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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Rock Inn Dairy 6/19/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

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

 

June 19, 2013
 
 
WARNING LETTER
 
Via UPS Overnight                                                                   
Refer to MIN 13 – 19
 
 
Thomas G. Hamus, Co-owner
Justin Hamus, Co-owner
Rock Inn Dairy
10688 Rock Inn Road
Auburndale, Wisconsin  54412
 
Dear Messrs. Hamus:
 
On April 2 and 4, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 10688 Rock Inn Road, Auburndale, 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 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 October 22, 2012, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about October 24, 2012, the calf was slaughtered at (b)(4). 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 0.824 parts per million (ppm) in the kidney tissue, and sulfamethazine at 31.64 ppm in the liver tissue and 31.514 ppm in the muscle tissue.
 
FDA has established a tolerance 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(a), 21 CFR 556.510(a), and a tolerance of 0.1 ppm for residues of sulfamethazine in the uncooked edible tissues of cattle, 21 CFR 556.670. However, these tolerances do not apply to the use of (b)(4) (sulfamethazine), NADA (b)(4), and (b)(4) (penicillin G benzathine and penicillin G procaine) Injectable Suspension, NADA (b)(4), in bob veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with the use of these drugs in this class of animal. 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 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 drugs (b)(4) (sulfamethazine), NADA (b)(4), and (b)(4) (penicillin G benzathine and penicillin G procaine) Injectable Suspension, NADA (b)(4). Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs in this manner is an extralabel use as defined under 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) (sulfamethazine), NADA (b)(4), and (b)(4) (penicillin G benzathine and penicillin G procaine) Injectable Suspension, NADA (b)(4), to your bob veal calf, identified with back tag (b)(4), without following the animal class as stated in the approved labeling. Your extralabel use of (b)(4) (sulfamethazine), NADA (b)(4), and (b)(4) (penicillin G benzathine and penicillin G procaine) Injectable Suspension, NADA (b)(4), was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a) and your extralabel use of (b)(4) (sulfamethazine), NADA (b)(4), and (b)(4) (penicillin G benzathine and penicillin G procaine) Injectable Suspension, NADA (b)(4), 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) 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 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.
 
Sincerely,
/S/ 
Michael Dutcher, DVM
Director
Minneapolis District
 
 
xc:  Robert Ehlenfeldt, DVM
      State Veterinarian
      WDATCP / Division of Animal Health
      P.O. Box 8911
      Madison, WI 53708-8911
 
      Chad Koplien
      Administrator, Div of Enforcement
      Wisconsin Department of Regulation & License
      P.O. Box 8935
      Madison, WI 53708-8935

(b)(4)