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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Paul Rothermel Livestock 21-Oct-08

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

Public Health Service
Food and Drug Administration

 

Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771


WARNING LETTER
(CIN-09-37666-01)

October 21, 2008

Via Federal Express

Paul W. Rothermel, Owner
Paul Rothermel Livestock
184 State Route 44
Hartville, OH 44632

Dear Mr. Rothermel:

On May 9, 2008, the U.S. Food and Drug Administration (FDA) conducted an investigation of your cattle operation located at 184 State Route 44, Hartville, OH 44632. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov.

We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the Act [21 U.S.C. 342(a)(2)(C)(ii)] a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act [21 U.S.C. 360b]. Further, under section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)] a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

Specifically, our investigation revealed that on or about February 20, 2008, you sold a bob veal calf, identified with back tag [(b)(4)] for slaughter as food. On or about February 21, 2008, [(b)(4)] slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of flunixin at 0.425 parts per million (ppm) in liver tissue and 0.035 ppm in muscle tissue. FDA has not established a tolerance for residues of flunixin in the edible tissues of calves. The presence of this drug in edible tissue(s) from this animal in these amounts 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 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 a system to ensure that animals you buy 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. In addition, you fail to keep accurate records of animals you buy and sell to ensure that the animal can be traced back to the producer or other dealer. 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)].

The above is not intended to be an all-inclusive list of violations. As a buyer and seller of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.

You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step 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 of receiving this letter, 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 Mark E. Parmon, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237. If you have any questions about this letter, please contact Compliance Officer Parmon at (513) 679-2700 Ext. 162, or by email at mark.parmon@fda.hhs.gov.

Sincerely yours,

/S/

Toniette K. Williams
Acting District Director
Cincinnati District

cc: Dr. Isabel Arrington, Director TA/C
United States Department of Agriculture (USDA)
Food Safety and Inspection Service (FSIS)
Suite 300 Landmark Center
1299 Farnam Street
Omaha, NE 68102