Inspections, Compliance, Enforcement, and Criminal Investigations
Heritage Dairy 09-May-05
Department of Health and Human Services
Public Health Service
Denver District Office
May 9, 2005
RETURN RECEIPT REQUESTED
Mr. Eric W. Daale
650 Curry Road F
Clovis, NM 88101-9208
Ref. #: DEN-05--11
Dear Mr. Daale:
A tissue residue report received by the Food and Drug Administration (FDA) from the United States Department of Agriculture (USDA) reported the presence of illegal drug residues in cows owned by your firm. As a follow-up to USDA's findings, an FDA investigator conducted an inspection of your dairy operation located at 650 Curry Road F, Clovis, New Mexico, on February 7-11, 2005. The inspection 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 (the Act), [21 U.S.C. 342(a)(2)(C)(ii)] and j21 U.S.C. 342(a)(4)]. In addition, you may have caused animal drugs to become adulterated within the meaning of section 501(a)(5) of the Act, [21 U.S.C. 351(a)(5)].
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. Two dairy cows owned by your firm and sold at auction for slaughter for human food were found to contain illegal levels of drug residues by USDA testing.
On July 7, 2004, USDA, Food Safety and Inspection Service (FSIS) collected a tissue sample from a culled dairy cow sold by you at auction for slaughter for human food with ear tag #[redacted] BT tag and Brucellosis tag # [redacted]). The tissue (USDA Sample No. 450426) tested positive for the presence of penicillin residue of 0.40 parts per million (ppm) in the kidney and 0.34 ppm in the liver. A tolerance of 0.05 ppm has been established for residues of penicillin in the uncooked edible tissues of cattle, Title 21, Code of Federal Regulations (CFR), Part 556.510 (21 CFR 556.510). The presence of this drug in uncooked edible tissue from this animal, in amounts exceeding the tolerance set out in 21 CFR 556.510, causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act.
Similarly, on September 14, 2004, USDA, FSIS collected a tissue sample from a culled dairy cow sold by you at auction for slaughter for human food with ear tag #[redacted] and Brucellosis tag #[redacted]. The tissue (USDA Sample No. 450439) tested positive for the presence of penicillin residue of 0.29 parts per million (ppm) in the kidney and 0.12 pprn in the liver. As noted above, a tolerance of 0.05 ppm has been established for residues of penicillin in the uncooked edible tissues of cattle (21 CFR 556.510), and the presence of this drug in uncooked edible tissue from this animal, in amounts exceeding the tolerance, 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 conditions that could allow medicated animals bearing potentially harmful drug residues 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 appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. 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 which are so inadequate, that medicated animals bearing possibly harmful drug residues are likely to enter the food supply.
In addition, you are adulterating the drug penicillin that your firm uses on dairy cows when you fail to use the drug in conformance with its approved labeling. Your practice of administering this drug for a longer period than specified in the drug's labeling and in amounts exceeding the drug's indicated dosage causes the drug to be unsafe for use within the meaning of section 512(a) of the Act and thus adulterated under section 501(a)(5) of the Act.
This is not intended to be an all-inclusive list of violations. 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, such as seizure and/or injunction. You should be aware that it is not necessary for you to have personally shipped an animal in interstate commerce to be responsible for a violation of the Act. The fact that you offered an animal for sale, thru a broker or auction, to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for violations of the Act.
You should notify this office, in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct these violations and preclude their recurrence . If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the timeframe within which the corrections will be completed. Please include with your response copies of any documentation demonstrating that corrections have been made. Your response should be sent to: William H. Sherer, Compliance Officer, U.S. Food and Drug Administration, P.O. Box 25087, Denver, Colorado, 80225-0087. You may reach Mr. Sherer at (303) 236-3051 if you have any questions about this matter.
B. Belinda Collins