Inspections, Compliance, Enforcement, and Criminal Investigations
Lucust Hill Farm 27-Sep-02
Department of Health and Human Services
Public Health Service
New York District
September 27, 2002
WARNING LETTER NYK 2002-48
RETURN RECEIPT REQUESTED
Timothy C. Alford, Owner
Locust Hill Farm
2263 Hoxie Road
Mannsville, New York 13661
Dear Mr. Alford:
An investigation performed by U.S. Food and Drug Administration Investigator William P. Chilton included an inspection of your dairy farm on August 8 and 12, 2002. The investigation confirmed you offered two cows for sale for slaughter as food in violation of Sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). In addition, your extra label usage, and the illegal tissue residues that resulted, caused the drug product Agri-Cillin (penicillin G procaine injectable suspension) to become adulterated within the meaning of Section 501 (a)(5) of the Act.
On or about August 8, 2001 you sold a cow identified with farm tag [redacted] and ear tag [redacted] for slaughter for human food, at [redacted] USDA analysis of samples collected from that animal on August 9, 2001 at [redacted] identified the presence of 00.35 parts per million (ppm) penicillin in liver tissue, and 00.31 ppm penicillin in kidney tissue.
On or about May 1, 2002 you sold a cow identified with farm tag [redacted] and ear tag [redacted] for slaughter for human food, at USDA analysis of tissue samples collected from that animal on May 2, 2002 [redacted] identified the presence of 00.16 ppm pencillin in kidney tissue.
A tolerance of 0.05 ppm has been established for residues of penicillin in edible tissues of cattle (Title 21 Code of Federal Regulations 556.510). The presence of penicillin, at the reported levels, inedible tissue from these animals, causes the food to be adulterated within the meaning of Section 402(a)(2)(C)(ii) of the Act.
Our investigation also found you hold animals under conditions whereby medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you lack an adequate system for assuring that drugs are used in a manner not contrary to the directions contained in the labeling, and for assuring that animals medicated on your farm have been 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) of the Act.
In addition, you are adulterating the veterinary drug [redacted] (penicillin G procaine injectable suspension) within the meaning of Section 501(a)(5) when you fail to use it either in accordance with its labeled instructions, or with a lawful order of a licensed veterinarian and in compliance with extralabel use regulations. You did not have a veterinarian's order to use this drug in cattle in the extralabel manner in which you used it, i.e. exceeding the recommended daily dosage and exceeding the maximum treatment duration specified on the product label. Use of this drug contrary to its labeled instructions, in a manner for which you did not have a veterinarian's order, causes the drug to be unsafe within the meaning of section 512 of the Act. Additionally, because your use of this drug resulted in the presence of drug residues in edible tissue that might present a risk to public health, use of the drug was not in compliance with extralabel use regulations [21 CFR 530.11(c)].
This letter is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for assuring that your overall operation and the foods you distribute are 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. This may include seizure or injunction.
It is not necessary for you to personally ship an adulterated anitnal in interstate commerce to be responsible for a violation of the Federal Food, Drug and Cosmetic Act. The fact that you caused the adulteration of an animal that was sold and subsequently offered for sale to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for a violation of the Act.
Please notify this office in writing, within 15 days, of the steps you have taken to prevent a recurrence of similar violations. Your response should be directed to James M. Kewley, Compliance Officer, at the above address.
Jerome G. Woyshner