Terrance L. Stammen
Dear Mr. Stammen:
On June 17 and 18, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 4965 State Route 705, New Weston, 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 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 March 3, 2014, you sold a dairy cow identified with ear tag (b)(4) and back tag (b)(4) and a second cow with ear tag (b)(4) and back tag (b)(4) for slaughter as food. On or about March 4, 2014, Tri-State Beef (Tri-State), Cincinnati, Ohio, slaughtered these animals. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from the cow with ear tag (b)(4) identified the presence of 0.72 parts per million (ppm) of desfuroylceftiofur (marker residue for ceftiofur) in the kidney. USDA/FSIS analysis of tissue samples collected from the cow with ear tag (b)(4) identified the presence of 1.8 ppm of desfuroylceftiofur in the kidney. FDA has established a tolerance of 0.4 parts per million (ppm) for residues of desfuroylceftiofur in the uncooked edible kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113(b)(3)(i) (21 C.F.R. 556.113(b)(3)(i)). The presence of this drug in these amounts in edible tissue from these animals cause 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 complete 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 found that you adulterated the drug Excede (NADA 141-209, ceftiofur crystalline free acid). Specifically, our investigation revealed that you did not use Excede as directed by the approved labeling. Use of the drug in this manner is an extralabel use. See 21 C.F.R. 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 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 Excede without following the dosage and withdrawal period as stated in the veterinarian’s prescription labeling. Your extralabel use of Excede was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of Excede resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Certain uses of ceftiofur (e.g. unapproved doses) are prohibited for extralabel use in cattle by 21 C.F.R. 530.41(a)(13)(ii). Because your use of this drug was not in conformance with the approved labeling and did not comply with 21 C.F.R. Part 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 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 that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.
Our investigations also revealed that on or about March 3, 2014, you provided to (b)(4) in (b)(4), a signed certification that states that the livestock you sell do not have illegal levels of drug residues. On or about March 3, 2014, you delivered a cow with ear tag (b)(4) and back tag (b)(4) and a second cow with ear tag (b)(4) and back tag (b)(4) to (b)(4) which contained residues of desfuroylceftiofur (marker residue for ceftiofur). Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. § 331(h). You should take appropriate actions to ensure that this violation does not recur.
We acknowledge your letter dated June 19, 2014. You stated that you have a new protocol and recording procedure to avoid more violations. We cannot evaluate the effectiveness of your actions because you did not provide any copies of your new procedure or your medication treatment records.
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 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 firstname.lastname@example.org
Paul J. Teitell