Himmelspach, William W. 12/4/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Ave SE, Suite 210
Bothell, WA 98021-4425
December 4, 2013
In reply, please refer to Warning Letter SEA 14-02
William W. Himmelspach, Owner
29595 Northwest Timber Road
Timber, Oregon 97144-9222
Dear Mr. Himmelspach:
On August 30, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dealer/hauler operation located at 29595 Northwest Timber Road, Timber, Oregon. Our investigation confirmed that a bob veal calf, identified with back tag (b)(4), sold by you on or about April 9, 2013, for slaughter for human food to (b)(4) located at (b)(4), was in violation of section 402(a)(2)(C)(ii), 21 U.S.C. § 342(a)(2)(C)(ii), of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov.
United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of flunixin in the kidney tissue, and sulfamethazine at 222.76 parts per million (ppm) in the liver tissue and at 119.96 ppm in the muscle tissue. In accordance with the approved labeling for flunixin, this drug is not permitted for use in calves to be processed for veal that may result in a residue. As such, there is no acceptable level of residue of flunixin in calves to be processed for veal. FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the uncooked edible tissues of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.670 (21 C.F.R. 556.670). Therefore, the presence of these drugs in edible tissues from this animal in these amounts causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).
The above is not intended to be an all-inclusive list of violations. As a dealer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.
You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction. As a dealer of animals, you are frequently the individual who introduces or offers for introduction into interstate commerce, the adulterated animal. As such, you share responsibility for violating the Federal Food, Drug, and Cosmetic Act. To avoid future illegal residue violations you should take precautions such as:
1. Implementing a system to identify the animals you purchase with records to establish traceability to the source of these animals.
2. Implementing a system to determine from the source of these animals whether the animals have been medicated and with what drug(s); and
3. If the animals have been medicated, implementing a system to withhold the animals from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissues. If you do not want to hold the medicated animals, then they should not be offered for human food, and they should be clearly identified and sold as a medicated animal.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. 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 fifteen (15) working days of receiving this letter, 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 written response should be sent to Patricia A. Pinkerton, Compliance Officer, U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4425. If you have any questions about this letter, please contact Compliance Officer Patricia Pinkerton at 425-302-0428.
Gerald D. Bromley, Jr.
Acting District Director
cc: Dr. Brad LeaMaster, State Veterinarian
Oregon State Department of Agriculture
Animal Health and Identification Division
635 Capitol Street NE
Salem, Oregon 97310-2532
cc: Dr. Paul Kohrs, Acting State Veterinarian
Washington State Department of Agriculture
P.O. Box 42560
Olympia, Washington 98504-2560