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FDA warnings: Iowa beef feedlot sufficiently addresses issues

Sunday, February 12, 2017 23:25
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The FDA issued a closeout letter to an Iowa beef feed lot operator earlier this month related to a warning letter sent in December 2015 regarding excessive antibiotic residue in meat from a cow slaughtered for human consumption.

The Feb. 3 closeout letter was just published by the Food and Drug Administration in recent days. It clears Gary Manternach, owner of Gary Manternach Farm in Monticello, IA, but indicates the FDA will continue to monitor the operation.

“Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections,” the FDA’s closeout letter states.

“This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance.”

A Dec. 4, 2015, warning letter cited the cattle operation for problems discovered during a Nov. 2-4, 2015, inspection. When FDA inspectors reviewed the feed lot’s records it found that the USDA’s Food Safety and Inspection Service had documented excessive levels of the bovine antibiotic florfenicol.

The USDA tests showed 5.73 parts per million (ppm) of the drug in the liver tissue of the slaughtered cow. That’s more than 150 percent more than the 3.7 ppm allowed by federal 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,” according to the FDA warning letter.

“For example, you failed to maintain 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).”

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