February 12, 2002 Food and Drug AdministrationDEPARTMENT 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
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
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