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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Acker, Dennis L. 1/30/09

  

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

Public Health Service
Food and Drug Administration
 Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7132
FAX: (612) 334-4142


January 30, 2009
 

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 09 - 09

Dennis L. Acker
813 Presido Drive
Waunakee, Wisconsin 53597-9801

Dear Mr. Acker:

An investigation of your cattle operation located at 5000 Pheasant Branch Road, Middleton, Wisconsin, was conducted by an investigator from the U.S. Food and Drug Administration (FDA), on August 25 and September 12, 2008. This investigation confirmed that you offered an animal for sale for slaughter as food that was adulterated under 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)]. You can find the Act and its associated regulations on the Internet through links on the FDA web page at www.fda.gov.

On or about May 19, 2008, you consigned a lot of seven cows and one bull (animals were not identified individually) for sale at [(b)(4)]. On or about May 19, 2008 one of these cows was purchased by [(b)(4)] and assigned back tap [(b)(4)]. On or about May 20, 2008, this cow was slaughtered at [(b)(4)] United States Department of Agriculture, Feed Safety and Inspection Service (USDA/FSIS), analyses of tissue samples collected from this cow identified the presence of 5.40 parts per million(ppm) sulfadimethoxine in liver tissue.

A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, section 556.640 (21 CFR 556.640). The presence of this drug in excess of this amount in uncooked edible tissues from this animal 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)].

Our investigation found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues may enter the food supply. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4)] of the Act [21 U.S.C. § 342(a)(4)]. You lack a system to ensure that animals you buy, hold, and then sell for slaughter as food have not been medicated or, if they have been medicated, to allow you to withhold the animals from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissues.

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 above is not intended to be an all-inclusive list of violations. It is your responsibility to ensure that your operations are in compliance with the law. As a buyer and seller of animals intended for slaughter as food, 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 Federal Food, Drug, and Cosmetic Act. To avoid future illegal residue violations, you should take precautions such as implementing a system or systems to determine and record the source of the animal, to determine whether the animal has been medicated and with what drug(s), and to withhold the animal from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissue.

You should notify this office in writing within 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 to prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

Your written response should be sent to Dr. Brian D. Garthwaite, Compliance Officer, at the address located on the letterhead. If you have any questions about this letter, please contact Dr. Garthwaite at (612) 758-7132.

Sincerely,

/S/

W. Charles Becoat
Director
Minneapolis District

BDG/ccl