Neb. inspector accused of faking mad cow tests
Published November 17, 2010
Associated Press
OMAHA, Neb. – A former Nebraska cattle inspector has been indicted on charges that he faked reports about mad cow disease, the U.S. Attorney's Office announced Wednesday.
Galen Niehues, 41, of Cozad, was charged Tuesday in U.S. District Court in Lincoln with making false statements and mail fraud.
Niehues was employed by the state Department of Agriculture from July 2009 through March under a U.S. Food and Drug Administration grant. The indictment says he submitted inspection reports on 92 Nebraska cattle operations, along with travel expenses, but never actually performed the inspections.
Niehues collected about $35,500 in pay and benefits while working for the state, the indictment says.
No number was listed for Niehues, and court records don't list his attorney.
His first court appearance is scheduled for Dec. 2. Niehues faces up to 25 years in prison and $500,000 in fines if convicted.
Agriculture Department spokeswoman Bobbie Kriz-Wickham referred comment to the FDA. A message left Wednesday for an FDA investigator wasn't immediately returned.
___
Online:
U.S. District Court, Nebraska: http://www.ned.uscourts.gov/
Nebraska Department of Agriculture: http://www.agr.state.ne.us/
U.S. Food and Drug Administration: http://www.fda.gov/
http://www.foxnews.com/us/2010/11/17/neb-inspector-accused-faking-mad-cow-tests/
From The Associated Press, November 17, 2010 - 4:59 PM
Former Neb. inspector accused of faking tests for mad cow disease; no longer works for state
OMAHA, Neb. (AP) - A former state cattle inspector has been indicted for faking tests for mad cow disease.
The two-count indictment announced Wednesday by the U.S Attorney's Office says 41-year-old Galen Niehues, of Cozad, submitted inspection reports on 92 cattle operations in Nebraska but never actually performed the inspections. He faces federal charges of making false statements and mail fraud.
No number was listed for Niehues, and court records don't list his attorney.
His first court appearance is scheduled for Dec. 2. Niehues faces up to 25 years in prison if convicted.
A message left with the Agriculture Department wasn't immediately returned. The indictment says Niehues worked for the department from July 2009 through March.
http://www.canadianbusiness.com/markets/market_news/article.jsp?content=D9JI50D00
Thursday, November 18, 2010
UNITED STATES OF AMERICA VS GALEN J. NIEHUES FAKED MAD COW FEED TEST ON 92 BSE INSPECTION REPORTS FOR APPROXIMATELY 100 CATTLE OPERATIONS
4:10-cr-03119-RGK -CRZ Doc # 1 Filed: 11/16/10 Page 1 of 4 - Page ID #1
FILED
U.S. DISTRICT COURT
DISTRICT OF NEBRASKA
10 NOV 16 PM 4:16
OFFICE OF THE CLERK
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEBRASKA
UNITED STATES OF AMERICA,
Plaintiff,
vs.
GALEN J. NIEHUES,
Defendant.
INDICTMENT
18 U.S.C. § 1001
18 U.S.C. § 1341
The Grand Jury charges that:
INTRODUCTION
see full text here ;
http://bse-atypical.blogspot.com/2010/11/united-states-of-america-vs-galen-j.html
Subject: USDA OIG SEMIANNUAL REPORT TO CONGRESS FY 2007 1st Half
(bogus BSE sampling FROM HEALTHY USDA CATTLE)
Date: June 21, 2007 at 2:49 pm PST
Owner and Corporation Plead Guilty to Defrauding Bovine Spongiform Encephalopathy (BSE) Surveillance Program
An Arizona meat processing company and its owner pled guilty in February 2007 to charges of theft of Government funds, mail fraud, and wire fraud. The owner and his company defrauded the BSE Surveillance Program when they falsified BSE Surveillance Data Collection Forms and then submitted payment requests to USDA for the services. In addition to the targeted sample population (those cattle that were more than 30 months old or had other risk factors for BSE), the owner submitted to USDA, or caused to be submitted, BSE obex (brain stem) samples from healthy USDA-inspected cattle. As a result, the owner fraudulently received approximately $390,000. Sentencing is scheduled for May 2007.
snip...
Topics that will be covered in ongoing or planned reviews under Goal 1 include:
soundness of BSE maintenance sampling (APHIS),
implementation of Performance-Based Inspection System enhancements for specified risk material (SRM) violations and improved inspection controls over SRMs (FSIS and APHIS),
snip...
The findings and recommendations from these efforts will be covered in future semiannual reports as the relevant audits and investigations are completed.
4 USDA OIG SEMIANNUAL REPORT TO CONGRESS FY 2007 1st Half
http://www.usda.gov/oig/webdocs/sarc070619.pdf
Office of the United States Attorney District of Arizona
FOR IMMEDIATE RELEASE For Information Contact Public Affairs
February 16, 2007 WYN HORNBUCKLE Telephone: (602) 514-7625 Cell: (602) 525-2681
CORPORATION AND ITS PRESIDENT PLEAD GUILTY TO DEFRAUDING GOVERNMENT’S MAD COW DISEASE SURVEILLANCE PROGRAM
PHOENIX -- Farm Fresh Meats, Inc. and Roland Emerson Farabee, 55, of Maricopa, Arizona, pleaded guilty to stealing $390,000 in government funds, mail fraud and wire fraud, in federal district court in Phoenix.U.S. Attorney Daniel Knauss stated, “The integrity of the system that tests for mad cow disease relies upon the honest cooperation of enterprises like Farm Fresh Meats. Without that honest cooperation, consumers both in the U.S. and internationally are at risk. We want to thank the USDA’s Office of Inspector General for their continuing efforts to safeguard the public health and enforce the law.” Farm Fresh Meats and Farabee were charged by Information with theft of government funds, mail fraud and wire fraud. According to the Information, on June 7, 2004, Farabee, on behalf of Farm Fresh Meats, signed a contract with the U.S. Department of Agriculture (the “USDA Agreement”) to collect obex samples from cattle at high risk of mad cow disease (the “Targeted Cattle Population”). The Targeted Cattle Population consisted of the following cattle: cattle over thirty months of age; nonambulatory cattle; cattle exhibiting signs of central nervous system disorders; cattle exhibiting signs of mad cow disease; and dead cattle. Pursuant to the USDA Agreement, the USDA agreed to pay Farm Fresh Meats $150 per obex sample for collecting obex samples from cattle within the Targeted Cattle Population, and submitting the obex samples to a USDA laboratory for mad cow disease testing. Farm Fresh Meats further agreed to maintain in cold storage the sampled cattle carcasses and heads until the test results were received by Farm Fresh Meats.
Evidence uncovered during the government’s investigation established that Farm Fresh Meats and Farabee submitted samples from cattle outside the Targeted Cattle Population. Specifically, Farm Fresh Meats and Farabee submitted, or caused to be submitted, obex samples from healthy, USDA inspected cattle, in order to steal government moneys.
Evidence collected also demonstrated that Farm Fresh Meats and Farabee failed to maintain cattle carcasses and heads pending test results and falsified corporate books and records to conceal their malfeasance. Such actions, to the extent an obex sample tested positive (fortunately, none did), could have jeopardized the USDA’s ability to identify the diseased animal and pinpoint its place of origin. On Wednesday, February 14, 2007, Farm Fresh Meats and Farabee pleaded guilty to stealing government funds and using the mails and wires to effect the scheme. According to their guilty pleas:
(a) Farm Fresh Meats collected, and Farabee directed others to collect, obex samples from cattle outside the Targeted Cattle Population, which were not subject to payment by the USDA;
(b) Farm Fresh Meats2 and Farabee caused to be submitted payment requests to the USDA knowing that the requests were based on obex samples that were not subject to payment under the USDA Agreement; (c) Farm Fresh Meats completed and submitted, and Farabee directed others to complete and submit, BSE Surveillance Data Collection Forms to the USDA’s testing laboratory that were false and misleading;
(d) Farm Fresh Meats completed and submitted, and Farabee directed others to complete and submit, BSE Surveillance Submission Forms filed with the USDA that were false and misleading;
(e) Farm Fresh Meats falsified, and Farabee directed others to falsify, internal Farm Fresh Meats documents to conceal the fact that Farm Fresh Meats was seeking and obtaining payment from the USDA for obex samples obtained from cattle outside the Targeted Cattle Population; and
(f) Farm Fresh Meats failed to comply with, and Farabee directed others to fail to comply with, the USDA Agreement by discarding cattle carcasses and heads prior to receiving BSE test results.
A conviction for theft of government funds carries a maximum penalty of 10 years imprisonment. Mail fraud and wire fraud convictions carry a maximum penalty of 20 years imprisonment. Convictions for the above referenced violations also carry a maximum fine of $250,000 for individuals and $500,000 for organizations. In determining an actual sentence, Judge Earl H. Carroll will consult the U.S. Sentencing Guidelines, which provide appropriate sentencing ranges. The judge, however, is not bound by those guidelines in determining a sentence. Sentencing is set before Judge Earl H. Carroll on May 14, 2007. The investigation in this case was conducted by Assistant Special Agent in Charge Alejandro Quintero, United States Department of Agriculture, Office of Inspector General. The prosecution is being handled by Robert Long, Assistant U.S. Attorney, District of Arizona, Phoenix.
CASE NUMBER: CR-07-00160-PHX-EHC RELEASE NUMBER: 2007-051(Farabee) # # #
http://www.usdoj.gov/usao/az/press_releases/2007/2007-051(Farabee).pdf
Nebraska Senator Mike Johanns
Wednesday, February 11, 2009
Atypical BSE North America Update February 2009
http://bse-atypical.blogspot.com/2009/02/atypical-bse-north-america-update.html
Tuesday, November 02, 2010
BSE - ATYPICAL LESION DISTRIBUTION (RBSE 92-21367) statutory (obex only) diagnostic criteria CVL 1992
IN CONFIDENCE
The information contained herein should not be disseminated further except on the basis of "NEED TO KNOW".
http://bse-atypical.blogspot.com/2010/11/bse-atypical-lesion-distribution-rbse.html
Rare BSE mutation raises concerns over risks to public health
SIR — Atypical forms (known as H- and L-type) of bovine spongiform encephalopathy (BSE) have recently appeared in several European countries as well as in Japan, Canada and the United States. This raises the unwelcome possibility that variant Creutzfeldt–Jakob disease (vCJD) could increase in the human population. Of the atypical BSE cases tested so far, a mutation in the prion protein gene (PRNP) has been detected in just one, a cow in Alabama with BSE;
http://www.plospathogens.org/article/fetchObjectAttachment.action?uri=info%3Adoi%2F10.1371%2Fjournal.ppat.1000156&representation=PDF
http://prionpathy.blogspot.com/2010/08/bse-case-associated-with-prion-protein.html
her healthy calf also carried the mutation (J. A. Richt and S. M. Hall PLoS Pathog. 4, e1000156; 2008).
This raises the possibility that the disease could occasionally be genetic in origin. Indeed, the report of the UK BSE Inquiry in 2000 suggested that the UK epidemic had most likely originated from such a mutation and argued against the scrapierelated assumption. Such rare potential pathogenic PRNP mutations could occur in countries at present considered to be free of BSE, such as Australia and New Zealand. So it is important to maintain strict surveillance for BSE in cattle, with rigorous enforcement of the ruminant feed ban (many countries still feed ruminant proteins to pigs). Removal of specified risk material, such as brain and spinal cord, from cattle at slaughter prevents infected material from entering the human food chain. Routine genetic screening of cattle for PRNP mutations, which is now available, could provide additional data on the risk to the public. Because the point mutation identified in the Alabama animals is identical to that responsible for the commonest type of familial (genetic) CJD in humans, it is possible that the resulting infective prion protein might cross the bovine–human species barrier more easily. Patients with vCJD continue to be identified. The fact that this is happening less often should not lead to relaxation of the controls necessary to prevent future outbreaks.
Malcolm A. Ferguson-Smith Cambridge University Department of Veterinary Medicine, Madingley Road, Cambridge CB3 0ES, UK e-mail: maf12@cam.ac.uk Jürgen A. Richt College of Veterinary Medicine, Kansas State University, K224B Mosier Hall, Manhattan, Kansas 66506-5601, USA
NATUREVol 45726 February 2009
http://www.nature.com/nature/journal/v457/n7233/full/4571079b.html
LET'S take a closer look at this new prionpathy or prionopathy, and then let's look at the g-h-BSEalabama mad cow.
This new prionopathy in humans? the genetic makeup is IDENTICAL to the g-h-BSEalabama mad cow, the only _documented_ mad cow in the world to date like this, ......wait, it get's better. this new prionpathy is killing young and old humans, with LONG DURATION from onset of symptoms to death, and the symptoms are very similar to nvCJD victims, OH, and the plaques are very similar in some cases too, bbbut, it's not related to the g-h-BSEalabama cow, WAIT NOW, it gets even better, the new human prionpathy that they claim is a genetic TSE, has no relation to any gene mutation in that family. daaa, ya think it could be related to that mad cow with the same genetic make-up ??? there were literally tons and tons of banned mad cow protein in Alabama in commerce, and none of it transmitted to cows, and the cows to humans there from ??? r i g h t $$$
ALABAMA MAD COW g-h-BSEalabama
In this study, we identified a novel mutation in the bovine prion protein gene (Prnp), called E211K, of a confirmed BSE positive cow from Alabama, United States of America. This mutation is identical to the E200K pathogenic mutation found in humans with a genetic form of CJD. This finding represents the first report of a confirmed case of BSE with a potential pathogenic mutation within the bovine Prnp gene. We hypothesize that the bovine Prnp E211K mutation most likely has caused BSE in "the approximately 10-year-old cow" carrying the E221K mutation.
http://www.plospathogens.org/article/info%3Adoi%2F10.1371%2Fjournal.ppat.1000156
http://www.plospathogens.org/article/fetchObjectAttachment.action?uri=info%3Adoi%2F10.1371%2Fjournal.ppat.1000156&representation=PDF
Saturday, August 14, 2010
BSE Case Associated with Prion Protein Gene Mutation (g-h-BSEalabama) and VPSPr PRIONPATHY
(see mad cow feed in COMMERCE IN ALABAMA...TSS)
http://prionpathy.blogspot.com/2010/08/bse-case-associated-with-prion-protein.html
2009 UPDATE ON ALABAMA AND TEXAS MAD COWS 2005 and 2006
http://bse-atypical.blogspot.com/2006/08/bse-atypical-texas-and-alabama-update.html
I ask Professor Kong ;
Thursday, December 04, 2008 3:37 PM Subject: RE: re--Chronic Wating Disease (CWD) and Bovine Spongiform Encephalopathies (BSE): Public Health Risk Assessment
''IS the h-BSE more virulent than typical BSE as well, or the same as cBSE, or less virulent than cBSE? just curious.....''
Professor Kong reply ;
.....snip
''As to the H-BSE, we do not have sufficient data to say one way or another, but we have found that H-BSE can infect humans. I hope we could publish these data once the study is complete.
Thanks for your interest.''
Best regards,
Qingzhong Kong, PhD Associate Professor Department of Pathology Case Western Reserve University Cleveland, OH 44106 USA
END...TSS
P26
TRANSMISSION OF ATYPICAL BOVINE SPONGIFORM ENCEPHALOPATHY (BSE) IN HUMANIZED MOUSE MODELS
Liuting Qing1, Fusong Chen1, Michael Payne1, Wenquan Zou1, Cristina Casalone2, Martin Groschup3, Miroslaw Polak4, Maria Caramelli2, Pierluigi Gambetti1, Juergen Richt5*, and Qingzhong Kong1
1Department of Pathology, Case Western Reserve University, Cleveland, OH 44106, USA; 2CEA, Istituto Zooprofilattico Sperimentale, Italy; 3Friedrich-Loeffler-Institut, Germany; 4National Veterinary Research Institute, Poland; 5Kansas State University, Diagnostic Medicine/Pathobiology Department, Manhattan, KS 66506, USA. *Previous address: USDA National Animal Disease Center, Ames, IA 50010, USA
Classical BSE is a world-wide prion disease in cattle, and the classical BSE strain (BSE-C) has led to over 200 cases of clinical human infection (variant CJD). Two atypical BSE strains, BSE-L (also named BASE) and BSE-H, have been discovered in three continents since 2004. The first case of naturally occurring BSE with mutated bovine PrP gene (termed BSE-M) was also found in 2006 in the USA. The transmissibility and phenotypes of these atypical BSE strains/isolates in humans were unknown.
We have inoculated humanized transgenic mice with classical and atypical BSE strains (BSE-C, BSE-L, BSE-H) and the BSE-M isolate. We have found that the atypical BSE-L strain is much more virulent than the classical BSE-C. The atypical BSE-H strain is also transmissible in the humanized transgenic mice with distinct phenotype, but no transmission has been observed for the BSE-M isolate so far.
http://www.istitutoveneto.it/prion_09/Abstracts_09.pdf
Thursday, October 07, 2010
Experimental Transmission of H-type Bovine Spongiform Encephalopathy to Bovinized Transgenic Mice
http://bse-atypical.blogspot.com/2010/10/experimental-transmission-of-h-type.html
Wednesday, July 28, 2010
re-Freedom of Information Act Project Number 3625-32000-086-05, Study of Atypical BSE UPDATE July 28, 2010
http://bse-atypical.blogspot.com/2010/07/re-freedom-of-information-act-project.html
Wednesday, November 10, 2010 McDonald's and USA BSE aka mad cow disease McDonald's AND Seriologicals USA NOT PROTECTED FROM MAD COW
http://bse-atypical.blogspot.com/2010/11/mcdonalds-and-usa-bse-aka-mad-cow.html
WAKE UP AMERICA !
with kindest regards, terry
layperson
FDA STATEMENT FOR IMMEDIATE RELEASE 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 30th, 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/NewsEvents/Newsroom/PressAnnouncements/2004/ucm108292.htm
Saturday, November 6, 2010
TAFS1 Position Paper on Position Paper on Relaxation of the Feed Ban in the EU Berne, 2010 TAFS
INTERNATIONAL FORUM FOR TRANSMISSIBLE ANIMAL DISEASES AND FOOD SAFETY a non-profit Swiss Foundation
http://madcowfeed.blogspot.com/2010/11/tafs1-position-paper-on-position-paper.html
Seven main threats for the future linked to prions
The NeuroPrion network has identified seven main threats for the future linked to prions.
First threat
The TSE road map defining the evolution of European policy for protection against prion diseases is based on a certain numbers of hypotheses some of which may turn out to be erroneous. In particular, a form of BSE (called atypical Bovine Spongiform Encephalopathy), recently identified by systematic testing in aged cattle without clinical signs, may be the origin of classical BSE and thus potentially constitute a reservoir, which may be impossible to eradicate if a sporadic origin is confirmed. *** Also, a link is suspected between atypical BSE and some apparently sporadic cases of Creutzfeldt-Jakob disease in humans. These atypical BSE cases constitute an unforeseen first threat that could sharply modify the European approach to prion diseases.
Second threat
In small ruminants, a new atypical form of scrapie currently represents up to 50% of detected cases and even involves sheep selected for resistance to classical scrapie. The consequences for animal and human health are still unknown and there may be a potential connection with atypical BSE. These atypical scrapie cases constitute a second threat not envisioned previously which could deeply modify the European approach to prion diseases.
Third threat
The species barrier between human and cattle might be weaker than previously expected and the risk of transmission of prion diseases between different species has been notoriously unpredictable. The emergence of new atypical strains in cattle and sheep together with the spread of chronic wasting disease in cervids renders the understanding of the species barrier critical. This constitutes a third threat not properly envisioned previously that could deeply modify the European approach to prion diseases.
Fourth threat
Prion infectivity has now been detected in blood, urine and milk and this has potential consequences on risk assessments for the environment and food as well as for contamination of surfaces including medical instruments. Furthermore the procedures recommended for decontamination of MBM (Meat and Bone Meal), which are based on older methodologies not designed for this purpose, have turned out to be of very limited efficacy and compromise current policies concerning the reuse of these high value protein supplements (cross-contamination of feed circuits are difficult to control). It should be noted that the destruction or very limited use of MBM is estimated to still cost 1 billion euros per year to the European economy,
whereas other countries, including the US,
Brazil, and Argentine do not have these constraints.
However, many uncertainties remain concerning the guarantees that can be reasonably provided for food and feed safety and scientific knowledge about the causative agents (prions) will continue to evolve. This decontamination and environmental issue is a fourth threat that could modify deeply the European approach to prion diseases.
Fifth threat The precise nature of prions remains elusive. Very recent data indicate that abnormal prion protein (PrPTSE) can be generated from the brains of normal animals, and under some conditions (including contaminated waste water) PrPTSE can be destroyed whereas the BSE infectious titre remains almost unchanged, a finding that underlines the possibility of having BSE without any detectable diagnostic marker. These are just two areas of our incomplete knowledge of the fundamental biology of prions which constitute a fifth threat to the European approach to prion diseases.
Sixth threat The absence of common methods and standardisation in the evaluation of multiple in vivo models with different prion strains and different transgenic mice expressing PrP from different species (different genotypes of cattle, sheep, cervids, etc) renders a complete and comprehensive analysis of all the data generated by the different scientific groups almost impossible. This deeply impairs risk assessment. Moreover, the possibility of generating PrPTSE de novo with new powerful techniques has raised serious questions about their appropriateness for use as blood screening tests. The confusion about an incorrect interpretation of positive results obtained by these methods constitutes a sixth threat to European approach to prion diseases.
Seventh Threat The detection of new or re-emerging prion diseases in animals or humans which could lead to a new crisis in consumer confidence over the relaxation of precautionary measures and surveillance programmes constitutes a seventh threat that could modify the European approach to prion diseases.
http://www.neuroprion.org/en/np-neuroprion.html
Thursday, August 12, 2010
Seven main threats for the future linked to prions
http://prionpathy.blogspot.com/2010/08/seven-main-threats-for-future-linked-to.html
http://prionpathy.blogspot.com/
Rural and Regional Affairs and Transport References Committee The possible impacts and consequences for public health, trade and agriculture of the Government's decision to relax import restrictions on beef Final report June 2010
2.65 At its hearing on 14 May 2010, the committee heard evidence from Dr Alan Fahey who has recently submitted a thesis on the clinical neuropsychiatric, epidemiological and diagnostic features of Creutzfeldt-Jakob disease.48 Dr Fahey told the committee of his concerns regarding the lengthy incubation period for transmissible spongiform encephalopathies, the inadequacy of current tests and the limited nature of our current understanding of this group of diseases.49
2.66 Dr Fahey also told the committee that in the last two years a link has been established between forms of atypical CJD and atypical BSE. Dr Fahey said that: They now believe that those atypical BSEs overseas are in fact causing sporadic Creutzfeldt-Jakob disease. They were not sure if it was due to mad sheep disease or a different form. If you look in the textbooks it looks like this is just arising by itself. But in my research I have a summary of a document which states that there has never been any proof that sporadic Creutzfeldt-Jakob disease has arisen de novo-has arisen of itself. There is no proof of that. The recent research is that in fact it is due to atypical forms of mad cow disease which have been found across Europe, have been found in America and have been found in Asia. These atypical forms of mad cow disease typically have even longer incubation periods than the classical mad cow disease.50
http://www.aph.gov.au/senate/committee/rrat_ctte/mad_cows/report/report.pdf
5 Includes 28 cases in which the diagnosis is pending, and 17 inconclusive cases;
6 Includes 28 (24 from 2010) cases with type determination pending in which the diagnosis of vCJD has been excluded
http://www.cjdsurveillance.com/pdf/case-table.pdf
CJD TEXAS 38 YEAR OLD FEMALE WORKED SLAUGHTERING CATTLE EXPOSED TO BRAIN AND SPINAL CORD MATTER
" Up until about 6 years ago, the pt worked at Tyson foods where she worked on the assembly line, slaughtering cattle and preparing them for packaging. She was exposed to brain and spinal cord matter when she would euthanize the cattle. "
http://www.recordandoalinda.com/index.php?option=com_content&view=article&id=19:cjd-english-info&catid=9:cjd-ingles&Itemid=8
According to the World Health Organisation, the future public health threat of vCJD in the UK and Europe and potentially the rest of the world is of concern and currently unquantifiable. However, the possibility of a significant and geographically diverse vCJD epidemic occurring over the next few decades cannot be dismissed.
The key word here is diverse. What does diverse mean?
If USA scrapie transmitted to USA bovine does not produce pathology as the UK c-BSE, then why would CJD from there look like UK vCJD?"
SEE FULL TEXT ;
http://www.promedmail.org/pls/apex/f?p=2400:1001:568933508083034::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1000,82101
5 Includes 28 cases in which the diagnosis is pending, and 17 inconclusive cases;
6 Includes 28 (24 from 2010) cases with type determination pending in which the diagnosis of vCJD has been excluded
http://www.cjdsurveillance.com/pdf/case-table.pdf
USA MAD COW POLICY, don't look, don't find, or screw the testing up so bad, everything comes out negative. UNLESS of course you get the end around by the Honorable Phyllis Fong of the OIG. Course, that was a one time deal. But what a coup it was. ...TSS
-------- Original Message --------
Subject: USA BIO-RADs INCONCLUSIVEs
Date: Fri, 17 Dec 2004 15:37:28 -0600
From: "Terry S. Singeltary Sr."
To: susan_berg@bio-rad.com
Hello Susan and Bio-Rad,
Happy Holidays!
I wish to ask a question about Bio-Rad and USDA BSE/TSE testing and there inconclusive. IS the Bio-Rad test for BSE/TSE that complicated, or is there most likely some human error we are seeing here?
HOW can Japan have 2 positive cows with No clinical signs WB+, IHC-, HP- , BUT in the USA, these cows are considered 'negative'?
IS there more politics working here than science in the USA?
What am I missing?
-------- Original Message --------
Subject: Re: USDA: More mad cow testing will demonstrate beef's safety
Date: Fri, 17 Dec 2004 09:26:19 -0600
From: "Terry S. Singeltary Sr." snip...end
Experts doubt USDA's mad cow results
snip...END
WELL, someone did call me from Bio-Rad about this, however it was not Susan Berg. but i had to just about take a blood oath not to reveal there name. IN fact they did not want me to even mention this, but i feel it is much much to important. I have omitted any I.D. of this person, but thought I must document this ;
Bio-Rad, TSS phone conversation 12/28/04
SNIP...
full text ;
http://madcowtesting.blogspot.com/2008/01/bse-oie-usda.html
Saturday, August 16, 2008
Qualitative Analysis of BSE Risk Factors in the United States February 13, 2000 at 3:37 pm PST (BSE red book)
http://bseusa.blogspot.com/2008/08/qualitative-analysis-of-bse-risk.html
48 hour traceback for BSE mad cow disease in the USA ???
NOT in your lifetime !
8 YEARS IN REVIEW OF THE MAD COW DEBACLE IN THE USA ;
http://bse-atypical.blogspot.com/2008/12/mad-cow-disease-usa-december-28-2008-8.html
Thursday, June 24, 2010
Accumulation of L-type Bovine Prions in Peripheral Nerve Tissues
Volume 16, Number 7–July 2010
http://bse-atypical.blogspot.com/2010/06/accumulation-of-l-type-bovine-prions-in.html
Saturday, June 19, 2010
U.S. DENIED UPGRADED BSE STATUS FROM OIE
see full text and reasons why here ;
http://usdameatexport.blogspot.com/2010/06/us-denied-upgraded-bse-status-from-oie.html
-------- Original Message --------
Subject: TESTIMONY OF THE HONORABLE MIKE JOHANNS USDA BEFORE THE U.S. SENATE COMMITTEE ON AGRICULTURE, NUTRITION & FORESTRY FEBRUARY 3, 2005 Date: Tue, 22 Feb 2005 16:29:55 -0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@LISTSERV.KALIV.UNI-KARLSRUHE.DE
##################### Bovine Spongiform Encephalopathy #####################
TESTIMONY OF THE HONORABLE MIKE JOHANNS UNITED STATES DEPARTMENT OF AGRICULTURE BEFORE THE U.S. SENATE COMMITTEE ON AGRICULTURE, NUTRITION & FORESTRY FEBRUARY 3, 2005
Chairman Chambliss, Mr. Harkin, Members of the Committee, thank you for holding this important hearing today and for the opportunity to testify before you. Accompanying me today are Dr. Keith Collins, USDA s Chief Economist and Dr. Ron DeHaven, Administrator of USDA s Animal and Plant Health Inspection Service (APHIS). They will be available to assist in answering any questions you might have.
Before I begin, I want to thank you all for the professionalism and courtesy extended to Stephanie and me during my recent confirmation process. I appreciate the close, positive working relationships that we have begun forging, and thanks to the diligence of this Committee, it was an honor and privilege for me to be the first Cabinet member confirmed during President Bush s second term. It is, therefore, a pleasure to return for my first hearing as Secretary.
I have said frequently that addressing Bovine Spongiform Encephalopathy (BSE) issues, particularly as they relate to trade disruptions, would be my top priority as Secretary. I have also heard from this Committee quite clearly on this topic, and I believe very strongly that we are all on the side of American agriculture. The Committee and your constituents have also posed some useful and valid questions that deserve thorough examination, which this hearing will help provide.
The actions that the U.S. Department of Agriculture and the federal government are taking in regard to BSE are potentially precedent-setting and could affect international trade patterns for years to come, with important economic implications for our cattle producers and the entire beef industry. Therefore, our actions must be undertaken with the utmost deliberation, using science as the basis. In the absence of that science, sanitary and phytosanitary (SPS) restrictions will be used arbitrarily by many nations, without any basis of protecting human or animal health.
Accordingly, this hearing could not be timelier. I want to be very clear that while protecting human and animal health must remain our top priorities, I am confident that we can seek to return to normal patterns of international commerce by continuing to use science as the basis for decision making by U.S. regulatory authorities and our trading partners.
Almost exactly one year ago, Secretary Veneman appeared before this Committee to discuss BSE. In the time since then, much has transpired:
On March 8, 2004, USDA published a notice reopening the comment period on a rule to establish minimal-risk regions for BSE (the minimal-risk rule ).
On March 15, 2004, consistent with the recommendations of an International Review Team (IRT) of scientific advisers, USDA announced that beginning June 1 it would implement an enhanced BSE surveillance program to test as many high risk animals as possible over a 12-18 month period. We wanted once and for all to clearly ascertain whether we had BSE in our cattle herd and, if so, how prevalent it might be. USDA began the work of setting up the infrastructure required, including laboratory equipment and certification, staff training, outreach efforts, and licensing and approval of rapid tests. The plan was reviewed by the IRT, which characterized it as comprehensive, scientifically based and address[ing] the most important points regarding BSE surveillance in animals.
On June 1, 2004, the enhanced surveillance program began. Our goal is to test as many high- risk cattle as possible in 12-18 months. If we test 268, 500 we will be able to detect the presence of as few as five targeted, high-risk cattle with BSE at a 99 percent confidence level. At the time, USDA officials consistently stated that the surveillance plan might uncover additional BSE-positive animals. To date, some eight months later, more than 200,000 animals have been tested, all of which have been negative.
In order to help raise awareness about potential BSE cases among animal-health professionals and livestock producers, education and outreach have also been critical components of these efforts. These activities have included advertisements in industry publications, media articles, presentations at trade shows, and other materials. The role of producers, renderers and others in helping obtain samples of high-risk animals has been indispensable to the success of our surveillance program, and the cooperation we have received has been outstanding.
On December 29, 2004, USDA announced the final minimal-risk rule, which designated Canada as the first minimal-risk region for BSE, and which will become effective on March 7, 2005.
On January 2, 2005, Canada confirmed its second domestic case of BSE in a cow that was born in October of 1996 (the first since May 20, 2003). It was followed nine days later by a third case, an 81-month-old cow.
On January 24, 2005, USDA dispatched a technical team to Canada. We sent the team to investigate the efficacy of Canada s ruminant to ruminant feed ban because the animal was born shortly after the implementation of that ban and to determine if there are any potential links among the positive animals. We have appreciated Canada s willingness to cooperate and assist us in these efforts.
The technical team is focusing both on the efficacy of Canada s feed ban and its epidemiological investigation of the new BSE cases. The team is composed of experts from APHIS in the areas of epidemiology, transmissible spongiform encephalopathies (the family of diseases to which BSE belongs), and official documentation.
An auditor from USDA s Agricultural Marketing Service (AMS) is also part of the team, which will also be joined by representatives of USDA s Foreign Agricultural Service (FAS) stationed in Canada. Technical experts from the Department of Health and Human Services Food and Drug Administration are accompanying the team in an advisory capacity.
We have been receiving regular updates from the team. We expect a final report on feed ban issues in mid-February and the epidemiological report by the end of March. These reports will be critical as we consider whether any adjustments to current policies are warranted.
The Minimal-Risk Rule
As you are aware, USDA s minimal-risk rule has come under legal challenge. I will address the process of promulgating the rule, which was transparent, deliberative and science-based.
Two rounds of public comment were conducted on the rule, with more than 3,300 comments received.
The final rule establishes criteria for geographic regions to be recognized as presenting minimal risk of introducing BSE into the United States. It places Canada in the minimal-risk category, and defines the requirements that must be met for the import of certain ruminants and ruminant products from Canada. A minimal-risk region can include a region in which BSE-infected animals have been diagnosed, but where sufficient risk-mitigation measures have been put in place to make the introduction of BSE into the United States unlikely.
Because the rule permits the import of live cattle under 30 months of age and ruminant products from older animals, it is useful to note the risk mitigation measures. These include: proper animal identification; accompanying animal health certification that includes information on individual animal identification, age, origin, destination, and responsible parties; the movement of the cattle to feedlots or slaughter facilities in sealed containers; the prohibition on cattle moving to more than one feedlot in the United States; and the removal of specified risk materials (SRMs) from cattle slaughtered in the United States.
For live sheep and goats under 12 months of age, all of the same mitigation measures apply, except for the requirement that SRMs be removed from the animal at slaughter.
We remain very confident that the combination of all of these requirements, in addition to the animal and public health measures that Canada has in place to prevent the spread of BSE, along with the extensive U.S. regulatory food-safety and animal-health systems, provide the utmost protection to U.S. consumers and livestock.
USDA continues to undertake several steps to ensure Canada s compliance with its BSE regulations. In addition to the investigation that I already discussed, USDA s Food Safety and Inspection Service in December 2004 conducted an intensive audit of Canada s compliance with the BSE requirements of the United States, with particular attention to SRM removal. FSIS visited several facilities that slaughter only cattle under 30 months of age and determined that they are effectively implementing the BSE regulations.
This month, FSIS will conduct a similar BSE audit of Canadian plants that slaughter cattle 30 months and older. Canada currently has only seven such plants that are certified to export meat to the United States.
I am aware of concerns with the portion of USDA s minimal-risk rule that would allow meat from animals over 30 months of age to be imported from Canada, but continue the prohibition on the importation of live animals of the same age for processing in the United States. Some have suggested that going forward with this rule will change the historical beef-trading patterns in North America to the detriment of U.S. packers.
As Secretary of Agriculture, I believe that the marketplace should determine cross-border trading patterns. We must make every effort to avoid policies that favor one group of packers over another. Decisions, however, related to sanitary and phytosanitary measures must be based on science.
I can assure you that I will be reviewing this issue very carefully in the days ahead as we move closer to the March 7 implementation date.
The Role of Science
I simply cannot emphasize strongly enough the central role of science in this entire process, particularly with regard to the rigorous evaluation of risk.
Since the discovery of the first case of BSE in Great Britain in 1986, we have learned a tremendous amount about this disease. That knowledge has greatly informed our regulatory systems and response efforts.
We have learned that the single most important thing we can do to protect human health regarding BSE is the removal of SRMs from the food supply. Likewise, the most significant step we can take to prevent the spread of BSE and bring about its complete eradication is the ruminant to ruminant feed ban. It is because of the strong systems the United States has put in place, especially these two essential firewalls, that we can be confident of the safety of our beef supply and that the spread of BSE has been prevented in this nation.
After Canada reported its first case of BSE in May 2003, USDA conducted a comprehensive risk analysis to review the potential threat it posed. The initial analysis followed the recommended structure of the World Organization for Animal Health, or OIE, and drew on findings from the Harvard-Tuskegee BSE risk assessment, findings from the epidemiological investigation of BSE in Canada, and information on Canadian BSE surveillance and feed ban, and history of imports of cattle and meat and bone meal from countries known to have BSE.
The results of that analysis, available on the USDA Website, confirmed that Canada has the necessary safeguards in place to protect U.S. consumers and livestock against BSE. These mitigation measures include the removal of SRMs from the food chain supply, a ruminant-to-ruminant feed ban, a national surveillance program and import restrictions. The extensive risk assessment conducted as part of USDA s rulemaking process also took into careful consideration the possibility that Canada could experience additional cases of BSE.
In the risk analysis update for the final rule, USDA also considered the additional risk protection from new slaughter procedures, such as the prohibition on the use of downer animals for food.
The public commented on the risk assessment that accompanied the proposed rule and the Explanatory Note released following the finding of BSE in a cow in Washington State. Over a period of months, USDA carefully considered these comments, and responses were published with the final rule. The comments were beneficial to the final risk analysis. The risk analysis was reviewed internally at USDA and by Dr. William Hueston, an international expert on BSE and a member of the International Review Team.
The OIE recommends the use of risk assessment to manage human and animal health risks of BSE. OIE guidelines, based on current scientific understanding, recognize that there are different levels of risk in countries or regions, and suggest how trade may safely occur according to the levels of risk. USDA used OIE as a basis in developing our regulations defining Canada as a minimal risk country.
Cattle and Beef Trade Impacts
While SPS regulations protecting human and animal health are the foremost concern, USDA also has examined the potential economic impacts of the minimal-risk rule and related BSE trade issues, as required by Executive Order 12866.
For more than three months following the May 20, 2003, BSE discovery in Canada, all imports of Canadian ruminants and ruminant products were barred. Then, certain Canadian ruminant products for which there is inherently lower risk were allowed to enter under permit beginning September 2003.
For all of 2003, the United States imported 336,000 metric tons of beef from Canada. Imports increased to an estimated 476,000 metric tons in 2004, up nearly 42 percent and back to about the level that prevailed in years prior to 2003. The cost-benefit analysis conducted as part of the final rule indicates that U.S. beef imports from Canada are projected to actually decrease slightly in 2005 (about 4 percent), as Canada shifts its slaughter capacity to lower-yielding older cattle not eligible for export to the United States.
At the same time since the border has been closed to live cattle since May 2003, imports of fed and feeder cattle under 30 months are expected to increase in 2005, which is expected to drive up U.S. beef production, reduce beef prices slightly and, consequently, reduce cattle prices. Our most recent forecast for all of 2005 is that fed cattle prices are expected to average $82 per cwt, assuming the Canadian border opens on March 7, 2005, and that Asian markets do not open to our beef during 2005. The precise economic effects will depend on the timing and volume of cattle and beef imports from Canada. If USDA s price forecast turns out to be correct, that would be the third-highest annual fed cattle price on record. Cattle futures prices may be less affected than indicated by our forecast, as market prices have likely already reflected some probability of the border opening. In addition, to the extent that we can continue to open markets that are currently closed to our beef, U.S. cattle price prospects will strengthen.
U.S. market-maintenance activities have been critical in helping restore our beef export markets. In 2003, the total export value of U.S. beef and ruminant products was $7.5 billion. After December 23, 2003, 64 percent of that market was immediately closed. Today, we have recovered well over a third of that, so that 41 percent of that market ($3.1 billion) remains closed. Two countries Japan ($1.5 billion) and Korea ($800 million) account for nearly three-quarters of the existing closures.
Opening the Japanese Market
As a leader in the critical Asian markets, Japan is a vital market to reopen to U.S. beef exports. We are aware that the decision to resume trade in this market will set an important precedent for trade resumption in many other markets. Therefore we have endeavored to use science in our ongoing efforts. Efforts to re-open this market have drawn on resources across the federal government and at the highest political levels. As I have previously said, this issue has occupied much of my first few days as Secretary. Just last week, I met with Ambassador Kato and also wrote to my counterpart, Minister Shimamura, on the importance of this issue. At the same time, Ambassador Baker continues to press this issue with Government of Japan officials in Tokyo, and other U.S. Government officials continue to contact their counterparts.
These efforts are just the latest in many policy discussions and technical exchanges over the past 13 months. Indeed, the issue has been a major focus of direct discussions between President Bush and Japanese Prime Minister Koizumi.
On October 23, 2004, Japan and the United States developed a framework to allow the resumption of bilateral beef trade following the conclusion of regulatory processes in both countries. As a step toward the resumption of normal trade, the agreement establishes an interim special marketing program, known as the Beef Export Verification (BEV) Program, to allow the United States to sell beef and beef products to Japanese importers from animals 20 months of age and under. Animal age will be determined through a combination of production records and physiological (grading) means. We are now working with Japanese officials to gain approval of the BEV under their regulatory process.
While we are focusing on Japan because of our important trading relationship and its leadership role in the region, we are also pursuing efforts to reopen all of the markets that have been closed to us. We are actively engaged with Korea, Hong Kong, Taiwan, China, Egypt, and Russia and have specific actions underway in each market to get trade resumed. I would be pleased to provide Members upon request additional detail on these and other secondary markets. While the progress that has been made has taken far longer than we had hoped, progress is indeed being made. And, I have stated that USDA, and indeed the entire U.S. Government, will exert every effort to resolve the matter at the earliest possible time.
Conclusion
As traditional trade barriers such as tariffs are lowered, our focus to eliminate unjustified non-tariff barriers such as non-science based SPS regulatory measures become all the more important to maintain the flow of mutually beneficial trade. For USDA, a common touchstone across these issues is the need to maintain consistency and predictability, to base our domestic regulations on science and to encourage the use of science-based solutions within the international community. The United States has long been a leader in this regard, including negotiating the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures during the Uruguay Round.
Even before the discovery of a single case of BSE in the United States, USDA had begun talking with other countries about the need for international trade standards to keep pace with the science, and we will redouble our efforts in this regard.
It is also critical that domestic trade rules reflect the current state of knowledge regarding BSE, and here the United States is leading, as well. We are confident that trade can be resumed with countries where BSE has been discovered, contingent upon strong protections within those countries, as well as the robust and effective regulatory system those imports are subject to when they enter the United States. These facts are reflected in the minimal-risk rule.
At the same time, we will continue to work with our trading partners to ensure the ongoing strength of their own BSE protection systems, especially the removal of SRMs and implementation of the feed ban. While trade opportunities are multiplying in an increasingly global marketplace, we must always remain mindful of our paramount responsibility to protect the public health and animal health.
In summary, I am confident that we are continuing to keep the protection of public and animal health foremost in our concerns. It is critical that we continue to use science as a basis for our decisions and regulations, and that the United States maintain its leadership role in advancing our scientific understanding of these kinds of SPS-related issues and appropriate science-based responses.
Mr. Chairman, thank you once again for holding this important hearing. I would now be pleased to take any questions you or other members may have.
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http://www.usda.gov/agency/ocr/download/Johanns.BSE.020305.doc
July 14 Ann Veneman , Secretary of Agriculture Joint Hearing: House Committee on Agriculture and House Committee on Government Reform Ongoing activities related to Bovine Spongiform Encephalopathy (BSE)
http://www.usda.gov/agency/ocr/download/Veneman.BSE.071404.doc
February 24 The Honorable Elsa Murano , Under Secretary for Food Safety; Dr. Ron DeHaven , Deputy Administrator for Veterinary Services Animal and Plant Health Inspection Service; Dr. Keith Collins, Chief Economist Senate Appropriations Committee BSE
http://www.usda.gov/agency/ocr/download/Murano.22404.doc
http://www.usda.gov/agency/ocr/download/Dehaven.22404.doc
http://www.usda.gov/agency/ocr/download/KeithCollins.22404.doc
January 2004 January 27 The Honorable Ann M. Veneman,
Secretary, USDA
Senate Agriculture
Committee
BSE-positive cow found in Washington State and USDA's response January 21 The Honorable Ann M. Veneman,
Secretary, USDA
House Agriculture
Committee
BSE-positive cow found in Washington State and USDA's response
http://www.usda.gov/agency/ocr/download/BSE.Veneman.012704.doc
http://www.usda.gov/agency/ocr/download/BSE.Veneman.012104.doc
June 19 Bobby Accord, Administrator, APHIS House Resources Subcommittee on Fisheries, Conservation, Wildlife & Oceans Chronic Wasting Disease; palentological resources
NO LINK
May 16 Dr. Jim Butler , Duputy Under Secretary for Marketing & Regulatory Programs House Committee of Resources - Subcommittees on Forest and Forest Health , and Fishery Conservation, Wildlife and Oceans Chronic Wasting Disease
http://www.usda.gov/agency/ocr/download/MRP-Butler-5.16.02.pdf
http://resourcescommittee.house.gov/107cong/forests/2002may16/agenda.htm
ARCHIVES FROM 2001
NOT
http://www.usda.gov/agency/ocr/testimony2001.htm
???
MORE on that OTHER LITTLE OLD MAD COW FROM TEXAS (real player)
Assigned vet wanted it tested.
Gov. insp. over rided and decided not to test.
SYSTEM broken around the Country.
PROBLEMS NATION WIDE!
APHIS inspectors do not follow through.
http://www.npr.org/dmg/dmg.php?prgCode=ME&showDate=07-May2004&segNum=8&mediaPref=RM
May 13, 2004
Failure To Test Staggering Cow May Reflect Wider Problems Rep. Waxman raises concerns that the recent failure of USDA to test an impaired cow for BSE may not be an isolated incident, citing the failure of USDA to monitor whether cows condemned for central nervous system symptoms are actually tested for mad cow disease.
- Letter to USDA
http://www.house.gov/reform/min/pdfs_108_2/pdfs_inves/pdf_food_usda_mad_cow_may_13_let.pdf
http://www.house.gov/reform/min/pdfs_108_2/pdfs_inves/pdf_food_usda_mad_cow_may_13_let.pdf
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THAT ONE TEXAS MAD COW IS ONLY TIP OF ICE BURG;
No mad cow results for nearly 500 cows
By Steve Mitchell United Press International Published 8/11/2004 11:23 AM
WASHINGTON, Aug. 11 (UPI) -- The U.S. Department of Agriculture failed to test for mad cow disease or collect the correct portion of the brain on nearly 500 suspect cows over the past two years -- including some in categories considered most likely to be infected -- according to agency records obtained by United Press International.
The testing problems mean it may never be known with certainty whether these animals were infected with the deadly disease. Department officials said these animals were not included in the agency's final tally of mad cow tests, but the records, obtained by UPI under the Freedom of Information Act, indicate at least some of them were counted...
snip...
--
Steve Mitchell is UPI's Medical Correspondent. E-mail sciencemail@upi.com Copyright © 2001-2004 United Press International
http://www.upi.com/view.cfm?StoryID=20040810-042935-2066r
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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
Chapter 5
Center for Veterinary Medicine
Last Update: August 07, 2003
Animal Feeds
Warning Letters Issued for CGMP Violations
* On March 8, 2001, the FDA s New Orleans District Office issued a Warning Letter to Prestage Farms, Inc., West Point, Mississippi. The firm manufactures medicated and non-medicated feeds for its own integrated swine enterprise. An FDA inspection of the facility on February 21 - 22, 2001, disclosed significant deviations from the Current Good Manufacturing Practice (CGMP) requirements for Medicated Feeds. These deviations included: failure to perform assays for the active drug ingredient in one product since 1999; failure to perform appropriate investigations and/or corrective actions for out of limit assays; and failure to have master production records. * The FDA s Dallas District Office issued a Warning Letter to Purina Mills, St. Louis, Missouri, on March 23, 2001. The Warning Letter followed the an FDA inspection of Purina Mills, Oklahoma City, Oklahoma, on February 2-6, and 13-14, 2001. The firm failed to follow Purina's SOP for Drug Sequencing Requirements. The SOP provides for sequencing production (without flushing the mixer) of animal feeds for a species for which a drug component of a prior medicated feed is not approved. Additionally, the firm had distributed bagged medicated feeds since June 2000, with faulty tagging equipment and no control to ensure that all bagged feeds were completely labeled.
Bovine Spongiform Encephalopathy (BSE)
To help prevent the establishment and amplification of BSE in the Unites States, FDA implemented a final rule that prohibits the use of most mammaliam protein in feeds for ruminant animals. This rule, Title 21 Part 589.2000 of the Code of Federal Regulations, became effective on August 4, 1997.
On August 23, 2001, Department of Health and Human Services (DHHS) Secretary Tommy Thompson unveiled a department-wide action plan outlining new steps to improve scientific understanding of BSE, commonly known as "mad cow disease," and related diseases known as TSEs. The plan incorporates a comprehensive approach to further strengthen surveillance, increase research resources, and expand existing inspection efforts to prevent BSE and TSEs from entering or taking hold in the U.S.
Warning Letters for BSE Violations
FDA Inspection Finds Numerous Violations of BSE Regulations
* On August 8, 2001, the FDA s Seattle District Office issued a Warning Letter to the owner of an animal feed manufacturing facility located in Tualatin, Oregon. FDA investigators conducted an inspection on July 12, 2001, which disclosed violations of the bovine feed ingredient regulations. The inspection revealed that the firm failed to separate the receipt, processing, and storage of products containing prohibited material from non-prohibited material; failed to establish a written system, including clean-out and flushing procedures, to avoid commingling and cross-contamination of equipment; and failed to maintain records sufficient to track the materials. In addition, the firm failed to label products with the required cautionary statement, Do Not Feed to Cattle or Other Ruminants.
Gamecock Feedmill Found Violating BSE Regulations
* On July 12, 2001, the FDA s Cincinnati District Office issued a Warning Letter to the Carrollton Farmers Exchange, Carrollton, Ohio, a feed mill. FDA investigators conducted an inspection on June 25, 2001, which found the firm was manufacturing gamecock feed containing prohibited proteins. The firm was not labeling the gamecock feed with the cautionary statement, Do not Feed to Cattle or Other Ruminants; was not flushing or sequencing after manufacturing the feed, and was not maintaining distribution information.
Warning Issued for Lack of Required BSE Cautionary Statement
* The FDA s New Orleans District Office issued a Warning Letter to Shields Feed and Supply, Coffeeville, Alabama, on March 7, 2001. An inspection conducted on February 1, 2001, of Shields animal feed operation showed the finished product label lacked the required ruminant cautionary statement. In addition, mixing and distribution records were not maintained; no written procedures were established for mixer cleaning; and the corn used for the mixer cleaning was not labeled and quarantined.
Firm Warned for No Measures to Avoid Commingling of Feed
* On May 3, 2001, the FDA s Minneapolis District Office issued a Warning Letter to Adrian Elevator, Inc., a Butterfield, Minnesota, a manufacturer of animal feeds. On March 16, 2001, an inspection conducted by the State of Minnesota (on behalf of FDA) found significant deviations from the BSE regulations. The firm failed to provide adequate measures to avoid commingling or cross-contamination and failed to maintain adequate records to assure that prohibited animal proteins were not incorporated into feeds that may be used for ruminants. For example, there was no documentation to verify that the amount of "flush" being used was sufficient, and there were no procedures or documentation to verify that production was properly sequenced and that flushes were performed.
Warned Issued for Failure to Take Adequate Steps to Prevent BSE
* The FDA s Seattle District Office issued a Warning Letter on May 14, 2001, to Wallowa County Grain Growers, Inc., Enterprise, Oregon, for violations FDA regulations regarding Animal Proteins Prohibited in Ruminant Feed. An inspection of the firm on April 11 - 12, 2001, disclosed that the firm was not taking adequate steps to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE) in that they failed to separate the receipt, processing, and storage of the product containing prohibited materials from non-prohibited material; failed to establish a written system, including clean-out, and flushing procedures to avoid commingling and cross-contamination of common equipment; and failed to maintain records sufficient to track the materials throughout the receipt, processing, and distribution of product.
Contract Feed Manufacturer Found Violating BSE Regulations
On May 1, 2001, the FDA s Chicago District Office issued a Warning Letter to Material Resources, a contract feed manufacturer in Washington Park, Illinois. An inspection of the firm in March 2001, disclosed several deviations from the BSE regulation. These included failure to maintain written procedures and provide adequate means to prevent commingling between feeds containing prohibited protein and all other protein products. The firm also lacked adequate records to track products that contained prohibited protein throughout their receipt and processing.
Firm Warned for Lack of Written Procedures for Clean-Out to Prevent Commingling
* On June 6, 2001, the FDA s Seattle District issued a Warning Letter to Superior Feeds, Chester, Montana. The firm is an animal feed manufacturing operation. An inspection of this firm on April 25, 2001, revealed that the firm failed to label their product with the required statement, Do Not Feed to Cattle or other Ruminants. In addition, the facility failed to maintain written procedures specifying the clean-out or sequencing procedures used to prevent commingling or cross-contamination of ruminant and non-ruminant containing feeds.
FDA Inspection Discloses Hog Feed Lacks BSE Statement
* The FDA s Minneapolis District Office issued a Warning Letter on May 30, 2001, to Round Lake Farmers Coop, Round Lake, Minnesota. The firm manufacturers animal feeds. An inspection by the State of Minnesota (on behalf of FDA) on March 30, 2001, found significant deviations from the requirements for Animal Proteins Prohibited in Animal Feed. The firm failed to label a hog feed with the required BSE caution statement. In addition, they failed to establish and implement procedures for handling prohibited animal proteins and failed to maintain records sufficient to track the receipt of products containing prohibited animal proteins.
Import Detentions
Possible Contamination of Fish Food Leads to Detention
The week of March 7, 2001, the FDA s New York District Upstate Import Operations Branch detained three entries of fish food under Import Alert 99-25 (Detention Without Physical Examination of Animal Feed, Animal Feed Ingredients And Other Products For Animal Use Consisting Or Containing Ingredients of Animal Origin) due to possible contamination with the infectious agent for BSE. The country of origin for the fish food was the Federal Republic of Germany. The local USDA/Philadelphia/PPQ Office was notified.
Vitamin Supplement for Pets Detained
* The week of February 14, 2001, the FDA s Atlanta District reported the detention of 8,777 cartons of vitamin supplements for cats, kittens, puppies, and older dogs. The detention included both dog and cat treats. The detention was based on Import Alert 99-25 (BSE). The products were manufactured by Beaphar, Raalte, Netherlands, and were valued at approximately $63,000.
Calf Ration Detained
The FDA s New York District Office reported that during the week of March 21, 2001, FDA investigators detained an entry of Calf Starter Ration and Calf Finisher Ration under Import Alert 99-25, since some of the ingredients originated from France and The Netherlands (both of which are listed on IA 99-25 as BSE susceptible countries). The manufacturer of the feed was Grober Inc., Cambridge, Ontario, Canada, and the consignee was Majestic View Farms in Milan, Pennsylvania. The USDA/APHIS/PPQ Buffalo, New York office was contacted.
Recall of Various Animal Feed Products
* The FDA s Cincinnati District Office reported that The Hyland Company, Coalton, Kentucky, conducted a recall of various animal feed products, including Ultra Bloom and Endurance Plus horse feeds, due to cross-contamination with prohibited bovine material. The firm's corrective action involved the application of a sticker-label that contained the required BSE warning statement on the labels of their affected products. The firm initiated the recall by telephone on July 25, 201, and letters on July 31, 2001. * During an FDA inspection by the Cincinnati District Office investigators determined that Central Farm Supply of Kentucky, Inc., Louisville, Kentucky, had received poultry feed manufactured by Burkmann Mills, Bowling Green, Kentucky, that contained prohibited protein, but lacked the required caution statement. On May 3, 2001, the district and the University of Kentucky Regulatory Services Division met with the responsible parties of the mill's parent firm, Burkmann Mills London, London, Kentucky. During the meeting the firm volunteered to recall all feed products manufactured at the Bowling Green mill due to the lack of the required caution statement.
FDA Announces Animal Feed Recall
On January 30, 2001, FDA issued a Press Release announcing 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. The results indicated that a very low level of prohibited material was found in the feed fed to cattle.
FDA 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 was 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., nonetheless announced that it was 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 would not enter the human food supply. FDA believes any cattle that did not consume feed containing the prohibited material was unaffected by this incident, and should be handled in the beef supply clearance process as usual.
FDA believes that Purina Mills acted 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 continues to work 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.
Drug Residues
Warning Letters Issued for Illegal Drug Residues
Gentamicin
* The FDA s New England District Office issued a Warning Letter on February 1, 2001, to D & K Farm, Middlefield, Connecticut, for selling a dairy cow for slaughter as human food which had the presence of Gentamicin. Gentamicin is not approved for use in cattle. An FDA inspection of this dairy operation located in Wallingford, Connecticut, disclosed that in November 2000, the owner sold a dairy cow for slaughter as human to a livestock dealer. USDA analysis of tissue samples collected from that animal identified the presence of Gentamicin in the animal s kidney at a level of 4.74 ppm. The Warning Letter also noted that the owner holds animals under conditions which are so inadequate that diseased animals and/or medicated animals bearing potentially harmful drug residues are likely to enter the food supply.
Penicillin
* On January 31, 2001, the FDA s New York District Office issued a Warning Letter to Jay N. Martin, a producer and the owner of Jay N. Martin, a.k.a. Horizon Dairy, in Clyde, New York. An FDA inspection of the firm on November 20-22, and 27, 2000, confirmed that the firm offered two dairy cows for slaughter with drug residues. A USDA sample analyses indicated the presence of penicillin at illegal levels in the kidneys of both slaughtered cows, and streptomycin, for which there is no published tolerance. * The FDA s Minneapolis District Office issued a Warning Letter on August 28, 2001, to Paskewitz Cattle Company of Vesta,Minnesota. The Warning Letter cited adulteration of two animals (a dairy cow and a steer) with residues of penicillin that were above tolerance. The investigation conducted by the Minnesota Department of Agriculture found that Paskewitz Cattle did not keep adequate records of their own drug treatment, and they did not have an adequate system for handling purchased animals that may have been treated with drugs. * The FDA s Denver District Office issued a Warning Letter to DeJong Dairy, Greeley, Colorado, on February 23, 2001, citing adulteration charges due to the presence of penicillin residue in a cow offered for slaughter. An FDA inspection of this dairy farm on February 7 and 9, 2001, confirmed that the owner offered an animal for slaughter in violation of the FD&C Act. Specifically, on October 27, 2000, Mr. DeJong offered a cow for slaughter as human food. USDA analysis of tissue samples collected from this cow identified the presence of penicillin residues at 0.89 ppm in the kidney. A tolerance of 0.05 ppm has been established for residues of penicillin in the edible tissue of cows. The analysis also identified the presence of gentamicin residue at 13.31 ppm in the kidney. The Warning Letter also addressed poor animal husbandry practices which lead to the residue. USDA condemned this cow which was also diagnosed with septicemia, pneumonia, pleuritis, peritonitis, hepatitis, nephritis, and lymphedenitis. * The FDA s San Francisco District Office issued a Warning Letter to Parreiro-Pinheiro & Sons Dairy, Tipton, CA. The dairy consigned for sale for human food a cow that had penicillin residue in the liver and kidney that were in excess of the allowable tolerance. The FDA s San Francisco District Office s inspection found that the dairy was not keeping complete medication records and lacked an adequate drug inventory system. In addition, The FDA s San Francisco District Office s investigation found that the dairy was adulterated the drug, in that it was not being used in conformance with its labeled instructions.
Sulfadimethoxine
* On June 15, 2001, the FDA s Denver District Office issued a Warning Letter to North Point Dairy, Clovis, New Mexico, citing adulteration charges due to the presence of sulfadimethoxine residue in a cow offered for slaughter. An FDA inspection of this dairy farm on April 17, 2001, confirmed that a cow was offered for sale for slaughter as food in violation of the FD&C Act. USDA analysis of tissues samples collected from this cow identified the presence of sulfadimethoxine residue of 0.36 ppm in the liver and 0.34 ppm in the muscle. A tolerance of 0.10 ppm has been established for residues of sulfadimethoxine in the edible tissues of beef cows. The Warning Letter also addressed poor animal husbandry practices, which led to the residue.
Neomycin
* The FDA s Florida District Office issued a tissue residue Warning Letter on April 30, 2001, to Larson's Dairy, Inc., Okeechobee, Florida. The FDA conducted an inspection of the diary farm on March 27 and 28, 2001, which confirmed that the firm offered an adulterated animal for sale or slaughter as food. USDA analysis of the dairy calf confirmed the presence of Neomycin in the kidney at the level of 153.12 ppm, more than 21 times the established tolerance of 7.2 ppm. The FDA s Florida District Office's investigation found the calf was fed medicated milk containing Neomycin and Aureomycin. * On June 22, 2001, the FDA s Baltimore District Office issued a Warning Letter to Richard Edwards, owner of Oakland View Farm, Ridgely, Maryland. Mr. Edwards sold veal calves for slaughter as human food that were treated with Neomycin, a drug that is unapproved for this use. In addition, an FDA inspection on May 30 - 31, 2001, revealed that Mr. Edwards did not maintain treatment records showing the dosage rate, the date the drug was administered, or the time period to withhold treated animals from sale.
Streptomycin
* The FDA s New Jersey District Office issued a Warning Letter on March 8, 2001, to Frank Carper, Cranbury, New Jersey. An FDA inspection of this facility on October 24 and 27, 2000, confirmed that a horse purchased and sold by Mr. Carper for use as human food was adulterated due to the presence of streptomycin above tolerance levels. USDA analysis of tissues from the equine revealed that streptomycin in the kidney tissue at 0.38 ppm. The tolerance level for streptomycin in the edible tissue of equines is 0.0 ppm. Any animals shipped to USDA slaughter facilities are considered to be for human consumption.
Consent Decree of Permanent Injunction Filed Against Joe Sozinho Dairies
Firm Enjoined for Continuing to Sell Cattle With Violative Drug Residue
On July 30, 2001, a Consent Decree of Permanent Injunction was filed in the Eastern District of California against Joe Sozinho Sr., Danny Sozinho, Dimas Sozinho, individuals d/b/a Joe Sozinho Dairy #1 and Joe Sozinho Dairy #2. The FDA s San Francisco District Office conducted six inspections in response to violative drug residues reported by USDA/FSIS of Joe Sozinho Dairies resulting in two Warning Letters sent to the firm. Despite repeated warnings during the FDA inspections, as well as nine USDA/FSIS warning letters for illegal drug residues, the Sozinho's failed to take adequate corrective action. Voluntary approaches were not successful in correcting the animal husbandry and drug adulteration problems by the Sozinho's.
The Consent Decree permanently restrains and enjoins the Sozinho's from selling cattle for human food until all of the specifications of the Decree are met which include an animal identification system, medication record keeping system, drug inventory system, drug use system, quarantine system, and animal sales certification system. In addition, the Sozinho's reimbursed FDA's costs in the amount of $12,314.38 for investigational expenses incurred subsequent to the 1994 inspection and Warning Letter.
On February 1, 2002, the Sozinho Dairies and the United States filed a stipulation settling a dispute concerning the Dairies' activities while they were under an order of injunction. Under the Stipulation, the Sozinhos admitted to continued violations of the law. They also admitted delivering "at least 56 animals intended for use as food during a thirty-six day period beginning on July 31, and ending on September 4, 2001." The United States had alleged in its motion for contempt that, under the injunction, such deliveries were prohibited until FDA inspected and cleared the Dairies to resume.
The Dairies were not cleared for such sales until December 2001. The Injunction entered by the Court in July 2001 continues in effect. The defendants have paid the U.S. Treasury fines in the amount of $140,000.
Ridge View Farms Consent Decree of Permanent Injunction
Consent Decree Provides FDA With Future Shutdown Authority
United States v. Ridge View Farms, Inc., Carol A. Castine, and Daniel A. Castine (N.D.N.Y.) On August 7, 2001, the U.S. District Court for the Northern District of New York entered a Consent Decree of Permanent Injunction that prohibits the defendants from introducing any food-producing animal into interstate commerce until they have established a system for drug administration and record-keeping to prevent the distribution of any animal containing illegal drug residues in its edible tissues.
The Decree also requires the defendants to provide a copy of the Decree to all persons to whom they have delivered cattle in the past year and to any person to whom they deliver cattle in the future. In addition, the Decree provides the government with the authority to require future shutdown of operations and to impose fines in the event of further violations.
Consent Decree Filed Against H & I Dairy
On November 28, 2000, a Consent Decree of Permanent Injunction was filed in the Eastern District of California against Heduino Brasil (dba H & I Dairy) of Tipton, California. Despite repeated warnings during FDA and the State of California inspections, including six USDA warning letters for illegal drug residue findings in cull cows sold or consigned for slaughter, Mr. Brasil failed to take adequate corrective action. The consent decree permanently restrains and enjoins Mr. Brasil from selling cattle for human food until all the specifications of the decree are met including animal identification, medication record keeping, drug inventory, quarantine, and sales certification systems.
Arie C. Van Leeuwen Sentenced
Violation of Probation Leads to Prison Sentence
United States v. Arie C. Van Leeuwen, (E.D. Cal.) On July 9, 2001, United States District Judge Robert E. Coyle sentenced Arie Van Leeuwen to six months imprisonment and one year of supervised release for probation violations. In 2000, Van Leeuwen pled guilty to two charges of criminal contempt and one felony charge of introducing adulterated food into interstate commerce, resulting from his repeated violations of the statutory and regulatory requirements for administering new animal drugs to food-producing animals.
Van Leeuwen admitted to the following probation violations: failure to obey all laws; failure to submit certain monthly report forms; failure to comply with home confinement conditions; and transporting animals to cattle auctions in violation of the probation terms. In light of Van Leeuwen's history of repeat violations, the Court sentenced him to six months in prison followed by a year of supervised release that includes mandatory attendance in dairy management classes.
http://www.fda.gov/ora/about/enf_story/archive/2001/ch5/default.htm
Veterinary Drugs
Warning Letter to Veterinary Drug Firm
The FDA s New Orleans District Office Nashville Branch issued a Warning Letter on April 10, 2001, to Classic Care Products, Inc., d.b.a. The River City Co., Chattanooga, Tennessee, as the result of an inspection of the firm on March 20 and 22, 2001. The inspection found topical veterinary drug products being manufactured under inadequate conditions. Deviations from the CGMPs included no component testing; no master production records; failure to conduct stability studies on finished products and to assign expiration dates based on these studies; and no label control. The firm also was not registered and the veterinary drug products were not listed.
Unapproved Veterinary Drugs Promoted on the Internet
On June 28, 2001, the FDA s Minneapolis District Office issued a Warning Letter to Vets Plus, Inc., Knapp, Wisconsin. FDA conducted an inspection of the firm s veterinary drug and nutritional supplement manufacturing facility on March 7 and 13, 2001.
The inspection disclosed that the firm was manufacturing veterinary products that, based on the labels and well as product catalogs, contained therapeutic and structure-function claims causing the products to be unapproved new animal drugs. The firm s web sites contained numerous promotional statements and claims for four lines of products marketed by the firm that established that the firm clearly intended the product to be used as animal drugs. In addition, the firm failed to list any of the products with the Center for Veterinary Medicine, and the products were not manufactured in compliance with CGMP regulations.
Distributor of Prescription Veterinary Drugs Receives Warning
On August 27, 2001, the FDA s Philadelphia District Office issued a Warning Letter to the president of Equirace Health and Speed Products, Washington, Pennsylvania. The firm is an exclusive distributor of prescription veterinary and human drugs to horse owners. The FDA conducted an inspection of Equirace on December 5, 2000. The inspection and a review of information from the New Mexico Livestock Board disclosed that the firm was distributing prescription veterinary and human drugs to lay persons without a lawful order from a licensed veterinarian who has a valid veterinarian-client-patient relationship with customers.
The Warning Letter advised the owner that Equirace s distribution business violates several sections of the FD&C Act. For example, the firm s prescription veterinary drugs are misbranded because they are not dispensed by or upon the lawful written or oral order of a licensed veterinarian in the course of the veterinarian s professional practice. Although there was a licensed veterinarian at the firm, he did not have a valid veterinarian-client-patient relationship with any of Equirace s customers. The Warning Letter also noted that certain prescription veterinary and human drugs offered for sale by Equirace were adulterated because they were new animal drugs that were not approved by the FDA for use in horses.
Illegal Veterinary Drugs Exported
On March 5, 2001, the FDA s San Juan District Office found that a shipment of veterinary drugs from Santo Domingo to the U.S. Virgin Islands, consisting of drugs such as antibiotics, hormones and dietary supplements, contained numerous unapproved drugs for veterinary use. The drugs were placed on hold by the U.S. Customs at the Aguadilla airport. The shipment was exported under Custom's supervision.
FDA Assists Customs in Seizure of Illegal Vet Drugs
On July 10, 2001, the FDA s San Juan District Office, in conjunction with U.S. Customs, detained and seized a shipment of veterinary drugs not approved for sale in the U.S. that was imported from Santo Domingo. U.S. Customs agents notified San Juan District Office that the shipment was imported as "Hair Products," but actually contained veterinary drugs. FDA s inspection of the shipment revealed that the veterinary drugs were smuggled among a variety of soaps. The shipment, which was originally thought to consist of a few bottles, contained a total of 793 bottles/pouches of a variety of illegal veterinary drugs. The shipment was detained by FDA and seized by U.S. Customs agents. The value of the shipment was approximately $7,000.
Importer Attempts to Re-Enter Vet Drugs Previously Refused Entry
On May 2, 2001, the FDA s San Juan District Office, in conjunction with U.S. Customs Service seized a shipment of IVOMEC-F, a veterinary drug not approved for sale in the U.S. The shipment was from importer Hacienda Las Carolinas, Santo Domingo. The San Juan District Office was notified by U.S. Customs agents that a shipment that had been refused entry on February 10, 2001, and had been exported under Customs supervision was re- introduced through the same port on March 16, 2001, by the same importer. The value of the shipment was $3,500.00.
Seizure at Veterinary Pharmacy
On December 20, 2000, an FDA investigator accompanied the U.S. Marshals Service in a seizure of unapproved new animal drugs at Veterinary Pharmacy Corporation (d.b.a. Vet Rx Pharmacy), St. Peter, Minnesota. The firm is a compounding pharmacy for veterinary drugs. The firm has a history of serious violations of the FD&C Act, particularly the 1994 Animal Medicinal Drug Use Clarification Act (AMDUCA). The seized drugs, valued at approximately $50,000, were intended for administration to food-producing animals, and were unapproved new drugs in that they were compounded from the bulk active ingredients. Such compounding violates AMDUCA and the implementing regulations, 21 C.F.R. Part 530. The FDA conducted inspections at the firm on June 27 - 29, and July 6 - 7, 2000. These inspections disclosed the above violations.
Consent Decree of Condemnation and Permanent Injunction
U.S. v. Sulfadiozie Sodium and Veterinary Pharmacy Corp. d.b.a. Vet Rx Pharmacy (D. Minn.) On February 28, 2002, a U.S. District Judge signed a Consent Decree of Condemnation and Permanent Injunction against this veterinary pharmacy and two corporate officers, as well as the drugs seized in this action. The Decree orders the defendants to destroy the seized drugs and enjoins them from engaging in compounding activities that fail to conform to the AMDUCA regulations.
http://www.fda.gov/ora/about/enf_story/archive/2001/ch5/cvm2.htm
http://www.fda.gov/ora/about/enf_story/archive/2001/ch5/cvm3.htm
Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION]
http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt
Docket Management Docket: 02N-0273 - Substances Prohibited From Use in
Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
Comment Number: EC -10
Accepted - Volume 2
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html
PART 2
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html
APHIS Statement: June 29 Inconclusive BSE Test is Negative
http://www.usda.gov/Newsroom/0275.04.html 07/02/2004
APHIS Statement: First Inconclusive BSE Test is Negative
http://www.usda.gov/Newsroom/0272.04.html 06/30/2004
APHIS Statement Regarding Second Inconclusive BSE Test
http://www.usda.gov/Newsroom/0266.04.html 06/29/2004
APHIS Statement Regarding First Inconclusive BSE Test
http://www.usda.gov/Newsroom/0198.04.html 06/25/2004
January 14, 2005
Dr. John R. Clifford, Deputy Administrator, Chief Veterinary Officer
Animal Plant Health Inspection Service
1400 Independence Ave. SW, Room 317-E
Jamie L. Whitten Federal Building
Washington, DC 20250
Dear Deputy Administrator Clifford,
We have a number of questions about your November 23, 2004 announcement that a cow, which had tested â¬Snot negative⬠in two runs of the Bio-Rad ELISA quick test for mad cow disease, was â¬Sindeed negative for BSE.⬠We are concerned because New Scientist reported last June that the false positive rate after such repeated testing is â¬Saround one in 100,000 for Bio-Rad.⬠We would appreciate a chance to meet with you this month to discuss the questions below.
1. You have indicated that the Biorad screening test was run twice and got a positive result both times. Were the two runs conducted by the same or different technicians? Did they use the same or different brain samples?
2. When the immunohistochemistry (IHC) test was conducted, what was the condition of the brain when it arrived at the National Veterinary Services Laboratory in Ames, Iowa? Did scientists note any deterioration?
3. How many slides were made and examined for the IHC test? Were they from only the obex, or other areas of the brain? Atypical strains of BSE have been found in Italy and Japan where the level of PrPres in the obex was low or non-detectable, unlike in traditional BSE. What portion(s) of the brain were examined?
4. Experienced technicians can sometimes disagree on the interpretation of IHC slides. Does one technician review the slides or more than one technician? If the latter, how many? Did they all agree on the conclusion?
5. The World Organization of Animal Health, known as O.I.E., recognizes use of immunoblotting (also know as Western Blot) as a further confirmation of the IHC test, and it is used in Japan and most European countries. USDA used the Western Blot test in December 2003 along with IHC to confirm the first case of mad cow disease in the United States . In Japan and Belgium cows that tested positive on two quick tests (in both cases using a Bio-Rad test), negative on IHC, yet positive on Western Blot and are considered to be confirmed BSE cases. Was Western blot or any other technique besides IHC used to confirm or rule out a positive result on this November 2004 cow? If so, what was the result? If not used, why not?
6. Were all the procedures referred to in your March 15, 2004 announcement of protocols to confirm any suspect positives utilized, particularly the reference to use of â¬Sfull battery of tests⬠that includes, but is not limited to IHC? If not, what protocol was used and what is your rationale for the differences?
7. Does USDA still have brain material from the cow in question? If so, could it be sent to the World BSE reference laboratory in Weybridge, United Kingdom for IHC and Western Blot analysis to confirm the USDA finding? If not, why not?
8. Canadian press has reported that â¬SCanadian authorities have been told that the cow, from Texas, didnâ¬"t have the metal ID tags that cows born here are given.⬠Is this correct? What was the age of the cow and where had it lived?
We would like to request a meeting with you between now and the end of January about these questions, which are very important to consumer confidence in the safety of the food supply.
Sincerely,
Jean Halloran, Director Michael Hansen, Ph.D.
Senior Research Associate
From http://www.ars.usda.gov/is/AR/archive/dec04/tse1204.htm
Yamakawa, Y. et al. 2003. op cit.
De Bosschere, H., Roels, S. and E. Vanopdenbosch. 2004. Atypical case of bovine spongiform encephalopathy in an East-Flemish Cow in Belgium. The International Journal of Applied Research, 2(4). Accessed at http://www.jarvm.com/articles/Vol2Iss1/DEBOSSCHERE.htm
In a technical briefing on the new BSE sureveillance plan, Dr. Ron DeHaven clearly stated that USDA would use multiple tests that included IHC: â¬SThe Department at NVSL will continue to use the immunohistochemistry, or IHC, for quality control testing, and in addition if any of the rapid screen test comes back with a suspect positive then NVSL will use the IHC as well as other tests necessary to confirm the results. . . Let me say up front that we expect that there will be positive results on these screening tests, and that's just the nature of the beast. That's because screening tests by design are intended to be very sensitive and not to miss any positive animals. But with that high degree of sensitivity also comes the possibility for false positive test results. And again that's to be expected. any suspect test results will be sent to NVSL for confirmatory testing with the full battery of tests. That would include the IHC. From: http://www.usda.gov/Newsroom/0106.04.html
From http://edmonton.cbc.ca/regional/servlet/View?filename=ed-mad-cow20041122
Greetings again,
I was told that they were to meet on Feb. 9, 2005 about these inconclusives.
I have heard nothing of the outcome. Maybe we will hear soon.
BUT of course we will never know the results of that first TEXAS mad
cow they covered up, the stumbling and staggering one they refused to
test, and decided to render, head and all...
Experts doubt USDA's mad cow results
By Steve Mitchell Medical Correspondent
Published 11/24/2004 4:34 PM
WASHINGTON, Nov. 24 (UPI) -- U.S. Department of Agriculture officials said a cow that initially tested positive for mad cow disease was found to be negative on follow-up tests, but both domestic and international experts told United Press International the way the agency handled the situation leaves them skeptical about the validity of the results.
"The testing process does indeed make experts scratch their heads," said Markus Moser, a molecular biologist and chief executive officer of the Swiss firm Prionics, which manufactures tests for detecting mad cow disease, also known as bovine spongiform encephalopathy.
"I think some, but not all, BSE people internationally have some degree of cynical de facto doubt about everything the United States does or doesn't do, mostly as a result of seeing so many similar situations where countries at risk deny and deny and deny and then end up having big problems," said Elizabeth Mumford, a veterinarian and BSE expert at Safe Food Solutions in Bern, Switzerland, a company that provides advice on reducing mad cow risk to industry and governments. Several countries, including Germany and Austria, that had been thought to be free of the disease, found out it was circulating in their herds after they initiated large-scale testing. The U.S. cow in question tested positive last week on two so-called rapid tests manufactured by Bio-Rad Laboratories in Hercules, Calif. The USDA said Tuesday the animal had tested negative on more sophisticated confirmatory tests called immunohistochemistry or IHC tests.
John Clifford of the USDA said in a statement that the negative IHC results "makes us confident that the animal in question is indeed negative."
A U.S. veterinarian knowledgeable about mad cow tests told UPI that experts she has spoken with are "very, very skeptical about" the USDA's negative test result.
The veterinarian, who requested anonymity because she feared repercussions for speaking out against the USDA, said the skepticism arose because the agency did not run another kind of mad cow test called a Western blot. The test sometimes can pick up positive cases that IHC misses and the agency has used it in the past to rule out suspect cases. Moser said a Western blot test would make sense for the United States, where the prevalence of mad cow is thought to be low. Other countries -- including Australia, New Zealand, Canada and Mexico -- that are either free of the disease or have low rates, have elected to use the Western blot as part of their surveillance programs, he said.
The veterinarian said concerns also have emerged because the USDA has not made a sample from the cow in question available for examination by outside experts. She added that the USDA did not notify state officials, as officials previously said they would about positive results on rapid tests. Knowledgeable people are saying "wait a minute, this doesn't add up here," the veterinarian said. At stake is the $70 billion U.S. beef industry, including a $3.3 billion export market. More than 60 countries, including Japan, closed their borders to U.S. beef last December after the first -- and so far only -- U.S. case of mad cow was detected.
Asked whether state officials were notified, USDA spokesman Ed Loyd told UPI the agency had not released any information about the cow in question. Loyd also said the false positives on the rapid test were not unexpected. Since June, the USDA has reported three false positives out of more than 121,000 cows tested.
Bio-Rad spokeswoman Sam Kennedy told UPI the company was unfamiliar with the details of this incident and thus could not comment.
Mumford said experts were surprised the USDA did not send samples from the cow in question for independent analysis by one of the three worldwide labs recognized as the foremost authorities on mad cow testing by the World Animal Health Organization. One of these facilities is located in Weybridge, England, where the USDA had sent the first U.S. case of mad cow disease for confirmation in December 2003.
Loyd said USDA officials who would know whether USDA planned to release a sample for verification by an outside party could not be reached Wednesday.
"Full transparency and cooperation would certainly promote the idea internationally that the U.S. is doing everything it can do," Mumford said. "But somehow the U.S. consumer doesn't seem to think that way, or has been appeasable at least up until now, so there seems to be no impetus to do anything more."
The concern is humans can contract a fatal brain illness known as variant Creutzfeldt Jakob disease from eating beef products contaminated with the mad cow pathogen.
Moser said despite USDA's reliance on the IHC test results, repeated negatives on that test does not necessarily rule out the cow being infected.
"The reason for this is that the IHC test ... is done on a different piece of tissue" than that used for the rapid test, he said. Prions, the pathogen thought to cause mad cow disease, tend to concentrate in a region of the brain called the obex, so the different outcomes of the different tests could be due to sampling a brain region that contains little or no prions. This could be made worse if the animal had lay dead for several days before its brain was collected. The brain might be so degraded that it would be difficult to locate the obex region for confirmatory testing and a sample might mistakenly be taken from a region that contains no prions. "So with these samples, the confirmatory testing would be even less reliable, not because of the confirmatory test itself, but because of the sampling," he said. --
E-mail sciencemail@upi.com
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TSS
######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html ##########
Subject: USDA VS CREEKSTONE BSE/BASE/TSE TESTING Civil Action No. 06-0544
Date: September 4, 2007 at 9:47 am PST USDA
AUGUST 21, 2007
Mr. Terry S. Singeltary Sr. Post Office Box 42 Bacliff, Texas 77518-0042
Dear Mr. Singeltary:
This is in response to your e-mails to Secretary Johanns concerning private testing for bovine spongiform encephalopathy (BSE) and a ruling by the U.S. District Court for the District of Columbia involving Creekstone Farms Premium Beef, LLC. We regret the delay in responding.
As you may know, the U.S. Department of Agriculture (USDA) filed an appeal of the U.S. District Court's order on June 15,2007. While we recognize your views, we cannot comment on any matters at issue in the pending litigation. However, we can assure you that USDA remains committed to ensuring effective, scientifically sound testing for significant animal diseases and to protecting U.S. animal and public health from BSE.
We understand that the effects of Creutzfeldt-Jakob disease (CJD) are devastating, and we are sorry to learn of the loss of your mother. Some of us at USDA have also lost family members to CJD and other degenerative neurological diseases. Although it is rare, the classical form of CJD does occur sporadically in the United States and worldwide. However, no cases of vCJD-the form of BSE that can be transmitted from animals to humans-are known to have originated in the United States. Because the U.S. Department of Health and Human Services' (HHS) Centers for Disease Control and Prevention (CDC) is responsible for addressing concerns about CJD and other human health issues, you may wish to contact that agency directly. The address is CDC, HHS, 200 Independence Avenue, SW., Washington, D.C. 20201.
We also wish to clarify that the U.S. Food and Drug Administration's 1997 ban on ruminant-to-ruminant feeding is the primary measure in place to protect animal health with regard to BSE. Protection of public health from BSE is achieved by the removal from the human food supply of the animal tissues-often referred to as specified risk
Mr. Terry S. Singeltary, Sr. Page 2
materials-in which the BSE infective agent would be found if present, and by other controls imposed at the slaughter level. These additional controls include the Food Safety and Inspection Services' ban on nonambulatory cattle from the human food chain; a prohibition on air-injection stunning of slaughter cattle; the requirement of additional process controls in advanced meat recovery systems; and, a prohibition on the use of mechanically separated beef in human food. Additionally, protection from BSE and other diseases is achieved by conducting antemortem inspections of slaughter cattle and excluding any animals that display clinical signs of neurological disease or other abnormalities.
We appreciate the opportunity to address your concerns. To learn more about USDA's BSE surveillance and safeguarding activities, please visit our Web site at www.aphis.usda.gov/newsroom/hot_issues/bse/index.shtml.
Sincerely,
Jere L. Dick Associate Deputy Administrator National Animal Health Policy and Programs Veterinary Services
============================END=========================
Greetings,
LIKE going back in time 25 to 30 years with the science in this reply to me from USDA on BSE. I would kindly like to comment;
Jere L. Dick states ;
Some of us at USDA have also lost family members to CJD
Although it is rare, the classical form of CJD does occur sporadically in the United States and worldwide
THIS is very disturbing to me that even USDA officials family members are dying of sporadic CJD, but yet they refuse to acknowledge the science to date, instead to go by prehistoric science dating back some 3 decades. IN short, there is much more to this sad story than that of the UKBSEnvCJD ONLY hypothesis/myth. Evidently, USDA did not even read the most up to date science i submitted to them, or just chose to ignore it. we now know that the sporadic CJD may not be as sporadic or spontaneous as these officials would have us to believe. THE USA has had two cases of atypical BSE i.e. BASE, which is more similar to some sporadic CJD, than that of the nvCJD, plus, there are some questions pertaining to the potential of some of these sCJD case being tied to either CWD in deer and or elk, and to the scrapie in sheep and goats, and there's other science showing that friendly fire from these sources i.e. iCJD is a very real threat. ...tss
Jere L. Dick states ;
Protection of public health from BSE is achieved by the removal from the human food supply of the animal
tissues-often referred to as specified risk materials-in which the BSE infective agent would be found if present,
and by other controls imposed at the slaughter level.
EXACTLY, and this policy has failed terribly, see recalls of 1,000's of TONS of these banned products that is suppose to protect us from all strains of mad cow disease, that are being fed out in commerce as we speak ;
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. BLOOD LACED MBM IN COMMERCE USA 2007
Date: March 21, 2007 at 2:27 pm PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II
___________________________________
PRODUCT
Bulk cattle feed made with recalled Darling's 85% Blood Meal, Flash Dried, Recall # V-024-2007
CODE
Cattle feed delivered between 01/12/2007 and 01/26/2007
RECALLING FIRM/MANUFACTURER
Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007.
Firm initiated recall is ongoing.
REASON
Blood meal used to make cattle feed was recalled because it was cross- contaminated with prohibited bovine meat and bone meal that had been manufactured on common equipment and labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
42,090 lbs.
DISTRIBUTION
WI
___________________________________
PRODUCT
Custom dairy premix products: MNM ALL PURPOSE Pellet, HILLSIDE/CDL Prot- Buffer Meal, LEE, M.-CLOSE UP PX Pellet, HIGH DESERT/ GHC LACT Meal, TATARKA, M CUST PROT Meal, SUNRIDGE/CDL PROTEIN Blend, LOURENZO, K PVM DAIRY Meal, DOUBLE B DAIRY/GHC LAC Mineral, WEST PIONT/GHC CLOSEUP Mineral, WEST POINT/GHC LACT Meal, JENKS, J/COMPASS PROTEIN Meal, COPPINI - 8# SPECIAL DAIRY Mix, GULICK, L-LACT Meal (Bulk), TRIPLE J - PROTEIN/LACTATION, ROCK CREEK/GHC MILK Mineral, BETTENCOURT/GHC S.SIDE MK-MN, BETTENCOURT #1/GHC MILK MINR, V&C DAIRY/GHC LACT Meal, VEENSTRA, F/GHC LACT Meal, SMUTNY, A- BYPASS ML W/SMARTA, Recall # V-025-2007
CODE
The firm does not utilize a code - only shipping documentation with commodity and weights identified.
RECALLING FIRM/MANUFACTURER
Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm initiated recall is complete.
REASON
Products manufactured from bulk feed containing blood meal that was cross contaminated with prohibited meat and bone meal and the labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
9,997,976 lbs.
DISTRIBUTION
ID and NV
END OF ENFORCEMENT REPORT FOR MARCH 21, 2007
http://www.fda.gov/bbs/topics/enforce/2007/ENF00996.html
NEW URL
http://www.fda.gov/Safety/Recalls/EnforcementReports/2007/ucm120446.htm
Thursday, March 19, 2009
MILLIONS AND MILLIONS OF POUNDS OF MAD COW FEED IN COMMERCE USA WITH ONGOING 12 YEARS OF DENIAL
http://madcowfeed.blogspot.com/2009/03/millions-and-millions-of-pounds-of-mad.html
Tuesday, March 2, 2010
Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded Rangen Inc 2/11/10 USA
http://madcowfeed.blogspot.com/2010/03/animal-proteins-prohibited-in-ruminant.html
Monday, March 1, 2010
ANIMAL PROTEIN I.E. MAD COW FEED IN COMMERCE A REVIEW 2010
http://madcowfeed.blogspot.com/2010/03/animal-protien-ie-mad-cow-feed-in.html
Tuesday, December 15, 2009
NAIS, COOL, FROM FARM TO FORK, MAD COW DISEASE
http://naiscoolyes.blogspot.com/2009/12/nais-cool-from-farm-to-fork-mad-cow.html
HARVARD BSE TSS COMMENTS AND HARVARD USDA ET AL REBUTAL
http://www.fsis.usda.gov/PDF/BSE_Risk_Assess_Response_Public_Comments.pdf
Monday, October 26, 2009
MAD COW DISEASE, AND U.S. BEEF TRADE
MAD COW DISEASE, CJD, TSE, SOUND SCIENCE, COMMERCE, AND SELLING YOUR SOUL TO THE DEVIL
http://usdameatexport.blogspot.com/2009/10/mad-cow-disease-and-us-beef-trade.html
Friday, March 13, 2009
NAIS comments NCBA and R-Calf Wednesday, March 11, 2009 – 10:30 a.m. Subcommittee on Livestock, Dairy, and Poultry — Public Hearing
http://usdameatexport.blogspot.com/2009/03/nais-comments-ncba-and-r-calf-wednesday.html
Saturday, August 16, 2008
Qualitative Analysis of BSE Risk Factors in the United States February 13, 2000 at 3:37 pm PST (BSE red book)
http://bseusa.blogspot.com/2008/08/qualitative-analysis-of-bse-risk.html
48 hour traceback for BSE mad cow disease in the USA ???
NOT in your lifetime !
8 YEARS IN REVIEW OF THE MAD COW DEBACLE IN THE USA ;
http://bse-atypical.blogspot.com/2008/12/mad-cow-disease-usa-december-28-2008-8.html
The most recent assessments (and reassessments) were published in June 2005 (Table I; 1, and included the categorisation of Canada, the USA, and Mexico as GBR III. Although only Canada and the USA have reported cases, the historically open system of trade in North America suggests that it is likely that BSE is present also in Mexico.
http://www.oie.int/boutique/extrait/06heim937950.pdf
GOC RELEASES CONSULTATION DOCUMENT ON NEW BSE IMPORT POLICY IN LINE WITH OIE: The Canadian Food Inspection Agency (CFIA) is inviting public comment on a proposed new Canadian Import Policy to prevent bovine spongiform encephalopathy (BSE) in bovine animals and their products. The proposed policy would bring Canada’s approach in line with new World Organization for Animal Health (OIE) standards as well as the proposed North American import standard announced on March 29, 2005. It is based on the recognition that international knowledge of bovine spongiform encephalopathy (BSE) and me asures to mitigate its transmission have advanced significantly since Canada’s existing import policy for controlling BSE was established in 1997. The new policy would be less restrictive than the current one. Canada’s current policy permits the importation of live ruminants including, cattle, sheep and goats, and products derived from them, only after the exporting country has been officially recognized as BSE-free. Current science recognizes that the “ BSE-free” requirement is unnecessarily restrictive. The draft policy is based on a proposed new OIE three-tier system for classifying bovine-trading countries based on their BSE risk management regimes. In all cases, exporting countries would also have to continue to meet other non-BSE food safety and animal health
GAIN Report - CA5038 Page 3 of 4
UNCLASSIFIED USDA Foreign Agricultural Service requirements before becoming eligible to ship to Canada under any of the new BSE risk categories. A consultation period ending on July 22, 2005 is being provided to allow interested parties the opportunity to provide comments on the draft policy. Notice of this consultation is being published in the Canada Gazette.
http://www.fas.usda.gov/gainfiles/200505/146129759.pdf
SNIP...
Dr. DeHaven has often represented the United States in delicate and often difficult trade negotiations. As the former U.S. Chief Veterinary Officer and U.S. delegate to the OIE, he routinely used his diplomatic skills as he facilitated agreements that are science-based. He was instrumental in building consensus that led to the current OIE BSE chapter
SNIP...
http://www.usaha.org/meetings/2007/2007_USAHA_Proceedings.pdf
“The U.S. has lower sanitary and phyto-sanitary standards (SPS) for imports than many other countries, especially those concerning bovine spongiform encephalopathy (BSE). These low standards have made the U.S. a dumping ground for beef from the countries that have experienced BSE problems. Food Safety and SPS issues continue to be problematic for our industry, as some countries comply with OIE standards, while others ignore them either for cultural reasons, or too often use them as trade barriers. The USITC October 7, 2008 release reported, ‘U.S. beef processors and beef cattle ranchers lose billions of dollars in export opportunities each year because of animal health and food safety measures in other countries that are inconsistent with international standards and vary by country.
http://www.cattlenetwork.com/USCA-Testifies--Before-USITC/2010-03-03/Article_Latest_News.aspx?oid=996238&fid=CN-LATEST_NEWS_
LIKE i said before, the OIE not only sold their soul to the devil over the BSE MRR, they sold yours too ;
Wednesday, February 10, 2010
NAIS MAD COW TRACEABILITY DUMPED BY USDA APHIS 2010
http://naiscoolyes.blogspot.com/2010/02/nais-mad-cow-traceability-dumped-by.html
The most recent assessments (and reassessments) were published in June 2005 (Table I; 1, and included the categorisation of Canada, the USA, and Mexico as GBR III. Although only Canada and the USA have reported cases, the historically open system of trade in North America suggests that it is likely that BSE is present also in Mexico.
http://www.oie.int/boutique/extrait/06heim937950.pdf
Scientific Report of the European Food Safety Authority on the Assessment of the Geographical BSE Risk (GBR) of the USA Question number: EFSA-Q-2003-083
Adopted: 1 July 2004 Summary (0.1Mb)
Report (0.2Mb)
Summary
The European Food Safety Authority and its Scientific Expert Working Group on the Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE) Risk (GBR) were asked by the European Commission (EC) to provide an up-to-date scientific report on the GBR in the United States of America, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in USA. This scientific report addresses the GBR of USA as assessed in 2004 based on data covering the period 1980-2003.
The BSE agent was probably imported into USA and could have reached domestic cattle in the middle of the eighties. These cattle imported in the mid eighties could have been rendered in the late eighties and therefore led to an internal challenge in the early nineties. It is possible that imported meat and bone meal (MBM) into the USA reached domestic cattle and leads to an internal challenge in the early nineties.
A processing risk developed in the late 80s/early 90s when cattle imports from BSE risk countries were slaughtered or died and were processed (partly) into feed, together with some imports of MBM. This risk continued to exist, and grew significantly in the mid 90’s when domestic cattle, infected by imported MBM, reached processing. Given the low stability of the system, the risk increased over the years with continued imports of cattle and MBM from BSE risk countries.
EFSA concludes that the current GBR level of USA is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. As long as there are no significant changes in rendering or feeding, the stability remains extremely/very unstable. Thus, the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent persistently increases.
http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1211902594180.htm
Monday, November 23, 2009
BSE GBR RISK ASSESSMENTS UPDATE NOVEMBER 23, 2009 COMMISSION OF THE EUROPEAN COMMUNITIES AND O.I.E.
http://docket-aphis-2006-0041.blogspot.com/2009/11/bse-gbr-risk-assessments-update.html
Docket APHIS-2006-0026 Docket Title Bovine Spongiform Encephalopathy; Animal Identification and Importation of Commodities Docket Type Rulemaking Document APHIS-2006-0026-0001 Document Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions, Identification of Ruminants and Processing and Importation of Commodities Public Submission APHIS-2006-0026-0012 Public Submission Title Comment from Terry S Singletary
http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064801e47e1
Docket APHIS-2006-0041 Docket Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived from Bovines Commodities Docket Type Rulemaking Document APHIS-2006-0041-0001 Document Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived From Bovines Public Submission APHIS-2006-0041-0028 Public Submission Title Comment from Terry S Singletary
Comment 2006-2007 USA AND OIE POISONING GLOBE WITH BSE MRR POLICY
THE USA is in a most unique situation, one of unknown circumstances with human and animal TSE. THE USA has the most documented TSE in different species to date, with substrains growing in those species (BSE/BASE in cattle and CWD in deer and elk, there is evidence here with different strains), and we know that sheep scrapie has over 20 strains of the typical scrapie with atypical scrapie documented and also BSE is very likely to have passed to sheep. all of which have been rendered and fed back to animals for human and animal consumption, a frightening scenario. WE do not know the outcome, and to play with human life around the globe with the very likely TSE tainted products from the USA, in my opinion is like playing Russian roulette, of long duration, with potential long and enduring consequences, of which once done, cannot be undone. These are the facts as I have come to know through daily and extensive research of TSE over 9 years, since 12/14/97. I do not pretend to have all the answers, but i do know to continue to believe in the ukbsenvcjd only theory of transmission to humans of only this one strain from only this one TSE from only this one part of the globe, will only lead to further failures, and needless exposure to humans from all strains of TSE, and possibly many more needless deaths from TSE via a multitude of proven routes and sources via many studies with primates and rodents and other species.
MY personal belief, since you ask, is that not only the Canadian border, but the USA border, and the Mexican border should be sealed up tighter than a drum for exporting there TSE tainted products, until a validated, 100% sensitive test is available, and all animals for human and animal consumption are tested. all we are doing is the exact same thing the UK did with there mad cow poisoning when they exported it all over the globe, all the while knowing what they were doing. this BSE MRR policy is nothing more than a legal tool to do just exactly what the UK did, thanks to the OIE and GW, it's legal now. and they executed Saddam for poisoning ???
go figure. ...
http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064801f8151
Docket APHIS-2006-0041 Docket Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived from Bovines Commodities Docket Type Rulemaking Document APHIS-2006-0041-0001 Document Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived From Bovines Public Submission APHIS-2006-0041-0028.1 Public Submission Title Attachment to Singletary comment
January 28, 2007
Greetings APHIS,
I would kindly like to submit the following to ;
BSE; MRR; IMPORTATION OF LIVE BOVINES AND PRODUCTS DERIVED FROM BOVINES [Docket No. APHIS-2006-0041] RIN 0579-AC01
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f8152&disposition=attachment&contentType=msw8
Owner and Corporation Plead Guilty to Defrauding Bovine Spongiform Encephalopathy (BSE) Surveillance Program
An Arizona meat processing company and its owner pled guilty in February 2007 to charges of theft of Government funds, mail fraud, and wire fraud. The owner and his company defrauded the BSE Surveillance Program when they falsified BSE Surveillance Data Collection Forms and then submitted payment requests to USDA for the services. In addition to the targeted sample population (those cattle that were more than 30 months old or had other risk factors for BSE), the owner submitted to USDA, or caused to be submitted, BSE obex (brain stem) samples from healthy USDA-inspected cattle. As a result, the owner fraudulently received approximately $390,000. Sentencing is scheduled for May 2007.
snip...
4 USDA OIG SEMIANNUAL REPORT TO CONGRESS FY 2007 1st Half
http://www.usda.gov/oig/webdocs/sarc070619.pdf
USDA: In 9,200 cases only one type of test could be used
WASHINGTON (AP)--The U.S. Department of Agriculture acknowledged Aug. 17 that its testing options for bovine spongiform encephalopathy were limited in 9,200 cases despite its effort to expand surveillance throughout the U.S. herd.
In those cases, only one type of test was used--one that failed to detect the disease in an infected Texas cow.
The department posted the information on its website because of an inquiry from The Associated Press.
Conducted over the past 14 months, the tests have not been included in the department's running tally of BSE tests since last summer. That total reached 439,126 on Aug. 17.
"There's no secret program," the department's chief veterinarian, John Clifford, said in an interview. "There has been no hiding, I can assure you of that."
Officials intended to report the tests later in an annual report, Clifford said.
These 9,200 cases were different because brain tissue samples were preserved with formalin, which makes them suitable for only one type of test--immunohistochemistry, or IHC.
In the Texas case, officials had declared the cow free of disease in November after an IHC test came back negative. The department's inspector general ordered an additional kind of test, which confirmed the animal was infected.
Veterinarians in remote locations have used the preservative on tissue to keep it from degrading on its way to the department's laboratory in Ames, Iowa. Officials this year asked veterinarians to stop using preservative and send fresh or chilled samples within 48 hours.
The department recently investigated a possible case of BSE that turned up in a preserved sample. Further testing ruled out the disease two weeks ago.
Scientists used two additional tests--rapid screening and Western blot--to help detect BSE in the country's second confirmed case, in a Texas cow in June. They used IHC and Western blot to confirm the first case, in a Washington state cow in December 2003.
"The IHC test is still an excellent test," Clifford said. "These are not simple tests, either."
Clifford pointed out that scientists reran the IHC several times and got conflicting results. That happened, too, with the Western blot test. Both tests are accepted by international animal health officials.
Date: 8/25/05
http://www.hpj.com/archives/2005/aug05/aug29/BSEtestoptionswerelimited.cfm
""These 9,200 cases were different because brain tissue samples were preserved with formalin, which makes them suitable for only one type of test--immunohistochemistry, or IHC."
THIS WAS DONE FOR A REASON!
THE IHC test has been proven to be the LEAST LIKELY to detect BSE/TSE in the bovine, and these were probably from the most high risk cattle pool, the ones the USDA et al, SHOULD have been testing. ...TSS
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...
FULL TEXT;
Completely Edited Version PRION ROUNDTABLE
Accomplished this day, Wednesday, December 11, 2003, Denver, Colorado
2005
=============================
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
Report on Food & Drug Administration Dallas District Investigation of Bovine Spongiform Encephalopathy Event in Texas 2005 Executive Summary: On June 24, 2005, USDA informed FDA that a cow in Texas tested positive for Bovine Spongiform Encephalopathy (BSE). Information provided by APHIS was that the BSE positive cow was born and raised in a herd in Texas and was approximately 12 years old. The animal was sampled for BSE at a pet food plant in Texas on November 15, 2004, as part of USDA's enhanced surveillance program.
http://www.fda.gov/cvm/texasfeedrpt.htm
Texas even had a 'secret' test that showed that mad cow positive; experimental IHC test results, because the test was not a validated procedure, and because the two approved IHC tests came back negative, the results were not considered to be of regulatory significance and therefore were not reported beyond the laboratory. . A Western blot test conducted the week of June 5, 2005, returned positive for BSE.
http://www.usda.gov/documents/vs_bse_ihctestvar.pdf
THIS confirms that the June 2004 Enhanced BSE cover-up, was just that. Like i said before, due to this terribly flawed system, those 388,000 testing to date for BSE in the USA were meaningless and should be retested. ...
Subject: USDA JOHANN'S MAD ABOUT FONG, PLANS HIS OWN LAB AND HIS OWN MAD COW ANTIBODIES ;-) Date: July 29, 2005 at 2:35 pm PST
Friday, July 29, 2005
http://madcowtesting.blogspot.com/search?updated-max=2007-12-18T12%3A13%3A00-08%3A00&max-results=7
USDA did not test possible mad cows
By Steve Mitchell United Press International Published 6/8/2004 9:30 PM
WASHINGTON, June 8 (UPI) -- The U.S. Department of Agriculture claims ittested 500 cows with signs of a brain disorder for mad cow disease last year, but agency documents obtained by United Press International show the agency tested only half that number.
USDA officials said the difference is made up in animals tested at state veterinary diagnostic laboratories, but these animals were not tested using the "gold standard" test employed by the agency for confirming acase of the deadly disease. Instead, the state labs used a less sensitive test that experts say could miss mad cow cases.
In addition, the state lab figures were not included in a March 2004 USDA document estimating the number of animals most likely to be infected among U.S. herds, and apparently were not given to a congressional committee that had requested agency data on the number of cows with brain disorder signs that had been tested for the disease.
"This is just adding to the demise of USDA's credibility," said Felicia Nestor, senior policy adviser to the Government Accountability Project, a group in Washington, D.C., that works with federal whistleblowers.
"If the USDA is going to exclude from testing the animals most likely to have the disease, that would seem to have a very negative impact on there liability of their conclusion," Nestor told UPI.
Nestor, who has monitored the USDA's mad cow surveillance program closely for several years, asked, "Are they deliberately avoiding testing animals that look like they have the disease?"
Concerns about the number of cows in U.S. herds with brain disorder symptoms have been heightened due to the recent case in Texas, in which USDA officials failed to test an animal with such symptoms, also known as central nervous system or CNS signs. This was a violation of USDA policy, which stipulates all CNS cows should be tested because they are considered the most likely to be mad cow infected. To date, the Washington cow that tested positive last December is the only confirmed case of mad cow disease -- also known as bovine spongiform encephalopathy -- among U.S. herds.
The Texas incident has alarmed the public and members of Congress because humans can contract a fatal brain disorder called variant Creutzfeldt-Jakob disease from consuming meat infected with the mad cow pathogen. If the USDA's surveillance program is allowing the riskiest cows to go untested, it raises concerns about the ability of the monitoring system to detect the disease reliably in U.S. herds, Rep.Henry Waxman, D-Calif., charged in a May 13 letter to Agriculture Secretary Ann Veneman.
Dr. Peter Lurie, of the consumer group Public Citizen, said CNS cows should be the one category that absolutely has to be tested to have a sound surveillance system.
"CNS animals are far and away the most important animals to test," said Lurie, who has done several analyses of the USDA's mad cow surveillance program.
"If there's any category that needs 100 percent testing, that's it, because they would be the most likely place to find mad cow in America," he told UPI. "Any CNS cow that slips into the food supply represents a major case of malpractice by USDA, and similarly, the failure to test the brain of that animal to see if it was indeed infected is really a failure to protect the public."
USDA officials said the agency has no estimate on how many CNS cows occur in U.S. herds. But spokesman Ed Loyd has told UPI, and at least one other media outlet, that 500 CNS cows were tested in fiscal year 2003. Yet agency testing records for the first 10 months of FY 2003, obtained by UPI under the Freedom of Information Act, show only 254 animals that fall under the CNS category -- or about half the number Loyd cited.
After failing to respond to repeated requests from UPI for clarification of the apparent discrepancy, Loyd finally offered the explanation that an additional 45 CNS cows were tested by the USDA during the final two months of FY 2003. The remainder, he said, was made up by CNS cases tested at various state veterinary diagnostic laboratories.
"We also include data reported to us from state veterinary diagnostic laboratories, and all of these are CNS cases that have been tested for BSE using a histological examination," Loyd said.
"We were not using any other labs during this period, other than (the USDA lab), to run the IHC tests for BSE, which is the gold standard," he said. "This (state laboratory) information contributes important data to our surveillance effort."
However, the state labs did not use the immunohistochemistry test, which the USDA has called the "gold standard" for diagnosing mad cow disease. Instead, the labs used a different test called histopathology, which theUSDA itself does not use to confirm a case, opting instead for the more sensitive IHC test.
The histopathology test, unlike the IHC test, does not detect prions --misfolded proteins that serve as a marker for infection and can be spotted early on in the course of the illness. Rather, it screens forthe microscopic holes in the brain that are characteristic of advanced mad cow disease.
According to the USDA's Web site, histopathology proves reliable only if the brain sample is removed soon after the death of the animal. If there is too much of a delay, the Web site states, it can be "very difficult to confirm a diagnosis by histopathology" because the brain structures may have begun to disintegrate.
That is one reason the agency began using the IHC test -- it can confirm a diagnosis if the brain has begun disintegrating or been frozen for shipping.
The state labs used histopathology to screen 266 CNS cases in FY 2003, as well as 257 cases in FY 2002, according to Loyd. He did not explain why this information was not included in the testing records the agency provided to UPI and has not responded to requests for the identity of the state labs.
Linda Detwiler, a former USDA veterinarian who oversaw the agency's madcow testing program, told UPI the histopathology test probably is adequate for screening CNS cows. If they have mad cow disease, she said, it would likely be an advanced stage that should be obvious.
Other mad cow disease experts, however, said having a back-up test suchas IHC would be advisable, because histopathology tests sometimes can miss evidence of infection.
The Food and Agriculture Organization of the United Nations offers similar recommendations in its protocol for conducing a histopathology test. The protocol states that even if histopathology is negative,"further sampling should be undertaken" in cases "where clinical signs have strongly suggested BSE" -- a criteria that includes all of the cows tested at the state labs.
The USDA seems to agree on the need for a back-up test. Its expanded surveillance program, which began June 1, calls for using IHC -- or another test called Western blot -- to confirm any positives found on rapid tests. The March 15 document that describes the new program does not mention using histopathology to confirm cases of mad cow disease.
"Subtle changes can be missed on histopathology that would probably not be as easy to miss using IHC," said Elizabeth Mumford, a veterinarian and BSE expert at Safe Food Solutions in Bern, Switzerland, a company that provides advice on reducing mad cow risk to industry and governments.
"Therefore I believe it is valuable to run (histopathology)," Mumford told UPI.
She noted that in Europe, two tests -- neither one the histopathology test -- are used to ensure no cases are missed. A rapid test is used initially for screening, followed by IHC as a confirmatory test.
Markus Moser, a molecular biologist and chief executive officer of the Swiss firm Prionics, which manufactures tests for detecting mad cow disease, agrees about the possibility of a case being missed by histopathology.
"There were cases which were (histopathology) negative but still clearly positive with the other (testing) methods," Moser said. "BSE testing based on histology on sub-optimal tissue was probably one of the reasons why Germany was allegedly BSE-free until our test discovered that they were not" in 2000, Moser told UPI.
He agreed with Detwiler that histopathology should be suitable for most cases of CNS cows, but added it still can fail to detect the disease in some CNS cases -- particularly if the sample is not optimum.
"It is difficult, if not impossible, to distinguish the subtle changes in a diseased brain from artifacts like ruptures in the tissue due to tissue damage during the sampling, transport or preparation," he said.
Loyd asserted the additional CNS cases from the state labs actually yielded a total of 565 such cows the USDA had tested -- 65 more than his original figure of 500. Whether the USDA considers its total to be 500 or 565, however, either figure would exceed the agency's own estimates for the total number of such cows that it identifies annually.
According to data the USDA provided to the House Committee on Government Reform, and numbers the agency included in the March document about its expanded surveillance plan, only 201 to 249 CNS cows are identified at slaughterhouses. Approximately 129 additional cases occur on farms annually. At most, that yields a combined total of 378 CNS cows, or nearly 200 less than the 565 Loyd claims the agency tested.
The USDA surveillance plan document makes no mention of the number of CNS animals tested at state veterinary diagnostic labs. The figure also does not appear to be included in the agency's estimates of the number of high-risk animals that occur in the United States each year. The latter number was used to help the USDA calculate the number of animals it will screen for mad cow disease in its expanded surveillance plan.
USDA officials also did not include the state lab figures in response to a question from the House Committee on Government Reform, a source close to the issue told UPI. The committee, on which Waxman is the ranking Democrat, had requested in a March 8 letter to Veneman that she provide "the number of BSE tests that were conducted on cattle exhibiting central nervous system symptoms" for each of the last five years.
Loyd did not respond to a request from UPI asking why agency officials did not provide that information to the committee or include it in USDA's explanation of its expanded surveillance plan.
The committee has taken note of the CNS issue and plans to delve into it further in a hearing slated for sometime in the next few months.
"The committee will explore this and other issues surrounding USDA and BSE testing at a hearing later this summer," Drew Crockett, spokesman for the committee, told UPI.
--
Steve Mitchell is UPI's Medical Correspondent. E-mail sciencemail@upi.com
Copyright © 2001-2004 United Press International
http://www.upi.com/view.cfm?StoryID=20040608-014607-3865r
''USDA gets a D or D minus," said Caroline Smith Dewaal of the Center for Science in the Public Interest, an advocacy group based in Washington. ''The best thing that came out of this is the work of the inspector general."
It was the department's in-house watchdog, Inspector General Phyllis Fong, who skirted the USDA hierarchy by ordering retesting with a different method more than six months after a routine second-round test, known as the immunohistochemistry, or IHC, test proved negative for the disease.
Agriculture Secretary Mike Johanns, who assumed office in January, has said he neither knew about nor authorized the retesting by the National Veterinary Services Laboratories in Ames, Iowa.
BESIDES the Texas mad cow that sat on the shelf for 7+ months before the Honorable Phyllis Fong of the OIG finally did the end around Johanns et al and finally had Weybridge bring that negative cow back from the dead to finally being a confirmed mad cow (hint, hint, getting MRR implemented first), was this simply another bumbling of BSE protocol, or just same old same old;
Jim Rogers (202) 690-4755
USDA Press Office (202) 720-4623
Statement by Chief Veterinary Medical Officer John Clifford Animal and Plant Health Inspection Service Regarding Non-Definitive BSE Test ResultsJuly 27, 2005
snip...
Our laboratory ran the IHC test on the sample and received non-definitive results that suggest the need for further testing. As we have previously experienced, it is possible for an IHC test to yield differing results depending on the "slice" of tissue that is tested. Therefore, scientists at our laboratory and at Weybridge will run the IHC test on additional "slices" of tissue from this animal to determine whether or not it was infected with BSE. We will announce results as soon as they are compiled, which we expect to occur by next week.
I would note that the sample was taken in April, at which time the protocols allowed for a preservative to be used (protocols changed in June 2005). The sample was not submitted to us until last week, because the veterinarian set aside the sample after preserving it and simply forgot to send it in. On that point, I would like to emphasize that while that time lag is not optimal, it has no implications in terms of the risk to human health. The carcass of this animal was destroyed, therefore there is absolutely no risk to human or animal health from this animal.
snip...
http://www.aphis.usda.gov/lpa/news/2005/07/bsestatement_vs.html
In Reply to: Re: Statement by Dr. John Clifford Regarding Non-Definitive BSE Test Results posted by TSS on July 27, 2005 at 12:53 pm:
o.k., let me get this right. i am pondering here;-)
all the time this TEXAS positive, positive, (secret) positive, inconclusive, negative, then Weybridge confirmed 2nd BSE documented case (thanks to the Honorable Phyllis Fong),all this time this BSe going on in TEXAS, was plastered all over the news, this guy forgot about that sample, and it just sat up on some shelf wasting away for months, as to be in such bad shape, they now cannot even test it properly. r i g h t ... like ooops, sorry. ...end
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The animal died in April, but the veterinarian forgot to send the sample to USDA until this month, Mr. Clifford said. "While that time lag is not optimal, it has no implications in terms of the risk to human health," he said.
IHC tests returned conflicting results on the Texas cow. Use of the preservative means that the other tests commonly done when mad cow is suspected, initial rapid screening and Western blot, can't be performed on this sample, the official said. Mr. Clifford said it's possible to get different results, "depending on the slice of tissue that is tested."
The fatal brain-wasting disease is known medically as bovine spongiform encephalopathy, or BSE. In people, eating tainted meat products has been linked to about 150 deaths from a fatal disorder called variant Creutzfeldt-Jakob disease. Most of the deaths were in the United Kingdom, where there was an outbreak in the 1980s and 1990s.
The U.S. banned Canadian cattle in May 2003 following Canada's first case of mad-cow disease. The U.S. was about to lift the ban in March when U.S. District Judge Richard Cebull in Billings, Mont., granted an injunction to a ranchers' group called R-CALF United Stockgrowers of America. The ranchers had sued to keep the border closed to Canadian cattle, saying the disease presented a risk to the U.S. beef industry as well as to American consumers.
The 9th U.S. Circuit Court of Appeals reversed the injunction earlier this month, allowing cattle shipments from Canada to resume. The lifting of the ban reopens the U.S. to cattle younger than 30 months and expands the list of beef products Canada is allowed to ship to the U.S. Older animals are still banned, because infection levels are believed to increase with age.
Copyright © 2005 Associated Press
http://online.wsj.com/
Greetings,
this is what you call the 'FONG' syndrome. make sure she can't make them do a WB on this sample.
I BEG THE OIG and the Honorable Phyllis Fong to investigate this blunder too. there is no way that sample sat on a shelf while the world waited on that Texas mad cow blunder dust to settle, and someone just forgets about it. i just don't believe this either...
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http://madcowtesting.blogspot.com/search?updated-max=2007-12-18T12%3A13%3A00-08%3A00&max-results=7
WAKE UP AMERICA !
with kindest regards, terry
layperson
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
flounder9@verizon.net
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