Inspections, Compliance, Enforcement, and Criminal Investigations
J & T Dairy 26-Jun-07
Department of Health and Human Services
Public Health Service
June 26, 2007
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 07-17
John M. Nauta, Owner
J & T Dairy
3851 North 1400 East
Buhl, Idaho 83316
Dear Mr. Nauta:
An investigation of your dairy operation, conducted by a representative of the U.S. Food and Drug Administration (FDA) on May 1 and 3, 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 investigation also revealed that you caused 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. 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 February 7, 2007, you sold a dairy cow with Back Tag 9324 for slaughter as human food to [redacted]. The United States Department of Agriculture, Food Safety, and Inspection Service (USDA/FSIS) analysis of a tissue sample collected from that animal identified the presence of sulfadimethoxine in both the liver at 3.53 parts per million (ppm) and the muscle at 1.38 ppm of the cow. A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Section 556.640 (21 CFR 556.640). The presence of this drug in uncooked edible tissues from this animal, in an amount that exceeds the established tolerance, 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 that include the name of the drug used on the animal, the individual who administered the drug, the dosage administered, the route of administration, the required withdrawal time, and the date the animal, or its byproducts, may be offered for human consumption. 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, you adulterated sutfadimethoxine within the meaning of section 501(a)(5)[21 U.S.C. § 351(a)(5)] of the Act when you failed to use the drug in conformance with its approved labeling. "Extralabel use," i.e., the actual or intended use of the 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, and in compliance 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. The extralabel use of sulfadimethoxine in lactating dairy cattle is prohibited by 21 CFR 530.41(a)(9). Nonetheless, you administered the sulfadimethoxine without following the dosage level, duration of treatment, and withdrawal period set forth in the approved labeling. 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)] 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 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 reply should be directed to Lisa M. Elrand, 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. Elrand at 425-483-4913.
Charles M. Breen
Isabel Arrington, D.V.M.
USDA-FSIS, Technical Service Center
Landmark Center, Suite 300
1299 Farnam Street
Omaha, Nebraska 68102
Pat Takasugi, Director
Idaho Department of Agriculture
P.O. Box 790
Boise, Idaho 83701-0791