Roth, Lonny M. 7/26/13
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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
July 26, 2013
via UPS Overnight
Refer to MIN 13 – 20
Lonny M. Roth
13896 County Highway K
Cadott, Wisconsin 54727
Dear Mr. Roth:
On May 29 and 31, 2013, the Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 13896 County Highway K, Cadott, Wisconsin. This letter notifies you of 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 were 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 February 25, 2013, you sold a dairy heifer identified with back tag (b)(4) for slaughter as food. On or about February 26, 2013, (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 penicillin at 0.91 parts per million (ppm) in the kidney, sulfadimethoxine at 1.02 ppm in the liver, and flunixin at 0.326 ppm in the liver.
- On or about March 4, 2013, you sold a dairy cow identified with back tag (b)(4) for slaughter as food. On or about March 5, 2013, (b)(4) slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of penicillin at 0.150 ppm in the kidney.
- On or about April 8, 2013, you sold a dairy cow identified with back tag (b)(4) for slaughter as food. On or about April 9, 2013, (b)(4), slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of penicillin at 0.108 ppm in the kidney.
FDA has established tolerances of:
- 0.05 ppm for residues of penicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, section 556.510 (21 CFR 556.510);
- 0.1 ppm for residues of sulfadimethoxine in the uncooked edible tissues of cattle as codified in 21 CFR 556.640; and
- 0.125 ppm for residues of flunixin in the liver tissue of cattle as codified in 21 CFR 556.286.
The presence of these drugs in edible tissues from these animals 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. 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 drug penicillin ((b)(4), NADA (b)(4), penicillin G procaine). Specifically, our investigation revealed that you did not use this drug as directed by its approved labeling. Use of this drug 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 routinely administered penicillin to your dairy cows without following the dose, frequency of treatment, and amount injected per site as stated in the approved label. Your extralabel use of penicillin was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 CFR 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), 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 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 Timothy G. Philips, Compliance Officer, at the address on this letterhead. If you have any questions about this letter, please contact Mr. Philips at (612) 758-7133.
Michael Dutcher, DVM