Inspections, Compliance, Enforcement, and Criminal Investigations
Opportunity Dairy 5/28/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
John Dollins, Tom Tune, and Tony Tune, Co-Owners
1101 N. Roosevelt Road 3
Clovis, NM 88101-1011
Ref: DEN-09-06 WL
Dear Mr. Dollins and Messrs. Tom and Tony Tune:
On January 20, 22, 23, and 28,2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 1101 N. Roosevelt Road 3, Clovis, New Mexico. 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 the FDA's web.page at www.fda.gov.
We found that you offered for sale two animals for slaughter as food that were 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 May 12, 2008, your dairy sold a cow identified with dairy ear tag (b)(4) for slaughter as food through (b)(4). USDA Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this cow on May 13, 2008, identified the presence of flunixin in the liver at 1.24 parts per million (ppm) and in the muscle at 0.042 ppm. In addition, USDA/FSIS analysis found the presence of sulfadimethoxine in the liver at 2.03 ppm and in the muscle at 1.02 ppm. Our investigation revealed that your dairy treated this cow with (b)(4) flunixin and (b)(4) sulfadimethoxine, but you could not produce records to show the exact drugs used on this cow, how the drugs were administered,any extra-label use of the drugs, and how the meat withdrawal time was calculated for this cow.
Our investigation further revealed that on July 7, 2008, your dairy sold a cow identified with dairy ear tag (b)(4) for slaughter as food through (b)(4). USDA/FSIS analysis of tissue samples collected from this cow on July 10, 2008, identified the presence of desfuroylceftiofur (drug brand names (b)(4)) in the kidney at 0.48 ppm. Our investigation revealed that your dairy treated this cow with desfuroylceftiofur, but you could not produce records showing the treatment of this cow.
FDA's regulations in Title 21, Code of Federal Regulations (CFR), Part 556, establish a tolerance for residues of flunixin of 0.125 ppm in the liver and .025 ppm in the muscle of cattle, 21 CFR § 556.286. The regulations establish a tolerance of 0.1 ppm for residues of sulfadimethoxine, 21 CFR § 556.640, and 0.4 ppm for residues of desfuroylceftiofur, 21 CFR § 556.113, in edible tissues of cattle. The presence of these drugs in excess of the established tolerance in edible tissues from the two cows mentioned above 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.
• You lack an adequate record-keeping system for assuring that animals have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. Your dairy does not record the date, the dosage, the method of administration, and the drugs that were used to treat the animal; therefore, you do not know the exact withdrawal times required to deplete potentially hazardous residues from the tissue of these animals.
• Your firm does not segregate treated animals in a manner that prevents the sale for slaughter of treated animals.
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).
It is not necessary for you to personally ship an adulterated animal in interstate commerce to be responsible for a violation of the Act. The fact that you caused the adulteration of an animal that was sold and subsequently offered for sale to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for a violation 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 assuring that your overall operation and the foods 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 within 15 working days of the steps, you have taken to bring your firm into compliance with the law. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If the corrective action cannot be completed within 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.
Please send your reply to the Food and Drug Administration, Attention: Carolyn A. Pinney, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in the letter, please contact Carolyn A. Pinney at (303)-236-3024.
H. Thomas Warwick, Jr.
Denver District Director