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From: TSS ()
Subject: Summary of Enhanced BSE Surveillance in the United States & BSE Prevalence Estimate for U.S. April 27, 2006
Date: April 28, 2006 at 7:40 am PST

Summary of Enhanced BSE Surveillance in the United States

Prepared by

Centers for Epidemiology and Animal Health

National Surveillance Unit

April 27, 2006

2

Summary of Enhanced BSE Surveillance in the United States

Introduction

Since 1990, the U.S. Department of Agriculture (USDA) has taken aggressive measures

to prevent the introduction and potential spread of bovine spongiform encephalopathy

(BSE). Following the confirmation of BSE in an imported cow in December 2003,

USDA designed and implemented an Enhanced BSE Surveillance Program to more

accurately determine the level of disease present in the U.S. cattle population. The

following report summarizes the data collected during the Enhanced BSE Surveillance

Program as well as the information gathered from earlier surveillance efforts.

The Enhanced BSE Surveillance Program tested as many cattle as possible in the targeted

high-risk population beginning June 1, 2004. Collection at an enhanced level has

continued beyond 18 months to ameliorate concerns of trading partners. Experience in

the United Kingdom and Europe has shown that if present, BSE is most likely to be

detected in adult cattle exhibiting clinical signs consistent with the disease.

Base Estimate of High Risk Population

In general, the highest risk categories are adult cattle showing clinical signs involving the

central nervous system (CNS), and dead and non-ambulatory cattle with clinical signs

that could not be adequately evaluated. This population was estimated to total 445,886

adult cattle per year in the United States. This number was derived in part from National

Animal Health Monitoring System (NAHMS) surveys of livestock producers and other

estimates.

Specifically, in the 1997 NAHMS breeding beef cattle survey,1 U.S. producers reported

that approximately 1.5 percent of the adult cattle population died annually. Producers

attributed these losses to a variety of causes including digestive, respiratory, weather, and

calving-related problems, as well as other known and unknown causes.

Similarly, in 2002, NAHMS data estimated that 4.8 percent of adult dairy cows die

annually. Again, these losses were attributed to various causes. Calculations resulted in

an estimate that 251,532 adult cattle die on-farm each year for unknown reasons, or

reasons that could be consistent with BSE-related clinical signs.2 In addition, other

described populations include 194,225 animals in the Food Safety and Inspection Service

(FSIS) condemnation categories, and 129 reported foreign animal disease (FAD)

investigations related to CNS abnormalities. These totals provide the basis for USDA’s

estimate of 445,886 adult cattle per year in the targeted high-risk population.

1 NAHMS Part I: Reference of 1997 Beef Cow-Calf Management Practices. USDA:APHIS:VS: CEAH,

National Animal Health Monitoring System. June 1997. Fort Collins, CO. #N238.398.

2 NAHMS Part I: Reference of Dairy Health and Management in the United States. National Animal Health

Monitoring System. 2002. Fort Collins, CO. #N377.1202.

3

This estimate includes adult cattle in the following categories:

• Condemned at slaughter for CNS signs;

• Moribund; dead; injured or emaciated (FSIS data 2002);

• CNS abnormalities reported for FAD investigations (APHIS data 2003);

• Died on-farm of unknown causes;

• Lameness or injury that resulted in euthanasia; and

• Cattle that died with signs of incoordination or severe depression.

The sampling strategy was designed to target animals in these categories.

Designation of Samples Collected during Enhanced BSE Surveillance

Samples collected during the enhanced surveillance period were designated as “targeted”

and “non-targeted.” Samples with valid test results having any of the following reasons

for submission, regardless of age or other criteria, were categorized as “targeted” in the

enhanced surveillance program:

• Highly suspicious for BSE;

• CNS signs;

• Rabies suspect;

• FSIS antemortem condemnation code of “CNS signs” or “rabies.”

Other samples collected during the period associated with the enhanced surveillance that

did not meet the above criteria were considered as follows:

• Samples with a reason for submission of “FSIS antemortem condemnation”

were recorded as targeted only if the condemnation code listed

nonambulatory, injuries, tetanus, dead, or moribund. In addition, the sample

must have originated from cattle with a recorded age of 30 months or older, or

from cattle with a recorded age of 24 to 29 months with the second set of

incisors erupted.3

• Samples with a reason for submission of nonambulatory, dead, or other

clinical signs that may be associated with BSE were recorded as targeted if

they originated from cattle with a recorded age of 30 months or older, or from

cattle with a recorded age of 24 to 29 months with the second set of incisors

erupted.

• Samples with a reason for submission of “apparently healthy animal at

slaughter” were recorded as targeted if they were collected at a slaughter plant

and they originated from cattle with a recorded age of 30 months or older, or

with the second set of incisors erupted.

3 Eruption of at least one of the second set of permanent incisors was used as the criterion upon which

cattle were determined to be at least 30 months of age.

4

Samples with the following invalid test results were not included in the targeted

population and were excluded from this report:

• Samples in which submitted tissue was not obex;4 and

• Samples not tested or where results have not been recorded in the BSE

Surveillance database.

Between June 1, 2004, and March 17, 2006, BSE samples were collected from 5,776

unique locations across the United States. These locations included slaughter plants,

renderers, farms, public health laboratories, veterinary diagnostic laboratories, and

salvage slaughter (3D-4D)5 plants.

Overall, 647,045 samples were designated as “targeted” based on the enhanced

surveillance criteria discussed above. Among these samples USDA identified two

confirmed positives over this time period (0.0003 percent test positive). Table 1

summarizes the number of samples from each type of collection site.

Sample collectors were required to categorize submissions into one of eight submission

type categories. These categories were not those provided in the World Organization for

Animal Health (OIE) Code for BSE surveillance, but offered a greater level of detail that

facilitated later classification into the OIE surveillance streams. ...SNIP...FULL TEXT 23 PAGES;

http://www.aphis.usda.gov/newsroom/hot_issues/bse/content/printable_version/SummaryEnhancedBSE-Surv4-26-06.pdf

DRAFT

An Estimate of the Prevalence of BSE in the United States

Prepared by

Centers for Epidemiology and Animal Health

National Surveillance Unit

April 27, 2006

THIS INFORMATION IS DISTRIBUTED SOLELY FOR THE PURPOSE OF

PRE-DISSEMINATION PEER REVIEW UNDER APPLICABLE

INFORMATION QUALITY GUIDELINES. It has not been formally disseminated

by the Animal and Plant Health Inspection Service. It does not represent and

should not be construed to represent ANY Agency DETERMINATION OR policy.

DRAFT

DRAFT DRAFT

4

Executive Summary

The United States has conducted bovine spongiform encephalopathy (BSE) surveillance

with increasing intensity since 1990, including an enhanced effort following the

identification of a Canadian cow that tested positive in 2003 (APHIS 2006). The goal of

this analysis is to estimate the prevalence of BSE in the United States using surveillance

data that have been collected over the 7-year period prior to March 17, 2006; this

surveillance timeframe reflects World Organization for Animal Health (OIE) guidelines,

which suggest determining prevalence over a 7-year period. This information will help

guide and support future requests for consideration of the overall BSE status of the

United States. This report is considered a draft and will undergo peer review. Moreover,

in the interest of transparency, this information will also be made publicly available on

the U.S. Department of Agriculture website.

Among the 735,213 cattle sampled in the 7 years prior to March 17, 2006, two infected

indigenous animals were identified by the surveillance in addition to the 2003 imported

cow from Canada. The results of this analysis suggest that the number of infected cattle

in the United States is very low.

We estimated the prevalence using two methods. The first estimate is from the BSurvE

model (Wilesmith et al., 2004) and is based only on surveillance testing data with no

additional information about an effective feed ban. The second method, the Bayesian

Birth Cohort model (BBC), was suggested by Vose Consulting in an independent review

of the analysis1 and uses the point assignments (sample’s information value) from the

BSurvE model. It assumes that the U.S. feed ban implemented in 1997 was at least as

effective as a feed ban initiated by the United Kingdom (UK) in 1988 and that prevalence

in the United States would decline proportionately. The mathematical techniques used in

this method combine the surrogate UK feed ban effectiveness with U.S. surveillance data

to provide a more precise estimation of the expected prevalence in the United States.

The most likely value (with upper and lower confidence levels) for the estimated number

of BSE infected cattle from the two models was 4(1 , 8) (BBC) and 7(3 , 24) (BSurvE) in

a population of approximately 42 million adult cattle. The results, including upper

bounds of both methods, support a conclusion that the prevalence of BSE in the United

States is less than 1 infected animal per million adults.

The data were re-analyzed to determine the sensitivity of the prevalence estimate to:

1. The BSurvE algorithm and its assumptions,

2. Inclusion of additional cases (for example, the Canadian origin animal) with the

same amount of negative surveillance, and

3. Alternatives for assumptions and input parameters to the BSurvE model.

In each case, the magnitude of change due to the uncertain parameters was not substantial

and did not change the conclusion that the prevalence of BSE is less than 1 BSE infected

1 Vose Consulting U.S. LLC, 14 Green Street, Princeton, NJ 08542, USA, www.risk-modelling.com.

DRAFT

DRAFT DRAFT

5

animal per million adult cattle. The upper and lower bounds from these analyses were 1

to 30 infected animals. Further, when as many as 5 BSE cases (2 indigenous and 3

hypothetical) were included in the surveillance data but no additional negatives, the

conclusion remained robust with an upper bound (95th percentile) of 40.

SNIP...FULL TEXT 43 PAGES

http://www.aphis.usda.gov/newsroom/hot_issues/bse/content/printable_version/BSEprevalence-estimate4-26-06.pdf

PEER REVIEW PLAN

http://www.aphis.usda.gov/about_aphis/printable_version/peer_review_plan_prevalence4-28-06.pdf

http://www.aphis.usda.gov/about_aphis/printable_version/peer_review_plan_prevalence4-28-06.pdf

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

USDA To Release Analysis Of US BSE Testing Friday

On June 1, 2004, the USDA sharply boosted the number of cattle it was testing for BSE in response to the December 2003 discovery of the first BSE case in the U.S. The effort, an "enhanced" BSE surveillance program, was designed to assess the prevalence of BSE in U.S. herds.

Since then, the USDA has tested nearly 700,000 cattle and found two more cased of the disease, making the total number found in the U.S. three.

http://www.cattlenetwork.com/content.asp?contentid=32789

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

The USDA June 2004 Enhanced BSE surveillance program was a sham, and everyone knows it now.

I find it sad and embarrassing that the USDA and my country, would continue this masquerade. I find it even more sad that the public accepts it. THE complete program, and the USDA should be dismantled and redone. Those test were meaningless under there flawed BSE protocols. ...TSS

CDC DR. PAUL BROWN TSE EXPERT COMMENTS 2006

The U.S. Department of Agriculture was quick to assure the public earlier this week that the third case of mad cow disease did not pose a risk to them, but what federal officials have not acknowledged is that this latest case indicates the deadly disease has been circulating in U.S. herds for at least a decade.

The second case, which was detected last year in a Texas cow and which USDA officials were reluctant to verify, was approximately 12 years old.

These two cases (the latest was detected in an Alabama cow) present a picture of the disease having been here for 10 years or so, since it is thought that cows usually contract the disease from contaminated feed they consume as calves. The concern is that humans can contract a fatal, incurable, brain-wasting illness from consuming beef products contaminated with the mad cow pathogen.

"The fact the Texas cow showed up fairly clearly implied the existence of other undetected cases," Dr. Paul Brown, former medical director of the National Institutes of Health's Laboratory for Central Nervous System Studies and an expert on mad cow-like diseases, told United Press International. "The question was, 'How many?' and we still can't answer that."

Brown, who is preparing a scientific paper based on the latest two mad cow cases to estimate the maximum number of infected cows that occurred in the United States, said he has "absolutely no confidence in USDA tests before one year ago" because of the agency's reluctance to retest the Texas cow that initially tested positive.

USDA officials finally retested the cow and confirmed it was infected seven months later, but only at the insistence of the agency's inspector general.

"Everything they did on the Texas cow makes everything USDA did before 2005 suspect," Brown said. ...snip...end

http://www.upi.com/ConsumerHealthDaily/view.php?StoryID=20060315-055557-1284r


CDC - Bovine Spongiform Encephalopathy and Variant Creutzfeldt ...
Dr. Paul Brown is Senior Research Scientist in the Laboratory of Central Nervous System ... Address for correspondence: Paul Brown, Building 36, Room 4A-05, ...


http://www.cdc.gov/ncidod/eid/vol7no1/brown.htm


CDC - Afterthoughts about Bovine Spongiform Encephalopathy and ...
Afterthoughts about Bovine Spongiform Encephalopathy and Variant Creutzfeldt-Jakob Disease. Paul Brown Senior Investigator, National Institutes of Health, ...


http://www.cdc.gov/ncidod/eid/vol7no3_supp/brown.htm


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


like i said, no in-between, either usda et al triple fire walls, feed ban of 8/4/97, no mad cow rhetoric was just that i.e. cover-up, or they all fell out of the Stupid tree and hit every branch on the way down a long time ago. ...


THE USDA BSE TESTING PROTOCOL WAS TERRIBLY FLAWWED FROM THE BEGINNING, AND THAT is the way it was suppose to be;


Dr. Detwiler, former top vet at the USDA and TSE aka mad cow expert tried to tell the bush administration this in more ways than one at a BSE ROUNTABLE event on Wednesday, December 11, 2003, in Denver, Colorado. shortly after this Dr. Detwiler was put out to pasture along with Dr. Miller and a few others that knew what was going on and spoke out about it;


USDA 2003

We have to be careful that we don't get so set in the way we do things that
we
forget to look for different emerging variations of disease. We've gotten
away from collecting the whole brain in our systems. We're using the brain
stem and we're looking in only one area. In Norway, they were doing a
project and looking at cases of Scrapie, and they found this where they did
not find lesions or PRP in the area of the obex. They found it in the
cerebellum and the cerebrum. It's a good lesson for us. Ames had to go
back and change the procedure for looking at Scrapie samples. In the USDA,
we had routinely looked at all the sections of the brain, and then we got
away from it. They've recently gone back.
Dr. Keller: Tissues are routinely tested, based on which tissue provides an
'official' test result as recognized by APHIS
.

Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't
they still asking for the brain? But even on the slaughter, they're looking
only at the brainstem. We may be missing certain things if we confine
ourselves to one area.


snip.............


Dr. Detwiler: It seems a good idea, but I'm not aware of it.
Another important thing to get across to the public is that the negatives
do not guarantee absence of infectivity. The animal could be early in the
disease and the incubation period. Even sample collection is so important.
If you're not collecting the right area of the brain in sheep, or if
collecting lymphoreticular tissue, and you don't get a good biopsy, you
could miss the area with the PRP in it and come up with a negative test.
There's a new, unusual form of Scrapie that's been detected in Norway. We
have to be careful that we don't get so set in the way we do things that we
forget to look for different emerging variations of disease. We've gotten
away from collecting the whole brain in our systems. We're using the brain
stem and we're looking in only one area. In Norway, they were doing a
project and looking at cases of Scrapie, and they found this where they did
not find lesions or PRP in the area of the obex. They found it in the
cerebellum and the cerebrum. It's a good lesson for us. Ames had to go
back and change the procedure for looking at Scrapie samples. In the USDA,
we had routinely looked at all the sections of the brain, and then we got
away from it. They've recently gone back.

Dr. Keller: Tissues are routinely tested, based on which tissue provides an
'official' test result as recognized by APHIS
.

Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't
they still asking for the brain? But even on the slaughter, they're looking
only at the brainstem. We may be missing certain things if we confine
ourselves to one area.


snip...


Completely Edited Version
PRION ROUNDTABLE


Accomplished this day, Wednesday, December 11, 2003, Denver, Colorado

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.”

###


http://www.house.gov/delauro

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

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


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

Executive Summary

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

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

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

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


snip...


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

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

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

43 A visual examination of brain tissue by a microscope.

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

SNIP...


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


PAGE 43;


Section 2. Testing Protocols and Quality Assurance Controls


snip...


FULL TEXT 130 PAGES


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

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


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


[2]

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

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


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

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


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

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

Marie A. Vodicka, PhD

Assistant Vice President

Biologics & Blotechnology

Scientlflc & Regulatory Affairs

SCIENCE & REG AFFAIRS

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, rrn . 1061

Rackville, MD 20862


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

No. 2002N-0273

February 14, 2006

Dear Sir or Madam :

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

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


snip...


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

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

December 20,2005

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane

Room 1061

Rockville, MD 20852

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

Substances Prohibited From Use in Animal Food and Feed

Dear Sir or Madame:

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

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

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


snip...


Given that BSE can be transmitted to cattle via an

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

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


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

December 19, 2005

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane

Room 1061

Rockville, MD 20852

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

Substances Prohibited From Use in Animal Food and Feed

Dear Sir or Madame:

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

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

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


snip.......


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

THE SEVEN SCIENTIST REPORT ***


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

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

TSS




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