Inspections, Compliance, Enforcement, and Criminal Investigations
Klutts, Walter J. 18-Oct-05
Department of Health and Human Services
|Public Health Service |
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3145
October 18, 2005
RETURN RECEIPT REQUESTED
Mr. Walter J. Klutts
Rt. 2, Box 232
Okemah, Oklahoma 74859
Dear Mr. Klutts :
An investigation of your cattle buyer/dealer operation conducted by representatives of the U.S. Food and Drug Administration (FDA) on May 3 and 5, 2005, confirmed that you repeatedly offered animals for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. 342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.
As outlined in the table below, you sold four beef cows for slaughter for food at [redacted], where each cow received a unique Back Tag Number. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from these animals identified the presence of the listed drugs for each tissue in which illegal residues were reported. A tolerance has been established for residues of the listed drugs in the edible tissues of cattle as codified in Title 21, Code of Federal Reaulations, Part 556 (21 CFR 556). The presence of me listed drugs at the reported levels in the edible tissues of these animals causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [21 U.S.C. 342(a)(2)(C)(ii)]
Back Tag No.
|Drug||Tissue||Level (ppm)||Tolerance (ppm)||21 CFR 556 (section)|
** 0.125 ppm equals 125 parts per billion
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. As demonstrated in the above table, you lack an adequate system to ensure that medicated animals have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example:
1. You fail to have a system in place that identifies the animals you purchase from individuals or other dealers and allows you to trace the source of the animals and determine from the source whether an animal has been medicated, with what drug(s), dates administered, and the remaining withdrawal period to be observed. Your system should identify individual animals by number or other identifier for this control process. If medicated, an animal should be withheld from slaughter according to the approved withdrawal time to deplete drug residues from the edible tissues of the animal. Your current system does not provide this control.
In addition, our investigation found that you had no information about the origin or producers of the animals, their medical history, or your date of purchase of the animals slaughtered at [redacted] under Back Tag Nos. [redacted] and [redacted]
2. You fail to have a system in place that helps you determine whether the animals you purchase have been treated with drugs or medicated feeds, and if so, the dates and drug(s) used to medicate the animals, and the approved withdrawal period to be observed prior to marketing the animal(s) for slaughter for food. Your current system does not provide this control.
In addition, our investigation found that you made no attempt to contact the producers of the animals purchased at livestock auctions to determine medication treatment history of the animals delivered and slaughtered at [redacted] under Back Tag Nos. [redacted] and [redacted] on March 15, 2005.
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). FDA files and USDA Tissue Residue Data show that you have marketed at least 22 animals that contained illegal residues since January 12, 1989. FDA has previously issued two warning letters to you for offering animals for sale for slaughter that contained illegal residues in their edible tissues. The first warning letter (94-DAL-WL- 54) was issued to you from this office on August 11, 1994. The second warning letter (97-DAL-WL-16) was issued to you on February 13, 1997. Copies of these warning letters are enclosed for your reference.
The above is not intended to be an all-inclusive list of violations. 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.
As a buyer and dealer of animals, you are responsible for ensuring that your overall operation and the food you distribute are in compliance with the law. We recommend that you meet with representatives of the Dallas District Office to discuss the Act's requirements.
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, state the reason for the delay and the time within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made and the date(s) you are available to meet with representatives of the FDA Dallas District Office.
Your response should be sent to James R. Lahar, Compliance Officer at the above letterhead address. If you have any questions about this letter, piease contact Compliance Officer James R. Lahar at 214-253-5219.
Sylvia Y. Yates for Michael A. Chappell