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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Lakeview Farms 16-Apr-03

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

Public Health Service
Food and Drug Administration

 

Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612) 33444100
FAX: (612) 3344134


VIA CERTIFIED MAIL
WARNING LETTER
Refer to MIN 03 - 17

April 16, 2003

Mark G. Kohlmann
Owner
Lakeview Farms
W 1392 Highway T
St. Cloud, Wisconsin 53079

Dear Mr. Kohlmann:

An investigation involving your dairy heifer operation located at St. Cloud, WI, conducted by our investigator on February 27 and March 13, 2003, confirmed that you offered an animal 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). On or about August 22, 2002, you sold a heifer (identified with back tag 35GR4072) for slaughter as human food to [redacted] who sold the animal to [redacted] USDA analysis of tissue samples collected from that animal identified the presence of penicillin at 0.18 ppm in the kidney. A tolerance of 0.05 ppm has been established for residues of penicillin in the edible tissues of cattle (Title 2 1, Code of Federal Regulations, Part 556.5 10). The presence of this drug in edible tissue from this animal causes the food to be adulterated within the meaning of Section 402(a)(2)(C)@) of the Act.

Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely 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. By your own admission, you treated a dairy heifer with back tag 35GR4072 with penicillin. You stated that you recorded the drug treatment on a calendar in your barn; however, you threw the calendar away and thus failed to maintain drug treatment records. Foods from animals held under such conditions are adulterated within the meaning of Section 402(a)(4) of the Act.

We are also aware of a January 14,2002, tissue residue violation (sulfadimethoxine at 0.47 ppm in the liver and 0.19 ppm in the muscle) involving a dairy animal identified with back tag no. 460 that was slaughtered at [redacted] USDA/FSIS traced that animal back to your operation. You stated that you did not recall treating any animals with sulfadimethoxine and did not recall the animal in question. However, by your own admission, you did not maintain drug treatment records or traceback records to substantiate those claims.

It is not necessary for you to personally ship an adulterated animal in interstate commerce to be responsible for a violation of the Act. The fact that you caused the adulteration of an animal that was sold and subsequently offered for sale to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for a violation of the Act.

The above 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 ensuring that your overall operation and the food 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, such as seizure and/or injunction, without further notice.

You should notify this office in writing within 15 working days of receipt of this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include each step that has been taken to correct the violations and 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 reply should be addressed to Compliance Officer Timothy G. Philips at the address on the letterhead.

Sincerely,

/s/
W. Charles Becoat
Director
Minneapolis District