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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Buss, Merle R. 11-Oct-05

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

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, TX 75204-3t45


 


October 11, 2005

Ref: 2006-DAl.-WL-01

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

Mr. Merle R. Buss
dba Rancho, Inc.
P.O. Box 3878
Shawnee, OK 74804-3878

Dear Mr. Buss:

An investigation of your cattle operation located at Shawnee, Oklahoma conducted by representatives of the U.S. Food and Drug Administration (FDA) on May 9 through May 10, 2005 confirmed that you offered an animal 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). The inspection also revealed that you have caused the new animal drug, penicillin G procaine, to become adulterated within the meaning of section 501(a)(5) [21 U.S.C. 351(a)(5)] and unsafe under section 512 of the Act [21 U.S.C. 360b]. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.

On March 7, 2005, you had a red cow delivered by your assistant. Mr. Jimmie Gwartney, to the [redacted] where the animal was identified with the back tag # [redacted] and offered for sale for slaughter. On March 15, 2005, this animal was slaughtered at [redacted] United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from the animal identified the presence of 1.18 parts per million (ppm) penicillin in the kidney tissue of the animal. A tolerance of 0.05 ppm has been established for residues of penicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (21 CFR), Section 556.510. Additionally, the USDA/FSIS analysis of the tissue samples identified the presence of 8.22 ppm sulfamethazine in the liver and 4.10 pprn sulfamethazine in the muscle of the animal. A tolerance of 0.1 ppm has been established for residues of sulfamethazine in in the uncooked edible tissues of cattle, see 21 CFR 556.670.

The presence of these drugs in the edible tissues of this animal 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)].

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. You lack an adequate system to ensure 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. For example, you lack an adequate system for documenting the date, drug administered, dosage, and route of administration for the medical treatment of specific animals, and you lack an adequate system for ensuring that drugs are used in a manner consistent with the directions contained in their labeling. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act t [21 U.S.C. 342 (a)(4)].

In addition, you adulterated penicillin G procaine within the meaning of section 501(a)(5) of the Act when you failed to use the drug in conformance with its approved labeling. "Extralabei use", i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) and 512(a)(5) of the Act and 21 CFR Part 530. Our investigation found that your extralabel use of penicillin G procaine failed to comply with these requirements. For example, you administered the penicillin G procaine without following the withdrawal period set forth in the approved labeling . You did so without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Furthermore, your extralabel use resulted in an illegal drug residue, in violation of 21 CFR 530.11(c). Because your extralabel use of this drug was not in compliance with 21 CFR Part 530, the drug was unsafe under section 512(a) of the Act [21 U.S.C. 360b(a)] and your use caused it to be adulterated within the meaning of section 501 (a)(5) of the Act [21 U.S.C. 351(a)(5))].

Our investigator also observed that you directed Mr. Gwartney to administer three sulfamethazine tablets to this animal the day before it was sold for slaughter. We would like to bring to your attention that sulfamethazine tablets have a ten day slaughter withdrawal time, see 21 CFR 520.2260. In addition, 21 CFR 530.41(a)(9) prohibits the extralabel use of sulfonamide drugs in lactating dairy cattle.

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 above violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice, including seizure and/or injunction.

We are in receipt of your May 16, 2005 written response to the inspection and the inspectional observations, Form FDA-483. Your response does not specify when your proposed corrective actions will be implemented. 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 violation and prevent its recurrence. If corrective action cannot be completed within fifteen (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 response should be sent to James R. Lahar, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, Texas, 75204. If you have any questions about this letter, please contact Compliance Officer, James R. Lahar, at 214-253-5219 or by e-mail at jlahar@ora.fda.gov.

Sincerely yours,

/S/

Michael A. Chappell
Dallas District Director