Inspections, Compliance, Enforcement, and Criminal Investigations
Prince, Barney G. 02-May-05
Department of Health and Human Services
Public Health Service
New York District
RETURN RECEIPT REQUESTED
May 2, 2005
File No. NYK 2005-12
Barney G. Prince
2056 River Rd.
Hamilton, NY 13346
Dear Mr. Prince:
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 farm. On March 11 and 14, 2005 an FDA investigator conducted an inspection at your farm, located in Hamilton, New York. This inspection confirmed that you offered an animal for sale for food that was adulterated within the meaning of Sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(2)(C)(ii) and 342(a)(4)].
The inspection also revealed that you caused an animal drug to be adulterated within the meaning of Section 501(a)(5) of the Act [21 U.S.C. 351(a)(5)]. On or about January 31, 2005, you offered for sale a cow identified with sale tag 273 for slaughter as human food. The cow was sold to and slaughtered at [redacted]. The USDA analysis of tissue samples collected from that animal identified the presence of 0.60 parts per million (ppm) penicillin in kidney tissue.
A tolerance of 0.05 ppm has been established for residues of penicillin in the uncooked edible tissues of cattle (Title 21, Code of Federal Regulations, Section 556.510). The presence of this drug in excess of the tolerance in the tissues of these animals causes the food to be adulterated within the meaning of Section 402(a)(2)(C)(ii) of the Act [21 U.S.C.342(a)(2)(C)(ii)].
Our investigation also found that you hold animals on your farm under conditions that are so inadequate that diseased animals and/or medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you lack adequate written treatment records for veterinary drugs administered to your herd. Your records for the subject cow lack all the dates of treatment, the dosage administered, the route of administration, the identity of the person administering the drug, and the withdrawal times for milk and beef. Foods from animals held under such conditions are adulterated under Section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)].
You also caused the drug Penicillin G Procaine to become adulterated within the meaning of Section 5O1(a)(5) of the Act [21 U.S.C. 351(a)(5)] when you failed to use the drug in conformance with the approved labeling. Your use of this drug without the oversight of a veterinarian, in excess of the recommended dosage limits, causes the drug to be unsafe for use under Section 512 of the Act [21 U.S.C. 360b].
You should not consider this an all-inclusive list of violations existing at your facility. As a producer of animals offered for use as food, you are responsible for assuring your overall operation and the foods you distribute are in compliance with the law.
You should take prompt action to correct these violations and to establish procedures whereby such violations do not recur. Failure to achieve prompt corrective action may result in regulatory action without further notice, such as seizure and/or injunction.
It is not necessary for you to personally ship an adulterated animal 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 offered for sale to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for a violation of the Act. Likewise, the fact that you caused the adulteration of a drug that had been sold in interstate commerce is sufficient to hold you
responsible for a violation of the Act.
Please notify this office in writing, within 15 working days, of the steps you have taken to bring your firm into compliance with the law. Your response should include each step you have taken or will take to prevent the recurrence of similar violations. 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 response should be directed to Richard T. Trainor, Compliance Officer, at the following address: FDA, 300 Hamilton Ave., White Plains, New York 10601.
Jerome G. Woyshner