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From: TSS ()
Date: February 22, 2005 at 9:33 am PST

-------- Original Message --------
Date: Tue, 22 Feb 2005 08:35:20 -0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy

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

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



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.


Michael A. Chappell
Dallas District Director


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