Inspections, Compliance, Enforcement, and Criminal Investigations
Russell County Stockyards 12-Feb-07
Department of Health and Human Services
Public Health Service
Cincinnati District Office
WARNING LETTER 07-32049-11
VIA FEDERAL EXPRESS
February 12, 2007
Arvis Loy, President
Autic Loy, Vice President
Jimmy Loy, Secretary
Russell County Stockyards
211 Loy Brothers Road
Russell Springs, Kentucky 42642
Dear Messrs. Loy:
An inspection of your cattle auction located in Russell Springs, Kentucky conducted by a representative from the U.S. Food and Drug Administration (FDA) on November 9, 14 and 15, 2006, confirmed that you caused the introduction of adulterated food into interstate commerce by offering a beef cow and a bull for sale for slaughter as food that were adulterated under Section 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] of the Federal Food, Drug, and Cosmetic Act (the Act). The introduction of adulterated food into interstate commerce is prohibited by section 301(a) [21 U.S.C. § 331(a)] of the Act. You are also in violation of section 301(h) [21 U.S.C. § 331(h)] of the Act in that you provided a false guaranty. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.
On or about August 2, 2006, a beef cow was consigned for sale at your auction, assigned back tag #9524, and sold to [redacted]. The cow was transported to [redacted] Georgia, where it was slaughtered on August 4, 2006. The United States Department of Agriculture/Food Safety and Inspection Service (USDA/FSIS) analyses of tissues collected from this animal disclosed the presence of the drug gentamicin in the kidney and liver.
On or about September 20, 2006, a bull was consigned for sale at your auction, assigned back tag #5431, and sold to [redacted]. This bull was transported to [redacted] where it was slaughtered September 23, 2006. USDA/FSIS analysis of tissues collected from this animal disclosed the presence of gentamicin in the kidney.
No tolerance has been established for residues of gentamicin in the edible tissues of cattle. The presence of this drug in edible tissue from these animals causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] of the Act.
Russell County Stockyards provided a certificate, dated May 19, 2006, and signed by Autic Loy, Vice President, to [redacted]., stating that to the best of its knowledge none of the livestock have an illegal drug residue and that it would require signed written statements from sellers regarding the medication status of animals it receives. During our inspection of your firm, it was determined that you are not obtaining such written statements and are not inquiring about the medication status of animals sold through your auction. In providing this false guaranty, you are in violation of 301(h) [21 U.S.C. § 331(h)] of the Act.
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 is in compliance with the law.
You should take prompt action to correct the above violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice such as injunction. To avoid future illegal residue violations you should take precautions such as:
1. Implementing a system to determine the source of the animal, whether the animal has been medicated, with what drug(s), and the date the withdrawal period (if any) terminates; and
2. Obtaining signed statements from the source of the animal if you are told the animal is not medicated.
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 Stephen J. Rabe, Compliance Officer. If you have any questions about this letter, please contact Stephen J. Rabe, Compliance Officer by telephone at: 513-679-2700 ext 163 or by mail at the address listed in this letterhead.
Carol A. Heppe
cc: Dr. William Thom
University of Kentucky
Division of Regulatory Service
103 Regulatory Service Building
Lexington, KY 40546-0275
Julie A. Comett, D.V.M.
Senior Veterinary Officer