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FDA Says Indiana Dairy Misused Antibiotics

A Central Indiana dairy farm sold a small herd of cattle for slaughter as food that tests showed had higher than permissible levels of various antibiotics in kidney and liver tissues, the U.S. Food and Drug Administration (FDA) says.

FDA sent a “Warning Letter” to Providence Dairy LLC in Twelve Mile, IN on March 17 to put it on notice about its sales of animals with illegal levels of drug residues.  The agency asked the dairy to respond within 15 working days.

vaccine5.jpgProvidence Dairy sold seven cows on various dates last spring and summer that were then subjected to tissue testing by the U.S. Department of Agriculture ‘s (USDA’s) Food Safety and Inspection Service (FSIS).

FDA has established tolerance levels for animal drugs.  For Penicillin, 0.05 parts per million (ppm) for residue in uncooked edible tissues is the allowed tolerance level.  Penicillin levels of 0.11 and 0.12 were found in two cows sold by Providence.

The tolerance level for Sulfadimethoxine is 0.1 ppm in the uncooked edible tissue of cattle.  Results from two cows sold by Providence were 0.50 ppm and 0.124 ppm.  Both of the excessive results came from kidney tissue samples.

Neomycin is tolerated up to 7.2 ppm.   The tissue samples of kidneys from two Providence cows returned test results of 21.47 ppm and 12.44 ppm.

The tolerance level for Flunixin in liver tissue of cattle is 0.125 ppm.  The cow Providence sold returned a 0.2428 level.

“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,” Joann M. Givens, FDA’s Detroit district director, wrote to the Providence Dairy.

“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).

“We also found that you adulterated the new animal drugs penicillin, flunixin, neomycin and sulfadimethoxine. Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs in this manner is an extralabel use in violation of 21 C.F.R. ยง 530.3(a),” she added.

FDA said the dairy had a signed “Livestock Owner Certificate” stating that none of the livestock sold for slaughter for food would have illegal levels of drug residues.

“Providing such a false guaranty is prohibited by section 301(h) of the Act, 21 U.S.C. 331(h),” Givens wrote.  “You should take appropriate actions to ensure that this violation does not recur.”

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