| Public Health Service Food and Drug Administration |
Detroit District |
Department of Health and Human Services
WARNING LETTER
2010-DT- 14
June 4, 2010
VIA UPS
Timothy A. Troyer, Owner
Harold Troyer, Owner
Troyer Farms
3378 South 500 East
Laotto, Indiana 46763
Dear Messrs. Troyer:
On March 9 and 10, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 3378 South 500 East, Laotto, Indiana. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov.
We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.
Specifically, our investigation revealed that on or about August 11, 2009, you sold a dairy cow, identified with backtag (b)(4) for slaughter as food. On or about August 12, 2009, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 1.0512 parts per million (ppm) of flunixin in the liver tissue and the presence of gentamicin residue in the kidney tissue. FDA has established a tolerance of 0.125 ppm for residues of flunixin in the liver of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.286 (21 C.F.R. 556.286). FDA has not established a tolerance for residues of gentamicin in the uncooked edible tissues of cattle. 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 Act, 21 U.S.C. § 342(a)(2)(C)(ii).
Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).
We also found that you adulterated the new animal drug gentamicin sulfate. Specifically, our investigation revealed that you did not use gentamicin sulfate as directed by its approved labeling or in the manner prescribed by your licensed veterinarian. Use of this drug in this manner is an extralabel use (21 C.F.R. 530.3(a)).
The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.
Our investigation found that you administered gentamicin sulfate to the cow identified with back tag (b)(4) without following the withdrawal period of 30 days contrary to the use prescribed by your veterinarian. Your extralabel use of gentamicin sulfate was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a) and your extralabel use of gentamicin sulfate resulted in an illegal drug residue in violation of 21 C.F.R. 530.11 (c). Because your use of this drug was not in conformance with its approved labeling or the use prescribed by your veterinarian and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the Act, 21 U.S.C. § 351(a)(5).
The above is not intended to be an all-inclusive list of violations. As a producer 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.
Scientific evidence indicates that gentamicin sulfate will remain in the tissues of animals up to eighteen (18) months. Prior to the use of gentamicin sulfate, you should consult with your veterinarian and other medical resources to determine an appropriate withdrawal period before you introduce into interstate commerce an animal for slaughter that may have illegal residues.
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 Tina M. Pawlowski, PhD., Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions about this letter, please contact Compliance Officer Pawlowski at 313-393-8217.
Sincerely,
/S/
Joan M. Given
District Director
Detroit District Office
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