Inspections, Compliance, Enforcement, and Criminal Investigations
Bernick's Registered Holsteins 10/1/12
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
October 1, 2012
RETURN RECEIPT REQUESTED
Refer to MIN 13 - 01
Clayton D. Bernick
Bernick’s Registered Holsteins
N7665 County Road Y
Spencer, Wisconsin 54479-9026
Dear Mr. Bernick:
On July 16, 20, and August 2, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at N7665 County Road Y, Spencer, Wisconsin. This letter notifies you of 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 an animal for slaughter as food that was 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 March 23, 2012, you sold a dairy cow identified with your farm bangle tag (b)(4) for slaughter as food. On or about March 23, 2012, (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 flunixin at 0.435 parts per million (ppm) in liver tissue and detected the presence of gentamicin in the kidney tissue. FDA has established a tolerance of 0.125 ppm for residues of flunixin in the uncooked edible liver tissue of cattle as codified in Title 21, Code of Federal Regulations (21 CFR), section 556.286(b)(1)(i), 21 CFR 556.286(b)(1)(i). FDA has not established a tolerance for residues of gentamicin in edible kidney tissue of cattle. The presence of these drugs in edible tissues from this animal 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 failed to have an effective system to control administration of drug treatments to your animals and to ensure that treatments are recorded by your employee. 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).
We also found that you adulterated the new animal drugs flunixin meglumine and gentamicin sulfate. Specifically, our investigation revealed that you did not use flunixin meglumine and gentamicin as directed by approved labeling or according to instructions directed by the prescribing veterinarian. Use of these drugs in this manner is an extralabel use, 21 CFR 530.3(a).
The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the 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 flunixin meglumine to a dairy cow identified with farm bangle tag (b)(4) without following the route of administration (intravenous) as stated in the approved labeling or as directed by the instructions provided by the prescribing veterinarian. Your extralabel use of flunixin meglumine was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a), and your extralabel use of flunixin meglumine resulted in an illegal drug residue, in violation of 21 CFR 530.11(d).
Our investigation also found that you administered gentamicin sulfate to a dairy cow identified with farm bangle tag (b)(4) without following the animal class as stated in the approved labeling or as directed by the instructions provided by the prescribing veterinarian. Your extralabel use of gentamicin sulfate was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a), and your extralabel use of gentamicin sulfate resulted in an illegal drug residue, in violation of 21 CFR 530.11(c).
Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 CFR Part 530, you caused the drugs to be unsafe under section 512(a)(4) of the Act, 21 U.S.C. § 360b(a)(4), and adulterated within the meaning of section 501(a)(5) of the 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.
We also observed in one of your treatment records that you used enrofloxacin, a fluoroquinolone, to treat a cow for milk fever. Enrofloxacin is not approved for use in dairy cattle 20 months of age or older. See 21 CFR 522.812(e)(2)(iii). Furthermore, in accordance with 21 CFR 531.41(a)(10), fluoroquinolones are prohibited from extralabel use in food producing animals.
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
Michael Dutcher, DVM
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