Inspections, Compliance, Enforcement, and Criminal Investigations
Domina, Gary 19-Jun-08
Department of Health and Human Services
Public Health Service
New England District
Return Receipt Requested
June 19, 2008
1496 Berkshire Ctr. Road
Enosburg Falls Vermont 05450-4456
Dear Mr. Domina:
An investigation of your dairy operation located at West Berkshire Road, Enosburg, Vermont conducted by two representatives of the U.S. Food and Drug Administration (FDA) on March 11 - 14, 2008, confirmed that you offered an animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(2)(C)(ii) and 21 U.S.C. § 342(a)(4)]. The investigation also revealed that you caused the new animal drug dihydrostreptomycin to become 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)].
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 December 17, 2007, you sold a dairy cow, identified by back tag [redacted] and ear tag [redacted] for slaughter as food to [redacted] On or about December 18, 2007, this cow was slaughtered at [redacted] The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 9.78 parts per million (ppm) of the drug dihydrostreptomycin in the kidney. A tolerance of 2.0 ppm has been, established residues of dihydrostreptomycin in the kidney of cattle as codified in Title 21 Code of Federal Regulations 556.200 (21 C.F.R. 556.200). The presence of this drug in this.
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 treatment records. 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)].
In addition, our investigation found you adulterated the new animal drug dihydrostreptomycin within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)] when you failed to use this drug in conformance with its approved The approved application for this drug, Quartermaster® brand of dihydrostreptomlycin, restricts this drug to use by or on the order of a licensed veterinarian. Your use of this drug was not by or on the order of a licensed veterinarian. Because your use of this drug deviated from its approved application, the drug was unsafe under section 512(a)(1)(A) of the Act [21 U.S.C. § 360b(a)(1)(A)] and your use caused it to be adulterated within the meaning of section 501(a)(5) of the 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 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 these violations and prevent their recurrence. If corrective actions cannot be completed within fifteen (15) working days, 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 directed to Anthony P. Costello, Compliance Officer, 1 Montvale Avenue, Stoneham, MA 02180. If you have any questions about this letter, please contact Compliance Officer Costello at 781-596-7716.
Michael R. Kravchuk
Acting District Director
New England District Office