|Subject:||Illegal Drug Residue|
|Issuer:||Denver District Office|
|Issued:||Nov. 14, 2007||Closed:||
Department of Health and Human Services
Public Health Service
Denver District Office
November 14, 2007
RETURN RECEIPT REQUESTED
Mr. John Visser
15605 Avenue 208
Strathmore, California 93267
Ref, #: DEN-08-08
Dear Mr. Visser:
An investigation of your cattle raising operation, Dairyman's Calf Ranch, located at 1548 South Roosevelt Road 6, Portales, New Mexico, conducted by a representative of the U.S. Food and Drug Administration (FDA) on June 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 drugs [redacted] USP to be unsafe under section 512 of the Act [21 U.S.C. 360b], and adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. 351(a)(5)]. Finally, you caused an animal feed to be unsafe within the meaning of section 512 [21 U.S.C. 360b] of the Act, and adulterated under section 501(a)(6) [21 U.S.C. 351(a)(6)] 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 February 20, 2007, you sold a bob veal calf, identified with ear tag 86725, to Mr. [redacted] a veal calf dealer, of [redacted] for delivery to [redacted] d.b.a. [redacted] in [redacted] for slaughter as human food. [redacted] Inc. is a custom slaughter plant for [redacted] in [redacted] This animal was slaughtered by [redacted] on February 21, 2007. 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 neomycin in the kidney at 14.95 parts per million (ppm) and sulfamethoxazole in the liver at 0.91 ppm and in the muscle at 0.58 ppm of the bob veal calf. A tolerance of 7.2 ppm has been established for residues of neomycin in the kidney of cattle as codified in Title 21, Code of Federal Regulations , Part 556.430 (21 C.F.R. 556.430). No tolerance has been established for residues of sulfamethoxazole in the edible tissues of cattle. The presence of these drugs in these amounts in edible tissue from this animal cause 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 drug from edible tissues. For example, you failed to maintain animal treatment records and failed to segregate treated animals to assure that drugs have been used only as directed and that appropriate withdrawal times have been observed prior to offering an animal for slaughter for human food. 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
USP within the meaning of section 501(a)(5) [21 U.S.C. 351 (a)(5)] of the Act when you failed to use these drugs in conformance with their approved labeling. Under sections 512(a)(4) and 512(a)(5) of the Act, "extralabel use," i.e., the actual or intended use of an approved veterinary or human drug in an animal in a manner that is not in accordance with the approved labeling, is permitted only if:
(1) the use is by or on the lawful order of a licensed veterinarian within the context of a valid
veterinarian/client/patient relationship; and (2) the extralabel use complies with 21 C.F.R. Part 530. Our investigation found that your extralabel use of [redacted] and [redacted] and [redacted] USP failed to comply with these requirements.
For example, you administered [redacted] , USP in milk replacer, an animal feed. While we acknowledge that our veterinarian, Dr. [redacted] , prescribed [redacted] , USP for the treatment of bovine respiratory disease and susceptible infections in calves, that prescription was for oral administration, i.e., direct oral administration. The prescription did not prescribe use in or on animal feed. In fact, the extralabel use of drugs in or on animal feed is specifically prohibited under 21 C.F.R. 530.11(b). Furthermore, your extralabel use resulted in illegal drug residues, in violation of 21 C.F.R. 530.11(c). Because your extralabel use of these drugs was not in compliance with 21 C.F.R. 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)].
You also caused the adulteration of an animal feed when you added [redacted] and [redacted] and [redacted] , USP to milk replacer. The addition of these drugs to milk replacer caused that animal feed to be unsafe under section 512(a)(2) [21 U.S.C. 360b(a)(2)] of the Act, and adulterated under section 501(a)(6) [21 U.S.C. 351(a)(6)] of the Act.
This is not intended to be an all-inclusive list of violations. We acknowledge that during the investigation your ranch manager, Mr. [redacted] stated that the ranch no longer employs the employees purportedly responsible for the above tissue residue violations. However, 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. In addition, we are aware that USDA/FSIS notified [redacted] by letter dated February 22, 2007 that a tissue sample collected from a bob veal calf sold by the ranch, marked with ear tag 85AZV1911 and slaughtered on January 31, 2007, identified the presence of [redacted] in the kidney at 24.16 ppm.
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 fifteen (15) working days of receipt of this letter, of the steps you have taken to correct these violations and preclude 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 Nancy G. Schmidt, Compliance Officer, U.S. Food and Drug Administration, P.O. Box 25087, Denver, Colorado 80225-0087. If you have any questions about this matter, please contact Compliance Officer Nancy G. Schmidt at (303) 236-3046.
B. Belinda Collins
Mr. Ronald C. Nelson, D.V.M
Denver District Manager
PO Box 25387
DFC, Bldg 45
Denver, CO 80225
I. Miley Gonzalez, Ph.D.
New Mexico Department of Agriculture
New Mexico State University
P.O. Box 300005, MSC 3189
Las Cruces, New Mexico 88003-8005