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From: TSS ()
Subject: Gov Perry and Ag Comm Susan Combs comment on ''Texas second mad cow'' (what about Texas/USA mad cow feed 2000-2005?)
Date: June 29, 2005 at 9:35 pm PST

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

Media/Press
For Immediate Release: June 29, 2005
Contact: Allen Spelce or Beverly Boyd
(512) 463-7664

Results Of BSE Test Announced

AUSTIN – The Texas Department of Agriculture reported today that DNA has confirmed the 12-year-old cow testing positive for Bovine Spongiform Encephalopathy – commonly known as mad cow disease – was from a Texas herd. The cow, which was originally tested and sampled in November 2004, was blocked and removed from the human food supply last year at the time of testing.

“Texas cattle producers are committed to ensuring that the nation’s beef supply remains safe for all consumers both here and abroad,” Agriculture Commissioner Susan Combs said. “It is important to remember that this animal was banned from the food or feed chain and that long-standing safeguards have been in place to protect public health.”

Because the animal was unable to walk, it was removed from the food supply and was processed at a facility that handles animals unsuitable for human consumption. The carcass was incinerated.

The infected cow was born before the industry’s ban on feeding ruminant-derived protein to cattle.

“Because of progressive steps taken by the U.S. cattle industry and the government and the strong firewalls in place, the American beef supply remains safe. For more than two decades, the government and industry have taken precautions to protect the public health,” Combs said. “Following the discovery of a Canadian-born cow with BSE in Washington state in December 2003, additional safeguards were added.”

In 2003, USDA banned from the human food supply any cattle that are unable to walk or show signs of possible neurological disease. In addition, USDA mandates that material that would most likely carry the BSE agent, such as the brain and spinal cord, be removed from the food supply.

“Last year I met with British veterinarians, researchers and cattle producers in the United Kingdom to learn how the United Kingdom had handled its outbreak of BSE. Their system had clearly been inadequate. This is not the case in the United States,” Combs said. “We have had a nearly 20-year plan with effective safeguards.

“Our strong vigilance should assure consumers that the United States has the safest beef supply in the world,” Combs said.

Texas is the leading cattle state in the nation with 13.8 million head or 15 percent of the total U.S. cattle inventory. In 2004, cattle added $8 billion to the Texas agricultural economy with a total economic impact of $14 billion on the state’s economy.

Return to Media/Press Index

Send Questions and Comments to: contact@agr.state.tx.us

http://www.agr.state.tx.us/media/press_releases/0605/com_062905.htm


Wednesday, June 29, 2005 - 7:21:57 PM
TX Gov. Comments on Mad Cow Disease





From news release:

AUSTIN – Gov. Rick Perry issued the following statement today on the announcement by the U.S. Department of Agriculture that a cow recently tested for Bovine Spongiform Encephalopathy – commonly known as mad cow disease – is from a Texas herd.

“I want to urge calm and reassure the public that they can have the highest confidence in our beef supply, and the safeguards we have in place to protect the public from the spread of BSE. There is not, nor has there ever been, a known instance of BSE contaminating the food supply in Texas or anywhere else in the United States. The animal in question was not processed into food or any other product. Texans can be sure that the beef they buy at their local supermarkets or restaurants is as safe today as it was yesterday, and I encourage Texans to continue to enjoy Texas beef products.”


http://www.kten.com/article.asp?id=8833
http://www.agr.state.tx.us/media/press_releases

how in the hell can beef be safe in Texas after getting caught lying about a Second MAD COW in TEXAS. they did not render that stumbling and staggering cow that showed all signs of BSE without any test at all for nothing. i wish Govern Perry would show me his mad cow crystal ball. we still feed cattle to cattle in TEXAS in 2005 for pete's sake. another mad cow official that is married to the industry. in fact, we feed a single cow 5.5 grams of ruminant feed in Texas, this is _documented_, probably more than that.

some things to ponder?

TEXAS MAD COW FEED INCIDENT ;


THE TEXAS GONZALES/PURINA INCIDENT SHOWED THAT 5.5 GRAMS OF
RUMINANT PROTEIN WAS FED TO CATTLE ;

FOR IMMEDIATE RELEASE
P01-05
January 30, 2001
Print Media:
301-827-6242
Broadcast Media:
301-827-3434
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.

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


GERMAN DER SPIEGEL MAGAZINE

24. Februar 2001

USA

Loch in der Mauer

Die BSE-Angst erreicht Amerika: Trotz strikter Auflagen gelangte in Texas verbotenes Tiermehl ins Rinderfutter - die Kontrollen der Aufsichtsbehörden sind lax.

snip...

"Löcher wie in einem Schweizer Käse" hat auch Terry Singeltary im
Regelwerk der FDA ausgemacht. Der Texaner kam auf einem tragischen Umweg
zu dem Thema: Nachdem seine Mutter 1997 binnen weniger Wochen an der
Creutzfeldt-Jakob-Krankheit gestorben war, versuchte er, die Ursachen
der Infektion
aufzuspüren. Er klagte auf die Herausgabe von
Regierungsdokumenten und arbeitete sich durch Fachliteratur; heute ist
er überzeugt, dass seine Mutter durch die stetige Einnahme von angeblich
kräftigenden Mitteln erkrankte, in denen - völlig legal - Anteile aus
Rinderprodukten enthalten sind.

Von der Fachwelt wurde Singeltary lange als versponnener Außenseiter
belächelt. Doch
mittlerweile sorgen sich auch Experten, dass ausgerechnet diese
verschreibungsfreien Wundercocktails zur Stärkung von Intelligenz,
Immunsystem oder Libido von den Importbeschränkungen ausgenommen
sind. Dabei enthalten die Pillen und Ampullen, die in Supermärkten
verkauft werden, exotische Mixturen
aus Rinderaugen; dazu Extrakte von Hypophyse oder
Kälberföten, Prostata, Lymphknoten und gefriergetrocknetem
Schweinemagen. In die USA hereingelassen werden auch Blut, Fett,
Gelatine und Samen. Diese Stoffe tauchen noch immer in
US-Produkten auf, inklusive Medizin und Kosmetika.

snip...

http://www.spiegel.de/spiegel/0,1518,119306,00.html

BSE/TSE .1 GRAM LETHAL NEW STUDY SAYS via W.H.O. Dr Maura Ricketts
[BBC radio 4 FARM news] (audio realplayer LISTEN)


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


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.

Published online January 27, 2005

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

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


TEXAS MAD COW INCONCLUSIVES IN ORDER ...TSS

#1 TEJAS MAD COW THAT WAS NOT TESTED AT ALL!

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


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

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

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

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

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

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

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

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

OOPS!..........TSS

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

TEJAS BSE COW (3rd inconclusive THAT TURNED UP POSITIVE FOR THE 4TH TIME SOME 7+ MONTHS LATER)

11/18/2004

APHIS Statement Regarding Third Inconclusive BSE Test


http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB?contentidonly=true&contentid=2004/11/0501.xml


RESULTS OF 3RD INCONCLUSIVE

Release No. 0508.04
Contact:
Office Of Communications (202)720 4623




Statement by John Clifford, Deputy Administrator Animal & Plant Health Inspection Service

November 23, 2004

"The USDA National Veterinary Services Laboratories (NVSL) in Ames, Iowa, has determined that the inconclusive screening test sample reported on Nov. 18 has tested negative for BSE upon confirmatory testing.

"The Nov. 18 sample is the first that has tested inconclusive under an APHIS protocol announced in August that calls for public reporting of screening results only after two reactive screens. NVSL used the immunohistochemistry (IHC) test, an internationally-recognized gold standard test for BSE, and received a negative result on Nov. 22. Because the Nov. 18 screening test results were reactive in both the first and second screens, NVSL scientists made the recommendation to run the IHC test a second time. On Nov. 23 they reported the second IHC test was negative. Negative results from both IHC tests make us confident that the animal in question is indeed negative for BSE.

"APHIS began an enhanced surveillance program on June 1 and to date has tested over 121,000 samples for BSE. Screening tests are designed to be extremely sensitive and false positives are not unexpected. APHIS has reported three inconclusives including the Nov. 18 sample and all have tested negative on confirmatory testing."

http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB?contentidonly=true&contentid=2004/11/0508.xml


Public Health Service
Food and Drug Administration

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


February 7, 2005

Ref: 2005-DAL-WL-12

WARNING LETTER

CERTIFIED MAIL
RETURNED RECEIPT REQUESTED

Mr. Dwayne Woody, Owner
W.W. Cattle Company
6391 Old Agnes Road
Poolville, TX 76487

Dear Mr. Woody:

An inspection of your feed manufacturing operation located at 6391 Old
Agnes Road, Poolville, Texas, was conducted on August 27 and September
2, 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). Because you failed to follow the
requirements of this regulation, the corn dogs containing cooked meat
and other ingredients used for manufacturing ruminant feed are
adulterated within the meaning of Section 402(a)(2)(C)(i) and misbranded
within the meaning of Section 403(a)(1) of the Federal, Food, Drug and
Cosmetic Act (the Act).

The use of protein derived from mammalian tissues, as defined in 21 CFR
589.2000(a)(1), as an animal feed ingredient or in animal feeds must
comply with the requirements of 21 CFR 589.2000. That regulation
provides that the use of protein derived from mammalian tissues in
ruminant feed is prohibited. The definition of “protein derived from
mammalian tissues” excludes inspected meat products which have been
cooked and offered for human food, such as the corn dogs you receive,
that have been further heat processed for use in animal feed. This
requirement was previously communicated to you in an April 3, 2001
letter from the Texas State Feed and Fertilizer Control Service. In the
absence of the required further heat processing, such products for use
in ruminant feeds are adulterated under Section 402(a)(2)(C)(i) of the Act.

Our inspection revealed that whole corn dogs which contain protein
derived from mammalian tissues and are sold by your firm to the
[redacted] for use in ruminant feed are not subjected to further
adulterated feed under Section 402(a)(2)(C)(i) of the Act.

In addition, because the whole corn dogs are not subjected to further
heat processing and are thus not exempt from the regulation, they must
bear the caution statement, “Do not feed to cattle or other ruminants.”
Our inspection revealed that they do not bear this caution statement,
which causes them to be misbranded animal feed under Section 403(a)(1)
of the Act.

Copies of the BSE Guidance documents 69, 70 and 76 were provided to Mr.
Billy J. Brooks, General Manager, and further discussed by personnel
from the Texas Feed and Fertilizer Control Service. Also, you received a
copy of the 21 CFR 589.2000, the BSE regulation which was again
explained in more specific detail. These serious violations 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 a
court injunction against further sale of protein derived from mammalian
tissues for use in ruminant feed or ruminant feed containing such materials.

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 that would involve the
continued use of corn dogs to manufacture ruminant feed and provide
specific timeframes for achieving compliance. 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

http://www.fda.gov/foi/warning_letters/g5184d.htm


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

http://www.fda.gov/foi/warning_letters/g5175d.htm

August 10th, 2004, 04:26 PM
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 ORay, CEO & President
Specialty Brands, Inc.
P.O. Box 51467
Ontario, CA 91761-1057

Dear Mr. ORay:

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.

snip...

http://www.fda.gov/foi/warning_letters/g4898d.htm

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.

snip...

http://www.fda.gov/foi/warning_letters/g4899d.htm



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

http://www.fda.gov/foi/warning_letters/g3091d.htm

wonder if any of these cattle got into the feed/food chain for human and animal consumption ?

NEWS RELEASE

Texas Animal Health Commission

Box 12966 • Austin, Texas 78711 • (800) 550-8242 • FAX (512) 719-0719

Linda L. Logan, D.V.M., Ph.D. • Executive Director

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

or ceverett@tahc.state.tx.us

For Immediate Release – April 30, 2001

Sixteen German-Imported Cattle Tested for BSE, All Negative

The National Veterinary Services Laboratory (NVSL) in Ames, Iowa, has reported

there was no evidence of bovine spongiform encephalopathy (BSE) in brain tissue

collected from 16 German-imported cattle euthanized at Texas A&M University in

early April. The animals were imported from Germany to Texas in l996, before BSE was

diagnosed in that country. In l997, BSE was detected in Belgium, and the U.S.

Department of Agriculture (USDA) authorities determined that contaminated feed was

being moved throughout the European Union. The agency then prohibited the importation

of cattle and meat products from the EU.

As a safety precaution, the German-imported cattle in Texas had been restricted to their

premises since March 1997. The animals were transported to Texas A&M University in

early April, where a veterinary team, headed by USDA's Dr. Gary Svetlik, euthanized the

animals and collected brain tissue for testing from each animal. The animal carcasses

were incinerated and did not enter the food chain.

One Texas producer imported four head of the German animals. He sold one animal for

diagnostic purposes and agreed to sell another for testing in about 45 days, but does not

want to sell the remaining two animals. The remaining animals are under restriction and

surveillance by a USDA field veterinarian. The owner also is instructed to report any

health problems so the animals can be re-examined immediately.

---30---

http://www.tahc.state.tx.us/news/pr/2001/2001Apr_german_bse.pdf


United Press International: USDA vet: Texas mad cow breach not unique...
Published 5/4/2004 5:01 PM WASHINGTON

http://www.upi.com/view.cfm?StoryID=20040504-012834-2365r


United Press International: USDA orders silence on mad cow in ...
Published 5/11/2004 10:16 PM WASHINGTON

http://www.upi.com/view.cfm?StoryID=20040511-015527-4917r


Feds reviewing Texas mad cow breach - (United Press International)
By Steve Mitchell United Press International.
Washington, DC, May. 5 (UPI) -- The US Department ...

http://washingtontimes.com/upi-breaking/20040505-064316-1509r.htm


No mad cow tests at Texas firm in 2004
By Steve Mitchell
United Press International

Published 5/14/2004 11:06 AM

WASHINGTON, May 14 (UPI) -- The U.S. Department of Agriculture did not test any cows for mad cow disease in the past seven months at the same Texas facility where federal testing policies for the deadly disorder were violated last month, United Press International has learned.

http://www.upi.com/view.cfm?StoryID=20040513-065401-5285r

USDA Ordered that Suspected Mad Cow in Texas Not Be Tested.
USDA's San Angelo vets and techs ordered not to test suspect cow.
by Daniel ...


USDA Ordered that Suspected Mad Cow in Texas Not Be Tested

USDA's San Angelo vets and techs ordered not to test suspect cow

by Daniel Yovich on 5/5/04 for Meatingplace.com


It was a trio of Agriculture Department staff < two veterinarians and one
technician < who were supposed to follow agency protocol by testing what
they determined was an older cow that likely had a central nervous system
disorder when it arrived April 27 at the Lone Star Beef plant in San Angelo,
Texas.

One government source and another within the industry, both of whom say they
have firsthand knowledge of events that day, said the final call on not to
test the animal was made by an APHIS supervisor in Austin, Texas, after an
APHIS technician at the plant advised her supervisor she was preparing to
take a tissue sample from the culled animal for BSE testing. Both sources
spoke to Meatingplace.com on condition of anonymity, and USDA officials did
not return telephone calls Tuesday seeking comment and confirmation of the
allegations.

What USDA has confirmed is that the agency's standard operating procedures
call for animals condemned due to a possible CNS disorder be kept until
APHIS officials can collect samples for testing. That clearly was done in
this case. The animal sat for more than 90 minutes and less than two hours
after it was condemned, stunned and killed before the APHIS tech told Lone
Star Beef management to dispose of the animal "in a routine manner."

As a condemned cow, there was never any chance that the meat from the animal
would enter the food chain. What is less clear is what went wrong at USDA
and why.

USDA spokesman Ed Loyd said the agency was conducting an investigation into
the issue < attempting to establish a timeline and chronology of who was
involved and who made the decisions last week in San Angelo.

What is clear, in the mind of the two sources who spoke to Meatingplace.com
, is that all three of USDA's key decision makers on the ground at the San
Angelo plant were overruled by a staffer with more authority in Austin.

"Everybody expected a test, and then the word came that there wasn't going
to be any test," one source said. "I'm not sure why that decision was made,
and I'm not going to speculate about the reasons for it. But I think what
USDA is going to find is that the final decision was made up the food chain,
and I think a lot of people will be interested in why that decision was
made."


http://www.organicconsumers.org/madcow/notest050704.cfm

i find it odd that there are no ruminant feed ban violation warning letters documented
before 2001 ???


Archived Warning Letters Index (November 1996 to June 2004) -


Central Ohio Farmers Cooperative, Inc.
5/24/01
Cincinnati District Office Animal Protein Prohibited in Ruminant Feed [PDF]
No
Material Resources, LLC
5/04/01
Chicago District Office Animal Protein Prohibited in Ruminant Feed [PDF]
No
Western Reserve Farm Cooperative
3/21/01
Cincinnati District Office Animal Protein Prohibited in Ruminant Feed [PDF]
No
River Valley Co-Op
3/22/01
Cincinnati District Office Animal Proteins Prohibeted in Ruminant Feed [PDF]
No
Adrian Elevator, Inc.
5/03/01
Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Alaska Garden and Pet Supply, Inc.
4/27/01
Seattle District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Carrollton Farmers Exchange
7/12/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
[HTML]
No
Centerburg Mill and General Store, Inc
3/23/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Centerburg Mill and General Store, Inc.
5/23/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Countryline Co-Op, Inc.
5/14/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Dorset Milling
4/16/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Earl B. Olson Feed Mill
4/23/01
Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Faler Feed Store, Inc.
3/21/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Farmers Mill & Elevator Company
3/30/01
Atlanta District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Greeley Elevator Company
4/04/01
Denver District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Himmelspach, William W.
8/08/01
Seattle District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
[HTML]
No
Integral Fish Foods, Inc.
6/12/01
Denver District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Jefferson Milling Company
4/16/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Lime Creek Ag Services, Inc.
4/25/01
Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Material Resources LLC
5/04/01
Chicago District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Medina Landmark, Inc.
3/23/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Perry Coal and Feed Company
4/16/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Rietdyk's Milling Company
3/05/01
Seattle District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
River Valley Co-Op
5/22/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Round Lake Farmers Coop.
5/30/01
Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Rudy, Inc.
5/22/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Rudy, Inc.
3/22/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Sandy Lake Mills
4/09/01
Philadelphia District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Shields Feed and Supply Company
3/07/01
New Orleans District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Stewart's Farm Supply
3/21/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Superior Feeds
6/06/01
Seattle District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
The Scoular Company
5/30/01
Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
University of Minnesota
5/10/01
Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Valley Feed Mill, Inc.
5/22/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Wallowa County Grain Growers, Inc.
5/17/01
Seattle District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Wallowa County Grain Growers, Inc.
5/17/01
Seattle District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Wilcox Farms, Inc.
9/14/01
Seattle District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
[HTML]
No
Yachere Feed, Inc.
4/09/01
Philadelphia District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Z & W Mill, Inc.
3/27/01
Denver District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Agri-Mark Farmers Co-op, Inc.
8/16/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF]
[HTML]
No
Copley Feed & Supply
8/17/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF]
[HTML]
No
Dixon Feeds, Inc.
10/24/01
Seattle District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF]
[HTML]
No
Farnam Companies, Inc.
7/20/01
Kansas City District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF]
[HTML]
No
Finlayson Ag Center
11/08/01
Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF]
[HTML]
No
The Hyland Co., Inc.
8/21/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF]
[HTML]
No
Buckeye Feed Mills, Inc.
9/20/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded [PDF]
[HTML]
No
The Feed Bucket
12/11/01
Atlanta District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded [PDF]
[HTML]
No
Minister Farmers Cooperative Exchange, Inc.
4/10/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Feed Mill [PDF]
No
Champaign Landmark, Inc.
3/05/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF]
No
F.W. Renner & Sons, Inc.
8/27/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF]
[HTML]
No
Tyson Foods
2/12/02
Seattle District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF]
[HTML]
No
Morcher GmbH
3/21/01


http://www.accessdata.fda.gov/scripts/wlcfm/subject_archive.cfm?FL=A


The page lists Warning Letters issued between June 2004 and June 2005

Menu Foods, Inc.
5/19/04
New Jersey District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
[HTML]
No
Millstone Agri Distributors
5/22/03
Nashville District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
[HTML]
No
Specialty Brands, Inc.
6/15/04
Dallas District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
[HTML]
No
Zephyr Feed Company
5/28/03
Florida District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
[HTML]
No
All American Feed & Tractor
4/01/02
Seattle District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF]
[HTML]
No
Brown Cattle Company
1/12/05
Dallas 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
W.W. Cattle Company
2/07/05
Dallas 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
A&A Services
4/06/05
San Francisco District Office Animal Proteins Prohibited in Ruminant Feed/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
Sunshine Mills, Inc.
12/09/04
New Orleans District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF]
[HTML]
No

http://www.accessdata.fda.gov/scripts/wlcfm/subject.cfm?FL=A



BSE Inspection Update

CVM Reports BSE Inspection Figures as of March 5 2005


As of March 5, 2005, the Food and Drug Administration (FDA) had received more than 35,000 reports of inspections done under the ruminant feed rule designed to prevent the establishment and spread of bovine spongiform encephalopathy (BSE) in the United States.

Approximately 70 percent of the inspections were conducted by State officials under contract to FDA, with the remainder conducted by FDA officials.

Inspections conducted by State and FDA investigators are classified to reflect the compliance status at the time of the inspection, based upon whether objectionable conditions were documented. Based on the conditions found, inspection results are recorded in one of three classifications:

• OAI (Official Action Indicated) when inspectors find significant objectionable conditions or practices and believe that regulatory sanctions are warranted to address the establishment’s lack of compliance with the regulation. An example of an OAI classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspectors will promptly re-inspect facilities classified OAI after regulatory sanctions have been applied to determine whether the corrective actions are adequate to address the objectionable conditions.

• VAI (Voluntary Action Indicated) when inspectors find objectionable conditions or practices that do not meet the threshold of regulatory significance, but warrant an advisory to inform the establishment that inspectors found conditions or practices that should be voluntarily corrected. VAI violations are typically technical violations of the 1997 BSE Feed Rule. These violations include minor recordkeeping lapses or conditions involving non-ruminant feeds.

• NAI (No Action Indicated) when inspectors find no objectionable conditions or practices or, if they find objectionable conditions, those conditions are of a minor nature and do not justify further actions.

(Note: The following figures are as of March 5.)

Renderers

These firms are the first to handle and process (i.e., render) animal proteins. After they process the material, they send it to feed mills and/or protein blenders for use as a feed ingredient.

• Number of active firms whose initial inspection has been reported to FDA – 255

• Number of active firms handling materials prohibited from use in ruminant feed – 169 (66 percent of those active firms inspected)

Of those 169 firms:

v 1 (0.6 percent) was classified as OAI

v 6 (3.5 percent) were classified as VAI

Licensed feed mills

• In the inspection report database, FDA lists medicated feed licensed feed mills separately from non-licensed feed mills. But the licensing has nothing to do with handling prohibited materials under the feed ban regulation. FDA requires feed mills to have medicated feed licenses to manufacture and distribute feed using certain potent drug products, usually those requiring some pre-slaughter withdrawal time, to produce certain medicated feed products.

• Number of active firms whose initial inspection has been reported to FDA – 1,066

• Number of active firms handling materials prohibited from use in ruminant feed – 402 (38 percent of those active firms inspected)

Of those 402 firms:

v 1 (0.2 percent) was classified as OAI

v 9 (2.2 percent) were classified as VAI

Feed Mills Not Licensed by FDA

These feed mills are not licensed by the FDA to produce medicated feeds.

• Number of active firms whose initial inspection has been reported to FDA – 5,133

• Number of active firms handling materials prohibited from use in ruminant feed – 1,785 (35 percent of those active firms inspected)

Of those 1,785 firms:

v 4 (0.2 percent) were classified as OAI

v 30 (1.7 percent) were classified as VAI

Protein blenders

These firms blend rendered animal protein for the purpose of producing feed ingredients used by feed mills.

• Number of active firms whose initial inspection has been reported to FDA – 302

• Number of active firms handling materials prohibited from use in ruminant feed – 86 (28 percent of those active firms inspected)

Of those 86 firms:

v 0 were classified as OAI

v 3 (3.5 percent) were classified as VAI

Renderers, feed mills, protein blenders

This category includes any firm that is represented by any of the above four categories, but includes only those firms that manufacture, process or blend animal feed or feed ingredients using prohibited materials.

• Number of active renderers, feed mills, and protein blenders whose initial inspection has been reported to FDA – 6,526

• Number of active renderers, feed mills, and protein blenders processing with prohibited materials – 568 (8.7 percent of those active firms inspected)

Of those 568 firms:

v 6 (1.1 percent) were classified as OAI

v 22 (3.9 percent) were classified as VAI

Other firms inspected

Examples of such firms include ruminant feeders, on-farm mixers, pet food manufacturers, animal feed salvagers, distributors, retailers and animal feed transporters.

• Number of active firms whose initial inspection has been reported to FDA – 12,009

• Number of active firms handling materials prohibited from use in ruminant feed – 3,001 (30 percent of those active firms inspected)

Of those 3,001 firms:

v 11 (0.4 percent) were classified as OAI

v 89 (3.0 percent) were classified as VAI

Total Firms

• Number of active firms whose initial inspection has been reported to FDA – 15,249

• Number of active firms handling materials prohibited from use in ruminant feed – 3,804 (25 percent of those active firms inspected)

Of those 3,804 firms:

v 13 (0.3 percent) were classified as OAI

v 95 (2.5 percent) were classified as VAI

(Note: A single firm that has more than one function can be listed in different industry segments, which also means that the total may be less than a combination of all the segments.)
Regulatory Activities


The following individuals and firms received Warning Letters for offering animals for slaughter that contained illegal tissue residues:

• David L. and Nancy E. Huebner, Owners, Huebner Farm, Columbus, WI

• Daniel W. Thuemmel, President, Thuemmel Dairy, Inc., Port Austin, MI

• Jay L. DeJong, Owner, Rhody Dairy, Sumas, WA

The above violations involved penicillin, gentamicin, and flunixin in dairy cows.

Warning Letters were issued to Roger Nutsch, Partner, U R Farms, Jerome, ID; Daniel W. Nolan, Owner, Nolan Livestock, Bonduel, WI; and Laurens A.T.M. Schilderink, President, Spandet Dairy, Inc., Hart, TX, because investigations found they were offering animals for slaughter that contained illegal tissue residues. The investigations further revealed deviations from rules for Extralabel Drug Use in Animals. The extralabel use of approved animal drugs by veterinarians is allowed by law, provided that the regulations contained in 21 CFR Part 530 are followed. Extralabel use of an approved animal drug that is not in compliance with the regulations renders the drug unsafe under Section 512 and thus adulterated under Section 501(a)(5) of the Federal Food, Drug, and Cosmetic Act (the Act.).

A Warning Letter was issued to -Joseph A. Gingerich, Co-Owner, Prime Veal Feed, Ltd., Kensington, OH, for selling and dispensing veterinary prescription drug products without a lawful order from a licensed veterinarian, which caused the products to be misbranded within the meaning of Section 503(f)(1)(C) of the Act. Examples of veterinary prescription drugs dispensed without the order from a licensed veterinarian include Banamine (flunixin meglumine), Micotil (tilmicosin), and Nuflor (florfenicol). In addition, these prescription veterinary drugs were misbranded within the meaning of 502(f)(1) of the Act because they did not bear adequate directions for use, and they do not fall into an exception to that requirement. FDA has defined “adequate directions for use” as “directions under which the layman can use a drug safely and for the purposes for which it is intended.” Inspection also revealed the firm dispensed Flunixin Meglumine Injection bearing a Dexamethasone label and Selenium-Vitamin E Injection (Mu-Se) bearing an Amoxicillin label. These drugs are misbranded under section 502(a) of the Act, because labeling is false or misleading, and 502(i)(3), in that they were offered for sale under the name of another drug. In addition, the inspection found the dispensing of human prescription drugs, such as Sulfamethoxazole and Trimethoprim tablets, Cephalexin capsules, and Amoxicillin capsules, for extralabel use in animals.

A Warning Letter was issued to Alan O. Bostick, President, Sunshine Mills, Inc., Red Bay, AL, because inspection at his feed manufacturing facility in Tupelo, MS, revealed significant deviations from the requirements sent forth in Title 21, Code of Federal Regulations (CFR), Part 589.2000 – Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of bovine spongiform encephalopathy. The inspection indicated the manufacturing of products containing beef meat and bone meal that require the cautionary statement, “Do not feed to cattle or other ruminants,” and the firm failed to label the products with this statement. Specifically, the products that contained protein derived from mammalian tissues, but lacked the required statement included “Happy Fishman” and “Premier” catfish feeds.

A Warning Letter was issued to -William B. Parrish, Chairman of the Board, Parrish & Heimbecker, Limited, Winnipeg, Manitoba, Canada, because inspection of his feed mill operation, Conway Feed, Inc., located in Conway, WA, found significant deviations from the requirements set forth in 21 CFR 589.2000. The investigation found that because the operation failed to adequately inspect the label of a raw material, an ingredient with the cautionary statement “Do not feed to cattle or other ruminants” was used in the manufacture of the finished product Game Bird Crum/Pellet. This final product did not display the cautionary statement that is required because this fish meal may contain prohibited animal proteins. Any product produced from the fish meal must also have the cautionary label. The investigation also revealed that the label of the Game Bird Crum/Pellet feed did not list fish meal as an ingredient. According to the information collected during the inspection fish meal is routinely added to this ration. Pursuant to 21 CFR 501.4(a), all ingredients required to be listed on the label in descending order of predominance by weight.

Correction

The November/December 2004 issue of FDA Veterinarian incorrectly listed in the Regulatory Activities section the location of Lake Country Veterinary Service, P.S. It is in Albany, MN

http://www.fda.gov/cvm/January2005.htm#5168

July/August 2004

BSE INSPECTION UPDATE

FDA Reports Latest BSE Inspection Figures

As of July 17, the Food and Drug

Administration (FDA) had received

more than 31,000 reports of inspections

done under the ruminant feed

rule designed to prevent the establishment

and spread of bovine spongiform

encephalopathy (BSE) in the

United States.

Approximately 70 percent of the inspections

were conducted by State of-

fi cials under contract to FDA, with the

remainder conducted by FDA offi cials.

Inspections conducted by State

and FDA investigators are classifi ed

to refl ect the compliance status at the

time of the inspection, based upon

whether objectionable conditions were

documented. Based on the conditions

found, inspection results are recorded

in one of three classifi cations:

• OAI (Offi cial Action Indicated)

when inspectors fi nd signifi cant objectionable

conditions or practices

and believe that regulatory sanctions

are warranted to address the

establishment’s lack of compliance

with the regulation. An example of

an OAI classifi cation would be fi ndings

of manufacturing procedures insuffi

cient to ensure that ruminant feed

is not contaminated with prohibited

material. Inspectors will promptly

re-inspect facilities classifi ed OAI

after regulatory sanctions have been

applied to determine whether the

corrective actions are adequate to address

the objectionable conditions.

• VAI (Voluntary Action Indicated)

when inspectors fi nd objectionable

conditions or practices that do

not meet the threshold of regulatory

signifi cance, but warrant an

advisory to inform the establishment

that inspectors found conditions or

practices that should be voluntarily

(Continued, next page)

FDA VETERINARIAN JULY/AUGUST 2004 7

corrected. VAI violations are typically

technical violations of the 1997 BSE

Feed Rule. These violations include

minor recordkeeping lapses or conditions

involving non-ruminant feeds.

• NAI (No Action Indicated) when

inspectors fi nd no objectionable

conditions or practices or, if they

fi nd objectionable conditions, those

conditions are of a minor nature and

do not justify further actions.

(Note: The following fi gures are as of

July 17.)

Renderers

These fi rms are the fi rst to handle

and process (i.e., render) animal proteins.

After they process the material,

they send it to feed mills and/or protein

blenders for use as a feed ingredient.

• Number of active fi rms whose initial

inspection has been reported to

FDA – 244

• Number of active fi rms handling

materials prohibited from use in

ruminant feed – 161 (66 percent of

those active fi rms inspected)

• Of those 161 fi rms:

. 0 were classifi ed as OAI

. 4 (2.5 percent) were classifi ed as

VAI

Licensed feed mills

In the inspection report database,

FDA lists medicated feed licensed feed

mills separately from non-licensed feed

mills. But the licensing has nothing to

do with handling prohibited materials

under the feed ban regulation. FDA

requires feed mills to have medicated

feed licenses to manufacture and distribute

feed using certain potent drug

products, usually those requiring some

pre-slaughter withdrawal time, to produce

certain medicated feed products.

• Number of active fi rms whose initial

inspection has been reported to

FDA – 1,081

• Number of active fi rms handling

materials prohibited from use in

FDA Reports Latest BSE Inspection Figures (Continued)

ruminant feed – 367 (34 percent of

those active fi rms inspected)

• Of those 367 fi rms:

. 3 (0.8 percent) were classifi ed as

OAI

. 5 (1.4 percent) were classifi ed as

VAI

Feed Mills Not Licensed by FDA

These feed mills are not licensed by

the FDA to produce medicated feeds.

• Number of active fi rms whose initial

inspection has been reported to

FDA – 5,059

• Number of active fi rms handling

materials prohibited from use in

ruminant feed – 1,358 (27 percent

of those active fi rms inspected)

• Of those 1,358 fi rms:

. 6 (0.4 percent) were classifi ed as

OAI

. 36 (2.7 percent) were classifi ed

as VAI

Protein blenders

These fi rms blend rendered animal

protein to produce feed ingredients

used by feed mills.

• Number of active fi rms whose initial

inspection has been reported to

FDA – 267

• Number of active fi rms handling

materials prohibited from use in

ruminant feed – 67 (25 percent of

those active fi rms inspected)

• Of those 67 fi rms:

. 1 (1.5 percent) was classifi ed as

OAI

. 2 (3.0 percent) were classifi ed as

VAI

Renderers, feed mills, protein

blenders

This category includes any fi rm that

is represented by any of the above four

categories, but includes only those

fi rms that manufacture, process or

blend animal feed or feed ingredients

using prohibited materials.

• Number of active renderers, feed

mills, and protein blenders whose

initial inspection has been reported

to FDA – 6,452

• Number of active renderers, feed

mills, and protein blenders processing

with prohibited materials – 556

(8.6 percent of those active fi rms

inspected)

• Of those 556 fi rms:

. 8 (1.4 percent) were classifi ed as

OAI

. 19 (3.4 percent) were classifi ed

as VAI

Other fi rms inspected

Examples of such fi rms include ruminant

feeders, on-farm mixers, pet food

manufacturers, animal feed salvagers,

distributors, retailers and animal feed

transporters.

• Number of active fi rms whose initial

inspection has been reported to

FDA – 10,915

• Number of active fi rms handling

materials prohibited from use in

ruminant feed – 2,205 (20 percent

of those active fi rms inspected)

• Of those 2,205 fi rms:

. 16 (0.7 percent) were classifi ed

as OAI

. 76 (3.4 percent) were classifi ed

as VAI

Total Firms

• Number of active fi rms whose initial

inspection has been reported to

FDA – 14,355

• Number of active fi rms handling

materials prohibited from use in

ruminant feed – 2,901 (20 percent

of those active fi rms inspected)

• Of those 2,901 fi rms:

. 17 (0.6 percent) were classifi ed

as OAI

. 86 (3.0 percent) were classifi ed

as VAI

(Note: A single fi rm that has more than

one function can be listed in different industry

segments, which also means that

the total may be less than a combination

of all the segments.)

http://www.fda.gov/cvm/Documents/JulAug04.pdf


Animal Drugs and Feeds
Selected FY 2004 Accomplishments

USING RISK-BASED MANAGEMENT PRACTICES
Bovine Spongiform Encephalopathy (BSE)
a.. For fiscal year 2004, inspected over 6,806 renderers, feed mills, and other firms, including on-farm mixers and ruminant feeders, to determine compliance with the BSE feed regulations. At the end of the FY 2004, 17 firms were classified as being out of compliance at the time of their last inspection. Re-inspections of these facilities determined to be out of compliance with the BSE regulation are still on-going;

b.. FDA and state investigators specifically inspected a high-interest subset of 645 firms as part of our annual BSE performance goal feed inspections obligation. This subset represented 100 percent of all known renderers and feed mills processing products containing prohibited material;

c.. In July 2004, co-published with USDA an advanced notice of proposed rulemaking (ANPRM) requesting comments and scientific information on several additional regulatory measures that would strengthen the feed regulation;

d.. Developed a real-time Polymerase Chain Reaction (PCR) based method capable of detecting cattle, swine, sheep, goats, horses, or deer material along with poultry, goose, and turkey for use in analyzing samples of animal feeds and feed ingredients in support of the animal protein prohibition;

e.. Evaluated two commercially available diagnostic test marketed to detect mammalian proteins in animal feed and feed ingredients;

f.. Issued 10 Warning Letters for animal proteins prohibited in ruminant feed, and 15 class II recalls involving 15 firms and 25 products in response to violations of the BSE rule;

g.. Issued assignments for collection of 600 samples from domestic animal feeds, 300 samples of animal feeds imported from countries not considered at risk for BSE, and 300 samples of animal feeds imported from countries considered at risk for BSE for subsequent feed analysis to determine possible non-compliance with the ruminant feed ban regulation and the import alert prohibiting importation of feeds containing animal tissues;

h.. Provided separate formal ruminant feed ban inspection training seminars to feed safety officials in the states of Montana, Washington, Oregon, New York, Wisconsin, Oklahoma, and Idaho;

i.. Participated in BSE working groups at three separate meetings of the Association of American Feed Control Officials;

j.. Provided staffing to the FDA and USDA/APHIS emergency operation centers, tracking the distribution and disposition of suspect material, communicating with state authorities, and overseeing the final disposition of destruction of suspect material after discovery of a BSE-infected cow in the U.S.; and,

k.. Issued Guidance for Industry (GFI #174) for the disposition of material from BSE positive cattle in animal feed.

http://www.fda.gov/cvm/CVMAccomp.htm

MAD COW FEED BAN VIOLATIONS 2003

Consent Decree of Permanent Injunction Filed Against X-Cel Feeds, Inc. Based on Violations of 1997 Animal Feed Rule

On July 11, 2003, FDA announced the filing of a Consent Decree of Permanent Injunction against X-Cel, Feeds Inc., and individual officers based on violations of the Food, Drug, and Cosmetic Act. In the Consent Decree, the Firm and officers admitted liability for introducing adulterated and misbranded animal feeds into interstate commerce and agreed to implement measures to correct the violations under FDA’s supervision.
X-Cel, a feed manufacturer headquartered in Tacoma, Washington, failed to comply with FDA regulations (the 1997 Animal Feed Rule) designed to prevent the establishment and spread of Bovine Spongiform Encephalopathy (BSE, also known as “Mad Cow Disease”) should it ever be found in the United States and FDA regulations concerning the manufacture of medicated feeds.

“No case of BSE has ever been documented in the U.S., despite aggressive surveillance, said FDA Commissioner Mark B. McClellan, M.D., Ph.D. “FDA’s animal feed regulations provide a firewall against BSE, and we are committed to strictly enforcing the rules that protect Americans from this disease.”

The Department of Justice, Civil Division, Office of Consumer Litigation and the United States Attorney’s Office of the Western District of Washington filed the Consent Decree in the United States District Court of the Western District in Tacoma, Washington. It permanently enjoins X-Cel from manufacturing animal feeds in violation of the Food, Drug, and Cosmetic Act and requires the firm, its officers, and employees to take specific steps to avoid future violations including, implementing clean-out procedures, obtaining protein supplier certifications and implementing standard operating procedures for compliance until it satisfies FDA that it has corrected its problems.

FDA’s animal feed regulations protect the United States from the potential threat of BSE by prohibiting the use of certain proteins derived from mammalian tissue in the feed for cattle and other ruminant animals.

In addition, FDA and the State regulatory agencies have increased the number of inspections of renderers, animal feed manufacturers, and other firms responsible for keeping prohibited mammalian protein out of cattle and other ruminant feed. U.S. industry compliance with the 1997 Animal Feed Rule currently exceeds 99 percent.
In order to prevent the establishment and spread of BSE in the United States the Animal Feed Rule requires animal feed manufacturers to: (1) take measures (including cleaning) to prevent contamination of ruminant feeds with mammalian proteins prohibited in ruminant feeds; (2) maintain sufficient records to track the mammalian proteins prohibited in ruminant feeds through their receipt, processing, and distribution; and (3) label animal feeds that contain mammalian proteins prohibited in ruminant feed with the required cautionary statement “Do not feed to cattle or other ruminants.”

snip...

Draft Guidance on Use of Material From Deer and Elk in Animal Feed; CVM Updates on Deer and Elk Withdrawn???

FDA has announced the availability of a draft guidance for industry entitled “Use of Material from Deer and Elk in Animal Feed.” This draft guidance document (GFI #158), when finalized, will describe FDA’s current thinking regarding the use in animal feed of material from deer and elk that are positive for Chronic Wasting Disease (CWD) or that are at high risk for CWD.

CWD is a neurological (brain) disease of farmed and wild deer and elk that belong in the cervidae animal family (cervids). Only deer and elk are known to be susceptible to CWD by natural transmission. The disease has been found in farmed and wild mule deer, white-tailed deer, North American elk, and farmed black-tailed deer. CWD belongs to a family of animal and human diseases called transmissible spongiform encephalopathies (TSEs). TSEs are very rare, but are always fatal.

This draft Level 1 guidance, when finalized, will represent the Agency’s current thinking on the topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternate method may be used as long as it satisfies the requirements of applicable statutes and regulations.

Draft guidance #158 is posted on the FDA/Center for Veterinary Medicine Home Page. Single copies of the draft guidance may be obtained from the FDA Veterinarian.


http://www.fda.gov/cvm/Jul_Aug03.htm#2101

http://www.fda.gov/cvm/Jul_Aug03.htm#2108


2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed


EMC 1
Terry S. Singeltary Sr.
Vol #:
1

http://www.fda.gov/ohrms/dockets/dailys/03/Jun03/060903/060903.htm


2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed


EMC 7
Terry S. Singeltary Sr.
Vol #:
1

2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed


EMC 7
Terry S. Singeltary Sr.
Vol #:
1


http://www.fda.gov/ohrms/dockets/dailys/03/oct03/100203/100203.htm


FDA VETERINARIAN SEPTEMBER/OCTOBER 2003 16

practices were found during the inspection

or the significance of the documented

objectionable conditions found

does not justify further actions.

The results to date are reported here

both by "segment of industry" and "in

total". NOTE – A single firm can operate

as more than one firm type. As a result,

the categories of the different industry

segments are not mutually

exclusive.

Renderers

These firms are the first to handle and

process (i.e., render) animal proteins and

to send these processed materials to feed

mills and or protein blenders for use as

a feed ingredient.

• Number of active firms whose initial

inspection has been reported to

FDA – 234

• Number of active firms handling materials

prohibited from use in ruminant

feed – 157 (67% of those active

firms inspected.)

• Of the 157 active firms handling prohibited

materials, their most recent

inspection revealed that:

. 0 firms (0%) were classified as OAI.

. 7 firms (4.5%) were classified as

VAI.

Liscensed Feed Mills

FDA licenses these feed mills to produce

medicated feed products. The license

is required to manufacture and

distribute feed using certain potent drug

products, usually those requiring some

pre-slaughter withdrawal time. This licensing

has nothing to do with handling

prohibited materials under the feed ban

regulation. A medicated feed license

from FDA is not required to handle materials

prohibited under 21 CFR

589.2000.

• Number of active firms whose initial

inspection has been reported to

FDA – 1,110

• Number of active firms handling materials

prohibited from use in ruminant

feed – 300 (27% of those active

firms inspected.)

• Of the 300 active firms handling prohibited

materials, their most recent

inspection revealed that:

. 2 firms (0.7%) were classified as

OAI.

. 15 firms (5.0%) were classified as

VAI.

Feed Mills Not Licensed by FDA

These feed mills are not licensed by

the FDA to produce medicated feeds.

• Number of active firms whose initial

inspection has been reported to

FDA – 5,084

• Number of active firms handling materials

prohibited from use in ruminant

feed – 579 (11% of those active

firms inspected.)

• Of the 579 active firms handling prohibited

materials, their most recent

inspection revealed that:

. 2 firms (0.3%) were classified as

OAI.

. 98 firms (17%) were classified as

VAI.

Protein Blenders

These firms blend rendered animal

protein for the purpose of producing a

quality feed ingredients that will be used

by feed mills.

• Number of active firms whose initial

inspection has been reported to

FDA – 220

• Number of active firms handling materials

prohibited from use in ruminant

feed – 62 (28% of those active

firms inspected.)

• Of the 62 active firms handling prohibited

materials, their most recent

inspection revealed that:

. 0 firms (0%) were classified as OAI.

. 4 firms (6.5%) were classified as

VAI.

Other Firms Inspected

Examples of such firms include ruminant

feeders, on-farm mixers, pet food

manufacturers, animal feed salvagers,

distributors, retailers, and animal feed

transporters.

• Number of active firms whose initial

inspection has been reported to

FDA – 6,905

• Number of active firms handling materials

prohibited from use in ruminant

feed – 1,053 (15% of those active

firms inspected)

• Of the 1,053 active firms handling

prohibited materials, their most recent

inspection revealed that:

. 3 firms (0.3%) were classified as

OAI.

. 137 firms (13%) were classified as

VAI.

Total Firms

Note that a single firm can be reported

under more than one firm category;

therefore, the summation of the

individual OAI/VAI firm categories will

be more than the actual total number of

OAI/VAI firms, as presented below.

• Number of active firms whose initial

inspection has been reported to

FDA – 11,375

• Number of active firms handling materials

prohibited from use in ruminant

feed – 1,664 (15% of those active

firms inspected)

• Of the 1,664 active firms handling

prohibited materials, their most recent

inspection revealed that:

. 6 firms (0.4%) were classified as

OAI.

. 171 firms (10%) were classified as

VAI.

Ruminant Feed (BSE) Enforcement Activities (Continued)

FDA VETERINARIAN SEPTEMBER/OCTOBER 2003 17

http://www.fda.gov/cvm/Documents/Sep-Oct03.pdf


RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES AS OF March 11, 2002

To help prevent the establishment and amplification of BSE through feed in the United States, FDA implemented a final rule that prohibits the use of most mammalian protein in feeds for ruminant animals. This rule, Title 21 Part 589.2000 of the Code of Federal Regulations, became effective on August 4, 1997. To date, active monitoring by the U.S. Department of Agriculture (USDA) has found no cases of bovine spongiform encephalopathy (BSE) in U.S. cattle. This is an update on FDA enforcement activities regarding the ruminant feed (BSE) regulation.

FDA's enforcement plan for the ruminant feed regulation includes education, as well as inspections, with FDA taking compliance actions for intentional or repeated non-compliance. FDA's Center for Veterinary Medicine (CVM) has assembled data from the inspections that have been conducted AND whose final inspection report has been submitted to CVM (i.e., "inspected/reported") as of March 11, 2002. There is a lag time between the completion of an inspection and the submission of a final inspection report to CVM. This lag period includes the time required to conduct quality assurance on the report and to evaluate the findings before a final report is submitted.

As of March 11, CVM had received inspection reports covering inspections (both initial inspections and re-inspections) of 10,458 different firms. The majority of these inspections (around 80%) were conducted by State officials under contract to FDA and the remainder by FDA officials.

Various segments of the feed industry had different levels of compliance with this feed ban regulation. The results to date are reported here both by "segment of industry" and "in total".

RENDERERS

(These firms are the first to handle rendered protein and send materials to feed mills and ruminant feeders.)

a.. NUMBER OF FIRMS WHOSE INITIAL INSPECTION HAS BEEN REPORTED TO CVM - 239

b.. NUMBER OF FIRMS HANDLING MATERIALS PROHIBITED FOR USE IN RUMINANT FEED - 171 (72% of those firms inspected/reported).

c.. Of the 171 renderers handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection):
- 4 (2%) had products that were not labeled as required
- 3 (2%) did not have adequate systems to prevent co-mingling
- 1 (1%) did not adequately follow record keeping regulations
- 4 (2%) firms were found to be out of compliance (some firms were out of compliance with more than one aspect of the rule)

FDA LICENSED FEED MILLS

(FDA licenses these mills to produce medicated feed products. This licensing has nothing to do with handling prohibited materials under the feed ban rule: 21 CFR 589.2000. A license from FDA is not required to handle materials prohibited under 21 CFR 589.2000.)

a.. NUMBER OF FIRMS WHOSE INITIAL INSPECTION HAS BEEN REPORTED TO CVM - 1,203

b.. NUMBER OF FIRMS HANDLING MATERIALS PROHIBITED FOR USE IN RUMINANT FEED - 370 (31% of those firms inspected/reported)

c.. Of the 370 licensed feed mills handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection):
- 8 (2%) had products that were not labeled as required
- 2 (1%) did not have adequate systems to prevent co-mingling
- 3 (1%) did not adequately follow record keeping regulations
- 10 (3%) firms were found to be out of compliance (some firms were out of compliance with more than one aspect of the rule)

FEED MILLS NOT LICENSED BY FDA

a.. NUMBER OF FIRMS WHOSE INITIAL INSPECTION HAS BEEN REPORTED TO CVM - 4,867

b.. NUMBER OF FIRMS HANDLING MATERIALS PROHIBITED FOR USE IN RUMINANT FEED - 1,224 (25% of those firms inspected/reported)

c.. Of the 1,224 feed mills not licensed by FDA handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection):
- 55 (4%) had products that were not labeled as required
- 28 (2%) did not have adequate systems to prevent co-mingling
- 28 (2%) did not adequately follow record keeping regulations
- 86 (7%) firms were found to be out of compliance (some firms were out of compliance with more than one aspect of the rule)

OTHER FIRMS INSPECTED

(Examples of such firms include: ruminant feeders, on-farm mixers, protein blenders, and distributors.)

a.. NUMBER OF FIRMS WHOSE INITIAL INSPECTION HAS BEEN REPORTED TO CVM - 4,710

b.. NUMBER OF FIRMS HANDLING MATERIALS PROHIBITED FOR USE IN RUMINANT FEED - 565 (12% of those firms inspected/reported)

c.. Of the 565 such firms handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection):
- 17 (3%) had products that were not labeled as required
- 2 (less than 1%) did not have adequate systems to prevent co-mingling
- 7 (1%) did not adequately follow record keeping regulations
- 25 (4%) firms were found to be out of compliance (some firms were out of compliance with more than one aspect of the rule)

TOTALS (as of March 11, 2002)

a.. NUMBER OF FIRMS WHOSE INITIAL INSPECTION HAS BEEN REPORTED TO CVM - 10,458

b.. NUMBER OF FIRMS HANDLING MATERIALS PROHIBITED FOR USE IN RUMINANT FEED - 2,153 (21% of those firms inspected/reported)

c.. Of the 2,153 firms handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection):
- 77 (4%) had products that were not labeled as required
- 34 (2%) did not have adequate systems to prevent co-mingling
- 35 (2%) did not adequately follow record keeping regulations
- 113 (5%) firms were found to be out of compliance

RE-INSPECTIONS

When firms are found to be out of compliance with the feed ban rule, FDA lists them for a re-inspection. As of March 11, 2002, reports of 2,185 re-inspections have been submitted to CVM. On re-inspection of these 2,185 firms, 32 (1%) were found still to be out of compliance with this rule. Firms previously found to be not in compliance have corrected problems through a variety of ways, including further training of employees about the rule, developing systems to prevent co-mingling, re-labeling their products properly, and adhering to record keeping regulations. Other firms have achieved compliance by eliminating prohibited materials from their operations.

DATABASE CHANGE

After March 11, 2002, FDA discontinued the database that was used to compile these numbers. The Agency is starting a new database on April 15, 2002, and future updates on BSE enforcement will draw from it.

http://www.fda.gov/cvm/May_June02.htm#2276

2001 MAD COW FEED VIOLATION REPORT



RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES

To help prevent the establishment and amplification of BSE through feed in the United States, FDA implemented a final rule that prohibits the use of most mammalian protein in feeds for ruminant animals. This rule, Title 21 Part 589.2000 of the Code of Federal Regulations, became effective on August 4, 1997. To date, active monitoring by the U.S. Department of Agriculture (USDA) has found no cases of bovine spongiform encephalopathy (BSE) in U.S. cattle.

This is an update on FDA enforcement activities regarding the ruminant feed (BSE) regulation. FDA previously provided information on this issue in three CVM UPDATEs, most recently one on July 6, 2001.

FDA's enforcement plan for the ruminant feed regulation includes education, as well as inspections, with FDA taking compliance actions for intentional or repeated non-compliance. As part of the enforcement plan, an initial inspection assignment was issued to all FDA District Offices in 1998 to conduct inspections of 100% of all renderers and known feed mills to determine compliance. Additional assignments have been issued to FDA District Offices regarding (1) further initial inspections of previously unknown firms potentially handling materials prohibited in ruminant feed and (2) re-inspections of firms found on initial inspection to be out of compliance with this regulation.

FDA's Center for Veterinary Medicine (CVM) has assembled data from the inspections that have been conducted AND whose final inspection report has been submitted to CVM (i.e., "inspected/reported") as of October 26, 2001. There is a lag time between the completion of an inspection and the submission of a final inspection report to CVM. This lag period includes the time required to conduct quality assurance on the report and to evaluate the findings before a final report is submitted.

As of October 26, 2001, CVM had received inspection reports covering inspections (both initial inspections and re-inspections) of 10,018 different firms. The majority of these inspections (around 80%) were conducted by State officials under contract to FDA and the remainder by FDA officials.

Various segments of the feed industry had different levels of compliance with this feed ban regulation. The results to date are reported here both by "segment of industry" and "in total".

RENDERERS

(These firms are the first to handle rendered protein and send materials to feed mills and ruminant feeders.)

a.. Estimated number of rendering firms in the U.S. — 264

b.. Number of firms that have received an initial inspection — 264

c.. Number of firms whose initial inspection has been reported to CVM — 232

d.. Number of firms handling materials prohibited for use in ruminant feed — 174 (75% of those firms inspected/reported).

e.. Of the 174 renderers handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection):

a.. 8 (5%) had products that were not labeled as required

b.. 6 (3%) did not have adequate systems to prevent co-mingling

c.. 2 (1%) did not adequately follow record keeping regulations

d.. 13 (7%) firms were found to be out of compliance (some firms were out of compliance with more than one aspect of the rule)

FDA LICENSED FEED MILLS

(FDA licenses these mills to produce medicated feed products. This licensing has nothing to do with handling prohibited materials under the feed ban rule: 21 CFR 589.2000. A license from FDA is not required to handle materials prohibited under 21 CFR 589.2000.)

a.. Number of FDA licensed feed mills in the U.S. as of October 26, 2001 — 1,231

b.. Number of firms that have received an initial inspection —1,240

c.. Number of firms whose initial inspection has been reported to CVM — 1,181

d.. Number of firms handling materials prohibited for use in ruminant feed — 406 (34% of those firms inspected/reported)

e.. Of the 406 licensed feed mills handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection):

a.. 24 (6%) had products that were not labeled as required

b.. 25 (6%) did not have adequate systems to prevent co-mingling

c.. 3 (1%) did not adequately follow record keeping regulations

d.. 42 (10%) firms were found to be out of compliance (some firms were out of compliance with more than one aspect of the rule)

FEED MILLS NOT LICENSED BY FDA

(FDA does not know the total number of these feed mills because they are not required to be licensed by FDA.)

a.. Estimated number of feed mills not licensed by FDA in the U.S. — 6,000-8,000

b.. Number of firms whose initial inspection has been reported to CVM — 4,835

c.. Number of firms handling materials prohibited for use in ruminant feed —1,439 (30% of those firms inspected/reported

d.. Of the 1,439 feed mills not licensed by FDA handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection):

a.. 133 (9%) had products that were not labeled as required

b.. 78 (5%) did not have adequate systems to prevent co-mingling

c.. 82 (6%) did not adequately follow record keeping regulations

d.. 228 (16%) firms were found to be out of compliance (some firms were out of compliance with more than one aspect of the rule

OTHER FIRMS INSPECTED

(Examples of such firms include: ruminant feeders, on-farm mixers, protein blenders, and distributors.)

a.. Estimated number of such firms in the U.S. — unknown

b.. Number of firms whose initial inspection has been reported to CVM — 4,237

c.. Number of firms handling materials prohibited for use in ruminant feed — 629 (15% of those firms inspected/reported)

d.. Of the 629 such firms handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection):

a.. 56 (9%) had products that were not labeled as required

b.. 21 (3%) did not have adequate systems to prevent co-mingling

c.. 27 (4%) did not adequately follow record keeping regulations

d.. 81 (13%) firms were found to be out of compliance (some firms were out of compliance with more than one aspect of the rule)

TOTALS (as of October 26, 2001)

a.. Number of firms whose initial inspection has been reported to CVM — 10,018

b.. Number of firms handling materials prohibited for use in ruminant feed — 2,501 (25% of those firms inspected/reported)

c.. Of the 2,501 firms handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection):

a.. 204 (8%) had products that were not labeled as required

b.. 116 (5%) did not have adequate systems to prevent co-mingling

c.. 106 (4%) did not adequately follow record keeping regulations

d.. 333 (13%) firms were found to be out of compliance (some firms were out of compliance with more than one aspect of the rule. These 333 firms will be re-inspected in the near future.)

RE-INSPECTIONS

When firms are found to be out of compliance with the feed ban rule, FDA lists them for a re-inspection. As of October 26, 2001, reports of 1,719 re-inspections have been submitted to CVM. On re-inspection of these 1,719 firms, 108 (6%) were found still to be out of compliance with this rule. Firms previously found to be not in compliance have corrected problems through a variety of ways, including further training of employees about the rule, developing systems to prevent co-mingling, re-labeling their products properly, and adhering to record keeping regulations. Other firms have achieved compliance by eliminating prohibited materials from their operations.

http://www.fda.gov/cvm/nov_dec01.htm#2358

2000 MAD COW PROTEIN DETECTION

November/December 2000 FDA Veterinarian

CVM sponsored a session at the

International Workshop on Diagnostics

of Transmissible Spongiform

Encephalopathies (TSEs) devoted to

its efforts to develop methods for detecting

prohibited protein in animal

feed. The workshop, sponsored by

FDA and the National Institutes of

Health (NIH), was held September

20 – 22, 2000, at the NIH campus in

Bethesda, MD. CVM Director Dr.

Stephen Sundlof opened the session,

followed by remarks from session

co-chairs Dr. Dan McChesney and Dr.

Avraham Rasooly. Other sessions at

the workshop focused on the latest

developments in antemortem and

postmortem diagnostic tests to detect

TSEs in man and other animals.

In seeking diagnostic tools to enforce

the mammalian-to-ruminant

feed ban, CVM drew on the BSE experience

of Europeans by inviting

speakers from the United Kingdom

(UK), Switzerland, and Italy to discuss

their tests and other efforts to control

the spread of TSEs through animal

feed. Among many distinguished

presenters, Dr. Mike Ansfield, Ministry

of Agriculture Fisheries and Food,

UK, talked about the challenges, both

CVM CONTINUES WORK ON METHODS TO DETECT PROHIBITED

PROTEIN

by Burt Pritchett, D.V.M., and Dragan Momcilovic, D.V.M.

scientific and regulatory, in enforcing

the UK feed ban, which is similar to

the U.S. feed ban. Dr. Lucas Perler,

Swiss Veterinary Authority, Switzerland,

gave an overview of the BSE situation

in Europe, with emphasis on the

highly regarded and highly effective

active surveillance program employed

by the Swiss to detect BSE in

their cattle population. France has

already begun using a similar surveillance

program and other European

countries are considering adopting it.

Dr. David Taylor, Sedecon 2000, UK,

elaborated on safety of meat and

(Continued, next page)

17

bone meal. Dr. Christoph von Holst,

European Union, Joint Research Center,

Italy, specified the validation criteria

for methods for detection of

prohibited ingredients in feed.

Dr. Don Franco, National Renderers

Association, elaborated on steps

and measures that his association

performs in order to maintain the

safety of the U.S. meat and bone

meal, while Dr. James Makowski presented

feed microscopy as a means

for detection of prohibited material.

Dr. Mike Myers, CVM, talked about

FDA’s validation of a method that is

based on use of polymerase chain reaction

(PCR). Dr. Dragan Momcilovic,

CVM, gave an overview on other

methods for detection of prohibited

materials in ruminant feed and elaborated

on the potential for their improvement

in the future.

Methods currently in use to detect

proteins in feed are inadequate for

reliably determining whether a

sample of animal feed complies with

the existing regulation. Development

of new methods for that purpose is

an important task that faces not only

FDA but also our European counterparts.

Dr. Pritchett is a Biologist with

CVM’s Feed Safety Team in the Division

of Animal Feeds. Dr. Momcilovic

is a Medicated Feed Specialist with

CVM’s Medicated Feeds Team in the

Division of Animal Feeds.

. . . WORK ON METHODS TO DETECT PROHIBITED PROTEIN (Continued)

http://www.fda.gov/cvm/Documents/november.PDF


FDA Statement
FOR IMMEDIATE RELEASE
Statement
June 24, 2005
Media Inquiries:
Suzanne Treviño, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Statement on USDA BSE Positive Test Results
"The Food and Drug Administration, along with the USDA, is committed to ensuring the safety of the U.S. human food and animal feed supply from BSE (bovine spongiform encephalopathy). Today we saw that the system worked. The safety measures that FDA and USDA have put in place successfully kept this animal that has tested positive for BSE out of the food and feed supply. These existing safeguards have proven extremely effective, and the American public should feel secure in knowing that the current animal feed rule already provides significant protection against the spread of BSE. We will continue to work closely with the USDA on this important public health issue and evaluate every option to strengthen the 1997 animal feed ban."

####

http://www.fda.gov/bbs/topics/NEWS/2005/NEW01193.html

TSS

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