February 12, 2002 Food and Drug Administration
DEPARTMENT OF HEALTH AND HUMUN 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
John Tyson, Chairman of the Board and CEO
Tyson Foods
3701 Johnson Road
Springdale, Arkansas 72762
WARNING LETTER
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 2
1, 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
John Tyson, Chairman of the Board and CEO
Tyson Foods, Springdale, Arkansas
Re:IBP Inc., Wallula, Washington
Re: Warning Letter SEA 02-29
Page 2
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 Offtcer, 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.
Charles M. Breen
District Director
cc: Raymond F. McGaugh, Assistant Vice President/Plant Manager
IBP Inc.
P.O. Box 4239
Pasco, Washington 99363
Enclosure: Form FDA 483
Small Entity Compliance Guide
