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
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.
#
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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
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.
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
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 ;
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
######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html
##########
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:
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
######### http://mailhost-alt.rz.uni-karlsruhe.de/warc/bse-l.html
##########
-------- 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:
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 #
################
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:
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
########### http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html
############
-------- 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 ???
http://www.thomasveterinarydrug.com/mailorder/catalog/default.php?manufacturers_id=11&sort=1a&page=4
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
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
########### http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html
############
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
LoweÃs 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
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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