Inspections, Compliance, Enforcement, and Criminal Investigations
Ciocca Dairy 09-Apr-04
Department of Health and Human Services
Public Health Service
April 9, 2004
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 04-23
Edward M. Ciocca, Owner
1648 East 2900 South
Wendell, Idaho 83355
Dear Mr. Ciocca:
An investigation at your dairy located at 1648 East 2900 South, Wendell, Idaho, conducted by a Food and Drug Administration (FDA) investigator on January 6 and 7, 2004, 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 FederaI Food, Drug, and Cosmetic Act (the Act). You also caused the adulteration of an animal drug because the drug was used in a manner that does not conform to its approved uses or the extralabel use regulations at Title 21, Code of Federal Regulations, Part 530 (21 CFR Part 530). This caused the drug to be unsafe under Section 512(a) of the Act and adulterated within the meaning of Section 501(a)(5) of the Act.
On or about, October 6, 2003, you sold 5 culled dairy cows, including back
tag number 82NE316, identified on USDA-FSIS Lab Form #435841. This cow was sold
for slaughter as human food [redacted] who in turn sold the cow to [redacted]
Agriculture (USDA) analysis of a tissue sample collected from that cow identified
the presence of gentamicin at 2.37 parts per million (PPM) in the kidney. There
is no established tolerance for residues of gentamicin in the kidney tissue
of cattle. The presence of gentamicin in the edible tissues of this animal caused
the food to be adulterated within the meaning of Section 402(a)(2)(C)(ii) of
A food is 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. As it applies in this case, insanitary conditions means that you hold animals which are ultimately offered for sale for slaughter as food under conditions that are inadequate to prevent animals bearing potentially harmful drug residues from entering the food supply. For example, our investigator noted the following conditions on your farm:
1. You lack an adequate system for assuring that animals to which you administer medication have been withheld from slaughter for appropriate periods of time to deplete potentially hazardous residues of drugs.
2. You lack an adequate system for assuring that drugs are not used in a manner contrary to the directions contained in their approved labeling.
The investigation also determined that you adulterated an animal drug within the meaning of Section 501 (a)(5) of the Act when you failed to use the drug in conformance with its approved conditions of use or the extralabel use regulations at 21 CFR Part 530. Specifically, you used the drug gentamicin, which was prescribed for use on calves that were under 3 weeks of age with an 18 month drug withdrawal time. Your use of this drug on an adult dairy cow without a prescription for such use is considered an extralabel use. Extralabel drug use is permitted only on the lawful order of a licensed veterinarian within the context of a valid veterinarian-client patient relationship and in conformance with all other criteria set forth in 21 CFR Part 530, including that there may be no residue above established tolerance levels. Your use of gentamicin failed to comply with the extralabel use regulations, causing the drug to be unsafe under Section 512(a) of the Act and adulterated within the meaning of Section 501(a)(5) of the Act.
You should be aware 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 offered an adulterated animal for sale that was
shipped in interstate commerce to a slaughterhouse is sufficient to make you
responsible for violations of the Act.
The above is not intended to be an all-inclusive list of violations. As a producer
of animals offered for sale for use as food, you are responsible for ensuring
that your operations 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 occur. Failure to do so may result
in regulatory action without further notice, such as seizure and/or injunction.
Please respond within fifteen (15) days of receipt of this letter and notify
this office in writing of the specific steps you have taken to correct these
violations and preclude their recurrence. If corrective action cannot be completed
within fifteen working days, state the reason for the delay and the time frame
within which corrections will be completed.
Please send your reply to the Food and Drug Administration, Attention: Bruce Williamson, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have questions regarding any issue in this letter, please contact Bruce Williamson, Compliance Officer, (425) 483-4976.
Russell Gripp for Charles M. Breen