Public Health Service
Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
October 9, 2014
WARNING LETTER NO. 2015-NOL-02
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Rex L. Jessee, Co-Owner
Rex L. Jessee
235 Neely Lane
New Tazewell, Tennessee 37825-3132
Dear Mr. Jessee:
On September 3 - 4, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your cattle operation, located at 235 Neely Lane, New Tazewell, Tennessee. 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 through links on FDA’s Internet home page at www.fda.gov.
We found you offered for sale an animal for slaughter as food that was adulterated. Under Section 402(a)(2)(C)(ii) of the Act, [21 United States Code (USC) 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 USC 360b]. Further, under Section 402(a)(4) of the Act, [21 USC 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 18, 2014, you sold a cow, identified with back tag (b)(4), for slaughter as food. On or about February 19, 2014, (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 0.229 parts per million (ppm) of sulfamethazine in the liver tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the liver tissues of cattle, as codified in Title 21, Code of Federal Regulations (CFR), 556.670 (21 CFR 556.670). The presence of this drug in edible tissues from this animal in this amount 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 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 failed to maintain treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, [21 USC 342(a)(4).
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 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 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 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 Kimberly A. Dutzek, Compliance Officer, U.S. Food and Drug Administration, 404 BNA Drive, Building 200, Suite 500, Nashville, Tennessee 37217. If you have any questions regarding this letter, please contact Mrs. Dutzek at (615) 366-7826.