Warning Letter for Hageman Dairy

On September 5 and October 8, 15, 16, 17, and 24, 2014, an investigator from the Iowa Department of Agriculture and Land Stewardship, acting on behalf of U.S. Food and Drug Administration (FDA), conducted an investigation of your beef cow-calf, beef cattle back-grounding, and beef cattle feeding operation located at 1569 205th Avenue., Ossian, Iowa.   This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the internet through links on FDA’s web page at www.fda.gov.

 

We found that you offered for sale two animals for slaughter as food that were adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

 

Specifically, our investigation revealed that on or about May 21, 2014, you sold a feeder steer, identified with retain tag (b)(4) and house tag (b)(4), for slaughter as food. On or about May 23, 2014, (b)(4) located in (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue sample collected from this animal identified the presence of neomycin in the kidney tissue at 50.52 parts per million (ppm).  FDA has established a tolerance of 7.2 ppm for residues of neomycin in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.430 (21 C.F.R. 556.430). The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii).

 

Further, our investigation revealed that on or about June 18, 2014, you sold a feeder heifer, identified with house tag (b)(4) and retain tag (b)(4), for slaughter as food.  On or about June 20, 2014, (b)(4), located in (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue sample collected from this animal identified the presence of sulfadimethoxine in the liver at 0.130 ppm and the presence of flunixin in the liver at 0.147 ppm. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the uncooked edible tissues of cattle as codified in 21 C.F.R. 556.640 and a tolerance of 0.125 ppm for residues of flunixin in the liver of cattle as codified in 21 C.F.R. 556.286. The presence of these drugs in edible tissue from this animal in these amounts causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii).

 

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Allisa Tamara Nembhard
Allisa Tamara Nembhard
2 months ago

Great article

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