

To Manufacturers of Biological Products

The Food and Drug Administration (FDA) has issued letters (date May 3, 1991, December 17, 1993, and May 9, 1996) and a guidance document (September 1997) requesting that materials derived from ruminants which have resided in or originated from countries where Bovine Spongiform Encephalopathy (BSE) has been diagnosed not be used in the manufacture of FDA-regulated products intended for administration to humans. The United States Department of Agriculture (USDA) also issued an interim rule on January 6, 1998, restricting the importation of ruminants, meat and meat products from ruminants, and certain ruminant products and byproducts from all countries of Europe. Because of the serious nature of this issue, the Center for Biologics Evaluation and Research (CBER) believes it critical to update the current recommendations.

CBER strongly recommends that manufacturers take whatever steps are necessary to assure that materials derived from all species of ruminant animals born, raised or slaughtered in countries where BSE is known to exist, or countries where the USDA has been unable to assure FDA that BSE does not exist, are not used in the manufacture of FDA-regulated products intended for administration to humans. The Agency has previously recommended that manufacturers take the following steps to prevent this occurrence:

1.Identify all ruminant-derived materials (e.g., culture medium, transferrin, albumin, enzymes, lipids) used in the manufacture of regulated products. FDA considers the manufacture of biological products to include the preparation of master (including the original cell line) and working cell banks, as well as materials used in fermentation, harvesting, purification and formulation of the products.

2.Document the country of origin and all countries where the live animal source has resided for each ruminant-derived material used in the manufacture of the regulated product. The regulated-product manufacturer should obtain this information from the supplier of the ruminant-derived product. The regulated-product manufacturer should also obtain the appropriate veterinary regulatory inspection certification of slaughter, as required by the country of origin of live animals, from the supplier. Documentation should be maintained for any new or in-process lots of licensed, cleared or approved products; products pending clearance or approval; and investigational products intended to be administered to humans.

3.Maintain traceable records for each lot of ruminant material and each lot of FDA-regulated product manufactured using these materials. These records should be part of the product batch records and available for FDA inspection. Such records should be maintained for products manufactured at foreign as well as domestic facilities.

It is the responsibility of the manufacturer to obtain up-to-date information regarding countries where BSE is known to exist, or countries where the USDA has been unable to assure FDA that BSE does not exist. This information is available from the USDA's Animal and Plant Health Inspection Service (APHIS) at telephonenumber 301-734-8364, website addresshttp://www.aphis.usda.gov/ncie, and codified at 9 CFR 94.18 (see attached).

Specific product-related questions should be directed to the appropriate application division within CBER's product offices. The phone numbers are:

Dr. David Asher, Office of Blood Research and Review 301-827-3524 Dr. Paul Richman, Office of Vaccines Research and Review 301-827-3070 James Crim, Office of Therapeutics Research and Review 301-827-5101

Thank you for your attention to this matter.

Sincerely,

Kathryn C. Zoon, Ph.D. Director Center for Biologics Evaluation And Research

Attachment



http://www.fda.gov/cber/ltr/bse041900.htm



better late than never, but leaving regulation up to the industry, will be like telling the wolf to guard the hen house. allowing that to happen with some pathogens is one thing, but we better think twice about human/animal TSE's. This same letter has been around for ten years with nobody taking heed to the potential dangers...TSS

How serious is this bit of deregulation? Here's what Dr. Lurie told the Senators:"For BSE (mad cow disease), this means that an unscrupulous manufacturer could literally take a British cow brain, crush it, dry it out, formulate it into a dietary supplement and export it to the U.S."



http://commerce.senate.gov/hearings/0404lur.PDF



another fine example;

snip...

In fact, the salesman now tells us he doesn't sell the machines anymore. But the quest for youth goes beyond facial creams and exotic contraptions, anti-agers are also ingesting some pretty wild-sounding dietary supplements. "Live proteins from sheep and pig from France, processed," says a representative.

Life-Cell Technologies touts the benefits of supplements that contain processed pig and sheep organs. "I have a lot of body builders and professional athletes that use these products because they strengthen and stimulate the different glands and organs,"says one woman. The idea, she implied, often is that ingesting ground up animal organs will strengthen human organs or even cure thyroid and adrenal diseases. "To my knowledge you can't just take pulverzied organs and feed them to somebody and think they're not going to have thyroid disease anymore or hypo-adrenalism," says Dr. Wexler. It would be kind of a medical miracle, wouldn't it? "It would be amazing, truly amazing," says Dr. Wexler. "Dateline" attended another anti-aging conference and expo in Chicago -- this time with ourcameras in plain view. Remember the exhibitor selling processed pig and sheep organs? We pressed her for scientific documentation. We asked, what is the science behind the idea? The woman tells us, "You would have to go on the Internet and get information, scientific studies."But this is her company, isn't it? "Yes it is," she says. "And if you don't mind, I don't want to be interviewed. I don't.""Dateline" tells her, "They are simple questions that any consumer would ask." Everywhere "Dateline" went at the anti-aging expo we heard a lot about so-called "scientific studies." "Well, it comes from 3,000 studies," a man at the expo tells us.

At one booth the product is called transfer factor, and theactive ingredient is colostrum -- the potent pre-milk fluid in a lactating mother's breast.

"We actually filtrate the transfer factor out of the colostrum," says one man. From where, mothers? "No," the man tells us. "From bovine colostrum, from cows."

http://www.msnbc.com/news/550100.asp?cp1=1 (url now dead...tss)

AS you can see below, i was trying to warn the public of this potential and highly likely route of TSE via nutritional supplements years before the above people were. THESE folks have PhDs, so maybe someone will listen now, maybe not $$$

Could you get mad cow from a pill ? Some doctors say a class of pills that promise smarts, energy, and sexual vitality may cause mad-cow disease. The government isn't worried. Should you be?

June 1, 2001 Health Magazine by Susan Freinkel



http://www.organicconsumers.org/madcow/pill6101.cfm



http://www.islandveg.com/publications/newsletters/01fall.pdf



GERMAN DER SPIEGEL MAGAZINE

Die BSE-Angst erreicht Amerika: Trotz strikter Auflagen gelangte in Texas verbotenes Tiermehl ins Rinderfutter - die Kontrollen der Aufsichtsbehörden sind lax.



http://www.spiegel.de/spiegel/0,1518,119306,00.html



MAD COW DISEASE AND NUTRITIONAL SUPPLEMENTS...

Subj: cjd/bse aka MADCOW DISEASE in the U.S.A., please let me count the ways...

Date: 31/07/00 17:51:30 GMT Daylight Time

SOMETHING TO CHEW ON



http://www.bmj.com/cgi/eletters/319/7220/1312/b#EL2



In reading the recent article in the BMJ about the potential BSE tests being developed in the U.S. and Bart Van Everbroeck reply. It does not surprize me, that the U.S. has been concealing vCJD. There have been people dying from CJD, with all the symptoms and pathological findings that resemble U.K. vCJD for some time. It just seems that when there is one found, they seem to change the clerical classification of the disease, to fit their agenda. I have several autopsies, stating kuru type amyloid plaques, one of the victims was 41 years of age. Also, my Mom died a most hideous death, Heidenhain Variant Creutzfeldt Jakob disease. Her symptoms resemble that of all the U.K. vCJD victims. She would jerk so bad at times, it would take 3 of us to hold her down, while she screamed "God, what's wrong with me, why can't I stop this." 1st of symptoms to death, 10 weeks, she went blind in the first few weeks. But, then they told me that this was just another strain of sporadic CJD. They can call it what ever they want, but I know what I saw, and what she went through.

Sporadic, simply means, they do not know. My neighbors Mom also died from CJD. She had been taking a nutritional supplement which contained the following; vacuum dried bovine BRAIN, bone meal, bovine EYE, veal bone, bovine liver powder, bovine adrenal, vacuum dried bovine kidney, and vacuum dried porcine stomach. As I said, this woman taking these nutritional supplements, died from CJD. The particular batch of pills that was located, in which she was taking, was tested. From what I have heard, they came up negative, for the prion protein. But, in the same breath, they said their testing, may not have been strong enough to pick up the infectivity. Plus, she had been taking these type pills for years, so, could it have come from another batch?

snip...end



http://www.freedomtocare.org/page142.htm



Evidence Of CJD/BSE Transmission Via Supplements From Terry S. Singeltary Sr. mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000096/!x-usc:mailto:flounder@wt.net 1-26-3



http://www.rense.com/general34/evidenBSE.htm



Scrapie (Mad Sheep Disease) May Pose a Risk to Humans From New Scientist magazine (UK) Online News March 28, 2001

Suspect symptoms

What if you can catch old-fashioned CJD by eating meat from a sheep infected with scrapie?

Exclusive from New Scientist magazine



http://www.organicconsumers.org/meat/scrapiecjd.cfm



Singeltary suspected an environmental cause in his mother's demise, a feeling reinforced a year later when a neighbor died of sporadic CJD. For years, the neighbor had been taking nutritional supp- lements that contained cow brain extracts.

"The FDA needs to review clinical studies on the safety and efficacy of dietary supplements. Organisations such as Public Citizen and the American Medical Assoc- iation are already taking steps to achieve these changes.

"However, they face immense opposition from groups such as the National Nutritional Foods Association, the American Herbal Association, and the Council for Responsible Nutrition.

"To overcome such resistance, consumer organisations, health-care providers, and government agencies need to approach this subject in unison. The public needs to be able to assess the risks and benefits of dietary supp- lements before consuming them.

Health-care providers and the more than 100 million Americans who consume these products should encourage the FDA to treat supplements with the stringent regulations it enforces on pharmaceutical products."

Animal ingredients of Nutritional Supplements by only ONE company;

Standard Process Co.

IPLEX;

bovine EYE PMG Extract, veal bone PMG Extract, bovine liver powder, vaccuum dried porcine stomach, vacuum dried bovine adrenal, vacuum dried bovine kidney, bovine adrenal, vacuum dried BOVINE BRAIN, bone meal,vacuum dried veal bone.

A-FBetafood R

vacuum dried bovine prostate, bovine liver powder, vacuum dried bovine kidney, bovine orchic glandular extract, bovine liver fat extract.

Arginex R

bovine liver powder, Adrenal, Desiccated TM, Vacuum dried bovine adrenal.

Albaplex R

bovine liver PMG Extract, vacuum dried bovine adrenal, bovine kidney

PMF Extract, bovine thymus Cytosol Extract, bovine liver powder, bone meal, vacuum dried bovine kidney, veal bone meal.

Allerplex TM

bovine lung PMF Extract, bovine adrenal PMF Extract, bovine liver fat extract (yakriton), bone meal, vacuum dried bovine kidney, vacuum dried veal bone.

Immuplex R

Bovine liver PMG Extract, bovine liver powder, veal bone PMF Extract, bovine spleen PMF Extract, vacuum dried bovine and ovine spleen, bovine thymus PMF Extract, bovine thymus Cytosol Extract.

Vasculin R

Bovine Heart PMG Extract, veal bone PMF Extract, bovine liver powder, vacuum dried porcine duodenum, bovine adrenal Cytosol Extract, vacuum dried bovine and ovine spleen.

WASHINGTON (Reuters Health) Mar 16 2001 - The nation's largest dietary supplements industry group has issued new guidance to manufacturers amid concerns that some alternative health products containing bovine mate- rials pose a risk of transmitting bovine spongiform encephalopathy (BSE) to humans.

The guidance, published by the National Nutritional Foods Association (NNFA), encourages manufacturers to eliminate all neuro- logical bovinematerials from their products. Consumption of brains and spinal cords from cows infected with BSE are widely believed to be the source of new variant Creutzfeldt-Jakob disease (vCJD) in humans.

We hope that the above data informs, but not overwhelms, the reader. For the technically literate there are numerous articles and links available via. www.google.com (http://www.google.com) searching for mad cow disease. If you have any questions for

Terry Singeltary write or e-mail mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000096/!x-usc:mailto:theleaguecitynews@aol.com and we will forward them to him.



http://www.organicconsumers.org/madcow/supplements11004.cfm



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

snip...

what did Paul Brown say about this previously;

i bring your attention to (page 500) Dr. Paul Brown statements;

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; [FULL TEXT ABOUT 600 PAGES] 3681t2.rtf



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



snip...



http://www.fda.gov/OHRMS/DOCKETS/DOCKETS/96n0417/96N-0417-EC-2.htm



Unregulated "foods" such as 'nutritional supplements' containing various extracts from ruminants, whether imported or derived from 3 US cattle/sheep/cervids ("antler velvet" extracts!) should be forbidden or at least very seriously regulated.

(neighbors Mom, whom also died from CJD, had been taking bovine based supplement, which contained brain, eye, and many other bovine/ovine tissues for years, 'IPLEX').



http://www.fda.gov/OHRMS/DOCKETS/AC/01/slides/3681s2_09.pdf



my plight with metabolife and there 'bovine complex' about risk factors of TSE in there product ;

Terry S. Singeltary Sr. wrote:

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

1. Dietary Supplements: Review of Health-Related Call Records for Users of Metabolife 356. GAO-03-494, March 31.



http://www.gao.gov/cgi-bin/getrpt?GAO-03-494


http://www.gao.gov/highlights/d03494high.pdf



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

Subject: METABOLIFE AND TSEs GAO-03-494 ''URGENT DATA'' Date: Thu, 01 May 2003 11:23:01 -0500 From: "Terry S. Singeltary Sr." To: NelliganJ at gao.gov

The General Accounting Office (GAO) today released the following reports and testimonies:

REPORTS

1. Dietary Supplements: Review of Health-Related Call Records for Users of Metabolife 356. GAO-03-494, March 31.



http://www.gao.gov/cgi-bin/getrpt?GAO-03-494


http://www.gao.gov/highlights/d03494high.pdf



GREETINGS GAO:

i was suprised that i did not see any listing of bovine tissue in metabolife on it's label. have they ceased using these desiccated tissues???

i see that the lable on this product METABOLIFE 356, does not state that it has any tissues of desiccated bovine organs? i no the product use to, so i am curious if they have ceased the use of the tissues of cattle they _use_ to use (see below)???

METABOLIFE 356 BOVINE COMPLEX/GLANDULAR SYSTEM OVARIES, PROSTATE, SCROTUM AND ADRENAL USDA SOURCE CATTLE

i tried warning them years ago of this potential threat of CJD/TSEs;

From: Randy Smith To: "'flounder at wt.net'" Subject: Metabolife Date: Mon, 7 Dec 1998 14:21:35 -0800

Dear Sir,

We are looking at reformulation. I agree that slow virus diseases present a problem in some areas of the world.

Our product uses healthy USDA inspected cattle for the glandular extract.

If you have any links to more information on this subject I would like to examine them.

Thank you for your interest and concern,

Dr. Smith ============

From: Randy Smith
To: "'flounder at wt.net'"
Subject: RE: [Fwd: Your submission to the Inquiry]
Date: Wed, 9 Dec 1998 10:37:07 -0800

Terry,

Thank you for your note and the information links you forwarded to me. I am new to Metabolife International, however hopefully as my role here enlarges I well have a greater impact on formulation and product development.

Metabolife International does believe in placing safety first. And I am going to do my best to see that we continue to do so.

Sincerely, Dr. Smith ============

-----Original Message-----
From: Terry S. Singeltary Sr. [mailto:flounder at wt.net]
Sent: Wednesday, December 09, 1998 5:49 PM
To: rsmith at metabolife.com Subject: [Fwd: Your submission to the Inquiry]

Dr. Smith,

I am truly impressed with you honesty, THANKS.....I am not just spouting off about the potential dangers, here. THEY ARE REAL.....I have forwarded an e-mail from the BSE Inquiry, in which I made a statement about them........You might want to go to the site and read through it........IT WILL TAKE A WHILE........ THINGS ARE HAPPENING HERE SIR, THAT YOU ARE NOT AWARE OF, AND AS MOST PEOPLE ARE NOT...............I JUST HOPE, THAT THE REFORMULATION YOU SPEAK OF, IS IN FACT GOING TO TAKE PLACE. The Department of Health, here in the U.S., is also worried about the potential dangers involved hear............Terry/MADSON

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

From: Randy Smith To: "'flounder at wt.net'" Subject: RE: [Fwd: MEDICINES "GREATER BSE RISK THAN BEEF"!!!!] Date: Fri, 18 Dec 1998 09:55:17 -0800 Return-Receipt-To: Randy Smith

Thanks very much for the info. I appreciate all these articles I can get. It does sound very familiar - just follow the green ($) trail.

-----Original Message----- From: Terry S. Singeltary Sr. [mailto:flounder at wt.net] Sent: Friday, December 18, 1998 5:15 PM To: rsmith at metabolife.com Subject: [Fwd: MEDICINES "GREATER BSE RISK THAN BEEF"!!!!]

Randy, thought you might be interested in this...............MADSON!!!!!1

snip... ===============================

Sender: "Patricia Cantos"
To: "Terry S Singeltary Sr. (E-mail)"
Subject: Your submission to the Inquiry Date: Fri, 3 Jul 1998 10:10:05 +0100

3 July 1998 Mr Terry S Singeltary Sr. E-Mail: Flounder at wt.net Ref: E2979

Dear Mr Singeltary,

Thank you for your E-mail message of the 30th of June 1998 providing the Inquiry with your further comments. Thank you for offering to provide the Inquiry with any test results on the nutritional supplements your mother was taking before she died.

As requested I am sending you our general Information Pack and a copy of the Chairman's letter. Please contact me if your system cannot read the attachments.

Regarding your question, the Inquiry is looking into many aspects of the scientific evidence on BSE and nvCJD. I would refer you to the transcripts of evidence we have already heard which are found on our internet site at http://www.bse.org.uk. Could you please provide the Inquiry with a copy of the press article you refer to in your e-mail? If not an approximate date for the article so that we can locate it? In the meantime, thank you for you comments. Please do not hesitate to contact me on 0171 261 8332 should you have any queries.

Yours sincerely Patricia Cantos Families Team Leader Attachments TSS

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

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

Subject: re: METABOLIFE AND TSEs GAO-03-494 ''URGENT DATA'' Date: Thu, 01 May 2003 16:04:35 -0400 From: "Marcia G Crosse" To: CC: "Charles W Davenport" , "Carolyn Feis Korman" , "Martin Gahart"

Mr. Singletary,

We were informed by representatives of Metabolife, Inc. that Metabolife 356 was reformulated to remove bovine complex as an ingredient in the product, approximately September 2001. We did not independently verify the contents of the product.

Sincerely, Marcia Crosse Acting Director Health CarePublic Health and Science Issues U.S. General Accounting Office 441 G Street, N.W. Washington, D.C. 20548

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

-------- Original Message -------- Subject: Re: METABOLIFE AND TSEs GAO-03-494 ''URGENT DATA'' Date: Thu, 01 May 2003 15:48:52 -0500 From: "Terry S. Singeltary Sr." To: Marcia G Crosse CC: Charles W Davenport , Carolyn Feis Korman , Martin Gahart References:

THANK YOU!

MIRACLES DO HAPPEN! ;-)

now all we need to do is;

snip......

one small step for man, one giant leap for mankind ;-)

however;

''We did not independently verify the contents of the product''

???

TSS

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

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

Subject: DOCKET-- 03D-0186 -- FDA Issues Draft Guidance on Use of Material From Deer and Elk in Animal Feed; Availability Date: Fri, 16 May 2003 11:47:37 -0500 From: "Terry S. Singeltary Sr." <mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000096/!x-usc:mailto:flounder@wt.net> To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000096/!x-usc:mailto:fdadockets@oc.fda.gov

Greetings FDA,

i would kindly like to comment on; Docket 03D-0186FDA Issues Draft Guidance on Use of Material From Deer and Elk in Animal Feed; Availability Several factors on this apparent voluntary proposal disturbs me greatly, please allow me to point them out;

snip...

Oral transmission and early lymphoid tropism of chronic wasting diseasePrPres in mule deer fawns (Odocoileus hemionus ) These results indicate that CWD PrP res can be detected in lymphoid tissues draining the alimentary tract within a few weeks after oral exposure to infectious prions and may reflect the initial pathway of CWD infection in deer. The rapid infection of deer fawns following exposure by the most plausible natural route is consistent with the efficient horizontal transmission of CWD in nature and enables accelerated studies of transmission and pathogenesis in the native species.

snip...



http://vir.sgmjournals.org/cgi/content/full/80/10/2757



now, just what is in that deer feed? _ANIMAL PROTEIN_

Subject: MAD DEER/ELK DISEASE AND POTENTIAL SOURCES

Date: Sat, 25 May 2002 18:41:46 -0700 From: "Terry S. Singeltary Sr." Reply-To: BSE-LTo: BSE-L

8420-20.5% Antler DeveloperFor Deer and Game in the wildGuaranteed Analysis Ingredients / Products Feeding Directions

snip...

_animal protein_



http://www.surefed.com/deer.htm



snip...

DEPARTMENT OF HEALTH & HUMAN SERVICESPUBLIC HEALTH SERVICEFOOD AND DRUG ADMINISTRATIONApril 9, 2001 WARNING LETTER01-PHI-12CERTIFIED MAILRETURN RECEIPT REQUESTED

Brian J. Raymond, Owner Sandy Lake Mills 26 Mill Street P.O. Box 117 Sandy Lake, PA 16145

PHILADELPHIA DISTRICT

Tel: 215-597-4390

Dear Mr. Raymond:Food and Drug Administration Investigator Gregory E. Beichner conducted an inspection of your animal feed manufacturing operation, located in Sandy Lake, Pennsylvania, on March 23,2001, and determined that your firm manufactures animal feeds including feeds containing prohibited materials. The inspection found significant deviations from the requirements set forth in Title 21, code of Federal Regulations, part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE) . Such deviations cause products being manufactured at this facility to be misbranded within the meaning of Section 403(f), of the Federal Food, Drug, and Cosmetic Act (the Act).Our investigation found failure to label your swine feed with the required cautionary statement "Do Not Feed to cattleor other Ruminants" The FDA suggests that the statement be distinguished by different type-size or color or other means of highlighting the statement so that it is easily noticed by a purchaser.

In addition, we note that you are using approximately 140 pounds of cracked corn to flush your mixer used in the manufacture of animal feeds containing prohibited material. This flushed material is fed to wild game including deer, a ruminant animal.Feed material which may potentially contain prohibited material should not be fed to ruminant animals which may become part of the food chain.The above is not intended to be an all-inclusive list of deviations fromthe regulations. As a manufacturer of materials intended for animalfeed use, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance withthe law. We have enclosed a copy of FDA's Small Entity Compliance Guideto assist you with complying with the regulation... blah, blah, blah...



http://www.fda.gov/foi/warning_letters/g1115d.pdf



snip...end...full text ;

2003D-0186 Guidance for Industry: Use of Material From Deer and Elk In Animal Feed

EMC 1 Terry S. Singeltary Sr. Vol #: 1



http://www.fda.gov/ohrms/dockets/dailys/03/Jun03/060903/060903.htm



http://www.fda.gov/ohrms/dockets/dailys/01/Oct01/101501/101501.htm



see my full text submission here ;



http://madcowfeed.blogspot.com/2008/07/docket-03d-0186-fda-issues-draft.html



Saturday, January 24, 2009

Research Project: Detection of TSE Agents in Livestock, Wildlife, Agricultural Products, and the Environment Location: 2008 Annual Report



http://bse-atypical.blogspot.com/2009/01/research-project-detection-of-tse.html



Friday, November 30, 2007

CJD QUESTIONNAIRE USA CWRU AND CJD FOUNDATION

snip...

*** NOTE ***

please include venison/sheep/lamb and the bovine to any of the above questions.

example=brain tanning deer/elk hide or any other topics that pertain to transmission of TSEs

_________________________________________________

example=antler velvet nutritional supplements

_________________________________________________

_any_ nutritional supplements??? name/ingredients

_________________________________________________

snip...



http://cjdquestionnaire.blogspot.com/



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



http://cjdquestionnaire.blogspot.com/




Subject: Regulation of Dietary Supplements (or the lack of) and TSE aka Transmissible Spongiform Encephalopathy i.e. CJD 2006
Date: March 22, 2006 at 2:21 pm PST

Greetings,

THOUGHT i might go and see what kinda of mad cow goodies still on the market for consumption for humans via the potential route from NUTRITIONAL SUPPLEMENTS, and what no better one to start with than Standard Process Co. i see gw's bse mrr policy mentality has seeped over into the food and cosmetics i.e. nutritional supplements with the ;

U. S. Food and Drug Administration Center for Food Safety and Applied Nutrition November 14, 2000

Letter to Reiterate Certain Public Health and Safety Concerns to Firms Manufacturing or Importing Dietary Supplements that Contain Specific Bovine Tissues To: Manufacturers and Importers of Dietary Supplements and Dietary Supplement Ingredients:

The Food and Drug Administration (FDA) is taking this opportunity to reiterate certain public health and safety concerns to firms manufacturing or importing dietary supplements that contain specific bovine tissues. The safety concerns about bovine-derived dietary supplement ingredients, including extracts or substances derived from such tissues, are a result of the fact that bovine-derived ingredients from cattle born, raised, or slaughtered in certain countries present a risk of transmitting the infectious agent that causes bovine spongiform encephalopathy (BSE) to humans consuming such products. FDA strongly recommends that firms should consider the public health consequences of this disease in taking whatever steps are necessary to assure themselves and the public that such ingredients do not come from cattle born, raised, or slaughtered in countries where BSE exists.

Background

BSE is a transmissible neurologic disorder of cattle and is prevalent in certain parts of the world. This neurological disease is one of a number of transmissible spongiform encephalopathies (TSE) known and is similar to other TSEs such as scrapie in sheep and Creutzfeldt-Jakob disease (CJD) in humans. It is believed that the spread of BSE in cattle in some countries, particularly Great Britain, was caused by the feeding of infected cattle and sheep tissues to cattle. While transmission of the causative agent of BSE to humans has not been definitively documented to date, inter-species transfer has been demonstrated (e.g., mice can be infected by exposure to infected bovine tissues). BSE has never been diagnosed in cattle in the United States. However, although steps have been taken to control the spread of BSE in cattle, new cases of BSE continue to be identified in certain European countries. This fact illustrates that serious public health risks associated with the consumption of animal-derived ingredients from animals sourced from BSE-positive countries remain because such tissues may contain the causative agent of BSE.

Recommendations

Although there is still no definitive evidence that the consumption of bovine tissues that contain the transmissible agent for BSE cause CJD in humans, FDA is concerned that appropriate measures to eliminate the use of bovine tissues from BSE-countries be instituted by firms that use bovine-derived ingredients in their products. The list of countries where BSE is known to exist is maintained by the U.S. Department of Agriculture (USDA) and codified in Title 9, Code of Federal Regulations, Part 94.18. Currently, the list of countries in which BSE is know to exist includes Great Britain, France, The Netherlands, Portugal, Luxembourg, Ireland, Switzerland, Oman, and Belgium.

We strongly recommend that firms manufacturing or importing dietary supplements which contain specific bovine tissues (see enclosure), including extracts or substances derived from such tissues, take all steps necessary to assure themselves and the public that such ingredients do not come from cattle born, raised, or slaughtered in countries where BSE exists. FDA believes that any firm using BSE-derived ingredients should take immediate and continued actions to minimize the potential risk of human exposure to the infectious agent that causes BSE in cattle.

We appreciate your attention to and cooperation in this matter. If you need more information or have questions, please contact the Director, Division of Compliance and Enforcement (HFS-810), Office of Nutritional Products, Labeling, and Dietary Supplements, 200 C St., SW, Washington, DC 20204 (telephone 202-205-5229) or your local FDA District Office.

Sincerely, Christine J. Lewis, Ph.D. Director Office of Nutritional Products, Labeling, and Dietary Supplements Center for Food Safety and Applied Nutrition

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

Enclosure List of Tissues with Suspected Infectivity(1)

Category I (High infectivity)

brain spinal cord Category II (Medium infectivity)

ileum lymph nodes proximal colon spleen tonsil dura mater pineal gland placenta cerebrospinal fluid pituitary gland adrenal gland Category III (Low infectivity)

distal colon nasal mucosa sciatic nerve bone marrow liver lung pancreas thymus gland List taken from Report of a WHO Consultation on Public Health Issues Related to Animal and Human Spongiform Encephalopathies, World Health Organization, Office of Interantional Epizootics, Geneva, Switzerland, November 12-14, 1991.

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

The absence of a specific tissue, organ, or gland from this list does not mean that such tissue, organ, or gland cannot contain the infectious agent responsible for BSE. It only means that there was not adequate information available at the time to assign the tissue, organ, or gland to a specific category.

[[ I BELIEVE THE SENTENCE DIRECTLY ABOVE WAS ADDED IN WAY AFTER THIS LETTER WAS WRITTEN...TSS]]



http://www.cfsan.fda.gov/~dms/dspltr05.html



Letter to Manufacturers of Biological Products Recommendations Regarding Bovine Spongiform Encephalopathy (BSE)

Department of Health and Human Services Public Health Service Food and Drug Administration 1401 Rockville Pike Rockville, MD 20852-1448

April 19, 2000

To Manufacturers of Biological Products

The Food and Drug Administration (FDA) has issued letters (date May 3, 1991, December 17, 1993, and May 9, 1996) and a guidance document (September 1997) requesting that materials derived from ruminants which have resided in or originated from countries where Bovine Spongiform Encephalopathy (BSE) has been diagnosed not be used in the manufacture of FDA-regulated products intended for administration to humans. The United States Department of Agriculture (USDA) also issued an interim rule on January 6, 1998, restricting the importation of ruminants, meat and meat products from ruminants, and certain ruminant products and byproducts from all countries of Europe. Because of the serious nature of this issue, the Center for Biologics Evaluation and Research (CBER) believes it critical to update the current recommendations.

CBER strongly recommends that manufacturers take whatever steps are necessary to assure that materials derived from all species of ruminant animals born, raised or slaughtered in countries where BSE is known to exist, or countries where the USDA has been unable to assure FDA that BSE does not exist, are not used in the manufacture of FDA-regulated products intended for administration to humans. The Agency has previously recommended that manufacturers take the following steps to prevent this occurrence:

Identify all ruminant-derived materials (e.g., culture medium, transferrin, albumin, enzymes, lipids) used in the manufacture of regulated products. FDA considers the manufacture of biological products to include the preparation of master (including the original cell line) and working cell banks, as well as materials used in fermentation, harvesting, purification and formulation of the products.

Document the country of origin and all countries where the live animal source has resided for each ruminant-derived material used in the manufacture of the regulated product. The regulated-product manufacturer should obtain this information from the supplier of the ruminant-derived product. The regulated-product manufacturer should also obtain the appropriate veterinary regulatory inspection certification of slaughter, as required by the country of origin of live animals, from the supplier. Documentation should be maintained for any new or in-process lots of licensed, cleared or approved products; products pending clearance or approval; and investigational products intended to be administered to humans.

Maintain traceable records for each lot of ruminant material and each lot of FDA-regulated product manufactured using these materials. These records should be part of the product batch records and available for FDA inspection. Such records should be maintained for products manufactured at foreign as well as domestic facilities. It is the responsibility of the manufacturer to obtain up-to-date information regarding countries where BSE is known to exist, or countries where the USDA has been unable to assure FDA that BSE does not exist. This information is available from the USDA's Animal and Plant Health Inspection Service (APHIS) at telephone number 301-734-8364, website address http://www.aphis.usda.gov/oa/bse/, and codified at 9 CFR 94.18 (see attached).

Specific product-related questions should be directed to the appropriate application division within CBER's product offices. The phone numbers are:

Dr. David Asher, 301-827-3524 Office of Blood Research and Review

Dr. Paul Richman, 301-827-3070 Office of Vaccines Research and Review

James Crim, 301-827-5101 Office of Therapeutics Research and Review

Thank you for your attention to this matter.

Sincerely,

--- signature --- Kathryn C. Zoon, Ph.D. Director Center for Biologics Evaluation And Research

Attachment

Updated May 13, 2002



http://www.fda.gov/cber/ltr/bse041900.htm



Letter to Manufacturers of Biological Products Recommendations Regarding Bovine Spongiform Encephalopathy (BSE)

§94.18 Restrictions on Importation of Meat and Edible Products From Ruminants Due To Bovine Spongiform Encephalopathy

Bovine spongiform encephalopathy exists in the following regions: Belgium, France, the Republic of Ireland, Liechtenstein, Luxembourg, Oman, The Netherlands, Portugal, Switzerland, and the United Kingdom.

The following regions, because of import requirements less restrictive than those that would be acceptable for import into the United States and/or because of inadequate surveillance, present an undue risk of introducing bovine spongiform encephalopathy into the United States: Albania, Austria, Bosnia-Herzegovina, Bulgaria, Croatia, the Czech Republic, Denmark, the Federal Republic of Yugoslavia, Finland, Germany, Greece, Hungary, Italy, the Former Yugoslav Republic of Macedonia, Norway, Poland, Romania, the Slovak Republic, Slovenia, Spain, and Sweden.

A region may request at any time that the Administrator consider its removal from a list set forth in paragraphs (a)(1) or (a)(2) of this section by following the procedures set forth in §§92.2(b) (1) through (4), 92.2(b) (5) through (11), and 92.2(c) of this chapter.

Except as provided in paragraph (d) of this section, the importation of fresh, frozen, and chilled meat, meat products, and edible products other than meat (excluding gelatin, milk and milk products), from ruminants that have been in any of the countries listed in paragraph (a) of this section is prohibited.

Gelatin. The importation of gelatin derived from ruminants that have been in any region listed in paragraph (a) of this section is prohibited unless the following conditions have been met:

The gelatin must be imported for use in human food, human pharmaceutical products, photography, or some other use that will not result in the gelatin coming in contact with reminants in the United States.

The person importing the gelatin must obtain a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors by filing a permit application on VS form 16-3.17

The permit application must state the intended use of the gelatin and the name and address of the consignee in the United States.

Transit shipment of articles. Fresh (chilled or frozen) meat, and edible products other than meat, that are prohibited importation into the United States in accordance with this section may transit the United States for immediate export if the following conditions are met:

The person moving the articles must obtain a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors by filing a permit application on VS form 16-3.18

The articles must be sealed in leakproof containers bearing serial numbers during transit. Each container must remain sealed during the entire time that it is in the United States.

The person moving the articles shall notify, in writing, the Plant Protection and Quarantine Officer at both the place in the United States where the articles will arrive and the port of export prior to such transit. The notification must include the:

United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors permit number;

Times and dates of arrival in the United States;

Times and dates of exportation from the United States;

Mode of transportation; and

Serial numbers of the sealed containers.

The articles must transit the United States in Customs bond.

(Approved by the Office of Management and Budget under control number 0579-0015)

[56 FR 63868, Dec. 6, 1991, as amended at 58 FR 65104, Dec. 13, 1993; 59 FR 24638, May 12, 1994; 59 FR 67616, Dec. 30, 1994; 62 FR 18264, Apr. 15, 1997; 62 FR 46181, Sept. 2, 1997; 62 FR 56023, Oct. 28, 1997; 62 FR 61434, Nov. 18, 1997; 62 FR 66000, Dec. 17, 1997; 63 FR 408, Jan. 6, 1998; 63 FR 4347, Jan. 28, 1998; 63 FR 71210, Dec. 24, 1998; 64 FR 38550, July 19, 1999]

17 & 18 VS form 16-3 may be obtained from the Animal and Plant Health Inspection Service, Veterinary Services, National Center for Import-Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231.

Updated May 13, 2002



http://www.fda.gov/cber/ltr/bseattach.htm



Subject: FDA Amends Interim Final Rule "Use of Materials Derived from Cattle in Human Date: September 6, 2005 at 8:54 am PST

FOR IMMEDIATE RELEASE Media Inquiries: Michael Herndon P05-58 301-827-6242 September 6, 2005 Consumer Inquiries: 888-INFO-FDA

FDA Amends Interim Final Rule "Use of Materials Derived from Cattle in Human Food and Cosmetics"

The U.S. Food and Drug Administration today published several amendments to the July 2004 interim final rule, "Use of Materials Derived from Cattle in Human Food and Cosmetics," that will allow the use of certain cattle-derived material in human foods and cosmetics.

The rule prohibits the use of cattle-derived materials that can carry the infectious agent for bovine spongiform encephalopathy (BSE), or mad cow disease, in human foods, dietary supplements, and in cosmetics. Based on the scientific information provided during the interim final rule's comment period, which demonstrates that a part of the cow's digestive tract called the distal ileum can be consistently and effectively removed from the other sections of the small intestine, it is no longer necessary to designate the entire small intestine as a prohibited cattle material.

As a result, FDA is amending the rule to allow use of the small intestine in human food and cosmetics, provided that the distal ileum has been removed. The U.S. Department of Agriculture is publishing today a similar amendment to its interim final rule on BSE.

The amendments also clarify that milk and milk products, hides and hide-derived products, and tallow derivatives are not prohibited for use in human food and cosmetics.

Finally, FDA has reconsidered the recommended method for determining insoluble impurities in a type of solid fat known as tallow, in response to information submitted to the agency, to cite 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 studies have demonstrated are highly likely to contain the BSE agent in cattle with the disease. The amended interim final rule provides the same level of protection against the agent that causes BSE as the original provisions.

The amendments to the interim final rule are effective on October 7, 2005 and comments are being are accepted on the amendments through November 7, 2005.

###



http://www.fda.gov/bbs/topics/news/2005/NEW01229.html



EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA) Last updated: 19 July 2005

Publication date: 20 August 2004



http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573_it.html



http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573/sr03_biohaz02_usa_report_summary_en1.pdf


http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573/sr03_biohaz02_usa_report_v2_en1.pdf



continuing on;

holy mad cow in a pill, i see they have indeed changed some of the ingredients around, but LOOK at some of the animal organs still used that could potentially expose you to the TSE agent. i have posted the latest and compared to what i posted several years back, and you can see for example they changed the bovine brain to porcine brain, but then left bovine anterior pituitary, daaa. however, we are now indeed finding the agent in the muscle tissue of many species, including humans, bovine, sheep, elk. just check out what is still allowed in these products for humans. i thought for sure they would change this$ NOT to forget, the TSE agent has been successfully transmitted to pigs by inoculation;



7 OF 10 LITTLE PIGGIES WENT ON TO DEVELOP BSE;

1: J Comp Pathol. 2000 Feb-Apr; 122(2-3): 131-43. Related Articles,

Links

Click here to read

The neuropathology of experimental bovine spongiform encephalopathy in the pig.

Ryder SJ, Hawkins SA, Dawson M, Wells GA.

Veterinary Laboratories Agency Weybridge, Woodham Lane, New Haw, Addlestone, Surrey, KT15 3NB, UK.

In an experimental study of the transmissibility of BSE to the pig, seven of 10 pigs, infected at 1-2 weeks of age by multiple-route parenteral inoculation with a homogenate of bovine brain from natural BSE cases developed lesions typical of spongiform encephalopathy. The lesions consisted principally of severe neuropil vacuolation affecting most areas of the brain, but mainly the forebrain. In addition, some vacuolar change was identified in the rostral colliculi and hypothalamic areas of normal control pigs. PrP accumulations were detected immunocytochemically in the brains of BSE-infected animals. PrP accumulation was sparse in many areas and its density was not obviously related to the degree of vacuolation. The patterns of PrP immunolabelling in control pigs differed strikingly from those in the infected animals.

PMID: 10684682 [PubMed - indexed for MEDLINE]



http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?holding=npg&cmd=Retrieve&db=PubMed&list_uids=10684682&dopt=Abstract



Title: Experimental Intracerebral and Oral Inoculation of Scrapie to Swine: Preliminary Report

Authors

Greenlee, Justin Kunkle, Robert Hamir, Amirali

Submitted to: American Association of Veterinary Laboratory Diagnosticians Publication Type: Abstract Publication Acceptance Date: November 5, 2005 Publication Date: November 5, 2005 Citation: Greenlee, J.J., Kunkle, R.A., Hamir, A.N. 2005. Experimental Intracerebral and Oral Inoculation of Scrapie to Swine: Preliminary Report [abstract]. Proceedings of the American Association of Veterinary Laboratory Diagnosticians 48th Annual Conference. P. 38.

Technical Abstract: Transmissible spongiform encephalopathies (TSEs, prion diseases) are chronic neurodegenerative diseases that occur in humans, cattle, sheep, goats, cervids, and a number of laboratory animal models. In a laboratory setting, the host range of a given TSE can be tested by inoculating animals with brain tissue from affected animals through various routes including oral and intracranial. There is no evidence of the natural occurrence of any form of TSE in the pig, but pigs have been shown to be susceptible to bovine spongiform encephalopathy (BSE) infection by multiple-route parenteral challenge. However, pigs orally exposed at eight weeks of age to large amounts of brain from cattle clinically affected with BSE did not support infection after seven years of observation. In the United States, feeding of ruminant by-products to ruminants is prohibited, but feeding of ruminant materials to swine and poultry still occurs. The potential for swine to have access to scrapie-contaminated feedstuffs exists, but the potential for swine to serve as a host for replication/accumulation of the agent of scrapie is unknown. The purpose of this study was to perform oral and intracerebral inoculation of the U.S. scrapie agent to determine the potential of swine as a host for the scrapie agent and their clinical susceptibility. This study utilized 26 swine randomly divided into three groups: controls (n=6), oral inoculates (n=8), and intracranial inoculates (n=12). Brain homogenate (10%) derived from scrapie-affected sheep was given by a single intracranial injection of 0.75 ml or by oral inoculation of 15 ml on four consecutive days. Scrapie inoculum was derived from clinically ill sheep inoculated with material derived from 13 sheep in seven source flocks. A sample of this material was also inoculated back into sheep to assure infectivity. Necropsies were planned for six months post inoculation, at approximately the time the pigs were expected to reach market weight. Samples collected were examined microscopically after routine staining (hematoxylin and eosin) and staining by standard immunohistochemical methods for prion protein (PrP**Sc). After approximately six months incubation time, no histologic lesions suggestive of spongiform encephalopathy or immunohistochemical evidence of prion infection were obtained. No evidence of scrapie infection was demonstrated in this short-term study, but positive results after an incubation period of only six months would be uncharacteristic. The only TSE with an incubation of six months or less known at this time is transmissible mink encephalopathy in mink, skunk, or raccoon hosts. However, scrapie in the raccoon model has a two-year incubation period. A replicate of littermate pigs has been inoculated and will be studied after long-term (3-7 years) incubation, and a similar study is underway with pigs inoculated with material derived from elk, mule deer, and whitetail deer affected by chronic wasting disease (CWD).

Last Modified: 03/19/2006



http://www.ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=180786



confindential

pigs & pharmaceuticals



http://www.bseinquiry.gov.uk/files/yb/1990/09/10007001.pdf



http://www.bseinquiry.gov.uk/files/yb/1990/08/23002001.pdf



http://www.bseinquiry.gov.uk/files/yb/1990/08/23004001.pdf



http://www.bseinquiry.gov.uk/files/yb/1990/08/29003001.pdf



Greetings again,

I think more importantly is the potential for the ruminant protein to be passed to other species via gut of a pig that was rendered and fed ruminant protein beforehand, then once rendered, the TSE agent spreads whether or not pig itself has the disease or not, it's in the gut, thus could be passed via rendering and feeding to other species. ...TSS

Standard Process INC.

Iplex® - Introduced in 1957 and is a member of these product groups: Minerals, Vitamins

Iplex is a special combination formula designed to support the healthy functioning of the eyes. Iplex contains desiccated porcine brain that includes tissue proteins from the pineal gland. †

Content Product No. 150 Capsules 5100

Suggested Use: Two capsules per meal, or as directed.

Proprietary Blend: 967 MG Arrowroot flour, inositol, calcium lactate, porcine eye PMG™ extract, phosphoric acid, dried buckwheat (leaf) juice, buckwheat (seed), veal bone PMG™ extract, carrot (root), bovine liver, magnesium citrate, porcine stomach, choline bitartrate, nutritional yeast, bovine adrenal, defatted wheat (germ), alfalfa flour, bovine kidney, dried alfalfa juice, allantoin, mushroom, manganese glycerophosphate, bovine adrenal Cytosol™ extract, porcine brain, bovine bone, dl-methionine, oat flour, soybean lecithin, veal bone, mixed tocopherols (soy), carrot oil, and peanut (bran).

Other Ingredients: Gelatin, water, ascorbic acid, potassium para-aminobenzoate, niacinamide, colors, calcium stearate, riboflavin 5'-phosphate, vitamin A palmitate, and pyridoxal 5'-phosphate.



http://www.standardprocess.com/sp_catalog_product_detail.asp



http://www.standardprocess.com/lit/healthissueinfocards/FocusOnEyeHealthL1022.pdf



http://www.standardprocess.com/lit/tabsheets/iplex5100.pdf



Immuplex® - Introduced in 1984 and is a member of these product groups: Minerals, Vitamins

Immuplex combines vitamins A, B12, C, and E, and folic acid, and minerals such as zinc, copper, chromium, iron, and selenium. Immuplex contains bovine thymus, liver, and spleen tissue extracts - nutrients and glandulars well known for their important roles in immune system health and function. †

Content Product No. 40 Capsules 4935 150 Capsules 4960

Suggested Use: Two capsules per meal, or as directed.

Proprietary Blend: 565 MG Bovine liver PMG™ extract, veal bone PMG™ extract, nutritional yeast, bovine spleen PMG™ extract, bovine thymus PMG™ extract, bovine thymus Cytosol™ extract, bovine liver, bovine spleen, and ovine spleen.

Other Ingredients: Gelatin, zinc liver chelate, ascorbic acid, iron liver chelate, water, chromium yeast, copper liver chelate, selenium yeast, mixed tocopherols (soy), colors, pyridoxine hydrochloride, calcium stearate, vitamin A palmitate, folic acid, and cyanocobalamin.



http://www.standardprocess.com/sp_catalog_product_detail.asp



Neuroplex® - Introduced in 1986 and is a member of these product groups: Minerals, Vitamins

The brain houses the primary center for regulating and coordinating bodily activities. The nervous system, along with the endocrine system, provides most of the control functions for the body. Neuroplex contains porcine brain tissue and bovine tissues from the hypothalamus, pituitary, and pineal glands. The pineal gland is the site of melatonin synthesis. †

Content Product No. 40 Capsules 5850

Suggested Use: Two capsules per day, or as directed.

Proprietary Blend: 696 MG Tillandsia usneoides, bovine orchic Cytosol™ extract, bovine spleen, porcine brain PMG™ extract, defatted wheat (germ), bovine hypothalamus, bovine anterior pituitary, calcium lactate, bovine liver, potassium para-aminobenzoate, bovine pituitary PMG™ extract, porcine brain, and ascorbic acid.

Other Ingredients: Gelatin, zinc liver chelate, iron liver chelate, niacinamide, water, pyridoxine hydrochloride, calcium stearate, colors, copper liver chelate, cocarboxylase, and riboflavin.



http://www.standardprocess.com/sp_catalog_product_detail.asp



Neurotrophin PMG® - Introduced in 1953 and is a member of these product groups: Protomorphogen™ Extracts

The nervous system provides much of the control functions for the body. In general, the nervous system governs the rapid activities of the body, such as muscle contractions, constantly changing visceral events, and even the rates of secretion for some of the endocrine glands. Neurotrophin PMG contains Protomorphogen™ extracts which are uniquely derived nucleoprotein-mineral extracts that support cellular health. Porcine brain PMG™ extract helps maintain the nervous system in a good state of repair to support healthy brain function. †

Content Product No. 90 Tablets 5900

Suggested Use: One tablet per meal, or as directed.

Proprietary Blend: 205 MG Porcine brain PMG™ extract and magnesium citrate.

Other Ingredients: Calcium lactate, cellulose, and calcium stearate.



http://www.standardprocess.com/sp_catalog_product_detail.asp



Contact Information

Address Standard Process Inc. 1200 West Royal Lee Drive PO Box 904 Palmyra, WI 53156-0904 Phone 262-495-2122 Toll Free 800-848-5061 (USA) e-mail mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000248/!x-usc:mailto:info@standardprocess.com

Page last modified: Friday, June 10, 2005 2:40:12 PM

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

NOW COMPARE BOVINE INGREDIENTS FROM;

2003 - 2004 Product Catalog

Standard Process Inc.

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...TSS

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE

Friday, January 19, 2001

Holiday Inn Bethesda Versailles I and II 8120 Wisconsin Avenue Bethesda, Maryland

2 PARTICIPANTS Paul W. Brown, M.D., Chairperson William Freas, Ph.D., Executive Secretary

VOTING MEMBERS Ermias D. Belay, M.D. David C. Bolton, Ph.D. Donald S. Burke, M.D. Dean O. Cliver, Ph.D. Bruce M. Ewenstein, M.D., Ph.D. Peter G. Lurie, M.D. Pedro Piccardo, M.D. Stanley B. Prusiner, M.D. Raymond P. Roos, M.D. Elizabeth S. Williams, D.V.M., Ph.D.

VOTING CONSULTANTS Linda A. Detwiler, D.V.M. David Gaylor, Ph.D.

Paul R. McCurdy, M.D. Kenrad E. Nelson, M.D.

NONVOTING CONSULTANT Susan Leitman, M.D.

GUESTS Richard Davey, M.D. Louis Katz, M.D.

snip...

page 501

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.

1/19/01

3681t2.rtf(845) page 501



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



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



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



http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_07.pdf



© 2006 American Society for Investigative Pathology

Detection and Localization of PrPSc in the Skeletal Muscle of Patients with Variant, Iatrogenic, and Sporadic Forms of Creutzfeldt-Jakob Disease Alexander H. Peden, Diane L. Ritchie, Mark W. Head and James W. Ironside From the National Creutzfeldt-Jakob Disease Surveillance Unit and Division of Pathology, School of Molecular and Clinical Medicine, University of Edinburgh, Western General Hospital, Edinburgh, United Kingdom

Variant Creutzfeldt-Jakob disease (vCJD) differs from other human prion diseases in that the pathogenic prion protein PrPSc can be detected to a greater extent at extraneuronal sites throughout the body, principally within lymphoid tissues. However, a recent study using a high-sensitivity Western blotting technique revealed low levels of PrPSc in skeletal muscle from a quarter of Swiss patients with sporadic CJD (sCJD). This posed the question of whether PrPSc in muscle could also be detected in vCJD, sCJD, and iatrogenic (iCJD) patients from other populations. Therefore, we have used the same high-sensitivity Western blotting technique, in combination with paraffin-embedded tissue blotting, to screen for PrPSc in muscle tissue specimens taken at autopsy from 49 CJD patients in the United Kingdom. These techniques identified muscle PrPSc in 8 of 17 vCJD, 7 of 26 sCJD, and 2 of 5 iCJD patients. Paraffin-embedded tissue blotting analysis showed PrPSc in skeletal muscle in localized anatomical structures that had the morphological and immunohistochemical characteristics of nerve fibers. The detection of PrPSc in muscle tissue from all forms of CJD indicates the possible presence of infectivity in these tissues, suggesting important implications for assessing the potential risk of iatrogenic spread via contaminated surgical instruments.



http://ajp.amjpathol.org/cgi/content/abstract/168/3/927



TSS

#################### https://lists.aegee.org/bse-l.html ####################

BSE ALSO;

PrPSc distribution of a natural case of bovine spongiform encephalopathy

Yoshifumi Iwamaru, Yuka Okubo, Tamako Ikeda, Hiroko Hayashi, Mori- kazu Imamura, Takashi Yokoyama and Morikazu Shinagawa Priori Disease Research Center, National Institute of Animal Health, 3-1-5 Kannondai, Tsukuba 305-0856 Japan mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000248/!x-usc:mailto:gan@affrc.go.jp

Abstract

Bovine spongiform encephalopathy (BSE) is a disease of cattle that causes progressive neurodegeneration of the central nervous system. Infectivity of BSE agent is accompanied with an abnormal isoform of prion protein (PrPSc). The specified risk materials (SRM) are tissues potentially carrying BSE infectivity. The following tissues are designated as SRM in Japan: the skull including the brain and eyes but excluding the glossa and the masse- ter muscle, the vertebral column excluding the vertebrae of the tail, spinal cord, distal illeum. For a risk management step, the use of SRM in both animal feed or human food has been prohibited. However, detailed PrPSc distribution remains obscure in BSE cattle and it has caused controversies about definitions of SRM. Therefore we have examined PrPSc distribution in a BSE cattle by Western blotting to reassess definitions of SRM. The 11th BSE case in Japan was detected in fallen stock surveillance. The carcass was stocked in the refrigerator. For the detection of PrPSc, 200 mg of tissue samples were homogenized. Following collagenase treatment, samples were digested with proteinase K. After digestion, PrPSc was precipitated by sodium phosphotungstate (PTA). The pellets were subjected to Western blotting using the standard procedure. Anti-prion protein monoclonal antibody (mAb) T2 conjugated horseradish peroxidase was used for the detection of PrPSc. PrPSc was detected in brain, spinal cord, dorsal root ganglia, trigeminal ganglia, sublingual ganglion, retina. In addition, PrPSc was also detected in the peripheral nerves (sciatic nerve, tibial nerve, vagus nerve). Our results suggest that the currently accepted definitions of SRM in 9/13/2005

179 Page 10 of 17

BSE cattle may need to be reexamined.

T. Kitamoto (Ed.) PRIONS Food and Drug Safety

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

ALSO from the International Symposium of Prion Diseases held in Sendai, October 31, to November 2, 2004; Bovine spongiform encephalopathy (BSE) in Japan

snip...

"Furthermore, current studies into transmission of cases of BSE that are atypical or that develop in young cattle are expected to amplify the BSE prion" NO. Date conf. Farm Birth place and Date Age at diagnosis 8. 2003.10.6. Fukushima Tochigi 2001.10.13. 23 9. 2003.11.4. Hiroshima Hyogo 2002.1.13. 21 Test results # 8b, 9c cows Elisa Positive, WB Positive, IHC negative, histopathology negative b = atypical BSE case c = case of BSE in a young animal b,c, No PrPSc on IHC, and no spongiform change on histology International Symposium of Prion Diseases held in Sendai, October 31, to November 2, 2004. Tetsuyuki Kitamoto Professor and Chairman Department of Prion Research Tohoku University School of Medicine 2-1 SeiryoAoba-ku, Sendai 980-8575, JAPAN TEL +81-22-717-8147 FAX +81-22-717-8148 e-mail; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000248/!x-usc:mailto:kitamoto@mail.tains.tohoku.ac.jp Symposium Secretariat Kyomi Sasaki TEL +81-22-717-8233 FAX +81-22-717-7656 e-mail: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000248/!x-usc:mailto:kvomi-sasaki@mail.tains.tohoku.ac.ip ================================= 9/13/2005 --------------------------------------------------------------------------------

Page 11 of 17 From: TSS

Subject: Atypical Proteinase K-Resistant Prion Protein (PrPres) observed in an Apparently Healthy 23-Month-Old Holstein Steer

Date: August 26, 2005 at 10:24 am PST


Atypical Proteinase K-Resistant Prion Protein (PrPres) observed in an Apparently Healthy 23-Month-Old Holstein Steer Jpn. J. Infect. Dis., 56, 221-222, 2003 Laboratory and Epidemiology Communications Atypical Proteinase K-Resistant Prion Protein (PrPres) Observed in an Apparently Healthy 23-Month-Old Holstein Steer Yoshio Yamakawa*, KenÕichi Hagiwara, Kyoko Nohtomi, Yuko Nakamura, Masahiro Nishizima ,Yoshimi Higuchi1, Yuko Sato1, Tetsutaro Sata1 and the Expert Committee for BSE Diagnosis, Ministry of Health, Labour and Welfare of Japan2 Department of Biochemistry & Cell Biology and 1Department of Pathology, National Institute of Infectious Diseases, Tokyo 162-8640 and 2Miistry of Health, Labour and Welfare, Tokyo 100-8916 Communicated by Tetsutaro Sata (Accepted December 2, 2003) *Corresponding author: Mailing address: Department of Biochemistry and Cell Biology, National Institute of Infectious Diseases, Toyama 1-23-1, Shinjuku-ku, Tokyo 1628640, Japan. Tel: +81-3-5285-1111, Fax: +81-3-5285-1157, E-mail: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000248/!x-usc:mailto:yamakawa@nih.go.jp

Since October 18, 2001, 'bovine spongiform encephalopathy (BSE) examination for all cattle slaughtered at abattoirs in the country' has been mandated in Japan by the Ministry of Health, Labour and Welfare (MHLW). 'Plateria' ELISA-kit (Bio-Rad Laboratories, Hercules, Calif., USA) is routinely used at abattoirs for detecting proteinase K (PK)-resistant prion protein (PrPSc) in the obex region. Samples positive according to the ELISA screening are further subjected to Western blot (WB) and histologic and immunohistochemical examination (IHC) at the National Institute of Infectious Diseases (NIID) or Obihiro University. If PrPSc is detected either by WB or by IHC, the cattle are diagnosed as BSE. The diagnosis is approved by the Expert Committee for BSE Diagnosis, MHLW. From October 18, 2001 to September 30, 2003, approximately 2.5 million cattle were screened at abattoirs. A hundred and ten specimens positive according to ELISA were subjected to WB/IHC. Seven showed positive by both WB and IHC, all exhibiting the typical electrophoretic profile of a high content of the di-glycosylated molecular form of PrPSc (1-3) and the distinctive granular deposition of PrPSc in neuronal cells and neuropil of the dorsal nucleus of vagus. An ELISA-positive specimen from a 23 month-old Holstein steer slaughtered on September 29, 2003, in Ibaraki Prefecture (Ibaraki case) was sent to the NIID for confirmation. The animal was reportedly healthy before slaughter. The OD titer in ELISA was slightly higher than the 'cut-off' level given by the manufacturer. The histology showed no spongiform changes and IHC revealed no signal of PrPSc accumulation typical for BSE. However, WB analysis of the homogenate that was prepared from the obex region and used for ELISA revealed a small amount of PrPSc with an electrophoretic profile different from that of typical BSE-associated PrPSc (1-3). The characteristics were (i) low content of the di-glycosylated molecular form of PrPSc, (ii) a faster migration of the non-glycosylated form of PrPSc on SDS-PAGE, and (iii) less resistance against PK digestion as compared with an authentic PrPSc specimen derived from an 83-month-old Holstein (Wakayama case) (Fig. 1). Table 1 summarizes the relative amounts of three distinctive glycoforms (di-, mono, non-glycosylated) of PrPSc calculated by densitometric analysis of the blot shown in Fig. 1. As 2.5 mg wet weight obex-equivalent homogenate of the Ibaraki case (Fig. 1, lane 4) gave slightly stronger band intensities of PrPSc than an 8 mg wet weight obex-equivqlent homogenate of a typical BSE-affected Wakayama case (Fig. 1, lane 2), the amount of PrPSc accumulated in the Ibaraki case was calculated to be 1/500 - 1/1000 of the Wakayama case. In the Ibaraki case, the PrPSc bands were not detectable in the homogenates of the proximal surrounding region of the obex. These findings were consistent with the low OD value in ELISA, i.e., 0.2 -0.3 for the Ibaraki case versus over 3.0 for the Wakayama case. The DNA sequence of the PrP coding region of the Ibaraki case was the same as that appearing in the database (GenBank accession number: AJ298878). More recently, we encountered another case that resembled the Ibaraki case. It was a 21-monthold Holstein steer from Hiroshima Prefecture. WB showed typical BSE-specific PrPSc deposition though IHC did not detect positive signals of PrPSc (data not shown). Though the clinical onset of BSE is usually at around 5 years of age or later, a 20-month-old case showing the clinical signs has been reported (4). Variant forms of BSE similar to our cases, i.e., with atypical histopathological and/or biochemical phenotype, have been recently reported in Italy (5) and in France (6). Such variant BSE was not associated with mutations in the prion protein (PrP) coding region as in our case (5,6). The Ministry of Agriculture, Forestry and Fisheries of Japan (MAFF) announced a ban of feeding ruminants with meat bone meal (MBM) on September 18, 2001, and a complete ban was made on October 15 of the same year. According to the recent MAFF report, the previous seven cases of BSE in Japan were cattle born in 1995 - 1996 and possibly fed with cross-contaminated feed. However, the two cattle in this report were born after the complete ban. Whether contaminated MBM was implicated in the present cases remains to be investigated.

REFERENCES Collinge, J., Sidle, K. C. L., Meads, J., Ironside, J. and Hill, A. F. (1996): Molecular analysis of prion strain variation and the aetiology of 'new variant' CJD. Nature, 383, 685690. Bruce, M. E., Will, R. G., Ironside, J. W., McConnell, I., Drummond, D., Suttie, A., McCardle, L., Chree, A., Hope, J., Birkett, C., Cousens, S., Fraser, H. and Bostock, C. J. (1997): Transmissions to mice indicate that 'new variant' CJD is caused by the BSE agent. Nature, 389, 498-501. Hill, A. F., Desbruslais, M., Joiner, S., Sidle, K. C. L., Gowland, I. and Collinge, J. (1997): The same prion strain causes vCJD and BSE. Nature, 389, 448-450. Matravers, W., Bridgeman, J. and Smith, M.-F. (ed.)(2000): The BSE Inquiry. p. 37. vol. 16. The Stationery Office Ltd., Norwich, UK. Casalone, C., Zanusso, G., Acutis, P. L., Crescio, M. I., Corona, C., Ferrari, S., Capobianco, R., Tagliavini, F., Monaco, S. and Caramelli, M. (2003): Identification of a novel molecular and neuropathological BSE phenotype in Italy. International Conference on Prion Disease: from basic research to intervention concepts. Gasreig, Munhen, October 8-10. Bicaba, A. G., Laplanche, J. L., Ryder, S. and Baron, T. (2003): A molecular variant of bovine spongiform encephalopatie. International Conference on Prion Disease: from basic research to intervention concepts. Gasreig, Munhen, October 8-10. Asante, E. A., Linehan, J. M., Desbruslais, M., Joiner, S., Gowland, I., Wood, A. L., Welch, J., Hill, A. F., Lloyd, S. E., Wadsworth, J. D. F. and Collinge, J. (2002). BSE prions propagate as either variant CJD-like or sporadic CJD-like prion strains in transgenic mice expressing human prion protein. EMBO J., 21, 6358-6366. 9/13/2005 Page 12 of 17


SEE SLIDES IN PDF FILE;


http://www.nih.go.jp/JJID/56/221.pdf



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



AND CWD;

Prions in Skeletal Muscles of Deer with Chronic Wasting Disease Rachel C. Angers,1* Shawn R. Browning,1*† Tanya S. Seward,2 Christina J. Sigurdson,4‡ Michael W. Miller,5 Edward A. Hoover,4 Glenn C. Telling1,2,3§ 1Department of Microbiology, Immunology and Molecular Genetics, 2Sanders Brown Center on Aging, 3Department of Neurology, University of Kentucky, Lexington, KY 40536, USA. 4Department of Microbiology, Immunology and Pathology, Colorado State University, Fort Collins, CO 80523, USA. 5Colorado Division of Wildlife, Wildlife Research Center, Fort Collins, CO 80526, USA. *These authors contributed equally to this work. †Present address: Department of Infectology, Scripps Research Institute, 5353 Parkside Drive, RF-2, Jupiter, Florida, 33458, USA. ‡Present address: Institute of Neuropathology, University of Zurich, Schmelzbergstrasse 12, 8091 Zurich, Switzerland. §To whom correspondence should be addressed: E-mail: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000248/!x-usc:mailto:gtell2@uky.edu Prions are transmissible proteinaceous agents of mammals that cause fatal neurodegenerative diseases of the central nervous system (CNS). The presence of infectivity in skeletal muscle of experimentally infected mice raised the possibility that dietary exposure to prions might occur through meat consumption (1). Chronic wasting disease (CWD), an enigmatic and contagious prion disease of North American cervids, is of particular concern. The emergence of CWD in an increasingly wide geographic area and the interspecies transmission of bovine spongiform encephalopathy (BSE) to humans as variant Creutzfeldt Jakob disease (vCJD) have raised concerns about zoonotic transmission of CWD. To test whether skeletal muscle of diseased cervids.........SNIP....END

Neurobiology

Adaptation of the bovine spongiform encephalopathy agent to primates and comparison with Creutzfeldt- Jakob disease: Implications for human health Corinne Ida Lasmézas*,, Jean-Guy Fournier*, Virginie Nouvel*, Hermann Boe*, Domíníque Marcé*, François Lamoury*, Nicolas Kopp, Jean-Jacques Hauw§, James Ironside¶, Moira Bruce, Dominique Dormont*, and Jean-Philippe Deslys* * Commissariat à l'Energie Atomique, Service de Neurovirologie, Direction des Sciences du Vivant/Département de Recherche Medicale, Centre de Recherches du Service de Santé des Armées 60-68, Avenue du Général Leclerc, BP 6, 92 265 Fontenay-aux-Roses Cedex, France; Hôpital Neurologique Pierre Wertheimer, 59, Boulevard Pinel, 69003 Lyon, France; § Laboratoire de Neuropathologie, Hôpital de la Salpêtrière, 83, Boulevard de l'Hôpital, 75013 Paris, France; ¶ Creutzfeldt-Jakob Disease Surveillance Unit, Western General Hospital, Crewe Road, Edinburgh EH4 2XU, United Kingdom; and Institute for Animal Health, Neuropathogenesis Unit, West Mains Road, Edinburgh EH9 3JF, United Kingdom

Edited by D. Carleton Gajdusek, Centre National de la Recherche Scientifique, Gif-sur-Yvette, France, and approved December 7, 2000 (received for review October 16, 2000)

Abstract

There is substantial scientific evidence to support the notion that bovine spongiform encephalopathy (BSE) has contaminated human beings, causing variant Creutzfeldt-Jakob disease (vCJD). This disease has raised concerns about the possibility of an iatrogenic secondary transmission to humans, because the biological properties of the primate-adapted BSE agent are unknown. We show that (i) BSE can be transmitted from primate to primate by intravenous route in 25 months, and (ii) an iatrogenic transmission of vCJD to humans could be readily recognized pathologically, whether it occurs by the central or peripheral route. Strain typing in mice demonstrates that the BSE agent adapts to macaques in the same way as it does to humans and confirms that the BSE agent is responsible for vCJD not only in the United Kingdom but also in France. The agent responsible for French iatrogenic growth hormone-linked CJD taken as a control is very different from vCJD but is similar to that found in one case of sporadic CJD and one sheep scrapie isolate. These data will be key in identifying the origin of human cases of prion disease, including accidental vCJD transmission, and could provide bases for vCJD risk assessment.



http://www.pnas.org/cgi/content/full/041490898v1



The EMBO Journal, Vol. 19, No. 17 pp. 4425-4430, 2000 © European Molecular Biology Organization

Evidence of a molecular barrier limiting susceptibility of humans, cattle and sheep to chronic wasting disease

G.J. Raymond1, A. Bossers2, L.D. Raymond1, K.I. O?Rourke3, L.E. McHolland4, P.K. Bryant III4, M.W. Miller5, E.S. Williams6, M. Smits2 and B. Caughey1,7

1NIAID/NIH Rocky Mountain Laboratories, Hamilton, MT 59840, 3USDA/ARS/ADRU, Pullman, WA 99164-7030, 4USDA/ARS/ABADRL, Laramie, WY 82071, 5Colorado Division of Wildlife, Wildlife Research Center, Fort Collins, CO 80526-2097, 6Department of Veterinary Sciences, University of Wyoming, Laramie, WY 82070, USA and 2ID-Lelystad, Institute for Animal Science and Health, Lelystad, The Netherlands 7Corresponding author e-mail: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000248/!x-usc:mailto:bcaughey@nih.gov Received June 7, 2000; revised July 3, 2000; accepted July 5, 2000.

Abstract

Chronic wasting disease (CWD) is a transmissible spongiform encephalopathy (TSE) of deer and elk, and little is known about its transmissibility to other species. An important factor controlling interspecies TSE susceptibility is prion protein (PrP) homology between the source and recipient species/genotypes. Furthermore, the efficiency with which the protease-resistant PrP (PrP-res) of one species induces the in vitro conversion of the normal PrP (PrP-sen) of another species to the protease-resistant state correlates with the cross-species transmissibility of TSE agents. Here we show that the CWD-associated PrP-res (PrPCWD) of cervids readily induces the conversion of recombinant cervid PrP-sen molecules to the protease-resistant state in accordance with the known transmissibility of CWD between cervids. In contrast, PrPCWD-induced conversions of human and bovine PrP-sen were much less efficient, and conversion of ovine PrP-sen was intermediate. These results demonstrate a barrier at the molecular level that should limit the susceptibility of these non-cervid species to CWD.

snip...

Clearly, it is premature to draw firm conclusions about CWD passing naturally into humans, cattle and sheep, but the present results suggest that CWD transmissions to humans would be as limited by PrP incompatibility as transmissions of BSE or sheep scrapie to humans. Although there is no evidence that sheep scrapie has affected humans, it is likely that BSE has caused variant CJD in 74 people (definite and probable variant CJD cases to date according to the UK CJD Surveillance Unit). Given the presumably large number of people exposed to BSE infectivity, the susceptibility of humans may still be very low compared with cattle, which would be consistent with the relatively inefficient conversion of human PrP-sen by PrPBSE. Nonetheless, since humans have apparently been infected by BSE, it would seem prudent to take reasonable measures to limit exposure of humans (as well as sheep and cattle) to CWD infectivity as has been recommended for other animal TSEs.

snip...



http://www.emboj.org/current.shtml



Oral transmission of kuru, Creutzfeldt-Jakob disease, and scrapie to nonhuman primates.

Gibbs CJ Jr, Amyx HL, Bacote A, Masters CL, Gajdusek DC.

Kuru and Creutzfeldt-Jakob disease of humans and scrapie disease of sheep and goats were transmitted to squirrel monkeys (Saimiri sciureus) that were exposed to the infectious agents only by their nonforced consumption of known infectious tissues. The asymptomatic incubation period in the one monkey exposed to the virus of kuru was 36 months; that in the two monkeys exposed to the virus of Creutzfeldt-Jakob disease was 23 and 27 months, respectively; and that in the two monkeys exposed to the virus of scrapie was 25 and 32 months, respectively. Careful physical examination of the buccal cavities of all of the monkeys failed to reveal signs or oral lesions. One additional monkey similarly exposed to kuru has remained asymptomatic during the 39 months that it has been under observation.

PMID: 6997404



http://www.ncbi.nlm.nih.gov/entrez/query.fcgicmd=Retrieve&db=PubMed&list_uids=6997404&dopt=Abstract



Bovine Spongiform Encephalopathy (BSE, or

“Mad Cow Disease”): Current and Proposed

Safeguards

Updated October 13, 2005

Geoffrey S. Becker

Specialist in Agricultural Policy

Resources, Science and Industry Division

Sarah A. Lister

Specialist in Public Health and Epidemiology

Domestic Social Policy Division

SNIP...



http://www.ncseonline.org/NLE/CRSreports/05oct/RL32199.pdf



EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA) Last updated: 19 July 2005 Adopted July 2004 (Question N° EFSA-Q-2003-083)

Report Summary Summary of the Scientific Report

The European Food Safety Authority and its Scientific Expert Working Group on the Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE) Risk (GBR) were asked by the European Commission (EC) to provide an up-to-date scientific report on the GBR in the United States of America, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in USA. This scientific report addresses the GBR of USA as assessed in 2004 based on data covering the period 1980-2003.

The BSE agent was probably imported into USA and could have reached domestic cattle in the middle of the eighties. These cattle imported in the mid eighties could have been rendered in the late eighties and therefore led to an internal challenge in the early nineties. It is possible that imported meat and bone meal (MBM) into the USA reached domestic cattle and leads to an internal challenge in the early nineties.

A processing risk developed in the late 80s/early 90s when cattle imports from BSE risk countries were slaughtered or died and were processed (partly) into feed, together with some imports of MBM. This risk continued to exist, and grew significantly in the mid 90’s when domestic cattle, infected by imported MBM, reached processing. Given the low stability of the system, the risk increased over the years with continued imports of cattle and MBM from BSE risk countries.

EFSA concludes that the current GBR level of USA is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. As long as there are no significant changes in rendering or feeding, the stability remains extremely/very unstable. Thus, the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent persistently increases.

Publication date: 20 August 2004



http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573_it.html



http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573/sr03_biohaz02_usa_report_summary_en1.pdf


http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573/sr03_biohaz02_usa_report_v2_en1.pdf



suppressed peer review of Harvard study October 31, 2002



http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf



UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE QUARTERLY ENFORCEMENT REPORT July 1, 2005 through September 30, 2005

snip...

Administrative Actions Pending or Taken at Small HACCP Plants [includes actions initiated in prior quarters]

snip...

DESERET MEAT 04852 M SPANISH FORK, UT 07/27/05 08/01/05 X On 7/27/05, a suspension action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.3.

snip...

Administrative Actions Pending or Taken at Small HACCP Plants [includes actions initiated in prior quarters]

snip...

MONTEBELLO MEAT PROCESSING, INC 19075 M19075 P MANATI, PR 08/01/05 08/18/05 X 09/26/05 On 8/1/05, an enforcement action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.4.

snip...

Table 7. Administrative Actions: Very Small HACCP Plants (7/01/05 to 9/30/05)

snip...

A.J. CEKAK'S MEAT MARKET 09/01/05 09/20/05 On 9/1/05, an enforcement action

21562 M

concerning failure to meet regulatory ORD, NE requirements for Escherichia coli X X X Biotype 1 (E. coli) and Bovine Spongiform Encephalopathy/Specified Risk Material was taken in accordance with 9 CFR Part 500.4.

snip...

Administrative Actions Pending or Taken at Very Small HACCP Plants [includes actions initiated in prior quarters]

snip...

BROWN'S PROCESSING 13100 M13100 P ELSBERRY, MO 08/08/05 08/16/05 X On 8/8/05, an enforcement action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.4.

snip...

Administrative Actions Pending or Taken at Very Small HACCP Plants [includes actions initiated in prior quarters]

snip...

FIVE STAR PACK INC. 08725 M08725 P GOLDEN CITY, MO 09/01/05 09/09/05 X X On 9/1/05, an enforcement action concerning failure to meet regulatory requirements for Escherichia coli Biotype 1 (E. coli) and Bovine Spongiform Encephalopathy/Specified Risk Material was taken in accordance with 9 CFR Part 500.4.

snip...

Administrative Actions Pending or Taken at Very Small HACCP Plants [includes actions initiated in prior quarters]

snip...

H AND P MEATS 21352 M SOUTH PITTSBURG, TN 07/28/05 08/08/05 08/17/05 08/19/05 X X On 8/17/05, a suspension action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.3.

snip...

HOPKINS PACKING COMPANY 11069 M BLACKFOOT, ID 07/28/05 08/01/05 X On 7/28/05, a suspension action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.3.

snip...

Administrative Actions Pending or Taken at Very Small HACCP Plants [includes actions initiated in prior quarters]

snip...

NORTHWEST PREMIUM MEATS LLC 11032 M11032 P NAMPA, ID 07/26/05 07/29/05 X X On 7/26/05, a suspension action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.3.

snip...

PARADISE LOCKER MEATS 31865 M31865 P TRIMBLE, MO 09/21/05 X On 9/21/05, an enforcement action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.4.

PARAGON SPRAY DRYING, LLC 31792 M31792 P WAUKON, IA 09/06/05 09/12/05 X On 9/6/05, an enforcement action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.4.

snip...

Administrative Actions Pending or Taken at Very Small HACCP Plants [includes actions initiated in prior quarters]

snip...

RANDALL MEAT COMPANY 10669 M HOT SPRINGS, AR 07/01/05 07/28/05 X On 7/1/05, an enforcement action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.4.

snip...

Administrative Actions Pending or Taken at Very Small HACCP Plants [includes actions initiated in prior quarters]

snip...

08/04/05

08/19/05

On 8/4/05,

an enforcement action 01046 M01046 P concerning Bovine SpongiformKANSAS CITY, MO X X Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.4.

Administrative Actions Pending or Taken at Very Small HACCP Plants [includes actions initiated in prior quarters]

snip...

THE MEAT SHOP 08/18/05 09/06/05

09/09/05

On 9/6/05, a suspension action 31561 M concerning Bovine SpongiformBENSON, VT Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.3. XX X X X

THEURER'S QUALITY MEATS, 07/27/05 07/29/05

On 7/27/05, a suspension action INC concerning Bovine Spongiform31647 M31647 P Encephalopathy and Specified Risk X X

LEWISTON, UT Material was taken in accordance with 9 CFR Part 500.3.

TOOELE VALLEY MEATS 07/25/05 08/01/05

On 7/25/05, a suspension action 20594 M20594 Pconcerning Bovine Spongiform

GRANTSVILLE, UT X X Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.3.

snip...

52 pages



http://www.fsis.usda.gov/PDF/QER_Q4_FY2005.pdf



FOR IMMEDIATE RELEASE Contact: Kate Cyrul Friday, February 3, 2006 (202) 225-3661

DeLauro Questions APHIS Officials over Retesting of Infected Cow

– IG Report finds agency officials overruled advice of field scientists –

WASHINGTON, D.C. – Congresswoman Rosa L. DeLauro (Conn.-3) today questioned the reasoning of officials at the Animal and Plant Health Inspection Service (APHIS) that overruled the advice of field scientists on the retesting of a domestic cow found to have the bovine spongiform encephalopathy (BSE) disease. After the USDA announced that the first case of BSE was identified in a native-born cow last June, officials at APHIS said no further testing of the animal was needed. The USDA’s inspector general, however, determined the testing used proved inconclusive results and said that a sample from the cow should be sent for further testing.

DeLauro is ranking member of the House Appropriations Agriculture subcommittee, which has jurisdiction and oversight responsibilities of USDA and FDA.

“I am concerned that the APHIS officials that reviewed these results seemed to make decisions based not on science, but on the economic ramifications a positive BSE finding in a domestic born animal could have on the U.S. economy,” said DeLauro. “When consumer safety is in question, APHIS should not be forced into additional testing of an inconclusive sample by its inspector general.

“While we are glad that this cow did not enter the human food supply, APHIS officials had a responsibility to further examine this sample that even our “gold standard” test proved inconclusive. By refusing to send samples for further testing, APHIS could have jeopardized consumer health and safety and put the industry at a disadvantage, drawing into question the safety of our beef.

“Today I am requesting that APHIS disclose which officials made this decision and further explain their reasoning for not voluntarily testing this inconclusive sample further.”

###



www.house.gov/delauro



http://www.house.gov/delauro/press/2006/February/APHIS_retesting_2_3_06.html



Audit Report Animal and Plant Health Inspection Service Bovine Spongiform Encephalopathy (BSE) Surveillance Program – Phase II and Food Safety and Inspection Service Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat Recovery Products - Phase III

UNITED STATES DEPARTMENT OF AGRICULTURE OFFICE OF INSPECTOR GENERAL Washington, D.C. 20250 January 25, 2006 REPLY TO ATTN OF: 50601-10-KC TO: W. Ron DeHaven Administrator Animal and Plant Health Inspection Service Barbara Masters Administrator Food Safety and Inspection Service ATTN: William J. Hudnall Deputy Administrator Marketing Regulatory Program Business Services William C. Smith Assistant Administrator Office of Program Evaluation, Enforcement, and Review FROM: Robert W. Young /s/ Assistant Inspector General for Audit SUBJECT: Animal and Plant Health Inspection Service - Bovine Spongiform Encephalopathy (BSE) Surveillance Program - Phase II and Food Safety and Inspection Service - Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat Recovery Products - Phase III This report presents the results of our audit of the enhanced BSE surveillance program and controls over specified risk materials and advanced meat recovery products. Your written response to the official draft report, dated January 20, 2006, is included as exhibit G with excerpts of the response and the Office of Inspector General’s (OIG) position incorporated into the Findings and Recommendations section of the report, where applicable. We accept the management decisions for all recommendations. Please follow your agency’s internal procedures in forwarding documentation for final action to the Office of the Chief Financial Officer (OCFO). We are providing a separate memorandum to the agencies and OCFO that provides specific information on the actions to be completed to achieve final action. We appreciate your timely response and the cooperation and assistance provided to our staff during the audit USDA/OIG-A/50601-10-KC/ Page i

Executive Summary

Animal and Plant Health Inspection Service - Bovine Spongiform Encephalopathy (BSE) Surveillance Program - Phase II and Food Safety and Inspection Service - Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat Recovery Products - Phase III

Results in Brief This report evaluates elements of the interlocking safeguards in place to protect United States (U.S.) beef from Bovine Spongiform Encephalopathy, widely known as BSE or "mad cow disease." Since 1990, the U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), has led a multi-agency effort to monitor and prevent BSE from entering the food supply. After discovering a BSE-positive cow in December 2003, APHIS expanded its BSE surveillance program. To further protect the food supply, USDA banned materials identified as being at risk of carrying BSE (specified risk materials (SRM)), such as central nervous system tissue. As part of this effort, USDA’s Food Safety and Inspection Service (FSIS) required beef slaughter and processing facilities to incorporate controls for handling such materials into their operational plans. Onsite FSIS inspectors also inspect cattle for clinical signs in order to prevent diseased animals from being slaughtered for human consumption. To evaluate the effectiveness of the safeguards, we assessed APHIS’ implementation of the expanded surveillance program, as well as FSIS’ controls to prevent banned SRMs from entering the food supply.

In June 2004, APHIS implemented its expanded surveillance program; participation by industry in this surveillance program is voluntary. As of May 2005, over 350,000 animals were sampled and tested for BSE. To date, two animals tested positive for BSE; one tested positive after implementation of the expanded surveillance program.

USDA made significant efforts to implement the expanded BSE surveillance program. Much needed to be done in a short period of time to establish the necessary processes, controls, infrastructure, and networks to assist in this effort. In addition, extensive outreach and coordination was undertaken with other Federal, State, and local entities, private industry, and laboratory and veterinary networks. This report provides an assessment as to the progress USDA made in expanding its surveillance effort and the effectiveness of its controls and processes. This report also discusses the limitations of its program and data in assessing the prevalence of BSE in the U.S. herd.

snip...

40 ELISA test procedures require two additional (duplicate) tests if the initial test is reactive, before final interpretation. If either of the duplicate tests is reactive, the test is deemed inconclusive.

41 Protocol for BSE Contract Laboratories to Receive and Test Bovine Brain Samples and Report Results for BSE Surveillance Standard Operating Procedure (SOP), dated October 26, 2004.

42 The NVSL conducted an ELISA test on the original material tested at the contract laboratory and on two new cuts from the sample tissue.

43 A visual examination of brain tissue by a microscope.

44 A localized pathological change in a bodily organ or tissue.

SNIP...

PLEASE SEE FLAMING EVIDENCE THAT THE USDA ET AL COVERED UP MAD COW DISEASE IN TEXAS ;

PAGE 43;

Section 2. Testing Protocols and Quality Assurance Controls

snip...

FULL TEXT 130 PAGES



http://www.usda.gov/oig/webdocs/50601-10-KC.pdf



[GAO-05-101 ] Mad Cow Disease: FDA's Management of the Feed Ban Has Improved, but Oversight Weaknesses Continue to Limit Program Effectiveness Size: 104986 , Score: 1000 , TEXT , PDF , SUMMARY



http://frwebgate.access.gpo.gov/cgi-bin/useftp.cgi?IPaddress=162.140.64.88&filename=d05101.txt&directory=/diskb/wais/data/gao



[2]

[GAO-05-101 ] Mad Cow Disease: FDA's Management of the Feed Ban Has Improved, but Oversight Weaknesses Continue to Limit Program Effectiveness Size: 104986 , Score: 1000 , TEXT , PDF , SUMMARY



http://frwebgate.access.gpo.gov/cgi-bin/useftp.cgi?IPaddress=162.140.64.88&filename=d05101.txt&directory=/diskb/wais/data/gao



[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

03-025IFA 03-025IFA-2 Terry S. Singeltary

Page 1 of 17

From: Terry S. Singeltary Sr. [flounder9@verizon.net]

Sent: Thursday, September 08, 2005 6:17 PM

To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000248/!x-usc:mailto:fsis.regulationscomments@fsis.usda.gov

Subject: [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirements

for the Disposition of Non-Ambulatory Disabled Cattle

Greetings FSIS,

I would kindly like to submit the following to [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and

Requirements for the Disposition of Non-Ambulatory Disabled Cattle

THE BSE/TSE SUB CLINICAL Non-Ambulatory Disabled Cattle

Broken bones and such may be the first signs of a sub clinical BSE/TSE Non-Ambulatory Disabled Cattle ;

SUB CLINICAL PRION INFECTION

MRC-43-00

Issued: Monday, 28 August 2000

NEW EVIDENCE OF SUB-CLINICAL PRION INFECTION: IMPORTANT RESEARCH

FINDINGS RELEVANT TO CJD AND BSE

Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518

9/13/2005



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



Subject: Substances Prohibited from Use in Animal Food or Feed, Proposed Rule, Docket No. 2002N-0273 C-534 VOL 45 (PhRMA) and Entered On February 17, 2006 Date: March 10, 2006 at 5:23 pm PST

Marie A. Vodicka, PhD

Assistant Vice President

Biologics & Blotechnology

Scientlflc & Regulatory Affairs

SCIENCE & REG AFFAIRS

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, rrn . 1061

Rackville, MD 20862

Re: Substances Prohibited from Use in Animal Food or Feed, Proposed Rule, Docket

No. 2002N-0273

February 14, 2006

Dear Sir or Madam :

The Pharmaceutical Research and Manufacturers of America (PhRMA) is providing

comment to the proposed rules issued. ......

snip...



http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000534-01-vol45.pdf



Subject: Docket No: 2002N-0273 (formerly Docket No. 02N-0273) Substances Prohibited From Use in Animal Food and Feed PAUL BROWN Date: January 20, 2006 at 9:31 am PST

December 20,2005

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane

Room 1061

Rockville, MD 20852

Re: Docket No: 2002N-0273 (formerly Docket No. 02N-0273)

Substances Prohibited From Use in Animal Food and Feed

Dear Sir or Madame:

As scientists and Irecognized experts who have worked in the field of TSEs for

decades, we are deeply concerned by the recent discoveries of indigenous BSE infected

cattle in North America and appreciate the opportunity to submit comments to this very.........

snip...

Given that BSE can be transmitted to cattle via an

oral route with just .OO1 gram of infected tissue, it may not take much infectivity to

contaminate feed and keep the disease recycling. ........



http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf



December 19, 2005

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane

Room 1061

Rockville, MD 20852

Re: Docket No: 2002N-0273 (formerly Docket No. 02N-0273)

Substances Prohibited From Use in Animal Food and Feed

Dear Sir or Madame:

The McDonald’s Corporation buys more beef than any other restaurant in the United States. It is

essential for our customers and our company that the beef has the highest level of safety.

Concerning BSE, ...........

snip.......



http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273_emc-000134-02.pdf



THE SEVEN SCIENTIST REPORT ***



http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf



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



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



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



U.S. Scientist should be concerned with a CJD epidemic in the U.S., as well...

2 January 2000



http://bmj.bmjjournals.com/cgi/eletters/320/7226/8/b#EL1



Re: vCJD in the USA * BSE in U.S.

15 November 1999



http://bmj.bmjjournals.com/cgi/eletters/319/7220/1312/b#5406



ALL CJD * As at 3rd March 2006 (see increase in sCJD)



http://www.dh.gov.uk/assetRoot/04/13/11/73/04131173.pdf



USA

notice steady increase, but also notice in 2005, # 7 the 38 pendings cases through Oct. and #8 includes 53 type pending, 1 type unknown.

if you look at 2003 there were 3 type unknown.

wonder if they were the same or different than the unknown in 2005?

considering the soup that has been brewing over here in the USA for years via the rendering of BSE and atypical TSE in cattle, CWD, Scrapie, a few TME cases (not too much due to scent gland, but there were a few rendered, but all this, and you have one hell of a recipe for a new strains of TSE in humans. then who knows what 'friendly fire' cases would look like from this soup via secondary transmission via medical/surgical/dental arena. ...TSS

National Prion Disease Pathology Surveillance Center case exams...



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



Coexistence of multiple PrPSc types in individuals with

Creutzfeldt-Jakob disease

Magdalini Polymenidou, Katharina Stoeck, Markus Glatzel, Martin Vey, Anne Bellon, and Adriano Aguzzi

Summary

Background The molecular typing of sporadic Creutzfeldt-Jakob disease (CJD) is based on the size and glycoform ratio of protease-resistant prion protein (PrPSc), and on PRNP haplotype. On digestion with proteinase K, type 1 and type 2 PrPSc display unglycosylated core fragments of 21 kDa and 19 kDa, resulting from cleavage around amino acids 82 and 97, respectively.

Methods

We generated anti-PrP monoclonal antibodies to epitopes immediately preceding the differential proteinase K cleavage sites. These antibodies, which were designated POM2 and POM12, recognise type 1, but not type 2, PrPSc.

Findings

We studied 114 brain samples from 70 patients with sporadic CJD and three patients with variant CJD. Every patient classified as CJD type 2, and all variant CJD patients, showed POM2/POM12 reactivity in the cerebellum and other PrPSc-rich brain areas, with a typical PrPSc type 1 migration pattern.

Interpretation

The regular coexistence of multiple PrPSc types in patients with CJD casts doubts on the validity of electrophoretic PrPSc mobilities as surrogates for prion strains, and questions the rational basis of current CJD classifications.

snip...

The above results set the existing CJD classifications

into debate and introduce interesting questions about

human CJD types. For example, do human prion types

exist in a dynamic equilibrium in the brains of affected

individuals? Do they coexist in most or even all CJD

cases? Is the biochemically identified PrPSc type simply

the dominant type, and not the only PrPSc species?



Published online October 31, 2005



http://neurology.thelancet.com



Full Text Diagnosis and Reporting of Creutzfeldt-Jakob Disease Singeltary, Sr et al. JAMA.2001; 285: 733-734



http://jama.ama-assn.org/cgi/content/full/285/6/733?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=dignosing+and+reporting+creutzfeldt+jakob+disease&searchid=1048865596978_1528&stored_search=&FIRSTINDEX=0&journalcode=jama



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

disease in the United States

Email Terry S. Singeltary:

mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000248/!x-usc:mailto: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



TSS

From: "Terry S. Singeltary Sr." <[log in to unmask]>
Subject: CHINA TO START IMPORTING COSMETICS FROM COUNTRIES WITH BSE



http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0704&L=sanet-mg&P=71



From: "Terry S. Singeltary Sr." <[log in to unmask]>
Subject: FDA Proposes Barring Certain Cattle Material From Medical Products As BSE Safeguard



http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0701&L=sanet-mg&P=5318



TSE ADVISORY COMMITTEE MEETING SEPTEMBER 18-19 2006 - Microbes ForumTransmission of the BSE agent to humans, leading to vCJD, is believed to occur via ... high-risk cattle material in food, dietary supplements and cosmetics. ...



http://www.microbes.info/forums/index.php?showtopic=377&view=getlastpost





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.

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 Hasks strong professional heritage has consumer recognition.



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



Use of Bovine offal in Cosmetics;



CONFIDENTIAL



http://www.bseinquiry.gov.uk/files/yb/1990/02/01004001.pdf



http://www.bseinquiry.gov.uk/files/yb/1990/02/01007001.pdf



http://www.bseinquiry.gov.uk/files/yb/1990/01/26018001.pdf



http://www.bseinquiry.gov.uk/files/yb/1990/01/29001001.pdf



http://www.bseinquiry.gov.uk/files/yb/1990/01/29015001.pdf



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://www.bseinquiry.gov.uk/files/yb/1991/06/00005001.pdf



http://www.bseinquiry.gov.uk/files/yb/1991/07/25003001.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://www.bseinquiry.gov.uk/files/yb/1991/06/26003001.pdf



http://www.bseinquiry.gov.uk/files/yb/1991/06/30001001.pdf



http://www.bseinquiry.gov.uk/files/yb/1991/10/15002001.pdf



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 infectionbecause 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://www.bseinquiry.gov.uk/files/sc/seac13/tab07.pdf



TSS

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



Subject: Re: FAT LIPS, BABES,and mad cow disease $ contact lenses made from 'catalase preparedfrom bovine liver'
Date: Tue, 12 Jun 2001 11:32:15 -0700
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000248/!x-usc:mailto:BSE-L@uni-karlsruhe.de References: 1

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

Greetings List Members,

Looking further into this, seems Pandora's Box just gets bigger and bigger...

Intergen.Biomanufacturing.Corporation

Catalase,.Lyophilized.(Liver)



http://strategis.ic.gc.ca/SSG/bt00255e.html



BOVINE PLASMA DIAGNOSTIC BASE™ (PDB)

Intergen's Bovine Plasma Diagnostic Base™ (PDB) is an amber to light brown, clear, non-sterile 2X (14% protein) solution, which is supplied frozen. PDB is a cost-effective alternative to human serum or human defibrinated plasma for preparing standards, controls and calibrators for a variety of clinical diagnostic assays. PDB is available in large batch sized to ensure consistency in final formulations.

FEATURES:

Intergen's PDB is prepared from defibrinated bovine plasma and manufactured under GMP guidelines at an FDA registered facility. The raw material is obtained from USDA-inspected abattoirs in the United States, which is considered to be free from BSE. Intergen's bovine PDB affords high optical clarity, excellent filterability, and minimal background interference.

APPLICATIONS:

PDB is used in a variety of clinical assays in the preparation of standards, controls and calibrators. This diagnostic matrix has been accepted and used by major producers of diagnostic reagents for many years. PDB, supplied as a 2X protein concentrate, offers maximum flexibility to the end user for independent adjustment of analytes. Intergen may also produce custom formulations and analyte-adjusted material on customer request.



http://www.intergenco.com/plasmabo.html



The raw material is obtained from USDA-inspected abattoirs in the United States, which is considered to be free from BSE.

or

BSE Validation Study: The manufacturing processes for several of Intergen's Bovine Albumins and for Aprotinin have been shown to remove or inactivate a model spongiform encephalopathy agent spiked at high titre. The clearance was demonstrated in three separate manufacturing steps for each process, with overall reduction factors in excess of 16 log10.



http://www.intergenco.com/body_cell_bse.html



yea, right;

PNAS -- Brown et al. 97 (7): 3418 scrapie agent live at 600*C



http://www.pnas.org/cgi/content/full/97/7/3418



'jimmany cricket'. can you believe that statement? don't get me wrong, i do realize that there are many products using bovine derived tissues in pharmaceuticals, blood products and vaccines that are needed, but what is NOT needed is the stupidity that comes with the greed $$$

With that said, how does this particular company, from MANY out there, how do they control cross-contamination between products from TSEs ??? It seems the chance of cross-contamination with these different products, and the other different 'BLOOD' products they manufacture, would be _great_.

i give you this data (below) as proof, they are so full of B.S.eee, you can smell it all they way in Texas.

While researching about fatlips and movie stars, i came across a document that stated that some contact lenses care products were made from catalase prepared from bovine liver, and i thought this most important, as i have not heard much about this. wonder if the U.S. distributes/manfactures contact lenses care products made from these cattle tissues???

BSE3/1 0008 Dr. ?? Raine MCA

From Dr. H Pickles RD1 Date: 8 July 1991

Copy: Mr. Murray EHF Mrs Turner MDD

BOVINE MATERIALS: LENS CARE PRODUCTS

As part of our exercise of looking at possible routes for BSE infection into man we noted that catalase prepared from bovine liver is used in some contact lens care products. Experimentally, the ocular route can be effective in SE transmissions. Some contact lens products are licensed and presumably this means the sourcing will be adequately controlled. Is there a possibility that unlicensed care products might use bovine catalase?

Dr. Hilary Pickles Room 1213 State House EXT 23899/23879

thank you, kind regards,

Terry S. Singeltary Sr., Bacliff, Texas USA

Subject: 'Gelatine', just how safe is it? (they don't really know) * The Safety of Gelatine, meeting of Jan 20/21 2000 Date: March 10, 2000 at 1:45 pm PST

Subject:'Gelatine', just how safe is it? (they don't really know) * 'The Safety of Gelatine' meeting of Jan. 20/21 2000 Date: Fri, 10 Mar 2000 10:26:34 -0800 From: "Terry S. Singeltary Sr." Reply-To:Bovine Spongiform Encephalopathy To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000248/!x-usc:mailto:BSE-L@uni-karlsruhe.de

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

Hello list members,

This is not very reassuring, considering what they have been telling us for the past 10 or 15 years. the pages below are pages 4,5,7,20 and 21 of 27 pages on their re-evaluation on 'The Safety of Gelatine' meeting on January 20/21, 2000 . It's also very scary in this day and time, how little they still know about human/animal TSE's, but yet the (U.S.) will go to their graves saying, "no problem, it ain't here", but yet people are dying from every state from human TSE's, (just does not make sense to me)...

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


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


(page 4/5) The European Commission Decision N© 97/534/EC of 30 July 1997 confirms the conditions for the manufacture of gelatine from bone raw material. In the 15 E.U. member states as well as for third countries exporting to the E.U. (the general rule applies to all: both for human consumption and for pharmaceutical and cosmetic use), the following risk materials should be excluded: skull, brain, eye, spinal cord, tonsils. The decision also excludes the use of the vertebral column of cattle, sheep and goats of over l 2 months of age for mechanically recovered meat for human consumption. So far, bones, a raw material for the production of gelatine, have been considered as a material with no detectable infectivity. Bovine bone marrow, by analogy with bone marrow from sheep with scrapie, was classified as belonging to the category of low potential infectivity materials, in its opinion adopted on8-9 December 1997, the Scientific Steering Committee states: (on) dorsal root gangila. New (unpublished) evidence shows that the dorsal root ganglia - located within the general structure of the vertebral column - should be considered as having an infectivity for BSE equivalent to that of the spinal cord. The dorsal root ganglia proved infective at the same time after infection as the spinal cord, i.e. 32 months. The trigeminal ganglia were also infective, but so far no autonomic nervous system tissue has been found to be infective. The dorsal root ganglia cannot be removed without extreme difficulty. This therefore means that as a precautionary proposal the removal of the whole vertebral column (other than the coccyx) is now appropriate. Care needs to be taken to ensure that the removal of the vertebral column incorporates the lateral aspect of the vertebral bodies. This dissection may sometimes be difficult in practice unless the musculature is selectively removed from the vertebral bones for selling as bone-free meat.

(on) Bone marrow: 1. Early studies with mice intracerebrally injected with bone marrow from cattle with spontaneous clinical BSE has not demonstrated infectivity (SEAC, 1994). However, studies on calves, experimentally infected by feeding lOOg of BSE infected brain tissue, have now shown bone marrow infectivity in cattle studied at 38 months after feeding the BSE infected brain. These animals were clinically affected by BSE. (MAFF, unpublished evidence 3.12.1997), This has wide-ranging implications because it implies that long bones as well as vertebral columns must be considered potentially infective. The concerns on contamination and the dorsal ganglia mean that on these grounds alone the vertebral columns of older animals should be included in the category of specified risk material.

2. Several issues now emerge from the new report on bone marrow infectivity. First the apparent infectivity of bone marrow might need to be redefined. Bone marrow (on the basis of scrapie studies) was placed in Category III, i.e. as showing low infectivity. In previous bone marrow studies on clinical cases of BSE injected cattle, no infectivity was detected which might have suggested that the WHO classification was inappropriate in persisting with a Category III, rather than a Category IV, rating, i.e. no demonstrable infectivity. However, new evidence shows 2 of 18 mice developing late clinical disease after having been injected with marrow from cattle of 38 months post injection. Another 3 mice also show immunocytological evidence of the presence of PrPsc having been injected with the same bone marrow extract. Given the late development of this demonstrable infectivity in cattle bone marrow despite the substantial infective dose (100 g untreated BSE infective brain) it now seems appropriate to maintain the WHO classification for BSE as well as for scrapie. This signifies that BSE is increasingly being revealed as having a tissue based infectivity which seems similar to that of scrapie.l

3. This conclusion reinforces the concepts [...] that the different levels of infectivity do reflect a graded phenomenon and that it is unwise to consider the BSE agent as either present or absent in particular tissues.

4. The bone marrow findings also raise the issue of whether bones from older animals, e.g. >30 months, should be removed from the human food chain."

As far as infectivity of bone marrow is concerned, the working group on gelatine of the Scientific Steering Committee noted that the above statements referred to infectivity resulting from a single group of experimentally challenged cattle. However,infectivity of the bone marrow of naturally infected bovines has, to present knowledge, not been detected. According to Hadlow et al. (1982), infectivity has been reported in bone marrow of Suffolk sheep with natural, clinical scrapie but (Hadlow et al., 1980) not in goats with natural scrapie.

(page 7) The total amount of raw material transformed yearly into gelatine in Europe is estimated to be near 500.000 tons with 100.000 tons gelatine produced: 52% from pig skins, 21% from bovine bones and 27% from bovine hides. The world-wide production of gelatine is 220.000 tons from which 44% is produced in Europe. Raw material for one given plant may originate from several sources and may be a mixture of materials from different slaughterhouses and suppliers. Various parts of the production process itself may be spread over several locations. The number of critical points in the whole production chain from source to final product which need to be controlled to minimise or neutralise the risk of possible residual infectivity of the final product, is large and their monitoring may not always be easy and evident...

(page 20/21) REGARDING THE EQUIVALENCY OF THE "133°/20'/3 BARS HEAT/PRESSURE/TIME CONDITIONS" WITH ACID-ALKALI PRODUCTION PROCESS IN TERMS OF ITS CAPACITY OF INACTIVATING/ELIMINATING POSSIBLE TSE INFECTIVITY IN THE RAW MATERIAL.

7.12 . The Scientific Steering Committee addressed the following question: "Is a treatment of all ruminant bone material which is not derived from animals born, reared and slaughtered in countries recognised BSE free or at negligible risk, to heating to at least 133°C throughout its substance for a minimum of 20 minutes at a pressure of three bars, with a particle size prior to processing of not more than 50 millimetres and complying with the updated report on MBM regarding the steam requirement without air trapped,

an acceptable alternative to the production conditions laid down in the opinion on the safety of gelatine, namely: a process which ensures that all bone material is finely crushed and degreased with hot water and treated with dilute hydrochloric acid (at minimum concentration of 4% and pH<> 12.5) for a period of at least 20 days with a sterilisation step of 138-140°C during 4 seconds"'.

7.13. The SSC recognised that it becomes more difficult to inactivate scrapie-infected brain-tissue by heat after it has been dried, that the raw material used for the production of meat-and-bone meal and for gelatine has a different composition (e.g., water, fat and protein content) and different physical characteristics and that there may be different heat transfer and inactivation conditions during production. In general, there is an uncertain comparability of "133°/20'/3 bars" heat/pressure/time conditions during the processing of fresh animal waste into meat-and-bone and (Fresh or dried) bone material into gelatine.

In the absence of a scientific and comprehensive report on or the results of a validation study on the TSE infectivity inactivating capacity of such processing conditions and the intended end-use of the produced gelatine being for human (and possibly animal) consumption, the uncertainties about the residual risk should therefore be reduced to the minimum possible.

The SSC is also concerned that an acceptance of the equivalent inactivation of TSE infectivity in the present process for the production of gelatine with the process described in the SSC opinion of 26-27 March 1998 may trigger the submission for approval of a number of other production processes for which no validation has been carried out.

Given these concerns, the SSC cannot conclude that "133°/20'/3 bars" heat/pressure/time conditions as described in the report of the Working Group would result in an equivalent safe product compared with the acid-alkaline industrial gelatine production process described in its opinion on the Safety of Gelatine of 26-27 March 1998.

Therefore, for gelatine derived from ruminant bones, the Scientific Steering Committee's Opinion on the Safety of Gelatine adopted on 26-27 March 1998 and updated on 3 April 1998, remains valid At present, the only preliminary conclusion can be that ruminant bones from animals certified fit for human consumption, to be used for production of gelatine with heat/pressure/time system, will have to come from BSE-free or BSE-negligible risk countries.

7.14. The industry is invited to organise an independent experiment showing that the series of successive "133°C/20'/3 bars" steps for the production of gelatine, results' in a BSE infectivity reduction which is at least equivalent to the reduction obtained during the "133°C/20'/3 bars" production process defined in the SSC opinion of 26-27 March 1998 and in the Updated Scientific Report of 24-25 September 1998 on the safety of meat-and-bone meal and which accept an infectivity reduction of at least 3 log10. These experiments should be carried out under conditions similar to the ones in the real industrial processes. The inactivation should be assessed at least for the series as a whole of successive "133°C/20'/3 bars" steps and preferably also for the production process as a whole. The data should clearly show that also dry contaminated material can be reduced in infectivity.

REGARDING THE EQUIVALENCY OF AN ALTERNATIVE, CONTINUOUS PROCESS WITH THE ACID-ALKALI PRODUCTION PROCESS IN TERMS OF ITS CAPACITY OF INACTIVATING/ELIMINATING POSSIBLE TSE INFECTIVITY IN THE RAW MATER1AL.

7.15. The SSC considers it impossible evaluate at present the equivalency of the alternative production process described in the attached report of the working group, in terms of the inactivation/elimination of TSE infectivity.

As for the classical acid alkaline and for the heat/pressure/time processes, a study with spiked BSE infected raw material is needed in order to estimate the infectivity reduction factor of the production process. The Scientific Steering Committee invites the industry to organise an independent experiment on the TSE inactivation/elimination capacity of the alternative process.

At present, the only preliminary conclusion can be that ruminant bones from animals certified fit for human consumption, to be used for production of gelatine with the alternative system, will have to come from BSE-free or BSE-negligible risk countries.

REGARDING THE EVALUATION ON A CASE BY-CASE BASIS OF ALTERNATIVE PRODUCTION PROCESSES.

7.16 The SSC wishes to propose that any future request for the evaluation of production processes in terms of their equivalency in TSE infectivity inactivation/elimination with other already documented and validated processes, should be accompanied with the results of a validation study and/or a supporting report on the TSE inactivation/elimination capacity of the process.

[[[for the full text, the URL is below...TSS]]]



http://europa.eu.int/comm/dg24/health/sc/ssc/out34_en.pdf



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


Use of Bovine offal in Cosmetics;




http://www.bseinquiry.gov.uk/files/yb/1990/02/01004001.pdf



http://www.bseinquiry.gov.uk/files/yb/1990/02/01007001.pdf



http://www.bseinquiry.gov.uk/files/yb/1990/01/26018001.pdf



http://www.bseinquiry.gov.uk/files/yb/1990/01/29001001.pdf



http://www.bseinquiry.gov.uk/files/yb/1990/01/29015001.pdf



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://www.bseinquiry.gov.uk/files/yb/1991/06/00005'001.pdf



http://www.bseinquiry.gov.uk/files/yb/1991/07/25003001.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://www.bseinquiry.gov.uk/files/yb/1991/06/26003001.pdf



http://www.bseinquiry.gov.uk/files/yb/1991/06/30001001.pdf



http://www.bseinquiry.gov.uk/files/yb/1991/10/15002001.pdf



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://www.bseinquiry.gov.uk/files/sc/seac13/tab07.pdf




LATER YEARS ... TSS


WHO Guidelines on Tissue Infectivity Distribution in Transmissible Spongiform Encephalopathies

http://www.who.int/bloodproducts/tse/WHO%20TSE%20Guidelines%20FINAL-22%20JuneupdatedNL.pdf

Copyright © 2008 Elsevier Inc. All rights reserved.

Bone marrow stroma cells are susceptible to prion infection

References and further reading may be available for this article. To view references and further reading you must purchase this article.

Yuka Takakuraa, b, Naohiro Yamaguchia, Takehiro Nakagakia, Katsuya Satohc, Jun-ichi Kirab and Noriyuki Nishidaa, ,

aDepartment of Molecular Microbiology and Immunology, Nagasaki University Graduate School of Biomedical Sciences, Sakamoto 1-12-4, Nagasaki 852-8523, Japan

bDepartment of Neurology, Kyushu University Graduate School of Medicine, Fukuoka, Japan

cDepartment of Clinical Neurology, Nagasaki University Hospital, Nagasaki, Japan

Received 27 September 2008. Available online 29 October 2008.

Abstract Abnormal protease-resistant prion protein (PrP-res) is the only surrogate biochemical marker for prion diseases, and a sensitive technique to detect PrP-res in blood or tissues is urgently needed. Primary cultured bone marrow stromal cells (MSCs) expressed PrP and were capable of supporting stable human prion infection. Using a mouse-adapted BSE strain, we demonstrated that PrP-res can be detected in expanded MSCs. We then analyzed the bone marrow cells collected at autopsy from two individuals with sporadic Creutzfeldt-Jakob disease (CJD), and, in both cases, cultured MSCs were positive for PrP-res. These data would suggest that ex vivo MSC expansion accompanied by PrP-res analysis could be a helpful tool in the definitive diagnosis of prion disease at an earlier stage in the disease process than is currently possible, and with considerably less distress to the patient.

Keywords: Prion protein; CJD; BSE; Bone marrow stromal cell; MSC

Article Outline Materials and methods Results and discussion Acknowledgements References

Fig. 1. Bone marrow stromal cells express PrPC. (A) Phase-contrast pictures of human, mouse, and rat MSCs. (B) Western blotting shows PrPC expression in these cells. All MSCs isolated from different animals were positive for PrPC. (C) Immunostaining for PrP on rat MSCs. Typical punctuated staining was seen on the cell surface.

View Within Article

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

Fig. 2. Ex vivo transmission of Nu-1 agent on rat MSCs. PrP signals for the Proteinase-K resistant form of PrP (PrPSc) were seen in the culture. N: uninfected normal control. P: Nu-1 rat brain homogenate sample. Numbers indicate times of passages from infection.

View Within Article

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

Fig. 3. PrPSc was detected in MSC culture from terminally sick animals and was infectious. (A) MSCs were isolated from mouse-BSE infected and Fukuoka-1 infected ddY mice. Both cultures were positive for PrPSc. (B) Immunostaining for PrPSc in spleen obtained from a mouse inoculated with BSE-MSCs, indicating the cells were truly carrying infectivity. (C) Time-course analysis of PrPSc in BSE-inoculated mice. MSCs were isolated from intraperitoneally infected mice and PrPSc was detected. Note that PrPSc was seen in MSCs as early as 16 wpi.

View Within Article

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

Fig. 4. (A) Ex vivo expanded MSCs from CJD patients were positive for PrPSc. (A) Bone marrow cells were isolated at autopsy of a sporadic CJD patient. After expansion of MSCs for a month, Western blotting for human PrP could detect PrPSc in the cell lysate. (B) MSCs from another sporadic CJD patient. Bone marrow was obtained immediately after death. PrPSc was seen in the culture even at P1. PK: Proteinase-K digested sample.

View Within Article

Corresponding author. Fax: +81 95819 7060.

http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6WBK-4TT1F2N-4&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&_docanchor=&view=c&_searchStrId=954469850&_rerunOrigin=google&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=5936ad33f46a947cd3ee50a49b29a10d



Title: Prion infected Meat-and-Bone Meal is still infectious after biodiesel production

Authors

Bruederle, Cathrin Hnasko, Robert Kraemer, Thomas - SAARLAND UNIV GERMANY Garcia, Rafael Haas, Michael Marmer, William Carter, John

Submitted to: PLoS Pathogens Publication Type: Peer Reviewed Journal Publication Acceptance Date: July 24, 2008 Publication Date: August 13, 2008 Citation: Bruederle, C.E., Hnasko, R.M., Kraemer, T., Garcia, R.A., Haas, M.J., Marmer, W.N., Carter, J.M. 2008. Prion infected Meat-and-Bone Meal is still infectious after biodiesel production. PLoS Pathogens. Available: http://dx.plos.org/10.1371/journal.pone.0002969

Interpretive Summary: The problem addressed by this research is safe disposal of slaughterhouse by-products. Some parts of cattle and sheep have low commercial value as human food. Much of this material has traditionally been processed into Meat-and-Bone Meal (MBM), a highly nutritious animal feed supplement. But MBM was linked to the spread of Bovine Spongiform Encephalopathy (BSE), and the BSE epidemic in the UK and EU was probably ended by banning MBM from feed. This has created a problem for MBM as an agricultural commodity. MBM is high in fat, and rising prices for crude oil have recently created a favorable market shift for biodiesel, which can be produced from this fat through a simple but harsh chemical reaction. Biodiesel is usually manufactured from relatively pure fat or oil, but we found the reaction worked equally well on MBM. We then used a hamster scrapie model of BSE, with two different methods to test whether the biodiesel reaction also destroyed infectivity in the MBM. When we used antibody-based detection (Western blot) we were unable to detect the proteinase-resistant protein marker for disease in the biodiesel or solid residue. This result agrees with published reports implying the method produces safe biodiesel. When we used a bioassay (intracranial inoculation) we found that the biodiesel method destroyed all infectivity in the biodiesel and 99.9999% of the infectious material in the solid residue. This suggests the biodiesel fraction is safe for use as fuel. However, this level of decontamination/disinfection is unfortunately not sufficient to allow use of the solid residue as a feed supplement for cows and sheep. We think minor changes to the biodiesel recipe, such as increased time and temperature, could make it strong enough to completely decontaminate MBM. Technical Abstract: The epidemic of bovine spongiform encephalopathy (BSE) has led to world-wide drop in the market for beef by-products, such as Meat-and-Bone Meal (MBM), a fat-containing product traditionally used as an animal feed supplement. While normal rendering is insufficient, the production of biodiesel from MBM has been suggested to destroy infectivity from transmissible spongiform encephalopathies (TSEs). In addition to producing fuel, this method simultaneously generates a nutritious solid residue. In our study we produced biodiesel from MBM under defined conditions using a modified form of alkaline methanolysis. We evaluated the presence of prion in the three resulting phases of the biodiesel reaction (Biodiesel, Glycerol and Solid Residue) in vitro and in vivo. Analysis of the reaction products from 263K scrapie infected MBM led to no detectable immunoreactivity by Western Blot. Importantly, and in contrast to the biochemical results the solid MBM residue from the reaction retained infectivity when tested in an animal bioassay. Histochemical analysis of hamster brains inoculated with the solid residue showed typical spongiform degeneration and vacuolization. Re-inoculation of these brains into a new cohort of hamsters led to onset of clinical scrapie symptoms within 75 days, suggesting that the intrinsic properties of the prion protein were not changed during the biodiesel process. Results from our study demonstrate biochemical detection by Western Blot is insufficient to conclude an absence of TSE infectivity. Furthermore the biodiesel reaction can not be considered a viable prion decontamination method despite increased survival time of hamsters and reduced infectivity greater than 6 log orders in the solid MBM residue.

Project Team

Carter, John - Mark Hnasko, Robert Stanker, Larry Silva, Christopher - Chris

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Animal Health (103)

Last Modified: 07/10/2009

http://www.ars.usda.gov/research/publications/publications.htm?seq_no_115=225834


Prion Infected Meat-and-Bone Meal Is Still Infectious after Biodiesel Production

http://www.plosone.org/article/info:doi/10.1371/journal.pone.0002969


Research Project: Study of Atypical Bse Location: Virus and Prion Diseases of Livestock

Project Number: 3625-32000-086-05 Project Type: Specific Cooperative Agreement

Start Date: Sep 15, 2004 End Date: Sep 14, 2009

Objective: The objective of this cooperative research project with Dr. Maria Caramelli from the Italian BSE Reference Laboratory in Turin, Italy, is to conduct comparative studies with the U.S. bovine spongiform encephalopathy (BSE) isolate and the atypical BSE isolates identified in Italy. The studies will cover the following areas: 1. Evaluation of present diagnostics tools used in the U.S. for the detection of atypical BSE cases. 2. Molecular comparison of the U.S. BSE isolate and other typical BSE isolates with atypical BSE cases. 3. Studies on transmissibility and tissue distribution of atypical BSE isolates in cattle and other species.

Approach: This project will be done as a Specific Cooperative Agreement with the Italian BSE Reference Laboratory, Istituto Zooprofilattico Sperimentale del Piemonte, in Turin, Italy. It is essential for the U.S. BSE surveillance program to analyze the effectiveness of the U.S diagnostic tools for detection of atypical cases of BSE. Molecular comparisons of the U.S. BSE isolate with atypical BSE isolates will provide further characterization of the U.S. BSE isolate. Transmission studies are already underway using brain homogenates from atypical BSE cases into mice, cattle and sheep. It will be critical to see whether the atypical BSE isolates behave similarly to typical BSE isolates in terms of transmissibility and disease pathogenesis. If transmission occurs, tissue distribution comparisons will be made between cattle infected with the atypical BSE isolate and the U.S. BSE isolate. Differences in tissue distribution could require new regulations regarding specific risk material (SRM) removal.


http://www.ars.usda.gov/research/projects/projects.htm?accn_no=408490


http://www.ars.usda.gov/research/projects/projects.htm?ACCN_NO=408490&showpars=true&fy=2008


Wednesday, February 11, 2009 Atypical BSE North America Update February 2009

http://bse-atypical.blogspot.com/2009/02/atypical-bse-north-america-update.html


Transgenic mice expressing porcine prion protein resistant to classical scrapie but susceptible to sheep bovine spongiform encephalopathy and atypical scrapie. Emerg Infect Dis. 2009 Aug; [Epub ahead of print]

http://nor-98.blogspot.com/2009/07/transgenic-mice-expressing-porcine.html


Saturday, June 13, 2009

Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States 2003 revisited 2009

http://cjdusa.blogspot.com/2009/06/monitoring-occurrence-of-emerging-forms.html


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1 Comments:

Blogger R said...

Nice blog. After a lot of research, it's quite apparent that this is a much bigger issue than most people realize.

What about gelatin in supplements?

6:00 PM  

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