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SUMMARY ENHANCE BSE SURVEILLANCE USA & BSE PREVALENCE ES

flounder

Well-known member
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. ...TSS


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



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
 

flounder

Well-known member
suppressed peer review of Harvard study October 31, 2002

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


:cry2:



TSS
 

Econ101

Well-known member
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.”

String them up, make them talk, and hold people accountable.

JoAnn Waterfield should be held to the same standard. It is required for good governance.
 
A

Anonymous

Guest
Heres the USDA Press Release

Release No. 0143.06

Contact:
Ed Loyd (202) 720-4623
Jim Rogers (202) 690-4755

USDA RELEASES BSE PREVALENCE ESTIMATE FOR U.S.

WASHINGTON, April 28, 2006-Agriculture Secretary Mike Johanns today announced USDA's estimate of the prevalence of bovine spongiform encephalopathy (BSE) in the United States.

"Our enhanced BSE surveillance program has been an enormous undertaking, but well worth the effort," said Johanns. "We can now say, based on science, that the prevalence of BSE in the United States is extraordinarily low. The testing and analysis reinforce our confidence in the health of the U.S. cattle herd, while our interlocking safeguards, including the removal of specified risk materials and the feed ban, protect animal and human health."

The estimate of BSE prevalence in the United States is based on data gathered from not only the enhanced surveillance effort that has been underway since June 2004, but also from surveillance conducted in the United States for the 5 years prior. USDA experts used two different methods, the BSurvE Prevalence B method and the Bayesian birth-cohort method, to analyze the prevalence of BSE based on all of the surveillance data.

The findings of the two methods were similar, indicating that the most likely number of cases present in the United States is between 4 and 7 animals. Therefore, USDA concludes that the prevalence of the disease in the United States is less than 1 case per million adult cattle, based on an adult cattle population in this country of 42 million animals.

The testing program is not part of U.S. food safety protections. The system of interlocking safeguards protects animal and public health. The most important safeguards are the removal of specified risk materials from the food supply, along with the Food and Drug Administration's (FDA) 1997 ruminant-to-ruminant feed ban. Science indicates that the longer the FDA's feed ban is in place, the lower the prevalence of BSE will be in this country.

USDA will use the prevalence analysis, once it is peer-reviewed, and international standards set by the World Animal Health Organization, to design an ongoing BSE surveillance program for the United States. The data and analysis will also assist in making science-based policy and regulatory decisions related to the disease.

USDA's enhanced BSE surveillance program followed the detection of BSE in an imported animal in December 2003. The target population of cattle tested included those animals where the disease is most likely to be found if it is present: non ambulatory cattle, cattle exhibiting signs of central nervous disorders or any other signs that may be associated with BSE, including emaciation or injury and dead cattle. Samples were drawn from more than 5,000 locations across the United States, including slaughter plants, renderers, farms, public health laboratories, veterinary diagnostic laboratories and salvage slaughter facilities.

USDA is providing its analysis to outside experts for a scientific peer review and making it available to the public. USDA is confident the conclusions drawn regarding BSE prevalence in the United States are sound and scientifically credible. The analysis, along with a summary report on the BSE enhanced surveillance program, are available at http://www.aphis.usda.gov/newsroom/hot_issues/bse.shtml


#
USDA News
[email protected]
 

Econ101

Well-known member
If the prevelance of bse is really that small, Creekstone testing in order to sell beef to Japan should be no problem at all. Their testing may even bolster the low incidence claims of bse in the U.S. by the USDA.

Anyone who trusts their government with no accountability is a fool. (SH are you listening?)
 

flounder

Well-known member
Release No. 0143.06
Contact:
Ed Loyd (202) 720-4623
Jim Rogers (202) 690-4755

Printable version
USDA RELEASES BSE PREVALENCE ESTIMATE FOR U.S.

WASHINGTON, April 28, 2006-Agriculture Secretary Mike Johanns today announced USDA's estimate of the prevalence of bovine spongiform encephalopathy (BSE) in the United States.

"Our enhanced BSE surveillance program has been an enormous undertaking, but well worth the effort," said Johanns. "We can now say, based on science, that the prevalence of BSE in the United States is extraordinarily low. The testing and analysis reinforce our confidence in the health of the U.S. cattle herd, while our interlocking safeguards, including the removal of specified risk materials and the feed ban, protect animal and human health."

The estimate of BSE prevalence in the United States is based on data gathered from not only the enhanced surveillance effort that has been underway since June 2004, but also from surveillance conducted in the United States for the 5 years prior. USDA experts used two different methods, the BSurvE Prevalence B method and the Bayesian birth-cohort method, to analyze the prevalence of BSE based on all of the surveillance data.

The findings of the two methods were similar, indicating that the most likely number of cases present in the United States is between 4 and 7 animals. Therefore, USDA concludes that the prevalence of the disease in the United States is less than 1 case per million adult cattle, based on an adult cattle population in this country of 42 million animals.

The testing program is not part of U.S. food safety protections. The system of interlocking safeguards protects animal and public health. The most important safeguards are the removal of specified risk materials from the food supply, along with the Food and Drug Administration's (FDA) 1997 ruminant-to-ruminant feed ban. Science indicates that the longer the FDA's feed ban is in place, the lower the prevalence of BSE will be in this country.

USDA will use the prevalence analysis, once it is peer-reviewed, and international standards set by the World Animal Health Organization, to design an ongoing BSE surveillance program for the United States. The data and analysis will also assist in making science-based policy and regulatory decisions related to the disease.

USDA's enhanced BSE surveillance program followed the detection of BSE in an imported animal in December 2003. The target population of cattle tested included those animals where the disease is most likely to be found if it is present: non ambulatory cattle, cattle exhibiting signs of central nervous disorders or any other signs that may be associated with BSE, including emaciation or injury and dead cattle. Samples were drawn from more than 5,000 locations across the United States, including slaughter plants, renderers, farms, public health laboratories, veterinary diagnostic laboratories and salvage slaughter facilities.

USDA is providing its analysis to outside experts for a scientific peer review and making it available to the public. USDA is confident the conclusions drawn regarding BSE prevalence in the United States are sound and scientifically credible. The analysis, along with a summary report on the BSE enhanced surveillance program, are available at http://www.aphis.usda.gov/newsroom/hot_issues/bse.shtml

http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB/.cmd/ad/.ar/sa.retrievecontent/.c/6_2_1UH/.ce/7_2_5JM/.p/5_2_4TQ/.d/1/_th/J_2_9D/_s.7_0_A/7_0_1OB?PC_7_2_5JM_contentid=2006%2F04%2F0143.xml&PC_7_2_5JM_parentnav=LATEST_RELEASES&PC_7_2_5JM_navid=NEWS_RELEASE#7_2_5JM


still digusted in Bacliff, Texas. ...TSS
 

flounder

Well-known member
##################### Bovine Spongiform Encephalopathy #####################


Subject: Re: Summary of Enhanced BSE Surveillance in the United States & BSE Prevalence Estimate for U.S. April 27, 2006
Date: April 28, 2006 at 10:20 am PST

Release No. 0143.06
Contact:
Ed Loyd (202) 720-4623
Jim Rogers (202) 690-4755

Printable version
USDA RELEASES BSE PREVALENCE ESTIMATE FOR U.S.

WASHINGTON, April 28, 2006-Agriculture Secretary Mike Johanns today
announced USDA's estimate of the prevalence of bovine spongiform
encephalopathy (BSE) in the United States.

"Our enhanced BSE surveillance program has been an enormous undertaking, but
well worth the effort," said Johanns. "We can now say, based on science,
that the prevalence of BSE in the United States is extraordinarily low. The
testing and analysis reinforce our confidence in the health of the U.S.
cattle herd, while our interlocking safeguards, including the removal of
specified risk materials and the feed ban, protect animal and human health."

snip...end

http://www.fsis.usda.gov/Regulations_&_Policies/Quarterly_Enforcement_Reports/index.asp




MEANWHILE, back at the ranch, with larry, curly, and mo at usda, in the real world, you will find that Johanns cannot open his mouth without lying about BSE. check out the SRM violation he claims are "while our interlocking safeguards, including the removal of specified risk materials and the feed ban, protect animal and human health.", espeically his BSe claim of 1 bse case per million head of cattle, in his dreams. ...TSS



UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE QUARTERLY ENFORCEMENT REPORT October 1, 2005 through December 31, 2005


snip....


CARGILL MEAT SOLUTIONS 00086K M DODGE CITY, KS X X On 10/11/05, a withholding action concerning labels for Advanced Meat Recovery System product was taken in accordance with 9 CFR Part 500.8.


EXCEL CORP 00086R M FORT MORGAN, CO 2/22/05 X X On 8/11/04, a withholding action concerning labels for Advanced Meat Recovery System product was taken in accordance with 9 CFR Part 500.8. On 12/22/04, plant appealed the withholding action. Appeal was denied on 1/25/05.


00245L M LEXINGTON, NE 3/12/04 3/18/04 X 5/4/05 X X On 3/10/05, a withholding action concerning labels for Advanced Meat Recovery System product was taken in accordance with 9 CFR Part 500.8.

9/16/05 9/29/05 X X TYSON FRESH MEATS INC. 09268 M PASCO, WA X X On 7/28/04, a withholding action concerning labels for Advanced Meat Recovery System product was taken in accordance with 9 CFR Part 500.8.

TYSON FRESH MEATS INC. X X 00245D M EMPORIA, KS On 12/23/04, a withholding action concerning labels for Advanced Meat Recovery System product was taken in accordance with 9 CFR Part 500.8.


DESERET MEAT 04852 M SPANISH FORK, UT 7/20/05 8/1/05 X X 12/29/05 The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.


NORTHERN PACKING COMPANY INC. 00571 M BRIAR HILL, NY 12/9/05 12/23/05 X X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.


A.J. CEKAK'S MEAT MARKET 9/1/05 9/20/05 X X X On 9/1/05, an enforcement action
21562 M
concerning failure to meet regulatory ORD, NE requirements for Escherichia coli Biotype 1 (E. coli) was taken. The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.


ALTA VISTA LOCKER
10/5/05 10/26/05 X X The enforcement action included, as a 31931 M basis, failure of the establishment toALTA VISTA, KS comply with Agency requirements
concerning specified risk material.


BROWN'S PROCESSING 13100 M13100 P ELSBERRY, MO 8/8/05 8/16/05 X X X 11/16/05 The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.


CHAMPLAIN BEEF INC 2/28/05 3/4/05 3/8/05 X X X
08547 M
WHITEHALL, NY
10/17/05 X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.


FIVE STAR PACK INC. 9/1/05 9/9/05 X X 12/29/05 On 9/1/05, an enforcement action
08725 M08725 P
concerning failure to meet regulatory GOLDEN CITY, MO requirements for Escherichia coli Biotype 1 (E. coli) was taken. The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material. FRESH FARMS BEEF 12/16/05 12/28/05 X X X The enforcement action included, as a 18579 M basis, failure of the establishment toRUTLAND, VT comply with Agency requirements concerning specified risk material.


GOETZ AND SONS WESTERN 11/15/05 11/23/05 12/1/05 X X
MEATS INC
06245 M06245 P
EVERETT, WA
12/17/05 12/28/05 X X X On 12/17/05, firm violated a regulatory control action by selling U.S.D.A retained product.


H AND P MEATS 21352 M SOUTH PITTSBURG, TN 7/28/05 8/8/05 8/17/05 8/19/05 X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.


HOPKINS PACKING COMPANY 11069 M BLACKFOOT, ID 7/28/05 8/1/05 X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.


NORTHWEST PREMIUM MEATS LLC 11032 M11032 P NAMPA, ID 7/26/05 7/29/05 X X 11/15/05 The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.


PARADISE LOCKER MEATS 31865 M31865 P TRIMBLE, MO 9/21/05 10/7/05 X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material. PARAGON SPRAY DRYING, LLC 31762 M31762 P WAUKON, IA 9/6/05 9/12/05 X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.


RANDALL MEAT COMPANY 10669 M HOT SPRINGS, AR 7/1/05 7/28/05 10/12/05 10/24/05 X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.


S & S MEAT COMPANY 01046 M01046 P KANSAS CITY, MO 8/4/05 8/19/05 X X 11/16/05 The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.


STEAK MASTER 21159 M21159 P ELWOOD, NE 11/4/05 11/17/05 X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.


THE MEAT SHOP 31561 M BENSON, VT 8/18/05 9/6/05 9/9/05 X X X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.


THEURER'S QUALITY MEATS, INC 31647 M31647 P LEWISTON, UT 7/27/05 7/29/05 X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.


TOOELE VALLEY MEATS 20594 M20594 P GRANTSVILLE, UT 7/25/05 8/1/05 X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.


WALNUT VALLEY PACKING LLC 32007 M32007 P EL DORADO, KS 12/15/05 12/30/05 X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.


YODER BROTHERS MEAT PROCESSING 17301 M PARIS, TN 10/3/05 10/12/05 X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.


full text 54 pages ;


http://www.fsis.usda.gov/PDF/QER_Q1_FY2006.pdf





----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Monday, March 20, 2006 4:26 PM
Subject: USDA FSIS QUARTERLY ENFORCEMENT REPORT (BSE) July 1, 2005 through September 30, 2005


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


Subject: USDA FSIS QUARTERLY ENFORCEMENT REPORT (BSE) July 1, 2005 through September 30, 2005
Date: March 20, 2006 at 12:58 pm PST


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


snip...


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



snip...


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



snip...


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



snip...


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



snip...

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


snip...


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

21562 M

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


snip...


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



snip...


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



snip...


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



snip...


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


snip...


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



snip...


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


snip...


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



snip...


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



snip...


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


snip...


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

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



snip...


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



snip...


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



snip...


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


snip...


08/04/05

08/19/05

On 8/4/05,

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


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


snip...


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

09/09/05

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


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

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

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


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

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

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


snip...


52 pages



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





TSS



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

flounder

Well-known member
Subject: Re: Summary of Enhanced BSE Surveillance in the United States & BSE Prevalence Estimate for U.S. April 27, 2006
Date: April 28, 2006 at 6:07 pm PST

Press Release

FOR IMMEDIATE RELEASE
Monday, Jan. 26, 2004

FDA Press Office
301-827-6242
Expanded "Mad Cow" Safeguards Announced
to Strengthen Existing Firewalls Against BSE Transmission


snip...


The first interim final rule will ban the following materials from FDA-regulated human food, (including dietary supplements) and cosmetics:

* Any material from "downer" cattle. ("Downer" cattle are animals that cannot walk.)
* Any material from "dead" cattle. ("Dead" cattle are cattle that die on the farm (i.e. before reaching the slaughter plant);
* Specified Risk Materials (SRMs) that are known to harbor the highest concentrations of the infectious agent for BSE, such as the brain, skull, eyes, and spinal cord of cattle 30 months or older, and a portion of the small intestine and tonsils from all cattle, regardless of their age or health; and
* The product known as mechanically separated beef, a product which may contain SRMs. Meat obtained by Advanced Meat Recovery (an automated system for cutting meat from bones), may be used since USDA regulations do not allow the presence of SRMs in this product.


snip...


http://www.fda.gov/bbs/topics/news/2004/hhs_012604.html


:liar:


UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE FSIS Directive 7160.3 Revision Dated 8/25/2003ADVANCED MEAT RECOVERY USING BEEF VERTEBRAL RAW MATERIALS I. PURPOSE Based on the first several months of regulatory (monitoring and follow-up surveillance) sampling, FSIS has determined that some establishments are not adequately addressing the presence of spinal cord tissue in boneless comminuted beef. FSIS is reissuing this directive to define more fully than it did in the initial directive the range of follow-up actions available to the Agency when product from an advanced meat recovery (AMR) system contains spinal cord tissue. This directive continues to provide inspection program personnel with instructions for sampling when a request is received from the Office of Public Health and Science (OPHS). NOTE: This directive only addresses the presence of spinal cord tissue. Other issues, such as calcium levels and the matters addressed in FSIS Directive 7160.1 and 7160.2, remain unchanged. II. CANCELLATION FSIS Directive 7160.3, dated 12/2/2002 III. REASON FOR REISSUANCE FSIS is reissuing this directive to reiterate that establishments whose AMR system repeatedly fails to produce product that is free of spinal cord will not be allowed to produce AMR meat from beef vertebrae, and that product containing spinal cord tissue will not be allowed to enter commerce labeled as meat. Paragraph VI. B has been entirely rewritten to provide for new enforcement procedures and a flowchart has been added that sets out the enforcement procedures. IV. REFERENCES 9 CFR 301.2 (the definition of meat) FSIS Directive 8800.2, revision 1 DISTRIBUTION: Inspection Offices; T/A Inspectors; OPI: OPPD Plant Mgt; T/A Plant Mgt; TRA; ABB; TSC;Import Offices
V. BACKGROUND A. Boneless comminuted beef product containing spinal cord tissue does not meet the regulatory definition of “meat” (301.2, meat) and, therefore, is misbranded. If boneless, comminuted product containing spinal cord tissue enters commerce, FSIS will likely request a recall and may take a number of additional actions, as outlined in this directive. B. This directive’s focus is on beef AMR product. Proper processing of pork AMR product also is of concern to the Agency, but for now, the Agency will focus on beef. FSIS is completing a survey of pork AMR systems to ascertain whether spinal cord tissues and other bone components (e.g., marrow) are being inappropriately incorporated into this product. C. The purpose of this AMR system sampling program is to determine whether an establishment’s AMR system is operating properly and not incorporating spinal cord tissue in AMR products. Agency sampling of AMR products will be directed by OPHS. VI. INSPECTION PROGRAM PERSONNEL RESPONSIBILITIES A. What are the random sampling procedures? 1. When sample collections are scheduled for an establishment, the Inspector-in-Charge (IIC) receives FSIS Form 10,210-3, “Requested Sample Programs,” from OPHS. When the forms are sent, certain blocks will be pre-printed on the form with information specific to the samples to be collected. Each sample request form is for the collection of a single composite sample (a total of two pounds) of AMR product from a selected AMR system. For the day designated on the form, inspection program personnel are to randomly collect a composite sample for every form received. In establishments with more than one AMR system, inspection program personnel are to randomly select from each of the systems. 2. Before collecting samples, inspection program personnel are to notify the establishment management and provide them the opportunity to hold the AMR products produced on the day of sampling from the AMR system from which the sample will be taken. Inspection program personnel are to provide the establishment management enough notice so that they can hold all products represented by the samples until the test results of the samples are available. 3. As specified on the sample request form, on the designated day inspection
program personnel will collect from the selected AMR system a 2-pound sample of
product made up of a composite of 4 grab sub-samples. Inspection program personnel
are to collect 4 sub-samples to constitute each composite sample by:
a. sampling at random times throughout the production of the designated day, or FSIS DIRECTIVE 7160.3
2
Revision 1 b. sampling from different locations within one or more randomly selected,
stored (and unfrozen) containers (e.g., sampling near the bottom, middle, and at the top
of randomly selected containers) that were produced on the designated day.
4. Inspection program personnel are to complete all requested information in blocks 19, 20, 22, 28, 29, 30, and 32 of Part II of the FSIS Form 10,210-3. Enter “N/A” if information is unavailable. In the statement “Product of the sample was made from carcasses or carcass parts of some / all / none / cannot determine appearing to be from cattle 30 months of age or older” in Block 28, inspection program personnel are to circle the appropriate choice. B. What enforcement actions are taken when an FSIS collected monitoring sample of AMR-system-produced boneless comminuted beef tests positive for spinal cord tissue? 1. Inspection program personnel are to inform the establishment management of the positive sample result and issue an FSIS Form 5400-4, Noncompliance Record (NR) using the Inspection System Procedure (ISP) Code 04A03. 2. Inspection program personnel are to take regulatory control: a. of any product produced by the system tested on the designated day of sampling (i.e., retaining product) in accordance with 9 CFR 500.2(a)(2) because the product is deemed misbranded, and b. against the AMR system equipment (i.e., reject equipment) in accordance with 9 CFR 500.2(a)(3) because the system is producing misbranded product. NOTE: If an FSIS sample tests positive for spinal cord tissue, and the establishment shipped the product produced on the designated day of sampling, FSIS will request a recall of that product (including all products containing the AMR product). The Recall Management Division (RMD) will coordinate a recall as outlined in FSIS Directive 8080.1. 3. Inspection program personnel are to verify that the establishment makes proper disposition of the product. C. How do inspection program personnel collect follow-up verification composite samples to verify the effectiveness of the establishment’s immediate and further preventive actions? 1. To determine the effectiveness of the actions, inspection program will verify the establishment’s corrective and preventive (or immediate and further planned) actions have been implemented and are operating as described in the plant’s response. Inspection personnel will also collect 10 follow-up composite samples. The samples are needed because spinal cord tissue, if present, is not uniformly distributed through the product. The Agency will make a determination on whether the AMR system is not in control (i.e., the system is producing product that contains spinal cord tissue) based on the results of the 10 composite samples. OPHS will send the IIC sample request forms that will state that they
3
are for follow-up verification sampling. 2. Upon receipt of the forms, inspection program personnel are to collect 5 follow-up verification composite samples and notify the establishment so that it may hold product represented by the sampling. Each composite sample is to consist of 4 grab sub-samples, for a total of 2 pounds per composite sample. Over a 24-hour production period, inspection program personnel randomly (for collection times) will collect the 5 follow-up verification composite samples. Inspection program personnel may collect the 5 follow-up verification composite samples by a random sampling of stored boxes of chilled (unfrozen) AMR products that represent the production of the day. 3. When the results of analyzing the samples are received: a. if any of the 5 results are positive, inspection program personnel are to take the actions described in paragraph VI D. below. b. if the 5 results are negative, inspection program personnel are to: i. inform the establishment it may ship any product that it held, ii. collect an additional 5 composite samples as described in paragraph VI C. 2 above: (A) if any one of the additional 5 results is positive, inspection program personnel take the actions described in paragraph VI D. below, and (B) if the additional 5 results are negative, then on the basis of 10 negative composite samples, there is no reason to find that product produced by the AMR system is misbranded. Inspection program personnel will continue to verify the AMR system as scheduled by PBIS. D. What enforcement actions are taken when an FSIS follow-up verification sample of AMR-system-produced boneless comminuted beef tests positive for spinal cord tissue? 1. A positive sample result from the follow-up verification testing provides the evidence that the product represented by the 5 composite samples from the 24-hour production period is misbranded, and that the AMR system is not in control. The product is misbranded in that it does not conform to the regulatory definition of AMR product (9 CFR 301 (meat, second paragraph). AMR product only contains meat. The sampled product contains material (spinal cord) that is not meat. Because the system is producing product that is not AMR product, labels representing the product as AMR product are false. 2. Inspection program personnel are to take the control actions as describe in VI B. 2. 3. The DO will advise the establishment that the use of labels representing product produced from the AMR system will be withheld from the product (21 U.S.C. 607(e)). FSIS DIRECTIVE 7160.3
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Revision 1 4. The DO will notify the establishment in writing of: a. the reason for withholding the use of the labels, b. the opportunity for the establishment to describe the steps that it will take to modify its process so that the product may be appropriately labeled as AMR product, c. the opportunity to request a hearing, as described in 9 CFR 500.8(c). 5. The use of the label will be withheld pending a final decision on any appeal by the Secretary, unless the establishment demonstrates that it has corrected its system as described in VI D. 6 below. 6. The DO will stop withholding the use of the label after: a. the establishment has taken immediate and further preventive actions to correct the AMR system, and such actions are verified by inspection program personnel, b. the establishment has provided to the DO evidence that 10 consecutive composite samples of product from the AMR system were negative for spinal cord tissue. It is the establishment’s obligation to have the samples analyzed in a qualified laboratory using an analytical method equivalent to that employed by FSIS, and c. FSIS has verified the establishment’s results by taking 1 additional composite sample and found it negative for spinal cord. NOTE: Product produced during this period would be held and the mark of inspection would not be applied. If inspection program personnel find that an establishment has made changes in the AMR system that raise concerns about the possible presence of spinal cord tissue in AMR product, they are to notify the DO through supervisory channels. Philip S. Derfler /s/ Assistant Administrator Office of Policy and Program Development................snip...........end


http://www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/7160.3Rev1.pdf


http://permanent.access.gpo.gov/websites/fsisusdagov/www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/7160.3Rev1.pdf


TSS
 

flounder

Well-known member
Subject: TRANSCRIPT OF JOHANNS, DEHAVEN ET AL LIES ABOUT USDA JUNE 2004 EHANCED BSE COVER UP PROGRAM April 28, 2006 WASHINGTON D.C.
Date: April 29, 2006 at 2:19 pm PST

Release No. 0149.06
Contact:
Press Office (202)720-4623


TRANSCRIPT OF TELENEWS CONFERENCE ON THE ENHANCED BSE SURVEILLANCE PROGRAM WITH AGRICULTURE SECRETARY MIKE JOHANNS AND APHIS ADMINISTRATOR DR. RON DEHAVEN April 28, 2006 WASHINGTON D.C.
MODERATOR: Good morning from Washington. I'm Larry Quinn speaking to you from the Broadcast Center at the U.S. Department of Agriculture. Welcome to today's news conference with Secretary of Agriculture Mike Johanns to discuss the analysis of the Enhanced BSE Surveillance Program. With the Secretary today is Dr. Ron DeHaven, administrator of USDA's Animal and Plant Health Inspection Service.

The reporters during our question period this morning, we remind you that if you'd like to ask a question please press *1 on your telephone touchpad. That will alert us to call on you.

Now it's my pleasure to introduce Secretary of Agriculture Mike Johanns.

SEC. MIKE JOHANNS: Well, thank you. And good morning. Thank you for joining me today. I want to visit with you about the completion of our draft analysis of the BSE Enhanced Surveillance Program. This analysis includes an estimate of the prevalence of BSE in the United States.

When USDA began the enhanced surveillance in June of 2004, the goal was to test as many as 268,500 animals. Well thanks to the commitment of states and industry to make this a successful effort, we've far surpassed our expectations.

To date we have tested more than 690,000 animals as part of the Enhanced Surveillance Program from the populations at highest risk for the disease. That's over 1,000 cattle per day from 5,700 locations across the country. That would include farms and slaughter plants and renderers.

Today we are making available our draft analysis of the data. This analysis is being subjected to a scientific peer review process to ensure our conclusions are in fact science based.

We hope the peer review will be completed by the end of May. In our analysis we looked at the data collected during and prior to the Enhanced Surveillance Program going back to 1999. So altogether our epidemiologists looked at more than 730,000 samples collected over a seven-year time frame.

The data shows that the prevalence of BSE in the United States is extraordinarily low. Our experts used two different methods to analyze the prevalence of BSE, both of which led to similar findings. They concluded that the most likely number of BSE cases present in the United States is between 4 and 7 animals out of a herd of 42 million cattle. Those would be adult cattle.

USDA experts conclude therefore that the prevalence of BSE in the United States is less than 1 case per 1 million adult cattle.

Science enables us to set a 95 percent confidence level in that estimate. In other words, we have an extraordinarily healthy herd of cattle in our country.

I want to make an important distinction. Our surveillance program is not part of our food safety protection. The surveillance program is designed to gather sufficient data to draw some statistically valid conclusions about the health of our herd.

Food safety is protected by an interlocking set of safeguards. The most important of these is the ban that keeps specified risk materials from the human food supply. Specified risk materials are cattle parts that are mostly likely to carry the disease if it were present.

Further, we have other controls at slaughter such as a ban on nonambulatory cattle being slaughtered for human consumption. The most important animal health safeguard is the 1997 ban on ruminant-to-ruminant feeding. This measure prevents the disease from spreading among cattle and by preventing such spread contributes to increased public health protection.

Countries that have implemented ruminant-to-ruminant feed bans as we did in 1997 have seen the incidence of BSE drop dramatically in their cattle population. The longer a feed ban has been in place, the fewer animals are left that would have been exposed to contaminated feed.

So we're dealing with an incredibly low prevalence of the disease in the United States, and science tells us with the safeguards, the prevalence is likely to decline. On top of that, we have strong safeguards in place that make a very low risk for cattle even lower still for humans.

So to recap, we are putting our analysis through a rigorous scientific peer review process to ensure that the conclusions we have drawn are sound and that they are scientifically credible. The enhanced surveillance program gives us the ability to stand on solid scientific ground in saying the prevalence of BSE in the United States is extraordinarily low. But I would argue that there's little justification for continuing surveillance at this level once our analysis is affirmed by peer review ensuring we have a very, very scientific prevalence estimate.

So I look forward to getting the results of the peer review and as I said we hope the peer review will be completed by the end of May. Then we'll see how science and international standards guide us from here.

The framework for our ongoing BSE testing program will also be based in science. I do expect we will move to a level of testing that is in line with international guidelines for a country like ours that is at minimal risk for the disease.

Now before I take your questions, I just want to say how very proud I am of the work that all of our employees and partners have done these last 23 months and are continuing to do. In my opinion the Enhanced BSE Surveillance Program has been a very significant accomplishment. Consumers both here and abroad should feel better than ever about the meat that they are buying, and U.S. producers should be prouder than ever of the great work that they do.

With that, we will be happy to take questions.

MODERATOR: Thank you, Mr. Secretary. Now we're ready for our questions. And our first question today comes from Libby Quaid of Associated Press. Libby?

REPORTER: Hi. Mr. Secretary, my question is really a two-part question. You said earlier that you wanted to persuade Japan to lift the ban on U.S. beef before doing any scaling back of tests. But it sounds like now you may go ahead and make that decision once the peer review is completed. Could you address that? And also, speaking of trade could you give us an update on the situation with Russia and poultry?

SEC. JOHANNS: On the first question, we continue to work with Japan. And I would describe our discussions as going well. I think the information that I released today will significantly aid the discussions. But I think the information I put out today will be positively received across the country. As you know, we have always said we will base our decisions on ongoing surveillance based on science and international standards, peer review. We would consult with our trading partners out there, and we are in the process of doing all those things.

We are on course. We are going to do everything we can to make sure that our decisions are based upon all those factors I mentioned. And today's announcement takes us a step further down that path.

The second thing I would say relative to your question about poultry -- and I appreciate that question -- I was extremely disappointed by the Russian action. There literally was no prenotification. This kind of action is enormously disruptive in terms of our trade relationship, and we are doing everything we can to minimize that disruption.

I immediately sent a letter to my colleague in Russia indicating my serious concern and urging action so there would not be a trade disruption. I appreciated that Ambassador Portman did the same with his colleague in Russia.

We have also been in contact with the ministries and legislative officials to express our grave concern. We understand that the Russian action is related to a growing frustration with fraudulent importing procedures and relates to their desire to better control the importing process.

We understand that. But we are urging that this be done in a manner that does not disrupt all trade nor penalize U.S. exporters who have followed the established procedures.

Under Secretary J.B. Penn spoke to Ambassador Burns in Moscow this morning. We now understand that product departing seaports before May 8 will be admitted. We also understand that the Russians are moving to implement a new import permit licensing system. We are urging that this be put in place immediately so as not to disrupt trade.

Finally I would mention this is very important to us. Russia is our largest export market for poultry with annual sales well over $600 million, so it's important, significant, and we are going to do everything we can to get this straightened out.

MODERATOR: Peter Shinn of the National Association of Farm Broadcasting will have the next question. Standing by should be Matt Kaye. Peter?

REPORTER: Yes. Thank you, Larry. And thank you, Mr. Secretary, for holding this call. Just a quick two-part question for you, Mr. Secretary. The question is, in terms of timing, as you say you've tested far more animals than you anticipated originally, so why go ahead and get this analysis out of the way and go back to a normal testing level now before all the beef markets are reopened to U.S. beef?

And then perhaps for Dr. Dehaven, what would a normal style BSE surveillance program look like?

SEC. JOHANNS: We did additional testing just simply because we wanted to make sure that we had touched all the bases. As we continued to review we wanted to make sure that we had touched all areas of the country. We wanted to make sure that we had a statistical number that gave us a very valid sample. We also as you know in the last months of this surveillance confirmed the previous USDA decision to test 20,000 animals. I re-read the transcript of my predecessor's statements to a House Subcommittee where Secretary Veneman clearly indicated that 20,000 healthy animals would be tested.

And so we needed to spend some time on getting that done, and that expanded the testing also.

And then of course we've been working with trading partners -- Japan, South Korea and others. But one of the things I pointed out in response to Libby's question is equally true in response to your question. We wanted to make sure that as we went along here we were paying attention to not only the sampling, our trading partners, but also that we were getting expert review. So the question may arise, well you've got your analysis so why not just end it today?

Well, we said we wanted to have experts look at this. We will factor in their advice. We hope that will be available by the end of May. And so that will be another step in the direction in terms of making a decision.

Now I will offer the mike here to Dr. Dehaven, and he can talk about ongoing surveillance because I'm very confident in telling you that I anticipate there will be ongoing surveillance.

DR. DEHAVEN: Thank you, Mr. Secretary. Indeed we are working now to develop what we think would be an appropriate level of maintenance testing as we refer to it, making sure that it is scientifically and statistically valid and also that it is consistent with the OIE requirements. The OIE establishes two kinds of BSE surveillance testing --Type A which would be for determining prevalence and that's what we're talking about today with the enhanced testing we've done. But then the OIE chapter also describes a maintenance level of testing or Type B so that when we finally determine a target number of animals to test for our maintenance surveillance testing program it will certainly be consistent and meet or exceed the OIE requirements for Type B or maintenance type of testing.

That testing program clearly will continue to focus on the same targeted high-risk animals, meaning that we will continue to test those animals that if they have the disease these would be the animals most likely to test positive.

I should point out too that in the Type A testing, the prevalence testing we have done, the OIE requirement is based on a point system based on the various categories of animals that are tested who are satisfying those requirements. A country with a high cattle population such as ours should accumulate over a seven-year period 300,000 points. Based on our calculations of the testing that we have done in the United States over the last seven years, our point total at this point would be somewhere in excess of 2.9 million points, nearly ten times the required level of testing by the current OIE chapter.

We'll make sure again with our maintenance testing that we meet or exceed and based on the current evaluation we estimate that number will be somewhere in the 40,000 animals per year level.

MODERATOR: Matt Kaye of the Burns Bureau will be next followed by Scott Kilman. Matt?

REPORTER: Thank you so much, Larry. And thanks, Mr. Secretary. A few weeks ago Acting Under Secretary Chuck Lambert laid out a schedule based on an agreement with Tokyo to resume beef trade. This include plant safety checklists and verification audits. Where exactly are we in that process? How do you see that unfolding in terms of actually encouraging the Japanese to reach a decision? And will you meet with the Japanese Ag Minister in Geneva next week? And how do you expect that meeting will affect this effort to reopen the market?

SEC. JOHANNS: I'll take your last question first. The answer is yes, I do intend to meet with Minister Nakagawa. It looks today like that meeting will be on Tuesday of next week. Give me some flexibility there because these meetings can move around a little bit depending upon demands of schedule. But at least today it looks like it will be Tuesday of next week when we will meet in Geneva.

In terms of the pathway to reopening the Japanese border to U.S. beef, I can also tell you that we are conducting the audits that we talked about. They have started. I would anticipate that they will take, oh, 10 days to two weeks to complete. We will share that information with Japan, answer any questions that they have about the audit. There will be some decision -- this has been a step-by-step process. I'm confident there will be some decision as to what they want to do in terms of any kind of auditing. And so we continue to work with Japan.

Again, I would say that the information we released today I'm confident will be very positively viewed by not only Japan but other trading partners around the world. When you consider the size of the U.S. herd and you apply the statistical analysis that we have applied and really use a couple different approaches and come to the conclusion that somewhere out there there might be four to seven animals, and then you also realize that we're going to subject this to a rigorous expert review to make sure the conclusions we've reached here at the USDA are valid conclusions -- you can really see the practices we've put in place over time have really made a huge difference here in terms of BSE in the United States.

But I think everything's going along as we'd hoped it would with Japan. I'm certainly as impatient as the next person and want this done now. But I'm confident that we're headed in the right direction there.

MODERATOR: Scott Kilman of Wall Street Journal will be next followed by Christopher Doring. Scott?

REPORTER: Mr. Secretary, a couple quick questions. One is, who are the experts who will be doing the peer review, and how much money has been spent annually on the enhanced surveillance program? And then the broader question is, how concerned are you that the rural backlash against having a national ID system could actually kill that program or really put off that idea?

SEC. JOHANNS: You do have some out there who are raising issues about the ID system. And we certainly are mindful of that. And we want to take into account people's attitudes about that ID system, so I am more than willing to listen to concerns and comments. I will also say this, that for those who are saying gosh, I don't want to go in this direction, for whatever reason, we also get a tremendous amount of support from the industry.

Here's the other thing I will tell you about the ID system that I think is very important to recognize. There will always be some who say, I don't want to do that, it's too big a change, or whatever. But the reality is that the rest of the world is moving in this direction, at least from my perspective.

You've got Australia out there moving in this direction very aggressively. They are a huge competitor to U.S. beef. You've got Canada that's been moving in this direction, and they won't be alone. You also have major purchasers of U.S. beef who are saying we need to move in this direction. I just noticed that in Australia a representative of McDonalds -- which of course is a major purchaser of beef -- made a statement about the need for this animal ID system.

And so I just think it's important to recognize that we can always adopt the attitude, I don't want to change, change is hard, I don't like the way this may affect me. But the reality is, that the day is going to arrive where I think we would be hugely criticized by everyone in the industry -- food safety people, by consumers, by purchasers of beef -- if we did not move in this direction. I think if we got four years out there and all of a sudden it was a situation where it was a crisis or something, people would be saying what have you been doing, why haven't you been moving us there? Our plan does that. So that's very important to me.

In terms of the amount of monies spent, it has been a very significant amount of money. But I will -- Dr. DeHaven may have an estimate he can give you, so I'll let him talk about that. And then I will also let him visit with you about the peer review.

DR. DEHAVEN: Thanks again, Mr. Secretary. In terms of the peer review process, in fact we have just let a contract with a Research Triangle Institute who will then contract with we think approximately three or more peer reviewers who are appropriately credentialed, have the scientific expertise to do the appropriate peer review on this process and ensure that they are nonconflicted.

The Office of Management and Budget puts out guidance on peer review process to include the qualifications of those who would be doing peer review. And so we will be carefully adhering to those procedures.

We would expect that as the Secretary mentioned that peer review process will commence in the very near future and hope to have the report back by the end of May.

In terms of the annual cost for our Enhanced Surveillance Program, we can get for you more exact numbers, but we do know in very rough numbers it's costing approximately $1 million a week to do this testing. And in a week's time historically we've tested typically between 5,000 and 7,000 animals. So it is expensive. And yet I think in reading this report that we're releasing today you'll see the value of the statistics that we've had in terms of appropriately characterizing the extremely low risk of BSE in this country.

MODERATOR: Christopher Doring of Reuters is next. And he'll be followed by Kaori Iida. Christopher?

REPORTER: Yes, thank you. A few of my questions have already been answered here. So if I hear you correctly you guys are still obviously in the process of determining what your future track is for the Enhanced Testing Program. Earlier this year you said early 2006. Do you have an estimated timetable as to when you might have a firm decision on that?

SEC. JOHANNS: Christopher, I'd hate to put a timetable on it. There's so many things tend to come up, and our hope is that we'll get the expert analysis by the end of May. But as you know that can always slip some here and there.

The bottom line for me is, as you know we talked about the need for outside peer review, and we want to make sure they have an opportunity to take a good look at what we're doing and that's just so important. Again I think this is a very important step today. But I would say it's a step. We are going to make sure we have outside experts to take a good look and give us their advice.

REPORTER: But it's safe to say at this point your only budgeted as I recall for I think it's 40,000 tests in the Fiscal '07 budget? Is that correct?

SEC. JOHANNS: Christopher, the thing is, I would say about that. I think that's been the case, certainly been the case in the two budgets that I've been here. We have been accessing funds kind of on a as-we-go basis. And I think everybody is anxious to have us do this in a way that is peer-reviewed and done right. And so that budget really hasn't applied here just simply because we've been accessing additional funding as we needed it to continue the surveillance.

REPORTER: And I guess without giving a specific number obviously -- I mean a lot of consumer groups have come out with this 40,000 estimate saying this is how much we budgeted and potentially here's what the scale-back would be. Is it safe to say it will be more than likely more than that 40,000 a lot of people have been talking about?

SEC. JOHANNS: Just today we won't even put an estimate on it, again because we believe here that these decisions need to be based upon science and international standards. And we're anxious to get folks, outside experts to look at it and make their recommendations. And so when we're all done here, not only will we have a report out but we will be able to tell people, whether it's consumer groups or the industry or trading partners or consumers across the United States that not only did we do the report but we subjected it to very, very rigorous review and here's their conclusions.

MODERATOR: Our next question comes from Kaori Iida from NHK Japan Broadcasting. He'll be followed by Philip Brasher. Kaori?

REPORTER: Yes. Thank you, Mr. Secretary. When you meet with Minister Nakagawa in Geneva next week, will you be discussing your scaling down on the Enhanced Surveillance Program? And also with regard to negotiations with Japan, do you plan to send Dr. Lambert or Dr. Penn to Tokyo once the reaudit is complete?

SEC. JOHANNS: We've always said, Kaori, that we would send whatever team is necessary. And I don't have current plans that it would be Dr. Penn or anyone else here at the USDA. But we can literally dispatch people and technical teams overnight as that is necessary. So we'll be happy to do that.

In terms of discussing with Minister Nakagawa, what I will do is share with him the analysis that we have done. I think he'll be very, very pleased to see it. I'm confident that he will. But then I will explain the process that is still ahead of us to make a decision about what an ongoing surveillance program, not what it would look like but how we're going to get to a decision point on that and how we're going to have experts involved, how we're going to base it on science, how we're going to base it on international standards.

So what I will do is explain the hurdles ahead before we get to a point where we make a final decision on what that would look like.

MODERATOR: Philip Brasher from Des Moines Register has the next question followed by Steve Kaye. Philip?

REPORTER: Yes. Thanks for taking my question. Do you have a breakdown or estimates for different populations of cattle, say slaughter steers versus dairy culls or breeding animals where I assume you'd have a higher risk?

SEC. JOHANNS: I'm not sure we do at least at this moment. What I'd like to do to answer that question is ask the folks here at the USDA to try to put together whatever information I can and get that to you, and we will do that.

MODERATOR: Next question comes from Steve Kaye of Cattle Buyers Weekly, followed by Daniel Enoch from Bloomberg. Steve?

REPORTER: Good morning, Mr. Secretary. As you know, two shipments at least to Hong Kong in recent weeks have resulted in suspension of the plants from which those shipments came because either bone fragments or pieces of cartilage of boneless beef products were found. That raises the issue as you know of zero tolerance versus commercial tolerances. And the industry recent weeks has said that if trade resumes soon to South Korea they're concerned that shipments could be interrupted at any time because of the finding of such bone fragments. And they say it's almost impossible to prevent those getting into boxes of boneless beef or other such products. What's USDA doing to address this issue?

SEC. JOHANNS: We are aware of the issue, very much aware of the issue. Let me offer a couple of thoughts if I might. First thing just relative to the response by Hong Kong, Hong Kong decided to take action that I have to tell you I thought was very thoughtful and measured. Instead of slamming the border shut to all U.S. beef, they worked directly with the plants involved.

That's the kind of response from a trading partner that should not go unmentioned, and needless to say we never like to see even a partial disruption but it was a thoughtful, scientifically based, internationally-standard-based response to the issue.

The second thing I'd like to say is there is this debate about absolute zero tolerance versus commercial tolerance, and we are in discussions with our various trading partners about how best to approach this. Whether you're talking about beef or cars, if the attitude is absolute zero tolerance on everything you could bring worldwide trade to a screeching halt. And that is just reality.

What we want to do is always make sure we're protecting consumers here and abroad, that we've got the right policies and procedures in place. How we do that and the common sense applied to this is very, very important. So we will continue those discussions.

My hope is that we can resolve them in a way that is based upon science, based upon international standards, and also based upon the notion that we need to work with each other and do everything we can to protect the consumer but also recognize that you just can't stop trade. There is some tolerance in about everything we do, and trying to find that magic approach is the key here.

REPORTER: Are there international standards that allow for commercial tolerances, Mr. Secretary?

SEC. JOHANNS: That I'm not as familiar with. Dr. DeHaven, maybe I can ask you. The question was, are there international standards that deal with tolerance?

SEC. JOHANNS: There are not. It really is an issue of the age of the animal and the product. So for example, when we're sending beef from animals under 30 months of age from a country with the very, very slim risk of BSE that's found in the United States, we're not talking about a scientific or risk issue. It's more of a marketing issue than it is a risk issue in terms of BSE.

So no, there's no international standards that would apply to this particular situation as it's not from a scientific standpoint a BSE risk issue.

MODERATOR: Our final question today comes from Daniel Enoch from Bloomberg. Daniel?

DR. DEHAVEN: Let me clarify that 40,000 number. We are going to make sure that the ongoing level of surveillance testing that we do is, one, scientifically based in terms of numbers as well as the animals that we target, and that it will meet and exceed the OIE standards for ongoing --

REPORTER: Right. I understand you said that. But you did put a number of 40,000.

DR. DEHAVEN: With a preliminary look at the OIE chapter and their requirements in our cattle population, certainly that 40,000 would appear to be in the ballpark. But again, we've not arrived at that number. And even when we do arrive at that number we want to make sure that it is scientifically peer-reviewed to again make sure that it meets the scientific requirements and meets or exceeds the OIE standards. So we really haven't arrived at any specific number yet.

REPORTER: Okay. But 40,000 is within the ballpark you're looking at?

SEC. JOHANNS: My analysis of this, my decision-making process as we get information back from the experts, I intend to start every discussion on this with a very simple question: What's the experts' advice on this? That's why we seek their peer review; that's why we continue to take this through the process that we described many months ago.

One of the things we said is, we would have a rigorous peer review, and we intend to do that. And I intend to ask what is their advice to me.

MODERATOR: Thank you. Secretary of Agriculture, Mike Johanns.


http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB/.cmd/ad/.ar/sa.retrievecontent/.c/6_2_1UH/.ce/7_2_5JM/.p/5_2_4TQ/.d/2/_th/J_2_9D/_s.7_0_A/7_0_1OB?PC_7_2_5JM_contentid=2006%2F04%2F0149.xml&PC_7_2_5JM_parentnav=TRANSCRIPTS_SPEECHES&PC_7_2_5JM_navid=TRANSCRIPT#7_2_5JM


:liar: :help: :liar: :help:


O.I.E. BSE GUIDELINES, ha, ha, ha, ... just look at the countries that thought they were bse free for all those years that went by those same OIE guidelines.

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





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


Sent: Saturday, June 04, 2005 8:07 AM
Subject: BSE OIE CHAPTER 2.3.13 (The Weakening of a already terribly flawwed BSE/TSE surveillance system)




http://p079.ezboard.com/fwolftracksproductionsfrm2.showMessage?topicID=470.topic




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


http://brain.hastypastry.net/forums/showthread.php?t=120372




Subject: Re: Summary of Enhanced BSE Surveillance in the United States & BSE Prevalence Estimate for U.S. April 27, 2006
Date: April 28, 2006 at 10:20 am PST

Release No. 0143.06
Contact:
Ed Loyd (202) 720-4623
Jim Rogers (202) 690-4755


http://disc.server.com/discussion.cgi?disc=167318;article=2815;title=CJD%20WATCH





Meanwhile, back at the ranch with larry, curly, and mo at USDA ET AL ON BSE ALABAMA STYLE



http://www.prwatch.org/node/4624



http://disc2.server.com/discussion.cgi?disc=167318;article=2763;title=CJD%20WATCH






TSS
 
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