Inspections, Compliance, Enforcement, and Criminal Investigations
Triple C Cattle Company LLC 28-May-08
Department of Health and Human Services
Public Health Service
Kansas City District
May 28, 2008
RETURN RECEIPT REQUESTED
Ref. KAN 2008-09
John L. and Cheryl E. Charleston
Triple C Cattle Company LLC
9407 County Road 70
Reeds, MO 64859
Dear Mr. and Mrs. Charleston:
An inspection of your culled calf feedlot operation located at 9407 Country Road 70, Reeds, Missouri, conducted by representatives of the U.S. Food and Drug Administration (FDA) on March 26 and 31, 2008, 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 caused Pro-Pen-G Injection (Penicillin G Procaine Injectable Suspension) (NADA 065-505) to become unsafe under section 512(a) of the Act [21 U.S.C. §360b(a)] and adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)]. You can find the Act and its associated regulations on the Internet through Iinks on the FDA's web page at www.fda.gov.
On or about January 17, 2008, you sold a heifer, identified with ear tag" for slaughter as food at (b)(4) where the animal was slaughtered on that same day. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 0.22 pails per million (ppm) of penicillin in the liver. A tolerance of 0.05 ppm has been established for residues of penicillin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Section 556.510 (21 C.F.R. 556.5 10). The presence of this drug in this amount in edible tissues from this animal 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 inspection 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 routinely administer penicillin to animals without following the dosage level set forth in the approved labeling, and you do so without the supervision of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. 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)].
In addition, you adulterated Pro-Pen-G Injection (Penicillin 0 Procaine Injectable Suspension) (NADA 065-505) within the meaning of section 50l(a)(5) of the Act (21 U.S.C. § 351(a)(5)] when you failed to use the drug in conformance with its approved labeling. "Extralabel 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 5l2(a)(4) and 512(a)(5) of the Act [21 U.S.C. § 360b(a)(4) and 21 U.S.C. § 360b(a)(5)] and 21 C.F.R. Part 530. Our investigation found that your extralabel use of Pro-Pen-G Injection (Penicillin G Procaine Injectable Suspension) (NADA 065-505) failed to comply with these requirements.
For example, you administered the Pro-Pen-G Injection (Penicillin G Procaine Injectable Suspension) (NADA 065-505) without following the dosage level set forth in the approved labeling and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your extralabel use of this drug was not in compliance with 21 C.F.R. 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)].
The above is not intended to be an all-inclusive list of violations. We are aware that this is not the first time you have offered animals for slaughter with illegal drug residues. 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 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, 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. You may direct your response to Nadine Nanko Johnson, Compliance Officer, Food and Drug Administration, at the above letterhead address.
John W. Thorsky
Kansas City District
cc: Dr. Shane Brookshire, Director and State Veterinarian
Missouri Department of Agriculture
Division of Animal Health, Dairy & Poultry
1616 Missouri Boulevard
P.O. Box 690
Jefferson City, Missouri 65102
Isabel Arrington, Ph.D., VMO
Director, Technical Assistance/Correlation
USDA Technical Service Center
1299 Farnam Street, Suite 300
Omaha, Nebraska 68102