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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Hand, Steve, M 05-Jun-07

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

Public Health Service
Food and Drug Administration

 

Atlanta District Office
60 8th Street, N.E.
Atlanta, Georgia 30309


June 5, 2007

VIA FEDERAL EXPRESS

WARNING LETTER
(07-ATL-09)

Steve M. Hand
471 Pinetta Road
Ocilla, Georgia 31774

Dear Mr. Hand:

An investigation of your cattle hauling operation conducted by a representative of the U.S. Food and Drug Administration on December 4, 2006, and January 11, 2007, confirmed that dairy cows purchased and sold by you on or about October 13, 2006, and October 26, 2006, respectively, were adulterated under section 402(a)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act on the Internet through links on FDA's web page at www.fda.gov.

On or about October 26, 2006, you sold a dairy cow, identified with Back Tag #[redacted] (possibly [redacted]), lot tag #[redacted], for slaughter as food at [redacted] in [redacted] slaughtered this cow on or about October 26. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of gentamicin in the liver and kidney tissues. The level of gentarnicin was not quantified. No tolerance has been established for residues of gentamicin in the edible tissues of cows as codified in Title 21, Code of Federal Regulations (21 CFR), Part 556.300. The presence of gentamicin in edible tissues from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)].

On or about October 13, 2006, you sold a dairy cow, identified with Back Tag #[redacted], Lot Tag #[redacted], for slaughter as food at [redacted] slaughtered this cow on or about October 13. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of penicillin at 18 ppm (parts per million) in the kidney tissue and at .12 ppm in the liver tissue. A tolerance of .05 ppm has been established for residues of penicillin in the edible tissues of cows as codified in 21 CFR 556.510. The presence of this drug in edible tissues from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)].

In addition, USDA has reported the finding of illegal residues in other dairy cattle sold by you and offered for slaughter for human food. The most recent incident (prior to the residues discussed above) being a dairy cow sold to [redacted] on or about July 14, 2006. USDA/FSIS analysis revealed the presence of gentamicin in the kidney tissue of this animal.

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.

The violations listed above are not intended to be an all inclusive list. It is your responsibility to assure that your operations are in compliance with the law. As a dealer of animals, you are frequently the individual who introduces or offers for introduction into interstate commerce, the adulterated animal. As such, you share the responsibility for violating the Act.

You should notify this office in writing within fifteen (15) working days of the steps you have taken to bring your firm into compliance with the law. Your response should include each step being taken, that has been taken, or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made. You reply should be directed to Philip S. Campbell, Compliance Officer, at the address noted in the letterhead.

Sincerely,

/S/

Mary Woleske, Director
Atlanta District