Inspections, Compliance, Enforcement, and Criminal Investigations
Washington County Livestock Center, Inc. 17-Jul-08
Department of Health and Human Services
Public Health Service
Cincinnati District Office
July 17, 2008
VIA FEDERAL EXPRESS
William L. Benedict, Owner
Washington County Livestock Center, Inc.
646 Bloomfield Road
Springfield, Kentucky 40069
Dear Mr. Benedict:
On February 28th and 29th, 2008, the U.S. Food and Drug Administration (FDA) conducted an inspection of your auction facility located at 646 Bloomfield Road, Springfield, Kentucky 40069. 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].
Specifically, our investigation revealed that on or about August 24, 2007, you sold a cow, identified with back tag number [redacted], for slaughter as food. On or about August 27, 2007 [redacted] 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 0.505 ppm tilmicosin in muscle tissue and 3.232 ppm tilmicosin in the liver tissue. USDA/FSIS analysis also identified the presence of gentamicin in the muscle and liver tissues.
FDA has established a tolerance of 1.2 parts per million (ppm) for residues of tilmicosin in the liver tissue and 0.1 ppm for residues of tilmicosin in the muscle tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.735 (21 C.F.R. 556.735). FDA has not established a tolerance for residues of gentamicin in the 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)].
The above is not intended to be an all-inclusive list of violations. As a distributor 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 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, 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 Gina M. Brackett, Compliance Officer, U.S. Food and Drug Administration, Cincinnati District Office, Central Region, 6751 Steger Drive, Cincinnati, Ohio 45237-3097. If you have any questions about this letter, please contact Ms. Brackett at (513) 679-2700, ext. 167 or by mail at the address listed above.
Acting District Director
Cc: Dr. William Thom
University of Kentucky
Division of Regulatory Service
103 Regulatory Service Building
Lexington, KY 40546-0275
Dr. Isabel Arrington
US Department of Agriculture/Food Safety and Inspection Service
1299 Farnam Street
Omaha, NE 68102