Inspections, Compliance, Enforcement, and Criminal Investigations
Livestock Dealer 04-May-07
Department of Health and Human Services
Public Health Service
May 4, 2007
Return Receipt Requested
3845 CR 12
Hereford, Texas 79045-9706
Dear Mr. Carrizales:
An investigation, which included an inspection of your animal buying operation located in Hereford, Texas, by a representative of the U.S. Food and Drug Administration on October 26-29, 2006, confirmed you offered three calves for slaughter for human food 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).
On or about June 15, 2006, you sold a calf (no tag number available) for slaughter as food to [redacted]. On or about July 3, 2006, this animal was slaughtered at [redacted]. In addition, on or about June 15, 2006, you sold a calf (identified by tag #74FBA2583) for slaughter as food to [redacted] On or about July 13, 2006, this animal was slaughtered at [redacted] United States Department of Agriculture, Feed Safety and Inspection Service (USDA/FSIS) analyses of tissues collected from these animals disclosed the presence of the drug gentamicin in the kidney of these calves. There is no tolerance established for residues of gentamicin in the edible tissues of bovine, Title 21, Code of Federal Regulations (CFR), Section 556.300.
On or about August 14, 2006, you sold a calf (identified by tag # MTX 080506 and ear tag #544) for slaughter as food to [redacted] On or about August 16, 2006, this animal was slaughtered at [redacted] USDA/FSIS analysis of tissue collected from this calf disclosed the presence of ivermectin in the liver and muscle of this calf at concentrations of 0.114 parts per million (ppm) and 0.023 ppm, respectively. Title 21 CFR Section 556.344 establishes a tolerance for ivermectin in the edible tissue of cattle at 100 parts per billion (ppb) (0.1 ppm) in the liver and 10 ppb (0.01 ppm) in the muscle. The presence of these drugs in these amounts in edible tissues of 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 which are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. You lack a system to ensure that animals you buy have not been medicated, or if they have been medicated, that allows you to provide this information to subsequent buyers to ensure that the animals are withheld 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 above is not intended to be an all-inclusive list of violations. It is your responsibility to assure that your operations are in compliance with the law. As a dealer of animals, you are frequently the individual who introduces or offers for introduction into interstate commerce the adulterated animal. As such, you share the responsibility for violating the Federal Food, Drug, and Cosmetic Act. To avoid future illegal residue violations, you should take precautions such as implementing a system or systems to determine and record the source of the animal, to determine whether the animal has been medicated and with what drug(s), and to withhold the animal from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissue.
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. Krolczyk, Compliance Officer.
Michael A. Chappell
Howard "Butch" Johnson, DVM
Texas Department of State Health Services
Environmental and Consumer Safety Section
Meat Safety Assurance Unit
1100 West 49th Street
Austin, Texas 78756
Julie Cornett, DVM
USDA-FSIS, Technical Service Center
Landmark Center, Suite 300
1299 Farnam Street
Omaha, Nebraska 68102