Inspections, Compliance, Enforcement, and Criminal Investigations
Mitchell Farms 26-Apr-05
Department of Health and Human Services
Public Health Service
Atlanta District Office
April 26, 2005
VIA FEDERAL EXPRESS
Horton Mitchell, Owner
927 Mitchell Road
Adairsville, Georgia 30203
Dear Mr. Mitchell:
An investigation of your cattle farm operation by a Food and Drug Administration investigator between December 9, 2004 and February 14, 2005, confirmed that you offered an animal for slaughter as food, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). The animal was adulterated food within the meaning of Sections 402(a)(2)(C)(ii) and 402(a)(4) of the Act, 21 U.S.C. §§ 342(a)(2)(C)(ii) and 342(a)(4). In addition, you were responsible for causing an animal drug product to become adulterated within the meaning of Section 501(a)(5) of the Act, 21 U.S.C. § 351(a)(5).
On or about July 22 2004, you sold a cow, identified with tag #1324, to [redacted]. This cow was sold for slaughter as human food. This cow was subsequently purchased by a cattle dealer that delivered the animal to a packing house in Pennsylvania for slaughter on or about July 23, 2004. The United States Department of Agriculture (USDA)/Food Safety and Inspection Service (FSIS) analysis of tissues collected from that animal (Case No. 8-1032-04) disclosed the presence of high levels of the drug tilmicosin in the liver and muscle tissue . The liver was found to contain 5.24 parts per million (ppm) and the muscle was found to contain .15 ppm of tilmicosin.
The tolerances established for residues of tilmicosin in the liver and muscle tissue of cattle are 1.2 ppm and .1 ppm respectively. The tolerances for tilmicosin are listed in Title 21, Code of Federal regulations (21 CFR), Section 556.735 (copy enclosed). The presence of this drug, at levels above the tolerances, in edible tissue 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 investigation also found that you hold animals under conditions that are likely to allow medicated animals, bearing potentially harmful drug residues, to enter the food supply. For example, you lack an adequate system for assuring that animals which have been treated are withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. Our investigator also found that you had failed to maintain animal medication records that would identify which animal had been medicated, what type of medication had been used, the treatment date, the dosage administered, the route of administration, and what the withdrawal times should be. 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 caused the adulteration of the drug tilmicosin, within the meaning of Section 501(a)(5) of the Act, 21 U.S.C. § 351(a)(5), when you failed to use it in conformance with its approved labeling. For example, [redacted] is a prescription drug but it was not prescribed for your use by a veterinarian. Instead, you received the [redacted] from a farmer as payment for helping treat their cattle. In addition, you failed to follow the labeled withdrawal period . The extralabel use of approved veterinary or human drugs is only allowed if the use complies with Sections 512(a)(4) and 512(a)(5) of the Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 CFR Part 530. Our investigation found that your extralabel use failed to comply with these requirements. For example, you administered the drug without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a), and your extralabel use resulted in an illegal drug residue, in violation of 21 CFR 530.11(c). Because your extra-label use of the drug was not in compliance with 21 CFR Part 530, the drug is unsafe to use 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-identified violations are not intended to be an all-inclusive list of deficiencies at your farm. The investigator issued a list of Inspectional Observations (FDA 483) to you at the conclusion of his visit (copy enclosed). As a producer of animals offered for use as food, you are responsible for assuring that your overall operation and the foods you distribute are in compliance with the law.
You should take prompt action to correct the above deficiencies 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 be aware that it is not necessary for you to have personally shipped an adulterated animal in interstate commerce to be responsible for a violation of the Act. The fact that you caused the adulteration of an animal that is sold and subsequently offered for sale to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for a violation of the Act.
Please notify this office in writing within fifteen (15) working days of receipt of this letter as to the specific steps you have taken to correct the stated violations . You should also include an explanation of each step taken to identify and make corrections to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections wilt be implemented.
Your reply should be sent to the attention of Philip S. Campbell, Compliance Officer, at the address noted in the letterhead.
Mary H. Woleske, Director