| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Minneapolis District Office |
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
RETURN RECEIPT REQUESTED
Refer to MIN 11 – 42
Clint A. Sampson
Clint Sampson Farm
N2906 Selmer Road
Melrose, Wisconsin 54642
Dear Mr. Sampson:
On May 23 and 24, 2011, the Food and Drug Administration (FDA) conducted an investigation of your beef cattle operation located at N2906 Selmer Road, Melrose, Wisconsin. This letter notifies you of 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 December 29, 2010, you consigned and sold a beef cow identified with back tag (b)(4) for slaughter as food. On or about December 29, 2010, (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 tilmicosin at 26.74 parts per million (ppm) in the liver and flunixin at 7.15 ppm in the liver. FDA has established a tolerance of 1.2 ppm for residues of tilmicosin in liver tissue of cattle as codified in Title 21, Code of Federal Regulations, section 556.735 (21 CFR 556.735) and a tolerance of 0.125 ppm for residues of flunixin in the liver tissue of cattle per 21 CFR 556.286. The presence of these drugs 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 and you lack an adequate inventory system for determining the quantities of drugs used to medicate your livestock. 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 tilmicosin (b)(4), tilmicosin phosphate) and flunixin (b)(4), flunixin meglumine). Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs in this manner is an extralabel use per 21 CFR 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 CFR 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.
During our investigation we found that you had several prescription new animal drugs on your farm that you claimed were used when you had a dairy operation, for which you did not have valid prescriptions from your veterinarian. These new animal drugs included the following: tilmicosin (b)(4), tilmicosin phosphate) and flunixin (b)(4), flunixin meglumine). Your use of these prescription new animal drugs was not by or on the lawful written or oral order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship in violation of sections 512(a)(4) and (5) of the Act, 21 U.S.C. § 360b(a)(4) and (5). Because your use of these drugs was not by or on the lawful written or oral order of a licensed veterinarian 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).
Our investigation found that you administered tilmicosin to a beef cow without following the withdrawal period as stated in the approved labeling. Also, our investigation found that you administered tilmicosin and flunixin to a beef cow beyond their labeled expiration dates. Your extralabel use of tilmicosin and flunixin was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a) and your extralabel use of these drugs resulted in illegal drug residues, in violation of 21 CFR 530.11(d). Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 CFR 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).
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 are 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 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 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 Timothy G. Philips, Compliance Officer, at the address on this letterhead. If you have any questions about this letter, please contact Mr. Philips at (612) 758-7133.
Gerald J. Berg