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From: TSS ()
Subject: Mad-Cow Feed Rules Will Be Tightened in U.S. in 2006 (Update1) yada yada yada
Date: February 17, 2006 at 2:11 pm PST

Mad-Cow Feed Rules Will Be Tightened in U.S. in 2006 (Update1)
Feb. 16 (Bloomberg) -- The U.S. probably will enact rules this year to ban the use in animal feed of cattle parts most likely to spread mad-cow disease, putting into effect a proposal announced last year, regulators said.

The Food and Drug Administration will publish by July 1 its final version of revised cattle-feed rules, said Stephen Sundlof, the head of the agency's Center for Veterinary Medicine, in an interview today. The rule will take effect a short time later, perhaps within a month, he said. The FDA announced the draft rules in October.

The revisions will be the first tightening of the rules since the FDA barred feeding cattle parts to cattle in 1997. The FDA has considered and then abandoned stronger measures for preventing the brain-wasting disease, also called bovine spongiform encephalopathy, said Representative Rosa DeLauro, the top Democrat on the House panel that oversees the FDA budget.

``We have been operating under rules from 1997, even though our understanding of how BSE is spread has increased dramatically since then,'' DeLauro, of Connecticut, told Acting FDA Commissioner Andrew von Eschenbach at a subcommittee meeting today on the agency's budget.

Mad cow disease, which has a fatal human form, appears to spread to cattle and people by eating infected meat. The disease appears to stem from abnormal proteins, called prions, which occur in cattle's small intestines, brains, eyes and spinal cords. The disease robs people of speech and control of their movement, leaving them immobile and mute, and then leading to death.

Ban by Japan

The first U.S. case of mad cow disease was discovered in December 2003, touching off a ban on the nation's beef by Japan, formerly the biggest importer of the product. Japan had only allowed imports to resume in December and then suspended them again in January following the discovery of banned spinal tissue in three boxes of a veal shipment.

Tommy Thompson, then U.S. Health and Human Services Secretary, said in January 2004 the FDA would bar cattle from receiving mammal blood in feed because of a theoretical risk of transmitting mad cow disease. Thompson also said the agency would bar feeding litter from chicken pens and table scraps from restaurants to cattle, as they can contain cattle meat.

None of these measures was included in the proposal the FDA released in October, DeLauro said. The FDA instead said it would focus on what it considered the biggest risk, and called for eliminating the brains and spinal cords of cows older than 30 months from animal feed.

The FDA is looking to change how all animals are fed to prevent cases of cattle eating food intended for other animals being exposed to mad cow disease.

The FDA will have a final rule by July 1, von Eschenbach said.

``We have approached this very much from the point of view of risk and concern about the risk and benefit that would come'' from further regulation, he said.

To contact the reporter on this story:
Kerry Young in Washington at kdooley@bloomberg.net.

Last Updated: February 16, 2006 18:24 EST


http://www.bloomberg.com/apps/news?pid=10000101&sid=aDKMsagz9GJI&refer=japan

Congressional Testimony
Latest: Andrew C. von Eschenbach, M.D.,
Acting Commissioner of the Food and Drug Administration -- FY07 Budget House Hearing -- February 16, 2006

http://www.fda.gov/ola/2006/budget_hearing0216.html

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/delaurotss

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: 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


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

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

OLD TSS SUBMISSIONS;

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

PDF]Freas, William TSS SUBMISSION

File Format: PDF/Adobe Acrobat -

Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary

Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ...

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

Asante/Collinge et al, 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;

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


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

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

> This compares to 100% mortality in less than 25 months in elk orally

> inoculated with different dosages of the CWD prion.


CWD kills 25% of elk IN PENS CONTAMINATED WITH CWD


Subject: Wasting disease kills 25% of elk IN PENS CONTAMINATED WITH CWD 11 OF 43 IN FOUR YEARS
Date: February 16, 2006 at 10:20 am PST

DRAFT

WYOMING GAME AND FISH DEPARTMENT

CHRONIC WASTING DISEASE MANAGEMENT PLAN

February 17, 2006


snip...


5. Predicted population effects on free-ranging elk based on captive elk chronically exposed to the CWD prion.
Forty-three female elk calves were trapped at the National Elk Refuge and transported to Sybille in February 2002. Elk were housed in pens, assumed to be environmentally contaminated with the CWD prion. Elk will be held throughout their lifetimes. Elk dying will be examined and cause of death determined. From these data, it will should be possible to model free-ranging elk mortality and population dynamics under extreme circumstances of CWD prion exposure and transmission. As of December 2005 (46 months post capture), 11 of 43 elk have died due to CWD. This compares to 100% mortality in less than 25 months in elk orally inoculated with different dosages of the CWD prion.


REVISED DRAFT


http://gf.state.wy.us/downloads/pdf/CWD2005reviseddraft.pdf


DRAFT


http://gf.state.wy.us/downloads/pdf/CWD2005Plan8-19-05.pdf

http://gf.state.wy.us/downloads/pdf/04-05_annual_report.pdf

tss



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