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From: TSS ()
Subject: IMPLEMENTATION OF GWs GLOBAL TRADING OF ALL STRAINS OF TSEs aka mad cow diseases
Date: July 19, 2005 at 7:33 am PST


Bovine Spongiform Encephalopathy (BSE)
BSE: Recent Information

7/15/05 Animal Products
Implementation: Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities from Canada PDF

http://www.aphis.usda.gov/lpa/issues/bse/trade/Dear_Product_importer.pdf
Live Animals
Importation of Bovines (Cattle or Bison) from Canada for Feeding PDF
BSE Minimal-Risk Regions and the Importation of Live Animals Importers, Brokers, and Other Interested Parties PDF
BSE Minimal-Risk Regions and the Importation of Live Animals Accredited Veterinarians or Other Interested Parties PDF
USDA, APHIS, Veterinary Services, National Center for Import and Export: Protocol for The Importation of Cattle or Bison for Feeding from Canada PDF
USDA, APHIS, Veterinary Services, National Center for Import and Export: Protocol for the Importation of Cattle, Bison, Sheep and Goats for Immediate Slaughter from Canada PDF
USDA, APHIS, Veterinary Services, National Center for Import and Export: Protocol for the Importation of Sheep and Goats for Feeding from Canada PDF
7/15/05 Johanns Announces Next Steps for Importing Canadian Cattle
Transcript of Tele-News Conference with Agriculture Secretary Mike Johanns
Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities— FINAL RULE— 9 CFR Parts 93, 94, 95, and 96 [Docket No. 03-080-3]
• Risk Document PDF
• Economic Analysis PDF
• Appendices to economic analysis PDF
• Final environmental assessment PDF
• Final Rule on BSE and Minimal-Risk Regions (Factsheet)
• Questions and Answers for Minimal Risk/Canada Rule
• Port of Entry for Eligible Ruminants


http://www.aphis.usda.gov/lpa/issues/bse/bse.html


Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL
IMPORTS FROM CANADA


https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed

From: TSS ()
Subject: Mad cow blamed on CFIA ''Canada followed U.S. policies''
Date: July 13, 2005 at 12:51 pm PST


Agency blamed for mad cow fallout

By DENNIS BUECKERT


OTTAWA (CP) - Canada's $8-billion mad cow disaster can be squarely attributed the failure of the Canadian Food Inspection Agency to assess economic consequences of even a single infection, says a leading expert.

William Leiss of the University of Ottawa, who is also a past president of the Royal Society of Canada, said the CFIA assessed the risk of mad cow to animal health and human health, but not the risk of losing export markets. Yet Canada was party to an international agreement providing for a ban on exports from any country with even a single case of the disease. The policy was known as "one cow and you're out."

"What would be the economic impact of one or just a few cases of BSE (bovine spongiform encepalopathy) in the Canadian herd?" Leiss asked at a World Health Organization conference on risk management.

"We failed completely to manage or even to recognize this risk at our great cost."

He said Canada followed U.S. policies in adopting a minimal testing program. But Canada's risk profile is completely different from that of the United States.

At the time, Canada exported 75 per cent of beef production while the United States exported only 10 per cent. Losing export markets was not a serious problem for the Americans, he said.

"In food issues we are cursed with the political attitude that we've just got to be onside with the U.S. and nothing else matters."

He said the CFIA also followed the U.S. lead in making a half-hearted effort to stop recycling infected protein in ruminant food, which is widely believed to be the cause of mad cow disease.


Leiss said the CFIA ban on feeding proteins from ruminants to ruminants remains "full of holes."

Leiss said the United States conducted a full risk assessment in 1997-98, but Canada did not do one until six years later.

CFIA spokesman Marc Richard said the agency didn't include economic consequences in its assessment because that is not the agency's mandate.

"We don't usually address the economic stuff," said Richard in an interview. "The risk assessment was based strictly on the disease. Overall we're the administrators of the Animal Health Act.

"The CFIA's risk assessments have to do with animal disease. That is our mandate and in our mandate we specifically don't address economics."

But another CFIA official, senior veterinarian Darcy Undseth, said economic consequences of a mad cow infection in Canada were considered in a 2002 risk assessment even though they were not quantified.

He said the consequences were described in that assessment as "extreme."

Undseth said the CFIA's response was "very successful because of the proactive steps taken since 1990 and the very measured response taken in a North American context.

"BSE has not established and amplified in North America but was captured on its way to eradication."

Asked about the estimated $8 billion in economic losses to date, Undseth said animal diseases do have economic impact but the BSE response "has been a successful program."

http://cnews.canoe.ca/CNEWS/Canada/2005/07/12/1128444-cp.html


USA BSE GBR RAISED TO BSE GBR III

Working Group Report on the Assessment of the Geographical BSE-Risk (GBR
III) of USA 2004 ''extremely/very unstable BSE/cattle system''

USA

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/574/sr03_biohaz02_usa_report_annex_en1.pdf>

CANADA

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/563/sr02_biohaz02_canada_report_annex_en1.pdf

MEXICO

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/566/sr04_biohaz02_mexico_report_annex_en1.pdf


Canada and the United States have been raised to level III (presence of BSE likely but not confirmed, or confirmed at a lower level) following a new assessment taking into account the most recent evidence. EFSAs Scientific Expert Working Group on geographic BSE risk assessment also evaluated the status of Mexico and South Africa which were classified as level III.

http://www.efsa.eu.int/press_room/press_release/575_en.html


From: Terry S. Singeltary Sr. [flounder@wt.net]
Sent: Tuesday, July 29, 2003 1:03 PM
To: fdadockets@oc.fda.gov
Cc: ggraber@cvm.fda.gov; Linda.Grassie@fda.gov; BSE-L
Subject: Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION
TO DOCKET 2003N-0312]

Greetings FDA,

snip...

PLUS, if the USA continues to flagrantly ignore the _documented_ science to date about the known TSEs in the USA (let alone the undocumented TSEs in cattle), it is my opinion, every other Country that is dealing with BSE/TSE should boycott the USA and demand that the SSC reclassify the USA BSE GBR II risk assessment to BSE/TSE GBR III 'IMMEDIATELY'. for the SSC to _flounder_ any longer on this issue, should also be regarded with great suspicion as well. NOT to leave out the OIE and it's terribly flawed system of disease surveillance. the OIE should make a move on CWD in the USA, and make a risk assessment on this as a threat to human health. the OIE should also change the mathematical formula for testing of disease. this (in my opinion and others) is terribly flawed as well. to think that a sample survey of 400 or so cattle in a population of 100 million, to think this will find anything, especially after seeing how many TSE tests it took Italy and other Countries to find 1 case of BSE (1 million rapid TSE test in less than 2 years, to find 102 BSE cases), should be proof enough to make drastic changes of this system. the OIE criteria for BSE Country classification and it's interpretation is very problematic. a text that is suppose to give guidelines, but is not understandable, cannot be considered satisfactory. the OIE told me 2 years ago that they were concerned with CWD, but said any changes might take years. well, two years have come and gone, and no change in relations with CWD as a human health risk. if we wait for politics and science to finally make this connection, we very well may die before any decisions
or changes are made. this is not acceptable. we must take the politics and the industry out of any final decisions of the Scientific community. this has been the problem from day one with this environmental man made death sentence. some of you may think i am exaggerating, but you only have to see it once, you only have to watch a loved one die from this one time, and you will never forget, OR forgive...yes, i am still very angry... but the transmission studies DO NOT lie, only the politicians and the industry do... and they are still lying to this day...TSS


http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt

Terry S. Singeltary Sr. P.O. BOX 42 Bacliff, TEXAS USA


From: TSS ()
Subject: MAD COW FEED BAN WARNING LETTER USA June 9, 2005
Date: July 5, 2005 at 8:46 am PST

Department of Health and Human Services Public Health Service
Food and Drug Administration

Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612) 758-7119
FAX: (612) 334-4142


June 9, 2005

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 05-15

Michael J. Langenhorst
President
Anamax Corporation
P.O. Box 10067
Green Bay, WI 54307

Dear Mr. Langenhorst:

Our inspection of your rendering plant located at 505 Hardman Avenue South, South St. Paul, Minnesota, from January 12-20, 2005, revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations , Part 589 .2000 (21 CFR 589 .2000), Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Because you failed to follow the requirements of this regulation, products being manufactured and distributed by your facility are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(4)], and misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)].

Our investigation found that you failed to provide for measures to prevent commingling or cross-contamination and to maintain sufficient written procedures [21 CFR 589.2000(e)] in that:

1. You failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues into feeds that may be used for ruminants.

2. You failed to maintain written procedures specifying the clean-out procedures or other means to prevent carryover of protein derived from mammalian tissues into feeds that may be used for ruminants.

Our investigation also found that you failed to label products that may contain protein derived from mammalian tissues with the statement, "Do not feed to cattle or other ruminants." For example, your Feather Meal and Stabilized Poultry By-Product Meal lack this statement, even though the absence of sufficient measures to avoid commingling or cross-contamination may result in these products containing protein derived from mammalian tissues. Because your products do not bear this caution statement, they are misbranded under Section 403(a)(1) of the Act [21 U.S .C. 343(a)(1)).

The above is not intended as an all-inclusive list of violations. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring that your overall operation and the products you manufacture and distribute are in compliance with the law.

You should acknowledge this letter within 15 working days of receiving and include any additional corrective actions concerning your facility. We have received your letter dated January 31, 2005, which replies to the Form FDA-483 issued on January 20, 2005, and your letter dated February 25, 2005, that states all corrections have been implemented. The corrections you have reported appear to be adequate but will be evaluated further during our follow-up inspection.

Your response should be directed to Compliance Officer Jane E . Nelson at the address on the letterhead. If you have any questions regarding this letter, you may phone Ms. Nelson at (612) 758-7119.

Sincerely,

/S/

W. Charles Becoat
Director
Minneapolis District


http://www.fda.gov/foi/warning_letters/g5373d.pdf


Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission)

https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument


Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL
IMPORTS FROM CANADA


https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed


Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION]

http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt

Docket Management Docket: 02N-0273 - Substances Prohibited From Use in

Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

Comment Number: EC -10

Accepted - Volume 2


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html

PART 2


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html


TSS




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