Friday, May 18, 2012

Update from APHIS Regarding a Detection of Bovine Spongiform Encephalopathy (BSE) in the United States Friday May 18, 2012

Update from APHIS Regarding a Detection of Bovine Spongiform Encephalopathy (BSE) in the United States Friday May 18, 2012



Contact:
Lyndsay Cole (970) 494-7410
Lawrence Hawkins (916) 930-5509



Update from APHIS Regarding a Detection of Bovine Spongiform Encephalopathy (BSE) in the United States



On April 24, USDA's Animal and Plant Health Inspection Service (APHIS) confirmed the nation's 4th case of Bovine Spongiform Encephalopathy (BSE) in an animal that was sampled for the disease at a rendering facility in central California. This animal was never presented for slaughter for human consumption, so at no time presented a risk to the food supply, or to human health in the United States.





After USDA's National Veterinary Services Laboratories (NVSL) completed testing of the samples from the index animal, the samples were sent to The World Organization for Animal Health (OIE) reference laboratories in Canada and England. Both laboratories have confirmed that the index cow was positive for atypical (L-type) BSE.



Both dairies that were previously held under quarantine during the investigation have been released from those quarantines, after inventories were completed and records were reviewed.




In addition, investigation of the feed records at the index dairy premises has found no anomalies, and audits of all the feed suppliers to the index premises have shown them to be in compliance with the regulations.



APHIS previously announced that it has identified two progeny of the positive cow. One progeny born to the positive cow in the last 2 years was stillborn; the second animal was appraised, humanely euthanized, and sampled for BSE at the National Veterinary Services Laboratories in Ames, Iowa. Test results for that animal were negative for BSE.



Of several hundred potential birth cohort cattle, the focus of the tracing is on a small number (10-12) of cattle which may still be alive and have records that might allow them to be located. The remaining potential cohorts are no longer alive or have otherwise been ruled out.




As the investigation moves toward completion, local officials from the California Department of Food and Agriculture and USDA APHIS Veterinary Services are now in charge of the incident command.




The United States has a longstanding system of three interlocking safeguards against BSE that protects public and animal health in the United States, the most important of which is the removal of specified risk materials - or the parts of an animal that would contain BSE should an animal have the disease - from all animals presented for slaughter. The second safeguard is a strong feed ban that protects cattle from the disease. The third safeguard - which led to this detection - is our ongoing BSE surveillance program that allows USDA to detect the disease if it exists at very low levels in the U.S. cattle population.




#




Note to Reporters: USDA news releases, program announcements and media advisories are available on the Internet and through Really Simple Syndication (RSS) feeds. Go to the APHIS news release page at
www.aphis.usda.gov/newsroom and click on the RSS feed link.





USDA is an equal opportunity provider, employer and lender. To file a complaint of discrimination, write: USDA, Director, Office of Civil Rights, 1400 Independence Ave., SW., Washington, DC 20250-9410 or call (800) 795-3272 (voice) or (202) 720-6382 (TDD).











The United States has a longstanding system of three interlocking safeguards against BSE that protects public and animal health in the United States, the most important of which is the removal of specified risk materials - or the parts of an animal that would contain BSE should an animal have the disease - from all animals presented for slaughter.





The second safeguard is a strong feed ban that protects cattle from the disease.





The third safeguard - which led to this detection - is our ongoing BSE surveillance program that allows USDA to detect the disease if it exists at very low levels in the U.S. cattle population.






IT seems a review of those mad cow triple firewalls interlocking safeguards are in order here. please see as follows ;









1st failed mad cow triple mad cow interlocking safeguard ;







“The United States has a longstanding system of three interlocking safeguards against BSE that protects public and animal health in the United States, the most important of which is the removal of specified risk materials - or the parts of an animal that would contain BSE should an animal have the disease - from all animals presented for slaughter.”






SPECIFIED RISK MATERIALS AKA SRM’s







Position Brief




on




Inadequate SRM Removal Policies in USDA Final Rule




Prepared by R-CALF USA




February 1, 2005




USDA asserts that the Final Rule will not result in increased human exposure to disease because

all material that could contain infectious levels of the BSE agent will be kept out of the meat

supply by requirements that “specified risk materials” (SRMs) be removed at slaughter before

further processing of the carcass. SRMs are defined to be the brain, skull, eyes, trigeminal

ganglia, spinal cord, portions of the vertebral column, and dorsal root ganglia in cattle 30 months

of age and older, and the tonsils and small intestine in all cattle regardless of age. In contrast,

O.I.E. guidelines for moderate-risk countries (including those, like Canada, that have not had a

feed ban in place for at least 8 years) require that meat for export from such countries not contain

the brain, eyes, spinal cord, distal ileum of the small intestine, or mechanically separated meat

from the skull or spinal column from animals over 6 months of age.i




As of December 2004, BSE has been confirmed in 21 head of cattle under 30 months old,

including 13 head of cattle that were 24 months of age or younger.ii There is uncertainty

regarding the exact age under which BSE is detectable in infected cattle. USDA, in its

negotiations with Japan, has conceded that the agency does not know the risk to human health

associated with central nervous system (CNS) tissues from cattle that carry the BSE disease, but

are too young for BSE to be detected using current testing methods. This admission strongly

suggests that any exposure to beef from younger cattle originating in a country where BSE is

known to exist presents an unknown risk to consumers. “Unknown” is not the same as

“miniscule,” “negligible,” or “de minimis.” The Japan-United States BSE Working Group

comprised of experts and working-level officials reported:




Japan and the U.S. agree that accumulated abnormal prion protein in younger

animals is unlikely to be detected using current testing methods. Japan and the

U.S. agree that at present any relationship of such undetectable levels of abnormal

prion protein in CNS tissues to consumers’ risk is unclear.iii




The Final Rule ignores this unknown risk to consumers and requires no mitigation measures

other than the removal of the small intestine and tonsils from cattle less than 30 months old,

thereby subjecting U.S. and international consumers to whatever risk scientists later determine is

presented by the remaining CNS tissues of younger cattle.




Both the presumption that the BSE infectious agent resides only in SRMs, and the implicit

assumption that SRMs can be removed from the carcass without exposing any of the remaining

meat to contamination with the BSE infectious agent, are further unjustified if BSE can be



2



transmitted through blood. (Scientists in the UK believe that the human form of BSE has been

spread through blood transfusions.)




Although EU countries have had years to adjust to a BSE epidemic, statistics indicate that

current control systems are not sufficient to prevent SRMs from entering domestic or imported

meat products. For example, Table 1 shows statistics on 139 detected cases of SRMs entering

the UK in imported beef during 2004. USDA’s description of the human health risks of the Final

Rule should have included the probable failure rate of SRM import controls, but it did not. The

Final Rule also did not justify treating Canadian and U.S. import control measures as more

reliable than those in the UK. As a result, SRM restrictions may be viewed as a means of

reducing the risk of contamination by SRMs, but not as a means of eliminating it.




Table 1: Finds of specified risk material in imported beef and sheep meat in the UK, 2004,

23 January 2004 – 31 December 2004




snip...






One hundred and thirty nine SRM imports controls breaches involving EU Member States.






Not only has the EU demonstrated that current control systems are not sufficient to prevent

SRMs from entering domestic or imported meat products, but the United States, as well, has less

than a stellar record of enforcing strict prohibitions against allowing Central Nervous System

(CNS) tissues from entering the U.S. food supply, thus providing further evidence that reliance

upon SRM removal policies is insufficient to prevent the introduction of the BSE agent into the

U.S. food supply. For example: Since 1995 the FSIS has prohibited spinal cord tissue in meat

products. See Revised Directive for Advanced Meat Recovery Systems, FSIS, December 2002.

However, in 2002, seven years after this prohibition, the FSIS conducted a survey of 34 facilities

using Advance Meat Recovery (AMR) systems. The FSIS survey concluded that 29 percent of

the finished products sampled contained prohibited spinal cord tissues. See Analysis of 2002

FSIS Bovine AMR Product Survey Results, FSIS-USDA, February 2003.





In addition, there is recent information (December 2004) from the union of U.S. food safety

inspectors that USDA Food Safety and Inspection Service requirements for removal of SRMs in

cattle over 30 months of age often are not being met at U.S. slaughter facilities.iv



4



It is of little consolation that while great uncertainty overshadows the scientific basis for USDA’s

reliance on SRM removal as the panacea of consumer protection against BSE, there is also a

known trail of non-compliance with USDA directives related to CNS tissues by the U.S. food

processing industry.





Conclusion: There is great uncertainty about the human health risks associated with BSE; there

is also a lack of evidence regarding the efficacy of currently practiced risk mitigation measures;

and there is statistical evidence from the US and theUK that shows that requirements for SRM

removal are not always completely met. Scientific research on BSE is rapidly evolving, with

new discoveries announced frequently. Among the new discoveries, for example, is the July

2004 reported finding of prions (the agent that causes BSE) in tissues where prions were not

known to exist, such as in the tongue muscle of hamsters.v This calls into question the notion

that the removal of SRMs provides complete protection from BSE-infected cattle.

i OIE Terrestrial Animal Health Code, 12th edition, 2004, Article 2.3.13.15 (5) and 2.3.13.18 (2).

ii Statistics – Youngest and oldest cases by year of onset – GB (Passive Surveillance Only), Department of

Environment, Food and Rural Affairs, United Kingdom, as of October 1, 2004, available at:






iii Final Report, Japan-United States BSE Working Group, July 22, 2004.

iv Charles S. Painter, Chairman, National Joint Council of Food Inspection Locals, American Federation of

Government Employees, Letter to Mr. William Smith, Assistant Administrator for Field Operations, USDA-Food

Safety Inspection Service, December 8, 2004

v See E. Mulcahy, J. Bartz, A. Kincaid, R. Bessen, Prion Infection of Skeletal Muscle Cells and Papillae in the

Tongue, J. Journal of Virology, Vol. 78 No. 13, 6792 -6798 (July 2004)
















NOW, what about those pesky prions and SRM removal in the USA ???






Saturday, July 23, 2011





CATTLE HEADS WITH TONSILS, BEEF TONGUES, SPINAL CORD, SPECIFIED RISK MATERIALS (SRM's) AND PRIONS, AKA MAD COW DISEASE

CATTLE HEADS WITH TONSILS, BEEF TONGUES, SPINAL CORD, SPECIFIED RISK MATERIALS (SRM's) AND PRIONS, AKA MAD COW DISEASE

Greetings,


I have put a few of these recalls together from previous SRM recalls. Probably missed some, but i am a bit disturbed that the FSIS has apparently chosen not to list this recall from July 14, 2011 due to SRM spinal cord contamination, that i could find. The state of Ohio made a statement about a voluntary recall of an unknown amount of beef products that may contain the spinal cord and vertebral column, which are considered specified risk materials (SRMs) {see below} ;


Thursday, July 14, 2011

Valley Farm Meats (DBA Strasburg Provision, Inc) Issues Precautionary Recall for Beef Products Due to Possible Contamination with Prohibited Materials SRM Ohio Department of Agriculture and Ohio Department of Health

http://transmissiblespongiformencephalopathy.blogspot.com/2011/07/valley-farm-meats-dba-strasburg.html



YET, FSIS seems to find it important enough to list this recall from Ohio ;


Ohio Firm Recalls Various Beef Jerky Products due to Misbranding and Undeclared Allergens

Recall Release CLASS II RECALL FSIS-RC-053-2011 HEALTH RISK: LOW

Congressional and Public Affairs (202) 720-9113 Adam Tarr

WASHINGTON, July 22, 2011 –

http://www.fsis.usda.gov/News_&_Events/Recall_053_2011_Release/index.asp



HOWEVER, look at the recalls of the past (see below), the first two were other voluntary recalls from other Companies, which i am using as an example (and see others that follow), but my question, WHY has the FSIS et al apparently chosen NOT to announce this recall on their website here ;


Valley Farm Meats (DBA Strasburg Provision, Inc) Issues Precautionary Recall for Beef Products Due to Possible Contamination with Prohibited Materials SRM Ohio Department of Agriculture and Ohio Department of Health

http://www.fsis.usda.gov/FSIS_Recalls/Open_Federal_Cases/index.asp


I have written both the FSIS and MEATINGPLACE.COM/, both of which have failed to report this important, life long exposure and human health risk factor for TSE from this voluntary recall, and all it got me was being banned from meatingplace.com/ again, and this time i did not even post anything, just sent them a kind note ;



----- Original Message -----

From: Terry S. Singeltary Sr. To: AgRepublicanPress@mail.house.gov

Sent: Friday, July 22, 2011 4:23 PM

Subject: Fw: Valley Farm Meats (DBA Strasburg Provision, Inc) Issues Precautionary Recall for Beef Products Due to Possible Contamination with Prohibited Materials SRM

Greetings USDA et al,

I have not seen this on the USDA site yet ???

have i missed it ???

thank you, kind regards, terry



Ohio Department of Agriculture and Ohio Department of Health

Governor

John R. Kasich

Lieutenant Governor

Mary Taylor

ODA Director

James Zehringer

ODH Director

Theodore E. Wymyslo, M.D.

DT: July 14, 2011

TO: Health Commissioners, Directors of Environmental Health and Interested Parties

RE: Recall Announcement (ODA/ODH) 2011-076

Valley Farm Meats (DBA Strasburg Provision, Inc) Issues Precautionary Recall for Beef Products Due to Possible Contamination with Prohibited Materials

snip...end...TSS


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


----- Original Message -----

From: Terry S. Singeltary Sr.

To: tjohnston@meatingplace.com

Sent: Thursday, July 21, 2011 2:17 PM

Subject: Valley Farm Meats (DBA Strasburg Provision, Inc) Issues Precautionary Recall for Beef Products Due to Possible Contamination with Prohibited Materials SRM


Hello Mr. Johnston !

i have not seen this posted on meatingplace ???

I have stopped commenting on the forum at meatingplace, because everytime i comment or leave some science, i get blocked.

but i thought this important enought to send you you directly.


kind regards, terry


Ohio Department of Agriculture and Ohio Department of Health

Governor

John R. Kasich

Lieutenant Governor

Mary Taylor

ODA Director

James Zehringer

ODH Director

Theodore E. Wymyslo, M.D.

DT: July 14, 2011

TO: Health Commissioners, Directors of Environmental Health and Interested Parties

RE: Recall Announcement (ODA/ODH) 2011-076

Valley Farm Meats (DBA Strasburg Provision, Inc) Issues Precautionary Recall for Beef Products Due to Possible Contamination with Prohibited Materials

[STRASBURG, Ohio] – Valley Farm Meats (DBA Strasburg Provision, Inc) of Strasburg, OH announces a voluntary recall of an unknown amount of beef products that may contain the spinal cord and vertebral column, which are considered specified risk materials (SRMs). SRMs must be removed from cattle over 30 months of age in accordance with federal and state regulations. SRMs are tissues that are known to contain the infective agent in cattle infected with Bovine Spongiform Encephalopathy (BSE), as well as materials that are closely associated with these potentially infective tissues. Therefore, federal and state regulations prohibit SRMs from use as human food to minimize potential human exposure to the BSE agent.

The products subject to recall include all beef products slaughtered and processed by or purchased from Valley Farm Meats retail store, 1317 N. Wooster Ave NW, Strasburg, OH 44680 or purchased from Ed Lind Livestock and Poultry, 3333 Church Rd B, Medina, Ohio 44256. These products were produced between 01/28/2011 and 07/05/2011 and offered for sale from 01/28/2011 through 07/11/2011.

The package labels or beef carcasses may bear the Ohio mark of inspection and “Est. 80”, however products processed through Ed Lind Livestock and Poultry may not contain such markings. The problem was discovered through routine inspection activities by the Ohio Department of Agriculture’s Division of Meat Inspection. The Department has received no reports of illnesses associated with consumption of this product.

The United States Department of Agriculture’s Food Safety and Inspection Service classifies this type of potential contamination as a low health risk, however individuals concerned about an illness should contact a health care provider.

Because of potential product contamination, Valley Farm Meats urges its customers who have purchased the suspect product(s) not to eat them and to return them to the company. Customers may bring those designated packages to Valley Farm Meats, 1317 N Wooster Avenue NW, Strasburg, OH 44680 during regular business hours or call the company’s owner, Paul Berry at 330-878-5557.


http://www.agri.ohio.gov/public_docs/recalls/2011/Recall_FS_76-2011.pdf



Valley Farm Meats issues beef recall

TimesReporter.com staff report

Posted Jul 13, 2011 @ 03:18 PM

http://www.timesreporter.com/communities/x401792774/Valley-Farm-Meats-issued-beef-recall



Greetings Friends and Family in Ohio !!!


DON'T let anyone fool you, there would be no immediate health effects from any BSE related contamination for years and years, maybe a decade or more.

FACT is, whomever consumed these banned products will not ever know, until it's too late.

FACT is, TSE prion disease are rampant in North America, and the USA is doing everything in it's power to keep that under lock and key.

FACT is, CJD is spreading in the USA, and sporadic CJD has now been linked to atypical BSE and atypical Scrapie, both of which are in North America.

FACT is, the media has failed us terribly in the complete truth behind the mad cow saga.

FACT is, our fine federal friends have systematically covered the mad cow debacle up, thanks to the help of the USDA and the OIE.

THESE are the facts as i have come to know them since loosing my mother to the Heidenhain Variant of Creutzfeldt Jakob disease.

YOU should know these facts too...

snip...end...tss

blocked...banned again...tss


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


has there been another change in protocol to help cover-up more needless expossure to the TSE in the USA ???

or did i just miss this recall ???

see old FSIS example of SRM recalls from the past ;


North Dakota Firm Recalls Whole Beef Head Products That Contain Prohibited Materials

Recall Release CLASS II RECALL FSIS-RC-023-2010 HEALTH RISK: LOW

Congressional and Public Affairs (202) 720-9113 Catherine Cochran

WASHINGTON, April 5, 2010 - North American Bison Co-Op, a New Rockford, N.D., establishment is recalling approximately 25,000 pounds of whole beef heads containing tongues that may not have had the tonsils completely removed, which is not compliant with regulations that require the removal of tonsils from cattle of all ages, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.

Tonsils are considered a specified risk material (SRM) and must be removed from cattle of all ages in accordance with FSIS regulations. SRMs are tissues that are known to contain the infective agent in cattle infected with Bovine Spongiform Encephalopathy (BSE), as well as materials that are closely associated with these potentially infective tissues. Therefore, FSIS prohibits SRMs from use as human food to minimize potential human exposure to the BSE agent.

The product subject to recall includes: Various weight cases of "Beef Heads KEEP FROZEN." Each case bears the establishment number "EST. 18859" inside the USDA mark of inspection and a case code number "16999." "North Dakota Natural Beef" is printed in the bottom left-hand corner of each label.

The recalled products were produced between June 25, 2009, and February 19, 2010. These products were shipped to distribution centers in Md., Mich., and Minn. for further sale.

The problem was discovered during FSIS inspection activities at the establishment. FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.

Media with questions about the recall should contact Philip Wicke, Vice President of Operations, at (701) 356-7723. Consumers with questions about the recall should contact Jeremy Anderson, Director of Customer Service, at (952) 545-2495.

Consumers with food safety questions can "Ask Karen," the FSIS virtual representative available 24 hours a day at AskKaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day. #

http://www.fsis.usda.gov/News_&_Events/Recall_023_2010_Release/index.asp


Missouri Firm Recalls Cattle Heads That Contain Prohibited Materials

Recall Release CLASS II RECALL FSIS-RC-021-2008 HEALTH RISK: LOW

Congressional and Public Affairs (202) 720-9113 Amanda Eamich

WASHINGTON, June 26, 2008 – Paradise Locker Meats, a Trimble, Mo., establishment, is voluntarily recalling approximately 120 pounds of fresh cattle heads with tonsils not completely removed, which is not compliant with regulations that require the removal of tonsils from cattle of all ages, the U.S. Department of Agriculture’s Food Safety and Inspection Service announced today.

Tonsils are considered a specified risk material (SRM) and must be removed from cattle of all ages in accordance with FSIS regulations. SRMs are tissues that are known to contain the infective agent in cattle infected with BSE, as well as materials that are closely associated with these potentially infective tissues. Therefore, FSIS prohibits SRMs from use as human food to minimize potential human exposure to the BSE agent.

The products subject to recall include: Boxes of “BEEF HEAD, PARADISE LOCKER MEATS.” Each shipping package bears the establishment numbers “EST. 31865” inside the USDA mark of inspection.

These products were sent to retail establishments and restaurants in the Kansas City, Kansas, area.

The problem was discovered through routine FSIS inspection that verified there had been incomplete removal of the tonsils by the recalling establishment.

Media and consumers with questions about the recall should contact company Production Supervisor Louis Fantasma at (816) 370-6328.

Consumers with food safety questions can “Ask Karen,” the FSIS virtual representative available 24 hours a day at AskKaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day. #

http://www.fsis.usda.gov/News_&_Events/Recall_021_2008_Release/index.asp


HAS the greed and money gotten so bad that the FSIS, USDA, APHIS, OIE et al, just decided that not only to exempt the atypical Scrapies and apparently now the BSE's, exempt them all, and just agreed to choose to not even speak about it anymore. i mean...really, the USDA and OIE have systematically covered up mad cow disease i.e. they call it SSS policy. where is USA burying them all at ? i do not accept the star trek like cloaking device that appears to be the only thing left that could be protecting the USA from mad cow disease....really. sadly, Canada has now taken the same low road as the USA in regards to discussing and making public documents on there mad cow cases. all this, 2011, with the science mounting, still follow the global myth of the UKBSEnvCJD only theory, and that all the sporadic CJDs (85%+ of all human TSE) are a mear happenstance of bad luck, when North America is plum full of different strains of the Transmissible Spongiform Encephalopathy in different species, all of which over a period of time, decades, were rendered and fed to food producing animals for human and animal food...really. i really just don't buy it...tss


some history on SRM's IN COMMERCE ;


SEE FULL TEXT HERE ;

Tuesday, July 1, 2008

Missouri Firm Recalls Cattle Heads That Contain Prohibited Materials SRMs

http://madcowfeed.blogspot.com/2008/07/missouri-firm-recalls-cattle-heads-that.html


Sunday, October 18, 2009

Wisconsin Firm Recalls Beef Tongues That Contain Prohibited Materials SRM WASHINGTON, October 17, 2009

http://madcowfeed.blogspot.com/2009/10/wisconsin-firm-recalls-beef-tongues.html


Thursday, October 15, 2009

Nebraska Firm Recalls Beef Tongues That Contain Prohibited Materials SRM WASHINGTON, Oct 15, 2009

http://madcowfeed.blogspot.com/2009/10/nebraska-firm-recalls-beef-tongues-that.html


Thursday, June 26, 2008

Texas Firm Recalls Cattle Heads That Contain Prohibited Materials

http://madcowfeed.blogspot.com/2008/06/texas-firm-recalls-cattle-heads-that.html


Friday, August 8, 2008

Texas Firm Recalls Cattle Heads That Contain Prohibited Materials SRMs 941,271 pounds with tonsils not completely removed

http://madcowfeed.blogspot.com/2008/08/texas-firm-recalls-cattle-heads-that.html


Saturday, April 5, 2008

SRM MAD COW RECALL 406 THOUSAND POUNDS CATTLE HEADS WITH TONSILS KANSAS

http://cjdmadcowbaseoct2007.blogspot.com/2008/04/srm-mad-cow-recall-406-thousand-pounds.html


Wednesday, April 30, 2008

Consumption of beef tongue: Human BSE risk associated with exposure to lymphoid tissue in bovine tongue in consideration of new research findings

http://cjdmadcowbaseoct2007.blogspot.com/2008/04/consumption-of-beef-tongue-human-bse.html


Wednesday, April 30, 2008

Consumption of beef tongue: Human BSE risk associated with exposure to lymphoid tissue in bovine tongue in consideration of new research findings

http://cjdmadcowbaseoct2007.blogspot.com/2008/04/consumption-of-beef-tongue-human-bse.html


Friday, October 15, 2010

BSE infectivity in the absence of detectable PrPSc accumulation in the tongue and nasal mucosa of terminally diseased cattle

http://bseusa.blogspot.com/2010/10/bse-infectivity-in-absence-of.html



SPECIFIED RISK MATERIALS SRMs

http://madcowspontaneousnot.blogspot.com/2008/02/specified-risk-materials-srm.html



http://madcowfeed.blogspot.com/



http://madcowspontaneousnot.blogspot.com/
SEE WHERE ONE OF THE BIGGEST BLUNDERS OF THE USDA ET AL WERE THE USDA NSLP DEAD STOCK DOWNER COW SCHOOL LUNCH PROGRAM, WHERE CHILDREN ALL ACROSS THE UNITED STATES WERE FED THE MOST HIGH RISK CATTLE FOR BSE I.E. DEAD STOCK DOWNER COWS, FOR OVER 4 YEARS THAT COULD BE DOCUMENTED. who will watch these children for the next 50 years for CJD prion disease ???

FINAL !
Subject: deadstock downer cows NSLP
> > > Ackerman says downed cattle are 50 times more likely to have mad cow disease (also known as Bovine Spongiform Encephalopathy, or BSE) than ambulatory cattle that are suspected of having BSE. Of the 20 confirmed cases of mad cow disease in North America since 1993, at least 16 have involved downer cattle, he said. < < <
don’t forget the children...
PLEASE be aware, for 4 years, the USDA fed our children all across the Nation (including TEXAS) dead stock downer cows, the most high risk cattle for BSE aka mad cow disease and other dangerous pathogens.
who will watch our children for CJD for the next 5+ decades ???
WAS your child exposed to mad cow disease via the NSLP ???
SCHOOL LUNCH PROGRAM FROM DOWNER CATTLE UPDATE
http://downercattle.blogspot.com/2009/05/who-will-watch-children.html
http://downercattle.blogspot.com/
DID YOUR CHILD CONSUME SOME OF THESE DEAD STOCK DOWNER COWS, THE MOST HIGH RISK FOR MAD COW DISEASE ???
you can check and see here ;
http://www.fns.usda.gov/fns/safety/pdf/Hallmark-Westland_byState.pdf


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




Archive Number 20101206.4364 Published Date 06-DEC-2010 Subject PRO/AH/EDR> Prion disease update 2010 (11)

PRION DISEASE UPDATE 2010 (11)

http://www.promedmail.org/pls/apex/f?p=2400:1001:5492868805159684::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1000,86129



Tuesday, May 3, 2011


PRION, TSE, typical, atypical BSE, aka mad cow disease, spray dried blood, feed, and a recipe for disaster

http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/prion-tse-typical-atypical-bse-aka-mad.html



NOW, what about that mad cow feed from atypical BSE in commerce and SRM regulations ???


Research Project: Study of Atypical Bse Location: Virus and Prion Research Unit

Project Number: 3625-32000-086-05 Project Type: Specific Cooperative Agreement

Start Date: Sep 15, 2004 End Date: Sep 14, 2009

Objective: The objective of this cooperative research project with Dr. Maria Caramelli from the Italian BSE Reference Laboratory in Turin, Italy, is to conduct comparative studies with the U.S. bovine spongiform encephalopathy (BSE) isolate and the atypical BSE isolates identified in Italy. The studies will cover the following areas: 1. Evaluation of present diagnostics tools used in the U.S. for the detection of atypical BSE cases. 2. Molecular comparison of the U.S. BSE isolate and other typical BSE isolates with atypical BSE cases. 3. Studies on transmissibility and tissue distribution of atypical BSE isolates in cattle and other species.

Approach: This project will be done as a Specific Cooperative Agreement with the Italian BSE Reference Laboratory, Istituto Zooprofilattico Sperimentale del Piemonte, in Turin, Italy. It is essential for the U.S. BSE surveillance program to analyze the effectiveness of the U.S diagnostic tools for detection of atypical cases of BSE. Molecular comparisons of the U.S. BSE isolate with atypical BSE isolates will provide further characterization of the U.S. BSE isolate. Transmission studies are already underway using brain homogenates from atypical BSE cases into mice, cattle and sheep. It will be critical to see whether the atypical BSE isolates behave similarly to typical BSE isolates in terms of transmissibility and disease pathogenesis. If transmission occurs, tissue distribution comparisons will be made between cattle infected with the atypical BSE isolate and the U.S. BSE isolate.

Differences in tissue distribution could require new regulations regarding specific risk material (SRM) removal.

http://www.ushrl.saa.ars.usda.gov/research/projects/projects.htm?accn_no=408490



Saturday, June 12, 2010

PUBLICATION REQUEST AND FOIA REQUEST Project Number: 3625-32000-086-05 Study of Atypical Bse

http://bse-atypical.blogspot.com/2010/06/publication-request-and-foia-request.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, May 2, 2012





ARS FLIP FLOPS ON SRM REMOVAL FOR ATYPICAL L-TYPE BASE BSE RISK HUMAN AND ANIMAL HEALTH










MAD COW USDA ATYPICAL L-TYPE BASE BSE, the rest of the story...



***Oral Transmission of L-type Bovine Spongiform Encephalopathy in Primate Model






***Infectivity in skeletal muscle of BASE-infected cattle






***feedstuffs- It also suggests a similar cause or source for atypical BSE in these countries.






***Also, a link is suspected between atypical BSE and some apparently sporadic cases of Creutzfeldt-Jakob disease in humans.







Friday, May 11, 2012


Experimental H-type bovine spongiform encephalopathy characterized by plaques and glial- and stellate-type prion protein deposits



***support risk assessments in some peripheral tissues derived from cattle affected with H-type BSE







Sunday, May 6, 2012


Bovine Spongiform Encephalopathy Mad Cow Disease, BSE May 2, 2012 IOWA State University OIE






Wednesday, May 16, 2012


OIE UPDATE BOVINE SPONGIFORM ENCEPHALOPATHY UNITED STATES OF AMERICA MAY 15, 2012








Friday, May 4, 2012



May 2, 2012: Update from APHIS Regarding a Detection of Bovine Spongiform Encephalopathy (BSE) in the United States














Sunday, March 11, 2012



APHIS Proposes New Bovine Spongiform Encephalopathy Import Regulations in Line with International Animal Health Standards Proposal Aims to Ensure Health of the U.S. Beef Herd, Assist in Negotiations







Wednesday, April 4, 2012



Bovine Spongiform Encephalopathy; Importation of Bovines and Bovine Products APHIS-2008-0010-0008 RIN:0579-AC68












2nd failed mad cow triple mad cow interlocking safeguard ;




“The second safeguard is a strong feed ban that protects cattle from the disease.”



California 2004




USA BSE/TSE TRIPLE FIREWALLS SEEPING IN 2004...TSS




Public Health Service Food and Drug Administration


San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94502-7070 Telephone: 510/337-6700


VIA HAND DELIVERY


Our Reference No. 1000123954


June 23, 2004


Ronald M. Foster, Manager Randall C. Boyce, Manager Trevor O. Foster, Manager George P. Foster, Manager Fresno Farming LLC P.O. Box 457 1000 Davis Street Livingston, California


WARNING LETTER


Dear Mssrs. Foster, Boyce, Foster, and Foster:


The U.S. Food and Drug Administration (FDA) conducted an inspection of your medicated animal feed mill operation, Fresco Farming LLC, located in Traver, California from April 14, 2004 through May 6, 2004, and found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Section 589.2000 (21 C.F.R. 589.2000) - Animal Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Because you failed to follow this rule, products you manufactured and distributed are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) because they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.


Our inspection found the following violations of 21 C.F.R. 589.2000:


1. Failure to provide for measures to avoid commingling or cross-contamination of products that contain or may contain protein derived from mammalian tissues into animal protein or feeds that may be used for ruminants to comply with 21 C.F.R. 589.2000(e)(1)(iii).


* Your firm uses a vacuum system to clean up spilled product in the tunnel area. This tunnel area houses the two receiving conveyor systems and the elevators for the two conveyor systems. When product, including ruminant meat and bone meal, is spilled onto the floor of this area, the spilled product is vacuumed up by the vacuum system and, via a discharge hose, was placed into a conveyor system that your firm had designated as free of ruminant meat and bone meal. Your firm admitted that it was unaware of the vacuum system discharging into the conveyor systems designated as free of ruminant meat and bone meal and that this had been in place since April 2003. Your firm remedied this problem during FDA s April/May 2004 inspection by removing the discharge hose connection to the conveyer system that your firm had designated as free of ruminant meat and bone meal . * Your firm uses a dust collection system that pulls dust from systems that receive both ruminant meat and bone meal and feed ingredients intended for ruminants. This dust system then discharged collected product back into the two conveyor systems via a cross connection, thereby making it likely that ruminant meat and bone meal became commingled with ruminant feed ingredients. Your firm admitted that it was unaware of the cross connection and that it had been in place since April 2003. Your firm removed the cross connection during FDA s April/May 2004 inspection.


2. Failure to maintain written procedures specifying the clean-out procedure or other means, and specifying the procedures for separating products that contain or may contain protein derived from mammalian tissue from all other protein products from the time of receipt until the time of shipment, to comply with 21 C.F.R. 589.2000(e)(1)(iv). This observation was also noted during FDA s July/August 2003 inspection of your firm.


* There are no written procedures for separating products that contain prohibited material from ingredients used in ruminant feeds from the time of receipt until the time of shipment. * The written procedure for cleaning out or flushing equipment after mixing feeds containing prohibited material was not adequate to prevent contamination of ruminant feed with prohibited material.


3. Failure to maintain records sufficient to track materials that contain protein derived from mammalian tissues throughout their receipt, processing, and distribution to comply with 21 C.F.R. 589.2000(e)(1)(i). This observation was also noted during FDA s July/August 2003 inspection of your firm.


* Specifically, your firm has failed to develop and implement complete written procedures to separate ruminant meat and bone meal from feed ingredients intended for ruminants from the time of receipt until the time of distribution. The written procedures that do exist fail to address the use of equipment common to ruminant meat and bone meal and ruminant feed ingredients.


The above is not intended to be an all-inclusive list of deficiencies at your facility. As a manufacturer of materials intended for use as animal feed, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law. You should take prompt action to correct these violations, and you should establish a system whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.


You should notify this office in writing within fifteen (15) working days of receiving this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step being taken to correct the violations and prevent their recurrence. If corrective actions cannot be completed in fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.


Please send your reply to the U.S. Food and Drug Administration, Attention: Ms. Harumi Kishida, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, California 94502-7070. If you have questions regarding this letter, please contact Ms. Kishida at (510) 337-6824.


Sincerely,


/s/


CD Moss, Acting DD for Barbara J. Cassens District Director San Francisco District


cc: VIA CERTIFIED MAIL RETURN RECEIPT REQUESTED C. Michael Blasco, Feed Mill Manager Fresno Farming LLC P.O. Box 430 Traver, California 93673









oh God, this is going to be long. there are too many mad cow feed ban warning letters and recalls of mad cow feed in commerce to list all of them here now, but here are a few 1000s+ tonnages of banned mad cow protein in commerce since the partial and voluntary mad cow feed ban was put into place August 4, 1997. this is not all by any means, just a few old warning letters in my files. remember, .005 gram is lethal. let’s start from 2007, the last year that the FDA et al publically published the mad cow feed ban warning letters, and then we will go back year by year, to August 4, 1997, when the partial and voluntary mad cow feed ban was put into effect...or rather inked on paper, because that’s about all that happened...TSS







2007





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











2006




Subject: MAD COW FEED RECALL USA SEPT 6, 2006 1961.72 TONS IN COMMERCE AL, TN, AND WV


Date: September 6, 2006 at 7:58 am PST

PRODUCT


a) EVSRC Custom dairy feed, Recall # V-130-6;

b) Performance Chick Starter, Recall # V-131-6;


c) Performance Quail Grower, Recall # V-132-6;


d) Performance Pheasant Finisher, Recall # V-133-6.


CODE


None


RECALLING FIRM/MANUFACTURER


Donaldson & Hasenbein/dba J&R Feed Service, Inc., Cullman, AL, by telephone
on June 23, 2006 and by letter dated July 19, 2006. Firm initiated recall is
complete.


REASON


Dairy and poultry feeds were possibly contaminated with ruminant based
protein.


VOLUME OF PRODUCT IN COMMERCE


477.72 tons


DISTRIBUTION


AL


______________________________


PRODUCT


a) Dairy feed, custom, Recall # V-134-6;


b) Custom Dairy Feed with Monensin, Recall # V-135-6.


CODE


None. Bulk product


RECALLING FIRM/MANUFACTURER


Recalling Firm: Burkmann Feed, Greeneville, TN, by Telephone beginning on
June 28, 2006.


Manufacturer: H. J. Baker & Bro., Inc., Albertville, AL. Firm initiated
recall is complete.


REASON


Possible contamination of dairy feeds with ruminant derived meat and bone
meal.


VOLUME OF PRODUCT IN COMMERCE


1,484 tons


DISTRIBUTION


TN and WV


http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html



Subject: MAD COW FEED RECALLS ENFORCEMENT REPORT FOR AUGUST 9, 2006 KY, LA, MS, AL, GA, AND TN 11,000+ TONS


Date: August 16, 2006 at 9:19 am PST



RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II


______________________________


PRODUCT


Bulk custom made dairy feed, Recall # V-115-6


CODE


None


RECALLING FIRM/MANUFACTURER


Hiseville Feed & Seed Co., Hiseville, KY, by telephone and letter on or about July 14, 2006. FDA initiated recall is ongoing.


REASON


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


VOLUME OF PRODUCT IN COMMERCE

Approximately 2,223 tons


DISTRIBUTION


KY

______________________________




PRODUCT


Bulk custom made dairy feed, Recall # V-116-6


CODE


None


RECALLING FIRM/MANUFACTURER


Rips Farm Center, Tollesboro, KY, by telephone and letter on July 14, 2006.


FDA initiated recall is ongoing.


REASON


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


VOLUME OF PRODUCT IN COMMERCE


1,220 tons


DISTRIBUTION


KY

______________________________




PRODUCT


Bulk custom made dairy feed, Recall # V-117-6


CODE


None


RECALLING FIRM/MANUFACTURER


Kentwood Co-op, Kentwood, LA, by telephone on June 27, 2006. FDA initiated recall is completed.


REASON


Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal.


VOLUME OF PRODUCT IN COMMERCE


40 tons


DISTRIBUTION


LA and MS

______________________________




PRODUCT


Bulk Dairy Feed, Recall V-118-6


CODE


None


RECALLING FIRM/MANUFACTURER


Cal Maine Foods, Inc., Edwards, MS, by telephone on June 26, 2006. FDA
initiated recall is complete.


REASON


Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal.


VOLUME OF PRODUCT IN COMMERCE


7,150 tons


DISTRIBUTION


MS

______________________________




PRODUCT


Bulk custom dairy pre-mixes, Recall # V-119-6


CODE


None


RECALLING FIRM/MANUFACTURER


Walthall County Co-op, Tylertown, MS, by telephone on June 26, 2006. Firm
initiated recall is complete.


REASON


Possible contamination of dairy animal feeds with ruminant derived meat and
bone meal.


VOLUME OF PRODUCT IN COMMERCE


87 tons


DISTRIBUTION


MS

______________________________




PRODUCT




Bulk custom dairy pre-mixes, Recall # V-120-6


CODE


None


RECALLING FIRM/MANUFACTURER


Ware Milling Inc., Houston, MS, by telephone on June 23, 2006. Firm
initiated recall is complete.


REASON


Possible contamination of dairy animal feeds with ruminant derived meat and
bone meal.


VOLUME OF PRODUCT IN COMMERCE


350 tons


DISTRIBUTION


AL and MS

______________________________




PRODUCT


a) Tucker Milling, LLC Tm 32% Sinking Fish Grower, #2680-Pellet,
50 lb. bags, Recall # V-121-6;


b) Tucker Milling, LLC #31120, Game Bird Breeder Pellet,
50 lb. bags, Recall # V-122-6;


c) Tucker Milling, LLC #31232 Game Bird Grower,
50 lb. bags, Recall # V-123-6;


d) Tucker Milling, LLC 31227-Crumble, Game Bird Starter, BMD
Medicated, 50 lb bags, Recall # V-124-6;


e) Tucker Milling, LLC #31120, Game Bird Breeder, 50 lb bags,
Recall # V-125-6;


f) Tucker Milling, LLC #30230, 30 % Turkey Starter, 50 lb bags,
Recall # V-126-6;


g) Tucker Milling, LLC #30116, TM Broiler Finisher,
50 lb bags, Recall # V-127-6


CODE


All products manufactured from 02/01/2005 until 06/20/2006


RECALLING FIRM/MANUFACTURER


Recalling Firm: Tucker Milling LLC, Guntersville, AL, by telephone and visit
on June 20, 2006, and by letter on June 23, 2006.


Manufacturer: H. J. Baker and Brothers Inc., Stamford, CT. Firm initiated
recall is ongoing.


REASON


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


VOLUME OF PRODUCT IN COMMERCE


7,541-50 lb bags


DISTRIBUTION


AL, GA, MS, and TN



END OF ENFORCEMENT REPORT FOR AUGUST 9, 2006

###


http://www.fda.gov/bbs/topics/ENFORCE/2006/ENF00964.html



Subject: MAD COW FEED RECALL MI MAMMALIAN PROTEIN VOLUME OF PRODUCT IN COMMERCE 27,694,240 lbs


Date: August 6, 2006 at 6:14 pm PST


PRODUCT


Bulk custom dairy feds manufactured from concentrates, Recall # V-113-6


CODE


All dairy feeds produced between 2/1/05 and 6/16/06 and containing H. J.
Baker recalled feed products.


RECALLING FIRM/MANUFACTURER


Vita Plus Corp., Gagetown, MI, by visit beginning on June 21, 2006. Firm
initiated recall is complete.


REASON


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


VOLUME OF PRODUCT IN COMMERCE


27,694,240 lbs


DISTRIBUTION


MI


END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006

###

http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html



Subject: MAD COW FEED RECALL AL AND FL VOLUME OF PRODUCT IN COMMERCE 125 TONS Products manufactured from 02/01/2005 until 06/06/2006


Date: August 6, 2006 at 6:16 pm PST


PRODUCT


a) CO-OP 32% Sinking Catfish, Recall # V-100-6;


b) Performance Sheep Pell W/Decox/A/N, medicated,
net wt. 50 lbs, Recall # V-101-6;


c) Pro 40% Swine Conc Meal -- 50 lb, Recall # V-102-6;


d) CO-OP 32% Sinking Catfish Food Medicated,
Recall # V-103-6;


e) "Big Jim's" BBB Deer Ration, Big Buck Blend,
Recall # V-104-6;


f) CO-OP 40% Hog Supplement Medicated Pelleted,
Tylosin 100 grams/ton, 50 lb. bag, Recall # V-105-6;


g) Pig Starter Pell II, 18% W/MCDX Medicated 282020,
Carbadox -- 0.0055%, Recall # V-106-6;


h) CO-OP STARTER-GROWER CRUMBLES, Complete
Feed for Chickens from Hatch to 20 Weeks, Medicated,
Bacitracin Methylene Disalicylate, 25 and 50 Lbs,
Recall # V-107-6;


i) CO-OP LAYING PELLETS, Complete Feed for Laying
Chickens, Recall # 108-6;


j) CO-OP LAYING CRUMBLES, Recall # V-109-6;


k) CO-OP QUAIL FLIGHT CONDITIONER MEDICATED,
net wt 50 Lbs, Recall # V-110-6;


l) CO-OP QUAIL STARTER MEDICATED, Net Wt. 50 Lbs,
Recall # V-111-6;


m) CO-OP QUAIL GROWER MEDICATED, 50 Lbs,
Recall # V-112-6


CODE


Product manufactured from 02/01/2005 until 06/06/2006


RECALLING FIRM/MANUFACTURER


Alabama Farmers Cooperative, Inc., Decatur, AL, by telephone, fax, email and
visit on June 9, 2006. FDA initiated recall is complete.


REASON


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


VOLUME OF PRODUCT IN COMMERCE


125 tons


DISTRIBUTION


AL and FL


END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006
###

http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html


Subject: MAD COW FEED RECALL KY VOLUME OF PRODUCT IN COMMERCE ?????


Date: August 6, 2006 at 6:19 pm PST


PRODUCT


Bulk custom made dairy feed, Recall # V-114-6


CODE


None


RECALLING FIRM/MANUFACTURER


Burkmann Feeds LLC, Glasgow, KY, by letter on July 14, 2006. Firm initiated
recall is ongoing.


REASON


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


VOLUME OF PRODUCT IN COMMERCE


?????


DISTRIBUTION


KY


END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006

###

http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html




MAD COW FEED RECALL USA EQUALS 10,878.06 TONS NATIONWIDE


Sun Jul 16, 2006 09:22


71.248.128.67


RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II


______________________________


PRODUCT


a) PRO-LAK, bulk weight, Protein Concentrate for Lactating Dairy Animals,
Recall # V-079-6;


b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg),
Recall # V-080-6;


c) PRO-PAK, MARINE & ANIMAL PROTEIN CONCENTRATE FOR USE IN ANIMAL
FEED, Recall # V-081-6;


d) Feather Meal, Recall # V-082-6


CODE


a) Bulk


b) None


c) Bulk


d) Bulk


RECALLING FIRM/MANUFACTURER


H. J. Baker & Bro., Inc., Albertville, AL, by telephone on June 15, 2006 and
by press release on June 16, 2006. Firm initiated recall is ongoing.


REASON


Possible contamination of animal feeds with ruminent derived meat and bone
meal.


VOLUME OF PRODUCT IN COMMERCE


10,878.06 tons


DISTRIBUTION


Nationwide



END OF ENFORCEMENT REPORT FOR July 12, 2006

###

http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html



Subject: MAD COW FEED BAN WARNING LETTER ISSUED MAY 17, 2006


Date: June 27, 2006 at 7:42 am PST


Public Health Service


Food and Drug Administration

New Orleans District
297 Plus Park Blvd.
Nashville, TN 37217
Telephone: 615-781-5380
Fax: 615-781-5391

May 17, 2006
WARNING LETTER NO. 2006-NOL-06
FEDERAL EXPRESS
OVERNIGHT DELIVERY
Mr. William Shirley, Jr., Owner
Louisiana.DBA Riegel By-Products
2621 State Street
Dallas, Texas 75204
Dear Mr. Shirley:
On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration
(FDA) investigator inspected your rendering plant, located at 509 Fortson
Street, Shreveport, Louisiana. The inspection revealed significant
deviations from the requirements set forth in Title 21, Code of Federal
Regulations, Part 589.2000 [21 CFR 589.2000], Animal Proteins Prohibited in
Ruminant Feed. This regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE). You failed to
follow the requirements of this regulation; products being manufactured and
distributed by your facility are misbranded within the meaning of Section
403(a)(1) [21 USC 343(a)(1)] of the Federal Food, Drug, and Cosmetic Act
(the Act).
Our investigation found you failed to provide measures, including sufficient
written procedures, to prevent commingling or cross-contamination and to
maintain sufficient written procedures [21 CFR 589.2000(e)] because:
You failed to use clean-out procedures or other means adequate to prevent
carryover of protein derived from mammalian tissues into animal protein or
feeds which may be used for ruminants. For example, your facility uses the
same equipment to process mammalian and poultry tissues. However, you use
only hot water to clean the cookers between processing tissues from each
species. You do not clean the auger, hammer mill, grinder, and spouts after
processing mammalian tissues.
You failed to maintain written procedures specifying the clean-out
procedures or other means to prevent carryover of protein derived from
mammalian tissues into feeds which may be used for ruminants.
As a result . the poultry meal you manufacture may contain protein derived
from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR
589.2000(e)(1)(i), any products containing or may contain protein derived
from mammalian tissues must be labeled, "Do not feed to cattle or other
ruminants." Since you failed to label a product which may contain protein
derived from mammalian tissues with the required cautionary statement. the
poultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the
Act.
This letter is not intended as an all-inclusive list of violations at your
facility. As a manufacturer of materials intended for animal feed use, you
are responsible for ensuring your overall operation and the products you
manufacture and distribute are in compliance with the law. You should take
prompt action to correct these violations, and you should establish a system
whereby violations do not recur. Failure to promptly correct these
violations may result in regulatory action, such as seizure and/or
injunction, without further notice.
You should notify this office in writing within 15 working days of receiving
this letter, outlining the specific steps you have taken to bring your firm
into compliance with the law. Your response should include an explanation of
each step taken to correct the violations and prevent their recurrence. If
corrective action cannot be completed within 15 working days, state the
reason for the delay and the date by which the corrections will be
completed. Include copies of any available documentation demonstrating
corrections have been made.
Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S.
Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie,
Louisiana 70001. If you have questions regarding any issue in this letter,
please contact Mr. Rivero at (504) 219-8818, extension 103.
Sincerely,
/S
Carol S. Sanchez
Acting District Director
New Orleans District

http://www.fda.gov/foi/warning_letters/g5883d.htm





2005





Subject: MAD COW FEED BAN WARNING LETTER December 21, 2005


Date: January 10, 2006 at 7:18 am PST Public Health Service Food and Drug Administration


Kansas City District Southwest Region 11630 West 80th Street Lenexa, Kansas 66214-3340


December 21, 2005


CERTIFIED MAIL RETURN RECEIPT REQUESTED


WARNING LETTER


Ref. KAN 2006-08


Mr. Paul Rasmussen, President Gold Eagle Cooperative Board of Directors 1145 Birch Ave Corwith, IA 50430


Dear Mr. Rasmussen:


An investigator from our office conducted two inspections of your animal feed manufacturing operations at 415 N. Locust St., Goldfield, Iowa on August 23 and August 25 -26, 2005. During these inspections, a significant deviation from the requirements set forth in Title 21, Code of Federal Regulations (CFR), Part 589 .2000 [21 CFR 589 .2000] - Animal Proteins Prohibited in Ruminant Feed, was identified . The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Our investigation found a failure to label one of your products, "ISLACT - IS LACTATION," a swine feed, with the statement "Do Not Feed to Cattle or Other Ruminants," as required by 21 CFR 589 .2000(d) . Although your swine feed is not formulated with protein derived from mammalian tissues as defined in 21 CFR 589 .2000(a)(1), which is prohibited in ruminant feed, your production practices may cause the finished product to contain such material. Our investigator found that your firm does not have a strategy for sequencing feeds and does not flush or otherwise clean shared production equipment between the manufacture of poultry feed formulated with protein derived from mammalian tissues and swine feed formulated without such material . As a result, swine feed may acquire protein derived from mammalian tissue from poultry feed residue remaining on the shared production equipment. Your failure to label your "ISLACT - IS LACTATION" swine feed with the statement "Do Not Feed to Cattle or Other Ruminants" causes it to be misbranded under section 403(a)(1) of the Act.


The above is not intended to be an all-inclusive list of deficiencies at your facility. As a manufacturer of animal feed, you are responsible for ensuring that your overall operation and the products you manufacture and distribute comply with the law.


You should take prompt action to correct this violation and establish a system whereby such violations do not recur. Failure to promptly correct this violation may result in regulatory action, such as seizure and/or injunction, without further notice.


You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include an explanation of each step being taken to correct the violation and prevent its recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.


Please send your reply to the Food and Drug Administration, Attention: Ralph Gray, Compliance Officer, 11630 West 80th Street, Lenexa, KS 66214-3340.


Sincerely, /s/


C.R. Pendleton for John W. Thorsky District Director Kansas City District








2005




-------- Original Message --------

Subject: MAD COW FEED BAN WARNING LETTER Petrolia TEXAS

Date: Tue, 8 Feb 2005 08:30:48 –0600

From: "Terry S. Singeltary Sr."

Reply-To: Bovine Spongiform Encephalopathy

To: BSE-L@LISTSERV.KALIV.UNI-KARLSRUHE.DE


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


Public Health Service Food and Drug Administration


Dallas District 4040 North Central Expressway Dallas, Texas 75204-3145


January 12, 2005


Ref: 2005-DAL-WL-11


WARNING LETTER


CERTIFIED MAIL RETURNED RECEIPT REQUESTED


Mr. William L. Brown, Owner Brown Cattle Company 1 Feed Lot Road P.O. Box 281 Petrolia, TX 76377


Dear Mr. Brown:


An inspection of your ruminant feeding operation located at 1 Feed Lot Road, Petrolia, Texas, was conducted on August 24 and September 8, 2004 by an Investigator from the Food and Drug Administration (FDA). The inspection found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed (21 CFR 589.2000). This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE).


Our inspection revealed that you feed prohibited material, as defined by 21 CFR 598.2000(a), to ruminants. This prohibited material consists of human food processing waste, which is derived from corn dog manufacturing and contains hot dogs and corn dogs. Inspected meat products that have been cooked and offered for human food and further heat processed for animal feed are not prohibited material. This is more fully described in Guidance for Industry 76, which was previously provided to your firm. The human food processing waste you are using has not been further heat processed. The failure to further heat process this material causes the feed to be adulterated within the meaning of Section 402(a)(2)(C)(i) of the Federal, Food, Drug, and Cosmetic Act.


During our previous inspection on January 17, 2002, copies of the BSE Guidance documents 69, 70 and 76 and 21 CFR 589.2000, the BSE regulation, were provided to and discussed with you.


Failure to correct these violations may result in FDA taking regulatory action without further notice including, but not limited to, seizure and/or injunction.


It is necessary for you to take action on this matter now. Please notify this office in writing within fifteen (15) working days from the date you received this letter. Your response should specifically identify the actions you are taking to correct the violations and provide specific timeframes for achieving compliance. Also, as part of your written response, you should provide information regarding the current feeding practices followed at your facility and information pertaining to the planned marketing of your animals. Your reply should be sent to Edwin Ramos, Compliance Officer, at the above stated address. If you have any questions concerning the stated matters, you may contact Mr. Ramos at 214-253-5218.


Sincerely,


/s/


Michael A. Chappell


Dallas District Director





TSS









2004




-------- Original Message --------
Subject: ''HOLY MAD COW'', USA NOW POSTING MAD COW FEED BAN WARNING LETTERS AGAIN WITH SICK SICK COWS
Date: Tue, 20 Apr 2004 08:31:34 -0500
From: "Terry S. Singeltary Sr."
Reply-To:
Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de


######## Bovine Spongiform Encephalopathy #########
Public Health Service
Food and Drug Administration

Cincinnati District Office
Central Region
6751 Stager Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771

VIA FEDERAL EXPRESS
April 8, 2004
Mr. Thomas S. Hurst, Jr., Owner
Bardstown Mill, Inc.
204 W. Muir St
Bardstown, KY 40004

WARNING LETTER CIN-04-20830
On January 7,21-22, 2004, a Food and Drug Administration investigator
conducted an inspection of your
feed mill located at 204 W. Muir St.,
Bardstown, KY 40004. The inspection revealed significant deviations from
the requirements set forth in Title 21, Code of Federal Regulations,
Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. This
regulation is intended to prevent the establishment and amplification of
Bovine Spongiform Encephalopathy (BSE).

Our inspection found your firm failed to label feeds or mark the
invoices of feeds that contain, or may contain, prohibited materials
with the required cautionary statement Do Not Feed To Cattle Or Other
Ruminants . We suggest this statement be distinguished by different type
size or color or other means of highlighting the statement so it is
easily noticed by the purchaser.

The deviations from the BSE regulations, as noted above, cause products
being manufactured and distributed by your facility to be misbranded
within the meaning of Section 403(a)(1) of the Federal Food Drug and
Cosmetic Act (the Act).

This letter is not intended to be an all-inclusive list of deficiencies
at your facility. As a manufacturer of materials intended for animal
feed use, you are responsible for assuring that your overall operation
and the products you manufacture and distribute are in compliance with
the law. We have enclosed a copy of the FDA s Small Entity Compliance
Guide to assist you with complying with the regulation. You should take
prompt action to correct these violations, and you should establish a
system whereby violations do not recur. Failure to promptly correct
these violations may result in regulatory action without further notice.
Such actions include seizure and/or injunction.

You should notify this office in writing within fifteen (15) working
days of the receipt of this letter of the steps you have taken to bring
your firm into compliance with the law. Your response should include an
explanation of each step being taken to correct the CGMP violations and
prevent their recurrence.

If corrective action cannot be completed within 15 working days, state
the reason for the delay and the date by which the corrections will be
completed. Include copies of any available documentation demonstrating
that corrections have been made.

Your response should be directed to Stephen J. Rabe, Compliance Officer
at the address listed above.

Sincerely,
/s/
Carol A. Heppe
District Director
Cincinnati District

Attachment: Small Entity Compliance Guide
http://www.fda.gov/foi/warning_letters/g4608d.pdf
Public Health Service
Food and Drug Administration

Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771

April 8, 2004
WARNING LETTER
via Federal Express

CIN-04-201679
Ralph K. Halter, President
Halter Feed & Grain, Inc.
11501 Baywood Street
Robertsville, OH 44670

Dear Mr. Halter:
An inspection of your unlicensed feed mill, Halter Feed & Grain, Inc.,
located at 405 Tremont Ave. SW, Massilon, OH 44646, conducted by Food
and Drug Administration investigators, on 11/21 - 12/03/2003, found
significant deviations from the requirements set forth in Title 21, Code
of Federal Regulations, Part 589.2000 (21 CFR 589.2000) - Animal
Proteins Prohibited in Ruminant Feed. This regulation is intended to
prevent the establishment and amplification of Bovine Spongiform
Encephalopathy (BSE). Such deviations cause products being manufactured
and distributed by your facility to be adulterated within the meaning of
Section 402(a)(4) and misbranded within the meaning of Section 403(f) of
the Federal Food, Drug, and Cosmetic Act (the Act).

Our investigator found the following violations of 21 CFR 589.2000:
1) failure to label products that contain or may contain prohibited
materials with the caution statement - Do not feed to
cattle or other
ruminants , as required by 21 CFR 589.2000(d)(1);

2) failure to establish and maintain written procedures, including
clean-out and flushing procedures, to avoid commingling and
cross-contamination of common equipment, as required by 21 CFR
589.2000(e)(1)(iv);

3) failure to maintain records sufficient to track prohibited materials
throughout their distribution in that you do not always document the
customer name or address for the sale and distribution of feeds
containing meat and bone meal, as required by 21 CFR 589.2000(d)(1).

The above is not intended as an all-inclusive list of CGMP violations.
As a manufacturer of materials intended for animal feed use, you are
responsible for assuring that your overall operation and the products
you manufacture and distribute are in compliance with the law.

You should notify this office, in writing, within fifteen (15) working
days of the receipt of this letter of the present operational status of
this facility. We understand that this facility may have been put out of
production by a fire that occurred on January 16, 2004. Since there is
the possibility that the facility will again be operational, you should
include an explanation of each step that will be taken to correct the
violations and prevent their recurrence.

Your response should be directed to Charles S. Price Compliance Officer,
U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH
45237-3097. If you have any questions regarding this letter, you may
call Mr. Price at telephone (513) 679-2700 extension 165.

Sincerely,
/s/
Carol A. Heppe
District Director
Cincinnati District

cc: George H. Snyder, Manager
Halter Feed & Grain, Inc.
P.O. Box 821
Massillon, OH 44648

http://www.fda.gov/foi/warning_letters/g4609d.pdf

snip...rest was antibiotic warning letters cause the animals were too sick to slaughter...tss




Public Health Service

Food and Drug Administration


Dallas District

4040 North Central Expressway

Dallas, Texas 75204-3145



June 15, 2004


Ref: 2004-DAL-WL-18


WARNING LETTER


CERTIFIED MAIL

RETURNED RECEIPT REQUESTED


Mr. Patrick O Ray, CEO & President

Specialty Brands, Inc.

P.O. Box 51467

Ontario, CA 91761-1057


Dear Mr. O Ray:


An inspection of your food manufacturing facility located at 601 E. 3rd

Street, Lampasas, Texas, was conducted on February 26 and March 1, 2004

by Investigators from the Food and Drug Administration (FDA). The

inspection found significant deviations from the requirements set forth

in Title 21, Code of Federal Regulations, Section 589.2000 - Animal

Proteins Prohibited in Ruminant Feed (21 CFR 589.2000). This regulation

is intended to prevent the establishment and amplification of Bovine

Spongiform Encephalopathy (BSE).


Our inspection revealed that your firm sells its reduction stream waste

for use as animal feed and that it contracted with [redacted] to dispose

of this manufacturing process stream waste. [redacted] used this process

stream waste as animal feed for ruminants.


At the close of the inspection, a list of inspectional observations (FDA

483) was issued to your firm and discussed with Mr. Anthony E. Rocz,

Plant Manager. The following violation was observed during the inspection:


Products that contain protein derived from mammalian tissues and that

are intended for use in animal feed must be labeled with the cautionary

statement, Do not feed to cattle or other ruminants, as required by 21

CFR 589.2000(d)(1). For example, your firm manufactures Mexican

specialty food products such as tortillas, taquitos, and burritos that

contain beef. The production process stream waste includes ground corn,

product shells, and filling material, it is then placed in a

transportable bin for disposal by feeding to livestock. This

transportable waste bin did not bear the cautionary statement Do Not

Feed to Cattle or Other Ruminants.


Because your manufacturing stream waste did not bear this cautionary

statement, these products are misbranded within the meaning of section

403(a)(1) of the Federal Food, Drug, and Cosmetic Act.


You should know that this serious violation of the law may result in FDA

taking regulatory action without further notice to you. These actions

include, but are not limited to, seizure and/or injunction.


We are in receipt of a letter from Mr. Anthony E. ROCZ, Plant Manager,

dated March 2, 2004, in which he stated that your factory was under a

contract with [redacted] to remove and dispose of the production stream

waste generated at the factory since April 15, 2003. Our investigators

conveyed to Specialty Brands, Inc., on February 24, 2004, that the

disposal container was not properly labeled to indicate that the

material is not to be fed to cattle or other ruminants in accordance

with the BSE regulation. On February 26, 2004, our investigators

returned to your plant and conveyed to Mr. Rocz that earlier that

morning they observed cattle consuming the manufacturing stream waste

supplied by your firm to [redacted] The practice of supplying process

stream waste to [redacted] was indefinitely suspended on February 26,

2004. At that time, an alternative waste removal service was obtained to

dispose of the process stream waste in a sanitary landfill facility and

each load would be logged, a manifest detailing the pounds of process

waste disposed would be generated, and a certification of proper

disposal is to be provided for the record. This alternative stream waste

disposal process appears to be acceptable. Your letter also states that

your corporate Food Safety and Quality Assurance department is in the

process of drafting a corporate wide policy to ensure that all of your

factories are in compliance with the BSE regulation.


It is necessary for you to take prompt action on this matter now. Please

notify this office in writing within fifteen (15) working days from the

date you receive this letter of the specific actions you have taken to

prevent the recurrence of the violations, and when those actions were

taken or will be taken at your other corporate facilities having similar

disposal plans. Your reply should be sent to Edwin Ramos, Compliance

Officer, at the above stated address. If you have any questions

concerning this letter, you may contact Mr. Ramos at 214-253-5218.


Sincerely,


/s/


Michael A. Chappell

Dallas District Director


cc:

Specialty Brands, Inc.

Mr. Anthony E. Rocz, Plant Manager

601 E Third Street

Lampasas, TX 76550-2903




Public Health Service

Food and Drug Administration


Dallas District

4040 North Central Expressway

Dallas, Texas 75204-3145



June 10, 2004


Ref: 2004-DAL-WL-17


WARNING LETTER


CERTIFIED MAIL

RETURNED RECEIPT REQUESTED


Mr. Jack Chapman, Owner

Chapman Ranch

11071 CR 1255

Lampasas, TX 76550


Dear Mr. Chapman:


An inspection of your ruminant feeding operation located at 11071 CR

1255, Lampasas, Texas, was conducted on February 26 and March 1, 2004 by

Investigators from the Food and Drug Administration (FDA). The

inspection found significant deviations from the requirements set forth

in Title 21, Code of Federal Regulations, Section 589.2000 - Animal

Proteins Prohibited in Ruminant Feed (21 CFR 589.2000). This regulation

is intended to prevent the establishment and amplification of Bovine

Spongiform Encephalopathy (BSE).


Our inspection revealed that you feed prohibited material, as defined by

21 CFR 589.2000(a), to ruminants. This prohibited material consists of

manufacturing process stream waste from [redacted] a manufacturer of

products such as fully cooked tacos, burritos, and taquitos that contain

beef. This manufacturing process stream waste contains meat products

that have been cooked and offered for human food but that have not been

further heat processed for feed. This failure to further heat process

the material causes the feed to be adulterated under section

402(a)(2)(C)(i) because it contains an unapproved food additive (i.e.,

the meat products that have not been further heat processed for feed).


At the close of the inspection, copies of the BSE Guidance documents 69,

70 and 76 were provided to you and further discussed. Also, you

previously received a copy of 21 CFR 589.2000, the BSE regulation, which

was again explained in more specific detail. You should know that this

serious violation of the law may result in FDA taking regulatory action

without further notice to you. These actions include, but are not

limited to, seizure and/or injunction.


It is necessary for you to take action on this matter now. Please send a

written response to this office within fifteen (15) working days from

the date you receive this letter. Your response should specifically

identify the actions you are taking to correct the violations and

provide specific timeframes for achieving compliance. Also, as part of

your written response, you should provide information regarding the

current feeding practices followed at your facility and information

pertaining to the planned marketing of your animals. Your reply should

be sent to Edwin Ramos, Compliance Officer, at the above stated address.

If you have any questions concerning this letter, you may contact Mr.

Ramos at 214-253-5218.


Sincerely,


/s/


Michael A. Chappell

Dallas District Director


horizonal rule





Public Health Service

Food and Drug Administration


Atlanta District Office

60 8th Street, N.E.

Atlanta, Georgia 30309



June 10, 2004


VIA FEDERAL EXPRESS


WARNING LETTER

(04-ATL-13)


M. Dennis Burroughs

President

B & G Seed Company

591 Beck Road

Hull, Georgia 30646


Dear Mr. Burroughs:


An inspection of your feed mill was conducted by a Food and Drug

Administration (FDA) investigator on March 30, 2004. Our investigator

determined that you manufacture various products, including ruminant

feeds, which are animal feeds within the meaning of section 201(w) of

the Federal Food, Drug, and Cosmetic Act (the Act}. The inspection

revealed significant deviations from the requirements set forth in Title

21, Code of Federal Regulations (21 CFR), Part 589.2000

--Animal-Proteins Prohibited in Ruminant Feed. This regulation is

intended to prevent the establishment and amplification of Bovine

Spongiform Encephalopathy (BSE). The deviations cause the feed being

manufactured and distributed by your facility to be misbranded within

the meaning of sections 403(a)(1) of the Act.


The inspection revealed that not all of your feeds that contain protein

derived from mammalian tissues and that are intended for use in animal

feed (prohibited material) were labeled with the statement Do not feed

to cattle or other ruminants, as required by 21 CFR 589.2000(d)(1) and

(c)(1)(i). An example is your B & G Pig Grower. In addition, you have

routinely provided scrap or salvage dog food containing prohibited

material to be used as pig feed that was not labeled with the required

statement. In the case of bulk feed ingredients, the statement could

appear on the placard and invoice that accompany the shipment. The lack

of the required statement causes these feeds to be misbranded as defined

in section 403(a)(1) of the Act.


Our investigator also noted that you had failed to provide for adequate

measures to avoid commingling or cross-contamination of products that

contain or may contain prohibited material into feeds that may be used

for ruminants, as required under 21 CFR 589.2000(e)(1)(iii). You also

failed to establish written procedures for separating products which may

contain prohibited material from all other protein products from the

time of receipt until the time of shipment, as required under 21 CFR

589.2000(e)(1)(iv).


The above is not intended as an all-inclusive list of violations at your

firm. As a manufacturer of animal feeds, you are responsible for

ensuring that your overall operation and the products you manufacture

and distribute are in compliance with the law. We have included a copy

of the FDA Guidance for Industry 68 - Small Entities Compliance Guide -

Protein Blenders, Feed Manufacturers, and Distributors.


You should take prompt action to correct the above violations, and you

should establish procedures whereby such violations do not recur.

Failure to promptly correct these violations may result in regulatory

action without further notice, such as seizure and/or injunction.


You should notify this office, in writing, within fifteen (15) working

days of the receipt of this letter of the steps you have taken to bring

your firm into compliance with the law. Your response should include an

explanation of each step being taken to correct the violations and

prevent their recurrence. We do note that you initiated some corrective

actions during the inspection, including a feed recall and printing new

labels. If corrective action cannot be completed within 15 working days,

state the reason for the delay and date by which the corrections will be

completed. Include copies of any available documentation demonstrating

that corrections have been made. Your response should be directed to

Philip S. Campbell, Compliance Officer, at the address noted in the

letterhead.


Sincerely,


/s/


Mary Woleske, Director

Atlanta District





TSS




-------- Original Message --------

Subject: MAD COW FEED BAN WARNING LETTERS JULY 20, 2004 USA

Date: Tue, 20 Jul 2004 09:14:11 –0500

From: "Terry S. Singeltary Sr."

Reply-To: Bovine Spongiform Encephalopathy

To: BSE-L@uni-karlsruhe.de


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


USA BSE/TSE TRIPLE FIREWALLS SEEPING IN 2004...TSS


Public Health Service Food and Drug Administration


San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94502-7070 Telephone: 510/337-6700


VIA HAND DELIVERY


Our Reference No. 1000123954


June 23, 2004


Ronald M. Foster, Manager Randall C. Boyce, Manager Trevor O. Foster, Manager George P. Foster, Manager Fresno Farming LLC P.O. Box 457 1000 Davis Street Livingston, California


WARNING LETTER


Dear Mssrs. Foster, Boyce, Foster, and Foster:


The U.S. Food and Drug Administration (FDA) conducted an inspection of your medicated animal feed mill operation, Fresco Farming LLC, located in Traver, California from April 14, 2004 through May 6, 2004, and found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Section 589.2000 (21 C.F.R. 589.2000) - Animal Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Because you failed to follow this rule, products you manufactured and distributed are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) because they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.


Our inspection found the following violations of 21 C.F.R. 589.2000:


1. Failure to provide for measures to avoid commingling or cross-contamination of products that contain or may contain protein derived from mammalian tissues into animal protein or feeds that may be used for ruminants to comply with 21 C.F.R. 589.2000(e)(1)(iii).


* Your firm uses a vacuum system to clean up spilled product in the tunnel area. This tunnel area houses the two receiving conveyor systems and the elevators for the two conveyor systems. When product, including ruminant meat and bone meal, is spilled onto the floor of this area, the spilled product is vacuumed up by the vacuum system and, via a discharge hose, was placed into a conveyor system that your firm had designated as free of ruminant meat and bone meal. Your firm admitted that it was unaware of the vacuum system discharging into the conveyor systems designated as free of ruminant meat and bone meal and that this had been in place since April 2003. Your firm remedied this problem during FDA s April/May 2004 inspection by removing the discharge hose connection to the conveyer system that your firm had designated as free of ruminant meat and bone meal . * Your firm uses a dust collection system that pulls dust from systems that receive both ruminant meat and bone meal and feed ingredients intended for ruminants. This dust system then discharged collected product back into the two conveyor systems via a cross connection, thereby making it likely that ruminant meat and bone meal became commingled with ruminant feed ingredients. Your firm admitted that it was unaware of the cross connection and that it had been in place since April 2003. Your firm removed the cross connection during FDA s April/May 2004 inspection.


2. Failure to maintain written procedures specifying the clean-out procedure or other means, and specifying the procedures for separating products that contain or may contain protein derived from mammalian tissue from all other protein products from the time of receipt until the time of shipment, to comply with 21 C.F.R. 589.2000(e)(1)(iv). This observation was also noted during FDA s July/August 2003 inspection of your firm.


* There are no written procedures for separating products that contain prohibited material from ingredients used in ruminant feeds from the time of receipt until the time of shipment. * The written procedure for cleaning out or flushing equipment after mixing feeds containing prohibited material was not adequate to prevent contamination of ruminant feed with prohibited material.


3. Failure to maintain records sufficient to track materials that contain protein derived from mammalian tissues throughout their receipt, processing, and distribution to comply with 21 C.F.R. 589.2000(e)(1)(i). This observation was also noted during FDA s July/August 2003 inspection of your firm.


* Specifically, your firm has failed to develop and implement complete written procedures to separate ruminant meat and bone meal from feed ingredients intended for ruminants from the time of receipt until the time of distribution. The written procedures that do exist fail to address the use of equipment common to ruminant meat and bone meal and ruminant feed ingredients.


The above is not intended to be an all-inclusive list of deficiencies at your facility. As a manufacturer of materials intended for use as animal feed, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law. You should take prompt action to correct these violations, and you should establish a system whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.


You should notify this office in writing within fifteen (15) working days of receiving this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step being taken to correct the violations and prevent their recurrence. If corrective actions cannot be completed in fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.


Please send your reply to the U.S. Food and Drug Administration, Attention: Ms. Harumi Kishida, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, California 94502-7070. If you have questions regarding this letter, please contact Ms. Kishida at (510) 337-6824.


Sincerely,


/s/


CD Moss, Acting DD for Barbara J. Cassens District Director San Francisco District


cc: VIA CERTIFIED MAIL RETURN RECEIPT REQUESTED C. Michael Blasco, Feed Mill Manager Fresno Farming LLC P.O. Box 430 Traver, California 93673






Public Health Service Food and Drug Administration


Chicago District 550 West Jackson Blvd., 15th Floor Chicago, Illinois 60661 Telephone: 312-353-5863


July 12, 2004


WARNING LETTER CHI-16-04


CERTIFIED MAIL RETURN RECEIPT REQUESTED


Mr. Donald E. Hamilton, President/Owner Illini Feeds, Inc. P.O. Box 86, 1145 State Hwy. 94 Aledo, Illinois 61231


Dear Mr. Hamilton:


On February 19 and 20, 2004, the Food and Drug Administration (FDA) conducted an inspection of your animal feed handling facility located at 1145 State Highway 94, Aledo, Illinois. The inspection found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 (21 CFR 589.2000) - Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). The deviations cause the swine feed manufactured by your facility to be misbranded within the meaning of Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).


Our investigation found that salvaged pet food containing prohibited material was added as an ingredient to the swine products manufactured at your facility. During the inspection, our investigator found that you failed to label your non-ruminant products with the required caution statement - Do not feed to cattle or other ruminants. [21 CFR 589.2000(d)(1)]


The above is not intended to be an all-inclusive list of violations. As a manufacturer of materials intended for use in animal feed, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law.


You should take prompt action to correct this violation, and you should establish a system whereby such violations do not recur. Failure to promptly correct this violation may result in regulatory action without further notice, such as seizure and/or injunction.


During the inspection, you told the investigator that you would put the required cautionary statement on your products that contain prohibited material, and maintain tracking documents for all incoming ingredients, including animal proteins prohibited in ruminant feed. Please notify this office in writing within 15 working days of receiving this letter of any further steps you have taken to assure that your firm is in compliance with the law. Your response should also include an explanation of each step taken to correct the violations, and prevent their recurrence. Please include copies of any available documentation such as written procedures, corrected labeling, etc., demonstrating that corrections have been made. If corrections cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed.


Your reply should be directed to Paul A. Boehmer, Compliance Officer, at the above address.


Sincerely,


/s/


Scott J. MacIntire District Director






Public Health Service Food and Drug Administration


Chicago District 550 West Jackson Blvd., 15th Floor Chicago, Illinois 60661 Telephone: 312-353-5863


June 15, 2004


WARNING LETTER


CERTIFIED MAIL RETURN RECEIPT REQUESTED


Mr. David W. Bernauer CEO and Chairman of the Board Walgreen co. 200 Wilmot Rd. Deerfield, IL 60015


Dear Mr. Bernauer:


Inspection of your firm s warehouse at 5100 Lake Terrace N.E., Mt. Vernon, Illinois, by the Illinois Department of Public Health and the U.S. Food and Drug Administration (FDA) on February 25, 26, and 27, and March 2, 2004, documented numerous insanitary conditions which caused the food and drug products stored there to become adulterated.


Our inspection showed that the food and drug products stored and held at your facility violated the Federal Food, Drug, and Cosmetic Act (the Act), rendering them adulterated. These adulterated fwd and drug products: a) consisted in whole or in part of filthy substances, including rodent fecal pellets, rodent hair, and insects, in violation of Section 402(a)(3) of the Act [21 U.S.C. 342(a)(3)]; and/or b) had been held under insanitary conditions whereby they have become contaminated with rodent filth, in violation of Sections 402(a)(4) and 501(a)(2)(a) of the Act [21 U.S.C. 342(a)(4), 351(a)(2)(a)].


Evidence of rodent activity documented throughout the old and new warehouse included dead mice in traps, excreta pellets, and gnawed paper material observed in, on, and near food and drugs stored in the warehouse. Rodents gnaw holes were observed into several packaged food products with rodent hairs at gnaw holes into products. Many more fecal pellets were on food and drug packages and still more were found near the stored foods, drugs, and cosmetics in the warehouse.


Other conditions observed during the inspection that could be contributing factors to rodent infestation include damaged and/or poorly fitting rail and truck dock doors, gaps around a conduit entry into the building, and the structural condition of the concrete and expansion gaps at floor/wall/support beam junctions in various areas of the warehouse allowing the entry or harborage of pests. Additionally, the investigators observed cobwebs, dead insects, dust, debris, product spillage, and papers in the warehouse, indicating a general lack of good sanitation practices.


Also, products that contain or may contain animal protein prohibited ruminant feed (BSE material) failed to bear the caution statement, Do not feed to cattle or other ruminants. Specifically, pet food products were salvaged, repackaged, and donated to [redacted] and other similar organizations in the area, without the proper labeling and agreement that they would not be used for ruminants. Please refer to Title 21, Code of Federal Regulations, Section 589.2000, concerning these requirements.


Our laboratory confirmed the findings of rodent excreta, rodent hairs on product gnaw holes, and rodent gnawed fibers (packaging material) sampled from the warehouse during the inspection.


The above listed violations are not intended to be all-inclusive. It is your responsibility to assure adherence with each requirement of the Act and its implementing regulations. The investigators reported that you destroyed food products that showed evidence of contamination and began to take some steps to correct the insanitary conditions in your facility. We request that you take prompt action to correct all violations.


Please provide this office, within 15 working days of receipt of this letter, a detailed response stating the actions you plan to take and have taken to correct and prevent the recurrence of these objectionable conditions. Provide the time within which corrections will be completed, reasons why any corrective action cannot be completed, and documentation to show that corrections have been made. Failure to take prompt action to correct all violations may result in regulatory action without further notice. Such action includes seizure and/or injunction.


Your reply should be directed to Paul A. Boehmer, Compliance Officer, at the Chicago District Office.


Sincerely,


/s/


Scott J. MacIntire District Director


cc: Stephen J. Lawrence, Distribution Center Manager Walgreen Co. 5100 Lake Terrace NE Mount Vernon, IL 62864-9665






USA BSE GBR SHOULD BE GBR III, but someone dropped the ball...




TSS








-------- Original Message --------

Subject: MAD COW WARNING LETTER 700 lbs. Steer feed and 1,500 lb. Pig sow fed Products may contain MAMMALIAN TISSUES USA
Date: Mon, 18 Oct 2004 11:32:17 -0500
From: "Terry S. Singeltary Sr."
Reply-To:
Bovine Spongiform Encephalopathy
To: BSE-L@UNI-KARLSRUHE.DE


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

a) Product is 9 Mile Steer Feed, packaged in white poly weaved
bags, each containing 100 lbs. A white label tied to the
inlet of each bag with twine identifies the product. Recall
# V-187-4;

b) Product is 9 Mile Pig and Sow Feed, packaged in white poly
weaved bags, each bag containing 100 lbs. A white label tied
to the inlet of each bag with twine identifies the product.
Recall # V-188-4.

CODE

The products contain no code date.

RECALLING FIRM/MANUFACTURER

Farmers Elevator, Co., Houston, OH, by telephone and letters dated
September 8, 2004. Firm initiated recall is ongoing.

REASON

Products may contain protein derived from mammalian tissues which is
prohibited in ruminant (steer) feed. FDA regulation, if the feed is
intended for non-ruminants (pigs), the bag labels must bear the
statement ìDo not feed to cattle or other ruminantsî.

VOLUME OF PRODUCT IN COMMERCE

700 lbs. Steer feed and 1,500 lb. Pig and sow fed.

DISTRIBUTION

OH.

http://www.fda.gov/bbs/topics/enforce/2004/ENF00869.html
################# BSE-L-subscribe-request@uni-karlsruhe.de #
################





-------- Original Message --------
Subject: MAD DEER FEED BAN WARNING LETTER RECALL 6 TONS DISTRIBUTED USA
Date: Wed, 20 Oct 2004 14:53:56 -0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@UNI-KARLSRUHE.DE


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

PRODUCT


Product is custom made deer feed packaged in 100 lb. poly bags. The
product has no labeling. Recall # V-003-5.


CODE


The product has no lot code. All custom made feed purchased between June
24, 2004 and September 8, 2004.


RECALLING FIRM/MANUFACTURER


Farmers Elevator Co, Houston, OH, by telephone and letter dated
September 27, 2004. Firm initiated recall is ongoing.


REASON


Feed may contain protein derived from mammalian tissues which is
prohibited in ruminant feed.


VOLUME OF PRODUCT IN COMMERCE


Approximately 6 tons.


DISTRIBUTION


OH.



END OF ENFORCEMENT REPORT FOR October 20, 2004

http://www.fda.gov/TSS

################# BSE-L-subscribe-request@uni-karlsruhe.de #################





Public Health Service

Food and Drug Administration


Seattle District

Pacific Region

22201 23rd Drive SE

Bothell, WA 9S9214421

Telephone: 425-486-8788

FAX: 425- 483-4996



November 18, 2004


VIA FEDEX


In reply refer to Warning Letter SEA 05-07


William B. Parrish, Chairman of the Board

Parrish & Heimbecker Limited

360 Main Street

Winnipeg, Manitoba, R3C 323 Canada


WARNING LETTER


Dear Mr. Parrish:


An inspection of your feed mill operation, Conway Feed, Inc., located at

18700 Main Street, Conway, Washington, conducted by a Washington State

Department of Agriculture Investigator, on June 17, 18 and 22, 2004,

under contract with the Food and Drug Administration (FDA), found

significant deviations from the requirements set forth in Title 21, Code

of Fedederal Regulations, Part 589.2000 (21 CFR 589.2000) Animal

Proteins Prohibited in Ruminant Feed. The regulation is intended to

prevent the establishment and amplification of Bovine Spongiform

Encephalopathy (BSE). Such deviations cause products being manufactured

and/or distributed by this facility to be adulterated within the meaning

of Section 402(a)(4) and misbranded within the meaning of Section 403(a)

and 403(f) of the Federal Food, Drug and Cosmetic Act (the Act).


Our investigation found that because you failed to adequately inspect

the label of a raw material, au ingredient with the cautionary statement

Do Not Feed to Cattle or Other Ruminants was used in the manufacture

of your finished product, Game Bird Crum/Pellet. Your final product,

however, did not have the cautionary statement. Because this fish meal

may have contained prohibited animal proteins, any product produced with

it must have the cautionary label. See 21 CFR 589.2000(d)(1).


The investigation also revealed that the label of your Game Bird

Crum/Pellet feed did not list fish meal as an ingredient. According to

the information we collected during the inspection fish meal is

routinely added to this ration. All ingredients are required to be

listed on the label in descending order of predominance by weight. See

21 CFR 501.4(a).


The above is not intended to be an all-inclusive list of deviations from

the regulations. As a manufacturer of materials intended for animal feed

use, you are responsible for assuring that your overall operation and

the products you manufacture and distribute are in compliance with the

law. We have enclosed a copy of the FDA s Small Entity Compliance Guide

to assist you with complying with the regulation.


You should take prompt action to correct these violations, and you

should establish a system whereby such violations do not recur. Failure

to promptly correct these violations may result in regulatory action

without further notice, such as seizure and/or injunction.


You should notify this office in writing within 15 working days of

receipt of this letter, of the steps you have taken to bring your firm

into compliance with the Iaw. Your response should include an

explanation of each step being taken to correct the violations, and

prevent their recurrence. If corrective action cannot be completed in 15

working days, state the reason for the delay and the date by which the

corrections will be completed. Include copies of any available

documentation demonstrating that corrections have been made.


Please send your reply to the Food and Drug Administration, Attention:

Bruce Williamson, Compliance Officer, 22201 23rd Drive SE, Bothell,

Washington 98021. If you have questions regarding any issue in this

letter, please contact Mr. Bruce Williamson at (425) 483-4976.


If you have questions regarding any issue in this letter, please contact

Mr. Bruce Williamson at (425) 483-4976.


Sincerely,


/S/


Charles M. Breen

District Director


cc: Scott C. McKnight, General Manager

Conway Feed Inc.

18700 Main Street

Conway, WA 98238-0576


Enclosure: Form FDA 483

Small Entity Compliance Guide







-------- Original Message --------

Subject: MAD COW FEED BAN WARNING LETTER Animal Proteins Prohibited in Ruminant Feed/Misbranded DEC. 9, 2004

Date: Tue, 21 Dec 2004 16:04:44 -0600

From: "Terry S. Singeltary Sr."

To: Bovine Spongiform Encephalopathy

CC: cjdvoice@yahoogroups.com



Public Health Service

Food and Drug Administration


New Orleans District

Southeast Region

6600 Plaza Drive, Suite 400

New Orleans, Louisiana 70127

Telephone: 504-253-4519

Facsimile: 504-253-4520



December 9, 2004


WARNING LETTER NO. 2005-NOL-07


FEDERAL EXPRESS

OVERNIGHT DELIVERY


Mr. Alan O. Bostick, President

Sunshine Mills, Inc.

500 6th Street SW

Red Bay, Alabama 35582


Dear Mr. Bostick:


On September 7 and 14, 2004, a United States Food and Drug

Administration (FDA) investigator inspected your animal feed

manufacturing facility, located at 2103 South Gloster Street, Tupelo,

Mississippi. The inspection revealed significant deviations from the

requirements set forth in Title 21, Code of Federal Regulations, Part

589.2000 (21 CFR 589.2000) - Animal Proteins Prohibited in Ruminant

Feed. The regulation is intended to prevent the establishment and

amplification of Bovine Spongiform Encephalopathy (BSE). Because you

failed to follow the requirements of this regulation, products you

manufactured and/or distributed are misbranded within the meaning of

Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).


The inspection indicated you manufacture products containing beef meat

and bone meal. Products that contain or may contain protein derived from

mammalian tissues, as defined by 21 CFR 589.2000(a), and are intended

for use in animal feed, must be labeled with the cautionary statement

Do not feed to cattle or other ruminants. This is required by 21 CFR

589.2000(c)(1)(i). Your firm failed to label your non-ruminant products

with this required cautionary statement. Specifically, the products that

contained protein derived from mammalian tissues but lacked the required

statement included your Happy Fisherman and Premier catfish feeds.

Under 21 CFR 589.2000(g)(2), failure of these feeds to bear the required

cautionary statement causes them to be misbranded under Section

403(a)(1) of the Act.


The above is not intended to be an all-inclusive list of deviations from

regulations. As a manufacturer of materials intended for animal feed

use, you are responsible for assuring your overall operation and

products you manufacture and distribute are in compliance with the law.

A copy of FDA s Small Entity Compliance Guide is enclosed to assist you

in complying with the regulations.


You should take prompt action to correct these violations and establish

a system whereby such violations do not recur. Failure to promptly

correct these violations may result in regulatory action, such as

seizure and/or injunction, without further notice.


We are aware you sent label corrections for the last shipment of each of

the mislabeled products. You also stated you plan [redacted] However,

you should notify this office in writing, within 15 working days of the

receipt of this letter, of the steps you have taken to bring your firm

into compliance with the law. Your response should include an

explanation of each step taken to correct violations and prevent their

recurrence. If corrective action cannot be completed within 15 working

days, state the reason for delay and date by which corrections will be

completed. Include copies of any available documentation demonstrating

corrections have been made.


Please send your reply to the U.S. Food and Drug Administration,

Attention: Nicole F. Hardin, Compliance Officer, at the above address.

If you have questions regarding any issue in this letter, please contact

Ms. Hardin at (504) 253-4519.


Sincerely,


/s


H. Tyler Thornburg

District Director

New Orleans District


Enclosures:

FDA Form 483

FDA s Small Entity Compliance Guide

21 CFR 589.2000


cc:

[redacted]

General Manager

Sunshine Mills, Inc.

2103 South Gloster Street

Tupelo, Mississippi 38801





TSS




2003




-------- Original Message --------

Subject: MAD COW FEED BAN WARNING LETTER Animal Proteins Prohibited in Ruminant Feed/Misbranded

Date: Tue, 23 Sep 2003 15:46:19 –0500

From: "Terry S. Singeltary Sr."

Reply-To: Bovine Spongiform Encephalopathy

To: BSE-L@uni-karlsruhe.de


Public Health Service Food and Drug Administration


DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Chicago

DiStriCt 550 West Jackson Blvd., 15th Floor


August 25,2003


Chicago, Illinois 60661


Telephone: 312-353-5863 WARNING LETTER CH-19-03 CERTIFIED MAIL RETURN RECEIPT REQUESTED


William H. Jenner, President Lincoln Land Livestock Co., Inc. 436 South Railway Ave. Maswutah, Illinois 62258



Dear Mr. Jenner: On April 14 and 15,2003, the Food and Drug Administration (FDA) conducted an inspection at your animal feed handling facility at 436 South Railway Ave., Mascoutah, Illinois, that, among other things. operates as an own label distributor of Hot Line brand feeds made for you by The inspection found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 (21 CFR 589.2000) - Animal Proteins Prohibited in Ruminant Feed.



This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Such deviations cause products being handled by your facility to be misbranded within the meaning of Section 403(a)(l) of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection also found significant deviations from the requirements set forth in 21 CFR 501 - Animal Food Labeling. Our investigator found the following violations during the inspection: Products that contain or may contain prohibited material fail to bear the caution statement - Do not feed to cattle or other ruminants as required by 21 CFR 589.2OOO(c)( l)(i). Specifically, your firm is responsible for preparing the formulations and labeling for Lincoln Land labeled products and some of the products lack the above required cautionary statement. Product ingredients are not listed on the label of the product Hotline Sow 100 by common or usual name in descending order of predominance by weight as required by 21 CFR 501.4. Also, the ingredient list on the label does not reflect all the ingredients.



Page 2 During the inspection FDA s investigator also found that you did not maintain written clean-out procedures to prevent carryover of protein derived fi-om mammalian tissues to animal protein or feeds that may be used for ruminants. You had no written procedures that describe the steps used to clean your truck after hauling bulk meat and bone meal. 21 CFR 589.2000 requires maintenance of written clean-out procedures. The above is not intended to be an all-inclusive list of violations. While you handle the animal feed label and distribution operations, the products man are directed, through contract arrangement with the above mentioned Your firm, as the handler and labeler of materials intended for animal feed use, is responsible for controlling your part of the operation to ensure that the products manufactured are in compliance with the law. You should take prompt action to correct all of these violations, and you should establish a system whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure, and/or injunction. Please provide this office within 15 working days of receipt of this letter the steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step taken to correct the violations, and prevent their recurrence. Please include copies of any available documentation such as written procedures, corrected labeling, etc. demonstrating that corrections have been made. If corrections cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed. Your reply should be directed to Paul A. Boehmer, Compliance Officer, at the above letterhead address. Sincerely, \s\ Arlyn H. Baumgarten District Director













Subject: MAD COW FEED BAN WARNING LETTER (disguised as medicated feed warning letter)

Date: Tue, 1 Apr 2003 08:39:26 -0600

From: "Terry S. Singeltary Sr."

Reply-To: Bovine Spongiform Encephalopathy

To: BSE-L@uni-karlsruhe.de


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


Food and Drug Administration

Cincinnati District Office

Central Region

6751 Steger Drive

Cincinnati, OH 45237-3097

Telephone: (513) 679-2700

FAX: (513) 679-2771


March 4, 2003


WARNING LETTER

CIN-03-16534

FedEx


William E. Leininger,

Director of Operations

Buckeye Egg Farm L.P.

11212 Croton Road

Croton, OH 43013


Dear Mr. Leininger:


An inspection of your medicated feed mill located at 10750 Croton Road,

Croton, OH 43013, conducted by Food and Drug Administration

investigators, on 1/27, 30/2003, found significant deviations from

Current Good Manufacturing Practice (CGMP) regulations for Medicated

Feeds (Title 21 CODE OF FEDERAL REGULATIONS, Part 225). Such deviations

cause feeds being manufactured at this facility to be adulterated within

the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and

Cosmetic Act.


Our investigation found:


1. failure to conduct potency assays on at least three

representative samples of each feed required to be manufactured by a

licensed feed mill at periodic intervals during the calendar year [21

CFR 225.58(b)(1);

2. failure to maintain a daily inventory record for each drug used

[21 CFR 225.42(b)(7)];

3. failure to calibrate scales and metering devices at least once a

year to insure their accuracy [21 CFR 225,30(b)(4)];

4. failure to properly identify drugs in the mixing area to maintain

their integrity and identity [21 CFR 225.42(b)(4);

5. failure to use all Type B medicated feed articles in accordance

with labeled mixing directions [21 CFR 225.142];

6. failure to have a qualified person check, date, and sign or

initial each Master Record File [21 CFR 225.102(b)(l);

7. failure to identify medicated feed with appropriate labeling

which, if adhered to, will assure the article is safe and effective for

its intended purpose [21 CFR 225.80(a)].


In addition to the, deviations described above, our investigators found

that your products, which contain or may contain prohibited materials,

fail to bear the caution statement: "Do not feed to cattle or other

ruminants", as required by 21 CFR 589.2000(d). This causes your

medicated feed to be misbranded within the meaning of section 403(a)(1)

of the Federal Food, Drug, and Cosmetic Act.


Your firm has also failed to maintain a current Drug Establishment

Registration in that your registration expired in April 2001. This

causes your medicated feed to be misbranded within the meaning of

section 502(o) of the Federal Food, Drug, and Cosmetic Act.


The above is not intended as an all-inclusive list of CGMP violations.

As a manufacturer of medicated and non-medicated feeds, you are

responsible for assuring that your overall operation and the products

you manufacture and distribute are in compliance with the law.


You should take prompt action to correct these CGMP violations, and you

should establish procedures whereby such violations do not recur.

Failure to promptly correct these CGMP violations may result in

regulatory and/or administrative sanctions. These sanctions include, but

are not limited to, seizure, injunction, and/or notice of opportunity

for a hearing on a proposal to withdraw approval of your Medicated Feed

Mill License under section 512(m)(4)(B)(ii) of the Act and 21 CFR

515.22(c)(2). This letter constitutes official notice under the law of

CGMP violations. Based on the results of the 01/27, 30/2003 inspection,

the methods used in, or the facilities and controls used for, the

manufacture, processing, and packing of medicated feeds are inadequate

to assure and preserve the identity, strength, quality, and purity of

the new animal drugs therein. This letter notifies you of our findings

and provides you an opportunity to correct the above deficiencies.


You should notify this office, in writing, within fifteen (15) working

days of the receipt of this letter of the steps you have taken to bring

your firm into compliance with the law. Your response should include an

explanation of each step being taken to correct the CGMP violations and

prevent their recurrence. If corrective action cannot be completed

within 30 working days, state the reason for the delay and the date by

which the corrections will be completed. Include copies of any available

documentation demonstrating that corrections have been made.


Your response should be directed to Charles S. Price Compliance Officer,

U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH

45237-3097. If you have any questions regarding this letter, you may

call Mr. Price at telephone (513) 679-2700 extension 165.


Sincerely,


/s/


Carol A. Heppe,


District Director


Cincinnati District





>In addition to the, deviations described above, our investigators

found that your products, which contain or may contain prohibited

materials, fail to bear the caution statement: "Do not feed to cattle or

other ruminants", as required by 21 CFR 589.2000(d). This causes your

medicated feed to be misbranded within the meaning of section 403(a)(1)

of the Federal Food, Drug, and Cosmetic Act.<



Greetings list members,


it would seem to me this should have been a separate warning

letter on the issues of 21 CFR 589.2000(d) and not hidden

and imbedded in a warning letter with the title;


Lacks Ruminant Caution/Medicated Feeds/Adulterated/Misbranded


opposed to past titles;


Animal Proteins Prohibited in Ruminant Feed/Adulterated




nice try;-)


TSS







-------- Original Message --------


Subject: 517,990 LBS. OF RUMINANT PROTEIN IN CATTLE FEED DISTRIBUTED AND MORE ...


Date: Tue, 29 Apr 2003 11:21:52 -0500

From: "Terry S. Singeltary Sr."

Reply-To: Bovine Spongiform Encephalopathy

To: BSE-L@uni-karlsruhe.de



RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II

______________________________


PRODUCT

Unlabeled bulk "Cattle Feed" sold by weight to user/farmers who pick it

up at the firm. Product is a ruminant feed used to feed beef cattle.

Recall # V-046-3.

CODE

Product is bulk and uncoded.

RECALLING FIRM/MANUFACTURER

Zephyr Feed Company, Zephyrhills, FL., by letters on March 19, 2003 and

March 26, 2003. FDA initiated recall is ongoing.

REASON

Cattle feed was distributed to farmers that may contain prohibited

protein for ruminants.

VOLUME OF PRODUCT IN COMMERCE

517,990 lbs.

DISTRIBUTION

FL.





RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE--CLASS II


_____________________________

PRODUCT

Red Rooster Booster, Super Gallo (brand), 60 capsules. Recall # V-011-3.

CODE

All codes.

RECALLING FIRM/MANUFACTURER

Thomas Laboratories, Tolleson, AZ, by letters on or about November 8,

2002. State initiated recall is ongoing.

REASON

Is not labeled "Do not feed to cattle or other ruminants" and contains a

bovine tissue derivative.

VOLUME OF PRODUCT IN COMMERCE

Unknown.

DISTRIBUTION

Nationwide.


_____________________________


PRODUCT

CATTLE FEED, Flock #999, Date: 12/5/02, Quantity 8000, Load A, Feed

C205, Grower# Z001, Tag C100. Recall # V-012-3.

CODE

C-205, C-210, C-220, C-302, C-406 and all other codes manufactured and

distributed by Grove River Mills, Inc.,

RECALLING FIRM/MANUFACTURER

Grove River Mills Inc., Pendergrass, GA, by telephone and letter on

December 9, 2002. Firm initiated recall is ongoing.

REASON

Cattle Feed contaminated with prohibited materials.

VOLUME OF PRODUCT IN COMMERCE

235,668 lbs.

DISTRIBUTION

GA.


END OF ENFORCEMENT REPORT FOR FEBRUARY 5, 2003




another description here;



FEBRUARY 2003


PRODUCT Red Rooster Booster, Super Gallo (brand), 60 capsules.


CODE All codes.

RECALLING FIRM/MANUFACTURER Thomas Laboratories, Tolleson, AZ,


REASON Is not labeled "Do not feed to cattle or other ruminants" and

contains a bovine tissue derivative.

VOLUME OF PRODUCT IN COMMERCE Unknown.

DISTRIBUTION Nationwide.



PRODUCT CATTLE FEED, Flock #999, Date: 12/5/02, Quantity 8000, Load A,

Feed C205, Grower# Z001, Tag C100.


CODE C-205, C-210, C-220, C-302, C-406 and all other codes manufactured

and distributed by Grove River Mills, Inc.,

RECALLING FIRM/MANUFACTURER Grove River Mills Inc., Pendergrass, GA,


REASON Cattle Feed contaminated with prohibited materials.

VOLUME OF PRODUCT IN COMMERCE 235,668 lbs.

DISTRIBUTION GA.




Red Rooster Booster - 60 Capsules $7.95

210-4610-C03



Concentrated nutritional supplement for body building gamebirds.





interesting;

Bone Meal with D3 - 25 lb. Powder $69.95

520-0210-P09






hell, no wonder humans are becoming resistant to antibiotics;


Fish Cillin (Ampicillin) 250mg - 30 Capsules


$11.95 00-10136-C01 Thomas Labs



Fish Cillin (Ampicillin) 250mg - 100 Capsules


$29.95 00-10136-C03 Thomas Labs



Fish Cycline (Tetracycline) 250mg - 30 Capsules


$7.95 00-10132-C01 Thomas Labs



Fish Cycline (Tetracycline) 250mg - 100 Capsules


$15.95 00-10132-C03 Thomas Labs



Fish Flex (Cephalexin) 250mg - 30 Capsules


$15.95 00-12136-C01 Thomas Labs



Fish Flex (Cephalexin) 250mg - 60 Capsules


$29.95 00-12138-C02 Thomas Labs



Fish Flex (Cephalexin) 250mg - 100 Capsules


$39.95 00-12138-C03 Thomas Labs



Fish Fungus (Ketoconazole) 200 mg - 30 Tablets


$39.95 00-0024-T01 Thomas Labs



Fish Mox (Amoxicillin) 250mg - 30 Capsules


$7.95 00-10131-C01 Thomas Labs



Fish Mox (Amoxicillin) 250mg - 100 Capsules


$15.95 00-10131-C03 Thomas Labs



Fish Mycin (Erythromycin) 250mg - 30 Tablets


$15.95 00-10902-T01 Thomas Labs



Fish Mycin (Erythromycin) 250mg - 100 Tablets


$29.95 00-10902-T03 Thomas Labs



Terramycin TM-20 - 8 oz. Powder



wonder if these mycin's are any relative of the VANCOMYCIN ???




TSS







-------- Original Message --------

Subject: Re: MAD COW FEED BAN WARNING LETTER USA (a real hum dinger) !

Date: Tue, 24 Jun 2003 16:59:41 -0500

From: "Terry S. Singeltary Sr."

To: Bovine Spongiform Encephalopathy

References: <3EE5D269.9040504@wt.net>



i hate to keep kicking a mad cow here, but i thought since the FDA et al

still refuses to tell us about _all_ the ruminant-to-ruminant feed ban

violations, i thought i would go over a few of the old ones i might have

missed. BOY, did i miss one. has all this feed been confirmed to have

been recalled? how much is still out there?



RECALLS AND FIELD CORRECTIONS: VETMED -- CLASS II



________

PRODUCT & CODES:

Animal feed products, packaged in 5, 25, 50, and 55 pound bags, and in bulk,

intended for both ruminant and non-ruminant animals. The products are as

follows:

Recall # V-195-1 through V-350-1.


RUMINANT FEED PRODUCTS:


RECALL NO. PRODUCT NO. PRODUCT NAME


V-195-1 40150 B. 30% Calf Pellet

V-196-1 40250 B. 16% Calf Pellet

V-197-1 40350 B. 16% Calf Ration

V-198-1 40450 B. 18% Calf Starter

V-199-1 40600 B. 38% Dairy Pellet

V-200-1 40650 B. 38% Dairy Pellet

V-201-1 40750 B. 16% Dairy Feed

V-202-1 40950 B. 40% Beef Pellet

V-203-1 41150 B. 18% Lamb Starter Pellet

V-204-1 41250 B. 39% Lamb Conc. Pellet

V-205-1 41350 B. 14% Lamb & Beef Pellet

V-206-1 41450 B. 16% Goat Feed

V-207-1 42150 B. 32% Expectation Pellet

V-208-1 42250 B. Llama & Alpaca Pellet

V-209-1 42350 B. 32% Calf Grower Pellet

V-210-1 42650 B. Llama & Alpaca Crums

V-211-1 42750 B. 38% Hay Booster 2

V-212-1 42850 B. 25% Pasture Booster

V-213-1 43100 B. 16% Grower/Dev Pellet

V-214-1 43150 B. 16% Grower/Dev Pellet

V-215-1 43700 WH 32% Calf Gro Pellet

V-216-1 43750 WH 32% Calf Gro Pellet

V-217-1 43850 B. 38% Dairy Mix

V-218-1 44250 B. 17% Doe Pellet

V-219-1 44350 B. 21% Buck Pellet

V-220-1 44450 Legends Ranch Pellet

V-221-1 44500 Legends 17% Breeder Pellet

V-222-1 1652 B. Vitamin E-20

V-223-1 1614 B. Vitamin A-30

V-224-1 44550 Legends 17% Breeder Pellet

V-225-1 44650 Legends 13.5% Rut Pellet

V-226-1 44750 Deer Starter (J)

V-227-1 44940 Llama Premix (J) FSC

V-228-1 45150 Empire 25% Calf Pellet

V-229-1 45450 Berry Llama Pellet

V-230-1 45950 50% Beef Conc. (Meal)

V-231-1 46250 B. 12% Sweet Livestock

V-232-1 46350 B. 1440 Bovatec Pellet

V-233-1 46400 Liberty 38% Dairy Pellet

V-234-1 46450 Liberty 38% Dairy Pellet

V-235-1 47150 B. 14% Gold-n-Grower

V-236-1 47250 B. 12% Gold-n-Conditioner

V-237-1 47450 B. 18% Gold-n-Lamb

V-238-1 47800 Homeworth Dairy Pellet

V-239-1 47850 Homeworth Dairy Pellet

V-240-1 47900 B. 36% Hi Fat Dairy Pellet

V-241-1 47950 B. 36% Hi Fat Dairy Pellet

V-242-1 48550 B. 16% Calf Pellet CA

V-243-1 49200 Mastead Dairy Base

V-244-1 49300 KLEJKA Dairy Base

V-245-1 49650 Deer Premix (J) HFB

V-246-1 49750 39% Lamb Premix (J) HFB

V-247-1 49850 Lamb Starter Premix (J) HFB

V-248-1 120850 Brood Cow Deluxe Mineral

V-249-1 152850 B. A-D-E Mix


NON-RUMINANT FEED PRODUCTS:


V-250-1 10150 B. Miracle Starter

V-251-1 10350 B. 21% Broiler Starter

V-252-1 10450 B. Pullet Grower & Developer

V-253-1 10550 B. 18% Layer Breeder Pellets

V-254-1 10750 B. 20% Gold Std. Laying Crum

V-255-1 10950 B. 17% Complete Laying Crums

V-256-1 11050 B. 16% Prosperity Layer Crums

V-257-1 11100 B. 40% Poultry Concentrate

V-258-1 11150 B. 40% Poultry Concentrate

V-259-1 11250 B. 28% Turkey Starter Crums

V-260-1 11350 20% Gig "4" Pellets

V-261-1 11450 B. 16% Prosperity Layer Pellets

V-262-1 11550 18% Game Bird Breeder Pellets

V-263-1 11650 B. 19% Ratite Grower Diet

V-264-1 11750 B. 23% Ratite Breeder Diet

V-265-1 12100 B. 40% Poultry Concentrate Crums

V-266-1 12550 B. 32% Base Poultry Mix

V-267-1 13250 B. 28% Turkey Starter

V-268-1 13450 B. 20% Poultry Grower

V-269-1 14325 B. Game Bird Mix - Coarse

V-270-1 20150 B. 18% Pig Starter Pellets

V-271-1 20250 B. 16% Pig Grower Pellets

V-272-1 20450 B. 14% Porkmaker 100 Pellets

V-273-1 20550 B. 40% Gro 'Em Lean

V-274-1 21850 B. 27% Hi-Fat Swine Base

V-275-1 23000 Mt. Hope Hevy Hog


V-276-1 30050 12% Pleasure Horse - Sweet

V-277-1 30150 Alfa + Performer 10 Sweet

V-278-1 30250 14% Grass + Perf Sweet

V-279-1 30450 12% Wrangler - Complete

V-280-1 30550 B. 12% Pleasure Horse Pellets

V-281-1 30650 B. 32% Gro' N Win Pellets

V-282-1 30750 12% Wrangler Cubes

V-283-1 30950 18% Foal Starter

V-284-1 31050 B. 14% Alfa + Dev Pellets

V-285-1 31150 B. Alfa + Performer 10 Pel

V-286-1 31200 Grass +Performer 14 Pel

V-287-1 31250 Grass +Performer 14 Pel

V-288-1 31350 12% Mustang

V-289-1 31450 Endurance - 101 Extruded

V-290-1 31550 B. Equine Energy - UK

V-291-1 31650 B. 16% Grass + Dev Pellets

V-292-1 31750 16% Grass + Dev Cubes

V-293-1 31850 16% Grass + Dev Sweet

V-294-1 31950 B. 11% Alfa Gro 'N Win Pel

V-295-1 32050 B. Sho' Win Pellets

V-296-1 32250 B. Senior Formula

V-297-1 32350 Oscar Horse Mix

V-298-1 32450 B. Ultimate Finish

V-299-1 32550 Crossfire Horse Feed

V-300-1 32650 B. Equine 16% Growth

V-301-1 32750 B. Reduced Energy Formula

V-302-1 32850 B. Training Formula

V-303-1 32950 B. Cadence Formula

V-304-1 33150 B. Track 12 Horse Feed

V-305-1 33350 Spears 16% GR + Dev Cubes

V-306-1 33400 B. 14% Supreme Horse Pellets

V-307-1 33450 B. 14% Supreme Horse Pellets

V-308-1 33650 B. Race'N Win

V-309-1 33750 B. 14% Prominent Horse Feed

V-310-1 33850 B. Unbeetable Horse Feed

V-311-1 34750 Cargill Senior Horse

V-312-1 34850 Cargill Vitality Gold

V-313-1 35150 Chagrin 12% Sweet Fd

V-314-1 35250 Smith Pure Pleasure

V-315-1 35750 Roundup 10% Horse Pellets

V-316-1 35850 12% Summerglo Horse

V-317-1 36255 B. Grass +Min&VitBase - Mexico

V-318-1 36850 Miller's 12% Horse Feed

V-319-1 37155 B. Gro'Win Base Mix - Mexico

V-320-1 38000 B. 32% Premium Mixer Pellets

V-321-1 38050 B. 32% Premium Mixer Pellets

V-322-1 38100 36% Maintenance Mixer Pellets

V-323-1 38150 36% Maintenance Mixer Pellets

V-324-1 50150 Terramycin Crumbles

V-325-1 60105 16% Rabbit Pellets

V-326-1 60125 16% Rabbit Pellets

V-327-1 60150 B. 16% Rabbit Pellets

V-328-1 60205 18% Rabbit Developer

V-329-1 60250 B. 18% Rabbit Developer

V-330-1 60450 B. 16% Rabbit Maintenance

V-331-1 90150 B. Buckeye Scratch

V-332-1 90225 Gold Standard Scratch

V-333-1 90250 Gold Standard Scratch

V-334-1 90350 Intermediate Scratch

V-335-1 90450 B. Chick Grains

V-336-1 90525 B. Shelled Corn

V-337-1 90550 B. Shelled Corn

V-338-1 90650 B. Cracked Corn

V-339-1 90825 B. Fine Cracked Corn

V-340-1 90850 B. Fine Cracked Corn

V-341-1 91000 Steam Flaked Corn

V-342-1 91050 Steam Flaked Corn

V-343-1 91750 Oats - HP Crimped

V-344-1 91850 B. HP Sweet Crimped Oats

V-345-1 95550 Land O' Lakes Shelled Corn

V-346-1 95650 Land O' Cracked Corn

V-347-1 95850 Land O' Lakes Chick Crack

V-348-1 100850 B. Alfalfa Pellets

V-349-1 101850 Cooked Full Fat Soybean

V-350-1 122200 Magnatone M-4-B Pels Bulk

MANUFACTURER:

Buckeye Feed Mills, Dalton, Ohio.





RECALLED BY:

Manufacturer visited local customers on April 17, 2001. On April 18 and 19,

2001, manufacturer mailed and faxed recall notices. Firm initiated recall is

ongoing.





DISTRIBUTION:

Al, CT, DE, FL, GA, IL, IN, IA, KY, ME, MD, MA, MO, MN, MS, NH, NJ, NY, NC, OH,

OR, PA, RI, TN, VA, WV, and WI.





QUANTITY:

2,790 tons of ruminant feed products and 14,000 tons of non-ruminant feed

products.





REASON:

The animal feed products may contain protein derived from mammalian tissues.


snip...


END OF ENFORCEMENT REPORT FOR June 6, 2001.







wish someone would give us that update they were speaking of a year

or so ago;


Database Change


IMPORTANT: After March 11, 2002, FDA discontinued the database that was

used to compile these listings. The Agency started a new database on

April 15, 2002, and future updates on BSE enforcement and inspectional

findings will draw from it. The format of the information presented here

may change, due to design changes of the new database. The site was to

be updated after a period of time to allow for transition into the new

database system. Please note that the information presently available

below is outdated. This site will be updated very shortly.






i guess figuring the time period on the reply from the FOIA request

of being about a year or so, and still no results, why should this surprise

me?


USA/CANADA/MEXICO BSE GBR SHOULD BE CHANGED TO BSE GBR III ASAP!





Subject: Re: MAD COW FEED BAN WARNING LETTER USA (FLOATING CATFISH FOOD MAY 2003) !

Date: June 24, 2003 at 8:03 pm PST

In Reply to: Re: MAD COW FEED BAN WARNING LETTER USA (a real hum dinger) ! posted by TSS on June 24, 2003 at 3:07 pm:



RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II


______________________________


PRODUCT

Consolidated Nutrition 32 % Floating Catfish Food, packaged in 50-lb bags. Recall # V-100-3.

CODE

Best By MAR 25 04; and Best By APR 16 04, The codes are ink-jetted on the bags.

RECALLING FIRM/MANUFACTURER

Doane Pet Care Company, Inc., Washington Courthouse, OH, by telephone and letter on April 16, 2003 and April 17, 2003. FDA initiated recall is ongoing.

REASON

The fish feed product lacks the required BSE warning statement, and the nutritional ingredient statement on the label.

VOLUME OF PRODUCT IN COMMERCE

210/50 lb bags.

DISTRIBUTION

OH, PA, and MI.


END OF ENFORCEMENT REPORT FOR MAY 21, 2003








-------- Original Message --------

Subject: MAD COW FEED BAN WARNING LETTER USA (a real hum dinger) !

Date: Tue, 10 Jun 2003 07:43:21 -0500

From: "Terry S. Singeltary Sr."

To: BSE-L@UNI-KARLSRUHE.DE

CC: CJDvoice , bloodcjd@yahoogroups.com



Public Health Service

Food and Drug Administration


New Orleano District

Nashville Branch Office

Plus Park Blvd.

Nashville, TN 37217

Tel: 615-781-6388

FAX: 615-781-6383



May 22, 2003


VIA FEDERAL EXPRESS

OVERNIGHT DELIVERY


Mr. John F. Turner, Owner, Manager

Millstone Agri Distributors

3721 E. Lamar Alexander Highway

Maryville, TN 37804


Warning Letter No 03-NSV-16


Dear Mr. Turner:


An inspection of your animal feed manufacturing operation, located at

Maryville, Tennessee conducted by a U.S. Food and Drug Administration

investigator on February 13, 2003, found significant deviations from the

requirements set forth in Title 21, Code of Federal Regulations (21

CFR.), Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. The

regulation is intended to prevent the establishment and amplification of

Bovine Spongiform Encephalopathy (BSE). Because you failed to follow

this rule, products you manufactured and distributed are adulterated

within the meaning of Sections 402(a)(2)(C) and 402(a)(4) of the Federal

Food,

Drug, and Cosmetic Act (the Act) since they contain an unsafe food

additive and were prepared, packed, or held under insanitary conditions

. . . whereby [they] may have been rendered injurious to health. Feed

you manuf~tured also was misbranded within the meaning of Section

403(a)(1) of the Act because of your failure to follow this rule.


Our investigation found the following violations of 21 C.F.R. 589.2000:


1. Failure to separate the receipt, processing, and storage of products

containing prohibited material from products not containing prohibited

material [21 C.F.R. 589.2000(e)(1)(iv)];


2. Failure to establish written procedures, including clean-out and

flushing procedures, to avoid commingling and cross-contamination of

common equipment [21 C.F.R. 589.2000(e)(1)(iii)(B)];


3. Failure to maintain records sufficient to track prohibited materials

throughout the receipt, processing, and distribution of your products

[21 C.F.R. 589.2000(c)(1)(ii)];


4. Failure to provide for measures to avoid commingling or

cross-contamination of feeds intended for ruminants and feeds intended

for nonruminants that may contain prohibited materials [21 C.F.R.

589.2000(c)(1)(iii)]. Specifically, our investigation found that the

ruminant product 10% Beef Conditioned was formulated primarily with

screenings and fines derived from previously manufactured non-ruminant

products, Premium Rooster Kicker in particular, that contain or may

contain prohibited material. Such deviations

cause the ruminant product 10% Beef Conditioner being manufactured at

this facility to be adulterated within the meaning of Sections

402(a)(2)(C) and 402(a)(4) of the Act;


5. Failure to label your non-ruminant products with the required

cautionary statement Do not Feed to Cattle or Other Ruminants [21

C.F.R. 589.2000(c)(1)(ii)]. Our investigation specifically found that

dog food containing prohibited material was added as an ingredient

to your product Premium Rooster Kicker. The failure of these feeds to

bear the required BSE warning statement causes them to be misbranded

within the meaning of Section 403(f) of the Act.


The above is not intended to be an all-inclusive list of deviations from

the regulations. As a manufacturer of materials intended for animal feed

use, you are responsible for assuring that your overall operation and

the products you manufacture and distribute are in compliance with the

law. We have enclosed a copy of the FDA s Small Entity Compliance Guide

to assist you with complying with the regulations.


You should take prompt action to correct these violations, and you

should establish a system whereby such violations do not recur. Failure

to promptly correct these violations may result in regulatory action

without further notice, such as seizure and/or injunction.

You should notify this office in writing within 15 working days of

receipt of this letter of the steps you have taken to bring your iirm

into compliance with the law. Your response should include an

explanation of each step being taken to correct the violations, and

prevent their recurrence. If corrective action cannot be completed in 15

working days, state the reason for the delay and the date by which the

corrections will be completed. Include copies of any available

documentation demonstrating that corrections have been made.


Your reply should be directed to the attention of Joseph E. Hayes,

Compliance Officer, U.S. Food and Drug Administration, 297 Plus Park

Boulevard, Nashville, TN 37217.


Sincerely,


/s/

Carl E. Draper

Director, New Orleans District Office









Subject: Re: USA ruminant-to-ruminant feed ban warning letters ??? (All the President's yes-men?)

Date: Wed, 29 Jan 2003 15:32:22 -0600

From: "Terry S. Singeltary Sr."

Reply-To: Bovine Spongiform Encephalopathy

To: BSE-L@uni-karlsruhe.de

References: <3E21C7B9.8040309@wt.net>


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


Nature 421, 459 (2003); doi:10.1038/421459a


All the President's yes-men?


George W. Bush's administration stands accused of biasing the process by

which the US government obtains scientific advice. There is a strong

case to answer, but the situation is not as unusual as it might at first

seem.


The relationship between science and politics is never perfect, but

critics charge that the current US administration has so politicized the

provision of scientific advice that it could permanently undermine

public trust.


Just last week, a storm of protest greeted the announcement that Jerry

Thacker, an HIV-positive Christian activist who has referred to AIDS as

a "gay plague", would be appointed to the Presidential Advisory

Commission on HIV and AIDS. Three months before, a committee advising

the Department of Health and Human Services on protecting volunteers in

clinical trials was asked to consider whether embryos should be included

within its remit (see Nature 420, 3–4; 2002) — a move that critics saw

as part of a wider anti-abortion agenda.


The controversy extends to committees that review grant applications.

Potential appointees to the panel advising the National Institute for

Occupational Safety and Health, for instance, were asked their views on

office safety standards — just one example, critics allege, of political

considerations impinging on appointments that should depend on

scientific merit. The fear is that scientists will refuse to serve on

panels that are seen as rubber stamps for administration policies,

undermining the quality of the advice given to government agencies and

eroding public trust.


Some of the recent developments are disturbing. If the committee on

human research subjects gets bogged down discussing abortion politics

instead of how to protect patients in clinical trials, lives could be

put at risk. Members of committees reviewing grant applications should

be selected for their scientific expertise, not their political views.


But successive US administrations, both Republican and Democrat, have

packed advisory committees with scientists and other experts who share

their political outlook. This only becomes a major issue for the

scientific community when the views in question jar with its majority

opinion, or the politicization is blatant.


Those with long memories say that the present outcry is reminiscent of

the furore inspired by Ronald Reagan's administration in the early

1980s, when it tried similar tactics with committees advising the

Environmental Protection Agency — then seen as a thorn in the side of

the administration's pro-business policies. This sorry episode alienated

environmental scientists, but thankfully the administration eventually

backed off and most of the damage was repaired.


There is some comfort to be gained from the checks and balances inherent

to the system. The degree of transparency in the formulation of

science-led policy in the United States has few parallels in the rest of

the world. It is rare indeed for the public to be able to influence

government decisions about who sits on the panels and what they discuss.

And so far, public input seems to be having a positive effect — last

week's storm led Thacker to withdraw from the HIV panel.


This does not mean that the critics should relax. They should look back

at the actions of previous administrations to determine the extent to

which the current moves represent a departure from accepted practice.

The National Academies' Committee on Science, Engineering, and Public

Policy is set to take up these questions at its next meeting on 19

February, providing a welcome and timely forum.


Scientists should fight undue attempts by the Bush administration to

politicize the advisory process, and extend the same scrutiny to future

administrations, whatever their political persuasion.


Macmillan MagazinesNature © Macmillan Publishers Ltd 2003 Registered No.

785998 England.




Greetings list members,


< This does not mean that the critics should relax.


o.k., i'm not relaxing and i want _all_ my ruminant-to-ruminant

aka mad cow feed ban violations since May 2002 to date,

not just that token one from Texas i posted today, that

they let slip by for whatever reason...


Food and Drug Administration

Dallas District

4040 North Central Expressway

Dallas, Texas 75204-3145


November 7, 2002


Re: 2003-DAL-WL- 05

WARNING LETTER

CERTIFIED MAIL

RETURN RECIEPT REQUESTED


Mr. Ronald A. Christensen

President & General Manager

Sunnymead Ranch, Inc.

Rt. 1, Box 49

Idalou, TX 79329


Dear Mr. Christensen:


An inspection of your feed mill located at Route 1, Idalou, Texas, was

conducted by Food and Drug Administration (FDA) Investigator Lisa Yoder

on September 9/11, 2002. The inspection found significant deviations

from the requirements set forth in Title 21, Code of Federal

Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed

(21 C.F.R. 589.2000). This regulation is intended to prevent the

establishment and amplification of Bovine Spongiform Encephalopathy

(BSE). The deviations cause the feed for sheep (a ruminant animal)

manufactured at your facility to be adulterated within the meaning of

Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).


Animal feeds and feed ingredients containing any mammalian derived

protein (prohibited material), such as bovine meat and bone meal, are

considered potentially injurious to ruminant and public health.

Therefore, the use of such materials in ruminant feed causes the feed to

be adulterated under Section 402(a)(4) of the Act.


Our inspection revealed that your firm manufactures feed for sheep, that

may contain residues of prohibited material. Your sheep feed is mixed in

the same equipment that is used for mixing chicken feed containing

bovine meat and bone meal. Your sheep, which are given this feed, are

ultimately auctioned for sale as food for human consumption.


A list of Inspectional Observations (FDA Form 483) was issued to your

firm and discussed with you at the conclusion of the inspection. The

following violations were observed during the inspection:


Failure to use clean-out procedures or other means adequate to prevent

carryover of protein derived from mammalian tissue to animal protein or

feeds that may be used for ruminants, 21 C.F.R. 589.2000(e)(1)(iii)(A)

and (B). Specifically, raw ingredients, such as soybean meal, limestone,

dehydrated alfalfa meal, and meat and bone meal (bovine) pass through

shared equipment. Your firm does not conduct any form of clean-out

between delivery of meat and bone meal and other feed ingredients like

alfalfa meal, limestone, and soybean meal used in both chicken and sheep

formulas.


Additionally, there is no clean-out between batches of chicken feed

which contain the meat and bone meal and the sheep feed which is not

intended to contain the meat and bone meal.


Failure to maintain written clean-out procedures to prevent carryover of

protein derived from mammalian tissues to animal protein or feeds that

may be used for ruminants, 21 C.F.R. 589.2000(e)(l)(iv). Specifically,

your firm does not have any written clean-out procedure to prevent

cross-contamination between the sheep feed and the chicken feed nor do

they practice/conduct any clean-out procedures to prevent the

cross-contamination between the chicken feed and sheep feed.


The above is not intended to be an all-inclusive list of deficiencies by

your firm. As a feed manufacturer and ruminant feeder of sheep intended

for slaughter as food, you are responsible for ensuring that your

operations are in full compliance with the law. We have attached a copy

of the BSE regulations to assist you in meeting complete compliance

under the law.


We are in receipt of your letter to this office dated September 13,

2002, in which you state your "intent to not manufacture any sheep feed

for the immediate future." It is unclear to us from your letter whether

you intend to permanently discontinue manufacturing feed for sheep and

whether you are now purchasing ruminant feed from some other source. We

cannot stress enough the seriousness of these deficiencies, and the

importance of your firm being in complete compliance with the BSE

regulations in regard to the mixing of ruminant feed, and feeding and

marketing of ruminant animals. Your firm must adhere to the regulations

to assure a safe ruminant feed and meat supply, or establish complete

and separate receiving, mixing, handling, and feeding conveyances and

equipment for ensuring such safety.


In your letter, you also indicated your unfamiliarity with the concept

of "residuals" of prohibited materials being carried over into ruminant

feeds, and you imply that discussions concerning residuals were not held

with your firm during FDA’s previous inspections. For your information,

FDA conducted inspections of your firm on July 27, 1999, and again on

December 4, 2001 for coverage of the BSE regulations. During both

inspections, investigators questioned your plant manager, John Brown,

about the activities of your firm relative to BSE, including specific

questions addressing whether your firm was a feeder of ruminant animals.

During both inspections, it was also not conveyed to our investigators

that your firm raises sheep (for slaughter as food) at this facility or

manufactures feed for sheep. Therefore, during each of those inspections

no discussion was held regarding "residuals" of prohibited material

being carried over to ruminant feeds. We have attached copies of the

following FDA guidance documents for your review: FDA Guidance for

Industry 68 - Small Entities Compliance Guide -


Protein Blenders, Feed Manufacturers, and Distributors; Guide 69 -

Feeders of Ruminant Animals With On-Farm Feed Mixing Operations; Guide

70 - Feeders of Ruminant Animals Without On-Farm Mixing Operations; and

Guide 76 - Questions and Answers BSE Feed Regulation.


You should take prompt action to correct these deviations, and establish

procedures whereby such violations do not recur. Failure to promptly

correct these deviations may result in regulatory action without further

notice. Such action could include, but is not limited to seizure and/or

injunction.


You should notify this office in writing within fifteen (15) working

days of receipt of this letter of the specific actions taken to bring

your firm in to compliance with the law. Your response should include an

explanation of each step taken, including any plans to be taken to

correct the violations that would involve the continued use of the

common mixing equipment for both sheep and chicken feeds, and a

timeframe for completion of the planned corrections. As part of your

written response, you should provide information regarding the current

feeding practices for sheep being kept at your facility, and information

about the current or planned marketing of such animals for slaughter.


Your written response should be directed to James R. Lahar, Compliance

Officer, at the above address. If you have any questions, you may

contact Mr. Lahar by telephone at (214) 253-5219.


Sincerely,


/s/


Reynaldo R. Rodriguez Jr. for Michael A. Chappell


Dallas District Director





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



Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001

Date: Tue, 9 Jan 2001 16:49:00 -0800

From: "Terry S. Singeltary Sr."

Reply-To: Bovine Spongiform Encephalopathy BSE-L



snip...end




http://tseac.blogspot.com/2011/02/usa-50-state-bse-mad-cow-conference.html






Date: Wed, 29 Jan 2003 12:26:10 -0600

Reply-To: Bovine Spongiform Encephalopathy

Sender: Bovine Spongiform Encephalopathy

From: "Terry S. Singeltary Sr."

Subject: MAD COW/SHEEP FEED BAN WARNING LETTER 'TEXAS' [holy madcow,

must have missed this one 11/7/02]


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


greetings list members,


i'm still here, but i find it odd that they happen to slide this one by me? i do not recall this one ever being posted on the TUESDAY warning letters post??? regardless, i have it now, and so do you. also, this goes to show you of my concern at the Jan. 9, 2001 BSE Emergency Conference call, when i stated how shocked i was as to how many folks in the 'industry' knew nothing of the supposedly 8/4/97 ruminant-to-ruminant voluntary feed ban. either they were sincere about not knowing about it, or they were just all playing stupid and simply ignoring it. either way, the consumer will now pay the fiddler for years to come;


Food and Drug Administration Dallas District 4040 North Central Expressway Dallas, Texas 75204-3145


November 7, 2002


Re: 2003-DAL-WL- 05 WARNING LETTER CERTIFIED MAIL RETURN RECIEPT REQUESTED


Mr. Ronald A. Christensen President & General Manager Sunnymead Ranch, Inc. Rt. 1, Box 49 Idalou, TX 79329


Dear Mr. Christensen:


An inspection of your feed mill located at Route 1, Idalou, Texas, was conducted by Food and Drug Administration (FDA) Investigator Lisa Yoder on September 9/11, 2002. The inspection found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed (21 C.F.R. 589.2000). This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). The deviations cause the feed for sheep (a ruminant animal) manufactured at your facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).


Animal feeds and feed ingredients containing any mammalian derived protein (prohibited material), such as bovine meat and bone meal, are considered potentially injurious to ruminant and public health. Therefore, the use of such materials in ruminant feed causes the feed to be adulterated under Section 402(a)(4) of the Act.


Our inspection revealed that your firm manufactures feed for sheep, that may contain residues of prohibited material. Your sheep feed is mixed in the same equipment that is used for mixing chicken feed containing bovine meat and bone meal. Your sheep, which are given this feed, are ultimately auctioned for sale as food for human consumption.


A list of Inspectional Observations (FDA Form 483) was issued to your firm and discussed with you at the conclusion of the inspection. The following violations were observed during the inspection:


Failure to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissue to animal protein or feeds that may be used for ruminants, 21 C.F.R. 589.2000(e)(1)(iii)(A) and (B). Specifically, raw ingredients, such as soybean meal, limestone, dehydrated alfalfa meal, and meat and bone meal (bovine) pass through shared equipment. Your firm does not conduct any form of clean-out between delivery of meat and bone meal and other feed ingredients like alfalfa meal, limestone, and soybean meal used in both chicken and sheep formulas.


Additionally, there is no clean-out between batches of chicken feed which contain the meat and bone meal and the sheep feed which is not intended to contain the meat and bone meal.


Failure to maintain written clean-out procedures to prevent carryover of protein derived from mammalian tissues to animal protein or feeds that may be used for ruminants, 21 C.F.R. 589.2000(e)(l)(iv). Specifically, your firm does not have any written clean-out procedure to prevent cross-contamination between the sheep feed and the chicken feed nor do they practice/conduct any clean-out procedures to prevent the cross-contamination between the chicken feed and sheep feed.


The above is not intended to be an all-inclusive list of deficiencies by your firm. As a feed manufacturer and ruminant feeder of sheep intended for slaughter as food, you are responsible for ensuring that your operations are in full compliance with the law. We have attached a copy of the BSE regulations to assist you in meeting complete compliance under the law.


We are in receipt of your letter to this office dated September 13, 2002, in which you state your "intent to not manufacture any sheep feed for the immediate future." It is unclear to us from your letter whether you intend to permanently discontinue manufacturing feed for sheep and whether you are now purchasing ruminant feed from some other source. We cannot stress enough the seriousness of these deficiencies, and the importance of your firm being in complete compliance with the BSE regulations in regard to the mixing of ruminant feed, and feeding and marketing of ruminant animals. Your firm must adhere to the regulations to assure a safe ruminant feed and meat supply, or establish complete and separate receiving, mixing, handling, and feeding conveyances and equipment for ensuring such safety.


In your letter, you also indicated your unfamiliarity with the concept of "residuals" of prohibited materials being carried over into ruminant feeds, and you imply that discussions concerning residuals were not held with your firm during FDA’s previous inspections. For your information, FDA conducted inspections of your firm on July 27, 1999, and again on December 4, 2001 for coverage of the BSE regulations. During both inspections, investigators questioned your plant manager, John Brown, about the activities of your firm relative to BSE, including specific questions addressing whether your firm was a feeder of ruminant animals. During both inspections, it was also not conveyed to our investigators that your firm raises sheep (for slaughter as food) at this facility or manufactures feed for sheep. Therefore, during each of those inspections no discussion was held regarding "residuals" of prohibited material being carried over to ruminant feeds. We have attached copies of the following FDA guidance documents for your review: FDA Guidance for Industry 68 - Small Entities Compliance Guide -


Protein Blenders, Feed Manufacturers, and Distributors; Guide 69 - Feeders of Ruminant Animals With On-Farm Feed Mixing Operations; Guide 70 - Feeders of Ruminant Animals Without On-Farm Mixing Operations; and Guide 76 - Questions and Answers BSE Feed Regulation.


You should take prompt action to correct these deviations, and establish procedures whereby such violations do not recur. Failure to promptly correct these deviations may result in regulatory action without further notice. Such action could include, but is not limited to seizure and/or injunction.


You should notify this office in writing within fifteen (15) working days of receipt of this letter of the specific actions taken to bring your firm in to compliance with the law. Your response should include an explanation of each step taken, including any plans to be taken to correct the violations that would involve the continued use of the common mixing equipment for both sheep and chicken feeds, and a timeframe for completion of the planned corrections. As part of your written response, you should provide information regarding the current feeding practices for sheep being kept at your facility, and information about the current or planned marketing of such animals for slaughter.


Your written response should be directed to James R. Lahar, Compliance Officer, at the above address. If you have any questions, you may contact Mr. Lahar by telephone at (214) 253-5219.


Sincerely,


/s/


Reynaldo R. Rodriguez Jr. for Michael A. Chappell


Dallas District Director





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





Subject: Re: USA ruminant-to-ruminant feed ban warning letters (Advisory Panels Stacked, Scientists Warn)


Date: Fri, 24 Jan 2003 08:37:49 –0600


From: "Terry S. Singeltary Sr."


To: Bovine Spongiform Encephalopathy References: <3E075C47.3080506@wt.net> <3E21BA6C.3040900@wt.net> <3E23107A.433C64BF@airtime.co.uk> 3E232ABD.8000005@wt.net




Advisory Panels Stacked, Scientists Warn




By J.R. Pegg


WASHINGTON, DC, January 23, 2003 (ENS) - American scientists are growing increasingly worried that the Bush administration is manipulating scientific advisory committees in order to further its political agenda.


The federal government relies on hundreds of these committees to provide agencies with unbiased advice based on the best science available as well as to peer review grant proposals for scientific research.


The Bush administration, many scientists fear, has distorted this process by putting committee members through political litmus tests, eliminating committees whose findings looked likely to disagree with its policies, and stacking committees with individuals who have a vested interest in steering conclusions to benefit effected industries.


scientist Scientist John Turner holds a beaker containing a solar cell electrolyzer submerged in an alkaline aqueous solution. (Photo by Richard Peterson courtesy NREL) "We've seen a consistent pattern of putting people in who will ensure that the administration hears what it wants to hear," said Dr. David Michaels, a research professor in the Department of Environmental and Occupational Health at George Washington University's School of Public Health. Addressing reporters at a press briefing today in Washington, Dr. Michaels said, "That doesn't help science, and it doesn't help the country."


The Bush administration says it is doing what every other administration has done in the past, but many scientists take issue with this defense.


"The Clinton administration did not do this," said Dr. Lynn Goldman, a pediatrician and professor at the Bloomberg School of Public Health at Johns Hopkins University. "They did not exclude people based on some sort of litmus test." Goldman Pediatrician Dr. Lynn Goldman was assistant administrator of the Office of Prevention, Pesticides and Toxic Substances of the U.S. EPA under the Clinton administration. (Photo courtesy Johns Hopkins Magazine)


"These are not just the concerns of a few scientists or members of the public health community but of a broad array of people across the country," added Kelly O'Brien, associate executive director of public affairs for the American Public Health Association (APHA).


The role of these committees is not to tell the administration what they want to hear, Michaels argues, but to tell them what science has concluded about the issue under discussion.


"You hire political appointees to move your political agenda forward," he observes. "But the role of scientific advisory committees is quite different. It is to give advice to the agencies and to the public on what is the best science."


"This is a threat to the fundamental principles that we want to make decisions based on the best available science," Goldberg added.


Americans may be unfamiliar with the role of scientific advisory committees, but the impact of the advice they give is extensive. Rules and regulations that govern clean air, clean water, food safety and pesticide use, among others, have been devised with scientific advice from such committees.


The growing concern from American scientists comes from a slew of examples. Members of the Center for Disease Control's (CDC) Advisory Committee on Childhood Lead Poisoning Prevention were replaced last year with individuals with close ties to the lead industry, including Dr. William Banner, who has provided written testimony on behalf of lead industry defendants in a lawsuit in Rhode Island.


Banner is on record as believing that lead is only harmful in levels that are seven to 10 times higher than the current CDC blood lead levels. The CDC estimates some 890,000 U.S. children ages one to five have elevated levels of lead in their blood.


Fifteen of the 18 members of the Advisory Committee to the Director of the National Health Center for Environmental Health were replaced last year. This committee assesses the health impact of exposure to environmental chemicals. Among the new members is the former president of the Chemical Industry Institute for Toxicology.


Thompson Health and Human Services Secretary Tommy Thompson (Photo courtesy U.S. Government) Tommy Thompson, Secretary of the Department of Health and Human Services (HHS), dissolved a committee charged with analyzing the federal system for protecting human research subjects. A committee tasked with giving the U.S. Food and Drug Administration advice on oversight of the genetics testing industry was similarly disbanded.


A respected scientist nominated to serve on an HHS peer review study section, which is charged with reviewing research grant proposals submitted to the National Institute for Occupational Safety and Health, was rejected for her support of an ergonomics rule overturned by the Bush administration last year.


A consultant to the Army Science Board was disapproved for full membership on the committee because, he was told, he contributed to Senator John McCain's campaign, an allegation that was false.


A new member of the Food and Drug Administration's Reproductive Health Drugs Advisory Committee, Dr. David Hager, helped the Christian Medical Association lobby for a safety review of a drug the committee approved two years ago. The announcement that Hager, who has very few research credits, had been put on the committee was released on Christmas Eve.


The trouble with this politicization of the process by which scientists advise the government, Michaels explained, is that they will directly impact the government's willingness to act.


"I don't think there is really any danger of a committee coming out and making a statement so far out of the mainstream that it takes us in a different direction," he explained. "What these committees will do, and I think this is what the administration wants, is to essentially throw their hands up and say there is too much uncertainty. That sort of paralysis is dangerous."


Apple Dr. Martin Apple (Photo courtesy University of Kansas Merrill Advanced Studies Center) The trust the public has in science, and in the scientific advice offered by the government for public health issues, could be gravely affected by these developments, said Dr. Martin Apple, president of the Council of Scientific Society Presidents.


"Public trust is like Humpty Dumpty," Apple said. "It is difficult to establish, easy to lose and nearly impossible to restore."


It is not that anyone expects scientific advisory committee members to be completely unbiased, Goldman said. Rather, it is critical that these committees are focused only on the science, leaving political, economic and religious bias out of the equation.


"If you attempt to predetermine the outcome of the scientific discussion by selecting certain people for science committees or by constructing a consensus before you bring the group together, then you are distorting the process," Goldman added. "For the past several months, again and again with this current administration, we've seen evidence of this occurring."


Goldman, who served as the assistant administrator for the Office of Prevention, Pesticide and Toxic Substances within the Environmental Protection Agency (EPA) from 1993 to 1998, has firsthand experience with the Bush administration's policy on scientific advisory committees. Goldman and two other experts on the effects of pesticides on children were invited to speak at an EPA funded conference that was scheduled for September 2002.


In July 2002, representatives from the pesticides industry wrote to the EPA to protest the conference and specifically the participation of Goldman and the other two scientists at the event. The EPA then rescheduled the conference for June 2003 and has not re invited any of the three.


The overarching concern, Goldman said, is the apparent influence of the pesticide industry on the EPA.


Waxman Congressman Henry Waxman has represented the Los Angeles area since 1974. (Photo courtesy Office of the Representative) California Representative Henry Waxman, a Democrat, agreed and sent EPA Administrator Christie Todd Whitman a letter on December 20, 2002 asking for an explanation by January 6, 2003.


Waxman's spokesperson Karen Lightfoot told ENS that the Congressman has not received any response from the EPA.


In late October 2002, Waxman and 11 other members of Congress sent a letter to HHS Secretary Thompson, detailing concern with "a pattern of events … suggesting that scientific decision making is being subverted by ideology and that scientific information that does not fit the administration's political agenda is being suppressed."


HHS did reply to Waxman and his colleagues, but their explanations did not satisfy the letter writers. A subsequent letter asking for more detailed information was sent on December 18, 2002.


Lightfoot said there has been no response to the December 18 letter, but added that Congressman Waxman will closely monitor "this trend of putting ideology before science."


Groups like the American Public Health Association, which has some 50,000 members, are calling on Congress to further explore just what the Bush administration is doing with scientific advisory committees. APHA drafted a series of recommendations, including the reevaluation of newly reconstituted advisory panels and the creation of criteria to guide the selection of members on public health advisory committees and peer review research committees at all levels of government - federal, state and local.


poster Poster for the Scientific Computing Division Advisory Panel convened by the National Center for Atmospheric Research (Photo courtesy ) There is concern that if the process continues forward without serious review that many qualified scientists will decline to involve themselves with future committees.


"Scientists and the federal government in the United States have established an effective system of providing expert advice," Apple said. "But the best scientists are only willing to serve on such advisory groups when they believe that they are unbiased and will produce scientifically sound results. Once this currency is debased, the best scientists will decline to take the time out from their lives to participate, and the government will lose an irreplaceable resource."


"This will cause severe and last damage to the national interest and should be actively prevented," Apple urged.


There is "no glory" for scientists to take part in the vast majority of scientific advisory committees, Michaels said. They are only compensated for travel and accommodations, and the work is often long and tedious.


"It is quite possible that these are isolated, anecdotal incidents," Goldman suggested. "But then why hasn't there been an attempt to rectify them?"


Copyright Environment News Service (ENS) 2003. All Rights Reserved.







Terry S. Singeltary Sr. wrote:


> ######## Bovine Spongiform Encephalopathy
> #########
>
> hello Dr. Dealler,
>
> please do not hold your breath for any USA
> ruminant-to-ruminant feed ban warning letters
> since May of 2002 to be released anytime soon,
> this could be fatal for you;-)
> i have not gotten them yet, if any exist.
> but i am trying.


> hopefully GW et al will not think i am one of
> the terrorist, and will allow for this information
> to be released (with no charge attached$$$)...
>
> kindest regards,
> terry
>


> Steve Dealler wrote:
>


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


>> This was absolutely excellent for Terry to have got this from the US
>> Government...you should have tried getting this sort of thing from
>> MAFF in the UK
>> at the beginning of the nineties!


>> Steve Dealler
>>
>> "Terry S. Singeltary Sr." wrote:
>>
>>


>>> ######## Bovine Spongiform Encephalopathy
>>> #########
>>>
>>> Greetings List Members,
>>>
>>> as you know, i finally had to request to the FOIA
>>> for the USA madcow feed ban warning letters. so i thought
>>> some of you may be interested in an update on this matter.
>>>
>>> so here it is;
>>>
>>> Subject: Request to FDA via FOIA of ALL USA Ruminant-to-Ruminant Feed
>>> Ban Violations Jan. 2001 to Jan. 2003
>>> Date: Mon, 6 Jan 2003 08:32:43 -0600
>>> From: "Terry S. Singeltary Sr."
>>> Reply-To: Bovine Spongiform Encephalopathy
>>> To: BSE-L
>>>
>>> Food and Drug Administration
>>> Office of Information Resources Management
>>> Division of Freedom of Information (HFI-35)
>>> 5600 Fishers Lane
>>> Rockville, MD 20857
>>>
>>> Or requests may be sent via fax to: (301) 443-1726. If there are
>>> problems sending a fax, call (301) 443-2414.
>>>
>>> 1/6/03
>>>
>>> Request to FDA via FOIA of ALL USA Ruminant-to-Ruminant Feed Ban
>>> Violations Jan. 2001 to Jan. 2003
>>>
>>> Greetings FDA and To Whom it may concern,
>>>
>>> i wish to request all ruminant-to-ruminant feed ban violations from Jan.
>>> 2001 to Jan. 2003. it seems none has been posted since May 2001 on the
>>> FDA site. I also kindly request that all fees be wavered due to the fact
>>> this is public information, public health is at risk, and this
>>> will be distributed 'freely' to the public...
>>>
>>> thank you,
>>> kind regards,
>>>
>>> I am sincerely,
>>>
>>> Terry S. Singeltary Sr.
>>> P.O. Box Bacliff, Texas USA 77518
>>> CJD Watch
>>> http://www.fortunecity.com/healthclub/cpr/349/part1cjd.htm
>>> ==========================================================
>>>
>>> now since then, just this past Friday 1/10/03, i get this from
>>> FDA;
>>>
>>> REPLY FROM DPH/FDA to TSS;
>>>
>>> PLEASE note, my request was for all R-T-R feed ban
>>> violations from Jan. 2001 to Jan. 2003. BUT in the
>>> reply, they posted Jan. 2002 to Jan. 2003. i called
>>> and this is to be corrected. hopefully this FOIA
>>> request will ignite some enthusiasm from the FDA
>>> into posting to the public any R-T-R MAD COW
>>> FEED BAN violations, since GW et al new policy
>>> on secrecy took effect on this matter in May of 2002
>>> (correcting my below 'since May 2001).
>>>
>>> TSS
>>>
>>> Department of Health & Human Services
>>>
>>> Food and Drug Administration
>>> Rockville MD 20857
>>>
>>> 1/7/03
>>>
>>> In reply refer to;
>>>
>>> xxxxxxx
>>>
>>> Dear Requester,
>>>
>>> The Food and Drug Administration (FDA) has received your
>>> Freedom of Information Act (FOIA) request for records
>>> regarding;
>>>
>>> RUMINANT-TO-RUMINANT FEED - BAN VIOLATIONS 1/02 - 1/03
>>>
>>> We will respond as soon as possible and may charge you a fee
>>> for processing your request. If you have any questions
>>> about your request, please call Edna G. Wilkerson,
>>> Information Technician, at 301-827-6564 or write to us
>>> at;
>>>
>>> Food and Drug Administration
>>> Division of Freedom of Information
>>> 5600 Fishers Lance, HFI - 35
>>> Rockville, MD 20857
>>>
>>> If you call or write, use the reference number above
>>> which will help us to answer your questions more quickly...
>>> ===========================================================
>>> now, Sunday, i read this in the Houston Chronicle 1/12/03;
>>>
>>> SENATOR AIMS TO UPGRADE FREEDOM OF INFORMATION
>>>
>>> TEXAS Sen. John Coprnyn says he wants to improve public access to
>>> government records in Washington, a position that appears to put
>>> him at odds with the Bush administration.
>>>
>>> Cornyn, a moderate Republican who sits on the Senate Judiciary
>>> Committee, said he'll work on legislation in the coming weeks to
>>> improve the Freedom of Information Act.
>>>
>>> "FOIA needs to be strenghened," he said, "We need to quicken the
>>> turnaround time and create a mechanism that allows an indepentent,
>>> third party to decide whether a record should be kept secret."
>>>
>>> Echoing sentiments he expressed while serving as Texas attorney
>>> general, Cornyn added: "I believe in a system of governement
>>> that allows consent of the people. And people can't consent if they
>>> don't what their elected officials are doing."
>>>
>>> Since taking office two years ago, the Bush Administration has
>>> taken steps to restrict access to governement information, an effort
>>> that was accelerated in the name of national security following
>>> the Sept. 11 terrorist attacks......
>>>
>>> Greetings again BSE-L list members,
>>>
>>> how would _USA_ ruminant-to-ruminant feed ban warning
>>> letters have anything to do with terrorism and National
>>> Security?
>>>
snip>>>
>>> Date: Wed, 2 Oct 2002 09:04:42 -0700
>>> Reply-To: Bovine Spongiform Encephalopathy
>>> Sender: Bovine Spongiform Encephalopathy
>>> From: "Terry S. Singeltary Sr."
>>> Subject: MAD COW FEED BAN WARNING LETTERS USA 'update' (where did
>>> all Terry's MAD COW warning letters go?)
>>>
>>> snip...END...2012...TSS














snip...end...2012...TSS






2002




DEPARTMENT OF HEALTH AND HUMAN SERVICES


Food and Drug Administration


Seattle District


Pacific Region


22201 23rd Drive SE


Bothell, WA 98021-4421


Telephone: 425-486-8788


FAX: 425-483-4896


February 12, 2002


CERTIFIED MAIL


RETURN RECEIPT REQUESTED


In reply refer to Warning Letter SEA 02-29


WARNING LETTER


John Tyson, Chairman of the Board and CEO


Tyson Foods


3 70 1 Johnson Road


Springdale, Arkansas 72762


Dear Mr. Tyson:


An inspection of your rendering operation, IBP, Inc., located at Dodd Road, Wallula,


Washington, conducted by a Washington State Department of Agriculture Investigator, on January 8, 2002, under contract with the Food and Drug Administration (FDA), found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Such deviations cause products being manufactured and/or distributed by this facility to be misbranded within the meaning of Section 403(f) of the Federal Food, Drug, and Cosmetic Act (the Act).


Our investigation found a failure to label your organ slurry product with the required cautionary statement "Do Not Feed to Cattle or Other Ruminants". The FDA suggests the statement be distinguished by different type size or color or other means of highlighting the statement so that it is easily noticed by a purchaser.


The above is not intended to be an all-inclusive list of deviations from the regulations, As a manufacturer of materials intended for animal feed use, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law. We have enclosed a copy of the FDA’s Small Entity Compliance Guide to assist you with complying with the regulation.


You should take prompt action to correct these violations, and you should establish a system whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.


You should notify this office in writing within 15 working days of receipt of this letter, of the steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step being taken to correct the violations, and prevent their recurrence. If corrective action cannot be completed in 15 working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.


Please send your reply to the Food and Drug Administration, Attention; Bruce Williamson, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021. If you have questions regarding any issue in this letter, please contact Mr. Williamson at (425) 483-4976.


Sincerely,


Charles M. Breen


District Director








Date: Wed, 17 Apr 2002 12:51:03 -0700
Reply-To: Bovine Spongiform Encephalopathy
Sender: Bovine Spongiform Encephalopathy
From: "Terry S. Singeltary Sr."
Subject: MAD COW FEED BAN WARNING LETTER 2002 & MORE Edible
Tissues/Adulterated WITH ANTIBIOTICS OR WHAT???

######## Bovine Spongiform Encephalopathy #########
April 1, 2002 VIA CERTIFIED MAIL RETURN RECEIPT REQUESTED In reply refer to Warning Letter SEA 02-38 Jeffrey T. Buck, Owner All American Feed & Tractor 502 West Alder Street Sandpoint, Idaho 83864
WARNING LETTER
Dear Mr. Buck:
An investigation at your feed mill and rendering operation located at 502 West Alder Street, Sandpoint, Idaho, conducted by a Food and Drug Administration investigator on March 5,2002, found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Such deviations cause products being manufactured and distributed by your facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act).
Our investigation found that you failed to maintain sufficient records and written procedures to prevent cross contamination 121 CFR 589.20001 in that:
1. Sufficient records are not maintained to track prohibited animal proteins throughout receipt, processing, and distribution. No records are maintained to document the order in which feeds were produced to demonstrate that a chicken feed flush was made after a dog feed containing prohibited material [21 CFR 589.2OOO(c)(ii)].
2. Written procedures are not maintained to prevent commingling or cross-contamination between feed containing prohibited animal proteins from feed intended for ruminants [21 CFR 589.2000(e)(iv)]. l There are no written procedures for cleaning out or flushing equipment after mixing feeds containing prohibited material. l There are no written procedures for separating products that contain or may contain prohibited material from ingredients used in ruminant feeds, from the time of receipt until the time of shipment.
Jeffrey T. Buck, Owner All American Feed & Tractor, Sandpoint, Idaho Re: Warning Letter SEA 02-38 Page 2
The above is not intended to be an all-inclusive list of deficiencies at your facility. As a manufacturer of materials intended for animal feed use, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law. You should take prompt action to correct these violations, and you should establish a system whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction. You should notify this office in writing within fifteen (15) working days of receipt of this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step being taken to correct the violations, and prevent their recurrence. If corrective action cannot be completed in fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Althar, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Lisa M. Althar, Compliance Officer at (425) 483-4940. Charles M. Breen District Director
http://www.fda.gov/foi/warning_letters/g3174d.pdf

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


February 21,2002 WARNING LETTER CERTIFIED MAIL RETURN RECEIPT REQUESTED Mr. Lowell F. Thomas, President Ward Thomas & Sons, Inc. R.R. #5, Box 152 Bruceton Mills, West Virginia 26525
Dear Mr. Thomas: The Food and Drug Administration (FDA) conducted an inspection of your dairy farm on January 23 and 24,2002. The inspection revealed that you offered an animal for sale for slaughter as human food, in violation of...
SNIP...
http://www.fda.gov/foi/warning_letters/g3167d.pdf


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

February 11,2002 WARNING LETTER CERTIFIED MAIL RETURN RECEIPT REQUESTED Mr. Paul H. Lambert, President Lambert Farms, Incorporated 10223 Lenhart Road Frederick, Maryland 2 170 1
Dear Mr. Lambert,
An inspection of your dairy operation located in Frederick, Maryland, by the Food and Drug Administration on January 4-14,2002, confirmed that a calf you offered for sale for slaughter as food, was in violation of...SNIP
http://www.fda.gov/foi/warning_letters/g3166d.pdf


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


TSS
########### http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############






Date: Tue, 7 May 2002 09:00:04 -0700

Reply-To: Bovine Spongiform Encephalopathy

Sender: Bovine Spongiform Encephalopathy

From: "Terry S. Singeltary Sr."

Subject: USA MAD COW FEED WARNING LETTER--Animal Proteins Prohibited in

Ruminant Feed/Adulterated


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


DEPARTMENT OF HEALTH AND HUMAN SERVICES


Food and Drug Administration Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 98021-4421 Telephone: 425-486-8788 FAX: 425-483-4996


April 17, 2002 VIA CERTIFIED MAIL RETURN RECEIPT REQUESTED In reply refer to Warning Letter SEA 02-42 WARNING LETTER


Kenneth M. Van Dyyke, President Van Dyke Grain Elevators, Inc. 485 Main North Plains, Oregon 97133


Dear Mr. Van Dyke:


An inspection at your feed mill and lamb meal blending operation located at 485 Main, North Plains, Oregon, conducted by a Food and Drug Administration investigator on February 27-28, 2002, found significant deviations from the requirements set forth in Title 2 1, Code of Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Such deviations cause products being manufactured and distributed by your facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).


Our investigation found that you failed to maintain sufficient written procedures and provide for measures to prevent cross contamination [21 CFR 589.2000] in that:


1. Written procedures are not maintained to specify the procedures for separating feed containing prohibited animal proteins from feed intended for ruminants from the time of receipt to the time of shipment [21 CFR 589.2000(e)(iv)].


* You have no written procedures for keeping lamb meal, a prohibited material, separated from fish meal, an animal feed ingredient intended for ruminants.


2. You have not provided for measures to prevent commingling or cross-contamination between feed containing prohibited animal proteins from feed intended for ruminants [21 CFR 589.2000(e)(iii)].


* The partial wall installed on February 28, 2002, does not completely separate the lamb meal, a prohibited material, from the fish meal, an animal feed ingredient


* There are no measures taken to prevent cross contamination from foot traffic between the area where prohibited material is stored on the floor and ingredients used in ruminant feeds. You are storing lamb meal, a prohibited material, directly on the floor within twenty feet from the area where you store fish meal directly on the floor. Employees walk back and forth between the two areas where these products are stored.


The above is not intended to be an all-inclusive list of deficiencies at your facility. As a manufacturer of materials intended for animal feed use, you are responsible for assuring that your overall operation and the products; you manufacture and distribute are in compliance with the law.


You should take prompt action to correct these violations, and you should establish a system whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.


You should notify this office in writing, within fifteen (15) working days of receipt of this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step being taken to correct the violations, and prevent their recurrence. If corrective action cannot be completed in fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.


Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 9802l-4421. If you have questions regarding any issue in this letter, please contact Lisa M. Elrand, Compliance Officer at (425) 483-4913.


Sincererly,


Charles M. Breen


District Director




TSS







please see history of FOIA on this one ;



Re: USA ruminant-to-ruminant feed ban warning letters ??? December 23, 2002 at 12:12 pm PST









May 7, 2002

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

In reply refer to Warning Letter SEA 02-46

WARNING LETTER


Mr. Philip C. Anderson, General Manager

Darling International, Inc.

2041 Marc Avenue

Tacoma, Washington 98401


Dear Mr. Anderson:


An inspection of your rendering operation conducted by Investigator Donald B. McKechnie, on February 22 and 26, 2002, found a significant deviation from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Such deviation causes products being manufactured and/or distributed by your facility to be misbranded within the meaning of Section 403(f) of the Federal Food, Drug, and Cosmetic Act (the Act).


Our investigation found a failure to consistently label your meat and bone meal product shipped to [redacted], with the required cautionary statement "Do Not Feed to Cattle or Other Ruminants". The meat and bone meal contains beef offal along with other ingredients including chicken, fish, and pork. The FDA suggests the statement be distinguished by different type size or color or other means of highlighting the statement so that it is easily noticed by a purchaser.


The above is not intended to be an all-inclusive list of deviations from the regulations. As a manufacturer of materials intended for animal feed use, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law. We have enclosed a copy of the FDA?s Small Entity Compliance Guide to assist you with complying with the regulation.


You should take prompt action to correct this violation, and you should establish a system whereby such violation does not recur. Failure to promptly correct this violation may result in regulatory action without further notice, such as seizure and/or injunction.


You should notify this office in writing within 15 working days of receipt of this letter, of the steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step being taken to correct the violation, and to prevent its recurrence. If corrective action cannot be completed in 15 working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.


Please send your reply to the Food and Drug Administration, Attention: Thomas S. Piekarski, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021. If you have questions regarding any issue in this letter, please contact Mr. Piekarski at (425) 483-4975.

Sincerely,

Charles Breen

District Director








Subject: MAD COW FEED BAN WARNING LETTER $ DISEASED ANIMALS GOING TO SLAUGHTER USA

Date: August 13, 2002 at 8:53 am PST

Food and Drug Administration

Kansas City District

Southwest Region

11630 West 60 Street

P.O. Box 15905

Lenexa, Kansas 66265-4905

Telephone: (913) 752-2100


July 29, 2002

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

WARNING LETTER

Ref. KAN 2002-09


Jerry Behimer, Owner

Bakery Trading Company/Ingredient Exchange

401 N. Lindbergh Blvd., Suite 315

St. Louis, MO 63141-7816


Dear Mr. Behimer:


An inspection of your animal feed premix-manufacturing operations, located at 14521 2nd Ave., Ottumwa, Iowa, was conducted by an Investigator from our office on June 18 & 19, 2002. During this inspection, a significant deviation from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed was identified. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Under 21 C.F.R. 589.2000(g)(2), such a deviation causes products being manufactured and/or distributed by your facility to be deemed misbranded within the meaning of Section 403(a)(l) of the Federal Food, Drug, and Cosmetic Act (the Act), and these products may not be lawfully introduced, or delivered for introduction, into interstate commerce.


Our investigation found a failure to label your Powdered Cooked Beef, Product No. 5013, produced during the period of 2/13/02 to approximately 4/18/02, with the cautionary statement "Do Not Feed to Cattle or Other Ruminants," as required by 21 C.F.R. 589.2000(d). The FDA suggests the statement be distinguished by different type size or color, or other means of highlighting the statement so that it is easily noticed by a purchaser.


The above is not intended to be an all-inclusive list of deviations from the regulations. As a manufacturer of materials intended for animal feed use, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law.


You should take prompt action to correct this violation, and you should establish a system whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.


It is necessary for you to take action on this matter now. We request you provide our office documentation of corrective action and final disposition for Lot 030402, approximately 21 tons, which was on hand during the inspection. Let this office know in writing within fifteen (15) working days from the date you received this letter what steps you are taking to correct the problem.


Your reply should be sent to Nadine Nanko Johnson, Compliance Officer, at the above address.


Sincerely,


/s/


Charles W. Sedgwick


District Director


Kansas City District








Date: Mon, 9 Sep 2002 12:07:02 -0700
From: "Terry S. Singeltary Sr."
Reply-To: BSE-L

so, i was nosing around the FDA warning letters and other files,
came across these and thought since 1/2 to 1 GRAM is lethal
to a cow, i thought these TONNAGE in some of these violations
i ran across most interesting. no telling how many dead road-kill
CWD infected carcasses were rendered into this, along with
whatever type TSE in USA cattle, and we can't forget about all
the scrapie infected sheep that may have been added to the soup.
with a combination of CWD, SCRAPIE, TME and all the different
variants that may have come from them over the years, what in the
world would you call the TSEs in USA cattle, once they test to find,
and then find? could be a nasty one. or maybe none at all?
doubtful though (just my opinion, if i still allowed one here);
PRODUCT


BioFlavor F2425, BioFlavor F21002 and BioFlavor C20058. The product,
packaged in 50 lb. bags, is labeled in part, "







*** PALATABILITY ENHANCER
INTENDED FOR CAT FOOD USE AT LESS THAN 10% *** INGREDIENT LISTING: ***
Beef Broth *** ".





Recall # V-140-2




CODE
Product Codes
F2425 107B-RB-1
107B-RB-2
149C
201D
202C
205D
210A
F21002 143B
143D
146D
144B
144D
139D
142D
150D
151D
152C
152D
201C
205C
206C
208A
211A
C20058 143D
144C
146C
208B


RECALLING FIRM/MANUFACTURER


Recalling Firm: Bioproducts, Inc., Fairlawn, OH, by telephone and letter
on April 5, 2002.
Manufacturer: Bioproducts, Inc., Aurora, MO.
Firm initiated recall is ongoing.


REASON


Animal feed product with beef protein does not contain required BSE
statement on labels.



VOLUME OF PRODUCT IN COMMERCE


354,150 lbs.

DISTRIBUTION


TX, KS, MO and MI.


_______________________



PRODUCT


Steamed Bonemeal in 50-lb. bags, product code C# 13581, packaged under
two different labels: Premium Steamed Bonemeal Manufactured by Buchheit
Premium Feeds, Perryville, MO, and Steamed Bonemeal Manufactured for
Siemer's Enterprises Inc., Teutopolis, IL.


Recall # V-141-2.


CODE


Not coded.


RECALLING FIRM/MANUFACTURER


Buchheit, Inc., Perryville, MO, by telephone on May 14, 2002.


FDA initiated recall is ongoing.


REASON


Label lacks BSE warning statement.

VOLUME OF PRODUCT IN COMMERCE
Approx. 902/50-lb. bags.
DISTRIBUTION


MO and IL.

END OF ENFORCEMENT REPORT FOR JUNE 5, 2002
####
PRODUCT
The following custom mixed animal feeds are recalled ---
a) [non-ruminant]: Horse Feed, Hog Feed, and 14% Pig Feed.
Recall # V-157-2;
b) [ruminant]: Dairy Feed, Steer Feed, New Goat Feed, Cattle Feed, and
Beef Feed. Recall # V-158-2.


CODE


The product is coded only with the manufacturing date and invoice
numbers. All feed products manufactured and shipped since July 9, 2001
are affected by this recall.


RECALLING FIRM/MANUFACTURER
Recalling Firm: Shepard Grain Company, Inc., Urbana, OH, by telephone on
January 11, 2002.


Manufacturer: Shepard Grain Company, Inc., W. Liberty, OH.
FDA initiated recall is complete.


REASON


Ruminant and non-ruminant animal feeds contain BSE prohibited material,
and are either misbranded or adulterated.

VOLUME OF PRODUCT IN COMMERCE
41,129 LBS (20.5 tons).
DISTRIBUTION
OH.
END OF ENFORCEMENT REPORT FOR AUGUST 28, 2002
####
PRODUCT:
Buckeye 40% Poultry Concentrate. Recall #V-016-1.


CODES:


The bags are uncoded. Firm is recalling product manufactured since
December 1998; however, they are only completing field corrections on
product manufactured within the last six months (November 2000).


MANUFACTURER:


Yachere Feed, Inc. Rockwood, Pennsylvania.


RECALLED BY:


Manufacturer, by visit on 3/19/01 and 3/20/01. Firm-initiated recall
complete.

DISTRIBUTION:
Pennsylvania.
QUANTITY:
Nine containers, each weighing 100 pounds.
REASON:


The animal feed contains product derived from mammalian tissues and
must bear the statement "Do not feed to cattle or other ruminants"
on the label to prevent the establishment and amplification of BSE
through feed. This statement does not appear on the label.
________

PRODUCT:
"Our Own Pig & Hog Grower" hog feed, packaged in 50 pound bags, with
paperboard tags sewn onto the bags. Recall #V-017-1.


CODES:


The bags are uncoded.


MANUFACTURER:


The Perry Coal and Feed Company, Perry, Ohio.
RECALLED BY:
Manufacturer, by telephone on March 22, 2001. Firm-initiated
recall complete.

DISTRIBUTION:
Ohio.
QUANTITY:
Approximately 350 pounds of hog feed (7/50 pound bags).
REASON:


The animal feed contains protein derived from mammalian tissues
and must bear the statement "Do not feed to cattle or other
ruminants" on the label to prevent the establishment and
amplification of BSE through feed. This statement does
not appear on the label.
________

PRODUCT
Loweís 40% Hog Concentrate - swine feed for mixing grower and
finisher rations, in 50-pound bulk bags.
Recall #V-057-0.
CODE
All codes between August 1, 1999 and November 23, 1999.
MANUFACTURER
Lowe's Feed & Grain, Inc., Bowling Green, Kentucky.
RECALLED BY
Manufacturer, by letter dated November 18, 1999, and by
telephone. Firm-initiated recall complete.
DISTRIBUTION
Ohio.
QUANTITY
12.46 tons were distributed.
REASON


Product contained protein derived from mammalian tissue and
according to regulation must bear the statement "Do not feed to
cattle or other ruminants" on the label. This regulation is
designed to prevent the establishment and amplification of BSE
through feed. This statement does not appear on the label.
________

RECALLS AND FIELD CORRECTIONS: VETMED -- CLASS II
________________________________
RECALL NUMBER, PRODUCT AND CODE:
V-353-1 through V-370-1,
Chicken feed products:
Recall # Tag # Product
V-353-1
587
B. Challenger Scratch Feed
V-354-1
588
B. 18% Gamebird Conditioner
V-355-1
2060
B. Kickin' Chicken Premium Game Cock Feed
V-356-1
2066
B. Kickin' Chicken Premium Gamebird 16%
V-357-1
586
B. Scratch Grain
V-358-1
2051
B. Pit Performer 17%
V-359-1
575
B. Classic Yard Feed
V-360-1
576
Eliminator Maintainer
V-361-1
578
Eliminator Conditioner
V-362-1
586
Producer Scratch Grain
V-363-1
4587
Producer 12% Gamebird Yard Feed
V-364-1
2065
Cleveland Trophy Cock Feed
V-365-1
80181AAA
Consolidated Hen Scratch
V-366-1
2051
B&B Maintenance 12
V-367-1
2052
B&B Conditioner 14
V-368-1
2050
B&B Scratch 10
V-369-1
4590
Kingsport Original Prater Mix
V-370-1
2062
PC 10 (unlabeled bags)
ALL CODES
The "B" indicates that the Burkmann Feeds brand name is listed on the tag
labels. The suspect products are also bagged and distributed under the
following private labels:
Producer Feeds, Louisville, Kentucky
Kingsport Milling, Kingsport, Tennessee
Consolidated Nutrition, L.C., Omaha, Nebraska
B&B Feeds, Knoxville, Tennessee
Eagle Roller Mill Co., Inc., Shelby, North Carolina
Central Farm Supply of Kentucky, Inc., Louisville, Kentucky
REASON:
The chicken feed products may contain proteins derived from mammalian
tissues.
The products are not labeled with the required BSE caution statement "Do
Not
Feed to Cattle or Other Ruminants."
MANUFACTURER/RECALLING FIRM:
Burkmann Feeds, London, Kentucky
RECALLED BY:
On May 5, 2001, the firm mailed recall letters with attached BSE
sticker-labels
to all customers outside the state of Kentucky. The recall notices were
hand-
delivered to customers within the state of Kentucky by Burkmann's Sales
Representatives. Customers were asked to complete and return a recall
response
form that was included with each letter documenting the numbers of bags and
varieties of products for which the customers affixed the BSE
sticker-labels.
The firm expanded their recall on May 10, 2001, and mailed recall
letters with
BSE labels and response forms to the affected customers.
FIRM INITIATED RECALL:
Ongoing


DISTRIBUTION:


KY, GA, NC, TN, VA

QUANTITY:
933 tons
_______________________________
RECALL NUMBER, PRODUCT AND CODE:


V-377-1, Renner's brand 45% meat and bone meal, packed in 100 pound bags.
REASON:
The product contained protein material derived from bovine mammalian
tissues;
however, the bags are not labeled with the required BSE cautionary
statement.


MANUFACTURER/RECALLING FIRM:
F. W. Renner & Sons, Inc., Canton, Ohio


RECALLED BY:
The recalling firm contacted the consignees by telephone on June 19, 2001.
FIRM INITIATED RECALL:


Complete

DISTRIBUTION:


OH

QUANTITY:


2,500 lbs


_______________________________

RECALL NUMBER, PRODUCT AND CODE:
V-378-1 to V-384-1, RenPro 58% (brand name) swine and poultry feeds in
bulk, as
follows:
V-378-1 - Poultry Layer #215 - guaranteed analysis 15% crude protein, 3%
crude
fat, and 3.5% crude fiber.
V-379-1 - Poultry Layer #216 - guaranteed analysis 16% crude protein, 3%
crude
fat, and 3.5% crude fiber.
V-380-1 - Poultry Layer #217 - guaranteed analysis 17% crude protein, 3%
crude
fat, and 3.5% crude fiber.
V-381-1 - Poultry Layer #218 - guaranteed analysis 18% crude protein, 3%
crude
fat, and 3.5% crude fiber.
V-382-1 - Poultry Layer #219 - guaranteed analysis 19% crude protein,
3.5% crude
fat, and 4% crude fiber.
V-383-1 - Poultry Prelay #115 - guaranteed analysis 16% crude protein,
3% crude
fat, and 5% crude fiber.
V-384-1 - Poultry Developer #110 - guaranteed analysis 14% crude
protein, 3%
crude fat, and 5.5% crude fiber.
MANFACTURER:
Esbenshade Mills, Mount Joy, PA
RECALLED BY:
On 5/24/01, the manufacturer notified their customers of the labeling
requirement via letter.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
PA
QUANTITY:


None. The product turn over is two weeks or less.

END OF ENFORCEMENT REPORT FOR July 25, 2001.
http://www.fda.gov/
on second thought, i now see why they are cutting back on
these warning letters of the infamous 8/4/97 ruminant-to-ruminant
feed ban in the USA, that never was. same reason they are not
testing cows in sufficient numbers to find any TSEs.
they simply don't want to know, and don't want the public
to know either, thus keep the gold card 'BSE FREE'.
one more time, to all EU/SEAC members please re-evaluate the
current GBR of the USA, and change from GBR II to GBR III.
the complete GBR assessment should be changed to include
_all_ TSEs...
P.S. i wonder how deer/elk feed would be listed on FDA site?
odd with all the products i sent through the list on deer/elk
feed with _animal protein_, i have not seen any warning letters
on deer/elk feed. course, it could be filed with the infamous
and very handy 'non-species coding system' that is used on
imports (i documented here many times).
still disgusted in Bacliff, Texas USA
Terry S. Singeltary Sr.
########### http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############






2001






DEPARTMENT OF HEALTH AND HUMAN SERVICES


Food and Drug Administration


Seattle District

Pacific Region

22201 23rd Drive SE

Bothell, WA 98021-4421


Telephone: 426-486-8788 FAX: 426-483-4996


August 8, 2001


VIA CERTIFIED MAIL

RETURN RECEIPT REQUESTED


In reply refer to Warning Letter SEA 01-75


William W. Himmelspach, Owner

22195 S.W. 78th

Tualatin, Oregon 97062


WARNING LETTER


Dear Mr. Himmelspach:


An investigation at your animal feed manufacturing operation located at

22195 S.W. 78th Tualatin, Oregon 97062, conducted by a Food and Drug

Administration investigator on July 12, 2001, found significant

deviations from the requirements set forth in Title 21, Code of Federal

Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant

Feed. The regulation is intended to prevent the establishment and

amplification of Bovine Spongiform Encephalopathy (BSE). Such deviations

cause products being manufactured at this facility to be adulterated

within the meaning of Section 402(a)(2)(C), and 402(a)(4) of the Federal

Food, Drug and Cosmetic Act (the Act).


Our investigation found a failure to separate the receipt, processing,

and storage of the product containing prohibited material from

non-prohibited material; failure to establish a written system,

including clean-out and flushing procedures, to avoid commingling and

cross-contamination of common equipment; and failure to maintain records

sufficient to track the materials throughout the receipt, processing,

and distribution of your products.


In addition, our investigation found a failure to label your products

with the required cautionary, statement "Do Not Feed to Cattle or Other

Ruminants," Your pig feeds, containing prohibited materials, were not

labeled with the cautionary statement, and you reuse poly-tote bags for

ruminant feed and pig feed, where the bags could become contaminated

with prohibited material. The FDA suggests the statement be

distinguished by different type size or color or other means of

highlighting the statement so that it is easily noticed by a purchaser.


The above is not intended to be an all-inclusive list of deviations from

the regulations. As a manufacturer of materials intended for animal feed

use, you are responsible for assuring that your overall operation and

the products you manufacture and distribute are in compliance with



William W. Himmelspach

Tualatin, Oregon

Re: Warning Letter SEA 01-75

Page 2


your overall operation and the products you manufacture and distribute

are in compliance with the law. We have enclosed a copy of the FDA's

Small Entity Compliance Guide to assist you with complying with the

regulation.


You should take prompt action to correct these violations, and you

should establish a system whereby such violations do not recur. Failure

to promptly correct these violations may result in regulatory action

without further notice, such as seizure and/or injunction.


You should notify this office in writing within 15 working days of

receipt of this letter, of the steps you have taken to bring your firm

into compliance with the law. Your response should include an

explanation of each step being taken to correct the violations, and

prevent their recurrence. If corrective action cannot be completed in 15

working days, state the reason for the delay and the date by which the

corrections will be completed. Include copies of any available

documentation demonstrating that corrections have been made.


Your reply should be directed to the Food and Drug Administration,

Attention: Bruce Williamson, Compliance Officer. If you have any

questions please contact Mr. Williamson at (425) 483-4976.


Sincerely,


Charles M. Breen

District Director


Enclosure;

Form FDA 483

Small Entity Compliance Guide










DEPARTMENT OF HEALTH & HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION


April 9, 2001 WARNING LETTER


01-PHI- 11


CERTIFIED MAIL


RETURN RECEIPT REQUESTED


Eugene P. Yachere, Owner Yachere Feed, Inc. 200 Main Street Rockwood, PA 15557


Dear Mr. Yachere:


Food and Drug Administration Investigator Gregory E. Beichner conducted an inspection of your animal feed manufacturing operation, located in Rockwood, Pennsylvania, on March 14, 2001, and determined that your firm manufactures animal feeds including feeds containing prohibited materials. The inspection found significant deviations from the requirements set forth in Title 21, code of Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy {BSE). Such deviations cause products being manufactured at this facility to be misbranded and adulterated within the meaning of Section 403(f), 402(a) (2) (C), and 402(a) (4) of the Federal Food, Drug, and Cosmetic Act (the Act).


Our inspection found failure to label your poultry feed products with the required cautionary statement "Do Not Feed to Cattle or other Ruminants". The FDA suggests that the statement be distinguished by different type-size or color or other means of highlighting the statement so that it is easily noticed by a purchaser.


Our inspection also found that all animal feeds you manufacture may contain prohibited material since you failed to provide for measures to avoid commingling and cross-contamination of feeds containing prohibited materials with feeds containing no prohibited materials. Additionally, you were unable to provide any documentation including manufacturing/production records which would identify animal feeds processed on the same equipment directly after the manufacture of poultry feeds containing prohibited material.


The above is not intended to be an all-inclusive list of deviations from the regulations. As a manufacturer of materials intended for animal feed use, you are responsible for assuring....









DEPARTMENT OF HEALTH & HUMAN SERVICES

PUBLIC HEALTH SERVICE

FOOD AND DRUG ADMINISTRATION


April 9, 2001 WARNING LETTER


01-PHI-12

CERTIFIED MAIL

RETURN RECEIPT REQUESTED


Brian J. Raymond, Owner

Sandy Lake Mills

26 Mill Street

P.O. Box 117

Sandy Lake, PA 16145

PHILADELPHIA DISTRICT


Tel: 215-597-4390


Dear Mr. Raymond:


Food and Drug Administration Investigator Gregory E. Beichner conducted

an inspection of your animal feed manufacturing operation, located in

Sandy Lake, Pennsylvania, on March 23, 2001, and determined that your

firm manufactures animal feeds including feeds containing prohibited

materials. The inspection found significant deviations from the

requirements set forth in Title 21, code of Federal Regulations, part

589.2000 - Animal Proteins Prohibited in Ruminant Feed. The regulation

is intended to prevent the establishment and amplification of Bovine

Spongiform Encephalopathy (BSE) . Such deviations cause products being

manufactured at this facility to be misbranded within the meaning of

Section 403(f), of the Federal Food, Drug, and Cosmetic Act (the Act).


Our investigation found failure to label your swine feed with the

required cautionary statement "Do Not Feed to cattle or other Ruminants"

The FDA suggests that the statement be distinguished by different

type-size or color or other means of highlighting the statement so that

it is easily noticed by a purchaser.


In addition, we note that you are using approximately 140 pounds of

cracked corn to flush your mixer used in the manufacture of animal

feeds containing prohibited material. This flushed material is fed to

wild game including deer, a ruminant animal. Feed material which may

potentially contain prohibited material should not be fed to ruminant

animals which may become part of the food chain.


The above is not intended to be an all-inclusive list of deviations from

the regulations. As a manufacturer of materials intended for animal

feed use, you are responsible for assuring that your overall operation

and the products you manufacture and distribute are in compliance with

the law. We have enclosed a copy of FDA's Small Entity Compliance Guide

to assist you with complying with the regulation... blah, blah, blah...







WARNING LETTER



June 12, 2001


Mr. Scott Nelson, Owner Integral Fish Foods, Inc. 715 South 7th Street Grand Junction, CO 81501


Ref. #: DEN-01-35


Dear Mr. Nelson,


An inspection of your fish feed manufacturing operation located at Grand Junction, Colorado, conducted by a Colorado Department of Agriculture Inspector on March 20, 2001, found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Such deviations cause products being manufactured and/or distributed by your facility to be adulterated within the meaning of section 402(a)(4) and misbranded within the meaning of Section 403(f) of the Federal Food, Drug, and Cosmetic Act (the Act).


The inspection found that your procedures to prevent cross-contamination are inadequate in that:


You do not have written procedures specifying the clean-out procedures for your feed mixer.


Our investigation also found that you fail to label your products, Fat Cat Catfish Fingerling Feed and Gold Nugget Trout Fry Feed #2 Crumble, each containing meat and bone meal, with the required cautionary statement "Do Not Feed to Cattle or Other Ruminants". The FDA suggests the statement be distinguished by different type size or color or other means of highlighting the statement so that it is easily noticed by a purchaser.


The above is not intended to be an all-inclusive list of violations. As a manufacturer of materials intended for animal feed use, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law. We have enclosed a copy of the FDA's Small Entity Compliance Guide to assist you with complying with the regulations.


Page 2 - Integral Fish Foods, Inc. June 12, 2001


We find it quite disturbing that the above violations STILL EXIST CONSIDERING YOU HAVE BEEN ADVISED ON 2 PREVIOUS OCCASIONS OF THESE REQUIREMENTS, INCLUDING APRIL 7, 1999 and MARCH 6, 2000....




Subject: MAD COW WARNING LETTER AND very sick cows going into food chain...


Date: Tue, 11 Sep 2001 10:35:24 –0700


From: "Terry S. Singeltary Sr."


Reply-To: Bovine Spongiform Encephalopathy







DEPARTMENT OF HEALTH AND HUMAN SERVICES


Food and Drug Administration


Cincinnati District Office

Central Region

6751 Steger Drive

Cincinnati, OH 45237-3097

Telephone: (513) 679-2700

FAX: (513) 679-2771


WARNING LETTER


WL-CIN-9475-01

August 21, 2001


HAND DELIVERY REOUESTED


Barbara J. Hinton, President

The Hyland Co., Inc.

P.O. Box 29

Ashland, KY 41105-0029


Dear Ms. Hinton:


>From 7/24-27/2001 representatives from the Food and Drug Administration

(FDA) and the State of Kentucky conducted an inspection of your feed

mill. The inspection found significant deviations from the requirements

set forth in Title 21, Code of Federal Regulations, Part 589.2000

-Animal Proteins Prohibited in Ruminant Feed. This regulation is

intended to prevent the establishment and amplification of Bovine

Spongiform Encephalopathy (BSE).


The inspection found your firm failed to label feeds that contain, or

may contain, prohibited materials with the required cautionary statement

"Do not feed to Cattle or Other Ruminants". We suggest this statement be

distinguished by different type size or color or other means of

highlighting the statement so it is easily noticed by the purchaser.


Your procedures for cleaning out and/or flushing equipment after mixing

feeds containing prohibited material are not adequate to prevent the

cross-contamination of feeds not formulated to contain prohibited

material.


You should establish adequate procedures and verify that the

flush/clean-out method you use cleans out the remainder of preceding

batches containing prohibited materials. Note: If you flush with feed

ingredients, or sequence with non-ruminant feed, you must also label

these products with the required cautionary statement "Do not feed to

Cattle or Other Ruminants".


The deviations from regulations as noted above cause products being

manufactured and distributed by your facility to be adulterated within

the meaning of Section 402(a)(4) and misbranded within the meaning of

Section 403(0 of the Federal Food, Drug, and Cosmetic Act (the Act).


This letter is not intended to be an all-inclusive list of deficiencies

at your facility. As a manufacturer of materials intended for animal

feed use, you are responsible for assuring that your overall operation

and the products you manufacture and distribute are in compliance with

the law. We have enclosed a copy


Page 1


snip...






DEPARTMENT OF HEALTH AND HUMAN SERVICES


Food and Drug Administration


Cincinnati District Office

Central Region

675t Steger Drive

Cincinnati, OH 45237-3097

Telephone: (513) 679-2700

FAX: (513) 679-2771


WARNING LETTER


WL-CIN-8748-01


CERTIFIED MAIL

RETURN RECEIPT REQUESTED


August 17, 2001


Mark W. Roesner, Owner/President

Copley Feed & Supply

1468 S. Cleveland Massilion Road

CopIcy, OH 44321


Dear Mr. Roesner:


On 6/19,21/2001 a Food and Drug Administration investigator conducted an

inspection of your medicated feed mill located at 1468 S. Cleveland

Massilion Road, Copley, OH. The inspection revealed significant

deviations from the requirements set forth in Title 21, Code of Federal

Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant

Feed. This regulation is intended to prevent the establishment and

amplification of Bovine Spongiform Encephalopathy (BSE).

Our inspection found your firm failed to label feeds that contain, or

may contain, prohibited materials with the required cautionary statement

"Do not feed to Cattle or Other Ruminants"· We suggest this statement be

distinguished by different type size or color or other means of

highlighting the statement so it is easily noticed by the purchaser.

It also revealed that your customer records are not sufficient to track

the distribution of products that contain, or may contain, prohibited

material

The deviations from the BSE regulations, as noted above, cause products

being manufactured and distributed by your facility to be adulterated

within the meaning of Section 402(a)(4) and misbranded within the

meaning of Section 403(f) of the Act.


This letter is not intended to be an all-inclusive list of deficiencies

at your facility. As a manufacturer of materials intended for animal

feed use, you are responsible for assuring that your overall operation

and the products you manufacture and distribute are in compliance with

the law. We have enclosed a copy of the FDA's Small Entity Compliance

Guide to assist you with complying with the regulation. You should take

prompt action to correct these violations, and you should establish a

system whereby violations do not recur. Failure to promptly correct

these violations may result in regulatory action without further notice.

Such actions include seizure and/or injunction.


snip...






DEPARTMENT OF HEALTH AND HUMAN SERVICES


Food and Drug Administration


Cincinnati District Office

Central Region

6751 Steger Drive

Cincinnati, OH 45237-3097

Telephone: (513) 679-2700

FAX: (513) 679-2771



WARNING LETTER


WL-CIN-9099-01


CERTIFIED MAIL

RETURN RECEIPT REQUESTED


August 16, 2001


Charles A. Holdten, CEO/President

Agri-Mark Farmers Co-op, Inc.

813 Clark Avenue

Ashland, OH 44805


Dear Mr. Holdten:


On 7/10,12-13/2001 two Food and Drug Administration investigators

conducted an inspection of your medicated feed mill located at 6800

Chestnut Street, Sterling, OH. The inspection revealed significant

deviations from the requirements set forth in Title 21, Code of Federal

Regulations, Part 589.2000 -Animal Proteins Prohibited in Ruminant Feed.

This regulation is intended to prevent the establishment and

amplification of Bovine Spongiform Encephalopathy (BSE).


Our inspection found your firm failed to label feeds that contain, or

may contain, prohibited materials with the required cautionary statement

"Do not feed to Cattle or Other Ruminants". We suggest this statement be

distinguished by different type size or color or other means of

highlighting the statement so it is easily noticed by the purchaser.


It also revealed that your customer records are not sufficient to track

the distribution of products that contain, or may contain, prohibited

material


The deviations from the BSE regulations, as noted above, cause products

being manufactured and distributed by your facility to 0e adulterated

within the meaning of Section 402(a)(4) and misbranded within the

meaning of Section 403(f) of the Act.


This letter is not intended to be an all.inclusive list of deficiencies

at your facility. As a manufacturer of materials intended for animal

feed use, you are responsible for assuring that your overall operation

and the products you manufacture and distribute are in compliance with

the law. We have enclosed a copy of the FDA's Small Entity Compliance

Guide to assist you with complying with the regulation. You should take

prompt action to coneet these violations, and you should establish a

system whereby violations do not recur. Failure to promptly correct

these violations may result in regulatory action, such as seizure and/or

injunction, without further notice.


Our investigators also found that you mixed and distributed a cattle

feed containing Lincomycin, a drug not indicated for use in cattle.

Further, you did not flush the mixer, storage bins, and bulk truck used

in the manufacture of the feed containing Lincomycin. The failure to

adequately flush this equipment immediately following this feed caused

the subsequent cross-contamination of the cattle feed, dairy cow feed

and calf feeds that were handled in this equipment after the original

product. You should implement procedures and/or practices to prevent the

recurrence of this type of violation.


You should notify this office in writing within fifteen (15) working

days of the receipt of this letter of the steps you have taken to bring

your firm into compliance with the law. Your response should include an

explanation of each step being taken to correct the CGMP violations and

prevent their recurrence. If corrective action cannot be completed

within 15 working days, state the reason for the delay and the date by

which the corrections will be completed. Include copies of any available

documentation demonstrating that corrections have been made.


Your response should be directed to Stephen J. Rabe, Compliance Officer

at the address listed above.


District Director

Cincinnati District


Attachment: Small Entity Compliance Guide


Cc:

Scott A. Crossen, Branch Manager

Agri-Mark Farmers Co-op, Inc.

6800 Chestnut Street

Sterling, OH 44276








WL-CIN-8758-01


August 27, 2001


Terry R. Renner, President F.W. Renner & Sons, Inc. 1866 Sherrick Dr. SE Canton, OH 44701


Dear Mr. Renner:


On 6/19/2001 and 6/22/2001 an FDA investigator conducted and inspection of your rendering plant at 1866 Sherrick Dr. Se, Canton, OH. The inspection revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE).


The inspection found your firm failed to label meat & bone meal that contains, or may contain, prohibited materials with the required cautionary statement "DO NOT FEED TO CATTLE OR OTHER RUMINANTS". We suggest this statement be distinguished by different type size or color or other means of highlighting the statement so it is easily noticed by the purchaser.


The deviations from the BSE regulations, as noted above, cause products being manufactured and distributed by your facility to be misbranded within the meaning of Section 403(f) of the Act.



snip...







2001




Warning Letters Index - Search Form Results Company Name Date Issued
Issuing Office
Subject
File Adrian Elevator, Inc. 5/03/01 Minneapolis District Office Animal
Proteins Prohibited in Ruminant Feed
View File Alaska Garden and Pet Supply, Inc. 4/27/01 Seattle District
Office Animal Proteins Prohibited in Ruminant Feed
View File Bryan Enterprises 2/20/01 Cincinnati District Office Feed
Mill/Animal Proteins Prohibited in Ruminant Feed/Adulterated
View File Carrollton Farmers Exchange 7/12/01 Cincinnati District Office
Animal Proteins Prohibited in Ruminant Feed
View File Centerburg Mill and General Store, Inc 3/23/01 Cincinnati
District Office Animal Proteins Prohibited in Ruminant Feed
View File Centerburg Mill and General Store, Inc. 5/23/01 Cincinnati
District Office Animal Proteins Prohibited in Ruminant Feed
View File Central Ohio Farmers Cooperative, Inc. 5/24/01 Cincinnati
District Office Animal Protein Prohibited in Ruminant Feed
View File Champaign Landmark, Inc. 3/05/01 Cincinnati District Office
Animal Proteins Prohibited in Ruminant Feed/Misbranded
View File Countryline Co-Op, Inc. 5/14/01 Cincinnati District Office
Animal Proteins Prohibited in Ruminant Feed
View File Dorset Milling 4/16/01 Cincinnati District Office Animal
Proteins Prohibited in Ruminant Feed
View File Earl B. Olson Feed Mill 4/23/01 Minneapolis District Office
Animal Proteins Prohibited in Ruminant Feed
View File Faler Feed Store, Inc. 3/21/01 Cincinnati District Office
Animal Proteins Prohibited in Ruminant Feed
View File Farmers Mill & Elevator Company 3/30/01 Atlanta District
Office Animal Proteins Prohibited in Ruminant Feed
View File Farnam Companies, Inc. 7/20/01 Kansas City District Office
Animal Proteins Prohibited in Ruminant Feed/Adulterated
View File Greeley Elevator Company 4/04/01 Denver District Office Animal
Proteins Prohibited in Ruminant Feed
View File Hartville Elevator Company, Inc. 2/22/01 Cincinnati District
Office Feed Mill/Animal Proteins Prohibited in Ruminant Feed/Adulterated
View File Himmelspach, William W. 8/08/01 Seattle District Office Animal
Proteins Prohibited in Ruminant Feed
View File Integral Fish Foods, Inc. 6/12/01 Denver District Office
Animal Proteins Prohibited in Ruminant Feed
View File Jefferson Milling Company 4/16/01 Cincinnati District Office
Animal Proteins Prohibited in Ruminant Feed
View File Lime Creek Ag Services, Inc. 4/25/01 Minneapolis District
Office Animal Proteins Prohibited in Ruminant Feed
View File Material Resources LLC 5/04/01 Chicago District Office Animal
Proteins Prohibited in Ruminant Feed
View File Material Resources, LLC 5/04/01 Chicago District Office Animal
Protein Prohibited in Ruminant Feed
View File Medina Landmark, Inc. 3/23/01 Cincinnati District Office
Animal Proteins Prohibited in Ruminant Feed
View File Minister Farmers Cooperative Exchange, Inc. 4/10/01 Cincinnati
District Office Animal Proteins Prohibited in Ruminant Feed/Feed Mill
View File Peco Foods, Inc. 2/23/01 New Orleans District Office CGMP
Requirements for Medicated Feeds/Animal Proteins Prohibited in Ruminant Feed
View File Perry Coal and Feed Company 4/16/01 Cincinnati District Office
Animal Proteins Prohibited in Ruminant Feed
View File Rietdyk's Milling Company 3/05/01 Seattle District Office
Animal Proteins Prohibited in Ruminant Feed
View File River Valley Co-Op 3/22/01 Cincinnati District Office Animal
Proteins Prohibeted in Ruminant Feed
View File River Valley Co-Op 5/22/01 Cincinnati District Office Animal
Proteins Prohibited in Ruminant Feed
View File Round Lake Farmers Coop. 5/30/01 Minneapolis District Office
Animal Proteins Prohibited in Ruminant Feed
View File Rudy, Inc. 3/22/01 Cincinnati District Office Animal Proteins
Prohibited in Ruminant Feed
View File Rudy, Inc. 5/22/01 Cincinnati District Office Animal Proteins
Prohibited in Ruminant Feed
View File Sandy Lake Mills 4/09/01 Philadelphia District Office Animal
Proteins Prohibited in Ruminant Feed
View File Shields Feed and Supply Company 3/07/01 New Orleans District
Office Animal Proteins Prohibited in Ruminant Feed
View File Stewart's Farm Supply 3/21/01 Cincinnati District Office
Animal Proteins Prohibited in Ruminant Feed
View File Superior Feeds 6/06/01 Seattle District Office Animal Proteins
Prohibited in Ruminant Feed
View File The Scoular Company 5/30/01 Minneapolis District Office Animal
Proteins Prohibited in Ruminant Feed
View File University of Minnesota 5/10/01 Minneapolis District Office
Animal Proteins Prohibited in Ruminant Feed
View File Valley Feed Mill, Inc. 5/22/01 Cincinnati District Office
Animal Proteins Prohibited in Ruminant Feed
View File Wallowa County Grain Growers, Inc. 5/17/01 Seattle District
Office Animal Proteins Prohibited in Ruminant Feed
View File Wallowa County Grain Growers, Inc. 5/17/01 Seattle District
Office Animal Proteins Prohibited in Ruminant Feed
View File Western Reserve Farm Cooperative 3/21/01 Cincinnati District
Office Animal Protein Prohibited in Ruminant Feed
View File Yachere Feed, Inc. 4/09/01 Philadelphia District Office Animal
Proteins Prohibited in Ruminant Feed
View File Z & W Mill, Inc. 3/27/01 Denver District Office Animal
Proteins Prohibited in Ruminant Feed
View File
http://63.75.126.221/scripts/wlcfm/resultswl.cfm






2004



Menu Foods, Inc.
5/19/04

New Jersey District Office Animal Proteins Prohibited in Ruminant Feed
[PDF]
[HTML]
No

Millstone Agri Distributors
5/22/03

Nashville District Office Animal Proteins Prohibited in Ruminant Feed
[PDF]
[HTML]
No

Specialty Brands, Inc.
6/15/04

Dallas District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
[HTML]
No

Zephyr Feed Company
5/28/03

Florida District Office Animal Proteins Prohibited in Ruminant Feed
[PDF]
[HTML]
No

All American Feed & Tractor
4/01/02

Seattle District Office Animal Proteins Prohibited in Ruminant
Feed/Adulterated [PDF]
[HTML]
No

Chapman Ranch
6/10/04

Dallas District Office Animal Proteins Prohibited in Ruminant
Feed/Adulterated [PDF]
[HTML]
No

Fresno Farming LLC
6/23/04

San Francisco District Office Animal Proteins Prohibited in Ruminant
Feed/Adulterated [PDF]
[HTML]
No

Sunnymead Ranch, Inc.
11/07/02

Dallas District Office Animal Proteins Prohibited in Ruminant
Feed/Adulterated [PDF]
[HTML]
No

Van Dyke Grain Elevators Inc
4/17/02

Seattle District Office Animal Proteins Prohibited in Ruminant
Feed/Adulterated [PDF]
[HTML]
No

Halter Feed & Grain, Inc.
4/08/04

Cincinnati District Office Animal Proteins Prohibited in Ruminant
Feed/Adulterated/Misbranded [PDF]

[HTML]
No

Horn's Feed Mill, Inc.
9/26/03

Chicago District Office Animal Proteins Prohibited in Ruminant
Feed/Adulterated/Misbranded [PDF]

[HTML]
No

Parrish & Heimbecker Limited
11/18/04

Seattle District Office Animal Proteins Prohibited in Ruminant
Feed/Adulterated/Misbranded [PDF]

[HTML]
No

B & G Seed Company
6/10/04

Atlanta District Office Animal Proteins Prohibited in Ruminant
Feed/Misbranded [PDF]
[HTML]
No

Bakery Trading Company
7/29/02

Kansas City District Office Animal Proteins Prohibited in Ruminant
Feed/Misbranded [PDF]
[HTML]
No

Bardstown Mill, Inc.
4/08/04

Cincinnati District Office Animal Proteins Prohibited in Ruminant
Feed/Misbranded [PDF]
[HTML]
No

Barr Animal Foods
5/06/03

Minneapolis District Office Animal Proteins Prohibited in Ruminant
Feed/Misbranded [PDF]
[HTML]
No

Darling International, Inc.
5/07/02

Seattle District Office Animal Proteins Prohibited in Ruminant
Feed/Misbranded [PDF]
[HTML]
No

Illini Feeds, Inc.
7/12/04

Chicago District Office Animal Proteins Prohibited in Ruminant
Feed/Misbranded [PDF]
[HTML]
No

Lincoln Land Livestock Co., Inc.
8/25/03

Chicago District Office Animal Proteins Prohibited in Ruminant
Feed/Misbranded [PDF]
[HTML]
No

Premium Nutritional Products, Inc.
4/15/04

Kansas City District Office Animal Proteins Prohibited in Ruminant
Feed/Misbranded [PDF]
[HTML]
No







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




P04.27


Experimental BSE Infection of Non-human Primates: Efficacy of the Oral Route


Holznagel, E1; Yutzy, B1; Deslys, J-P2; Lasmézas, C2; Pocchiari, M3; Ingrosso, L3; Bierke, P4; Schulz-Schaeffer, W5; Motzkus, D6; Hunsmann, G6; Löwer, J1 1Paul-Ehrlich-Institut, Germany; 2Commissariat à l´Energie Atomique, France; 3Instituto Superiore di Sanità, Italy; 4Swedish Institute for Infectious Disease control, Sweden; 5Georg August University, Germany; 6German Primate Center, Germany


Background:


In 2001, a study was initiated in primates to assess the risk for humans to contract BSE through contaminated food. For this purpose, BSE brain was titrated in cynomolgus monkeys.


Aims:


The primary objective is the determination of the minimal infectious dose (MID50) for oral exposure to BSE in a simian model, and, by in doing this, to assess the risk for humans. Secondly, we aimed at examining the course of the disease to identify possible biomarkers.


Methods:


Groups with six monkeys each were orally dosed with lowering amounts of BSE brain: 16g, 5g, 0.5g, 0.05g, and 0.005g. In a second titration study, animals were intracerebrally (i.c.) dosed (50, 5, 0.5, 0.05, and 0.005 mg).


Results:


In an ongoing study, a considerable number of high-dosed macaques already developed simian vCJD upon oral or intracerebral exposure or are at the onset of the clinical phase. However, there are differences in the clinical course between orally and intracerebrally infected animals that may influence the detection of biomarkers.


Conclusions:


Simian vCJD can be easily triggered in cynomolgus monkeys on the oral route using less than 5 g BSE brain homogenate. The difference in the incubation period between 5 g oral and 5 mg i.c. is only 1 year (5 years versus 4 years). However, there are rapid progressors among orally dosed monkeys that develop simian vCJD as fast as intracerebrally inoculated animals.


The work referenced was performed in partial fulfilment of the study “BSE in primates“ supported by the EU (QLK1-2002-01096).






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


Risk of oral infection with bovine spongiform encephalopathy agent in primates


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


snip...


BSE bovine brain inoculum


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


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


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


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


PrPres biochemical detection


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


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


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


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


Published online January 27, 2005








Calves were challenged by mouth with homogenised brain from confirmed cases of BSE. Some received 300g (3 doses of 100g), some 100g, 10g or 1g. They were then left to develop BSE, but were not subjected to the normal stresses that they might have encountered in a dairy herd. Animals in all four groups developed BSE. There has been a considerable spread of incubation period in some of the groups, but it appears as if those in the 1 and 10g challenge groups most closely fit the picture of incubation periods seen in the epidemic. Experiments in progress indicate that oral infection can occur in some animals with doses as low as 0.01g and 0.001g. .........







It is clear that the designing scientists must also have shared Mr Bradley's surprise at the results because all the dose levels right down to 1 gram triggered infection.







6. It also appears to me that Mr Bradley's answer (that it would take less than say 100 grams) was probably given with the benefit of hindsight; particularly if one considers that later in the same answer Mr Bradley expresses his surprise that it could take as little of 1 gram of brain to cause BSE by the oral route within the same species. This information did not become available until the "attack rate" experiment had been completed in 1995/96. This was a titration experiment designed to ascertain the infective dose. A range of dosages was used to ensure that the actual result was within both a lower and an upper limit within the study and the designing scientists would not have expected all the dose levels to trigger infection. The dose ranges chosen by the most informed scientists at that time ranged from 1 gram to three times one hundred grams. It is clear that the designing scientists must have also shared Mr Bradley's surprise at the results because all the dose levels right down to 1 gram triggered infection.







The beef import forecast for the second quarter was unchanged from last month’s, despite pressure from higher-than-expected domestic cow slaughter that has remained high through most of this period. Beef imports into the United States from Australia, New Zealand, and Uruguay provide additional processing beef that, along with domestic cow and bull beef, is mixed with 50-percent trim from fed cattle to make ground beef. Forecast beef exports were raised slightly, mainly on continued (though gradual) improvements in sales to major Asian markets. In late May the World Animal Health Organization – known by its French acronym, OIE – designated the United States as having “controlled risk status” for bovine spongiform encephalopathy, or BSE. This designation reflects the OIE’s view that beef produced in the United States is safe for export, since BSE control measures such as feed bans and removal of specified risk materials result in negligible risk to consumers. However, the OIE standards are only guidelines. Individual countries may adopt differing standards, and those countries that do accept OIE standards must still undertake the bureaucratic processes to revise their rules and procedures.








3rd failed mad cow triple mad cow interlocking safeguard ;



“The third safeguard - which led to this detection - is our ongoing BSE surveillance program that allows USDA to detect the disease if it exists at very low levels in the U.S. cattle population.”





NOW, what about that mad cow BSE surveillance and testing program ???


PAUL BROWN COMMENT TO ME ON THIS ISSUE


Tuesday, September 12, 2006 11:10 AM


"Actually, Terry, I have been critical of the USDA handling of the mad cow issue for some years, and with Linda Detwiler and others sent lengthy detailed critiques and recommendations to both the USDA and the Canadian Food Agency."


OR, what the Honorable Phyllis Fong of the OIG found ;


Audit Report


Animal and Plant Health Inspection Service


Bovine Spongiform Encephalopathy (BSE) Surveillance Program – Phase II


and


Food Safety and Inspection Service


Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat Recovery Products - Phase III


Report No. 50601-10-KC January 2006


Finding 2 Inherent Challenges in Identifying and Testing High-Risk Cattle Still Remain




""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






FINAL REPORT 2ND TEXAS MAD COW




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




-MORE 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 Meats 2 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) # # #




Section 2. Testing Protocols and Quality Assurance Controls


In November 2004, USDA announced that its rapid screening test, Bio-Rad Enzyme Linked Immunosorbent Assay (ELISA), produced an inconclusive BSE test result as part of its enhanced BSE surveillance program. The ELISA rapid screening test performed at a BSE contract laboratory produced three high positive reactive results.40 As required,41 the contract laboratory forwarded the inconclusive sample to the APHIS National Veterinary Services Laboratories (NVSL) for confirmatory testing. NVSL repeated the ELISA testing and again produced three high positive reactive results.42 In accordance with its established protocol, NVSL ran its confirmatory test, an immunohistochemistry (IHC) test, which was interpreted as negative for BSE. In addition, NVSL performed a histological43 examination of the tissue and did not detect lesions44 consistent with BSE.


Faced with conflicting results, NVSL scientists recommended additional testing to resolve the discrepancy but APHIS headquarters officials concluded no further testing was necessary because testing protocols were followed. In our discussions with APHIS officials, they justified their decision not to do additional testing because the IHC is internationally recognized as the "gold standard." Also, they believed that conducting additional tests would undermine confidence in USDA’s established testing protocols.






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.


#




SEE FULL TEXT OF ALL THIS HERE ;


2009 UPDATE ON ALABAMA AND TEXAS MAD COWS 2005 and 2006




ALABAMA MAD COW CASE






Saturday, August 14, 2010


BSE Case Associated with Prion Protein Gene Mutation (g-h-BSEalabama) and VPSPr PRIONPATHY


(see COPIOUS AMOUNTS OF mad cow feed in COMMERCE IN ALABAMA...TSS)




Texas BSE Investigation Final Epidemiology Report August 2005




State-Federal Team Responds to Texas BSE Case


JUNE 30, 2005


(please note 7+ month delay in final confirmation so the BSE MRR policy could be set in stone first. $$$...tss)








SEE ATTEMPTED COVER-UP BEFORE THE END AROUND BY FONG ET AL OF THE O.I.G


The U.S. Department of Agriculture confirmed June 29 that genetic testing had verified bovine spongiform encephalopathy (mad cow disease) in a 12-year-old cow that was born and raised in a Texas beef cattle herd.


Subsequent epidemiological investigations resulted in the culling and testing of 67 adult animals from the index herd. Bio-Rad tests for BSE were conducted on all 67 animals by the National Veterinary Services Laboratory (NVSL) in Ames, Iowa. All tests were negative.


On July 12, Texas officials lifted the quarantine on the source herd. At press time, USDA's Animal and Plant Health Inspection Service was tracing animals of the same age that had left the ranch.


Timeline


The BSE-positive animal was a Brahman-cross cow born and raised in a single Texas herd. The location of the ranch was not disclosed.


On Nov. 11, 2004, the 12-year-old cow was taken to a Texas auction market. Because of its condition, the cow was sent to Champion Pet Foods in Waco, Texas. The company produces several blends of dog food, primarily for the greyhound industry.


On Nov. 15, the animal arrived dead at Champion. Under procedures established by USDA's intensive surveillance program, a sample was sent to the USDA-approved Texas Veterinary Medical Diagnostic Testing Laboratory (TVMDL) at Texas A&M University.


Between June 1, 2004, and June 1, 2005, TVMDL tested nearly 34,000 samples from Texas, New Mexico, Arkansas and Louisiana. They tested the sample from Champion on Nov. 19 using a Bio-Rad ELISA rapid test for BSE. Initial results were inconclusive.


Because of the inconclusive results, a representative from USDA took the entire carcass to TVMDL where it was incinerated. USDA's Animal and Plant Health Inspection Service (APHIS) began tracing the animal and herd.


The sample was then sent to the National Veterinary Services Laboratory for further testing. Two Immunohistochemistry (IHC) tests were conducted and both were negative for BSE. At that point APHIS stopped their trace.


USDA scientists also ran an additional, experimental IHC "rapid" tissue fixation test for academic purposes. This test has not been approved internationally.


Some abnormalities were noted in the experimental test, but because the two approved tests came back negative, the results were not reported beyond the laboratory.


Monitoring by OIG


USDA's Office of Inspector General (OIG) has been monitoring implementation of the BSE expanded surveillance program and evaluating the following:


* Effectiveness of the surveillance program;


* Performance of BSE laboratories in complying with policies and procedures for conducting tests and reporting results;


* Enforcement of the ban on specified risk materials in meat products;


* Controls to prevent central nervous system tissue in advanced meat recovery products;


* Ante mortem condemnation procedures; and


* Procedures for obtaining brain tissue samples from condemned cattle.


While reviewing voluminous records, OIG auditors noticed conflicting test results on one sample-rapid inconclusive, IHC negative, experimental reactive.


Sample retested


At the recommendation of the Inspector General, the sample was retested during the week of June 5 with a second confirmatory test, the Western Blot. The results were reactive.


USDA scientists then conducted an additional IHC confirmatory test, using different antibodies from the November 2004 test. On Friday, June 10, Secretary of Agriculture Mike Johanns publicly announced the results as a "weak positive."


On June 16 an official with USDA's National Veterinary Services Laboratory hand-carried samples for further testing to the Veterinary Laboratory Agency (VLA) in Weybridge, England. Since 1991, the VLA has been a BSE reference laboratory for the World Organization for Animal Health (OIE).


Experts from the Weybridge lab confirmed the accuracy of the results of USDA's November confirmatory IHC test, concurring that the case could not have been confirmed on the basis of this sample. They also examined the November experimental IHC test and interpreted the results to be positive.


Weybridge also conducted additional tests, including IHC, OIE-prescribed Western Blot, NaTTA Western Blot and Prionics Western Blot tests.


To better understand the conflicting results, USDA also conducted Bio-Rad and IDEXX rapid screening tests, IHC and OIE-prescribed Western Blot. USDA also used DNA sequencing to determine the prion protein gene sequence of the animal.




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.




48 hr BSE confirmation turnaround took 7+ months to confirm this case, so the BSE MRR policy could be put into place. ...TSS


-------- Original Message --------


Subject: re-USDA's surveillance plan for BSE aka mad cow disease


Date: Mon, 02 May 2005 16:59:07 -0500


From: "Terry S. Singeltary Sr."


To: paffairs@oig.hhs.gov, HHSTips@oig.hhs.gov, contactOIG@hhsc.state.tx.us


Greetings Honorable Paul Feeney, Keith Arnold, and William Busbyet al at OIG, ...............


snip...


There will be several more emails of my research to follow. I respectfully request a full inquiry into the cover-up of TSEs in the United States of America over the past 30 years. I would be happy to testify...


Thank you, I am sincerely, Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518 xxx xxx xxxx


Date: June 14, 2005 at 1:46 pm PST


In Reply to:


Re: Transcript Ag. Secretary Mike Johanns and Dr. John Clifford, Regarding further analysis of BSE Inconclusive Test Results


posted by TSS on June 13, 2005 at 7:33 pm:


Secretary of Agriculture Ann M. Veneman resigns Nov 15 2004, three days later inclusive Mad Cow is announced. June 7th 2005 Bill Hawks Under Secretary for Marketing and Regulatory Programs resigns. Three days later same mad cow found in November turns out to be positive. Both resignation are unexpected. just pondering... TSS


MAD COW IN TEXAS NOVEMBER 2004. ...TSS


-------- Original Message --------


Subject: Re: BSE 'INCONCLUSIVE' COW from TEXAS ???


Date: Mon, 22 Nov 2004 17:12:15 -0600


From: "Terry S. Singeltary Sr."


To: Carla EverettReferences: [log in to unmask]; [log in to unmask] ;


Greetings Carla, still hear a rumor;


Texas single beef cow not born in Canada no beef entered the food chain?


and i see the TEXAS department of animal health is ramping up for something, but they forgot a url for update?


I HAVE NO ACTUAL CONFIRMATION YET...


can you confirm??? terry


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


-------- Original Message --------


Subject: Re: BSE 'INCONCLUSIVE' COW from TEXAS ???


Date: Fri, 19 Nov 2004 11:38:21 -0600


From: Carla Everett


To: "Terry S. Singeltary Sr."References;[log in to unmask];


The USDA has made a statement, and we are referring all callers to the USDA web site. We have no information about the animal being in Texas.


Carla


At 09:44 AM 11/19/2004, you wrote:


Greetings Carla,


i am getting unsubstantiated claims of this BSE 'inconclusive' cow is from


TEXAS. can you comment on this either way please?


thank you,


Terry S. Singeltary Sr


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


-------- Original Message --------


Subject: Re: BSE 'INCONCLUSIVE' COW from TEXAS ???


Date: Mon, 22 Nov 2004 18:33:20 -0600


From: Carla Everett


To: "Terry S. Singeltary Sr."References: <[log in to unmask]><[log in to unmask] us><[log in to unmask]> <[log in to unmask]us> <[log in to unmask]>


our computer department was working on a place holder we could post USDA's announcement of any results. There are no results to be announced tonight by NVSL, so we are back in a waiting mode and will post the USDA announcement when we hear something.


At 06:05 PM 11/22/2004,


you wrote:


why was the announcement on your TAHC site removed?


Bovine Spongiform Encephalopathy:


November 22: Press Release title here


star image More BSE information


terry


Carla Everett wrote:


no confirmation on the U.S.'inconclusive test...


no confirmation on location of animal. ;


FROM HERE, IT TOOK 7 MONTHS TO CONFIRM THIS MAD COW, while the BSE MRR policy was being bought and sold...(in my opinion...tss)






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)




TEXAS OFFICIALS DEAD WRONG ON AMOUNT OF INFECTIVITY TO CAUSE A TSE PRION DISEASE ;


"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."


5.5 GRAMS OF INFECTIOUS PROHIBITED MAD COW FEED FOR EACH OF THE 1,222 ANIMALS (5.5 GRAMS X 1,222 ANIMALS) IS ENOUGH INFECTIOUS MAD COW FEED TO KILL A SMALL HERD OF COWS...TSS


U.S. Food and Drug Administration FDA News | Today the Food and Drug Administ…U.S. Food and Drug Administration FDA News


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.




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


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.







Wednesday, May 16, 2012




Independent experts should be kept from undue suspicion as well as undue influence




IN REPLY TO ;














P.4.23


Transmission of atypical BSE in humanized mouse models


Liuting Qing1, Wenquan Zou1, Cristina Casalone2, Martin Groschup3, Miroslaw Polak4, Maria Caramelli2, Pierluigi Gambetti1, Juergen Richt5, Qingzhong Kong1 1Case Western Reserve University, USA; 2Instituto Zooprofilattico Sperimentale, Italy; 3Friedrich-Loeffler-Institut, Germany; 4National Veterinary Research Institute, Poland; 5Kansas State University (Previously at USDA National Animal Disease Center), USA


Background: 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). Atypical BSE cases have been discovered in three continents since 2004; they include the L-type (also named BASE), the H-type, and the first reported case of naturally occurring BSE with mutated bovine PRNP (termed BSE-M). The public health risks posed by atypical BSE were largely undefined.


Objectives: To investigate these atypical BSE types in terms of their transmissibility and phenotypes in humanized mice. Methods: Transgenic mice expressing human PrP were inoculated with several classical (C-type) and atypical (L-, H-, or Mtype) BSE isolates, and the transmission rate, incubation time, characteristics and distribution of PrPSc, symptoms, and histopathology were or will be examined and compared.


Results: Sixty percent of BASE-inoculated humanized mice became infected with minimal spongiosis and an average incubation time of 20-22 months, whereas only one of the C-type BSE-inoculated mice developed prion disease after more than 2 years. Protease-resistant PrPSc in BASE-infected humanized Tg mouse brains was biochemically different from bovine BASE or sCJD. PrPSc was also detected in the spleen of 22% of BASE-infected humanized mice, but not in those infected with sCJD. Secondary transmission of BASE in the humanized mice led to a small reduction in incubation time.*** The atypical BSE-H strain is also transmissible with distinct phenotypes in the humanized mice, but no BSE-M transmission has been observed so far.


Discussion: Our results demonstrate that BASE is more virulent than classical BSE, has a lymphotropic phenotype, and displays a modest transmission barrier in our humanized mice. BSE-H is also transmissible in our humanized Tg mice. The possibility of more than two atypical BSE strains will be discussed.


Supported by NINDS NS052319, NIA AG14359, and NIH AI 77774.









MAD COW USDA ATYPICAL L-TYPE BASE BSE, the rest of the story...


***Oral Transmission of L-type Bovine Spongiform Encephalopathy in Primate Model






***Infectivity in skeletal muscle of BASE-infected cattle






***feedstuffs- It also suggests a similar cause or source for atypical BSE in these countries.






***Also, a link is suspected between atypical BSE and some apparently sporadic cases of Creutzfeldt-Jakob disease in humans.






full text ;


atypical L-type BASE BSE






Tuesday, May 1, 2012


BSE MAD COW LETTERS TO USDA (Tom Vilsack, Secretary of Agriculture) and FDA (Magaret Hamburg, Commissioner of FDA) May 1, 2012






Wednesday, May 2, 2012


ARS FLIP FLOPS ON SRM REMOVAL FOR ATYPICAL L-TYPE BASE BSE RISK HUMAN AND ANIMAL HEALTH






Friday, May 4, 2012


May 2, 2012: Update from APHIS Regarding a Detection of Bovine Spongiform Encephalopathy (BSE) in the United States
















Sunday, March 11, 2012


APHIS Proposes New Bovine Spongiform Encephalopathy Import Regulations in Line with International Animal Health Standards Proposal Aims to Ensure Health of the U.S. Beef Herd, Assist in Negotiations






Wednesday, April 4, 2012


Bovine Spongiform Encephalopathy; Importation of Bovines and Bovine Products APHIS-2008-0010-0008 RIN:0579-AC68






Sunday, May 6, 2012


Bovine Spongiform Encephalopathy Mad Cow Disease, BSE May 2, 2012 IOWA State University OIE








SPONTANEOUS ??? NOT...


How the California cow got the disease remains unknown. Government officials expressed confidence that contaminated food was not the source, saying the animal had atypical L-type BSE, a rare variant not generally associated with an animal consuming infected feed.


However, a BSE expert said that consumption of infected material is the only known way that cattle get the disease under natural conditons.


“In view of what we know about BSE after almost 20 years experience, contaminated feed has been the source of the epidemic,” said Paul Brown, a scientist retired from the National Institute of Neurological Diseases and Stroke.


BSE is not caused by a microbe. It is caused by the misfolding of the so-called “prion protein” that is a normal constituent of brain and other tissues. If a diseased version of the protein enters the brain somehow, it can slowly cause all the normal versions to become misfolded.


It is possible the disease could arise spontaneously, though such an event has never been recorded, Brown said.







Friday, May 11, 2012


Experimental H-type bovine spongiform encephalopathy characterized by plaques and glial- and stellate-type prion protein deposits


In addition, the present data will support risk assessments in some peripheral tissues derived from cattle affected with H-type BSE.

















Wednesday, April 25, 2012




USA MAD COW DISEASE AND CJD THERE FROM SINGELTARY ET AL 1999 – 2012








lost my mom to hvCJD ‘confirmed’, and just made a promise. I must keep them honest $$$




senior layperson



Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518















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