| Public Health Service |
Denver District Office |
Department of Health and Human Services
October 9, 2007
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Dennis D. Luce
Owner
4 D Cattle
Route 1, Box 98
Fort Sumner, NM 88119
Ref. #: DEN-08-03
Dear Mr. Luce:
An investigation of your dairy operation located at 1262 Lande View Road, Fort. Sumner,, New Mexico, conducted by a representative of the U.S. Food and Drug Administration (FDA) on May 31 - June 2, 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 drugs Tilmicosin and Phenylbutazone to become adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)] and unsafe under section 512 of the Act [21 U.S.C. § 360b]. 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 January 10, 2007, you sold a Holstein steer, identified with back tag [redacted] for slaughter as food to [redacted]. This animal was slaughtered by [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 18.6 parts per million (ppm) Tilmicosin in the liver tissue, and 7.5 ppm Tilmicosin in the muscle tissue. In addition, the USDA/FSIS analysis identified 8888 ppm Phenylbutazone in the kidney tissue.
A tolerance of 1.2 ppm has been established for residues of Tilmicosin in the liver tissue of cattle, and 0.1 ppm in cattle muscle tissue, as codified in Title 21, Code of Federal Regulations, Section 556.735, (21 CFR 556.735). The presence of this drug in the edible tissues of this animal in amounts exceeding the tolerance set out in 21 CFR 556.735 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)].
No tolerance has been established for residues of Phenylbutazone in edible tissues of cattle. Phenylbutazone injection is only approved for use in dogs and horses, as set out in 21 CFR 522.1720. The presence of this drug in the edible tissues of this animal 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 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 and review complete treatment records, and you lack an adequate inventory system for determining the quantities of drugs used to medicate your 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)].
In addition, you adulterated Tilmicosin and Phenylbutazone within the meaning of section 501(a)(5) [21 U.S.C. § 351 (a)(5)] of the Act when you failed to use the drugs in conformance with their approved labeling. "Extra-label 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 extra-label use of approved .veterinary or human drugs must comply with sections 512(a)(4)and (5) of the Act [21 U.S.C. §§ 360b(a)(4), (5)] and 21 C.F.R. Part 530.
For example, you administered Tilmicosin without-following the withdrawal period set forth in the approved labeling and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). In addition, you administered Phenylbutazone to a species not approved on the labeling. Furthermore, your extra-label use resulted in illegal drug residues, in violation of 21 C.F.R. 530.11(c). Because your extra-label use of these drugs did not comply with 21 CFR Part 530, the drugs were unsafe under section 512(a) of the Act [21 U.S.C. § 360b(a)], and your use caused them 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 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 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 with your response copies of any documentation demonstrating that corrections have been made.
Your response should be sent to U.S. Food and Drug Administration, P.O. Box 25087, Denver, Colorado 80225-0087, Attention: William H. Sherer, Compliance Officer. If you have any questions about this letter, please contact Mr . Sherer at (303) 236-3051.
Sincerely,
/S/
B. Belinda Collins
Denver District Director
cc:
Ronald K. Jones, D.V.M.
Denver District Manager
USDA/FSIS
PO Box 25387
DFC, Bldg 45
Denver, CO 80225
I. Miley Gonzalez, Ph.D.
Secretary
New Mexico Department of Agriculture
New Mexico State University
P.O. Box 300005, MSC 3189
Las Cruces, NM 88003-8005
Lee C. Jan, D.V.M.
Director
Texas Department of Health
Meat Safety Assurance Unit
1100 West 49th Street
Austin, TX 78756-7466
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