Inspections, Compliance, Enforcement, and Criminal Investigations
Tri Mast Dairy 05-Oct-07
Department of Health and Human Services
Public Health Service
Cincinnati District Office
October 5, 2007
VIA FEDERAL EXPRESS
Michael Brent Masterson
Tri Mast Dairy
1707 Brown Forman Road
Lebanon, Kentucky 40033
Dear Mr. Masterson:
An investigation of your dairy operation, located at 1707 Brown Forman Road, Lebanon, Kentucky, conducted by a representative of the U.S. Food and Drug Administration (FDA) on June 21 and 22, 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 sulfadimethoxine to become adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] and unsafe under section 512 [21 U.S.C. § 360b] of the Act because the drug was used in a manner that did not conform with its approved uses or the regulations for Extra label Drug Use in Animals, Title 21, Code of Federal Regulations (21 CFR) Part 530. You can find the Act and its associated regulations on the Internet through links on the FDA web page at www.fda.gov.
On or about February 7, 2007, you consigned a dairy cow with back tag [redacted] for slaughter as food at [redacted] of [redacted] without notifying either the hauler or the auction of the medication status of the animal. On or about February 8, 2007, this animal was slaughtered at [redacted] (a Division [redacted] Inc.), [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 1.36 parts per million (ppm) sulfadimethoxine in the muscle tissue and 1.82 ppm sulfadimethoxine in the liver tissue. A tolerance of 0.1 ppm has been established for the residues of sulfadimethoxine in edible tissues of cattle as codified in 21 CFR section 556.640. The presence of this drug in these amounts in uncooked edible tissues 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 keep treatment records of animals you medicated. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) [21 U.S.C. §342(a)(4)] of the Act.
In addition, our investigation found that you administered [redacted] brand of sulfadimethoxine bolus to treat mastitis in a lactating dairy cow, which is not an approved use of this drug. "Extralabel use," i.e., the actual or intended use of the drug in an animal in a manner that is not in accordance with 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 animal 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. 21 CFR section 530.41(a)(9) prohibits the extralabel use of sulfadimethoxine in lactating dairy cattle, except approved uses. Your use was not one of the approved uses of sulfadimethoxine boluses, which are listed in 21 CFR section 520.2220b(d)(3) Because your extralabel use of this drug was not in compliance with 21 CFR Part 530, the drug was unsafe under section 512(a) [21 U.S.C . 360b(a)] of the Act 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 are 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 frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your reply should be directed to Gina M. Brackett, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237-3097. If you have any questions about this letter, please contact Compliance Officer Gina M. Brackett at (513) 679-2700, ext. 167.
Carol A. Heppe
Isabel Arrington, D. V.M.
USDA-FSIS, Technical Service Center
Landmark Center, Suite 300
1299 Farnam Street
Omaha, Nebraska 68102
Dr. Wilbur Frye, Executive Director
Office of Consumer and Environmental Protection
Kentucky Department ofAgriculture
107 Corporate Drive
Frankfort, Kentucky 40601