7777 Old Highway Road Peosta, IA51938 United States
Kansas City District Office
Kansas City District Office
8050 Marshall Drive - Suite 205
Lenexa, Kansas 66214-1524
March 17, 2017
VIA UPS OVERNIGHT
Brian J. Merges
7777 Old Highway Road
Peosta, IA 52068
CMS Case: 519383
Dear Mr. Merges:
On January 31, 2017 and February 1, 2017, the Iowa Department of Agriculture and Land Stewardship (IDALS) conducted an investigation of your dairy operation located at 7777 Old Highway Road, Peosta, IA 52068 on behalf of the U.S. Food and Drug Administration (FDA). This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the 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 an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the 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 Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the 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 December 15, 2016, you consigned a cow, identified with ear tag 31 (back tag (b)(4)) for slaughter as food. On or about December 16, 2016 (b)(4) 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 desfuroylceftiofur in kidney tissue at 5.905 parts per million (ppm) and flunixin in liver tissue at 0.3 ppm. FDA has established a tolerance of (level) for residues of desfuroylceftiofur (the marker residue for ceftiofur) at 0.4 ppm in the edible tissues of cattle when sampled from the kidney as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.113 [21 C.F.R. § 556.113]. FDA has established a tolerance of (level) for residues of flunixin in the edible tissues of cattle at 125 parts per billion (0.125 ppm) when sampled from the liver as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.286 [21 C.F.R. § 556.286]. The presence of these drugs in edible tissues from this animal in these amounts causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the 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. 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).
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 Andrew A. Hoopes, Compliance Officer, U.S. Food and Drug Administration, 210 Walnut Street, Suite 369, Des Moines, IA 50309. If you have any questions about this letter, please contact Compliance Officer, Andrew A. Hoopes at 515-244-0480, ext. 1002 or firstname.lastname@example.org.
Cheryl A. Bigham
Kansas City District
Randy Watts, Bureau Chief
Iowa Department of Agriculture and Land Stewardship (IDALS)