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Animal Drug Abuse Found After Sales

Alleged abuse of animal drugs was the subject of three warning letters released this week by the U.S. Food and Drug Administration (FDA).

Two of the letters went out May 10, one to the Aurora Ridge Dairy in Aurora, NY, and the other to Len-acres in Lynden, WA.

The third warning letter went to David L. Miller of Wyoming, NY on May 12.

“We found that you offered an animal for sale for slaughter as food that was adulterated,” the FDA warning letter to Aurora Ridge Dairy said.

FDA said a dairy cow sold by the dairy “for slaughter as food” was found by the United States Department of Agriculture’s Food Safety and Inspection Service (FSIS) to contain an unacceptable level the antimicrobial called desfuroylceftiofur.

The analyses of tissue samples collected from the animal identified the presence of desfuroylceftiofur in the kidney at 0.61 parts per million (ppm).

FDA has established a tolerance for residues of ceftiofur in the uncooked edible tissue of cattle at 0.4 ppm.  Higher levels in the edible tissue of the animal means the meat is adulterated under the law.

“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,” wrote Ronald M. Pace, FDA’s New York district director.

“For example, you failed to maintain complete treatment records. 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).”

Len-acres, the Washington state dairy farm, was also warned about selling a cow that was juiced with an antibiotic sulfa drug.

FDA said the post sale “analysis of tissue samples collected from that animal identified the presence of Sulfadimethoxine at 1.160 parts per million (ppm) in the liver.”

FDA has established a tolerance of 0.1 ppm for residues of Sulfadimethoxine in the edible tissues of cattle.

“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, wrote Charles M. Breen, FDA’s Seattle district director.

“You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues.”

The Washington state dairy was also charged with providing the government with a “false guaranty” in that it signed a Drug Residue Affidavit certifying that its cattle are drug residue-free.

Miller’s warning letter says FDA inspected his Wyoming, NY “residence,” and found he offered two animals for sale that were slaughtered as food that were adulterated.

A dairy cow Miller sold to a livestock-buying station was found in tissue sample tests to have the presence of 4.38 parts per million (ppm) of sulfamethazine in the liver and 4.825 ppm sulfamethazine in the muscle.

FDA has established a tolerance for residues of sulfamethazine in the uncooked edible tissue of cattle of 0.1 ppm.

On another Miller animal, tests identified the presence of 0.24 ppm penicillin in the liver and 0.3 ppm penicillin in the kidney of the cow.

FDA has established a tolerance for residues of penicillin in the uncooked edible tissues of cattle at 0.05 ppm.

“We also found that you adulterated the new animal drugs Albon Boluses (sulfadimethoxine) and Agri-Cillin (penicillin G procaine), wrote Ronald M. Pace, FDA’s New York district director.

“Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling.”

Each party getting a warning letter is asked to respond within 15 business days on how they are going to come into compliance with the law.   None of three cases have yet been “closed out” by FDA.

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