| Public Health Service Food and Drug Administration |
Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 334-4100 FAX: (612) 334-4142 |
Department of Health and Human Services
September 15, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 11 -54
John L. Bednarek
Tom Bednarek
Bob Bednarek
Owners
Bednarek Brothers
N 283 Ruby Drive
Stetsonville, Wisconsin 54480
Dear Mssrs. Bednarek:
On July 13 and 14, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at N 283 Ruby Drive, Stetsonville, WI. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C 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 FD&C 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 FD&C Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the FD&C 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 November 30, 2010, you sold a bob veal calf identified with back tag number (b)(4) for slaughter as food. On or about November 30,2010, (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 tilmicosin at 40.868 parts per million (ppm) in the liver and 4.616 ppm of in the muscle, the presence of flunixin at 0.19 ppm in liver, and the presence of tulathromycin in kidney.
FDA has established a tolerance of 1.2 ppm for residues of tilmicosin in the uncooked edible liver tissue of cattle as codified in Title 21, Code of Federal Regulations, section 556.735(b)(1)(i), 21 CFR 556.735(b)(1)(i), a tolerance of 0.1 ppm for residues of tilmicosin in the uncooked muscle tissue of cattle as codified in 21 CFR 556.735(b)(1)(ii), and a tolerance of 0.125 ppm for residues of flunixin in the uncooked edible liver tissue of cattle, 21 CFR 556.286(b)(1)(i). However, these tolerances do not apply to the use of these drugs in calves to be processed for veal (pre-ruminating calves), and there is no tolerance established for the presence of tulathromycin in kidney tissue of calves to be processed for veal. Therefore, the presence of these drugs in these tissues from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C 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 complete treatment records, and you failed to have an animal identification system in place for medicated animals that assures that withdrawal times were observed prior to offering an animal for slaughter for human food. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C 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 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 Dr. Brian D. Garthwaite, Compliance Officer, 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.
Sincerely,
/S/
Gerald J. Berg
Director Minneapolis District
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