1582 370th Avenue Brooklyn, IA52211-8661 United States
Kansas City District Office
Kansas City District Office
8050 Marshall Drive - Suite 205
Lenexa, Kansas 66214-1524
CMS # 510763
November 21, 2016
RETURN RECEIPT REQUESTED
Johanes A. Boelen (Jan Boelen), Owner
Bear Creek Dairy LP
1582 370th Avenue
Brooklyn, Iowa 52211-8661
Dear Mr. Boelen:
On October 3-17, 2016, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy cow operation located at 1582 370th Avenue, Brooklyn, Iowa. This letter notifies you of 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 June 14, 2016, you sold in Iowa a cow identified with an ear tag # (b)(4)and back tag # (b)(4) for slaughter as food. On or about June 15, 2016, (b)(4) located in (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 0.883 ppm of Flunixin in the liver. FDA has established a tolerance of 0.125 ppm for residues of Flunixin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.286 (21 C.F.R. § 556.286). Also USDA/FSIS analysis of tissue samples collected from this animal identified the presence of 0.54 ppm of Desfuroyceftiofur in the kidney. FDA has established a tolerance of 0.4 ppm for residues of Desfuroylceftiofur in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.113 (21 C.F.R. § 556.113).
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. Also you failed to properly maintain an inventory system for determining quantities of drugs used to medicate your livestock. 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 Danial S. Hutchison, Compliance Officer, U.S. Food and Drug Administration, 8050 Marshall Drive, Suite 205, Lenexa, KS 66214. If you have any questions about this letter, please contact Compliance Officer Hutchison at 913-495-5154 or email@example.com.