| Public Health Service Food and Drug Administration |
| Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 |
Department of Health and Human ServicesJuly 28, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 11 – 40
Kenneth L. Uttecht
Co-owner
Uttecht Dairy Farm
N9127 Bluebird Road
Birnamwood, Wisconsin 54414
Dear Mr. Uttecht:
An investigation of your dairy operation at N9127 Bluebird Road, Birnamwood, Wisconsin, was conducted by a representative of the Food and Drug Administration (FDA) on May 23-25, 2011. That investigation confirmed that you offered animals for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii), 21 U.S.C. § 342(a)(2)(C)(ii), and 402(a)(4), 21 U.S.C. § 342(a)(4), of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov.
On or about December 6, 2010, you sold a veal calf identified with backtag number (b)(4) through (b)(4). On or about December 8, 2010, that animal was slaughtered for food at (b)(4). United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of neomycin at 14.91 ppm in kidney tissue. A tolerance of 7.2 ppm has been established for residues of neomycin in the uncooked edible kidney tissue of cattle as codified in Title 21, Code of Federal Regulations, 556.430, 21 CFR 556.430. The presence of this drug in this amount in edible tissue from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii), 21 U.S.C. § 342(a)(2)(C)(ii).
On or about March 7, 2011, you sold a veal calf identified with backtag number (b)(4) through (b)(4). On or about March 9, 2011, that animal was slaughtered for food at (b)(4). USDA/FSIS analysis of tissue samples collected from that animal identified the presence of neomycin at 124.54 ppm in kidney tissue and penicillin at 0.07 ppm in kidney tissue. A tolerance of 7.2 ppm has been established for residues of neomycin in the uncooked edible kidney tissue of cattle as codified in 21 CFR 556.430. A tolerance of 0.05 ppm has been established for residues of penicillin in the uncooked edible tissues of cattle as codified in 21 CFR 556.510. The presence of these drugs in these amounts in edible tissues from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii), 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 lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you fail to maintain drug treatment records, you lack an adequate inventory system for determining the quantities of drugs used to medicate your animals, and you lack a system for identifying animals that you transport and deliver for sale. 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 above violations and to establish procedures whereby such 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, 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 Timothy G. Philips, Compliance Officer, at the address in this letterhead. If you have any questions about this letter, please contact Mr. Philips at (612) 758-7133.
Sincerely,
/S/
Gerald J. Berg
Director
Minneapolis District
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