Inspections, Compliance, Enforcement, and Criminal Investigations
Kemp Cattle 10-Apr-07
Department of Health and Human Services
Public Health Service
April 10, 2007
Return Receipt Requested
Steve T. Kemp, Owner
1204 NW 35th Street
Fort Worth, Texas 76106
Dear Mr. Kemp:
An investigation of your operation located in Fort Worth, Texas, by a Food and Drug Administration investigator from August 29, through November 29, 2006, and from December 15, 2006, through January 16, 2007, confirmed you offered for slaughter as human food one calf on or about July 18, 2006, and three calves on or about November 7, 2006, at [redacted] that were adulterated within the meaning of sections 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and its associated regulations on the Internet through links on the FDA web page at www.fda.gov.
United States Department of Agriculture, Food Safety Inspection Service (USDA/FSIS) analyses of tissues collected from the animal slaughtered on July 18, 2006, identified the presence of the drug penicillin at 0.45 parts per million (ppm) in the liver and at 0.11 ppm in the kidney. A tolerance of 0.05 ppm has been established for residues of penicillin in uncooked, edible tissues of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.510 (21 C.F.R. 556.510). The presence of this drug in these amounts in edible tissues of this animal 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.
Further, USDA/FSIS analysis of tissues collected from three animals offered for slaughter on November 7, 2006, identified the presence of the drug gentamicin in the liver and kidney of two calves and in the kidney of the third calf. There is no tolerance established for residues of gentamicin in the edible tissues of cattle.
The presence of this drug in edible tissues 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.
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. You lack an adequate system to ensure that animals you buy have not been medicated, or if they have been medicated, would enable you to withhold them from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Act.
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 seizure and/or injunction:
The violations listed above are not intended to be an all-inclusive list. It is your responsibility to assure that your operations are in compliance with the law. You should notify this office in writing within fifteen (15) working days of the steps you have taken to bring your firm into compliance with the law. Your response should include each step being taken, 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 reply should be directed to the Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204, Attention: Sherrie L. Kroiczyk, Compliance Officer.
Michael A. Chappell
cc: Howard "Butch" Johnson, DVM
Texas Department of State Health Services
Environmental and Consumer Safety Section
Meat Safety Assurance Unit
1100 West 4 9th Street
Austin, Texas 78756
Julie Cornett DVM
USDA-FSIS, technical Service Center
Landmark Center, Suite 300
1299 Farnam Street
Omaha, Nebraska 68102