Inspections, Compliance, Enforcement, and Criminal Investigations
Berlin Valley Farm 11/14/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771
VIA United Parcel Service
November 14, 2013
Dennis A. Miller, Owner
Berlin Valley Farm
5898 Township Road 363
Millersburg, OH 44654
WARNING LETTER CIN-DO 14-411908-03
Dear Mr. Miller:
On August 15 and 28, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 5898 Township Road 363, Millersburg, Ohio. This letter notifies you of the 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 May 21, 2013, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about May 22, 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 22.3 parts per million (ppm) of neomycin residue in the kidney. 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 (CFR), Section 556.430 (21 CFR 556.430). However, this tolerance does not apply to the use of NT Concentrate (type-B medicated feed containing Neomycin Sulfate and Oxytetracycline) in calves to be processed for veal (pre-rumination calves), and there is no acceptable level of residue associated with the use of this drug in veal calves. The presence of this drug in edible tissue from this animal in this amount 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 maintain complete treatment records and you lack a drug inventory system for assuring that drugs are properly accounted for and used appropriately. 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 neomycin sulfate and oxytetracycline found in NT Concentrate, a type-B medicated feed containing neomycin sulfate and oxytetracycline. Specifically, our investigation revealed that you did not use NT Concentrate as directed by its approved labeling. Use of NT Concentrate containing neomycin sulfate and oxytetracycline, 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 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 NT Concentrate, a type-B medicated feed containing neomycin sulfate and oxytetracycline in a class of animal (veal calf with back tag (b)(4) not set forth in the approved labeling in violation of 21 CFR 530.11(a). Furthermore, your extralabel use of NT Concentrate resulted in an illegal residue, in violation of 21 CFR 530.11(c). Because your use of this type-B medicated feed was not in conformance with its approved labeling and did not comply with 21 CFR Part 530, you caused the type-B medicated feed to be unsafe under section 512(a) of the Act [21 U.S.C. § 360b(a)] and adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)].
In addition, you adulterated NT Concentrate within the meaning of section 501(a)(6) of the Act [21 U.S.C. § 351(a)(6)], when you failed to use the type-B medicated feed in conformance with its approved labeling. Your use of this type-B medicated feed without following the animal class as directed by the approved labeling caused this type-B medicated feed to be unsafe within the meaning of section 512 of the Act [21 U.S.C. § 360b]. Section 512 of the Act [21 U.S.C. § 360b] and 21 CFR 530.11(b) do not permit the extra-label use of medicated feed.
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.
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 Karen Gale Sego, 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 Sego at (513) 679-2700, Ext. 2164 or Email at Karen.Sego@fda.hhs.gov.
Paul J. Teitell
cc: Dr. Tony Forshey, Chief
Ohio Department of Agriculture
Division of Animal Health
8995 East Main Street
Reynoldsburg, OH 43068-3399