Public Health Service
Food and Drug Administration
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761
July 25, 2014
William E. Rausch, Owner
R Style Holsteins
2059 State Route 95
Edison, Ohio 43320
Dear Mr. Rausch:
On April 22, 2014 and April 29, 2014 the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 2059 State Route 95, Edison, Ohio. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. 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.
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 FD&C 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 FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C 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 January 17, 2014 you sold a dairy cow identified with ear tag (b)(4) for slaughter as food. On or about January 17, 2014 (b)(4), slaughtered this animal. The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analyzed tissue samples collected from this animal and identified the presence of 0.193 parts per million (ppm) of flunixin in the liver. FDA has established a tolerance of 0.125 (ppm) for residues of flunixin in the liver (target tissue) of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.286 (b)(1)(i) (21 C.F.R. 556.286(b)(1)(i)). Also identified was the presence of 0.056 parts per million (ppm) of penicillin in the kidney (target tissue). FDA has established a tolerance of 0.50 ppm for residues of penicillin in the kidney (target tissue) of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.510 (a) (21 C.F.R. 556.510(a). The presence of these drugs in edible tissues from this animal in these amount caused 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).
Our investigation also found that you hold animals under conditions whereby medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).
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 Allison C. Hunter, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Compliance Officer Hunter at 513-679-2700, ext. 2134, or Allison.Hunter@fda.hhs.gov.