Inspections, Compliance, Enforcement, and Criminal Investigations
Brady's Angus Farm 16-Mar-05
Department of Health and Human Services
Public Health Service
March 16, 2005
RETURN RECEIPT REOUESTED
Mr. James J. Brady, Owner
Brady's Angus Farm
P.O. Box 1309
La Salle, Illinois 61301
Dear Mr. Brady:
A tissue residue report received by the Food and Drug Administration (FDA) from the United States Department of Agriculture (USDA) reported the presence of an illegal drug residue in a bull owned by your farm. As a follow-up to USDA's finding, our investigator performed an inspection of your Black Angus livestock operation on October 28-29, 2004. The inspection confirmed that you offered an animal for sale for slaughter as food that was adulterated within the meaning of Sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), and that you caused an animal drug to become adulterated within the meaning of section 501(a)(5) of the Act.
A food is adulterated under Section 402(a)(2)(C)(ii) of the Act if it bears or contains a new animal drug that is unsafe within the meaning of Section 512. A bull owned by your farm and culled for slaughter for human food was found to contain illegal residue levels of a drug by the USDA testing. Your use of the drug contrary to the approved labeling and in a manner that does not conform to extralabel use regulations in 21 CFR Part 530 causes the drug to be unsafe under Section 512 of the Act.
On August 25, 2004, a bull from your live stock operation was sold for slaughter as human food to [redacted], which sold the animal for slaughter and food to [redacted]. USDA analysis of tissue samples collected from that animal identified the presence of 58.83 parts per million (ppm) oxytetracycline in the kidney tissue, 9.67 ppm in the liver tissue and 2.75 ppm in the muscle tissue. Tolerance levels for residues of animal drugs in foods are found in Title 21, Code of Federal Regulations, Part 556 (21 CFR 556). The established tolerance for residues of oxytetracycline in cattle is 12 ppm in the kidney, 6 ppm in the liver and 2 ppm in the muscle tissue (21 CFR 556.500). The presence of this drug, at a level above the tolerance, in tissue from the animal causes the food to be adulterated pursuant to Section 402(a)(2)(C)(ii) of the Act.
A food is also adulterated under Section 402(a)(4) of the Act "if it has been prepared, packed, or held under insanitary conditions. . .whereby it may have been rendered injurious to health." As it applies in this case, "insanitary conditions" means that you hold animals which are ultimately offered for sale for slaughter as food under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. As noted on the Form FDA-483 issued to you on October 29, 2004, you do not maintain drug treatment records. Foods from animals held under such conditions are adulterated pursuant to Section 402(a)(4) of the Act.
In addition, you caused the adulteration of the drug oxytetracycline that you use on cattle within the meaning of Section 501(a)(5) when you failed to use the drug in conformance with its approved labeling or the extralabel use regulations at 21 CFR Part 530. Specifically, you used oxytetracycline solution [redacted] but did not withhold the animal from slaughter for the labeled withdrawal time. Your use of the drug contrary to the directions for the labeled withdrawal period causes the drug to be unsafe under Section 512 of the Act and thus adulterated under Section 501(a)(5) of the Act.
The above is not intended as an all-inclusive list of violations. As a producer of animals offered for human consumption, you are responsible for assuring that your overall operation and the food products you produce for distribution are in compliance with the law.
You should take prompt action to correct the violation, and you should establish procedures whereby such violation does not recur. Failure to promptly correct the violation may result in regulatory action without further notice, such as seizure and/or injunction. This letter constitutes notification under the law.
Please advise this office in writing within 15 working days of receipt of this letter of the steps you have taken to bring your firm into compliance with the law. 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, 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 directed to Richard Harrison, Director, Compliance Branch.
Scott J. MacIntire