| Public Health Service Food and Drug Administration |
| Chicago District 550 West Jackson Blvd., 15th Floor Chicago, Illinois 60661 Telephone: 312-353-5863 |
Department of Health and Human Services
April 27, 2010
WARNING LETTER
CHI-06-10
CERTIFIED MAIL
RETURN ADDRESS REQUESTED
Michael D. Martin, Owner
Martin Feed Lot
1010 Mitchellsville Road
Harrisburg, Illinois 62946
Dear Mr. Martin:
On December 29, 2009, and January 5, 2010, the U.S Food and Drug Administration (FDA) conducted an investigation of your feed lot operation located at 1010 Mitchellsville Road, Harrisburg Illinois. 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 on the Internet through links on FDA's web page at www.fda.gov.
We found that you offered for sale an animal for slaughter as food that was adulterated. Under Section 402(a)(2)(C)(ii) of the Act [21 U.S.C. 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 U.S.C. 360b. Further, under Section 402(a)(4) of the Act [21 U.S.C. 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 July 7, 2009, you sold a beef heifer, identified with back tag (b)(4) for slaughter as food. On or about July 10, 2009, 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 sulfamethazine at 38.855 parts per million (ppm) in liver tissue and the presence of flunixin at 0.1781 ppm in liver tissue. FDA has established a tolerance of 0.1 ppm for negligible residues of sulfamethazine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Section 556.670 [21 CFR 556.670] and a tolerance of 0.125 ppm (or 125 parts per billion) for residues of flunixin in the liver (the target tissue) of cattle as codified in 21 CFR 556.286. The presence of these drugs in edible tissues from this animal in these amounts 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 so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain complete treatment records. 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)].
We also found that you adulterated the new animal drug flunixin. Specifically, our investigation revealed that you did not use flunixin as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See 21 CFR 530.3(a).
The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with Sections 512(a)(4) and (5) of the Act [21 U.S.C. 360b(a)(4) and (5)], and 21 CFR Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.
Our investigation found that you administered flunixin to a beef heifer, identified with back tag (b)(4) without following the route of administration as indicated in its approved labeling. Your extralabel use of flunixin was not under 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(d). Because your extralabel use of this drug was not in conformance with its approved labeling and did not comply with 21 CFR Part 530, you caused the drug to be 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).
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 Richard Harrison, Director, Compliance Branch, at the address of the letterhead. If you have any questions regarding this letter, please contact Mr. Richard Harrison at 312-596-4220 or via e-mail at RICHARD.HARRISON@FDA.HHS.GOV.
Sincerely,
/S/
Scott J. MacIntire
District Director
Enclosure: FDA-483 dated July 30, 2009
cc: (b)(4)
Illinois Department of Agriculture
Bureau of Animal Health
State Fairgrounds - P.O. Box 19281
Springfield, Illinois 62794-9281
United States Department of Agriculture
Food Safety and Inspection Service
Office of Policy, Program and Employee Development
1299 Farnam Street, Suite 300
Omaha, Nebraska 68102
Attention: Residue Staff
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