Inspections, Compliance, Enforcement, and Criminal Investigations
Klever Holstein Farms Ltd. 03-May-05
Department of Health and Human Services
Public Health Service
Cincinnati District Office
May 3, 2005
VIA FEDERAL EXPRESS
James M. Klever, Part-Owner
Klever Holstein Farms Ltd.
19762 Divelbiss Road
Fredricktown, Ohio 43019
Dear Mr. Klever:
An inspection of your dairy farm located in Fredricktown, Ohio by the U.S . Food and Drug Administration (FDA) on February 8, 2005 confirmed that you offered animals for sale for slaughter as human food in violation of sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act).
The United States Department of Agriculture/Food Safety Inspection Service (USDA/FSIS) reported the presence of illegal drug residues in a bob veal calf that originated from your dairy farm. On July 5, 2004, you sold a calf, back tag [redacted] to [redacted]. This calf was taken to [redacted] slaughter on July 7, 2004. The USDA/FSIS laboratory's analytical report #450527 for this bob veal calf shows that the USDA analysis detected 31.13 ppm of neomycin in the kidney tissues. The tolerances for neomycin are listed in Title 21 Code of Federal Regulations (21 CFR), Section 556.430. The presence of neomycin at the level reported in the animals you sold causes the food to be adulterated under section 402(a)(2)(C)(ii) of the Act because it contains a new animal drug which is unsafe within the meaning of section 512 of the Act.
Our investigation also found that you hold animals under conditions that 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 the medicated animals have been identified and segregated, and 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 which identify the animal, date of medication, the drug, the dosage administrated, and the drug pre-slaughter withdrawal time.
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. Please note that the Act does not permit the extralabel use of medicated feeds. "Extralabel use" means 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 Federal Food Drug & Cosmetic 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