Inspections, Compliance, Enforcement, and Criminal Investigations
Lonely Ranch Dairy 15-Jan-04
Department of Health and Human Services
Public Health Service
San Francisco District
VIA FEDERAL EXPRESS
Our Reference: 1000123842
January 15, 2004
Manuel O. Rocha
Lonely Ranch Dairy
29558 West Marshall Road
Gustine, CA 95322
Dear Mr. Rocha:
A tissue residue report from the United States Department of Agriculture (USDA) and an inspection of your dairy farm located at 29558 West Marshall Road, Gustine, CA 95322, on November 18 and 21, 2003, by a Food and Drug Administration (FDA) investigator, confirmed that you offered a cow for sale for slaughter as food in violation of Sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act(the Act), and that you caused animal drugs to become adulterated within the meaning of Section 501(a)(5) of the Act. At the conclusion of the inspection, a Form FDA 483, Inspectional Observations, was issued to and discussed with you. A copy of this form is attached for your ready reference.
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 further adulterated under Section 402(a)(4) of the Act if it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.
On August 19, 2003, yousold a cull dairy cow, later identified with back tag [redacted] USDA retain tag# [redacted], and house tag [redacted] for slaughter as human food. USDA analysis of tissue samples collected from that animal (Lab Report Serial [redacted] identified the presence of sulfadimethoxine in the liver at 0.42 ppm (parts per million) and in the muscle at 1.57 ppm. Presently, the tolerance level for sulfadimethoxine in the uncooked edible tissues of cattle is 0.1 ppm (Title 21 Code of Federal Regulations (CFR), Section 556.640(b)). The presence of this drug at a level above the tolerance in edible tissues of these animals causes the food to be adulterated under Section 402(a)(2)(G)(ii) of the Act.
Our investigation also found that you hold animals which are ultimately offered for slaughter as food, under conditions which are so inadequate that 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 have been treated only with drugs which have been approved for use in those species; for assuring that drugs are used in a manner not contrary to the directions contained in the labeling; and for assuring 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. Foods from animals held under such conditions are adulterated under Section 402(a)(4) of the Act.
The introduction or delivery for introduction into interstate commerce of any adulterated food is prohibited under Section 301(a)of the Act. 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 and subsequently offered for sale to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for a violation of the Act.
It was further determined that you are adulterating drug by using drugs in a manner contrary to their approved labeling:
The drug [redacted](penicillin G procaine) injectable suspension U.S.P. is adulterated within the meaning of Section 501(a)(5) since you fail to use it in conformance with its approved labeling. Specifically, you administer this drug intrauterine to treat infections, a use that is not in accordance with the drug's approved labeling.
The drug [redacted](tylosin 200mg/ml) injection is adultented within the meaning of Section 501(a)(5) since you fail to use it in conformance with its approved labeling. Specificatiy, you administer this drug to lactacting dairy cattle, whereas the drug is only approved and labeled for use in beef cattle, non-lactating dairy cattle, and swine.
The manner,in which you use these and other drugs outside of their FDA-approved labeling causes them to be unsafe within the meaning of Section 512 of the Act.
The violations listed above are not meant to be all-inclusive. 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.
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, including seizure and/or injunction.
Please respond in writing within fifteen (15) working days of receipt of this letter. Your response should outline the specific things you are doing to correct the violations. If you cannot complete all corrections before responding, we expect you will explain the reason for any delay and the time period within which the corrections will be completed. Your response should be directed to Paul A. Peterson, Compliance Officer, Food and Drug Administration, 2431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding any issue in this letter, you may contact Mr. Petersonat (510) 337-6856.
Elizabeth A. Keville
Acting District Director