Inspections, Compliance, Enforcement, and Criminal Investigations
Hector Stechnij Dairy 13-Nov-03
Department of Health and Human Services
Public Health Service
Los Angeles District
November 13, 2003
RETURN RECEIPT REQUESTED w/L 07-04
Hector Stechnij Dairy
3440 S. Hawes Rd.
Mesa, AZ 85212
Dear Mr. Stechnij:
Our records reflect you are one of the partners of Hector Stechnij Dairy located at 3440 S. Hawes Rd, Mesa, AZ. An investigation of your dairy operation conducted by our investigators on July 10-11, 2003, confirmed that you offered animals 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 (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 further 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 May 14, 2003, you sold a culled dairy cow identified by USDA Laboratory report 447625 for slaughter as human food. USDA analysis of tissue samples collected from that animal identified the presence of penicillin in the kidney at 0.88 parts per million (ppm). A tolerance of 0.05 ppm has been established for residues of penicillin in the edible tissues of cattle (Title 21, Code of Federal Regulations, Section 556.510). The presence of this drug, at the reported levels in the edible tissue of this animal, causes the food to be adulterated within the meaning of Section 402(a)(2)(C)(ii) of the Act.
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 Food from animals held under
such conditions is adulterated within the meaning
of Section 404(a)(4) of the Act.
It was further determined that you are using 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 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. Specifically:
You are adulterating injectable penicillin, such as Agrilabs Agri-Cillin, that you use on dairy cattle in a manner contrary to the approved labeling. Injectable penicillin is labeled for intramuscular use at 1 cc per hundred pounds of body weight. Your use of this drug at 30 ccs per intravenous dose is not in agreement with the approved labeling.
You are adulterating oral tetracycline that you use on dairy cattle in a manner contrary to the approved labeling. Tetracycline powder is labeled for use in the drinking water of animals. Your use as a spray for the treatment of foot warts is not in agreement with the approved labeling.
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:
Robert B. McNab
Acting Director, Compliance Branch
U.S. Food and Drug Administration
Irvine, CA 92612
Alonza E. Cruse