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From: TSS ()
Subject: BSE, BOVINE - USA (02): FEED RECALL ProMED
Date: August 10, 2006 at 7:52 am PST

BSE, BOVINE - USA (02): FEED RECALL
*********************************************
A ProMED-mail post

ProMED-mail is a program of the
International Society for Infectious Diseases

[1]
Date: Wed, 9 Aug 2006 22:26:49 +0100
From: "Mary Marshall"
Source: Cattle Network 8 Aug 2006 [edited]


Huge Feed Recall Due To Mammalian Protein
---------------------------------------------
The Food and Drug Administration announced 2 recalls, one for 27 million
pounds of feed produced in Michigan and the other an unknown amount of feed
produced in Kentucky. Both were suspected of being adulterated with ruminant
or mammalian protein, including ruminant meat and bone meal in the 2nd
recall.

Vita Plus Corp., Gagetown, Michigan, has recalled 27 694 240 pounds of dairy
feed produced between February of 2005 and 16 Jun 2006, because it is
believed it was contaminated with mammalian protein. The feed was
distributed in Michigan and the recall is complete.

Burkmann Feeds LLC, Glasgow, Kentucky, has recalled an unknown amount of custom
feed because it contains an ingredient called Pro-Lak, which may contain
ruminant-derived meat and bone meal. The Burkmann feed was distributed in
Kentucky.

[By Pete Hisey on Tuesday, August 08, 2006 ]

--
Mary Marshall

*****
[2]
Date: 7 Aug 2006
From: Terry Singeltary
Source: FDA [weekly] Enforcement Report, 2 Aug 2006 [edited]


(1) PRODUCT: Animal and fish feeds Recall # V-112-6

CODE: Product manufactured from 1 Feb 2005 to 6 Jun 2006

RECALLING FIRM/MANUFACTURER: Alabama Farmers Cooperative, Inc.,
Decatur, Alabama, by telephone, fax, email and visit on 9 Jun 2006.
FDA initiated recall is complete.

REASON: Animal and fish feeds which were possibly contaminated with
ruminant-based protein not labeled as "Do not feed to ruminants."

VOLUME OF PRODUCT IN COMMERCE: 125 tons

DISTRIBUTION: Alabama and Florida

(2) PRODUCT: Bulk custom dairy feeds manufactured from concentrates,
Recall # V-113-6

CODE: All dairy feeds produced between 1 Feb 2005 and 16 Jun 2006 and
containing H. J. Baker recalled feed products.

RECALLING FIRM/MANUFACTURER: Vita Plus Corp., Gagetown, Michigan, by
visit beginning on 21 Jun 2006. Firm initiated recall is complete.

REASON: The feed was manufactured from materials that may have been
contaminated with mammalian protein.

VOLUME OF PRODUCT IN COMMERCE: 27 694 240 lbs

DISTRIBUTION: Michigan

(3) PRODUCT: Bulk custom made dairy feed, Recall # V-114-6

CODE: None

RECALLING FIRM/MANUFACTURER: Burkmann Feeds LLC, Glasgow, Kentucky,
by letter on 14 Jul 2006. Firm initiated recall is ongoing.

REASON: Custom made feeds contain ingredient called Pro-Lak, which
may contain ruminant derived meat and bone meal.

VOLUME OF PRODUCT IN COMMERCE: Unknown

DISTRIBUTION: Kentucky

--
Terry Singeltary


[A codified rule indicates that no mammalian material is to be
included in feed for ruminants. When it is found that such a
situation has occurred, then a recall is issued. Several years ago, a
similar situation happened in Gonzales, Texas, and the herd was
depopulated. The difference must be that the regulatory authorities
do not know where all the herds are that have consumed the feed. - Mod.TG]


[see also:
BSE, bovine - USA: feed recall 20060621.1718]
..................................................tg/msp/jw


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FOR IMMEDIATE RELEASE
P01-05
January 30, 2001
Print Media: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

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

Note: On Dec. 23, 2003, the U.S. Department of Agriculture reported that a cow in Washington state had tested positive for bovine spongiform encephalopathy (BSE, or mad cow disease). As a result, information on this Web page stating that no BSE cases had been found in the United States is now incorrect. However, because other information on this page continues to have value, the page will remain available for viewing.

FDA ANNOUNCES TEST RESULTS FROM TEXAS FEED LOT


Today the Food and Drug Administration announced the results of tests taken on feed used at a Texas feedlot that was suspected of containing meat and bone meal from other domestic cattle -- a violation of FDA's 1997 prohibition on using ruminant material in feed for other ruminants. Results indicate that a very low level of prohibited material was found in the feed fed to cattle.

FDA has determined that each animal could have consumed, at most and in total, five-and-one-half grams - approximately a quarter ounce -- of prohibited material. These animals weigh approximately 600 pounds.

It is important to note that the prohibited material was domestic in origin (therefore not likely to contain infected material because there is no evidence of BSE in U.S. cattle), fed at a very low level, and fed only once. The potential risk of BSE to such cattle is therefore exceedingly low, even if the feed were contaminated.

According to Dr. Bernard Schwetz, FDA's Acting Principal Deputy Commissioner, "The challenge to regulators and industry is to keep this disease out of the United States. One important defense is to prohibit the use of any ruminant animal materials in feed for other ruminant animals. Combined with other steps, like U.S. Department of Agriculture's (USDA) ban on the importation of live ruminant animals from affected countries, these steps represent a series of protections, to keep American cattle free of BSE."

Despite this negligible risk, Purina Mills, Inc., is nonetheless announcing that it is voluntarily purchasing all 1,222 of the animals held in Texas and mistakenly fed the animal feed containing the prohibited material. Therefore, meat from those animals will not enter the human food supply. FDA believes any cattle that did not consume feed containing the prohibited material are unaffected by this incident, and should be handled in the beef supply clearance process as usual.

FDA believes that Purina Mills has behaved responsibly by first reporting the human error that resulted in the misformulation of the animal feed supplement and then by working closely with State and Federal authorities.

This episode indicates that the multi-layered safeguard system put into place is essential for protecting the food supply and that continued vigilance needs to be taken, by all concerned, to ensure these rules are followed routinely.

FDA will continue working with USDA as well as State and local officials to ensure that companies and individuals comply with all laws and regulations designed to protect the U.S. food supply.


http://www.fda.gov/bbs/topics/NEWS/2001/NEW00752.html

NEWS RELEASE

Texas Animal Health Commission

Box l2966 •Austin, Texas 78711 •(800) 550-8242• FAX (512) 719-0719

Linda Logan, DVM, PhD• Executive Director

For info, contact Carla Everett, information officer, at 1-800-550-8242, ext. 710,

or ceverett@tahc.state.tx.us

For Immediate Release--

Feed Contamination Issue Resolved by FDA

Although many of you may have heard the latest regarding the resolution of the cattle feed

contamination situation in Texas, I wanted to ensure that you received this statement issued

by the Food and Drug Administration (FDA), the agency in charge of regulating feed

components. The FDA has said the cattle involved are to be rendered and the material will not

enter ruminant or human food channels. The Texas Animal Health Commission (TAHC) will

provided assistance to the FDA as requested and needed.

FDA ANNOUNCES TEST RESULTS FROM TEXAS FEED LOT

Today (Tuesday, Jan. the Food and Drug Administration announced the results of tests taken

on feed used at a Texas feedlot that was suspected of containing meat and bone meal from

other domestic cattle -- a violation of FDA's 1997 prohibition on using ruminant material in

feed for other ruminants. Results indicate that a very low level of prohibited material was

found in the feed fed to cattle.

FDA has determined that each animal could have consumed, at most and in total,

five-and-one-half grams - approximately a quarter ounce -- of prohibited material. These

animals weigh approximately 600 pounds.

It is important to note that the prohibited material was domestic in origin (therefore not likely

to contain infected material because there is no evidence of BSE in U.S. cattle), fed at a very

low level, and fed only once. The potential risk of BSE to such cattle is therefore exceedingly

low, even if the feed were contaminated.

According to Dr. Bernard Schwetz, FDA's Acting Principal Deputy Commissioner, "The

challenge to regulators and industry is to keep this disease out of the United States. One

important defense is to prohibit the use of any ruminant animal materials in feed for other

ruminant animals. Combined with other steps, like U.S. Department of Agriculture's (USDA)

ban on the importation of live ruminant animals from affected countries, these steps represent

a series of protections, to keep American cattle free of BSE."

Despite this negligible risk, Purina Mills, Inc., is nonetheless announcing that it is voluntarily

purchasing all 1,222 of the animals held in Texas and mistakenly fed the animal feed

containing the prohibited material. Therefore, meat from those animals will not enter the

human food supply. FDA believes any cattle that did not consume feed containing the

prohibited material are unaffected by this incident, and should be handled in the beef supply

clearance process as usual.

FDA believes that Purina Mills has behaved responsibly by first reporting the human error

that resulted in the misformulation of the animal feed supplement and then by working

closely with State and Federal authorities.

This episode indicates that the multi-layered safeguard system put into place is essential for

protecting the food supply and that continued vigilance needs to be taken, by all concerned, to

ensure these rules are followed routinely.

FDA will continue working with USDA as well as state and local officials to ensure that

companies and individuals comply with all laws and regulations designed to protect the U.S.

food supply.

---30--

http://www.tahc.state.tx.us/News/pr/2001/101FEED_ISSUE_RESOLVED.pdf

WE know now, and we knew decades ago, that 5.5 grams of suspect feed in TEXAS was enough to kill 100 cows.


look at the table and you'll see that as little as 1 mg (or 0.001 gm) caused 7% (1 of 14) of the cows to come down with BSE;


Risk of oral infection with bovine spongiform encephalopathy agent in primates

Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog, Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe Deslys
Summary The uncertain extent of human exposure to bovine spongiform encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease (vCJD)--is compounded by incomplete knowledge about the efficiency of oral infection and the magnitude of any bovine-to-human biological barrier to transmission. We therefore investigated oral transmission of BSE to non-human primates. We gave two macaques a 5 g oral dose of brain homogenate from a BSE-infected cow. One macaque developed vCJD-like neurological disease 60 months after exposure, whereas the other remained free of disease at 76 months. On the basis of these findings and data from other studies, we made a preliminary estimate of the food exposure risk for man, which provides additional assurance that existing public health measures can prevent transmission of BSE to man.


snip...


BSE bovine brain inoculum

100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg

Primate (oral route)* 1/2 (50%)

Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%) 1/15 (7%)

RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)

PrPres biochemical detection

The comparison is made on the basis of calibration of the bovine inoculum used in our study with primates against a bovine brain inoculum with a similar PrPres concentration that was

inoculated into mice and cattle.8 *Data are number of animals positive/number of animals surviving at the time of clinical onset of disease in the first positive animal (%). The accuracy of

bioassays is generally judged to be about plus or minus 1 log. ic ip=intracerebral and intraperitoneal.

Table 1: Comparison of transmission rates in primates and cattle infected orally with similar BSE brain inocula


Published online January 27, 2005

http://www.thelancet.com/journal/journal.isa


It is clear that the designing scientists must

also have shared Mr Bradley’s surprise at the results because all the dose

levels right down to 1 gram triggered infection.


http://www.bseinquiry.gov.uk/files/ws/s145d.pdf

2

6. It also appears to me that Mr Bradley’s answer (that it would take less than say 100

grams) was probably given with the benefit of hindsight; particularly if one

considers that later in the same answer Mr Bradley expresses his surprise that it

could take as little of 1 gram of brain to cause BSE by the oral route within the

same species. This information did not become available until the "attack rate"

experiment had been completed in 1995/96. This was a titration experiment

designed to ascertain the infective dose. A range of dosages was used to ensure

that the actual result was within both a lower and an upper limit within the study

and the designing scientists would not have expected all the dose levels to trigger

infection. The dose ranges chosen by the most informed scientists at that time

ranged from 1 gram to three times one hundred grams. It is clear that the designing

scientists must have also shared Mr Bradley’s surprise at the results because all the

dose levels right down to 1 gram triggered infection.


http://www.bseinquiry.gov.uk/files/ws/s147f.pdf

Re: BSE .1 GRAM LETHAL NEW STUDY SAYS via W.H.O. Dr Maura Ricketts

[BBC radio 4 FARM news]


http://www.maddeer.org/audio/BBC4farmingtoday2_1_03.ram

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

2) Infectious dose:

To cattle: 1 gram of infected brain material (by oral ingestion)


http://www.inspection.gc.ca/english/sci/bio/bseesbe.shtml


Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518


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

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


Page 1 of 17

From: Terry S. Singeltary Sr. [flounder9@verizon.net]

Sent: Thursday, September 08, 2005 6:17 PM

To: fsis.regulationscomments@fsis.usda.gov

Subject: [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirements

for the Disposition of Non-Ambulatory Disabled Cattle

Greetings FSIS,

I would kindly like to submit the following to [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and

Requirements for the Disposition of Non-Ambulatory Disabled Cattle

THE BSE/TSE SUB CLINICAL Non-Ambulatory Disabled Cattle

Broken bones and such may be the first signs of a sub clinical BSE/TSE Non-Ambulatory Disabled Cattle ;

SUB CLINICAL PRION INFECTION

MRC-43-00

Issued: Monday, 28 August 2000

NEW EVIDENCE OF SUB-CLINICAL PRION INFECTION: IMPORTANT RESEARCH

FINDINGS RELEVANT TO CJD AND BSE


Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518

9/13/2005

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

TEXAS also renders it's suspect mad cows, instead of testing for BSE/TSE ;

FOR IMMEDIATE RELEASE
Statement
May 4, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

Statement on Texas Cow With Central Nervous System Symptoms
On Friday, April 30 th , the Food and Drug Administration learned that a cow with central nervous system symptoms had been killed and shipped to a processor for rendering into animal protein for use in animal feed.

FDA, which is responsible for the safety of animal feed, immediately began an investigation. On Friday and throughout the weekend, FDA investigators inspected the slaughterhouse, the rendering facility, the farm where the animal came from, and the processor that initially received the cow from the slaughterhouse.

FDA's investigation showed that the animal in question had already been rendered into "meat and bone meal" (a type of protein animal feed). Over the weekend FDA was able to track down all the implicated material. That material is being held by the firm, which is cooperating fully with FDA.

Cattle with central nervous system symptoms are of particular interest because cattle with bovine spongiform encephalopathy or BSE, also known as "mad cow disease," can exhibit such symptoms. In this case, there is no way now to test for BSE. But even if the cow had BSE, FDA's animal feed rule would prohibit the feeding of its rendered protein to other ruminant animals (e.g., cows, goats, sheep, bison).

FDA is sending a letter to the firm summarizing its findings and informing the firm that FDA will not object to use of this material in swine feed only. If it is not used in swine feed, this material will be destroyed. Pigs have been shown not to be susceptible to BSE. If the firm agrees to use the material for swine feed only, FDA will track the material all the way through the supply chain from the processor to the farm to ensure that the feed is properly monitored and used only as feed for pigs.

To protect the U.S. against BSE, FDA works to keep certain mammalian protein out of animal feed for cattle and other ruminant animals. FDA established its animal feed rule in 1997 after the BSE epidemic in the U.K. showed that the disease spreads by feeding infected ruminant protein to cattle.

Under the current regulation, the material from this Texas cow is not allowed in feed for cattle or other ruminant animals. FDA's action specifying that the material go only into swine feed means also that it will not be fed to poultry.

FDA is committed to protecting the U.S. from BSE and collaborates closely with the U.S. Department of Agriculture on all BSE issues. The animal feed rule provides crucial protection against the spread of BSE, but it is only one of several such firewalls. FDA will soon be improving the animal feed rule, to make this strong system even stronger.

####

http://www.fda.gov/bbs/topics/news/2004/NEW01061.html

TEXAS also submits suspect mad cow tissue samples for testing 7+ months LATE, something that is suppose to be done in 48 hours, but this only after an act of Congress and thanks to the Honorable Phyllis Fong of the OIG ;

USDA ANNOUNCES BSE TEST RESULTS AND NEW BSE CONFIRMATORY TESTING PROTOCOL

WASHINGTON, June 24, 2005 -- Agriculture Secretary Mike Johanns today announced that the U.S. Department of Agriculture has received final test results from The Veterinary Laboratories Agency in Weybridge, England, confirming that a sample from an animal that was blocked from the food supply in November 2004 has tested positive for bovine spongiform encephalopathy (BSE). Johanns also directed USDA scientists to work with international experts to thoughtfully develop a new protocol that includes performing dual confirmatory tests in the event of another "inconclusive" BSE screening test. ...snip...end

http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB?contentidonly=true&contentid=2005/06/0232.xml

"So let me start first with the test results. As you are aware, last November we had an inconclusive report from a rapid screening test. USDA then conducted two IHC confirmatory tests, and both came out negative. A few weeks ago an additional confirmatory test was conducted, and that test is referred to as the Western blot test.

"On June 10 I learned that test was reactive and shared those results at that time.

"We now have the test results from the lab in Weybridge, England, as well as the results from additional testing in our own lab, and again I am here today to share those results with you.

"The results confirm the presence of BSE in this animal, an animal that was blocked from entering the food supply thanks to the firewalls that are in place. It is critically important to note that this animal was identified as a high risk animal. A sample was taken, and the carcass was incinerated. ...snip...end



http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB?contentidonly=true&contentid=2005/06/0233.xml

QUESTION: Yes, thank you, and good evening. This is Peter Shinn with the National Association of Farm Broadcasters. Until all of the animals in question, herd mates, are identified, will the herd in question be quarantined? That's the first question. And then, secondly, why wait to say that this animal was from Texas until this period of time when that information was almost virtually publicly available.

DR. CLIFFORD: I didn't hear the last part of the question.

QUESTION: "Well, we'll start with the first one again, if I don't -- the first one is more important to me, which is the issue of quarantine. Will the herd in question be quarantined until all traceback efforts have been completed?"

DR. CLIFFORD: " The state of Texas, yes, has applied a hold order on this herd. As far as the second part of the question, I didn't understand."

QUESTION: I'm just asking why did you wait to confirm that this animal in question was from Texas, when it's been published that it was from Texas for some time. It seems like you're trying to clear up confusion and minimize questions and market disruption. And it seems like disclosing all information that you have, like for example that this animal was slaughtered at a facility in Texas might be useful in calling some of that market disruption. ...snip...end

http://www.usda.gov/wps/portal/usdahome?contentidonly=true&contentid=2005/06/0235.xml

EXACTLY, thus, two weeks later GWs and the OIE legal trading of all strains of TSE globally was finalized, it was all about timing ;


7/15/05 Importation of Bovines (Cattle or Bison) from Canada for Feeding PDF
BSE Minimal-Risk Regions and the Importation of Live Animals Importers, Brokers, and Other Interested Parties PDF
BSE Minimal-Risk Regions and the Importation of Live Animals Accredited Veterinarians or Other Interested Parties PDF
USDA, APHIS, Veterinary Services, National Center for Import and Export: Protocol for The Importation of Cattle or Bison for Feeding from Canada PDF
USDA, APHIS, Veterinary Services, National Center for Import and Export: Protocol for the Importation of Cattle, Bison, Sheep and Goats for Immediate Slaughter from Canada PDF
USDA, APHIS, Veterinary Services, National Center for Import and Export: Protocol for the Importation of Sheep and Goats for Feeding from Canada PDF
Animal Products
Implementation: Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities from Canada PDF
Johanns Announces Next Steps for Importing Canadian Cattle
Transcript of Tele-News Conference with Agriculture Secretary Mike Johanns
Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities— FINAL RULE— 9 CFR Parts 93, 94, 95, and 96 [Docket No. 03-080-3]
Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities; Partial Delay of Applicability [Docket No. 03-080-6] — Final rule; partial delay of applicability — 9 CFR Parts 94 and 95
Published March 11, 2005 — 70 FR 12112-12113 Text | PDF
• Risk Document PDF
• Economic Analysis PDF
• Appendices to economic analysis PDF
• Final environmental assessment PDF
• Final Rule on BSE and Minimal-Risk Regions (Factsheet)
• Questions and Answers for Minimal Risk/Canada Rule
• Port of Entry for Eligible Ruminants


WHAT the Honorable Phyllis Fong and the OIG found ;

USDA Testing Protocols and Quality Assurance Procedures

In November 2004, USDA announced that its rapid screening test produced an inconclusive BSE test result. A contract laboratory ran its rapid screening test on a brain sample collected for testing and produced three high positive reactive results. As required, the contract laboratory forwarded the inconclusive sample to APHIS’ National Veterinary Services Laboratories (NVSL) for confirmation. NVSL repeated the rapid screening test, which again produced three high positive reactive results. Following established protocol, NVSL ran its confirmatory test, an immunohistochemistry (IHC) test, which was interpreted as negative for BSE.

Faced with conflicting results between the rapid screening and IHC tests, NVSL scientists recommended additional testing to resolve the discrepancy but APHIS headquarters officials concluded that no further testing was necessary since testing protocols were followed and the confirmatory test was negative. In our discussions with APHIS officials, they justified their decision to not do additional testing because the IHC test is internationally recognized as the "gold standard" of testing. Also, they believed that

USDA/OIG-A/50601-10-KC/ Page iv

conducting additional tests would undermine confidence in USDA’s testing protocols.

OIG obtained evidence that indicated additional testing was prudent. We came to this conclusion because the rapid screening tests produced six high positive reactive results, the IHC tests conflicted, and various standard operating procedures were not followed. Also, our review of the relevant scientific literature, other countries’ protocols, and discussions with experts led us to conclude that additional confirmatory testing should be considered in the event of conflicting test results.

To maintain objectivity and independence, we requested that USDA’s Agricultural Research Service (ARS) perform the Office International des Epizooties (OIE) Scrapie-Associated Fibrils (SAF) immunoblot test. The additional testing produced positive results. To confirm, the Secretary of Agriculture requested that an internationally recognized BSE laboratory in Weybridge, England (Weybridge) perform additional testing. Weybridge conducted various tests, including their own IHC tests and three Western blot tests. The tests confirmed that the cow was infected with BSE. The Secretary immediately directed USDA scientists to work with international experts to develop new protocols that include performing dual confirmatory tests in the event of an inconclusive BSE screening test.

We attribute the failure to identify the BSE positive sample to rigid protocols, as well as the lack of adequate quality assurance controls over its testing program. Details of our concerns are discussed in Findings 3 and 4.

snip...

see findings 3 and 4 starting on page 44 of full text ;


Office of Inspector General

Great Plains Region


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

Report No. 50601-10-KC January 2006

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

TSS




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