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Health Law

: Food Safety News

Three Dairy Farms Get FDA Warning Letters

By Dan Flynn and Suzanna Schreck

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Dairy farms in Wisconsin and Washington state received warning letters in June about alleged abuse of animal drugs, the U.S. Food and Drug Administration (FDA) has disclosed.

The first of three letters went out June 15 to Elmwood, WS dairy farmer John Skogen about misuse of the heat-stable antibiotic gentamicin.

In the letter, FDA said a dairy cow sold for slaughter as food last Sept. 9 by Skogen was subjected to tissue sampling by the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS).   Gentamicin was found in the edible tissue of the animal, and there is no tolerance level for this particular antibiotic in food.

"We also found that you adulterated the new animal drugs gentamicin sulfate solution, sulfadimethoxine injection, flunixin meglumine, penicillin G procaine injectable suspension, oxytetracycline hydrochloride injection, and penicillin G benzathine and penicillin G procaine injectable suspension," the letter continued.  "Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling."

Keith and Patricia Haldiman own the other Wisconsin dairy farm receiving a warning letter from FDA.  Theirs went out June 30.

They also sold a dairy cow for slaughter as food where FSIS testing found animal drugs remaining in edible tissues at higher than acceptable levels for the animal antibiotic drug sulfamethazine.

Samples from the cow from the Hibert, WS dairy farm came back at 37.280 parts per million (ppm) in the liver tissue, and 65.57 ppm in the muscle tissue.

The tolerance level for sulfamethazine is 0.1 ppm.

"However, this tolerance does not apply to sulfamethazine in lactating dairy cattle, the warning letter said.  There is no acceptable level of sulfamethazine residue in lactating dairy cattle. There is also no acceptable level of phenylbutazone residue in lactating dairy cattle."

FDA said the presence of those drugs in edible tissue mean the meat is "adulterated" under federal laws and regulations.

"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 said.

FDA said the dairy farm's treatment and inventory records are inadequate for taking care of medicated animals.

The third warning letter went to Coldstream Farm, LLC, located near Deming, WA on June 21. FDA said the farm offered animals for sale for slaughter as food that were adulterated.

FDA said Coldstream sold a dairy cow for slaughter for use as human food on July 8, 2009 that "analysis of tissue samples collected from this animal identified the presence of penicillin in the kidney at 0.39 parts per million (ppm).  FDA has established a tolerance of 0.05 ppm for residues of penicillin in the uncooked edible tissues of cattle..."

Further results from cow sold last Nov. 19 returned, "USDA/FSIS analysis of tissue samples collected from this animal identified the presence of flunixin in the liver at 0.3279 ppm. FDA has established a tolerance of 0.125 ppm for residues of flunixin in the liver tissues of cattle, as codified in 21 C.F.R. 556.286. The presence of flunixin in the liver tissue from this animal in this amount causes the food to be adulterated..."

FDA said the dairy was using Penicillin Injection in a manner not consistent with label instructions.

All three dairy operations were asked to respond to FDA within 15 days of the receipt of their individual warning letters.

Full post as published by Food Safety News on July 12, 2010 (boomark / email).

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