Inspections, Compliance, Enforcement, and Criminal Investigations
D & D Hawkins 1/27/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Minneapolis District Office|
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7132
FAX: (612) 334-4142
January 27, 2009
RETURN RECEIPT REQUESTED
Refer to MIN 09 - 05
Douglas J. Hawkins
D & D Hawkins Dairy, Inc.
8777 County Road X
Chippewa Falls, Wisconsin 54729-5767
Dear Messrs. Hawkins:
On December 4, 2008, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 8777 County Road X, Chippewa Falls, 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 8, 2008, you sold a bob veal calf to [(b)(4)] for slaughter as food. [(b)(4)] applied back tag [(b)(4)] to this animal. On or about July 9 2008, [(b)(4)], transported this animal to [(b)(4)] On or about July 10, 2008, [(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 (the marker residue for ceftiofur) at 6.24 parts per million (ppm) in kidney tissue, and the presence of flunixin at 3.17 ppm in liver tissue. FDA has not established a tolerance for residues of desfuroylceftiofur or flunixin in the edible tissues of veal calves. The presence of these drugs in edible tissues from this animal 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 feed to calves intended for slaughter as food discarded milk from cows treated with medications, which may cause illegal drug residues in calves consuming the discarded milk. 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.
You should 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 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 Dr. Brian D. Garthwaite, Compliance Officer, U.S. Food and Drug Administration, at the address located on the letterhead. If you have any questions about this letter, please contact Dr. Garthwaite at (612) 758-7132.
W. Charles Becoat