Inspections, Compliance, Enforcement, and Criminal Investigations
Idyl Wild Farms Inc. 10-May-05
Department of Health and Human Services
Public Health Service
Cincinnati District Office
May 10, 2005
VIA FEDERAL EXPRESS
Paul S . Weber, President
Idyl Wild Farms Inc.
2536 County Road 175
Loundonville, Ohio 44842-9621
Dear Mr. Weber:
An inspection of your farm, located in Loundonville, Ohio, by the U.S . Food and Drug Administration (FDA) on 1/21 & 27/2005 confirmed that you offered an animal for sale for slaughter as human food that was adulterated within the meaning of sections 402(a)(2)(C)(ii) and 402(a)(4) of the Food, Drug and Cosmetic Act (the Act). A food is adulterated under section 402(a)(2)(C)(ii) of the Act if it contains a new animal drug which is unsafe within the meaning of section 512 of the Act.
The United States Department of Agriculture (USDA) reported the presence of an illegal drug residue in a bull calf that originated from your dairy farm. On or about October 18, 2004, you sold a calf, back tag #[redacted] to [redacted] through [redacted]. This calf was later given tag #[redacted] and was taken to [redacted] for slaughter on October 22, 2004. The USDA laboratory's analytical report #452503 for the calf with dealer back tag # 071 shows that the USDA analysis detected gentamicin in the liver and kidney tissues of the referenced animal. Gentamicin sulfate is not approved for use in the bovine species. No tolerance for residues of gentamicin in the edible tissues of the bovine species has been established (21 CFR 556.300).
The presence of gentamicin in the edible tissues of this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act. Gentamicin is not approved for use in the bovine species; use of gentamicin in calves is therefore contrary to the approved conditions of use. Such an extralabel 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 the criteria set forth in 21 CFR Part 530, including that there be no residue which may present a risk to human health. Because your use of gentamicin resulted in the presence of a drug residue in edible tissue that might present a risk to human health; use of the drug was not in compliance with extralabel use regulations, 21 CFR 530.11(c). The drug is therefore unsafe under section 512 of the Act, which causes the food to be adulterated under section 402(a)(2)(C)(ii).
In addition, a food is adulterated under Section 402(a)(4) of the Act if the food "has been prepared, packed, or held under insanitary conditions . . . whereby it may have been rendered injurious to health. As it applies in this instance, "insanitary conditions," refers to your lack of records for medicated animals. Our investigation found that you hold animals under conditions that are inadequate to prevent animals bearing potentially harmful drug residues from entering the food supply. For example:
You lack an adequate system for assuring that the medicated animals have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues.
You fail to maintain treatment records for heifer and bull calves.
You lack an adequate system for determining the quantity of drugs used to medicate your livestock.
Food derived from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act.
The investigation also found that you treated your calves with a medicated milk replacer containing neomycin. Neomycin sulfate is not approved for use in milk replacers fed to calves to be processed for veal, 21 CFR 558.364. Please note that the Act does not permit the extralabel use of medicated feeds. "Extralabel use" includes actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, such as not following the labeled withdrawal times or using the drug contrary to a warning on the label. For your information, attached is a copy of the regulations on extralabel use.
You should be aware that it is not necessary for you to have personally shipped an adulterated animal in interstate commerce to violate the Act. The fact that you offered an adulterated animal for sale, which was slaughtered and held for sale 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. Failure to promptly correct these deficiencies may result in regulatory action being initiated by the Food and Drug Administration without further notice. Possible actions include, but are not limited to, seizure and/or injunction.
Please notify this office within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the reoccurrence of similar violations . If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which corrections will be completed.
Your response to this Warning Letter should be sent to Gina M. Brackett, Compliance Officer, Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237.
Carol A. Heppe