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From: TSS ()
Subject: Re: NCBA enlists President Bush to assist with South Korea trade problems with USDA MAD COW BEEF
Date: December 5, 2006 at 12:31 pm PST

In Reply to: NCBA enlists President Bush to assist with South Korea trade problems with USDA MAD COW BEEF posted by TSS on December 4, 2006 at 4:03 pm:

FTA talks get off to a shaky start



BIG SKY, Montana - Seoul and Washington began their fifth round of free trade negotiations in the U.S. state of Montana, faced with the challenge of making progress in sensitive areas such as agriculture, pharmaceuticals and tariff rates.
"We have made very little progress in the talks (today)," Korea's top negotiator Kim Jong-hoon told reporters. "But my counterpart Wendy Cutler and I agreed that it is important to make progress on major issues in this round, because it is the final round of talks this year."

Both countries are holding five days of talks at a ski resort in Big Sky. They hope to conclude negotiations by March to seal a trade pact by July 2007, the expiration of the Bush administration's fast-track trade promotion authority. But thorny issues including the U.S. demand for wider access to Korea's agriculture and automobile markets, pharmaceutical sector, and Korea's demand for wider access to the U.S. textile market have not yet made any progress, raising doubts over the possibility of meeting the deadline.

"For an agreement to be sealed we must be creative and make tough political decisions," Wendy Cutler, chief U.S. negotiator and assistant trade representative, said at a news conference.

In line with making "tough political" decisions, the United States has been aggressively lobbying for Korea to reopen its market to U.S. beef ahead of the talks, even though beef import safety issues do not fall within the purview of the FTA. Seoul's rejection of two recent shipments of American beef after the detection of bone fragments has heightened a beef trade dispute, intensifying the political tension between the two countries.

"Technically it is correct that our talks to reopen the beef market are not part of the KORUS (Korea-U.S.) negotiations," said Cutler. "However, we've made it very clear to our Korean counterparts that in order for a successful Korea-U.S. FTA to be ratified by our Congress, we need to see the full reopening of Korea's beef market to U.S. beef."

Seoul's top negotiator confirmed that beef and the FTA are separate issues. But he agreed that the beef dispute could have a negative effect when it comes to the U.S. Congress signing off on the agreement.

"I do agree that the beef issue may obstruct the U.S. Congress in its decision in passing the FTA, but we can only wait and see how much importance Congress places on the beef issue when the time comes for them to decide whether to pass the agreement," Kim told reporters. "So beef shouldn't affect the contents of our FTA."

Part of the U.S. political effort includes holding the FTA talks in Montana, which is part of the beef belt in the United States. Korea was the third-largest market for U.S. beef before Seoul began an import ban in December 2003 following the discovery of a case of mad cow disease in Washington state.

"U.S. beef is safe with or without bones," said Democratic Senator Max Baucus from Montana at a luncheon with Korean officials and the chief negotiators a day ahead of the talks. "I hope our beef can be freely sold in the Korean market."

Kim said making progress in trade remedies will be important for advancing the overall negotiations in this fifth round. The Bush administration has until this year to secure a draft for trade remedies.

"I stressed that making progress on trade remedies is important in this round," Kim said.

While Korea faces the challenge of persuading strong FTA opponents at home, such as the farming and movie industries, over their fears of losing competitiveness against a flood of U.S. products, it needs to resolve automobile and pharmaceuticals issues.

"We are extremely disappointed with the progress (in pharmaceuticals)," said Cutler. "This is a very important issue for us in the negotiations that our suggestions were not incorporated or reflected in the draft regulation that Korea is now finalizing and intends to put into place by the end of the year."

Washington opposes the Korean government's medicine reimbursement policy, citing potential discrimination against U.S. pharmaceutical companies.

"We remain extremely concerned that Korea is going forward with regulations that in our view will deny Korean patients treatment with the most innovative drugs in the world," stressed Cutler.

Kim in response admitted that he was "very disappointed" at what Cutler said, stressing that U.S. negotiators had earlier accepted Korea's new pharmaceutical regulation that is to be enforced by the end of this year.

Pressure is also intensifying for Seoul to ease its trade barriers for automobiles.

"I think what happens in autos during this round will be largely dependent on how responsive Korea is to our proposal to address the range of non-tariff measures that impede access to our companies in Korea," declared Cutler.

She cited high taxes and discriminatory and non-transparent standards as barriers for U.S. automakers.

Kim, however, expressed some optimism.

"We stressed that sensitive areas need to be addressed in this round," he told reporters.

(sohjung@heraldm.com)


By Yoo Soh-jung


2006.12.06


http://www.koreaherald.co.kr/SITE/data/html_dir/2006/12/06/200612060039.asp

Greetings,


>>>"Technically it is correct that our talks to reopen the beef market are not part of the KORUS (Korea-U.S.) negotiations," said Cutler. "However, we've made it very clear to our Korean counterparts that in order for a successful Korea-U.S. FTA to be ratified by our Congress, we need to see the full reopening of Korea's beef market to U.S. beef." <<<

hmmm, blackmail by proxy, that seems to be America's way now. seems GW et al will force feed everyone there BSe via the BSE MRR policy, the legal Trading of all strains of TSE globally. ...


>>>"U.S. beef is safe with or without bones," said Democratic Senator Max Baucus from Montana at a luncheon with Korean officials and the chief negotiators a day ahead of the talks. "I hope our beef can be freely sold in the Korean market."<<<


My God, another political idiot, playing like he knows about TSE, in line for the Gummer award, long with GW et al, and
Prime Minister Jean Chretien lying to the public about Canadian beef at a Ottawa restaurant ;

http://news.bbc.co.uk/onthisday/hi/dates/stories/may/16/newsid_2913000/2913807.stm


http://www.maddeer.org/canadianprimeminister.JPG

we must get politics and trade out of TSE science, if it is not to late already. ...


>>>While Korea faces the challenge of persuading strong FTA opponents at home, such as the farming and movie industries, over their fears of losing competitiveness against a flood of U.S. products, it needs to resolve automobile and pharmaceuticals issues. <<<


PHARMACEUTICALS AND TSE


i wonder if the kind people of S Korea are aware of TSE and what the SEAC has said about FDA USA medical implants and risk factor there ???

in case they might have missed this, here it is ;

USA GBR
15. USA was initially assigned GBR II by the SSC in 20007. A
reassessment by EFSA in 2004 changed the level to GBR III8 (see
Annex 1). This was based upon:
(i) the extent of external challenge since 1980. The USA imported
cattle and MBM from BSE risk countries, including the UK, during
periods of time when a risk of importation of infected animals and
contaminated feed existed (see pages 2-8 of the technical annex at
Annex 1).
(ii) the stability of USA system to mitigate against the external
challenge since 1980. The USA system was considered extremely
unstable such that should BSE infectivity have entered the system
it would have recycled and amplified quickly (see pages 8-14 of the
technical annex at Annex 1).
16. In 2005, BSE was confirmed from a reanalysis of sample collected
as part of routine surveillance from a single native USA animal that
died in 20049 supporting the change in GBR level.
SEAC CONSIDERATION
Implantable medical devices containing bovine material
17. MHRA recently identified a range of implants (heart valves, heart
valve conduits, vascular grafts and pericardial patches) on the UK
market that use bovine tissue (mainly pericardium) sourced from
an open herd in the USA. The devices were certified by a Spanish
Notified Body despite objections being made about the source of
the material by the UK and other Member States. The basis for the
Spanish certification was that no alternative devices would be
available until the manufacturer found another bovine source (i.e.
from a closed herd or from a GBR I country). However, since
these implants were sourced from an open herd in a GBR III
country, MHRA took the view that the TSE-related risk had not
been minimised and the products were removed from the UK
market.
7 http://europa.eu.int/comm/food/fs/sc/ssc/out137_en.pdf
8 http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573_en.html
9 http://www.aphis.usda.gov/lpa/issues/bse/epi-updates/bse_final_epidemiology_report.pdf

snip...full text 12 pages ;


http://www.seac.gov.uk/papers/91-2.pdf

i seem to recall mentioning all this back in 2000;


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


Two million children innoculated with BSE vaccines

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


Recommendations for the Use of Vaccines Manufactured with Bovine-Derived Materials

Bovine-derived materials have traditionally been used in the manufacture of many biological products, including vaccines. Bovine spongiform encephalopathy (BSE), so-called "mad-cow disease," was first recognized in the United Kingdom (UK) in the 1980s(1). The Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has been concerned about eliminating any potential for contamination of biological products with the BSE agent. This concern was heightened by the appearance of the human transmissible spongiform encephalopathy known as variant Creutzfeldt-Jakob Disease (vCJD, also referred to as new-variant CJD) in the UK in 1996; vCJD has been attributed, among other possibilities, to eating beef products from cattle infected with the agent of BSE (2). To date, there are no reports of BSE contamination of pharmaceutical or biological products. To minimize the possibility of contamination in such products, the FDA, in 1993 (published in the Federal Register on August 29, 1994, 59 FR 44591), and again in 1996, recommended that manufacturers not use materials derived from cattle that were born, raised, or slaughtered in countries where BSE is known to exist; the FDA referred manufacturers to the listing of such countries that is maintained by the U.S. Department of Agriculture (USDA)(3).

In 1991 the USDA list included only countries and other regions in which BSE was known to exist, such as France, Great Britain, Northern Ireland, the Republic of Ireland, Oman, and Switzerland. In 1998, the USDA expanded the list to include countries and other regions in which BSE had not been documented but in which import requirements were less restrictive than requirements that would be acceptable for import into the United States or in which surveillance was inadequate. Thus, all European countries, even those that have had no reported BSE cases, are currently on the USDA list, which is published in the Code of Federal Regulations, title 9, part 94 (9 C.F.R. part 94).

In 2000, CBER learned that its recommendations regarding the sourcing of bovine materials for the manufacture of vaccines had not been followed in at least one instance. As a result of this finding, CBER requested all vaccine manufacturers to review the source for all bovine-derived materials used in the manufacture of their vaccines. This review identified additional vaccines manufactured with bovine-derived materials that had been obtained from European countries on the USDA list.

No evidence exists that any case of vCJD has resulted from the administration of a vaccine product(4), and no cases of vCJD have been reported in the United States. To evaluate the risk of disease that might result from a vaccine manufactured with a process that utilizes bovine materials potentially contaminated with the BSE agent, CBER conducted risk assessments and convened a special joint meeting of the Transmissible Spongiform Encephalopathy Advisory Committee and the Vaccines and Related Biological Products Advisory Committee on July 27, 2000. In assessing the potential risk of vaccines, CBER and the joint Committees considered: (1) the likelihood that any cattle that were used might be infected (i.e., the time period and country of origin) and animal husbandry procedures; (2) the amount of bovine material that might be present in the final vaccine; and (3) the inherent infectivity of the various types of bovine materials that were used. The joint Committees concluded that the risk of vCJD posed by vaccines in the scenarios that were presented was theoretical and remote. They also noted that the benefits of vaccination far outweigh any remote risks of vCJD. The joint Committees made several recommendations.


Bovine-derived materials used in the routine production of vaccines that are sourced from countries on the USDA list should be replaced with bovine-derived materials from countries not on the USDA list.

Working bacterial and viral seed banks and working cell banks that were established using bovine-derived materials sourced from countries on the USDA list should be re-derived with bovine-derived materials from countries not on the USDA list. However, master bacterial and viral seed banks established in a similar manner do not need to be re-derived; the potential risk presented by the master seed banks is even more remote than that presented by the working seed banks and is outweighed by the risk of altering the bacterial or viral vaccine through re-derivation.

These issues are of public interest and, therefore, the public should be informed about the safety of vaccines that used materials sourced from countries on the USDA list, and the assessment of the nature of any risk of vCJD from such vaccines.
As noted above, there is no evidence that any case of vCJD has been caused by or is related to vaccines manufactured with bovine-derived materials obtained from countries in which BSE or a significant risk of BSE exists (i.e., countries on the USDA list), and thus the risk of vCJD is theoretical. The joint Committees' recommendation to replace such bovine-derived materials with bovine-derived materials from countries not on the USDA list was a precautionary measure intended to minimize even the remote risk of vCJD from vaccines.

The source of the bovine-derived materials may be unknown, in part because manufacturers have not always maintained or had access to records of the source of such materials, particularly in the 1980s and early 1990s, before the connection between BSE and vCJD was first suggested (the current best estimate is that BSE first emerged in 1980). Vaccines using bovine-derived materials from a country on the USDA list or from an unknown source to manufacture only the master seed are not listed on this website; the joint Advisory Committees indicated that master seeds need not be re-derived. Additional information on such vaccines can be obtained upon request.

The FDA requested that manufacturers of vaccines using bovine-derived materials obtained from countries on the USDA list or from an unknown source replace these materials with materials from countries not on the USDA list, consistent with the recommendations of the joint Advisory Committees. The manufacturers have fully implemented these changes. No US-licensed vaccine uses bovine derived materials from countries on the USDA list.

The Public Health Service (PHS) recommends that all children and adults continue to be immunized according to current immunization schedules(5). At the present time, the PHS has no preference for using one licensed vaccine product over another based on the source of bovine-derived materials used in vaccine production. The recommendations of the FDA Advisory Committees and the actions of the FDA are, as described, precautionary and have been taken to reduce even the remote potential of a risk of vCJD and to maintain public confidence in the safety of vaccines. Failure to obtain the recommended vaccinations with licensed vaccines poses a real risk of serious disease.

References


Wells G.A.H. et al. 1987. A novel progressive spongiform encephalopathy in cattle. Veterinary Record 121:419-420
Spongiform Encephalopathy Advisory Committee of UK statement of 20 March 1996 (http://www.defra.gov.uk/)
USDA 9 CFR part 94.18
P. D. Minor, R.G. Will and D. Salisbury. 2000. Vaccines and variant CJD. Vaccine 19:409-410.
http://www.cdc.gov/nip/recs/child-schedule.htm; http://www.cdc.gov/nip/recs/adult-schedule.pdf
Table of Contents

Transcripts of 27 July, 2000, Joint Meeting of the Transmissible Spongiform Encephalopathy and Vaccines and Related Biologicals Products Advisory Committees
On July 27, 2000, the Center for Biologics Evaluation and Research (CBER) convened a special joint meeting of the Transmissible Spongiform Encephalopathy and the Vaccines and Related Biological Products Advisory Committees. The purpose of the joint meeting was to ask these committees to consider the potential risks and possible actions that should be taken with regard to licensed and investigational vaccines that contain bovine derived material sourced from countries on the current USDA list of BSE-risk countries. The transcripts of this meeting and copies of the briefing materials provided to the committee members can be found at: http://www.fda.gov/ohrms/dockets/ac/cber00.htm

Table of Contents

CBER and FDA Guidance on Sourcing of Bovine Derived Raw Materials
Letters to manufacturers and other guidance documents are part of the mechanism by which regulated industry and the public are informed about safety issues and expectations of the FDA regarding the development, testing and licensure of vaccines. Although these documents do not have the force of law, they do represent the current thinking of the agency on licensure and control of FDA regulated products.

The following is a summary of the guidance documents and letters from FDA and CBER which relate to the potential for contamination of products with the agent that causes BSE.


Dear Biologic Product Manufacturer
In a May 1991 letter to manufacturers of biological products, CBER requested information on sourcing and control of animal substances. Specifically CBER asked for a list of materials of bovine origin used in the product or in manufacture of the product, as well as supplier information and a description of controls to assure and document the health and origin of the animals used.

Points to Consider in the Characterization of Cell Lines Used for the Production of Biologics
In a letter to manufacturers in July 1993 CBER asked manufacturers to review the May 1993 revision of the 1987 document "Points to Consider in the Characterization of Cell Lines Used for the Production of Biologics". In the revised version of this document CBER indicated that manufacturers should be able to provide detailed information on cell culture history, isolation, media, identity, and adventitious agent testing of cell lines used in the production of biological products.

Manufacturers of FDA-regulated Products
Since 1993 the FDA has recommended that bovine-derived material from cattle which have resided in or originated from countries where BSE has been diagnosed not be used for the manufacture of FDA-regulated products intended for administration to humans. This letter referred to a list of countries where BSE is known to exist - France, Great Britain (including the Falklands), Northern Ireland, Oman and Switzerland. This list is maintained by the USDA. The USDA has the authority to restrict the importation of certain animals, birds, poultry, animals by-products, hay and straw into the US in order to prevent the introduction of various animal diseases including BSE.

Letter to Manufacturers of FDA-regulated Drug/Biological/Device Products
In 1996 following the appearance of vCJD CBER recommended that manufacturers take whatever steps necessary to ensure they are not using bovine material from cattle born, raised or slaughtered in BSE-countries. At that time the BSE-list included France, Great Britain and the Falklands, Northern Ireland, the Republic of Ireland, Oman, Switzerland and Portugal.

Guidance for Industry - The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use
In September 1997 following an April 1997 TSE advisory committee review FDA issued a guidance document for industry addressing the sourcing and processing of gelatin to reduce the potential risk of transmission of BSE through FDA-regulated products for human use.

1998 USDA Interim Rule on Import Restrictions of Ruminant Material from Europe (FR 63(3):406-408, 1/6/98)
In January, 1998, the USDA updated the list of BSE-countries to include not only those countries where BSE was known to exist but to include countries where no case of BSE had been identified but which the USDA believed had less restrictive import requirements than the US and/or inadequate surveillance. This expansion applied all the USDA ruminant and import restrictions to the whole of Europe, including those countries where BSE had not been shown to exist.

Letter to Manufacturers of Biological Products: Recommendations Regarding Bovine Spongiform Encephalopathy - (Text), (PDF)
In April 2000 CBER sent a letter to manufacturers requesting that ruminant derived material from Europe not be used in the manufacture of FDA-regulated products for humans.


http://www.fda.gov/cber/BSE/BSE.htm

THE INFAMOUS DEAR MAD COW VACCINE MANUFACTURE LETTER, kinda like the dear mad cow nutritional supplements manufacturer letter;


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

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

POT CALLING KETTLE BLACK


§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


NOW, bottom line, decades ago, medical authorities tried to warn NOT to use SAFs i.e. scrapie associated fibers of any type in the manufacturing of vaccines, this was in 1968, OOOPS, nobody listened here either, this knowing full well what the Louping vaccine did decades ago killing thousands of sheep from sheep scrapie via a scrapie contaminated vaccine i.e. the Louping ill vaccine. ...

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

THE scientific community on the most part has also stated that the route by inoculation is the most efficient mode of transmission with TSEs ;

8. The Secretary of State has a number of licences. We understand that
the inactivated polio vaccine is no longer being used. There is a stock
of smallpox vaccine. We have not been able to determine the source
material. (Made in sheep very unlikely to contain bovine ingredients).

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


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


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


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


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


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


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


(It was noted with concern that hormone extracts could be manufactured by a veterinary surgeon for administration to animals under his care without any Medicines Act Control.)


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


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


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


TWA LITTLE STATEMENT 331


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


COMMERCIAL IN CONFIDENCE


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

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


NOT FOR PUBLICATION


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


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


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


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


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


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


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


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


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


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

Subject: FDA 50 STATE EMERGENCY BSE CONFERENCE CALL JANUARY 9, 2001


Date: Sun, 7 Jan 2001 09:45:19 -0800
Reply-To: Sustainable Agriculture Network Discussion Group
<[log in to unmask]>
Sender: Sustainable Agriculture Network Discussion Group
<[log in to unmask]>
From: Beth von Gunten <[log in to unmask]>
Subject: [BSE] FDA/IMPORTANT NOTICE: 50 STATE CONFERENCE CALL


IMPORTANT NOTICE: 50 STATE CONFERENCE CALL - BSE

TUESDAY, JANUARY 9, 2001
1:00-2:00 PM EST CALL: 1-888-273-9887

A special "50 STATE CONFERENCE CALL" to discuss BSE (Bovine
Spongiform Encephalopathy) issues for Food and Drug Administration
(FDA) regulated animal feed products in the United States and
imported animal feeds. The conference call will
discuss the FDA proposed response to the current BSE issue and the
assistance needed from state feed and agriculture programs. THIS
ISSUE MAY IMPACT ALL STATES AND ALL ANIMAL FEED AND PRODUCTION
INDUSTRIES.

The 50 State call is scheduled for Tuesday, January 9, 2001 from
1:00-2:00 pm EST. Any state agency responsible for animal feed issues
wishing to participate should call 1-888-273-9887 and ask to be
connected to the "50 State BSE Call". The conference host operator
will explain how to participate, including asking questions during
the call. If possible, please coordinate within your state to utilize
only one phone line per state agency.

We request that you forward this message to your agency management
and feed coordinators or other agencies or departments who may be
responsible for any animal feed issues related to FDA regulated
products.

The agenda will be as follows:

1. Center For Veterinary Medicine (FDA) - Discussion of the problem
related to BSE events in Europe and the impact on US feed ingredients
for animals and feed operations. Discussion of the proposed
actions/inspections/compliance of licensed and unlicensed feed mills,
commercial feed manufacturers, animal feed imports, renderer's,
protein blenders, on-farm mixers, and ruminant feeders.

2. Office of Regional Operations (FDA) - Discussion of
contracting/working with states to inspect the universe of feed
mills/industry for "Animal Proteins Prohibited from Use in Animal
Feed". Discussion of working with FDA field offices.

3. Questions and answers.

Richard H. Barnes, Director
Division of Federal-State Relations (HFC-150)
5600 Fishers Lane Room 1207
Rockville, Md. 20857
ph: (301) 827-6906 FAX: (301) 443-2143
Email: [log in to unmask] http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0101&L=sanet-mg&P=13410
Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001 Date: Tue, 9 Jan 2001 16:49:00 -0800 From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To: BSE-L@uni-karlsruhe.de ######### Bovine Spongiform Encephalopathy ######### Greetings List Members, I was lucky enough to sit in on this BSE conference call today and even managed to ask a question. that is when the trouble started. I submitted a version of my notes to Sandra Blakeslee of the New York Times, whom seemed very upset, and rightly so. "They tell me it is a closed meeting and they will release whatever information they deem fit. Rather infuriating." and i would have been doing just fine, until i asked my question. i was surprised my time to ask a question so quick. (understand, these are taken from my notes for now. the spelling of names and such could be off.) [host Richard Barns] and now a question from Terry S. Singeltary of CJD Watch. [TSS] yes, thank you, U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds? [no answer, you could hear in the back ground, mumbling and 'we can't. have him ask the question again.] [host Richard] could you repeat the question? [TSS] U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds? [not sure whom ask this] what group are you with? [TSS] CJD Watch, my Mom died from hvCJD and we are tracking CJD world-wide. [not sure who is speaking] could you please disconnect Mr. Singeltary [TSS] you are not going to answer my question? [not sure whom speaking] NO from this point, i was still connected, got to listen and tape the whole conference. at one point someone came on, a woman, and ask again; [unknown woman] what group are you with? [TSS] CJD Watch and my Mom died from hvCJD we are trying to tract down CJD and other human TSE's world wide. i was invited to sit in on this from someone inside the USDA/APHIS and that is why i am here. do you intend on banning me from this conference now? at this point the conference was turned back up, and i got to finish listening. They never answered or even addressed my one question, or even addressed the issue. BUT, i will try and give you a run-down for now, of the conference. IF i were another Country, I would take heed to my notes, BUT PLEASE do not depend on them. ask for transcript from; RBARNS@ORA.FDA.GOV 301-827-6906 he would be glad to give you one ;-) Rockville Maryland, Richard Barns Host BSE issues in the U.S., How they were labelling ruminant feed? Revising issues. The conference opened up with the explaining of the U.K. BSE epidemic winding down with about 30 cases a week. although new cases in other countries were now appearing. Look at Germany whom said NO BSE and now have BSE. BSE increasing across Europe. Because of Temporary Ban on certain rendered product, heightened interest in U.S. A recent statement in Washington Post, said the New Administration (old GW) has a list of issues. BSE is one of the issues. BSE Risk is still low, minimal in U.S. with a greater interest in MBM not to enter U.S. HOWEVER, if BSE were to enter the U.S. it would be economically disastrous to the render, feed, cattle, industries, and for human health. (human health-they just threw that in cause i was listening. I will now jot down some figures in which they told you, 'no need to write them down'. just hope i have them correct. hmmm, maybe i hope i don't ???) 80% inspection of rendering *Problem-Complete coverage of rendering HAS NOT occurred. sizeable number of 1st time FAILED INITIAL INSPECTION, have not been reinspected (70% to 80%). Compliance critical, Compliance poor in U.K. and other European Firms. Gloria Dunason Major Assignment 1998 goal TOTAL compliance. This _did not_ occur. Mixed level of compliance, depending on firm. Rendering FDA license and NON FDA license system in place for home rendering & feed 76% in compliance 79% cross contamination 21% DID NOT have system 92% record keeping less than 60% total compliance 279 inspectors 185 handling prohibited materials Renderer at top of pyramid, significant part of compliance. 84% compliance failed to have caution statement render 72% compliance & cross contamination caution statement on feed, 'DO NOT FEED TO CATTLE' 56 FIRMS NEVER INSPECTED 1240 FDA license feed mills 846 inspected "close to 400 feed mills have not been inspected" 80% compliance for feed. 10% don't have system. NON-FDA licensed mills There is NO inventory on non licensed mills. approximately 6000 to 8000 Firms ??? 4,344 ever inspected. "FDA does not have a lot of experience with" 40% do NOT have caution statement 'DO NOT FEED'. 74% Commingling compliance "This industry needs a lot of work and only half gotten to" "700 Firms that were falitive, and need to be re-inspected, in addition to the 8,000 Firms." Quote to do BSE inspection in 19 states by end of January or 30 days, and other states 60 days. to change feed status??? Contract check and ask questions and pass info. At this time, we will take questions. [I was about the third or fourth to ask question. then all B.S.eee broke loose, and i lost my train of thought for a few minutes. picked back up here] someone asking about nutritional supplements and sourcing, did not get name. something about inspectors not knowing of BSE risk??? the conference person assuring that Steve Follum? and the TSE advisory Committee were handling that. Some other Dr. Vet, whom were asking questions that did not know what to do??? [Dennis Wilson] California Food Agr. Imports, are they looking at imports? [Conference person] they are looking at imports, FDA issued imports Bulletin. [Linda Singeltary ??? this was a another phone in question, not related i don't think] Why do we have non-licensed facilities? (conference person) other feed mills do not handle as potent drugs??? Dennis Blank, Ken Jackson licensed 400 non FDA 4400 inspected of a total of 6000 to 8000, (they really don't know how many non licensed Firms in U.S. they guess 6000 to 8000??? TSS) Linda Detwiler asking everyone (me) not to use emergency BSE number, unless last resort. (i thought of calling them today, and reporting the whole damn U.S. cattle herd ;-) 'not' Warren-Maryland Dept. Agr. Prudent to re-inspect after 3 years. concerned of Firms that have changed owners. THE END TSS ############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############ FROM New York TIMES Subject: Re: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA Posting of cut version... Date: Thu, 11 Jan 2001 22:02:47 -0700 From: "Sandy Blakeslee" To: "Terry S. Singeltary Sr." References: 1 Hi terry -- thanks for all your help. I know it made a difference with the FDA getting out that release. ----- Original Message ----- From: "Terry S. Singeltary Sr." To: Sent: Thursday, January 11, 2001 2:06 PM Subject: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA Posting of cut version... > http://www.vegsource.com/talk/madcow/messages/8219.html > http://www.vegsource.com/talk/madcow/messages/8220.html > http://www.vegsource.com/talk/madcow/messages/8221.html > http://www.vegsource.com/talk/madcow/messages/8222.html > http://www.vegsource.com/talk/madcow/messages/8230.html > > hi sandy, >From the New York Times NYTimes.com, January 11, 2001 Many Makers of Feed Fail to Heed Rules on Mad Cow Disease By SANDRA BLAKESLEE Large numbers of companies involved in manufacturing animal feed are not complying with regulations meant to prevent the emergence and spread of mad cow disease in the United States, the Food and Drug Administration said yesterday. The widespread failure of companies to follow the regulations, adopted in August 1997, does not mean that the American food supply is unsafe, Dr. Stephen Sundlof, director of the Center for Veterinary Medicine at the F.D.A., said in an interview. But much more needs to be done to ensure that mad cow disease does not arise in this country, Dr. Sundlof said. The regulations state that feed manufacturers and companies that render slaughtered animals into useful products generally may not feed mammals to cud-chewing animals, or ruminants, which can carry mad cow disease. All products that contain rendered cattle or sheep must have a label that says, "Do not feed to ruminants," Dr. Sundlof said. Manufacturers must also have a system to prevent ruminant products from being commingled with other rendered material like that from chicken, fish or pork. Finally, all companies must keep records of where their products originated and where they were sold. Under the regulations, F.D.A. district offices and state veterinary offices were required to inspect all rendering plants and feed mills to make sure companies complied. But results issued yesterday demonstrate that more than three years later, different segments of the feed industry show varying levels of compliance. Among 180 large companies that render cattle and another ruminant, sheep, nearly a quarter were not properly labeling their products and did not have a system to prevent commingling, the F.D.A. said. And among 347 F.D.A.-licensed feed mills that handle ruminant materials - these tend to be large operators that mix drugs into their products - 20 percent were not using labels with the required caution statement, and 25 percent did not have a system to prevent commingling. Then there are some 6,000 to 8,000 feed mills so small they do not require F.D.A. licenses. They are nonetheless subject to the regulations, and of 1,593 small feed producers that handle ruminant material and have been inspected, 40 percent were not using approved labels and 25 percent had no system in place to prevent commingling. On the other hand, fewer than 10 percent of companies, big and small, were failing to comply with the record-keeping regulations. The American Feed Industry Association in Arlington, Va., did not return phone calls seeking comment. http://www.nytimes.com/2001/01/11/science/11COW.html Subject: USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001 Date: Wed, 10 Jan 2001 14:04:21 -0500 From: "Gomez, Thomas M." Reply-To: Bovine Spongiform Encephalopathy To: BSE-L@uni-karlsruhe.de ######### Bovine Spongiform Encephalopathy ######### USDA/APHIS would like to provide clarification on the following point from Mr. Singeltary's 9 Jan posting regarding the 50 state conference call. [Linda Detwiler asking everyone (me) not to use emergency BSE number, unless last resort. (i thought of calling them today, and reporting the whole damn U.S. cattle herd ;-) 'not'] Dr. Detwiler was responding to an announcement made during the call to use the FDA emergency number if anyone wanted to report a cow with signs suspect for BSE. Mr. Singeltary is correct that Dr. Detwiler asked participants to use the FDA emergency number as a last resort to report cattle suspect for BSE. What Mr. Singeltary failed to do was provide the List with Dr. Detwiler's entire statement. Surveillance for BSE in the United States is a cooperative effort between states, producers, private veterinarians, veterinary hospitals and the USDA. The system has been in place for over 10 years. Each state has a system in place wherein cases are reported to either the State Veterinarian, the federal Veterinarian in Charge or through the veterinary diagnostic laboratory system. The states also have provisions with emergency numbers. Dr. Detwiler asked participants to use the systems currently in place to avoid the possibility of a BSE-suspect report falling through the cracks. Use of the FDA emergency number has not been established as a means to report diseased cattle of any nature. ############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############ Subject: Re: USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE CALL Jan.9, 2001 Date: Wed, 10 Jan 2001 13:44:49 -0800 From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To: BSE-L@uni-karlsruhe.de References: 1 ######### Bovine Spongiform Encephalopathy ######### Hello Mr. Thomas, > What Mr. Singeltary failed to do was provide > the List with Dr. Detwiler's entire statement. would you and the USDA/APHIS be so kind as to supply this list with a full text version of the conference call and or post on your web-site? if so when, and thank you. if not, why not? > The system has been in place for over 10 years. that seems to be a very long time for a system to be in place, and only test 10,700 cattle from some 1.5 BILLION head (including calf crop). Especially since French are testing some 20,000 weekly and the E.U. as a whole, are testing many many more than the U.S., with less cattle, same risk of BSE/TSEs. Why does the U.S. insist on not doing massive testing with the tests which the E.U. are using? Why is this, please explain? Please tell me why my question was not answered? > U.S. cattle, what kind of guarantee can you > give for serum or tissue donor herds? It was a very simple question, a very important question, one that pertained to the topic of BSE/feed, and asked in a very diplomatic way. why was it not answered? If all these years, we have been hearing that pharmaceutical grade bovines were raised for pharmaceuticals vaccines etc. But yet the USA cannot comply with feed regulations of the ruminant feed ban, PLUS cannot even comply with the proper labelling of the feed, cross contamination etc. Then how in the world can you Guarantee the feed fed to pharmaceutical grade bovine, were actually non ruminant feed? Before i was ask to be 'disconnected', i did hear someone in the background say 'we can't'-- have him ask the question again. could you please be so kind, as to answer these questions? thank you, Terry S. Singeltary Sr. Bacliff, Texas USA P.S. if you will also notice, i did not post that emergency phone number and do not intend on passing it on to anyone. I was joking when i said i should call and report the whole damn U.S. Herd. So please pass that on to Dr. Detwiler, so she can rest easily. BUT, they should be reported, some are infected with TSE. The U.S. is just acting as stupid as Germany and other Countries that insist they are free of BSE. TSS Subject: Report on the assessment of the Georgraphical BSE-risk of the USA July 2000 (not good) Date: Wed, 17 Jan 2001 21:23:51 -0800 From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To: BSE-L@uni-karlsruhe.de ######### Bovine Spongiform Encephalopathy ######### Greetings List Members and ALL EU Countries, Because of this report, and the recent findings of the 50-state BSE Conference call, I respectfully seriously suggest that these Countries and the SSC re-evaluate the U.S.A. G.B.R. to a risk factor of #3. snip... Terry S. Singeltary Sr., P.O. Box 42, Bacliff, Texas USA 77518 http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html

CVM Update
<January 10, 2001

UPDATE ON RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES

Bovine spongiform encephalopathy (BSE) is a type of “transmissible spongiform encephalopathy” disease that infects cattle. After the first case in 1986 in the United Kingdom, BSE quickly became an epidemic in cattle herds there. No cases of BSE have been found in U.S. cattle, despite active monitoring.

Rendered feed ingredients contaminated with an infectious agent are believed to be the source of BSE infection in cattle. Some of the feed given to cattle includes remnants of the slaughtering process, such as the brain and spinal cord, which may harbor the agent that causes BSE. Although the material is cooked during the rendering process, the BSE agent can survive.

To prevent the establishment and amplification of BSE through feed in the United States, FDA implemented a final rule that prohibits the feeding of mammalian protein to ruminant animals in most cases. This rule, Title 21 Part 589.2000 of the Code of Federal Regulations, became effective on August 4, 1997.

FDA developed an enforcement plan with the goal of 100% compliance with this rule. For the first two years it was in effect, the enforcement plan included education as well as inspections with FDA taking compliance actions for egregious actions or repeated non-compliance. As part of the enforcement plan, an assignment was issued to all FDA District Offices in 1998 to conduct inspections of 100% of all renderers and feed mills and some ruminant feeders to determine compliance.

FDA's Center for Veterinary Medicine (CVM) has assembled data from the inspections conducted thus far, and presented the following data in a conference call FDA held with Federal and State feed control officials on January 9, 2001.

To date, there have been a total of 9,947 inspections. The majority of these inspections (around 80%) were conducted by State officials and the remainder by FDA. Various segments of the feed industry had different levels of compliance.

For Renderers, who are at the "top of the pyramid" since they are the first to handle rendered protein, and who send materials to feed mills and other ruminant feeders:

Total number of inspections -- 239. Firms handling prohibited material -- 180

Firms whose products were labeled with the required caution statement -- 84%

Had a system to prevent commingling -- 72%

Followed recordkeeping regulations -- 96-98%

For FDA Licensed Feed Mills -- 1,240 total -- Inspected -- 846. Of those feed mills inspected, 347 were handling prohibited material:

Firms whose products were labeled with the required caution statement -- 80%

Had a system to prevent commingling -- 91%

Followed recordkeeping regulations -- 98

For Non-FDA Licensed Feed Mills -- 4,344 inspected (FDA does not know the total number since they are not required to be licensed by the Agency, but it could be 6,000 - 8,000.) Of those feed mills inspected, 1,593 were handling prohibited material:

Firms whose products were labeled with the required caution statement -- 59%

Had a system to prevent commingling -- 74%

Followed recordkeeping regulations -- 91%

FDA is continuing its enforcement efforts to achieve the goals of 100% inspection of all renderers and feed mills and some ruminant feeders and 100% compliance with the ruminant feed regulations. FDA Field offices have an assignment to re-inspect 700 firms that were not in full compliance with the rule but have committed to implementing the regulation. In addition, FDA is seeking assistance from State feed control officials to identify non-FDA licensed feed mills and to conduct additional inspections in all categories. FDA anticipates higher levels of compliance after completion of follow-up inspections.


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

Issued by:
FDA, Center for Veterinary Medicine,
Office of Management and Communications, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (301) 827-3800 FAX: (301) 827-4065
Internet Web Site: http://www.fda.gov/cvm

http://www.fda.gov/cvm/bseup.htm


From:

Subject: confidential


To: flounder@wt.net


Sorry did not get back to you. (Ran out of time!!)

Of interest...don't repeat. On Jan 9, was somewhere
and not able to tie into conference call. Was around
an official who should have been on conference
call..another person with me also remembered it and we
both inquired as to how the call went. Was told (to
both of us) that the call had been cancelled!! (Told
us several times that the call was cancelled and they
did not know why!!!) I will try to find out why this
person said that...maybe they got off the call or they
were told to tell everyone that the call was cancelled.
You need to POST your interaction with the conference
call on a web site....let me know when you do...

snip...

There must be a reason for
the lying....??? Surely people who are really
interested will found out what went on? There are
quite a few people who listened in and declined to
identify or acknowledge that they listened in...why
the big secrecy or this person may have been told to
do this. Need to know!!! Something dirty is going
on...some sort of treachery seems to be in the works...
Not a good situation for me right now...wish I could
tell you more as to what is going on...but too
dangerous right now...got to sort it out.


***

Date: Sun, 21 Jan 2001 23:50:31 +0000 (GMT)


From:

Subject: stuff


To: "Terry S. Singeltary Sr."

Confidential:


Budget: let me know what you find out and the
breakdown. There may be some stuff stuffed into it
which is not legit... They may figure some salaries
and such...the real gist of the matter is the shocking
amount of $ that is actually used to "ferret" out the
disease and the $ that are used to P.R. the whole
affair and give appearance of being concerned and
involved...again it was said years ago and it should
be taken seriously....BSE will NEVER be found in the US!


As for the BSE conference call...I think you did a
great service to freedom of information and making
some people feign integrity...I find it scary to see
that most of the "experts" are employed by the federal
government or are supported on the "teat" of federal
funds. A scary picture!


snip...


The most frightening thing I have read all day is the
report of Gambetti's finding of a new strain of
sporadic cjd in young people.........Dear God, what in
the name of all that is holy is that!!!
If the US has different strains of
scrapie.....why????than the UK...then would the same
mechanisms that make different strains of scrapie here
make different strains of BSE...if the patterns are
different in sheep and mice for scrapie.....could not
the BSE be different in the cattle, in the mink, in
the humans.......I really think the slides or tissues
and everything from these young people with the new
strain of sporadic cjd should be put up to be analyzed
by many, many experts in cjd........bse.....scrapie
Scrape the damn slide and put it into
mice.....wait.....chop up the mouse brain and and
spinal cord........put into some more mice.....dammit
amplify the thing and start the damned
research.....This is NOT rocket science...we need to
use what we know and get off our butts and move....the
whining about how long everything takes.....well it
takes a whole lot longer if you whine for a year and
then start the research!!!
Not sure where I read this but it was a recent press
release or something like that:
I thought I would fall out of my chair when I read
about how there was no worry about infectivity from a
histopath slide or tissues because they are preserved
in formic acid, or formalin or formaldehyde.....for
God's sake........ Ask any pathologist in the UK what
the brain tissues in the formalin looks like after a
year.......it is a big fat sponge...the agent
continues to eat the brain ......you can't make slides
anymore because the agent has never stopped........and
the old slides that are stained with Hemolysin and
Eosin......they get holier and holier and degenerate
and continue...what you looked at 6 months ago is not
there........Gambetti better be photographing every
damned thing he is looking at.....

Okay, you need to know. You don't need to pass it on
as nothing will come of it and there is not a damned
thing anyone can do about it. Don't even hint at it
as it will be denied and laughed at..........
USDA is gonna do as little as possible until there is
actually a human case in the USA of the
nvcjd........if you want to move this thing along and
shake the earth....then we gotta get the victims
families to make sure whoever is doing the autopsy is
credible, trustworthy, and a saint with the courage of
Joan of Arc........I am not kidding!!!!
so, unless we get a human death from EXACTLY the same
form with EXACTLY the same histopath lesions as seen
in the UK nvcjd........forget any action........it is
ALL gonna be sporadic!!!

And, if there is a case.......there is gonna be every
effort to link it to international travel,
international food, etc. etc. etc. etc. etc. They
will go so far as to find out if a sex partner had
ever traveled to the UK/europe, etc. etc. ....
It is gonna be a long, lonely, dangerous twisted
journey to the truth. They have all the cards, all
the money, and are willing to threaten and carry out
those threats....and this may be their biggest
downfall...

Thanks as always for your help.
(Recently had a very startling revelation from a rather senior person in
government here..........knocked me out of my chair........you must keep
pushing. If I was a power person....I would be demanding that there be a
least a million bovine tested as soon as possible and agressively
seeking this disease. The big players are coming out of the woodwork as
there is money to be made!!!
In short: "FIRE AT WILL"!!! for the very dumb....who's "will"! "Will
be the burden to bare if there is any coverup!"

snip...end

***

TSS

CORRECT AS OF 21ST SEPTEMBER 2006

17

Medical Implants Containing Bovine Material

At SEAC 91 (February 2006) the Medicines and Healthcare products

Regulatory Agency (MHRA) asked the committee to consider the

potential BSE risks to humans from medical implants using bovine

material from the USA.

The regulations on medical devices containing animal materials are

based on the principle that TSE risks must be eliminated or reduced as

much as possible and residual risks must be acceptable when weighed

against the benefits to patients. Currently no guidance exists on the

acceptability of TSE risk control measures applied to animal material in

medical devices.

The MHRA requested advice on three 3 issues. (i) can TSE risk

associated with medical implants using USA sourced bovine material be

estimated given that it might vary over time? (ii) is there, or has there

been a significant risk that might warrant action in addition to that

already taken? (iii) can the standards that support the regulations be

altered to facilitate a consistent approach about the acceptability of

products?

The committee concluded that:

• a risk assessment should be conducted on each device because

of the large number of variables that influence associated TSE

risks.

Key factors which should be considered when assessing risks are:

• the animal source. Use of material from closed herds or from

herds that are managed carefully to prevent the introduction of

the BSE agent.

• use of material from young animals would markedly lower risk

compared with older animals.

• the geographical risk of BSE. The geographical BSE risk

status of a country gives an imprecise indication of BSE risk. It

would be better to use an estimated prevalence of BSE in a

country based on data from a robust surveillance system.

• the potential TSE infectivity of the source tissue(s) based on a

careful assessment of the available data on tissue infectivity.

CORRECT AS OF 21ST SEPTEMBER 2006

18

• the site of implantation. Sites with contact with the blood supply

or CNS may increase risk.

• whether TSE testing is undertaken on the source animal(s).

• the number of source animals used for each device.


snip...


CORRECT AS OF 21ST SEPTEMBER 2006

44

Conformation-dependent immunoassay (CDI) for abnormal prions

At SEAC 88 (June 2005), SEAC commented on a recent paper11 which

had reported that the conformation-dependent immunoassay (CDI) for

abnormal prions was more sensitive than other biochemical tests.

The committee:

• commented that, unlike most biochemical tests, it did not rely on

proteinase K (PK) digestion of prions and could detect PK

sensitive forms of abnormal prions.

• expressed caution about the assumption that the test was

capable of measuring the infectious agent, as the form of prion

constituting the infectious agent was still unclear.

11 Safar et al. (2005) Diagnosis of human prion disease. Proc. Natl. Acad. Sci. U S A. 102,

3501-3506.


snip...


5. Dr Brian Matthews noted that the available information on the

incidence of CJD in various countries, other than the UK, indicates

that there is no obvious decline in the numbers of cases being

reported. However, in the UK there seems to have been a steady

decline in the number of suspected cases, and therefore of

confirmed cases, for the past several years. He asked 3

questions: (i) What are the causes of the decline in the number of

suspected cases reported in the UK over the past few years? (ii)

What is the effect of this decline in reports of suspected cases on

the certainty of the decline of the number of new cases of vCJD

reported in the UK? (iii) What is the effect of this decline in reports

of suspected cases on the certainty that new cases of iatrogenic

transmission of CJD and/or vCJD could be identified?

6. Professor Ironside commented that the number of suspected cases

of sCJD reported each year had varied since surveillance began,

but numbers had appeared to decline in the past 2 years.

However, this was unlikely to be due to significant numbers of

cases being missed. As a way of checking to see if cases had

been missed, NCJDSU had looked back at diagnosed cases of

atypical dementia but had not identified any cases of CJD. The

recent decrease in numbers of suspected cases reported was

therefore probably due to improvements in clinical diagnostic

criteria and the resultant improved quality of referrals. NCJDSU

had very good links with clinicians and pathologists across the UK.


http://www.seac.gov.uk/pdf/issue_summary.pdf

I find this interesting ;

(i) What are the causes of the decline in the number of

suspected cases reported in the UK over the past few years?


(ii) What is the effect of this decline in reports of suspected cases on

the certainty of the decline of the number of new cases of vCJD

reported in the UK?


SO, the cases of nvCJD in the UK went up for years and years and then started declining as with BSE cases due to the feed ban rules, surveillance, eradication, and other factors, and sporadic CJD cases went up and up too, and then started going down at about the same time. interesting? probably just another coincidence ;-) look at Italy in 2005 98 sporadic CJD cases, Germany 81, and France at 81 cases in 2005 as well, all well known BSE countries, all with increases of sporadic CJD since 1993. ...


http://www.eurocjd.ed.ac.uk/sporadic.htm


-------- Original Message -------- Subject: re-BSE prions propagate as

either variant CJD-like or sporadic CJD Date: Thu, 28 Nov 2002 10:23:43

-0000 From: "Asante, Emmanuel A" To:
"'flounder@wt.net'"

Dear Terry,

I have been asked by Professor Collinge to respond to your request. I am

a Senior Scientist in the MRC Prion Unit and the lead author on the

paper. I have attached a pdf copy of the paper for your attention. Thank

you for your interest in the paper.

In respect of your first question, the simple answer is, yes. As you

will find in the paper, we have managed to associate the alternate

phenotype to type 2 PrPSc, the commonest sporadic CJD.

It is too early to be able to claim any further sub-classification in

respect of Heidenhain variant CJD or Vicky Rimmer's version. It will

take further studies, which are on-going, to establish if there are

sub-types to our initial finding which we are now reporting. The main

point of the paper is that, as well as leading to the expected new

variant CJD phenotype, BSE transmission to the 129-methionine genotype

can lead to an alternate phenotype which is indistinguishable from type

2 PrPSc.


I hope reading the paper will enlighten you more on the subject. If I

can be of any further assistance please to not hesitate to ask. Best wishes.


Emmanuel Asante

<> ____________________________________

Dr. Emmanuel A Asante MRC Prion Unit & Neurogenetics Dept. Imperial

College School of Medicine (St. Mary's) Norfolk Place, LONDON W2 1PG

Tel: +44 (0)20 7594 3794 Fax: +44 (0)20 7706 3272 email:

e.asante@ic.ac.uk (until 9/12/02)

New e-mail: e.asante@prion.ucl.ac.uk (active from now)

____________________________________

snip...

full text ;

http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm


TSS



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