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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Longhenry Farms 13-Sep-01

DEPARTMENTOF HEALTH & HUMAN SERVICES

Food and Drug Administration

Minneapolis District

240 Hennepin Avenue

Minneapolis MN 55401-1999

Telephone: 612-334-4100

September 13, 2001
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 01-75

Thomas E. Longhenry
Owner
Longhenry Farms
16998 ? 453rd Avenue
Glencoe, Minnesota 55335

Dear Mr. Longhenry:

An investigation at your cattle operation located at Glencoe, MN, conducted by our investigators on July 10, 2001, 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), and that you may have caused animal drugs to become adulterated within the meaning of Section 501(a)(5).

On or about January 29, 2001, you sold a dairy cow, identified with retain tag #42056659, for slaughter as human food at [redacted] USDA analysis of tissue samples collected from that animal identified the presence of tilmicosin in the Liver (4.50 ppm), muscle (1.00 ppm), and kidney (13.40 ppm). A tolerance of 1.2 ppm has been established for residues of tilmicosin in the liver of cattle (Title 21, Code of Federal Regulations, Part 556.735). The USDA analysis also identified the presence of phenylbutazone in the kidney. There is no established tolerance for phenylbutazone in cattle. The presence of these drugs in edible tissue from this animal causes the food to be adulterated.

Our investigation also found that you hold animals under conditions which are so inadequate that diseased animals and/or 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 have been treated only with drugs which have been approved for use in those species, for assuring that drugs are used in a manner not contrary to the directions contained in the labeling, and 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. Foods from animals held under such conditions are adulterated.

You are adulterating the drugs tilmicosin, phenylbutazone and dipyrone within the meaning of Section 501(a)(5) when you fail to use the drugs in conformance with approved labeling. Your use of tilmicosin without following the labeled withdrawal period causes the drug to be unsafe. Your use of phenylbutazone in cattle, a species for which the drug is not approved, causes the drug to be unsafe. Your use of dipyrone, which is not approved for use in my species, causes the drug to be unsafe.

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 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.

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 with a drug that was shipped in interstate commerce is sufficient to hold you responsible for a violation of the Act.

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 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 directed to Compliance Officer Timothy G. Philips at the address indicated on the letterhead.

Sincerely,
Cheryl A. Bigham
Acting Director
Minneapolis District