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Dear Messrs. Welter:

On July 17-18, and 20, 2018, the U.S. Food and Drug Administration (FDA) conducted an investigation of your beef cattle operation located at 16836 Hannan Road, Holy Cross, 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 an animal for sale as food that was 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 March 29, 2018, you delivered a beef steer, identified with red ear tag #32 and back tag #42DE4216, for slaughter as food.  On or about March 30, 2018, Long Prairie Packing Co., Long Prairie, Minnesota, slaughtered this animal.  United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of sulfamethazine at 0.756 parts per million (ppm) in the liver, and 0.533 ppm in the muscle.  FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.670 (21 C.F.R. § 556.670).  The presence of this drug in edible tissues from this animal above the tolerance 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).

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.  You failed to maintain treatment records or identify treated animals.  Specifically, your firm does not maintain any physical or written records for your beef cattle, including treatment records for injured or sick cattle. You also fail to maintain records regarding the identity, purchase, or sale of your cattle.  Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).

The above is not intended to be an all-inclusive list of violations.  As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.

You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur.  Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter.  Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence.  If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed.  Please include copies of any available documentation demonstrating that corrections have been made.

Your written response should be sent to Danial S. Hutchison, Compliance Officer, U.S. Food and Drug Administration, 8050 Marshall Drive – Suite 205, Lenexa, Kansas 66214.  If you have any questions about this letter, please contact Compliance Officer Hutchison at 913-495-5154 or danial.hutchison@fda.hhs.gov.

Sincerely yours,
/S/
Cheryl A. Bigham
Program Division Director
Office of Human and Animal Food
West Division II

cc:  Mr. Randy Watts, Bureau Chief
       Food Safety and Animal Health Division
       Commercial Feed and Fertilizer Bureau
       Department of Agriculture and Land Stewardship
       Wallace State Building
       502 E. 9th Street
       Des Moines, Iowa 50319
       randy.watts@iowaagriculture.gov