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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Bozenkill Dairy Farm 30-Dec-04

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

New York District
158-15 Liberty Avenue
Jamaica, NY 11433


WARNING LETTER

File No: NYK 2005-03

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

December 30, 2004

Carl O. Peterson, Owner
Bozenkill Dairy Farm
1102 Bozenkill Road
Delanson, NY 12053-2422

Dear Mr. Peterson:

On November 15 and 16, 2004, a U.S. Food and Drug Administration investigator conducted an inspection at your farm located in Delanson, New York. This inspection confirmed that you offered two animals for sale for food that were 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). The inspection also revealed that you caused the drug Penicillin G Procaine to be adulterated within the meaning of Section 501(a)(5) of the Act.

On or about August 3, 2004, you offered for sale a cow identified with farm tag [redacted] human food. The cow was sold to [redacted] and slaughtered at [redacted]. USDA analysis of tissue samples collected from that animal identified the presence of 0.3 parts per million (ppm) of penicillin in the liver tissue and 0.11 ppm penicillin in the kidney tissue.

On or about July 20, 2004, you offered for sale a cow identified with farm 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 0.15 ppm of penicillin in the 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 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.

Our investigation also found that you hold animals on your farm under conditions that are so inadequate that diseased animals andlormedicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you lack a system for assuring that drugs are used in a manner not contrary to label instructions, and for assuring animals medicated on your farrn have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous drug residues from edible tissues. Foods from animals held under such conditions are adulterated under Section 402(a)(4) of the Act.

You also caused the drug Penicillin G Procaine, to become adulterated within the meaning of Section 501(a)(5) of the Act when you failed to use the drug in conformance with the approved labeling. Your use of this drug without adhering to the labeled withdrawal period, causes the drug to be unsafe for use under Section 512 of the Act.

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.

Sincerely,

/S/

Jerome G. Woyshner
District Director