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Drug Levels in Edible Tissues too High

A bull calf sold for slaughter as food by an Ohio dairy farm was found to have higher than allowed levels of an animal drug in its edible tissues.

In a June 17 warning letter, the U.S. Food and Drug Administration said a dairy operation owned by Atlee W. Hostetler at Apple Creek, Ohio is violating the federal Food, Drug, and Cosmetic Act.

Tissue samples taken from the bull calf came back with 0.876 parts per million (ppm) of sulfamethoxazole in the muscle and 0.465 ppm of sulfamethoxazole in the liver.  FDA has not established a tolerance for sulfamethoxazole in edible tissues of calves.

“Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply,” the warning letter said.

“For example, you failed to maintain treatment records and failed to keep an inventory system for determining the quantities of drugs used to medicate cows and calves. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4).

FDA found that the Ohio dairy adulterated the new animal drugs Sulfamethoxazole and Trimethoprim. Both drugs were used in a manner inconsistent with label instructions.  Such “extralabel” uses require “the lawful order of a licensed veterinarian” with the context of client/patient relationship.

“Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the Act, 21 U.S.C. 351(a)(5), the warning letter continued.

FDA gave the dairy 15 business days to respond to the violations cited in the warning letter.

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