Public Health Service
Food and Drug Administration
Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
April 12, 2016
Via UPS Overnight Delivery
Refer to MIN 16 – 10
Bruce P. Vande Hey
915 Washington Street
Wrightstown, Wisconsin 54180
Dear Mr. Vande Hey:
On December 10, 2015, and January 13 and 28, 2016, an investigator from the Wisconsin Department of Agriculture, Trade, and Consumer Protection, representing the U.S. Food and Drug Administration (FDA), conducted an investigation of your dairy operation located at 915 Washington Street, Wrightstown, Wisconsin. 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 July 16, 2015, you sold a dairy cow identified with backtag #(b)(4), corresponding to your farm ear tag #(b)(4) and metal vaccination tag #(b)(4), for slaughter as food. On or about July 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 oxytetracycline at 121.17 parts per million (ppm) in kidney tissue. The FDA has established a tolerance of 12 ppm oxytetracycline in the kidney tissue of cattle, as codified in Title 21, Code of Federal Regulations (21 CFR), section 556.500 (21 CFR 556.500). The presence of this drug in edible kidney 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 Act, 21 U.S.C. § 342(a)(2)(C)(ii).
Our investigation also found that you hold animals under conditions that fail to prevent medicated animals bearing potentially harmful drug residues from entering the food supply. For example, you failed to have an adequate system to verify the entry of written treatment records into your electronic treatment records to ensure that meat and milk withhold times are met. 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 are 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.
Please notify this office in writing of the steps you have taken to bring your firm into compliance with the law within 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 15 working days of receiving this letter, state the reason for the delay and the timeframe 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 Brian D. Garthwaite, Ph.D., Compliance Officer, at the address listed on this letterhead. If you have any questions about this letter, please contact Dr. Garthwaite at (612) 758-7132.