Turner County Dairy, LLP 23-Dec-03

December 23, 2003

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED Refer to MIN 04 - 10

Walter Bones
President
Turner County Dairy, LLP
27 167 - 458th Avenue
Parker, South Dakota 57053

Dear Mr. Bones:

On September 8-9, 2003, an investigator from the Food and Drug Administration (FDA) conducted an inspection at your dairy farm located in Parker, SD. That inspection confirmed that you offered a dairy cow 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). You also caused the adulteration of an animal drug because the drug was used in a manner that does not conform to its approved uses , or the extralabel use regulations at Title 21, Code of Federal Regulations, Part 530 (21 CFR Part 530, copy enclosed). This caused that animal drug to be unsafe under Section 512(a) of the Act and adulterated within the meaning of Section 501(a)(5) of the Act.

On or about February 17, 2003, you sold a dairy cow identified with ear tag #4357 for slaughter as human food to [redacted] United States Department of Agriculture (USDA) analysis of tissue samples collected from that animal identified the presence of 0.51 parts per million (ppm) sulfadimethoxine in the muscle tissue and 0.71 ppm in the liver tissue. A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in uncooked, edible tissues of cattle (per 21 CFR 556.640, copy enclosed). The presence of sulfadimethoxine above established tolerance levels in the edibles tissues of this animal causes the food to be adulterated within the meaning of Section 402(a)(2)(C)(ii) of the Act.

Our investigation found that you hold animals under conditions that are inadequate to prevent animals bearing potentially harmful drug residues from entering the food supply. For example, you lack an adequate system for assuring that drugs are not used in a manner contrary to the labeled directions, and you fail to maintain complete drug treatment records. Foods from animals held under such conditions are adulterated within the meaning of Section 402(a)(4) of the Act.

The investigation also determined that you adulterated an animal drug within the meaning of Section 501 (a)(5) of the Act when you failed to use the drug in conformance with its approved conditions of use or the extralabel use regulations at 21 CFR Part 530. Specifically, your pneumonia treatment procedure calls for a three-day treatment with 60cc of sulfadimethoxine administered intravenously. This is higher than the dosage on the drug’s approved labeling, and is an extralabel use of the drug. Approved uses of sulfadimethoxine injectable solution are found in 21 CFR 522.2220 (copy enclosed).

Extralabel drug use is permitted only on the lawful order of a licensed veterinarian within the context of a valid veterinarian-client-patient relationship and in conformance with all other criteria set forth in 21 CFR Part 530, including that there may be no residue above established tolerance levels. Your use of sulfadimethoxine failed to comply with the extralabel use regulations, causing the drug to be unsafe under Section 512(a) of the Act and adulterated within the meaning of Section 501(a)(5) of the Act.

The above 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 ensuring that your operations 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 occur. Failure to do so 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 held 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 15 working days of receipt of this letter of the steps you have taken to bring your dairy operation into compliance with the law. Your response should include each step that has been taken or will be taken to correct the noted violations and prevent their recurrence. Please include copies of any available documentation that corrections have been made.

Your reply should be directed to Compliance Officer Timothy G. Philips at the address indicated on the letterhead.

Sincerely,
/s/

W. Charles Becoat
Director
Minneapolis District