Inspections, Compliance, Enforcement, and Criminal Investigations
Bar-B-R Farm 15-Apr-05
Department of Health and Human Services
Public Health Service
New York District
RETURN RECEIPT REQUESTED
April 15, 2005
Art R. Mills, Co-owner
Roger A. Mills, Co-owner
558 Lane School Rd.
Andover, New York 14806
File No: NYK 2005-11
Dear Messrs. Mills:
On December 1, 2 and 10, 2004, a U.S. Food and Drug Administration investigator conducted an inspection at your farm located in Andover, New York. This inspection confirmed that in June 2004 you offered a culled cow 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 serious deviations from the regulations for Extralabel Drug Use in Animals (Title 21, Code of Federal Regulations, Part 530). These deviations caused an animal drug to become adulterated within the meaning of Section 501(a)(5) of the Act [21 U.S.C. 351(a)(5)].
On or about June 22, 2004, you offered for sale a cow identified with tag [redacted] for slaughter as human food. The cow was sold to and slaughtered at [redacted]. USDA analysis of tissue samples collected from that animal identified the presence of 0.62 and 0.31 parts per million (ppm) sulfadimethoxine in liver and muscle tissue, respectively.
A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in edible tissues of cattle (Title 21 Code of Federal Regulations 556.640). The presence of this drug in excess of the tolerance in the liver and muscle tissues of this animal 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 lack the reason for drug administration, site of drug administration, dosage amount administered, 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 failed to use the drug [redacted] containing sulfadimethoxine, in conformance with the approved labeling, for example by using it for an indication for which it is not approved and not adhering to the labeled withdrawal times. The extralabel use of approved veterinary or human drugs is allowed if the use complies with Sections 512(a)(4) and 512(a 5) of the Act and 21 CFR Part 530. Our investigation found that your extralabel use of.gailed to comply with these requirements . For example, you administered the drug without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a), and your extralabel use resulted in an illegal drug residue, in violation of 21 CFR 530.11(c) . Because your extralabel use of this drug was not in compliance with 21 CFR 530, the drug was unsafe under Section 512(a) of the Act [21 U.S.C. 360b(a)l and your use caused it to be adulterated within the meaning of Section 501(a)(5) of the Act [21 U.S.C. 351(a)(5)].
In addition to the current violations, we also note a prior illegal residue violation that occurred on or about January 15, 2004, when you offered for sale a cow identified with tag [redacted] slaughter as human food. The cow was sold to and slaughtered at [redacted]. USDA analysis of samples collected from that animal identified the presence of 8.19 ppm gentamicin in kidney tissue and 0.09 ppm gentamicin in liver tissue. There is no approved tolerance level for gentamicin in edible tissues of cattle 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 fiuther notice . This may include 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 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.
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. 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. Your response should include each step you have taken or will take to prevent the recurrence of similar violations . Your response should be directed to Richard T. Trainor, Compliance Officer, at the following address: FDA, 300 Hamilton Ave., White Plains, New York 10601.
Robert L. Hart for Jerome G. Woyshner