Inspections, Compliance, Enforcement, and Criminal Investigations
Walk, William M. 06-Dec-02
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60861
December 6, 2002
RETURN RECEIPT REQUESTED
William M. Walk, Co-Owner
RR 1, P.O. Box 133A
Sigel, IL 62464
Dear Mr. Walk:
An investigation of your livestock grower partnership conducted on 11/4/02, found that a beef steer from your establishment was offered for sale for slaughter as human food in violation of Section 402(a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act (Act).
On 8/26/02, a steer was sold for slaughter as human food to [redacted] USDA analysis of tissue samples collected from that animal identified the presence of 1.07 parts per million (ppm) sulfadimethoxine in the liver tissue, and 0.28 ppm in the muscle tissue. The established tolerance level for sulfadimethoxine in cattle is 0.1 ppm (Title 21, Code of Federal Regulations, Section 556.640). The presence of tilmicosin at 2.86 ppm in the kidney tissue was also identified. There is no established tolerance level for this drug in kidney tissue. The presence of these drugs in the edible tissue from this animal causes the food to be adulterated under the Act.
Our investigations also found that you lack an adequate system for assuring that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues from edible tissue. You need to implement a system in which to record and maintain permanent drug treatment records that will adequately identify drug treated animals.
The above is not intended as an all-inclusive list of violations. As a producer of animals offered for human consumption, you are responsible for assuring that your overall operation and the food products you produce for distribution are in compliance with the law.
You should take prompt action to correct the violation, and you should establish procedures whereby such a violation does not recur. Failure to promptly correct the violation may result in regulatory action being initiated by FDA without further informal notice. These actions may include, but are not limited to, seizure and/or injunction.
Please advise 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 each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your response should be directed to Richard Harrison, Director, Compliance Branch.
Arlyn H. Baumgarten