Inspections, Compliance, Enforcement, and Criminal Investigations
Troyer, Todd 12/22/08
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Cincinnati District Office|
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771
December 22, 2008
VIA FEDERAL EXPRESS
Todd Troyer, Owner
5701 Rosedale Milford Center Road
London, Ohio 43140
Dear Mr. Troyer:
On July 24, 28 and, August 1 and 26, 2008, the U.S. Food and Drug Administration (FDA) conducted an investigation of your veal operation located at 5701 Rosedale Milford Center Road London, OH 43140. 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 webpage 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 where by it may have been rendered injurious to health.
Specifically, our investigation revealed that on or about February 14, 2008, you sold a veal calf, for slaughter as food through the [(b)(4)], Ohio. At the time you sold the calf, it did not have any identification tag or sticker. On or about February 15, 2008 [(b)(4)], Pennsylvania, slaughtered this animal which, by that time, had been identified by [(b)(4)], with backtag number [(b)(4)]. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 99.30 parts per million (ppm) neomycin in the kidney of this animal. A tolerance of 7.2 ppm has been established for residues of neomycin in the kidney tissue of cattle, as codified in Title 21, Code of Federal Regulations, 556.430 (21 CFR 556.430). However, this tolerance does not apply to use of NeoMed 325 in veal calves, and there is no acceptable level of residue associated with use of NeoMed 325 in veal calves.
In addition, USDA/FSIS analysis of tissue samples collected from this animal identified the presence of .22 ppm sulfamethoxazole in the liver and .27 ppm sulfamethoxazole in the muscle of this animal. USDA/FSIS analysis of tissue samples collected from this animal also identified the presence of .075 ppm flunixin in the liver and .021 ppm flunixin in the muscle of this animal. FDA has not established a tolerance for sulfamethoxazole or flunixin residues in the edible tissues of veal calves. The presence of these drugs in edible tissues from this animal 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 complete drug treatment records for your medicated animals. 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 drugs neomycin, sulfamethoxazole and flunixin. Specifically, our investigation revealed that you did not use neomycin, sulfamethoxazole and flunixin as directed by their approved labeling. The use of these drugs 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 added neomycin and sulfamethoxazole to milk replacer and fed it to your calves. The extralabel use of approved animal or human drugs is prohibited in or on feed by 21 U.S.C. § 360b(a)(4) and 21 C.F.R. 530.11(b). We also found that you used neomycin and sulfamethoxazole without following the route of administration or withdrawal times prescribed by your veterinarian. These uses violate section 512(a) of the Act, 21 U.S.C. § 360b(a). We also found that you use flunixin outside your veterinarian's prescription in that you give a shot of flunixin to all calves that show signs of illness, such as runny nose, teary eyes, drooping ear, or fever. Your veterinarian's prescription sheet lists the indications for use for flunixin as pain killer, anti-inflammatory, and antitoxin.
Further, your extralabel use of neomycin, sulfamethoxazole and flunixin resulted in tissue residues which may present a risk to the public health, in violation of 21 C.F.R. 530.11(c). Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs 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).
In addition, you adulterated animal feed within the meaning of section 501(a)(6), 21 U.S.C. § 351(a)(6) when you added neomycin and sulfamethoxazole-trimethoprim, to milk replacer. The addition of these drugs to milk replacer caused that animal feed to be unsafe under section 512(a)(2) of the Act, 21 U.S.C. § 360b(a)(2), and adulterated under section 501(a)(6) of the Act, 21 U.S.C. § 351(a)(6).
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.
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 Stephen J. Rabe, Compliance Officer, U.S. Food and Drug
Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Mr. Rabe at 513-679-2700 ext. 163 or the address listed above.
Theresa C. Thompson
cc: Dr. Jeffery L. Pyle, Owner
Manchester Veterinary Clinic and Supply
11798 N. State Road 13
Manchester, IN 46962