Inspections, Compliance, Enforcement, and Criminal Investigations
T & J Dairy 29-Jun-04
Department of Health and Human Services
Public Health Service
San Francisco District
VIA FEDERAL EXPRESS
Our Reference: 3004537249
June 29, 2004
6219 East Panama Lane
Bakersfield, CA 93313
Dear Mr. Weststeyn:
A tissue residue report from the United States Department of Agriculture (USDA) and an inspection of your dairy farm located at 6219 East Panama Lane, Bakersfield, CA 93313, on Apri1 29, 2004, by a Food and Drug Administration (FDA) investigator, confirmed that you offered an animal 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.
On February 23, 2004, you sold a cull dairy cow identified with back tag [redacted] later identified with 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 #442405) identified the presence of gentamicin in the kidney at 1.75 ppm (parts per million) and flunixin in the liver at 0.236 ppm.
There is no established tolerance level for gentamicin in the edible tissues of cattle (Title 21 Code of Federal Regulations Section 556.300). Presently, the tolerance level for flunixin in cattle liver (target tissue) is 0.125 ppm (Title 21 Code of Federal Regulations Section 556.286(b)). The presence of gentamicin and the presence of flunixin at a level above the tolerance in edible tissues of this animal causes the food to be adulterated under Section 402(a)(2)(C)(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 drugs by using drugs in a manner contrary to their approved labeling:
The drug [redacted] (flunixin meglumine) Injectable Solution, 50 mg/mL, 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 to lactating dairy cows, whereas the drug is labeled for use in non-lactating dairy cows.
The drug [redacted] (penicillin G procaine) Aqueous Suspension, 300,000 units/mL, 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 to dairy cows averaging 1400 pounds as a 20-cc(mL) injection into one site, whereas the drug is labeled for administration at a dosage of one mL for each 100 pounds of body weight and warns against injecting more than 10 mL into one site.
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.
A Form FDA 483, Inspectional Observations, was issued to [redacted] Herdsman, at the conclusion of the inspection. A copy of this form is attached for your ready reference.
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, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding any issue in this letter, you may contact Mr. Peterson at (510) 337-6856.
Barbara J. Cassens
Attachment: FDA Form 483, Inspectional Observations