Reiland, James M. 11/15/11
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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) 334-4100
FAX: (612) 334-4142
November 15, 2011
RETURN RECEIPT REQUESTED
Refer to MIN 12 - 05
James M. Reiland
N4212 Meade Street
Appleton, Wisconsin 54913
Dear Mr. Reiland:
On August 9-10, 2011, the Food and Drug Administration (FDA) conducted an investigation of your hauler/grower operation located at N4212 Meade Street, Appleton, Wisconsin. This letter notifies you of the 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 animals for slaughter as food that were 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 December 14, 2010, you sold a calf, identified with back tag number (b)(4) for slaughter as food. On or about December 16, 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 0.695 parts per million (ppm) of flunixin in the liver tissue, 0.34 ppm of penicillin in the kidney tissue, and the presence of gentamicin in the kidney tissue. FDA has not established a tolerance for residues of flunixin and gentamicin in the edible tissue of veal calves. FDA has established a tolerance of 0.05 ppm for residues of penicillin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (21 CFR), section 556.510 (21 CFR 556.510).
In addition, USDA/FSIS has reported the finding of illegal residues in two other calves, identified with back tag number (b)(4) and (b)(4), sold by you and offered for slaughter for human food. On or about February 25, 2011, (b)(4), slaughtered these animals. USDA/FSIS analysis of tissue samples collected from the animal with back tag number (b)(4) identified the presence of 125.45 ppm of neomycin in the kidney tissue, and 313.62 ppm of neomycin in the kidney of the animal with back tag number (b)(4) FDA has established a tolerance of 7.2 ppm for residues of neomycin in the edible tissues of cattle as codified in 21 CFR 556.430. The presence of this drug in edible tissue from these animals 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 lack a system to ensure that animals you buy and then sell for slaughter as food have not been medicated or, if they have been medicated, to allow you to withhold the animals from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissues. In addition, you fail to keep accurate records of animals you buy and sell to ensure that the animals can be traced back to the producer or other dealer. 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).
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.
The violations listed above are not intended to be an all-inclusive list. It is your responsibility to ensure that your operations are in compliance with the law. As a hauler/grower of animals, you are frequently the individual who introduces or offers for introduction into interstate commerce, the adulterated animals. As such, you share responsibility for violating the Federal Food, Drug, and Cosmetic Act. To avoid future illegal residue violations you should take precautions such as:
1. Implementing a system to identify the animals you purchase with records to establish traceability to the source of the animal; and
2. Implementing a system to determine from the source of the animals whether the animals have been medicated and with what drug(s); and
3. If the animal has been medicated, implementing a system to withhold the animal from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissue. If you do not want to hold the medicated animal then it should not be offered for human food, and it should be clearly identified and sold as a medicated animal.
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 Demetria Lueneburg, Compliance Officer, Food and Drug Administration, 250 Marquette Avenue, Suite 600, Minneapolis, Minnesota 55401. If you have any questions about this letter, please contact Compliance Officer Lueneburg at (612) 758-7210.
Elizabeth A. Waltrip