Inspections, Compliance, Enforcement, and Criminal Investigations
Sun Valley Jerseys 04-Dec-03
Department of Health and Human Services
Public Health Service
Los Angeles District
December 4, 2003
RETURN RECEIPT REQUESTED
Robert D. Hogg
Sun Valley Jerseys
8171 Chino Ave.
Ontario, CA 91761
Dear Mr. Hogg:
Our records reflect you are the owner of Sun Valley Jerseys, located at 8171 Chino Ave., Ontario, CA. An investigation of your dairy operation conducted by our investigator on October 14-22, 2003, confirmed that you offered animals for sale for slaughter as food which were in violation of Sections 402(a)(2)(C)(ii) and 402(a)(4) (21 U.S.C.§ 342(a)(2)(C)(ii) and 342(a)(4)) of the Federal Food, Drug and Cosmetic Act (henceforth the Act).
A food is adulterated under Section 402(a)(2)(C)(ii) of the Act if it contains a new animal drug that is unsafe within the meaning of Section 512 of the Act. A food is also adulterated under Section 402(a)(4) of the Act if it has been held under conditions whereby it may have been rendered injurious to health.
On or about August 1, 2003, you sold a culled dairy cow identified by USDA
Laboratory report 441303 for slaughter as human food. USDA analysis of tissue
samples collected from that animal identified the presence of penicillin in
the kidney at 0.10 parts per million (ppm). A tolerance of 0.05 ppm has been
established for residues of penicillin in the edible tissues of cattle. See
21 CFR 556.510.
Additionally, on or about August 5, 2003, you sold a culled dairy cow identified by USDA Laboratory report 441308 for slaughter as human food. USDA analysis of tissues samples collected from that animal identified the presence of oxytetracycline in the liver at 20.8 ppm, in the kidney at 16.0 ppm and in the muscle at 18.4 ppm. Tolerances of 6.0 ppm in the liver, 12.0 ppm in the kidney and 2 ppm in the muscle have been established for residues of oxytetracycline in the edible tissues of cattle. See 21 CFR 5 556.500.
Our investigation also found that you hold animals under improper conditions
whereby diseased animals and/or medicated animals bearing potentially harmful
drug residues are likely to enter the food supply. For example, you lack an
adequate system for assuring that animals medicated by you have been withheld
from slaughter for the appropriate periods of time to permit depletion of potentially
hazardous residues of drugs from edible tissues. Foods from animals held under
such conditions are considered adulterated under the Act (21 U.S.C. 342(a)(4)
It was further determined that you are using animal drugs in a manner contrary to their approved labeling. Such extra-label use is not permitted, except by or on the lawful written or oral order of a licensed veterinarian within the context of a valid veterinarian-client-patient relationship, and otherwise in compliance with the limitations set forth for specific extra-label uses. [21 CFR 530.10 and 530.11] Your use of animal drugs in any manner other than as labeled causes those drugs to be adulterated under Section 501 (a)(5) of the Act because there is no approval for such use as required by Section 512 (a)(1)(B) of the Act.
You are adulterating powdered tetracycline such as Tetracycline 324 Powder, that you use on your dairy cattle in a manner contrary to the approved labeling. Your use of this drug as an intra-uterine infusion for the treatment of retained placentas is contrary to the labeled directions for use in the drinking water of calves for scours or shipping fever.
The above is not intended to be an all-inclusive list of violations. As a producer of animals, which are offered for use as food, you are responsible for assuring that your overall operations and the food you distribute are in compliance with the law.
Please note that 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 to a slaughterhouse which ships in interstate commerce is sufficient to hold you responsible for a violation of the Act.
You should take prompt action to correct the above violations and to assure that the procedures you have established will prevent their recurrence. Failure to do so may result in regulatory action, such as injunction, without further notice. This letter constitutes official notification under the law and provides you an opportunity to correct.
Please advise this office in writing within fifteen (15) working days of receipt of this letter of the steps you have taken to bring your dairy into compliance with the law. Your response should include each step that has been taken to correct the violations and prevent their recurrence. If corrective action cannot be taken within fifteen (15) working days, state the reason for the delay and the time within which such corrections will be made. If you have any questions or need clarifications regarding this letter prior to your written response, you may contact Barbara Rincon, Compliance Officer at telephone number (949) 608-4439.
Your written response should be directed to:
Acting Director, Compliance Branch
U.S. Food and Drug Administration
Irvine, CA 92612
Alonza E. Cruse