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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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De-Rene Dairy 13-May-05

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
Telephone: 303-236-3000
FAX: 303-238-3100







May 13, 2005

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Douglas B. Handley
Owner .
Do-Rene Dairy
1461 Curry Road 6
Clovis, NM 88101

Ref. #: DEN-05-13

Dear Mr. Handley:

A tissue residue report received by the U.S. Food and Drug Administration (FDA) from the United States Department of Agriculture (USDA) reported the presence of an illegal drug residue in a cow owned by your firm. As a follow-up to the USDA's findings, an FDA investigator conducted an inspection of your dairy operation located at 1461 Curry Road 6, Clovis, New Mexico, on February 1-5, 2005. The inspection confirmed that you offered an animal for sale for slaughter as food which contained an illegal drug residue, 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 342(a)(4)].

A food is adulterated under Section 402(a)(2)(C)(ii) of the Act, [21 U.S.C. 342(a)(2)(C)(2)], if it contains a new animal drag that is unsafe within the meaning of Section 512 of the Act, 21 U.S.C. 360b]. You sold a dairy cow through [redacted] which was' found to contain an illegal level of drug residue by USDA testing.

On September 30, 2004, USDA collected a tissue sample from a culled dairy cow sold by you at auction for slaughter for human food with ear tag #[redacted] Brucellosis tag #[redacted] and BT #[redacted]. The tissue (USDA Sample No. 450443) tested positive for the presence of sulfadimethoxine residue of 3.53 parts per million (ppm) in the liver and 1.26 ppm in the muscle. A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in the uncooked edible tissues of cattle in Title 21 Code of Federal Regulations 556.640 (21 CFR 556.640).

During our investigation, you reported your firm treated the subject dairy cow (ear tag #[redacted]) with [redacted] (Sulfadimethoxine injection - 40%). The presence of this drug in uncooked edible tissue from this animal in amounts exceeding the tolerance set out in 21 CFR 556.640 causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, [21 U.S.C. 342(a)(2)(C)(ii)].

You were previously notified by USDA of another illegal sulfadimethoxine residue found in one of your marketed dairy cows on January 16, 2003.

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, animal treatment records are missing, and 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, [21 U.S .C. 342(a)(4)], "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.

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 a violation of the Act.

You should notify this office in writing, within fifteen (15) working days of receipt of this letter, of the 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 time frame 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.

Sincerely,

/S/

B. Belinda Collins
District Director