Inspections, Compliance, Enforcement, and Criminal Investigations
Diamond S Dairy 15-May-07
Department of Health and Human Services
Public Health Service
May 15, 2007
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 07-14
Michael F. Stubbs, Owner
Diamond S Dairy
1096 South 1900 East
Hazelton, Idaho 83335-5450
Dear Mr. Stubbs:
An investigation of your dairy operation, conducted by a representative of the U.S. Food and Drug Administration (FDA) on February 6-7, 2007, confirmed that you offered an animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. § 342 (a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. § 342 (a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection also revealed that you caused the new animal drug tilmicosin to become unsafe under section 512 [21 U.S.C. § 360b] of the Act, and adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.
On or about November 29, 2006, you sold a dairy cow subsequently issued back tag 035 for slaughter as food at [redacted]. On or about November 30, 2006, this animal was slaughtered at [redacted]. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of tilmicosin at 0.69 parts per million (ppm) in the muscle. A tolerance of 0.1 ppm has-been established for residues of tilmicosin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Part 556.735(b)(ii). The presence of this drug in the muscle tissue from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] of the Act.
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. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain complete treatment records. Food from animals held under such conditions are adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)].
In addition, you adulterated tilmicosin within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act when you failed to use, this drug in conformance with its approved labeling. "Extralabel use," i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) [21 U.S.C. § 360b(a)(4)] and 512(a)(5) [21 U.S.C. § 360b(a)(5)] of the Act and 21 CFR Part 530. Our investigation found that your extralabel use of tilmicosin failed to comply with these requirements. For example, you administered the tilmicosin to a lactating dairy cow when it is indicated for use in cattle, you did not follow the withdrawal period set forth in the approved labeling and you did so without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Furthermore, your extralabel use resulted in an illegal drug residue, in violation of 21 CFR 530.11(d). Because your extralabel use of this drug was not in compliance with 21 CFR Part 530, the drug is unsafe under section 512(a) [21 U.S.C. § 360b(a)] and your use caused it to be adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act.
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 above violations and to establish procedures whereby such 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, state the reason for the delay and the time 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 Lisa M. Althar, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any questions about this letter, please contact Compliance Officer Lisa M. Althar at 425-483-4940.
Charles M. Bren
cc: Isabel Arrington, PhD, D.V.M.
Director, Technical Assistance/Correlation Staff
Department of Agriculture/Food Safety and Inspection Service
Technical Service Center
1299 Farnam Street
Omaha, NE 68102