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U.S. Department of Health and Human Services

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Enforcement Actions

Ernest P. Shoup Farm 5/22/12

  

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

Public Health Service
Food and Drug Administration
 Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761

May 22, 2012

WARNING LETTER CIN-12-300661-19

VIA UPS

Ernest P. Shoup, Owner
Ernest P. Shoup Farm
1487 Tannerville Road
Dalton, Ohio 44618

Dear Mr. Shoup:

On January 30, February 3, 15, and 23, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1487 Tannerville Road, Dalton, Ohio. 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 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 July 26, 2011, you sold a bob veal calf identified with back tag # (b)(4) for slaughter as food. On or about July 27, 2011, (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 23.67 parts per million (ppm) of neomycin in the kidney and 7.743 ppm of sulfamethazine in the liver. The FDA has established a tolerance of 7.2 ppm for residues of neomycin in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations, 556.430 (21 C.F.R. 556.430) and 0.1 ppm sulfamethazine in the liver of cattle as codified in 21 C.F.R., Part 556.670. However, this tolerance does not apply to use of Scour Gard Soluble Scour Control Formula (a medicated milk replacer containing neomycin and oxytetracycline) and Sustain III Calf Bolus, NADA 120-615 (sulfamethazine bolus) in bob veal calves (pre-ruminating calves). There is no acceptable level of residue associated with the use of these drugs in veal calves.  The presence of these drugs in the edible tissue of this calf 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 the animals medicated, you failed to maintain an adequate inventory of drugs used to treat your animals, and you failed to have an adequate system for the identification of animals on your farm. 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 medicated animal feed Scour Gard Scour Control Formula (Scour Gard) and the new animal drug Sustain III Calf Bolus. Specifically, our investigation revealed that you did not use Scour Gard and Sustain III Calf Bolus as directed by their approved labeling. Use of the medicated feed in this manner is an extra-label use. 21 C.F.R. 530.3(a).

The extra-label use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extra-label 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 C.F.R. 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 Scour Gard to a bob veal calf identified with back tag # (b)(4) without following the animal class as stated in the approved labeling. Your extra-label use of Scour Gard was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extra-label use of Scour Gard was in or on feed, in violation of 21 C.F.R. 530.11(b) and your extra-label use of Scour Gard resulted in and illegal residue, in violation of 21 C.F.R. 530.11(c). In addition, our investigation found that you administered Sustain III Calf Bolus to a bob veal calf identified with back tag #(b)(4) without following the animal class as stated in the approved labeling. Your extra-label use of Sustain III Calf Bolus was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extra-label use of Sustain III Calf Bolus resulted in an illegal residue, in violation of 21 C.F.R. 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).

In addition, you adulterated Scour Gard within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6), when you failed to use the medicated feed in conformance with its approved labeling. Your use of this medicated feed without following the animal class as directed by its approved labeling caused this medicated feed to be unsafe within the meaning of section 512 of the FD&C Act, 21 U.S.C. § 360b. Section 512 of the FD&C Act, 21 U.S.C. § 360b and 21 C.F.R. 530.11(b) do not permit the extra-label use of medicated feeds.

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 is in compliance with the law.

You should take prompt action to correct the violations described in this letter and to establish procedures to ensure 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 fifteen (15) working days of receiving this letter. Your response should include an update for 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 fifteen (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 Stephen J. Rabe, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Compliance Officer Rabe at 513-679-2700, ext. 2163 or stephen.rabe@fda.hhs.gov.

Sincerely,

/S/

J. Teitell
District Director
Cincinnati District