Inspections, Compliance, Enforcement, and Criminal Investigations
Desertland Dairy 23-May-06
Department of Health and Human Services
Public Health Service
Denver District Office
May 23, 2006
RETURN RECEIPT REQUESTED
Mr. Edward DeRuyter
17900 S. Stern Road
P.O. Box 10, Drawer A
Mesquite, NM 88048-0010
Ref. #: DEN-06-17
Dear Mr. DeRuyter:
An investigation of your dairy operation located at 17900 South Stern Road, Mesquite, NM, conducted by a representative of the U.S. Food and Drug Administration (FDA) on April 3 - 6, 2006, confirmed that you offered two animals for sale for slaughter as food that were 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 Sulfadimethoxine and Flunixin Meglumine 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 November 17, 2005, you sold a dairy cow, identified with ear tag [redacted], for slaughter as food to [redacted]. This animal was slaughtered at [redacted] on November 18, 2005. The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 8,329 parts per million (ppm) Flunixin in the liver tissue.
A tolerance of 0.125 ppm has been established for residues of Flunixin in cattle liver tissue, as codified in Title 21, Code of Federal Regulations, Section 556.286, (21 CFR 556.286). The presence of this drug in the edible tissue of animals in amounts exceeding the tolerance set out in 21 CFR 556.286 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)].
On January 26, 2006, you sold a dairy cow, identified with ear tag [redacted] for slaughter as food to [redacted]. This animal was slaughtered by [redacted] on January 27, 2006. The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 1.87 ppm Sulfadimethoxine in the liver tissue, and 1.30 pp in Sulfadimethoxine in the muscle tissue.
A tolerance of 0.1 ppm has been established for residues of Sulfadimethoxine in the edible tissues of cattle, as codified in 21 CFR 556.640. The presence of this drug in the edible tissues of this animal in amounts exceeding the tolerance set out in 21 CFR 556.640 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. For example, you failed to maintain and review complete treatment records for your cattle. You therefore 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. 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 Flunixin Meglumine and Sulfadimethoxine 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. The "extra-label" use of approved veterinary or human drugs must comply with sections 512(a)(4) and 512(a)(5) of the Act [21 U.S.C. 351(a)(4) and (a)(5)] and 21 CFR Part 530. "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.
Our investigation found that your extra-label use of Sulfadimethoxine and Flunixin Meglumine failed to comply with these requirements. For example, you administered the Sulfadimethoxine boluses without following the withdrawal period set forth in the approved labeling. In addition, you administered the Flunixin Meglumine intramuscularly rather than intravenously as set forth in the approved labeling. You did so in both instances without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Furthermore, your extra-label use resulted in drug residues above an established safe level, safe concentration or tolerance, in violation of 21 CFR 530.11(d). 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. § 301(a)(5)].
Additionally, USDA/FSIS previously notified you in July 2000 and April 2003 of illegal Penicillin residues found in your marketed dairy cows.
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 thc 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) 23G-3051.
B. Belinda Collins
Denver District Director