Inspections, Compliance, Enforcement, and Criminal Investigations
Elder Grove Dairy 8/30/13
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
August 30, 2013
via UPS Overnight
Refer to MIN 13 – 22
James G. Rankel
Elder Grove Dairy
W1110 Colby Factory Road
Colby, Wisconsin 54421
Dear Mr. Rankel:
On April 16 and 18, 2013, the United States Food and Drug Administration (FDA), conducted an investigation of your dairy farm operation located at W1110 Colby Factory Road, Colby, Wisconsin. 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 animals 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 January 16, 2012, you sold two bob veal calves identified with back tags (b)(4) and (b)(4) for slaughter as food. On or about January 18, 2013, (b)(4), slaughtered these animals. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS), analysis of tissue samples collected from bob veal (b)(4) identified the presence of 32.36 parts per million (ppm) of tilmicosin in liver tissue, 11.901 ppm of tilmicosin in muscle tissue, and the presence of gentamicin in kidney tissue. TheUSDA/FSIS analysis of tissue samples collected from bob veal (b)(4) detected the presence of 3.535 ppm of tilmicosin in liver tissue, 0.681 ppm of tilmicosin in muscle tissue, and the presence of gentamicin in kidney tissue.
FDA has established tolerances of 1.2 ppm tilmicosin in the uncooked edible liver tissue of cattle, and 0.1 ppm tilmicosin in uncooked edible muscle tissue of cattle, as codified in Title 21, Code of Federal Regulations, section 556.735(b)(1), 21 CFR 556.735(b)(1). FDA has not established a tolerance for residues of gentamicin in edible tissue of veal calves. The presence of these drugs in these amounts 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 treatment records for calves that you medicate, and you failed to have a reliable system to assure 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).
We also found that you adulterated the new animal drugs (b)(4) Tilmicosin Injection (NADA (b)(4)) and Gentamicin Sulfate Solution (ANADA (b)(4)). Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling or by the directions of the prescribing veterinarian. Use of these drugs in this manner is an extralabel use. See 21 CFR 530.3(a).
The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 CFR Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.
Our investigation found that you administered (b)(4) and gentamicin to two bob veal calves identified with back tags (b)(4) and (b)(4) without following the slaughter withhold period as stated in their approved labeling or the veterinarian prescription labeling. Your extralabel use of these drugs was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Your extralabel use of (b)(4) resulted in illegal drug residues, in violation of 21 CFR 530.11(d). Your extralabel use of gentamicin resulted in illegal drug residues, in violation of 21 CFR 530.11(c). Because your use of these drugs was not in conformance with their approved labeling or the veterinarian’s prescription label, you caused the drugs to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a)(4), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).
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, 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.
Michael Dutcher, DVM