| Public Health Service |
| Atlanta District Office |
Department of Health and Human ServicesSeptember 13, 2005
VIA FEDERAL EXPRESS
WARNING LETTER
(05-ATL-23)
John Anthony, Owner
A & H Farms
1570 East Cherokee Street
Blacksburg, SC 29702
Dear Mr. Anthony.
A tissue residue report received by the U.S. Food and Drug Administration (FDA) from the United States Department of Agriculture (USDA) reported the presence of illegal drug residues in a cow that originated from your livestock operation. Subsequently, an investigation of your livestock operation by a Food and Drug Administration investigator on August 4, 2005, confirmed that a dairy cow purchased and sold on or about May 5, 2005, for slaughter for human food to [redacted] in [redacted] was adulterated within the meaning of 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 United States Department of Agriculture (USDA)Food Safety and Inspection Service (FSIS) analysis of tissue collected from that animal (Case No.8-0221-05) disclosed the presence of illegal levels of the drug dihydrostreptomycin in the kidney tissue. The kidney tissue was found to contain 4.19 parts per million (ppm) of dihydrostreptomycin. A tolerance of 2.0 ppm has been established for residues of dihydrostreptomycin in the edible tissues of cattle. The tolerances for dihydrostreptomycin are listed in Title 21, Code of Federal Regulations. Section 555.200 (21 CFR 555.200).
In addition, USDA/FSIS has reported the finding of illegal residues in another cow sold by you and offered for slaughter for human food. You offered for sale for slaughter a beef cow to [redacted] in [redacted] on or about February 9, 2005. USDA/FSIS analysis of tissue collected from that animal (Sample number 415922) disclosed the presence of illegal levels of the drug penicillin in the liver and kidney tissues. The liver tissue was found to contain .09 ppm of penicillin and the kidney was found to contain .78 ppm of penicillin. A tolerance of .05 ppm has been established for residue of penicillin in the edible tissues of cattle. The tolerances for penicillin are listed in 21 CFR 556.510. Copies of the referenced 21 CFR regulations are enclosed.
Our investigation found that you routinely fail to inquire about the medication status of the animals that you or your associates purchase and subsequently deliver for slaughter for human consumption. You make no effort to determine if these animals have been medicated and require withholding from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissues. You maintain no records sufficient to determine the source of the animals you purchase. In fact, you and your associates routinely remove animal identification tags after purchase so as to make any efforts to trace back the source of the animal extremely difficult, if not impossible.
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. 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 Act. To avoid future illegal residue violations you should take precautions such as:
1. Implementing a system to identify the animals you purchase with records to establish traceability to the source of the animal;
2. Implementing a system to determine from the source of the animal whether the animal has been medicated and with what drug(s); and
3. If the animal has been medicated, implementing a system to withhold the animal from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissue. If you do not want to hold the medicated animal then it should not bb offered for human food, and it should be clearly identified and sold as a medicated animal.
You should be aware that it is not necessary for you to have personally shipped an animal in interstate commerce to be responsible for a violation of the Act. The fact that you offered an animal for sale to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for a violation of the Act.
You should notify this office in writing within fifteen (15) working days of the steps you have take 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 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 reply should be directed to the attention of Philip S. Campbell, Compliance Officer, at the address noted in the letterhead.
Sincerely,
/S/
Mary H. Woleske, Director
Atlanta District
